cyrilzakka/clinical-trials huggingface dataset:
Improving Diagnosis in Idiopathic Cytopenia Using Gene Sequencing

10% of the cases referred to the specialist diagnostic haemato-pathology service at RMH are for cytopenias.

The hypothesis to be tested is that a proportion of patients with idiopathic cytopenias have mutations in myelodysplasic syndrome (MDS)-associated genes. The investigators will sequence a panel of known MDS-associated genes in patient material (bone marrow and blood) that is sent routinely to the diagnostic service where conventional techniques have failed to establish a clear diagnosis. 200 patients with idiopathic cytopenia will be followed up to determine their survival, blood counts and development of acute leukaemia and other haematological malignancies. The clinical outcomes will be correlated with any mutations detected.

Patients with cytopenias will be identified by their local District General Consultant haematologist and consent obtained. A bone marrow sample will be sent to RMH as per usual diagnostic pathway.

Once received at the RMH, an aliquot will be frozen down for sequencing by the Molecular Pathology lab. Only those cases of cytopenia without a specific diagnosis will be the focus of this study.

Results will be fed back to referring consultants with caveats regarding significance.

Patients will undergo telephone follow up and data will also be provided by local consultants.

The investigators will look at overall survival, development of haematological malignancies and full blood count. This will occur annually.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Patients \>= 18 years old
* Life expectancy more than 12 months
* Cytopenia defined as Hb \< 110g/L and/or Neutrophils \<1.5 x109/L and/or Platelets \<100 x109/L

Exclusion Criteria:

* Known haematological malignancy or aplastic anaemia/paroxysmal nocturnal haemoglobinuria
* Cytopenia of known aetiology (after examination of blood film and other investigations have occurred). These include haematinic deficiency (patients unresponsive to appropriate haematinic deficiency may enter the study), autoimmune cytopenias, chronic renal anaemia (for those with isolated anaemia), known haemoglobinopathy (for those with isolated anaemia), chronic viral diseases (Hep B/C/HIV), cytopenias associated with liver disease, cytopenias associated with systemic autoimmune conditions (eg SLE, rheumatoid arthritis), anaemia of chronic disease (for those with isolated anaemia).
* Cytotoxic chemotherapy or other myelosuppressive drugs or radiotherapy within 12 months
* Inadequate bone marrow sample for gene testing
Effect of EECP on Anterior Ischemic Optic Neuropathy

Enhanced External Counterpulsation(EECP) therapy may promote the recovery of visual function by improving the blood perfusion of eyes. The present study aims to investigate the effect of EECP on Anterior Ischemic Optic Neuropathy.

Patients with Anterior Ischemic Optic Neuropathy are randomized into two groups: one group receive standard medical treatment for ischemic optic neuropathy, the other group plus EECP therapy besides standard medical treatment.

Eligibility Criteria:
Inclusion Criteria:

* ischemic optic neuropathy
* within 1 month

Exclusion Criteria:

* Hemorrhagic disease
* thrombophlebitis or infection lesions
* severe hypertensive patients
* Atrial fibrillation
* Aortic regurgitation
MoviPrep® Versus GoLYTELY® Bowel Preparation in Hospitalized Patients Undergoing Colonoscopy

Adequate bowel cleansing is a critical component in the care of hospitalized patients undergoing colonoscopy. However, inpatient status is a well-established risk factor for inadequate bowel preparation. However, few strategies have been rigorously shown to reduce the risk of inadequate bowel preparation. Moreover, inadequate bowel preparation is frequently related to the poor tolerability of high volumes of bowel preparation in the medically complex and comorbid hospitalized population. Low volume bowel preparations have been developed that have been shown to be noninferior compared to high volume bowel preparation with regards to adequacy of bowel preparation but with improved tolerability. However, the use of low volume bowel preparations for colonoscopies have largely been evaluated in the outpatient setting. In this study, we plan to compare rates of adequate bowel preparation and tolerability of a low volume bowel preparation, MoviPrep, compared to standard high volume bowel preparation, GoLYTELY, in hospitalized patients undergoing colonoscopy. This study promises to highlight low volume bowel preparation as a viable and better tolerated alternative to high volume bowel preparation in hospitalized patients which may ultimately decrease delays in inpatient endoscopy as well as hospital length of stay.


Eligibility Criteria:
Inclusion Criteria:

1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Male or female, aged 18 or greater
4. Hospitalized patient scheduled to undergo colonoscopy with bowel preparation (not including preparation with enemas alone)
5. Ability to take bowel preparation and be willing to adhere to the regimen

Exclusion Criteria:

1. Patients presenting to the hospital with ileus, toxic megacolon, evidence of gastrointestinal obstruction
2. Receipt of bowel preparation for other reasons during their hospitalization prior to their colonoscopy
3. Patients with prior significant gastrointestinal surgeries including colonic resection, subtotal colectomy, abdomino-perineal resection, Hartmann's procedure or other similar surgeries involving structure/function of small intestine or colon
4. Unable to give informed consent to the procedure
5. Known glucose-6-phosphate dehydrogenase deficiency
6. Known phenylketonuria
7. Known hypersensitivity to polyethylene glycols or ascorbic acid
8. Patients undergoing colonoscopy for foreign body removal and/or decompression
9. Pregnancy or lactating women
Investigation of Vascular Inflammation in Migraine Using Molecular Nano-imaging and Black Blood Imaging MRI

The investigators aim to investigate inflammation of cranial and meningeal arteries during pharmacologically induced migraine attacks, using ultrasmall superparamagnetic iron oxide (USPIO) nanoparticles and black blood imaging (BBI) MRI.

Migraine is the most common neurological disorder, ranked as the 7th most debilitating disease worldwide by the WHO. While much research has been and continues to be conducted to illuminate the enigma of migraine pathophysiology, key aspects still remain a conundrum. Specifically, the process of headache generation is perhaps the most complex and debated part of migraine pathophysiology. The vascular hypothesis of migraine has traditionally focused on the simple dilatation of cranial arteries. However, a possible contribution of perivascular pain sensitive structures should also be considered, as aseptic inflammation of the arterial walls and perivascular space may activate afferent nerve endings. Interestingly, giant cell arteritis caused by aseptic arterial wall inflammation may present clinically as localized headache with migraine-like features (i.e. throbbing pain, localized in the temporal region, and allodynia).

The primary trigeminal nociceptor is the first integral part of the headache-generating pathway. Animal models of migraine have suggested that activation and sensitization of perivascular trigeminal nociceptors caused by inflammatory substances may explain head pain in migraine. However, there is no human evidence to date to suggest perivascular and arterial wall inflammation as a source of pain in migraine.

The investigators hypothesize that unilateral migraine without aura is associated with ipsilateral inflammation of the cranial arteries and meninges. The investigators also suggest that sumatriptan inhibits this perivascular inflammation. To test the hypotheses the investigators will perform MRI scans on subjects with provoked migraine attacks, using two different methods to visualize perivascular inflammation: USPIO-MRI, using iron-oxide nanoparticles as contrast agent, and BBI MRI.

To pharmacologically induce migraine headache in the study subjects, the investigators will use the drug cilostazol, which is a phosphodiesterase 3 inhibitor.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Subject has migraine without aura according to criteria of the International Headache Society (IHS)
* Subject has unilateral migraine 70% of the time
* Migraine can be pharmacologically provoked in the subject using cilostazol.
* Subject is on birth control
* Subject has no other medical history

Exclusion Criteria:

* Subject suffers from bilateral migraine
* Subject suffers from migraine with aura
* Subject suffers from other primary headaches as specified by IHS criteria
* Pregnant or breast feeding subjects
* Subjects with contraindications for undergoing MRI scans
* Any known drug allergy
* Any signs or disorders of iron overload, including but not limited to hemosiderosis and porphyria cutanea tarda
Comparative Exercise-Induced Hypoalgesia in Upper and Lower Limbs: A Randomized Controlled Trial in Healthy Individuals

This randomized controlled trial with healthy subjects aims to compare exercise-induced hypoalgesia among three groups: one utilizing a lower limb cycle ergometer, another using an upper limb cycle ergometer, and a control group. The exercise protocol involves 30 minutes of aerobic activity at 70-80% of the heart rate reserve. Exercise-induced hypoalgesia will be assessed by measuring pressure pain thresholds in the thigh and elbow. Additionally, a secondary objective is to compare the lower limb and upper limb cycle ergometer groups in terms of their effects on pressure pain thresholds in the thigh and elbow. Thus, the study anticipates observing differences in local and distal hypoalgesia based on the trained region.


Eligibility Criteria:
Inclusion Criteria:

* Asymptomatic subjects aged between 18 and 64 years.

Exclusion Criteria:

* Cardiovascular, respiratory, metabolic, neurological, or osteomuscular signs or pathologies.
* History of epilepsy.
* Pregnant
* Pharmacological treatment.
* Participants who present any type of pain on the day of the measurements or who have frequently suffered pain during the previous 12 weeks.
Use of a Support Bra to Reduce Pain and Improve Surgical Healing in Women Undergoing Sternotomy for Cardiac Surgery

The primary purpose of this study is to examine whether a properly fitted support bra on females improves their quality of life post-sternotomy. Specifically, does a support bra reduce discomfort, pain and wound dehiscence.

Participants will be randomized to one arm of the study. One group will be fitted for a support bra and will be asked to wear this bra 24 hours a day for their 6 week post-course. They will submit to 3 questionnaires (at hospital discharge, at 3 weeks post-op and at their 6 week post-op visit with their surgeon. They will diary over this 6 week period re: pain, comfort, wound healing. The group in the no bra arm will also be measured for breast size and will submit to 3 questionnaires (at the same intervals) and will be asked to diary over their 6 week post-op course re: pain, comfort, wound healing. Chronic pain and quality of life markers will be assessed through a 6month and 1 year follow-up telephone call and questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* Adult women (≥ 18 yrs) who are undergoing cardiac surgery with a sternotomy

Exclusion Criteria:

* Patients who have had a previous mastectomy
* Previous radiotherapy to the chest
* Patients who do not read, write or have issues comprehending English
* Patients with cognitive impairments who will not be able to comply with the research study protocol
* Patients requiring physical restraints
* Patients requiring the application of a sternal binder
Clinical, Metabolic and Endocrine Effects of the Treatment With Drospirenone and Ethinyl Estradiol Alone or in Combination With Myo-inositol in Young Women With Polycystic Ovary Syndrome (PCOS) and Insulin Resistance

Polycystic ovary syndrome (PCOS) is a heterogeneous syndrome with a variety of metabolic and endocrine abnormalities and clinical symptoms.

The primary defect in PCOS consists of an abnormal androgen synthesis and secretion, particularly by ovarian theca cells. Insulin resistance and obesity may act as triggers, explaining the frequent association of PCOS with these metabolic conditions. Hyperinsulinaemia, which results from insulin resistance, stimulates both ovarian and adrenal androgen secretion and suppresses sex hormone-binding globulin synthesis from the liver. It results in an increase in free, biologically active androgens which are related to clinical signs such as hirsutism, acne, seborrhea, and alopecia.

Combined oral contraceptive (COC) therapy is a common treatment for PCOS and it was widely used in this group of patients providing clinical improvement in the areas of excessive hair growth, unpredictable menses, acne, and weight gain.

More recent studies outlined a deficiency in myo-inositol in women with PCOS and insulin-resistance. Myo-inositol is a precursor for many inositol-containing compounds and it plays critical and diverse roles in signal transduction, membrane biogenesis, vesicle trafficking, and chromatin remodeling. It is a precursor in the synthesis of phosphatidylinositol polyphosphates (PIPs) that are a source of several second messengers.

It has been reported that the administration of myo-inositol reduces serum insulin, decreases serum testosterone and enhances ovulation.

Due to the different beneficial actions, the aim of the present study is to evaluate the clinical, metabolic and endocrine effects of treatment with COC (drospirenone and ethinyl estradiol)alone or in combination with myo-inositol, in young women with PCOS and insulin resistance.


Eligibility Criteria:
Inclusion Criteria:

* Women fulfilled two out of three diagnostic criteria for PCOS, according to the 2003 Rotterdam Consensus conference
* Women with PCOS, insulin resistance, acne, hirsutism and seborrhea

Exclusion Criteria:

* Women with pre-existing secondary endocrine disorders
* Women wishing to conceive during the next 12 months
* Women with contradictions to oral contraceptive use
* Women with personal history of hypertension, diabetes mellitus or cardiovascular disorders
* Women who received treatment with oral contraceptives, or other drugs for the previous 6 months before entering the study.
Outcome of Pulpotomy With MTA and Biodentin in Permanent Teeth With Caries Exposure

The success of pulpotomy treatment is affected by the type of biologically active material used.The effects of MTA and biodentine are compared in mature permanent teeth with caries exposure.It is expected that pulpotomy using biodentine will have a high success rate in caries exposed mature teeth compared to mineral trioxide aggregate.


Eligibility Criteria:
Inclusion Criteria:

* mature permanent teeth

Exclusion Criteria:

* Teeth with restorations
Personalized Trial for Chronic Lower Back Pain

The Personalized Trial of Chronic Lower Back Pain will test the feasibility of employing technology to facilitate remote N-of-1 interventions to research participants with self-identified back pain. Participants will spend 14 weeks alternating between massage, yoga, and usual care methods to treat their back pain, while answering daily questions and wearing an activity tracker. After 14 weeks, participants will have the ability to share their opinions about a Personalized Trials platform. We believe a Personalized Trials platform will be satisfactory to participants and feasible to scale to large randomized controlled trials, and eventually to clinical practice.

The Personalized Trial of Chronic Lower Back Pain will facilitate remote N-of-1 interventions to research participants with self-identified back pain persisting longer than 12 weeks. Participants will be randomized in a multiple crossover design to receive Swedish massage in-home by a commercial wellness service, yoga instruction in-home by a commercial wellness service, and no intervention/usual care. Participants will evaluate their pain intensity, pain interference, fatigue and stress daily through self-reported questionnaires. Online screening and enrollment methods, text-message reminders and questionnaire prompts, and wearable devices will be employed to collect data. At the end of the study, participants will receive a personalized report summarizing their observed data in each treatment period. Participants will evaluate the system usability of Personalized Trials, will debrief their experience with a member of the research team, and will share their overall satisfaction with Personalized Trials.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* Fluent in English
* Experiencing symptoms of low back pain for \> 12 weeks
* Self-reported pain intensity \> 8 on the PROMIS pain intensity scale during screening
* Able to receive massage and yoga interventions (2x/week between 8 am and 10 pm)
* Owns and can regularly access a smartphone capable of receiving text messages
* Owns and can regularly access an e-mail account

Exclusion Criteria:

* Pregnant women
* History of spinal surgery
* Complex back pain (e.g. sciatica, spinal stenosis, or other pre-existing condition)
* Previous diagnosis of a serious mental health condition or psychiatric disorder
* Previous diagnosis of opioid use disorder or treatment for any substance use disorder
* Previously advised that yoga or massage is unsafe for their condition
* Current opioid use
* Current physical activity restrictions
* Planned surgery or procedures within 6 months of recruitment
* Planned travel outside the United States within treatment period time-frame
* Weight greater than or equal to 500 lbs.
CHildhood ASthma and Environment Research Study - CHASER Study

"CHildhood ASthma and Environment Research study - CHASER study" is an observational longitudinal study in outpatient clinic of Pediatric Allergology \& Pulmonology (PAP) of Respiratory Disease Research Center (RDRC) within the Institute of Biomedicine and Molecular Immunology (IBIM) of the National Research Council (CNR) of Palermo (RDRC-IBIM CNR), Italy.

The first phase - transversal study will identify determinants of pediatric asthma control

The second phase - longitudinal study, in patients with persistent asthma, will be focused on:

* predictors for asthma exacerbations and loss of control
* real life adherence to asthma therapy guidelines
* phenotypic characterization through the collection of saliva samples
* assessment of alterations and inflammatory changes in the nasal mucosa through nasal brushing
* evaluation of the presence of 8-isoprostane, nicotine, cotinine and bisphenol-A through urine analysis.

Chaser Project is expected to improve the knowledge of pediatric asthma in patients with different level of control, identifying predictors for asthma exacerbations and loss of control.


Eligibility Criteria:
Inclusion Criteria:

* age 5-16 years
* asthma
* not asthma

Exclusion Criteria:

* chest deformity
* active smoking
Effects of SIMEOX on Flow and Volume

This study will investigate the effects of the SIMEOX (an airway clearance device) on flow and volume generated in healthy subjects

This is a pilot study assessing the effect of the SIMEOX device on flow and volume generated in healthy subjects.

Assessment of flow and volume will be performed before and during the application of the SIMEOX. Vital capacity and expiratory flow will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Able to understand the instructions

Exclusion Criteria:

* Obesity (BMI \> 30kg/m²)
* Active smoker
* Severe scoliosis
* Cardiovascular ou neuromuscular disease
Arm Function and Quality of Life Following Mastectomy.

To measure arm function and quality of life of mastectomy patients.

Treatment: Randomized to one of two treatment arms. Group One: Basic active exercise program at home. Group Two: Instruction in the same active exercise program along with additional exercises using exercise equipment and stretching exercises. Range of Motion measurements will be taken at the first session, 1 month, 6 weeks, 3 months, 6 months and 1 year. Patients will complete demographic form, functional questionnaire, and QOL questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have been referred from UNMH to CRTC for further treatment following mastectomy/lumpectomy surgery.

Exclusion Criteria:

* Not specified
Effect of Caffeine Supplementation and Personalized Insoles on Females

Several studies have shown the positive effect that caffeine has on athletic performance related variables. Nonetheless, most studies have been developed in males and have not studied the possible effects on biomechanics and related injuries. Moreover, the inclusion of personalized insoles could also affect biomechanical patterns and thus injury incidence that has shown to be higher when athletes are fatigued. Therefore, the aim of the present randomized controlled trial is to evaluate the effect of fatigue, caffeine supplementation and personalized insoles on biomechanics and athletic performance in female adult soccer players.


Eligibility Criteria:
Inclusion Criteria:

* Females
* Soccer players who have been competing for at least 3 years

Exclusion Criteria:

* Participants with major injuries in the lower limbs within the 12 months before testing.
* Participants consuming ephedrine or related medicines
PET/CT to Identify "Vulnerable" Arterial Plaque

The purpose of this research is to evaluate the presence, location and intensity of FDG uptake in the large arteries using the new technology of fused PET/CT imaging and to compare FDG uptake with the presence of arterial calcifications as seen on the simultaneously acquired CT, in order to determine if FDG was increases incalcified plaque or in a different location in the arterial wall. we will also evaluate the relationship between FDG localization and future cardiovascular events in out patient population


Eligibility Criteria:
Inclusion Criteria:

* Patients referred for clinical FDG-PET/CT studies
* Patients 50 yr or older
* Patients signed informed consent

Exclusion Criteria:

* Patients unable or unwilling to tolerate the scan until its completion
A Study of Tirzepatide (LY3298176) Compared With Dulaglutide on Major Cardiovascular Events in Participants With Type 2 Diabetes

The purpose of the trial is to assess the efficacy and safety of tirzepatide to dulaglutide in participants with type 2 diabetes and increased cardiovascular risk.


Eligibility Criteria:
Inclusion Criteria:

* Have a diagnosis of type 2 diabetes
* Have confirmed atherosclerotic cardiovascular disease
* HbA1c ≥7.0% to ≤10.5%
* Body mass index (BMI) ≥25 kilograms per meter squared (kg/m²)

Exclusion Criteria:

* Have had a major cardiovascular event within the last 60 days
* Have type 1 diabetes mellitus
* Have a history of severe hypoglycemia and/or hypoglycemia unawareness within the last 6 months
* Are currently planning treatment for diabetic retinopathy and/or macular edema
* Currently planning a coronary, carotid, or peripheral artery revascularization
* Have a history of pancreatitis
* Have a history of ketoacidosis or hyperosmolar state/coma
* Have a known clinically significant gastric emptying abnormality, have undergone or currently planning any gastric outlet obstruction, or have undergone or currently planning any gastric bypass (bariatric) surgery or restrictive bariatric surgery
* Have a history of an active or untreated malignancy or are in remission from a clinically significant malignancy for less than 5 years
* Have a family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)
* Have had a blood transfusion or severe blood loss within 90 days prior to screening or have known hematological conditions that may interfere with HbA1c measurement