cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Treatment Satisfaction and Preference for Sumavel DosePro in the Treatment of Migraine

The purpose of the study is to evaluate the treatment satisfaction of subjects using Sumavel DosePro to treat their moderate to severe migraines.

Single arm, open-label, multicenter study to evaluate the treatment satisfaction, treatment confidence, and subject preference for Sumavel DosePro in adult subjects diagnosed with migraines and currently treated with triptans. Subjects will treat up to 4 migraines over a 60 day period and complete migraine diaries and questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* History of 2 to 6 migraine headaches per month
* Migraines should have been present for at least 1 year with age at onset of migraine less than 50 years
* History of 24 hours of freedom between migraine attacks
* Current users of triptan medications
* Able to distinguish interval or other non-migrainous headaches from typical migraine
* General good health

Exclusion Criteria:

* History or symptoms, or signs of ischemic cardiac, cerebrovascular, or peripheral vascular syndromes
* Significant underlying cardiovascular diseases including uncontrolled hypertension
* Hemiplegic or basilar migraine
* History or diagnosis of severe hepatic or renal impairment
* History of epilepsy or seizure or other serious neurologic condition
* History of allergy, anaphylaxis, or hypersensitivity to sumatriptan or any of its components or similar drugs including sulphonamides
* History of scleroderma (systemic sclerosis)
* Pregnant or breastfeeding
* Use of contraindicated prescription medications, monoamine oxidase inhibitors (MAO-A), selective serotonin reuptake inhibitors, or lithium agents
Pilot of Pragmatic Delivery of Behavioral Approaches to Reduce Diabetes Distress in Adults With Type 1 Diabetes

This study is designed to test the feasibility and acceptability of behavioral approaches to reduce diabetes distress ("the expected burdens, concerns, fears, and threats that arise from the challenges of living with diabetes") in adults with type 1 diabetes. This is a pilot study, which will enroll a small group of participants to enroll and give feedback on their experience.

At the study baseline, participants will be randomized to take part in one of two virtual, group-based interventions (the "Primary" intervention) utilizing either an emotions-focused or a problem-solving approach to reduce diabetes distress. After the intervention, participants will attend focus groups and fill out anonymous qualitative surveys to give feedback on their experience. Results of the pilot will inform and improve an upcoming research study of the same design.

The study will test the feasibility and acceptability of two behavioral-based interventions to reduce diabetes distress (DD). The investigators will enroll one cohort (N=15) adults 30 years and older with type 1 diabetes (T1D) and elevated DD from a single clinical site to participate in a 5-week intervention. All interventions and assessments will be delivered in a pragmatic and entirely virtual format.

The investigators will compare two evidence-based, virtual group interventions to reduce DD in adults with T1D. The study includes a randomization to one of two 5-week Primary Interventions: "ReCharge", an Acceptance and Commitment Therapy (ACT)-focused approach that will help to reduce the emotional burden of diabetes management; or "TakeCharge", a problem-solving focused approach that will equip participants with new skills to manage type 1 diabetes.

After the 5-week intervention period, participants will provide final outcome data and feedback on their experience using surveys and focus groups. Quantitative and quantitative results will be used to improve the intervention prior to rollout of a longer-term trial of the same design. Long-term data will be collected at 12-weeks post enrollment.

Eligibility Criteria:
Inclusion Criteria:

* Adults 30 years and older
* Type 1 diabetes OR latent autoimmune diabetes in adults (LADA) clinically managed as type 1 diabetes
* Elevated diabetes distress, defined as a score \>= 2.0 on the T1-DDAS core scale
* English speaking

Exclusion Criteria:

* Does not receive diabetes care at UNC Endocrinology at Eastowne
* Cannot commit to the pre-scheduled weekly, virtual sessions
* Diagnosis of any major medical or psychiatric condition that would preclude participation
* Diagnosis of dementia or other conditions that affect memory or information retention, such as cognitive impairment
* Visual or auditory impairment that would interfere with participation in a group intervention
* Receiving inpatient psychiatric treatment or history of a suicide attempt within the past 12 months at the time of enrollment
LaCE (Lactobacillus Paracasei LPB27 On Early Childhood Eczema)

The LaCE study is a double-blind, randomised, placebo-controlled trial examining the effectiveness of the probiotic Lactobacillus paracasei LPB27 in treating eczema in young children.

Childhood eczema is a common and chronic, relapsing disease of the skin which affects up to 20% of the paediatric population. Eczema has significant impact on the quality of life of those affected. Its main symptoms are dry skin and intense itching.

There is currently no cure for eczema but there are treatments that try to relieve symptoms. These commonly include topical moisturisers and topical corticosteroids.

Although topical corticosteroids are effective in minimising symptoms, there is a prevailing and universal fear of using topical corticosteroids which is one of the main reasons for poor treatment compliance.

There have been emerging interests in prevention and treatment of eczema through modulation of the gut microbiome. The gut microbiome is a key regulator for the immune system and there is evidence that the composition of gut microbiome may reduce allergies by driving maturation of the immune system. It was shown that people with eczema have different bacteria in their gut compared to people without eczema. Therefore, this study's hypothesis is that administration of oral probiotics will benefit young children with eczema by improving their gut microbiome and quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Age: 3 months to 3 years old
* Diagnosis: Eczema (atopic dermatitis) diagnosed clinically by a paediatric dermatologist or immunologist.
* Severity: Investigator Global Assessment for Atopic Dermatitis (IGA) severity of 1-3 (almost clear, mild, moderate) and a SCORAD score greater than 8.7.
* Willingness and ability of the subject to comply with the protocol requirements.

Exclusion Criteria:

* Patients on systemic immunosuppression and/or biologic agents (participants who start systemic immunosuppression and/or biologic agents mid-way through the study will be considered to have not achieved treatment success and will be withdrawn, regardless of their SCORAD index scores).
* Mothers who are breastfeeding and on probiotics but not willing to stop probiotics.
* Child already on probiotics and parents not willing to stop during the entire study period (washout period of 4 weeks; including formulas that contains probiotics).
* Eczema complicated by active skin infection e.g. impetigo/cellulitis/ eczema herpeticum (can be considered once active infection resolved).
* Child currently on oral or IV antibiotics (washout period of 4 weeks allowable once antibiotics completed). Participants who require antibiotics after being enrolled in the study may continue on the study as usual.
* Immunodeficient disorders.
* Chronic disorder involving the gastrointestinal tract (e.g., inflammatory bowel disease, short gut syndrome, cystic fibrosis).
* Known hypersensitivity to components contained in study product.
Sentence Production Training in Aphasia

This project focuses on developing a novel treatment for sentence production and comprehension in aphasia, using implicit priming. First set of experiments will aim examine which learning conditions are most effective in creating maximal training gains. Then, in a later study, the investigators will develop and test the efficacy of a novel treatment study based on findings from the first set of the studies.

Over five years, the investigators will conduct a series of studies to develop a novel intervention strategy for improving sentence production and comprehension in persons with aphasia. Specifically, the investigators will use implicit learning of grammar as a novel facilitator for language recovery in aphasia. The planned studies seek to test the hypothesis that implicit learning alters the central language system in PWA, creating lasting and generalized improvements in both sentence production and comprehension. Aim 1 will determine the extent to which different learning conditions modulate immediate and long-term improvement in sentence production. The investigators integrate multiple theories of language learning and apply them to make predictions about the trajectory of priming-induced learning in PWA. In Aim 2, using a set of eyetracking and sentence comprehension tasks, it will be investigated whether the effects of priming in production generalize to off-line (accuracy) and on-line (eye fixations) sentence comprehension and determine which learning conditions result in greater cross-modality generalization. In Aim 3, the investigators will develop and establish Phase I efficacy data of an implicit priming treatment, incorporating the crucial learning conditions supporting maximal retention from Aims 1 and 2. The project will recruit both individuals with aphasia and without aphasia.

Eligibility Criteria:
Inclusion Criteria:

* Individuals with post-stroke aphasia
* At least 6 months post-onset of eft hemisphere stroke
* Native speaker of English
* Normal or corrected to normal hearing and vision
* High-school educated
* Difficulty communicating in sentences, with some ability to use words independently

Exclusion Criteria:

* Severe apraxia of speech
* Other neurological conditions affecting communication (e.g., dementia)
* Uncontrolled psychiatric/psychological conditions affecting thinking and communication
* Active alcohol/substance abuse
Study of NOTES-TME Versus L-LAR in Rectal Cancer

INTRODUCTION: Transanal TME (T-TME) combined with laparoscopy, called hybrid-NOTES, is a less invasive procedure that responds to some of the limitations of the rectal laparoscopic approach.

MAIN OBJECTIVE: To analyze that the T-TME gets a faster recovery due to a lower conversion rate to open surgery than laparoscopic low anterior resection (L-LAR) in rectal cancer with the same pathological, functional and oncologic results.

METHODOLOGY: A prospective multicenter randomized controlled study of patients with rectal cancer that, were randomized in the T-TME- and L-LAR group. The main variables are: general morbidity, anastomotic dehiscence, conversion rate to open surgery and hospital stay. The sample calculation is 58 patients per group.

INTRODUCTION: The laparoscopic total mesorectal excision (TME) has provided better patient recovery with less morbidity and shorter hospital stay compared with open surgery. However in laparoscopic low rectal surgery, overall conversion to open surgery is around 20%. Transanal TME (T-TME) combined with laparoscopy, called hybrid-NOTES, is a less invasive procedure that responds to some of the limitations of the rectal laparoscopic approach.

MAIN OBJECTIVE: To analyze that the T-TME gets a faster recovery due to a lower conversion rate to open surgery than laparoscopic low anterior resection (L-LAR) in rectal cancer with the same pathological, functional and oncologic results.

METHODOLOGY: A prospective multicenter randomized controlled study of patients diagnosed with adenocarcinoma of the rectum that after inclusion and exclusion criteria, were randomized in the T-TME- and L-LAR group. The main variables are: general morbidity, anastomotic dehiscence, conversion rate to open surgery and hospital stay. The other variables studied were: demographic, surgical, pathological, 30-day morbidity and mortality, quality of life and oncologic results. The sample calculation is 53 patients per group. With an estimated loss of 10%, the final number will be 116 patients.

Eligibility Criteria:
Inclusion Criteria:

* Age over 18 years
* Patients with rectal cancer stage: cT1-2-3, cN0-1, cM0.
* Tumor equal or below 10 cm from the anal verge, candidates to (ETM) low anterior resection and anastomosis, with or without preoperative chemo-radiotherapy.
* Adenocarcinoma of low or moderate differentiation
* ASA I, II, III.

Exclusion Criteria:

* Do not sign informed consent
* Pregnant patients
* Liver cirrhosis
* Undifferentiated adenocarcinoma.
* cT4
* Metastatic disease (M1)
* chronic renal failure on dialysis
* ASA IV
* BMI \<18 and\> 35 kg / m2
The Cerebellum as a Potential Treatment Site for PD Motor Symptoms

The role of the cerebello-thalamo-cortical loop in the generation of tremor, gait impairments and postural instability has been made evident. The current study will use a Magstim Rapid 2 to deliver rTMS with the aim of modulating the activity in the vermal/paravermal region of the cerebellum, and consequently the cerebello-thalamo-cortical pathway. Analysis of the effects of an acute session of stimulation will be made to determine the therapeutic potential of the protocol. Motor symptom improvement will be assessed immediately following stimulation to detect motor symptom improvement up to one hour following stimulation, providing insight into the effectiveness of the protocol to produce benefits which outlast the period of stimulation.

Participants will each receive one session of stimulation in the ON state of medication. A pre-assessment will be performed before beginning the session and a post-assessment will be performed immediately following stimulation. There will be two groups, which will both undergo the exact same protocol, however one group will receive real stimulation, and one group will receive sham stimulation.


Eligibility Criteria:
Inclusion Criteria:

* diagnosed with idiopathic Parkinson's disease
* ability to walk 10 metres unassisted
* ability to stand for 5 minutes unassisted
* understand verbal instructions in English

Exclusion Criteria:

* presence of brain implants (aneurysm clips, deep brain stimulation electrodes)
* cochlear implants
* diagnosed with vascular Parkinson's disease
* history or increased risk of seizure
* severe dyskinesia of neck muscles
Experiences and Perceptions of Colonoscopy and New Technologies

Bowel cancer is the 3rd most common cancer in males and females. Most bowel cancers develop from precancerous polyps in the bowel. Colonoscopy can detect and remove these polyps, thereby reducing the risk of developing bowel cancer. However, colonoscopy is an invasive procedure with inherent risk, and can be both uncomfortable and embarrassing to undergo. The risks and numerous other barriers often mean colonoscopy, and cancer preventing polyp removal, is not performed.

The investigators aim to start the first in-human feasibility clinical investigation of a robotic magnetic colonoscope in 2021. The new device aims to reduce the discomfort and risk associated with colonoscopy. As part of the patient and end user involvement aspect of the project the investigators aim to perform a mixed methodology inductive type research project exploring experiences of colonoscopy for patient and endoscopists.

The study will follow an exploratory mixed methodology format with two parallel work-streams for patients and endoscopists. Each work-stream will consisting of a focus groups (1-2 for each patients and endoscopists), followed by 20 endoscopist and 30 patient in-depth interviews, then an online questionnaire. Each stage will be thematically analysed to form the semi-structured questions for the next stage. The target population will be endoscopists who perform colonoscopy and people who have undergone, or refused to undergo, a colonoscopy. Focus groups will be performed in groups of 6-10 participants, and both interview and focus groups will be performed via video/teleconferencing.


Eligibility Criteria:
Inclusion Criteria:

One of:

* undergone a colonoscopy
* offered a colonoscopy but declined
* perform or training to perform colonoscopy

Exclusion Criteria:

* Non-English speaking
* Unable to comply with any study requirements
* New or ongoing diagnosis of bowel cancer
Assessing PTSD After Earthquake in Turkey

Assessing the prevalence and natural course of PTSD after the 1999 Turkish earthquake


Eligibility Criteria:
Inclusion Criteria:

* People were in the earthquake area while it occured

Exclusion Criteria:

* People were not in the earthquake area while it occured
Evaluation of Investigational Hearing Instrument Features

The goal of this clinical trial is to learn how hearing instruments perform in varying environmental settings in adults with hearing loss. The main questions it aims to answer are:

How do varying versions of hearing instrument features perform based on exposure to different environments? What is the hearing instrument user preference between varying versions of hearing instrument features?

Participants will be fit with hearing instruments in the lab, and asked to wear them for the duration of the study period in their home environment. Participants will be asked to answer questionnaires throughout the study period.


Eligibility Criteria:
Inclusion Criteria:

* Adult, age 18 - 95 years
* N4 hearing loss
* Experienced hearing aid user
* English fluency
* Cognitively able to complete complex listening tasks

Exclusion Criteria:

* Normal hearing, or hearing loss outside the specified range
* No hearing aid experience
* Unable to speak, read, or write English fluently
* Cognitive impairment
* Any other condition or situation that impacts eligibility to participate in or complete study tasks, at the discretion of the investigator
To Assess the Effects of Valsartan on Albuminuria/Proteinuria in Hypertensive Patients With Type 2 Diabetes Mellitus

This study is designed to assess the efficacy of the different dosage forms of Valsartan\[80, 160, and 320 mg\] in reducing microalbuminuria/proteinuria in hypertensive patients with type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Males or females aged 35 to 75.
* Type 2 diabetes mellitus (DM) patients coupled with hypertension \[sitting systolic blood pressure (SSBP) 140-179 mm Hg and/or SDBP 90-109 mm Hg\].
* Urinary albumin creatinine Ratio (UACR)) indicating microalbuminuria/proteinuria \[30-1000 mg/g or 2.5-25 mg/mmol\]
* Body mass index (BMI) \<40 kg/m2
* Patients who will sign an informed consent.

Exclusion Criteria

* Type 1 DM
* All causes of secondary diabetes mellitus
* Women of childbearing potential who refuse to use contraception.
* Pregnant or lactating females.
* Severe hypertension \[SSBP\> 180 mmHg, sitting diastolic blood pressure (SDBP) \> 110 mmHg \]
* Patients who are on combo therapy to control BP
* Patients who are already on Valsartan.
* Hypersensitivity to Valsartan.
* Renal artery stenosis \[ unilateral or bilateral\]
* Patients taking β blockers, (Angiotensin Converting Enzyme Inhibitor (ACEI) or spironolactone
* Heart Failure
* History of myocardial infarction, Percutaneous Transluminal Coronary Angioplasty(PTCA) or cerebrovascular accident within the preceding 3 months.
* Creatinine levels \> 1.4 mg/dl \[ 0.07mmol/l\]. Liver enzymes \> 2 times Upper Limit of the Normal Range(ULN). Diabetic keto-acidosis (DKA) within the last 6 months. Presence of diabetic neuropathy or retinopathy. Diabetic foot complications. Presence of infection at time of screening. Hyperkalemia (serum K+ \> 5.5 mmol/L)
Study of Ceftazidime-Avibactam Blood Concentrations in Intensive Care Unit Patients With Renal Failure Requiring Continuous Dialysis

The study's primary objective is to determine plasma and dialysis fluid concentrations in patients prescribed ceftazidime-avibactam as the standard treatment for their infection and requiring continuous venovenous hemodiafiltration (CVVHDF) as part of the standard treatment for acute or chronic renal failure. Secondarily, the study will evaluate the pharmacokinetics of ceftazidime-avibactam in these patients on CVVHDF. The study will also determine if the prescribed dose meets pharmacodynamic targets.


Eligibility Criteria:
Inclusion Criteria:

* Adults \> 18 years of age
* Patients requiring continuous renal replacement therapy (CRRT) due to acute or chronic renal failure
* documented or suspected infection requiring a prescription for ceftazidime-avibactam

Exclusion Criteria:

* Patients on CRRT \< 24 hours
* Patients on ceftazidime-avibactam \< 24 hours
* Patients unable to remain on CRRT for 32 hours continuously without clotting
Efficacy and Safety of SPD417 in Treatment of Manic Symptoms in Adults With Bipolar I Disorder

The purpose of this study is to compare the efficacy and safety of SPD417 in treating bipolar manic symptoms, when given once daily in the evening vs. twice daily.


Eligibility Criteria:
Inclusion Criteria:

* DSM-IV criteria for bipolar I disorder
* Screen YMRS score =\> 16
* Women of childbearing potential agree to take adequate precautions against contraception

Exclusion Criteria:

* Hospitalization required for treatment of psychiatric symptoms
* Patients who meet DSM-IV for ultra-rapid cycling
* History of serious suicide attempt requiring medical intervention
Genetic Expression and Prediction of Response to Neoadjuvant Docetaxel or Doxorubicin in Locally Advanced Breast Cancer

After a core biopsy of the tumor is obtained, patients with locally advanced breast cancer are randomized to receive 4 cycles of full dose doxorubicin (75 mg/m2 e3w) or docetaxel (100 mg/m2 e3w). After the fourth cycle, patients are submitted to surgery to ascertain pathological response. They then receive the opposite drug, hormones, Herceptin, and radiation as indicated.

The aim of the study is to define the genetic signature which predicts the response to single drug doxorubicin versus docetaxel. 250 patients will be included. cDNA microarrays will be produced and the genetic pattern will be correlated with the response to doxorubicin and docetaxel. Secondary aim is the prediction of response by means of IHC determinations (her2, ER, PgR, Ki67, protein TAU), FISH (topoisomerase II alpha, her2) and PCR (topoisomerase II alpha).

Eligibility Criteria:
Inclusion Criteria:

* Locally advanced, inoperable breast carcinoma or stage II not amenable to breast preserving surgery (amendment introduced on november 2006)
* Signed informed consent

Exclusion Criteria:

* Age \>75
* Cardiac disease; LEFT \<50%
* Hyperbilirubinemia