cyrilzakka/clinical-trials huggingface dataset:
Chromoendoscopy in Inflammatory Bowel Disease

Patients with longstanding ulcerative colitis (inflammatory bowel disease, IBD) have increased risk of developing colorectal cancer (CRC) when compared with that of the general population. Therefore patients with longstanding colitis undergo regular screening colonoscopy at varied time intervals depending on their individual risk. This is thought to detect early mucosal (interior bowel lining) abnormalities, known as dysplasia, which can progress to CRC. Until recently, IBD surveillance has relied upon colonoscopy with multiple (at least 33) random biopsies of the bowel lining to detect dysplasia, but now international guidelines recommended a technique called chromoendoscopy.

Chromoendoscopy involves applying a dye, called indigo-carmine, to the bowel lining whilst performing colonoscopy which highlights more subtle abnormalities, therefore increasing dysplasia detection rate.

There is no standard international concentration of the dye spray used during chromoendoscopy. Studies have used different concentrations of indigo-carmine dye ranging from 0.1 to 0.4%. We have recently shown that 0.2% dye improves detection rates compared to high definition white light. The recent international SCENIC guidelines suggest using 0.03% indigo-carmine via a foot pump. However there are no trials comparing the two methods and no previous trials have used the 0.03%. We therefore aim to perform a randomised control trial, comparing 0.03% indigo-carmine dye versus 0.2% in detecting dysplasia in patients undergoing surveillance colonoscopy in IBD. Any lesions seen will assessed using standard endoscopic appearance but also using optical biopsy forceps to further characterise the lesion, then manage the lesion as standard guidelines. We will also take two additional rectal biopsies, which will be snap frozen in liquid nitrogen and then studied using Raman Spectroscopy, Infra Red spectroscopy and electrochemical impedance to develop optical markers to identify patients at higher risk of dysplasia.


Eligibility Criteria:
Inclusion Criteria:

* 1) Patients with longstanding (more than 8 years of disease), extensive (extending proximal to splenic flexure) colitis attending for surveillance colonoscopy. 2) Patients aged over 18 years of age 3) Patients with Primary Sclerosing Cholangitis and Inflammatory Bowel Disease colitis.

Exclusion Criteria:

* 1) Pregnant 2) Unwilling or unable to give informed consent 3) Severe active colitis 4) Poor bowel preparation 5) Unable to reach the caecum
Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection

This study will evaluate efficacy and safety information about RBX2660 for the treatment of recurrent Clostridium difficile infection (CDI), and will compare the efficacy of one treatment with RBX2660 versus antibiotic-treated historical controls. Enrolled subjects will receive one treatment consisting of two doses of RBX2660 (microbiota suspension).

This is a prospective, multicenter, open-label study assessing the efficacy and safety of RBX2660 as an adjunct to antibiotics for the treatment of recurrent CDI. Efficacy of RBX2660, measured by the recurrence-free rate of CDI diarrhea without the need for retreatment with C. difficile anti-infective therapy or fecal transplant through 56 days after completion of study treatment with RBX2660, will be evaluated by comparing the recurrence-free rate observed in the study population to the recurrence-free rate identified from antibiotic-treated historical controls.

Patients who have had either a) at least two recurrences after a primary episode (i.e., at least three episodes) and have completed at least two rounds of standard-of-care oral antibiotics or b) have had at least two episodes of severe CDI resulting in hospitalization may be eligible to participate in the study. Study visits are 1- and 8-weeks after treatment with additional follow-up assessments at 3,6,12, and 24 months post treatment.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years old.
* Medical record documentation of recurrent CDI including a positive C. difficile test within 60 days prior to enrollment and either: a) at least two recurrences after a primary episode and has completed at least two rounds of standard-of-care oral antibiotic therapy or b) has had at least two episodes of severe CDI resulting in hospitalization.
* Documented history that the subject's recurrent CDI is controlled while on antibiotics even if the subject is not currently on antibiotics.
* A positive stool test for the presence of C. difficile within 60 days prior to enrollment

Exclusion Criteria:

* A known history of continued CDI diarrhea despite being on a course of antibiotics prescribed for CDI treatment.
* Requires continuous antibiotic therapy for a condition other than CDI.
* Previous successful (resolution of CDI diarrhea) fecal transplant for recurrent CDI \< 6 months prior to study enrollment.
* Previous unsuccessful (recurrent CDI diarrhea was unresolved) fecal transplant.
* Previous treatment with RBX2660.
* Diagnosis of inflammatory bowel disease (IBD), e.g., ulcerative colitis, Crohn's disease, or microscopic colitis.
* Diagnosis of irritable bowel syndrome (IBS) as determined by Rome III criteria.
* History of chronic diarrhea.
* History of celiac disease.
* Disease symptoms caused by a confirmed intestinal pathogen other than C. difficile.
* Colostomy.
* Planned surgery requiring perioperative antibiotics within 3 months of study enrollment.
* Life expectancy of \< 12 months.
* Compromised immune system
Efficacy of Silodosin in the Treatment of Symptomatic Benign Prostatic Hyperplasia (BPH)

In this study the investigators had evaluated the effectiveness SILODOSIN (8 mg daily orally) in Benign prostatic Hyperplasia in comparison to Tamsulosin (0.4 mg daily orally) in a randomized controlled trial design. Study population would be patients attending Urology OPD of BSMMU Hospital, Dhaka. Target sample size will be 136 evaluable patients in each group (assuming dropout rate 20%), suffering from Benign prostatic Hyperplasia .Subjects would be observed for 1 week without any drug. At the end of 1 week, they would be randomly allocated to Silodosin or Tamsulosin and treatment continued for 12 weeks. Interim follow-up visits would be at 1,4 and 12 weeks. USG confirmation of BPH would be required for recruitment. Effectiveness of the drugs would be assessed by International Prostate Symptom score, a quality of life (QoL) assessment done by a 7-point scale. Prostate weight/volume determination by USG, Change in post voidal residual urine (PVR) by USG and Changes in peak urine flow rate by uroflowmetry. Safety would be assessed by following up vital signs, treatment emergent adverse events and routine laboratory tests for drug safety.

Benign prostatic hyperplasia (BPH) is the most common cause of lower urinary tract symptoms in elderly men. Selective α1-adrenergic antagonists are now ﬁrst-line drugs in the medical management of BPH. This Hospital based randomized controlled clinical study designed to evaluate the efficacy of the new α1-blocker silodosin in the treatment of symptomatic benign prostatic hyperplasia (BPH).Ambulatory patients of age between 50 to 70 years, who were diagnosed as benign prostatic hyperplasia, were divided into two groups after fulfilling selection criteria. After informed consent \& random sampling by lottery, silodosin 8 mg was given to group A (study) \& tamsulosin 0.4 mg was given to group B (control). Total 149 patients were enrolled in this study but 8 patients were lost during follow up. Hence 141 patients completed the study, during the period of June 2017 to August 2018.

Eligibility Criteria:
Inclusion Criteria:

* Ambulatory male patients between 50 to 70 years and had diagnosis of lower urinary tract symptoms associated with benign prostatic hyperplasia (BPH)
* International prostate symptoms score (IPSS)≥ 8
* Peak urinary flow rate (Qmax)\<15ml/sec for a voided volume of 150 ml or more
* Post voidal residual urine volume ≥ 50 ml (by transabdominal ultrasonogram)
* Volume of prostate determine by transabdominal ultrasonogram ≥ 30 gm

Exclusion Criteria:

* History of prostate cancer/raised PSA\>4 ng/ml
* Previous prostate surgery /Periurethral surgery.
* Patient undergone surgery to the bladder neck/Bladder neck contracture.
* Urethral stricture
* History of LUTS not due to benign prostatic hyperplasia (BPH).
* Postvoid residual urine volume of \>150ml
* Bladder stone
* Active urinary tract infection which might affect micturition
* Large intravesical protrusion \> 2 cm
* Known hypersensitivity or history of active substance abuse
Periodontal and Salivary Evaluation of Type 1 Diabetes Mellitus Patients

Diabetes Mellitus is a risk factor for periodontal disease increasing its prevalence, extension and severity. Periodontal disease is considered the sixth complication of diabetes. There is a global epidemic of diabetes, including an increase of incidence of type 1 diabetes in younger patients. Thus, the aim of this observational study was to evaluate the periodontal and salivary condition of a sample of patients with type 1 diabetes of a brazillian city.


Eligibility Criteria:
Inclusion Criteria:

* Diagnose of Type 1 diabetes mellitus
* Age between 18 and 35 years old
* Presenting on tooth per quadrant

Exclusion Criteria:

* Diagnose of Type 2 diabetes mellitus
* Edentulous patients
* Other systemic diseases
Modafinil for Atypical Depression

The purposes of the study are to: 1) evaluate the short-term efficacy and safety of modafinil in atypical depression; and 2) to evaluate the efficacy of modafinil in preventing relapse of atypical depression. The hypothesis is that modafinil is safe and effective in the treatment of atypical depression.

This study on the safety and efficacy of modafinil on atypical depression has an initial 12-week open label treatment period with modafinil that is followed by a 12-week double-blind, randomized parallel treatment period with either modafinil or matching placebo. Patients who demonstrate at least minimal improvement after 12 weeks are randomly assigned to either continuing treatment at their current dose or switched to matching placebo for 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* adults 18-65 years of age
* DSM-IV criteria for major depressive episode with atypical features as assessed by the Atypical Depression Diagnostic Scale
* minimum score of 18 on the Hamilton Depression Scale (29-item version) at baseline
* baseline Clinical Global Impressions Severity score of 4 or more
* written informed consent
* negative serum pregnancy test for women of childbearing potential

Exclusion Criteria:

* any current primary DSM-IV Axis I disorder other than depression
* history of DSM-IV diagnosis of bipolar I disorder, schizophrenia or other psychotic disorder, mental retardation or other pervasive developmental disorder, or cognitive disorder due to a general medical condition
* history of substance abuse or dependence within the last 3 months
* suicide risk or serious suicide attempt with the last year
* clinically significant medical condition or laboratory or EKG abnormality
* history of non-response to three prior adequate trials of antidepressants
* women of childbearing potential who are unwilling to practice an acceptable method of contraception
* history of hypersensitivity to modafinil
* use of an investigational medication within the last 28 days
* use of antidepressant medication with 28 days of screening
PROTECTED TAVR: Stroke PROTECTion With SEntinel During Transcatheter Aortic Valve Replacement

To demonstrate that use of the Sentinel® Cerebral Protection System significantly reduces the risk of peri-procedural stroke (≤72 hours) after transcatheter aortic valve replacement (TAVR).


Eligibility Criteria:
Inclusion Criteria:

* Subject has documented aortic valve stenosis and is treated with an approved TAVR device via transfemoral access
* Subject has the recommended artery diameter at the site of filter placement per the Sentinel® Cerebral Protection System Instructions For Use: 9-15 mm for the brachiocephalic artery and 6.5-10 mm in the left common carotid artery.
* Subject (or legal representative) provides written informed consent.

Exclusion Criteria:

* Subject has arterial stenosis \>70% in either the left common carotid artery or the brachiocephalic artery.
* Subject's brachiocephalic or left carotid artery reveals significant stenosis, ectasia, dissection, or aneurysm at the aortic ostium or within 3 cm of the aortic ostium.
* Subject has compromised blood flow to the right upper extremity.
* Subject has access vessels with excessive tortuosity.
* Subject has uncorrected bleeding disorders.
* Subject is contraindicated for anticoagulant and antiplatelet therapy.
Accuracy of Oximeters With Hypoxia and Methemoglobin or Carboxyhemoglobin

Accuracy of the oximeter.

The conventional pulse oximeter has been a standard in clinical care for non-invasive hemodynamic monitoring, which only measures the arterial blood oxygenation. There are many clinical situations where tissue hypoxia may exist despite normal values obtained by conventional pulse oximeter. This can be cause by inadequate monitoring of oxygen demand (i.e. venous oxygen saturation) of the tissues.

The existing method for venous blood oxygenation monitored is either through an invasive fiber optic catheter, or intermittently by blood sampling and CO-oximetry. However, catheterization can be costly and can include inherent risks. Therefore, due to the inherent risks of catheterization, venous oximetry is limited only to those critically ill patients. The clinical application of venous oximetry is numerous, including severe sepsis and septic shock, severe trauma and hemorrhagic shock, and heart failure and cardiac arrest.

More complete information on patient hemodynamics can be provided by non-invasively monitoring of venous blood oxygenation.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers between the ages of 21 and 49 years of either gender

Exclusion Criteria:

* smokers
* pregnancy
* any chronic medical condition including heart disease, hypertension, pulmonary disease, liver or kidney disease
* obesity
* evidence of abnormal neck vein anatomy
A Study of Ipatasertib (GDC-0068) in Combination With Fluoropyrimidine Plus Oxaliplatin in Participants With Advanced or Metastatic Gastric or Gastroesophageal Junction Cancer

This multicenter, randomized, double-blind, placebo-controlled study will evaluate the efficacy of ipatasertib in combination with oxaliplatin, 5-fluorouracil, and leucovorin (modified FOLFOX6 \[mFOLFOX6\]) chemotherapy in participants with advanced or metastatic gastric or gastroesophageal junction (GEJ) cancer. Participants will be randomized to receive either ipatasertib or placebo orally daily on Days 1 to 7 of each 14-day cycle in combination with mFOLFOX6 on Day 1 of each cycle.


Eligibility Criteria:
Inclusion Criteria:

* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Histologically documented, inoperable locally advanced or metastatic or recurrent gastric/GEJ adenocarcinoma, not amenable to curative therapy
* Measurable disease, according to RECIST v1.1
* Life expectancy greater than or equal to (\>/=) 12 weeks
* Adequate hematologic and organ function

Exclusion Criteria:

* Previous chemotherapy for inoperable locally advanced or metastatic gastric/GEJ adenocarcinoma. Participants may have received prior neoadjuvant or adjuvant chemotherapy and/or radiation treatment for locally advanced gastric/GEJ adenocarcinoma, provided all treatments were completed \>/= 6 months prior to randomization.
* Known human epidermal growth factor receptor 2 (HER2)-positive gastric/GEJ adenocarcinoma
* Radiation treatment within 28 days of randomization. Participants who have received palliative radiation treatment to peripheral sites (eg, bone metastases) within 28 days of randomization may be enrolled in the study if they have recovered from all acute, reversible effects and with notification of the Medical Monitor.
* Previous therapy for gastric/GEJ adenocarcinoma with Akt, phosphatidylinositol 3-kinase (PI3K), and/or mammalian target of rapamycin (mTOR) inhibitors
* Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to randomization or anticipation of need for a major surgical procedure during the course of the study
Management of Insomnia in Breast Cancer Patients

To provide preliminary data on the effects of brief behavioral therapy for insomnia (BBT-I) on insomnia in breast cancer patients expecting to receive cancer treatment (unspecified).

Participants will be randomized into 4 groups:

* Arm 1: Brief Behavioral Treatment of Insomnia (BBT-I) + Armodafinil 150 mg/day.
* Arm 2: Behavioral therapy for insomnia (CBT-I) + Armodafinil 150 mg/day.
* Arm 3: Brief Behavioral Treatment of Insomnia (BBT-I) without pharmaceutical intervention.
* Arm 4: Behavioral therapy for insomnia (CBT-I) without pharmaceutical intervention.

The purpose of this study is to test the efficacy of Brief Behavioral Treatment of Insomnia (BBT-I) in the treatment of insomnia in humans.

Insomnia is an extraordinarily common problem for cancer patients that is often associated with diminished social and vocational functioning and QOL. It is also likely that insomnia exacerbates other cancer-related symptoms (eg, fatigue, nausea, depressive mood, pain and/or reduced pain tolerance) and thus gives rise to the possibility of additive or multiplicative interactions. It is possible that untreated insomnia in the context of cancer therapy may lead to chronic forms of insomnia in cancer survivors which, in turn, independently confers risk for increased psychiatric and medical morbidity.

Thus, insomnia, by itself, is a significant problem that requires better understanding in order that its high prevalence can be reduced.

Developing interventions that might prevent onset of insomnia in breast cancer patients is vital.

Eligibility Criteria:
INCLUSION CRITERIA

* Be scheduled for cancer treatment with chemotherapy or biologics (prior chemotherapy and/or diagnosis of metastatic breast are allowed)
* Have at least 6 weeks of treatment remaining
* ≥ 21 years old
* Able to understand written and spoken English
* Able to swallow medication (until amendment omitting armodafinil treatment)
* Score of 3+ on the Sleep Disruption Evaluation form, OR a score of 8+ on Insomnia Severity Index (ISI)

EXCLUSION CRITERIA

* Prior treatment with armodafinil or modafinil (until amendment omitting armodafinil treatment)
* Prior treatment with psycho-stimulant medication within the past 28 days (until amendment omitting armodafinil treatment)
* Prior treatment with antiseizure medications (until amendment omitting armodafinil treatment)
* Has continuously taken sleep medication daily for the last 28 days (until amendment omitting armodafinil treatment)
* History (self-reported) of unstable medical or psychiatric illness (within the last 5 years)
* History of uncontrolled, cardiac disease, hypertension, severe headaches, glaucoma, or seizures (until amendment omitting armodafinil treatment)
* Pregnant or nursing
* History of substance abuse or meet criteria for current alcohol abuse or dependence
* History (self-reported) of chronic, preexisting insomnia, sleep apnea, or restless leg syndrome (RLS)
* Severe hepatic impairment (until amendment omitting armodafinil treatment)
Lipid Transport Disorder Italian Genetic Record (LIPIGEN)

LIPIGEN is an observational study involving Italian physicians and researchers in the field of diseases related to blood lipid levels. This study aims to improve the diagnosis and treatment of people with familial dyslipidaemias, including very common conditions such as familial hypercholesterolaemia (FH) and less common ones such as familial chylomicronidaemic syndrome (FCS).

What does the study do?

It collects information on Italian patients with Familial Hypercholesterolaemia (FH), following them in their normal clinical examination without adding extra procedures.

It uses the data collected to further our understanding of diseases such as familial hypercholesterolaemia, examining how it is diagnosed clinically and by genetic testing, and evaluating the effectiveness of different treatments.

It seeks to identify the genetic mutations that cause familial hypercholesterolaemia and other dyslipidaemias, helping to choose the most effective treatments.

It evaluates the impact of long-term treatments and patient adherence to medication, as well as monitoring the incidence of cardiovascular events and other important outcomes.

Who can participate?

The study is aimed at people of all ages, from children to adults, with familial hypercholesterolaemia or other genetic dyslipidaemia.

More than 50 centres throughout Italy are involved, making the study accessible to many.

What does participation entail?

Participants will continue with their normal clinical practice.

Data such as family history, personal clinical findings and genetic information will be collected, without additional procedures.

For some, further evaluations, such as ultrasounds, may be required to better study their condition.

The LIPIGEN study not only helps to better understand diseases related to high cholesterol but also aims to improve patients\&#39; lives through more precise diagnosis and personalised treatments.


Eligibility Criteria:
Inclusion Criteria:

* Molecular or clinical diagnosis of genetic dyslipidemia
* Informed consent signed

Exclusion Criteria:

* None
Healthcare Costs Among Patients With CML Receiving Dasatinib or Nilotinib in a Commercial and Medicare Population

The purpose of this study is to examine the healthcare costs among patients with CML receiving dasatinib or nilotinib as first line therapy in a commercially or Medicare insured population.


Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Age \>18 years
* International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9 CM) code for CML (205.1x)
* At least 2 prescriptions for dasatinib or nilotinib from July 1, 2008 to June 31, 2013
* Continuous eligibility for the 6 months pre- and post-index date (defined as the date of first fill for dasatinib or nilotinib)

Exclusion Criteria:

* History of bone marrow or stem cell transplant as identified in the 6 month pre-period