cyrilzakka/clinical-trials huggingface dataset:
The COMBINE Study: The CKD Optimal Management With BInders and NicotinamidE

The COMBINE clinical trial is a pilot study evaluating the effects of nicotinamide and lanthanum carbonate on serum phosphate and fibroblast growth factor 23 (FGF23) in patients with Chronic Kidney Disease (CKD) stages 3-4.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with estimated glomerular filtration rate (eGFR) 20-45 ml/min/1.73m2
2. Age 18-85 years
3. Serum phosphate ≥ 2.8 mg/dL
4. Platelet count ≥ 125,000/mm3
5. Able to provide consent
6. Able to travel to study visits
7. Able to eat at least two meals a day
8. In the opinion of the site investigator, willing and able to follow the study treatment regimen and comply with the site investigator's recommendations.

Exclusion Criteria:

1. History of allergic reaction to nicotinamide, niacin (excluding flushing), multivitamin preparations, or lanthanum carbonate
2. Liver disease, defined as known cirrhosis by imaging or physician diagnosis, documented alcohol use \> 14 drinks/week, or aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase, or total bilirubin concentrations \> 2 times the upper limit of the local laboratory reference range
3. Creatine kinase (CK) concentrations \> 2 times the upper limit of the local laboratory reference range
4. Major hemorrhagic event within the past six months requiring in-patient admission
5. Blood or platelet transfusion within the past six months
6. Secondary hyperparathyroidism (PTH \> 5 times the upper limit of normal range for the laboratory) or currently taking cinacalcet (Sensipar)
7. Current, clinically significant malabsorption, as determined at the discretion of the site investigator
8. Anemia (screening Hg \< 9.0 g/dl)
9. Serum albumin \< 2.5 mg/dl
10. Anticipated initiation of dialysis or kidney transplantation within 12 months as assessed by and at the discretion of the site investigator.
11. Use of immunosuppressive medications (stable oral steroids ≤ 10 mg of prednisone/day or inhaled steroids are exempted)
12. In the opinion of the site investigator, active abuse of alcohol or drugs
13. Recent (within the last 14 days) initiation or change in dose of treatment with 1,25 (OH)2 vitamin D or active vitamin D analogues (paricalcitol or hectorol). Patients on stable doses of these agents initiated more than 14 days prior to screening are eligible to participate.
14. Current or recent treatment (within the last 14 days) with phosphate binder or niacin/nicotinamide \> 100 mg/day
15. Current participation in another clinical trial or other interventional research
16. Currently taking investigational drugs
17. Institutionalized individuals, including prisoners and nursing home residents
18. Malignancy requiring therapy within 2 years (basal or squamous cell skin carcinoma and localized prostate cancer are exempted)

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Advanced Ovarian Cancer and Sexuality Phase 1

Women with Advanced Ovarian Cancer (AOC) suffer from severe sexual side effects from treatment. The prevalence of the sexual issues is not known.

The degree to which these sexual side effects is affected by treatment is also not known, as the literature in this area focuses on post-treatment analysis.

Specific Aim #1 (Quantitative Phase): To determine the prevalence and types of sexual difficulties using self-report questionnaires in women about to receive treatment for Stage III or IV Ovarian Cancer at the BCCA and over time, and to correlate these symptoms with degree of cancer symptoms, well-being, depressive symptoms, and relationship satisfaction

Hypothesis 1a: Compared to baseline pre-treatment data, and to existing data for women with early-stage gynaecologic cancer, rates of sexual difficulties will be significantly higher and frequency of sexual intercourse will be significantly lower in women with advanced ovarian cancer. We hypothesize that difficulties specifically in the domains of sexual desire, sexual distress, and genital pain will be the most common types of sexual dysfunction to characterize women with advanced ovarian cancer.

Hypothesis 1b: We hypothesize that the degree of sexual symptoms will be significantly greater at 3 months and 10 months post-treatment than compared to pre-treatment, and that sexual difficulties may be significantly greater at 3 months post-treatment than at 10-months post-treatment.

Hypothesis 1c: We hypothesize that degree of sexual difficulty and sexual distress will be significantly correlated with (a) overall well-being; (b) depressive symptoms; and (c) relationship satisfaction.

Hypothesis 1d: As an exploratory analysis, we will investigate the relationship of ovarian cancer-related variables (i.e., type of treatment, duration of treatment, number of medications), and demographic variables (i.e., age, relationship duration, education) on each of the hypotheses in 1a - 1c.

Eligibility Criteria:
Inclusion Criteria:

* Women with Advanced Ovarian Cancer (AOC) who have not received treatment yet, but who are seeking treatment at the BC Cancer Agency.
* Women must be able to understand English enough to fill out the questionnaire packages.
* Mastery of written English is required. No translation services will be available for this study.

Exclusion Criteria:

* Anyone without an AOC diagnosis, who are not seeking treatment at BCCA, or who cannot understand enough English to complete the questionnaires will be excluded.
* Those who do not have a mastery of written English are excluded.
Retrospective Observational Study Investigating Fluciclovine (18F) (FACBC)

This retrospective observational multi centered study has been established to collect the clinical experience relating to the administration of Fluciclovine 18F employed in both investigator initiated studies and named patient/compassionate use programmes in up to 5 sites.

This study will collect clinical data from consenting patients (unless a HIPAA waiver or equivalent was granted) who received the PET radiotracer Fluciclovine 18F (FACBC) (a synthetic amino acid analog) for imaging of patients with various cancers at participating sites in the US and Europe.

Data collection will cover baseline medical history and medications in all patients.

The result of PET radiotracer and other imaging findings, and reports of histopathology from biopsied tissue (where available) and in a time window relevant to the use of PET imaging in the diagnosis of primary/recurrent prostate cancer will be recorded.

In all subjects, with regards to safety monitoring, available data for physical examination, vital signs and laboratory test results will be collected from 28 days prior to and out to a 35 day window after Fluciclovine 18F (FACBC) administration.

The major goals of the investigation are to consolidate the safety profile of Fluciclovine 18F (FACBC), to evaluate its use in the detection of local and extraprostatic recurrence of prostate cancer and to evaluate its ability to detect malignancy in patients undergoing screening for primary prostate cancer.

Eligibility Criteria:
Inclusion Criteria:

* Patient managed by a site at which ethical committee approval for retrospective data collection under this protocol has been received
* Patient has received at least one injection of fluciclovine (18F) for the detection of a malignant tumour at any location

Exclusion Criteria:

* Subjects will be excluded from the analyses if any of the following criteria are met:
* Patients participating in clinical trials or open access programmes at countries or sites not participating in this study.
* Patients managed at sites without ethical committee approval for retrospective data collection under this protocol.
Linkage Analysis in Interstitial Cystitis

Urologic pelvic pain syndrome (UCPPS), variably termed painful bladder syndrome/interstitial cystitis (PBS/IC) in females and chronic prostatitis/chronic pelvic pain syndrome in men (CP/CPPS), is a chronic, debilitating clinical syndrome presenting as severe pelvic pain with extreme urinary urgency and frequency in the absence of any known cause. The etiologic mechanisms underlying UCPPS are unknown, but recurrence, risks to siblings of affected individuals, concordance among monozygotic twins, and our own preliminary studies indicate a strong genetic contribution to the cause of UCPPS. The overall goal of this proposal is use novel approaches to understand the basis of UCPPS, to identify candidate genes containing mutations that result in UCPPS and determine how the different encoded proteins of these genes interact with one another in a common biological pathway. Ultimately, understanding how mutations in at least five different genes yield the symptoms of UCPPS should lead to improved diagnosis and possible therapies.


Eligibility Criteria:
Inclusion Criteria:

* Have symptoms for at least 3 months within the preceding 6 months:
* Pain in the pelvic area
* Urinary frequency and/or
* Urinary urgency and/or
* Sexual dysfunction (erectile dysfunction)
* Have CP/CPPS, IC, PBS, or BFS
* Be willing to provide a saliva and urine sample
* Agree to complete several brief questionnaires
* Family of someone with CP/CPPS, PBS, IC or BFS
* Live in the USA or Canada

Exclusion Criteria:

* Major structural/anatomical urinary tract abnormalities
* Underlying inborn or congenital conditions
Study of Healthy Cohort for Early Detection of Cancer

Cancer produces a significant burden on society with a majority diagnosed at late stages when the chance of cure is low. Early diagnosis improves patient outcomes. Data consisting of lifestyle factors, medications, physical activity, years before conventional cancer diagnosis is also worthwhile for to determine early detection. This is only achievable with longitudinal tracking of a large number of healthy individuals and identifying those who do develop cancer over time.

To conduct a longitudinal cohort study of patients who do not have a malignancy at the time of enrollment and are followed over a 20 year period to see if patients develop a malignancy and associate clinical and lifestyle factors as well as collection of blood. All adults 18 years of age and older undergoing upper or lower endoscopy for routine medical care will be eligible for this study.

Eligibility Criteria:
Inclusion Criteria:

* All adults 18 years of age of older undergoing upper or lower endoscopy for routine medical care.

Exclusion Criteria:

* Persons with current malignancy
* Persons with history of malignancy and treatment within last 5 years of enrollment, excluding non-melanoma skin cancer or cervical in-situ.
* Persons who are unable or unwilling to provide repeat blood samples and complete follow-up questionnaires
* Persons who lack the capacity to provide consent
* Persons who do not speak English
* Persons who are visually or hearing impaired.
Measurement of the Diaphragm Loading During the Training With a IMT Device

It is well known that the the training with the IMT device increases the Maximal Inspiratory Pressure. Nonetheless, there are doubts about which muscles are involved during this training. The aim of this study is to determine the diaphragm loading of healthy subjects during the training with a IMT device from a low . Therefore, each subject will be monitored using esophageal and gastric manometry.

This study has a quasi-experimental design. The investigators will recruit ten healthy adult volunteers without anticoagulation or esophageal lesions, after signing a consent form.

After checking the appropriate correct position of each catheter, each subject will use the IMT device throughout different randomized loads (percentages of the maximal inspiratory pressure, counting by tens from 10% to 100%). FluxMed® GrT MBMed respiratory mechanic monitor will be used. Each percentage of resistive load will be maintained for 5 inspirations. Meanwhile, an operator will register the esophageal pressure,the gastric pressure and the transdiaphragmatic pressure. Diaphragm collaboration in each percentage of resistive load will be determine by calculating the relation between the gastric pressure and the transdiaphragmatic pressure (∆Pgas/∆Pdi).

Eligibility Criteria:
Inclusion Criteria:

* older than 18 years
* healthy subjects

Exclusion Criteria:

* without anticoagulation
* without esophageal lesions
* without airway lesions
* without spirometry alterations
Open Label Study to Evaluate the Efficacy of the Home Based Electrical Transcutaneous URIS I in the Treatment of Overactive Bladder (OAB).

Open label Study to Evaluate the Efficacy of the Home Based Electrical Transcutaneous NeuroModulation (eTNM) Treatment Via Nerve Stimulator URIS I in the Treatment of Overactive Bladder.

Open label, Multi center Study to Evaluate the Efficacy of the Home Based Electrical Transcutaneous NeuroModulation (eTNM) Treatment Via Nerve Stimulator URIS I in the Treatment of Overactive Bladder (OAB).

Eligibility Criteria:
Inclusion Criteria:

* Women 18 years or older, inclusive
* Diagnosis of OAB or mixed incontinence with the predominance of OAB symptoms
* Dissatisfaction with any current or previous pharmacotherapy treatment of OAB for any reason within the past 12 months
* Treatment Satisfaction VAS \<50
* Ability to understand and sign ICF
* Subject agreed to attend all follow up evaluations and was willing to completely and accurately fill out voiding diaries and questionnaires, and was willing to complete required exams and tests
* Subject agreed not to participate in another research study from the time of screening until the final study visit
* Subject agreed not to use a pharmacotherapy treatment for OAB from the time of screening until the final study visit

Exclusion Criteria:

* Prior treatment with botulotoxin for OAB
* Previous pharmacotherapy for OAB if \>12 months ago
* Urinary retention with post void residual \> 150ml
* Neurological disease affecting urinary bladder function, including but not limited to Parkinson's disease, multiple sclerosis, stroke, spinal cord injury and nerves of lower limbs
* History or presence of stress incontinence, or mixed incontinence where stress incontinence was predominant
Dose Finding Study of Single Dose GHB11L1 in Healthy Adults

The purpose of this phase IIa trial is to evaluate the immunogenicity of a single dose of GHB11L1 administered by liquid nasal spray for vaccination against influenza A (H1N1) virus.

This study is also performed to assess safety, tolerability and pharmacokinetics (shedding) of a single dose of GHB11L1 administered by liquid nasal spray.

GHB11L1 intends to provide a novel vaccination for influenza virus infection. 48 healthy volunteers will be included in this phase IIa study investigating three dose levels. 16 subjects will be randomised at a ratio of 3:1 for GHB11L1 or placebo.

Healthy male volunteers, 18-50 years of age and seronegative with respect to the applied virus antigens (antibody titers \<1:10 detected) will be randomised.

GHB11L1 will be administered once on day 1. Follow-up visits will be performed on days 2, 8 and 29.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male volunteers, 18-50 years
* Seronegative for H1N1 (Influenza A/Brisbane/59/07 antibody titres \<1:10 detected in haemagglutination inhibition assay)
* Written informed consent to participate in this study

Exclusion Criteria:

* Acute febrile illness (\>37.0°C)
* Signs of acute or chronic upper or lower tract respiratory illnesses (sneezing, cough, tonsillitis, otitis etc.)
* History of severe atopy
* Seasonal influenza vaccination in 2007/2008 and/or later seasons and/or pandemic influenza vaccination at any time
* Known increased tendency of nose bleeding
* Volunteers with clinically relevant abnormal paranasal anatomy
* Volunteers with clinically relevant abnormal laboratory values
* Simultaneous treatment with immunosuppressive drugs incl. Corticosteroids (≥2 weeks) within 4 weeks prior to study medication application
* Clinically relevant history of renal, hepatic, GI, cardiovascular, haematological, skin, endocrine, neurological or immunological diseases
* History of leukaemia or cancer
* HIV or Hepatitis B or C seropositivity
* Volunteers who underwent rhino or sinus surgery, or surgery of another traumatic injury of the nose within 30 days prior to application of study medication
* Volunteers who have received antiviral drugs, treatment with immunoglobulins or blood transfusions, or an investigational drug within four weeks prior to study medication application
* Volunteers who have received anti-inflammatory drugs 2 days prior to study medication application
* Volunteers who are not likely to cope with the requirements of the study or with a significant physical or mental condition that may interfere with the completion of the study
Artificial Intelligence Performance in Colonoscopy in Daily Practice

randomized, controlled single center, single investigator study mainly in colorectal screening population in daily practice with and without artificial intelliegence (AI) named DiscoveryTM from Pentax medical. Patient randomly are allocated to one of four groups: Pentax i10 colonoscopes without any additional device, Pentax i 10 with DiscoveryTM (AI), Pentax i 10 with EndocuffTM and Pentax i10 with EndocuffTM and DiscoveryTM (AI).

The different groups are compared in terms of the different parameters: e.g. time of endoscopy, polyps (PDR) and adenoma detected (ADR).

From August 2021 through August 2022 all patients undergoing a colonoscopy in a gastroenterologist's private practice are assigned using randomization tables to one or the other above mentioned groups. Time of the endoscopy (ascent, descent and intervention time), polyps detected and their histology are written down real time with a tablet computer anonymized with the patient number. Furthermore dosage of sedatives and over all satisfaction is traced.

1. endpoint is time gain in the different phase of the colonoscopy
2. endpoint is adenoma detection rate (ADR)

Eligibility Criteria:
Inclusion Criteria:

* all patients referred and fit for an ambulant colonoscopy

Exclusion Criteria:

* none
Hypertrophic Cardiomyopathy Pilot Study

This study evaluates mechanisms of arrhythmogenicity in hypertrophic cardiomyopathy, in comparison to patients with well-understood arrhythmogenic substrate (ischemic cardiomyopathy), as well as to individuals free from arrhythmogenic substrate


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed HCM
* Documented history of sustained ventricular tachyarrhythmia or resuscitated sudden cardiac arrest
* Maximal left ventricular wall thickness of \> 30mm
* Extensive fibrosis on cardiac MRI (\>15% of total myocardial volume)
* \>7.5%/5-year risk of sudden cardiac death as determined by HCM risk-SCD

Exclusion Criteria:

* age \< 18 years
* Pregnancy
* Atrial Fibrillation
Ph 2a Study of HU6 on Energy Metabolism, Muscle and Liver Substrate Metabolism, and Mitochondrial Function in Subjects Who Are Overweight or Obese With Type 2 Diabetes

This is a randomized, double-blind, placebo-controlled parallel group study of HU6 and placebo in subjects who are overweight or obese with T2D.

The study will be conducted in 4 stages.

This is a randomized, double-blind, placebo-controlled parallel group study of HU6 and placebo in subjects who are overweight or obese with T2D.

The study will be conducted in 4 stages (Figure 1).

* Stage 1: (screening) is conducted over a 29-day window (Day -48 to Day -20). Subjects who meet all of the eligibility criteria may proceed Stages 2 to 4 of the study.
* Stage 2 (baseline \[pre-randomization\]) is conducted over a 19-day period prior to randomization and includes a 13-day run-in and the first 6-day inpatient assessment period. At the end of Stage 2, subjects will be randomized 1:1 to HU6 or placebo.
* Stage 3 (double-blind dosing) is conducted after randomization. Day 1 is the first dose of double-blind study drug, and dosing continues over an approximate 26-week period. During this time, there will be study visits for safety, PK, and PD. Stage 3 of the study concludes with a 3-day run-in followed by the second 6-day inpatient assessment period.
* Stage 4 (washout) is conducted after dosing has ended and includes an approximate 4-week washout duration including a 3-day run-in followed by the third inpatient assessment period (3-day duration). The last day of the 3-day inpatient stay is the end-of-study. (Note that there will be a separate early termination visit for any subject who prematurely discontinues from the study

Eligibility Criteria:
Inclusion Criteria:

1. Able to understand the procedures and requirements of the study and provide written informed consent and authorization for protected health information disclosure.
2. Willing and able to comply with the requirements of the study protocol.
3. Male or female 18 to 70 years of age, inclusive, at time of informed consent.
4. Body mass index (BMI) \>28.0 kg/m2 and able to fit into the MRI machine.
5. Subject has T2D meeting all of the following criteria:

Exclusion Criteria:

1. Body weight \>450 pounds.
2. Subject-reported history of weight gain or loss \>5% in 3 months prior to screening.
3. The subject participates in programmed exercise \>3 hours per week.
Clinical Translational Science Institute (CTSI) Brain HQ Modules vs. Active Controls for Elderly Survivors of ICU

The purpose of this project is to test whether an online cognitive rehabilitation program or online thinking exercises helps improve memory and thinking in elderly patients who survive a severe infection.

Currently, over 50% of patients are estimated to develop an Alzheimer's like disease following their hospitalization. This means they might have trouble remembering simple things or doing simple tasks. This can make returning to normal life difficult. This project will test whether online thinking exercises can help speed up patient's recovery.

Eligibility Criteria:
Inclusion Criteria:

1. Admitted to the Intensive Care Unit (ICU) at Froedtert Memorial Lutheran Hospital (FMLH)
2. Diagnosis of Sepsis
3. Age 65 years or older
4. Required mechanical ventilation or vasopressor therapy while in the ICU
5. Had delirium while in the ICU

Exclusion Criteria:

1. Non-English Speaking
2. Severe Dementia that would interfere with the ability to participate in the study activities
3. Prior or current structural neurological injury that would confound study results
4. Inability to communicate for any reason
5. Current chemotherapy or radiation treatment
6. Recent history of substance abuse
7. Life expectancy \< 6 months
8. Planned discharge to long term acute care facility or nursing home
9. Lack reliable access to the internet either through a computer or smart device
Objective Assessment and Promotion of Physical Activity in Elderly

The purpose of the present study is to evaluate the short-term and long-term effects of a cycle ergometer program on physical activity and physical fitness in elderly (65+). Therefore, physical activity, physical fitness and functionality are measured at baseline, after 10 weeks (after the intervention period), after 6 months and after 1 year.

Different coaching techniques (to promote the use of a cycle ergometer and cycle ergometer program) will also be evaluated. What is the best (coaching) approach for long-term adherence (physical activity)?


Eligibility Criteria:
Inclusion Criteria:

* 65 yrs
* residents of a service flat
* No frequent use of bike / cycle ergometer

Exclusion Criteria:

* recent cardiovascular event or fracture
* vestibular or thrombotic disorder
* severe dementia
* need for oxygen supplementation during daily activities