cyrilzakka/clinical-trials huggingface dataset:
Allogenic Stem Cells Derived From Lipoaspirates for the Treatment of Recto-vaginal Fistulas Associated to Crohn's Disease (ALOREVA)

The purpose of this study is to determine safety and efficacy of allogenic eASCs (expanded adult stem cells) for the treatment of recto-vaginal fistula in patients with Crohn´s disease.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent.
* Patients with Crohn´s disease diagnosed at least 12 months earlier in accordance with accepted clinical, endoscopic, anatomopathological and/or radiologic criteria.
* Fulfilling one of the following criteria:

  * At least, one previous surgery for fistulous disease.
  * Physical status which discourage liposuction.
* Rectovaginal fistula.
* Women of a childbearing age. Good general state of health according to the findings of the clinical history and the physical examination.

Exclusion Criteria:

* Presence of severe proctitis (prominent friability, spontaneous bleeding, multiple erosions, deep ulcers) or dominant active luminal disease requiring immediate therapy, assessed by rectosigmoidoscopy
* Patients with CDAI≥201
* Patients with an abscess unless a complete toilet of the area with drainage of the collections and the absence of abscess and other collections is confirmed prior to treatment start
* Patients who have received infliximab or any other anti TNF agent in the 8 weeks before the cell treatment administration
* Patients who have received tacrolimus or cyclosporine in the 4 weeks before the cell treatment administration
* Patients with a history of abuse of alcohol or other addictive substances in the 6 months prior to inclusion
* Patients with malignant tumor, except for basal cell or cutaneous squamous cell carcinoma, or patients with a prior history of malignant tumors, unless the neoplastic disease has been in remission for the previous 5 years
* Patients with cardiopulmonary disease which, in opinion of the investigator, in unstable or sufficiently serious to exclude the patient from the study.
* Patients with any type of medical or psychiatric disease which, in the opinion of the investigator, could be grounds for exclusion from study
* Patients with congenital or acquired immunodeficiencies. HIV, HBV, HCV or treponema infection, whether active or latent.
* Patients allergic to local anesthetics or gadolinium (MRI contrast) MRI is unfeasible (e.g. due to the presence of pacemakers, hip replacements or severe claustrophobia)
* Patients who have suffering major surgery or severe trauma in the prior 6 months
* Pregnant or breastfeeding women
* Patients currently receiving, or having received within 1 month prior to enrolment into this clinical trial, any investigational drug.
A Study to Evaluate the Effect of Itraconazole on JNJ-56136379 in Healthy Adult Participants

The main purpose of this study is to assess the effect of itraconazole at steady-state on a single-dose pharmacokinetic (PK) of JNJ-56136379 in healthy adult participants.


Eligibility Criteria:
Inclusion Criteria:

* Healthy on the basis of physical examination, clinical laboratory tests, medical history, and vital signs performed at screening. If there are abnormalities, the participant may be included only if the investigator judges the abnormalities to be not clinically significant or to be appropriate and reasonable for the population under study. This determination must be recorded in the participant's source documents and initialed by the investigator
* Must not use nicotine-containing substances including tobacco products for at least 3 months prior to screening and during the study
* A woman of childbearing potential must have a negative highly sensitive serum pregnancy test (beta-human chorionic gonadotropin) at screening and a negative urine pregnancy test at Day -1 of the first treatment period
* Body mass index (weight kilogram \[kg\]/height\^2 meter \[m\]\^2) between 18.0 and 30.0 kg/m\^2 (inclusive), and body weight not less than 50.0 kg
* Blood pressure (after the participant is supine for 5 minutes) between 90 and 140 millimeters of Mercury (mmHg) systolic, inclusive, and no higher than 90 mmHg diastolic. If blood pressure is out of range, up to 2 repeated assessments are permitted

Exclusion Criteria:

* History of cardiac arrhythmias (example \[e.g.\], tachycardia at rest), history of risk factors for Torsade de Pointes syndrome (e.g., hypokalemia, family history of long QT Syndrome) at screening
* Any evidence of heart block or bundle branch block at screening
* Any current, or history of, clinically significant skin disease at screening requiring intermittent or chronic treatment (at the investigator's discretion) such as, but not limited to, dermatitis, eczema, drug rash, psoriasis, food allergy, and urticaria
* Known allergies, hypersensitivity, or intolerance to JNJ-56136379 or itraconazole or its excipients at screening
* History of clinically significant drug allergy at screening such as, but not limited to, sulfonamides and penicillins, or drug allergy witnessed in previous studies with experimental drugs
Impact of Inner Engineering on Relationships

This study aims to assess the impact of Shambhavi Mahamudra Kriya on human relationships in terms of overall well-being associations with interpersonal and relational outcomes.

Specific aims include:

1. To quantitatively assess the impact of Shambhavi Mahamudra Kriya on measures of relationship quality, interpersonal mindfulness, and overall well-being
2. To qualitatively explore the experience and the general Social and Relational impact of Shambhavi Mahamudra Kriya on participants.

This observational cross-sectional study aims to enroll participants who are already registered for an Inner Engineering program to learn Shambhavi Mahamudra Kriya

The practice participants are learning is a multi-component 21-minute meditation called Shambhavi Mahamudra Kriya. It is offered by the non-profit Isha Foundation. It incorporates a combination of different breathing patterns and meditative components. The intervention training provides precise, step by step and easy to follow instructions on how to perform this practice. Performed in a seated posture, this is a simple, safe and accessible intervention that requires no previous experience of meditation.

Some Inner Engineering programs where participants learn Shambhavi Mahamudra Kriya have a pre-requisite of taking the Inner Engineering Online (IEO) program. The IEO program consists of seven online modules. These modules give the participants an opportunity to intellectually explore the basics of life using methods that are from the distilled essence of yogic sciences. The course imparts wisdom to manage the body, mind, emotions, and the fundamental life energy within.

Importantly, the participants would be able to attend their Inner Engineering program and subsequent meditation and yoga practices would occur regardless of whether or not they decided to participate in the study.

With this study we aim to evaluate the impact of Shambhavi Kriya on relationships using validated scales and qualitative analysis. Enrollment into the study will be ongoing until we are able to get a sufficient sample size. Apart from the surveys and qualitative interviews at select points over a 6-month period, there is no additional study procedures involved in the study, details of which are discussed below.

Eligibility Criteria:
Inclusion Criteria:

* Participants who have registered to take an Inner Engineering program to learn Shambhavi Mahamudra Kriya.
* Participants must be able to read and understand English.

Exclusion Criteria:

* Not currently residing in United States
* Below the age of 18
Efficacy of a Pacemaker Algorithm in Promotion of the Intrinsic Heart Activity.

The purpose of this study is to provide evidence that the Refined Ventricular Pacing Algorithm leads to clinically relevant reduction (at least 50% reduction) of the incidence of ventricular pacing.

Electrical stimulation in the apex of the right ventricle ( ventricular pacing) usually improves the heart function of patients with a pacemaker and can even be life-saving. However, evidence is accumulating that ventricular pacing may also have undesired long-term cardiac effects. Therefore, it makes sense to limit ventricular pacing to the absolute required minimum. The functionality RVP (Refined Ventricular Pacing) in the C-series 2nd generation pacemakers of Vitatron B.V. Arnhem, the Netherlands is designed to reduce ventricular pacing.

After implantation of the Vitatron C50 D model C50A2 (pacemaker) or Vitatron C60 DR model C60A2 (pacemaker) and a 4-6 weeks stabilization period, proper functioning of pacemaker and leads (stimulation- and sensing parameters) is checked. The pacemakers will be programmed according to predefined settings.

In the following 4-weeks Baseline period diagnostic data (atrial fibrillation burden and percentage of ventricular pacing (% VP)) are collected in the pacemaker memory. Based on these data, patients will be excluded from further participation (patients with more than 15% atrial fibrillation) or subdivided into three groups: (a) \< 30% VP (30- VP group), (b) \>30% VP, Sick Sinus Syndrome and normal conductivity (SSS group), (c) \>30% VP, 1st or 2nd degree AV block. Patients in these three groups will be treated for 4 weeks alternatively with the RVP functionality switched ON or OFF. The order will be determined by randomization. At the end of these two cross-over periods the % VP and the judgment of the patients of the last period will be assessed. Adverse events will be recorded from the moment of study enrolment.

Eligibility Criteria:
Inclusion Criteria:

* Patients shall be willing to sign the Patient Informed Consent for this study
* Patients shall have at least one of the following indications for a pacemaker: - Sick Sinus Syndrome with normal QRS complexes
* First degree AV block with a PR interval \<_220 ms for patients \<_ 70 years of age, or \<_ 260 for patients over 70 years
* Second-degree AV block, mobitz I (wenckebach) or mobitz II
* Patients shall be available for follow-up for the duration of their participation.

Exclusion Criteria:

* Patients involved in another investigation study conducted in parallel to this study
* Patients younger than 18 years of age and/or patients that do NOT meet other local requirements for participation
* Pregnant patients
* Patients with lead integrity problems (and the lead is not being replaced)
* Patients with persistant AF
* Patients with a complete AV block
* Patients with NYHA (New York Heart Association0 class III and IV
* Patients who underwent thoracic surgery in the last three months or are expected to have in the near future
* Patients with a 2:1 block
* Patients with a life expectancy less than half a year
AMG 319 Lymphoid Malignancy FIH

This is a multi-center, phase 1, open-label first-in-human study of AMG 319 in subjects with relapsed or refractory lymphoid malignancies. This study consists of two parts. The dose exploration in part 1, studies cohorts of 3 subjects with relapsed or refractory lymphoid malignancies and uses a practical continuous reassessment model \[CRM\] to guide dose escalation and to define the MTD. The dose expansion in part 2 will enroll 20 subjects with CLL at a dose no higher than the MTD and further explore the safety, PK, and clinical activity of AMG 319 in this patient population.


Eligibility Criteria:
Inclusion Criteria:

- Part 1 (Dose Exploration): Relapsed or refractory lymphoid malignancy of the following type for which standard treatment does not exist or is no longer effective:

B-cell Chronic Lymphocytic Leukemia (CLL) confirmed by immunophenotype or Non-Hodgkin Lymphoma: Low or intermediate grade B-cell NHL, mantle cell lymphoma, non-cutaneous T-cell NHL confirmed by histology and/or immunophenotype

* Part 2 (Dose Expansion): Subjects must have relapsed or refractory B-cell Chronic Lymphocytic Leukemia confirmed by immunophenotype for which standard treatment does not exist or is no longer effective.
* Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2
* Life expectancy of \> 3 months, in the opinion of the investigator
* Men or women ≥ 18 years old
* Hematological function, as follows:

Absolute neutrophil count (ANC) ≥ 1.5 x 109/L (unless due to disease-related bone marrow involvement as documented by bone marrow biopsy, ≥ 0.5 x 109/L) Platelet count ≥ 50 x 109/L (without a transfusion within 14 days before enrollment) Hemoglobin ≥ 9 g/dL

- Hepatic function, as follows: Aspartate aminotransferase (AST) \< 3.0 x ULN Alanine aminotransferase (ALT) \< 3.0 x ULN Alkaline phosphatase (ALP) \< 2.0 x ULN (\< 5 x ULN in subjects whom the PI and sponsor agree that clinical data suggest an extrahepatic source of elevation) Total bilirubin \< 1.5 x ULN (\< 3.0 x ULN for subjects with documented Gilbert's Disease or for whom the indirect bilirubin level suggests an extrahepatic source of elevation) Amylase ≤ 2.0 x IULN Lipase ≤ 2.0 x IULN

Exclusion Criteria:

* Primary or disseminated tumor involving the central nervous system (CNS)
* A history of other malignancies, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer, or other solid tumors curatively treated with no evidence of disease for ≥ 2 years
* History of allogeneic stem-cell (or other organ) transplantation
* Clinically significant ECG changes which obscure the ability to assess the PR, QT, and QRS interval; congenital long QT syndrome
* QTcF interval \> 470 msec
* Active or chronic hepatitis B or hepatitis C infection, determined by serologic tests
* Recent infection requiring intravenous anti-infective treatment that was completed ≤ 14 days before enrollment
Exercise Substrate Utilisation and Endurance Performance Following Short-term Manipulation of Dietary Fat Intake

The capacity to burn fat as fuel for exercise may have important implications for sporting performance, with dietary fat intake positively influencing this ability.

Endurance performance and the ability to burn fat will be measured in women runners following the consumption of 3 diets varying in the amount of fat and carbohydrate.

Dietary fat intake positively influences the ability to burn fat during exercise in women but not men, whereas carbohydrate intake negatively influences fat oxidation in both sexes. The independent nature of dietary fat intake as a predictor of the ability to burn fat in women suggests that in conditions of adequate carbohydrate intake providing additional fat may increase fat oxidation in women whereas it does not in men. It is of interest to explore if indeed women are responsive (i.e., increase in fat oxidation) to short-term increases in dietary fat intake induced by overfeeding (adequate carbohydrate) or if as appears to be the case in men reduced carbohydrate intake as typically employed in high-fat, low carbohydrate dietary studies is also a prerequisite for enhancing fat oxidation in women, and whether this translates into a difference in exercise endurance performance.

Eligibility Criteria:
Inclusion Criteria:

* BMI \>17.0 \< 25 kg/m2
* Good General Health
* Accustomed to vigorous physical activity
* Run \> 2 times per week
* V̇O2max \>50ml/kg/min
* Weight Stable \> last 6months
* Non Smoker
* Pre-menopausal, and either eumenorrheic and regularly menstruating, or using monophasic hormonal oral contraceptives for \> 3 months.

Exclusion Criteria:

* Currently taking part in another scientific/clinical study
* Taking any prescription drug / supplement thought to influence metabolism
* Following unusual dietary practices (such as intermittent fasting or low carbohydrate diets)
* Pregnant
* Breast Feeding
Chiropractic Care, Medication, and Self-Care for Neck Pain

This study will compare the effectiveness of chiropractic care, medications, and self-care on neck pain, a very common condition. The broad, long-term objective of this study is to identify effective therapies for neck pain sufferers and to increase understanding of neck pain conditions.

Neck pain is very common, with considerable socioeconomic consequences. Although some therapies appear promising, there are too few randomized clinical trials of sufficient quality to support the use of one therapy over another. This is especially true for acute/subacute neck pain. Although commonly treated with prescription medications, neck pain sufferers are increasingly seeking relief through complementary and alternative medicine therapies, such as chiropractic spinal manipulation. Little is known, however about the short- and long-term relative efficacy of these therapies and how they compare to giving patients simple advice on self-care.

The broad, long-term objective of this research is to identify effective therapies for neck pain sufferers and to increase our understanding of neck pain conditions. This randomized, observer-blinded clinical trial is a unique collaborative effort by experienced chiropractic and medical researchers and will focus on patients with acute/subacute neck pain (\<12 weeks duration). The study will determine the relative efficacy of chiropractic spinal manipulation, prescription medication, and self-care advice for neck pain in both the short term (after 6 weeks) and long term (after 52 weeks), using patient-rated neck pain as the main indicator of success.

Eligibility Criteria:
Exclusion Criteria:

* Pregnant women, due to use of diagnostic procedures (x-rays) and study treatments (NSAIDs and narcotic medications)
Cognitive Behavioural Therapy for Social Phobia in People With Bipolar Disorder

We are doing this study to find out how well cognitive behavioural therapy for social phobia works in people with bipolar disorder, who also have social phobia.

Social phobia is a very prevalent anxiety disorder in people with bipolar disorder and is associated with adverse outcomes. Yet, social phobia is treatable by cognitive behavioural therapy or antidepressant medication. As antidepressants are often contra-indicated in people with bipolar disorder, cognitive behavioural therapy is the likely first choice treatment for social phobia in this population. However, people with bipolar disorder were excluded from previous clinical trials on treatment of social phobia. Our aim is to evaluate the acceptability and to provide a rough estimate of efficacy of cognitive behavioural therapy protocol for social phobia in people with bipolar disorder in a systematic case series. We will also prepare pilot data for evaluating the impact of treatment of comorbid social phobia on the long-term course of bipolar disorder.

Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of bipolar disorder I or II according to DSM-IV criteria and established in a structured interview
* Bipolar disorder in remission for at least 12 weeks; defined as absence of depressive or manic episode according to DSM-IV criteria established in a structured interview and confirmed by Montgomery-Åsberg Depression Rating Scale score ≤ 12 and Young Mania Rating Scale score ≤ 7
* Stable medication regime for at least 4 weeks prior to commencing CBT
* Current diagnosis of social phobia according to DSM-IV criteria and established in a structured interview, including duration of social phobia of at least 6 months irrespective of age.
* Social phobia is one of the primary complains (when bipolar disorder is in remission), justifying a therapeutic focus on this disorder.
* Ability and willingness to consent to treatment
* Ability to speak and write English

Exclusion Criteria:

* Current substance use disorder
* A previous adequate course of CBT for social phobia (at least 8 sessions) delivered by a trained therapist
* Currently receiving any psychological therapy
* Cognitive impairment that would preclude psychological therapy
* Actively suicidal
Urinalysis Results in Healthy Individuals

This is a prospective, observational study assessing the results of urine dipsticks on adult volunteers with no acute symptoms. We seek to determine the frequency of leukocytes or nitrites in this group of individuals.

The urinalysis (UA) is one of the most commonly utilized tests in the emergency department (ED). In some busy EDs, a UA is routinely ordered by protocol on patients with abdominal pain, and in elderly patients, a UA is often ordered for a variety of chief complaints including dizziness and altered mental status. When these patients, who often do not specifically have symptoms of a urinary tract infection, have a urinalysis demonstrating pyuria or bacteria, it may be interpreted as an atypical presentation of a UTI. However, it is possible that these patients do not have urinary tract infections, but have baseline pyuria or bacteriuria. One prior study found that 5% of sexually active healthy women 18-40 have asymptomatic bacteriuria \[1\], and the rate of asymptomatic bacteriuria increases with age, such that it is present in 8-10% of women from 70-80 years of age \[2\]. Moreover, one prior article stated that 30-50% of residents of long term nursing facilities have positive urine cultures at any given time \[3\].

The above statistics come from the results of urine cultures. In the ED, the decision to treat or not treat a patient for a UTI is not made based upon culture results, but upon a urinalysis (microscopic or dipstick). Only one prior study has looked at the frequency of abnormal urinalyses in healthy individuals, and it found that over a third of asymptomatic women had at least 1+ leukocytes in their urine \[4\]. This is evidence that a substantial number of people who do not have symptomatic UTIs have UAs that could be interpreted as UTIs. If these results could be replicated and expanded to include a wider group of individuals (males, elderly patients, various races, etc.), it would provide valuable information about how we can better interpret and utilize the results of a UA.

Thus, the investigators propose a prospective study to assess the frequency of abnormal UAs in a wide variety of individuals without acute symptoms.

Urine samples will be obtained from adults with no acute symptoms, and performed urine dipsticks to assess the frequency of leukocytes or nitrites in the urine. Patients will be divided into groups to determine if there are certain factors (gender, age, or medical history) that increase the chance of having leukocytes or nitrites in the urine.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Able to spontaneously provide a urine sample

Exclusion Criteria:

* Any acute symptoms (including but not limited to vaginal bleeding, vaginal discharge, abdominal pain, back pain, dysuria, hematuria, and fever)
* Pregnancy
* Prisoner status
* Antibiotics within 72 hours
* Urologic procedure within a week
Polycystic Ovary Syndrome and BETATROPHIN

This is an original study giving an information about the association body mass index, polycystic ovary syndrome and betatrophin.

Introduction: Betatrophin is a protein hormone which has a significant role in glucose homeostasis and lipid metabolism. The aim of this study is to compare the levels of serum betatrophin in overweight and normal weight women with PCOS.

Material and Method: Thirty-five patients normal weight women with PCOS (BMI\<25) and 38 obese women with PCOS (BMI≥25) were included in this prospective, cross-sectional study. Patients were selected according to Rotterdam criteria. Serum betatrophin levels were studied by ELISA method and then compared between these two groups besides the following additional parameters as waist circumference/hip circumference ratio, fasting blood glucose, 75 g OGTT (oral glucose tolerance test) results and HOMA-IR levels.

Eligibility Criteria:
Inclusion Criteria:

-Polycystic ovary syndrome according to 2003 Rotterdam PCOS Consensus diagnostic criteria

Exclusion criteria

* pregnancy,
* an additional systemic disease (i.e.,hyperprolactinemia, thyroid dysfunction, liver or kidney diseases, cardiovascular disease, hyperlipidemia, type 1 or type 2 diabetes, chronic or acute infection within the previous 30 days),
* morbid obesity,
* smoking,
* the use of medications for contraception, androgen excess, hypertension, hyperglycemia or dyslipidemia at least 3 months before the study.