cyrilzakka/clinical-trials huggingface dataset:
PMS Promotes the Recovery of Patients After Heart Valve Replacement

Acute gastrointestinal injury (AGI) is related to poor outcomes in patients after heart valve replacement. The purpose of this study is to evaluate the effect of the probiotic mixture supplementation (PMS) in patients after heart valve replacement by preventing acute gastrointestinal injury (AGI).

Patients with heart valve diseases often have chronic cardiac insufficiency. Accumulating evidence supports a relationship between the complexity and diversity of the gut microbiota and heart failure. Bacterial colonization and translocation of their toxins to the bloodstream due to altered intestinal permeability are directly correlated with systemic inflammation. The activation of pro-inflammatory pathways and chronic inflammation was hypothesized as a major contributing factor in the pathogenicity and progression of heart failure (HF) Patients undergoing heart valve replacement with cardiopulmonary bypass (CPB) are always complicated with gastrointestinal tract ischemia-reperfusion injury, which usually leads to AGI. AGI is related to poor outcomes of critically ill patients through many underlying mechanisms. It can leads to infectious complications, multiple organ dysfunction syndromes (MODS), and even death. On the other hand, the supply of probiotics, the good bacteria, is beneficial, despite still having a few controversial results. Therefore, it is important to carefully assess the efficacy of probiotics in the prevention of AGI and other complications in patients undergoing heart valve replacement surgery with CPB, as well as to evaluate the safety of its use.

Eligibility Criteria:
Inclusion Criteria:

* Moderate to severe congestive heart failure (CHF) (NYHA functional class III to IV)
* Patients with heart valve diseases undergoing CPB cardiac surgery
* Age \> 18 years and ≤ 70 years

Exclusion Criteria:

* Patients with severe low left ventricular function: LVEF ≤ 30%
* Patients with infective endocarditis
* Have received major gastrointestinal surgery (including gallbladder and appendectomy) within 5 years
* Inflammatory bowel disease (IBD), including ulcerative colitis, Crohn's disease, or colitis
* Acute gastroenteritis
* Clostridium difficile or Helicobacter pylori infection
* Chronic constipation
* Peptic ulcer
* Polyps in the stomach or intestines
* Gastrointestinal neoplasms
* Abdominal hernia
* Irritable bowel syndrome
* Acute or chronic cholecystitis, hepatitis
* Used antibiotics and probiotics in the past 1 month
* Patients used antidiarrheals, laxatives, or prebiotics within 1 week
* Pregnant or pregnant during follow-up
* Failure to give informed consent (e.g. severe cognitive impairment)
* The patient has been enrolled in other ongoing clinical trials
Urdu Version of Kujala Questionnaire: A Reliability and Validity Study

The aim of this research is to interpret and make Kujala Questionnaire adaptable culturally into Urdu to investigate its validity and reliability in Pakistani population among anterior knee pain or patello femoral knee pain. Also check its correlation with 36-Item Short Form Health Survey questionnaire, Lysholm Knee Scoring Scale and 2000 International Knee Documentation Committee Subjective Knee Evaluation Form.

The original English version of Kujala Questionnaire will be translated and culturally adapted as per previous recommendation. In patients with anterior knee pain or patella femoral knee pain, Kujala Questionnaire-Urdu will be distributed among hundred participants choose a convenience sampling technique based on pre-defined inclusion and exclusion criteria. To test reliability of inter/intra observer of ultimate final Urdu Version of Kujala, 36-Item Short Form Health Survey questionnaire, Lysholm Knee Scoring Scale and 2000 International Knee Documentation Committee Subjective Knee Evaluation Form will be filled from patients on the equivalent day, by 2 different bystanders, and for inter observer valuation, with an interval of 30 minutes between the first and second application. Third assessment will be carried out after 7 days of the Observer -1 (re-testing), for intra-observer assessment. Data will be entered and analyzed Cronbach alpha value. Test-retest reliability will be assessed using an intraclass correlation coefficient. Urdu Version of Kujala was evaluated for content validity, construct validity, criterion validity and responsiveness.

Eligibility Criteria:
Inclusion Criteria:

1. Both genders
2. Ages range from 18-40 years
3. They have clinically diagnosed with patello femoral pain syndrome (the diagnosis was established by a positive patellar grind test and pain on touch sensation, found in medial and lateral patellar facets)
4. Participants who acquire 40 to 80 score on Kujala patellofemoral questionnaire before the treatment start
5. Patients willing to participate.

Exclusion Criteria:

1. Participants of the study who has gone through any treatment protocol curative measure for patellofemoral pain syndrome during the last 3 months.
2. Any indication or medical record of lower extremity fracture or surgical procedure
3. History of certain chronic disease e.g. Diabetes Mellitus
4. Participants unable to understand Urdu Version of Kujala
Cross-sectional Study of Fibromyalgia

This study is designed to collect data on precipitating factors, diagnosis, morbidity, therapy, quality of life, and symptom severity, etc. informations in patients with fibromyalgia.

Patients fulfilling 1990 ACR criterion for fibromyalgia will be recruited in Fibromyalgia outpatient service which is belonged to the Department of Rheumatism. Except collecting patients' demographic and social characteristic informations, rheumatologist also carry out a comprehensive evaluation including patient current history, current medication use, and tender point examination for a diagnosis or confirmation of fibromyalgia and treatment recommendations. Patients with fibromyalgia will be asked to fill a set of questionnaires to evaluate their quality of life, symptoms severity, quality of sleep and emotion. The study will be conducted in Beijing, China.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older.
* Fulfills the American College of Rheumatology (ACR) 1990 classification criteria for Fibromyalgia.

Exclusion Criteria:

* Don't fulfill any classification criterions for Fibromyalgia.
Assessment of Immunoglobulins (IgG) in a Long-term Non-interventional Study

This non-interventional, epidemiological study assesses long-term outcomes in subjects receiving immunoglobulins (IgG) for any treatment purpose, irrespective of the regimen prescribed by the treating physician, under routine clinical conditions in Germany.

Long-term outcome data are collected on patient characteristics in the various indications, drug utilization of intravenous and subcutaneous IgG (e.g. treatment and dosing patterns), effectiveness (i.e. number of infections), tolerability, health related quality of life, and economic variables (number of hospitalizations, sick-leave days etc.) with the possibility to estimate direct costs.

In view of the broad range of indications in immunodeficiency and immunomodulation, it is of interest to document the use of IgG under the conditions of everyday practice and to analyze the endpoints (outcomes). A prospective cohort study such as this is an important evidence source for such rare diseases as those mentioned above. The aim of this outcome study is to fill the gap of the lack of long-term data in these rare diseases treated with IgG.

Eligibility Criteria:
Inclusion Criteria:

* Subjects of either gender with primary, severe secondary immunodeficiency and recurrent infections or neurological autoimmune diseases
* Naïve to IgG, or pre-treated with IgG
* Subject or parent/legally authorized representative has provided written informed consent.

Exclusion Criteria:

* None
Characterization of Metabolic Biomarkers in Varying Subjects

Traditional dietary, lifestyle, behavioral and pharmacologic treatment strategies have proven relatively ineffective for treating obesity, and once metabolic abnormalities such as Type 2 Diabetes (T2D) develop, definitive strategies to prevent major cardiovascular events remain elusive. More positively, the identification of a scientific resolution for obesity and T2D in the short-term is not outside the bounds of reality. Because the complexity of metabolic regulation is likely to include already characterized biomarkers, as well as other unidentified factors, it is logical to sample subjects of various ages, gender, ethnicity, body mass distribution, dietary habits, exercise habits, medication requirements, and disease states to discover associations and pathways related to the restoration of normal metabolism.

As an observational study design, study investigators will prospectively identify potential subjects from various primary care and/or specialty care clinics in Western New York. Prior to the commencement of any study procedures, subjects will document informed consent and acknowledgement of HIPPA rights. Following approval from their practitioner, subjects may be asked on multiple occasions to complete or undergo any or all of the following types of study procedures:

* Medical record review and follow-up
* Fasting blood sample (volume limitations stipulated within)
* Pre-meal, during meal, and post-meal blood sample (volume limits within)
* Short-term and/or long-term dietary intervention (MD approved)
* Short-term and/or long-term exercise intervention (MD approved)
* Blood glucose log
* Food and exercise diaries
* Pre- and post-medication blood sampling (neutraceutical or Rx products)
* 24-hour urine sampling
* Spot urine sampling
* Stool microbiologic sampling
* Intestinal microbiologic sampling (gastric bypass subjects only)

Eligibility Criteria:
Inclusion Criteria:

* Age =\>18
* Weight =\>110 pounds

Exclusion Criteria:

* Age \<18
* Weight \<110 pounds
* Pregnant
* Poor venous access or poor likelihood to adhere with study procedures
Prevention of Preterm Labor in Patients With a Previous Episode of Threatened Preterm Labor With Progesterone

The purpose of this study is to determine if the use of 250 mg of intramuscular progesterone biweekly can reduce the incidence of preterm labor in patients with an episode of threatened preterm labor during the current pregnancy.

Preterm birth is one of the main causes of neonatal mortality and morbidity around the world, with serious repercussions on the health system and the families of the preterm baby. Many drugs have been evaluated with the purpose of preventing preterm birth in the patient at risk. One of these drugs is 17 α hydroxyprogesterone caproate. The purpose of this study is to evaluate if the use of biweekly doses of 17 α hydroxyprogesterone caproate in patients hospitalized with the diagnosis of threatened preterm labor, defined as the presence of uterine contractions and a short cervix (below the 10th percentile for the gestational age), can reduce the incidence of preterm birth in this high risk group population.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women between 26 and 34 weeks of gestation.
* Cervical length (determined by transvaginal ultrasound) below the 10th percentile for the gestational age.

Exclusion Criteria:

* Multiple gestations.
* Maternal pathologies in which preterm termination of pregnancy is required.
Levocarnitine in Treating Patients With Vismodegib-Associated Muscle Spasms

This randomized clinical trial studies levocarnitine in treating patients with vismodegib-associated muscle spasms. Levocarnitine may decrease muscle spasms caused by vismodegib.

PRIMARY OBJECTIVES:

I. To determine the effect of levocarnitine on muscle spasm frequency compared to placebo (median percentage comparison)

SECONDARY OBJECTIVES:

I. To assess intensity of muscle spasms after levocarnitine compared to placebo.

II. To assess responses related to activities of daily living or psychosocial function after levocarnitine compared to placebo.

III. To assess the number of body locations affected by muscle spasms after levocarnitine or placebo.

IV. To assess the frequency and severity of all adverse effects on levocarnitine versus placebo.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive levocarnitine orally (PO) twice daily (BID) during weeks 1-4. Washout is from weeks 5-8. Patients then cross-over to placebo PO twice daipy for weeks 9-12.

ARM II: Patients receive placebo PO twice daily during weeks 1-4. Washout is from weeks 5-8. Patients then cross-over to levocarnitine for weeks 9-12.

Eligibility Criteria:
Inclusion Criteria:

* Taking vismodegib daily
* Subject answers item #1 of muscle spasms questionnaire as moderate or severe intensity at time of screening
* At least one muscle spasm per day at time of screening
* Muscle spasms onset after starting vismodegib
* Willing and able to understand and sign consent form

Exclusion Criteria:

* Presence of muscle spasms or active neurologic disease prior to start of vismodegib
* Use of thyroid medication at the time of screening
* Use of Coumadin or acenocoumarol at time of screening
* Change in regimen of muscle relaxant medications within four weeks of enrollment
* If on stable muscle relaxant medication regimen for 4 weeks prior to enrolling, not willing to maintain muscle relaxant regimen without change during course of the study
* Presence of significant renal disease or hemodialysis which would result in dramatic reductions of systemic levocarnitine levels
* History of seizures
* Known deficiency in carnitine (genetic, etc.)
* Any uncontrolled medical condition which may place the patient at increased risk during study participation (at the discretion of the clinical investigator)
* Unable or unwilling to comply with study procedures
* Pregnant or lactating
* All female patients of childbearing potential including those who are within 1 year of last menstrual period will be required to take a pregnancy test during screening, enrollment and at week 0, 4, 8 and 12
* If female of reproductive age, or male partner of female of reproductive age, unwilling to use two medically reliable forms of birth control while on vismodegib
* Unwilling to refrain from donation of bodily fluid (blood, platelets, etc.) within 7 months of last vismodegib dose
Functional Impairment in Albinism

Albinism is a genetic and hereditary anomaly that affects pigmentation. This pathology is characterized by a deficit in melanin production. In humans, the clinical diagnosis of albinism is based on a number of factors, including :

* In the integumentary region: fair skin tone, with white hair, eyelashes and eyebrows.
* Ophthalmological: reduced visual acuity, photophobia, nystagmus, transilluminated blue irises, hypopigmentation of the retina at the back of the eye with fovea plana.

As treatment options begin to emerge for certain albinism-induced anomalies (including, for example, the depigmentation that causes photophobia), it is desirable to understand what these patients' complaints are, and to gather their views on the emergence of treatments targeting just one of their complaints, namely glare.


Eligibility Criteria:
Inclusion Criteria:

* All patients with albinism
* Patients \> 18 years of age
* Non-opposition to study participation

Exclusion Criteria:

No diagnosis according to Kruijt et al. criteria Impossibility (visual, technological) of completing questionnaire
Increasing Community-acquired Pneumonia Protocol Adherence by Antibiotic Stewardship

The purpose of this study is to determine the effect of a multifaceted antibiotic stewardship intervention on protocol adherence of moderate-severe community-acquired pneumonia.

The purpose of the study is to show a decrease in broad-spectrum antibiotics with a non-inferiority in 90-day mortality. Hospitals with a pre-intervention protocol adherence of \>70% are excluded from the primary analysis. Primary analysis will be done with a mixed effects model with a random effects for clusters and time. Crude outcomes and outcomes adjusted for potential confounders will be reported. Primary analysis will be tested one-sided for a decrease in mortality. Secondary analysis to test two-sided for mortality will be performed.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with CAP who get admitted to a non-ICU department are eligible for inclusion.

Exclusion Criteria:

* Patients aged below 18 years
* Residence in a nursing home or long-term care facility in the last 14 days
* Patients hospitalized in an acute care hospital for two or more days in the last 14 days
* Patients with a history of Cystic Fibrosis
* Patients with immunodeficiency, defined as having one or more of the following criteria:

  * HIV infection with a last CD4 count of \<300//μL
  * Cytotoxic chemotherapy or radiotherapy in the previous 3 months
  * Chronic hemodialysis \> 3 months
  * History of receiving an organ or bone marrow transplant
  * Using immunosuppressive therapy, include corticosteroid treatment only when dosage is high (\>0,5mg/kg/day) for a longer period of time (\>14 days)
The Impact of an Animated Video on Preoperative Anxiety in Children Undergoing Elective Otoplasty

The study is a prospective, randomized, single-blind controlled superiority trial to evaluate the effect of viewing an informative animated video a day prior to surgery on preoperative anxiety in pediatric patients scheduled for elective otoplasty. The primary outcome will be modified Yale Preoperative Anxiety Scale (mYPAS) score at the time of general anesthesia induction compared between families that were assigned to view the animated video the day before and those that were not. The participants for this study will be children undergoing elective otoplasty at the IWK Health Centre. Those participants randomized to the intervention group will receive a link to a short survey gauging parent anxiety levels. The survey will be followed by a link to an informative animated video which the participants and their families will watch. The control group will be participants assigned not to receive the email link to the informative animated video.


Eligibility Criteria:
Inclusion Criteria:

* They are undergoing an otoplasty alone with no other procedures on the same day
* The patient must not have previously undergone an otoplasty; the patient must be between the ages of 4 and 12;
* The patient must understand spoken English;
* The participating parent must be able to read English at a grade six level; and the patient should not have received premedication.

Exclusion Criteria:

* Under the age of 4 or over the age of 12
* Have not undergone a previous otoplasty
Safety and Performance Study of the CyPass System Applier Model 241

This is a retrospective chart review of cases in which the CyPass Micro-Stent was implanted using the Model 241 Applier. The objective of this study is to characterize and evaluate the safety of the Model 241 Applier when used for CyPass Micro-Stent implantation.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of OAG
2. CyPass Micro-Stent implantation (using the CyPass system 241) following uncomplicated phacoemulsification cataract removal and intraocular lens implantation

Exclusion Criteria:

1. Diagnosis of acute angle closure, traumatic, congenital, malignant, uveitic or neovascular glaucoma
2. Prior incisional glaucoma surgery
Pharmacologic Relapse Prevention for Alcoholic Smokers

This study will compare the long-term use of bupropion (Wellbutrin) and placebo for reducing the rate of smoking relapse in recovering alcoholics who achieved initial abstinence from smoking with nicotine patch therapy. The study will also determine the cessation rate in the 8th week of treatment among recovering alcoholics using a nicotine patch. The patch dose is projected to serve as a 100-percent replacement.

The purpose of this trial was to recruit 292 recovering alcoholic smokers (abstinent from alcohol for a minimum of 1 year), who want to stop smoking and provide them with 100% nicotine replacement. The 100% nicotine replacement will be undertaken using a nicotine patch. By measuring their nicotine levels at study entry we can determine the patch dosing needed. The patch dosing will vary from 22 mg to 44 mg. Those who are able to achieve tobacco abstinence by week 8 will enter a relapse prevention phase for the remaining 44 weeks. In this phase, they will be randomized to active or placebo bupropion (300 mg/day). After 44 weeks of the relapse prevention trial (at week 52 of study participation), they will enter a post medication follow up for 6 months.

Eligibility Criteria:
Inclusion Criteria:

* History of alcohol dependence and at least one year of abstinence from alcohol intake.
* Has a history of smoking 20 or more cigarettes per day for the prior year.
* Can read and write English.
* Stated ability to fully participate in the study and keep all scheduled appointments.
* Has provided written informed consent.
* General good health.

Exclusion Criteria:

* Recent history (within three months) of a clinically significant myocardial infarction, unstable angina pectoris, serious cardiac arrhythmia or any other medical condition which the physician investigator deems incompatible with study participation.
* Current major depression. A past history of major depression will not be an exclusionary criteria.
* Current or previous use of bupropion (Wellbutrin).
* Active non- nicotine drug dependence.
* Past or current history of bipolar disorder, pain disorder or psychosis, schizophrenia, or other major psychiatric disorders.
* Current medically indicated use of psychiatric drugs.
* Females who are pregnant, lactating, or likely to become pregnant during the first year which includes the nicotine patch and bupropion (Wellbutrin) phase.
* History of severe skin allergies or evidence of severe chronic skin disorders.
* Current use of nicotine containing medication or tobacco products other than cigarettes.
* Current use (within 30 days of initiation of patch therapy) of the following medications for smoking cessation: clonidine, buspirone, or doxepin.
* A predisposition to seizures.
* A history of or current diagnosis of anorexia nervosa or bulimia.
* Medical disorder that would interfere with the absorption, metabolism, or excretion of bupropion (Wellbutrin).
Central Blood Pressure in Adolescents and Young Adults

This study aims to investigate in adolescents and young adults:

* the 24h diurnal variation of ambulatory central blood pressure
* the association of central compared to peripheral blood pressure with indices of asymptomatic target-organ damage


Eligibility Criteria:
Inclusion Criteria:

* Adolescents and young adults (age range 12-25 years)

Exclusion Criteria:

* Subjects with any acute or significant chronic disease, with evidence of secondary hypertension, or on regular drug treatment will be excluded
ARMOR1: Study of TOK-001 to Treat Castration Resistant Prostate Cancer

The purpose of this study is to determine whether TOK-001 is safe and shows biological effect in the treatment of castration resistant prostate cancer (CRPC).


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent form
* Confirmed cancer of the prostate
* Progressing disease in spite of androgen ablation therapy
* Able to swallow multiple capsules

Exclusion Criteria:

* Participation in another clinical trial \< 4 weeks prior to enrollment
* Metastatic disease with one or more of the following:

  * Liver involvement
  * Bone pain associated with confirmed evidence of metastases
  * Non-hepatic visceral involvement
* The following medications:

  * Prior treatment with MDV3100, abiraterone, Provenge or TAK700
  * Prior treatment with ketoconazole
  * Prior treatment with chemotherapy
  * Prior radiation therapy completed ≤ 4 weeks prior to enrollment
* The following medical conditions:

  * Active angina pectoris
  * History of Hepatitis B or Hepatitis C
  * Known HIV infection
  * Ongoing hypertension

Note: There are additional inclusion and exclusion criteria. The clinical site center will determine if you are eligible. If you are not eligible for the trial, site staff will detail the reasons to you.