cyrilzakka/clinical-trials huggingface dataset:
Different Dosing Time of Bowklean for the Bowel Preparation

The primary objective of this study is to compare the efficacy of administration routine bowel cleansing medication (Bowklean) for the Bowel Preparation at Different Times Prior Colonoscopy in the morning or in the afternoon.

Sodium picosulfate/magnesium citrate (SPMC) is a small-volume bowel cleansing agent with similar efficacy and better tolerability than polyethylene glycol. However, there was limited data about the bowel cleansing efficacy of SPMC in comparing the same-day and split-dose preparation for afternoon colonoscopy.

This randomized, single-center, endoscopist-blinded, non-inferior study compared same-day (101 subjects) and split-dose (96 subjects) preparation with SPMC for afternoon colonoscopy. One additional prospective observation group of 100 subjects receiving colonoscopy in the morning was included as an observation group to compare bowel preparation in morning and afternoon colonoscopy. Efficacy of bowel cleansing was evaluated by the Aronchick Scale, Ottawa Bowel Preparation Scale (OBPS), Boston Bowel Preparation Scale (BBPS), and the Bubble Scale (TBS).

Eligibility Criteria:
Inclusion Criteria:

1. Subject is 20 and 99 years, inclusive.
2. Men or non-pregnant women who are scheduled for an elective colonoscopy.
3. Subjects should be willing, able to complete the entire procedure and to comply with study instructions.
4. Written informed consent obtained prior to study.

Exclusion Criteria:

1. Patients who are not suitable for colonoscopy

   * Acute surgical abdominal conditions (e.g. acute obstruction or perforation, etc.)
   * Active (acute/exacerbation of/severe/uncontrolled) Inflammatory Bowel Disease (IBD)
   * Colon disease (history of colonic cancer, toxic megacolon, toxic colitis, idiopathic pseudo- obstruction, hypomotility syndrome)
   * Gastrointestinal disorder (active ulcer, outlet obstruction, gastric retention, gastroparesis, ileus)
   * Uncontrolled angina and/or Myocardial Infarction (MI) within last 3 months before randomization, Congestive Heart Failure (CHF), arrhythmia, cardiomyopathy or uncontrolled hypertension
   * Renal insufficiency
2. Any prior colorectal surgery

   * in the past 3 months, excluding appendectomy, hemorrhoid surgery or prior endoscopic procedures
   * History of upper gastrointestinal surgery (gastric resection, gastric banding, gastric by-pass)
3. Severe chronic constipation
4. Hypersensitivity to any ingredient in the study medication
Postoperative Analgesis for Pain Management After Thoracotomy

Thoracotomy is among the most painful surgical procedures and can cause severe pain. Postoperative pain causes many complications. Therefore, pain management is important in patients undergoing thoracotomy. For this purpose, systemic analgesics are used along with ultrasound-guided nerve blocks in thoracotomy pain. The effectiveness of thoracic paravertebral block and serratus plane block in the treatment of post-thoracotomy pain will be evaluated by comparing their effectiveness and complications on postoperative pain. Since the epidural spread of the thoracic paravertebral block is more effective, the effectiveness of postoperative pain relief will be more effective

Thoracotomy is among the most painful surgical procedures and can cause severe pain. This pain causes postoperative complications in patients who have thoracotomy surgery. Uncontrolled pain can cause respiratory and thromboembolic events. Therefore, effective pain management is important in patients undergoing thoracotomy. Investigators aim to compare the analgesic effectiveness and complications of thoracic paravertebral block and serratus anterior plane block in relieving thoracotomy pain, which is one of the most painful surgical procedures. It is aimed to compare the effectiveness and complications of thoracic paravertebral block and serratus plane block in postoperative pain control after thoracotomy. Providing pain control reduces postoperative complications and reduces hospital stay, which increases patient comfort and reduces costs. In this research, postoperative morphine consumption after block applications will be compared, and patients' analgesic needs will be evaluated according to the participants' VAS score. Post-operative 3rd, 6th, 9th, 12th, 24th. Morphine consumption will be evaluated by monitoring the hours. It will be evaluated whether there is a need for additional analgesics. During the operation, the patient's heart rate, blood pressure, saturation and temperature variable values will be closely monitored. Standard monitoring methods will be used when examining these parameters.

Eligibility Criteria:
Inclusion Criteria:

* 18-75 aged patients
* American Society of Anesthesiologists Classification (ASA) I-II-III patients
* patients who scheduled elective thoracic surgery

Exclusion Criteria:

* American Society of Anesthesiologists Classification (ASA) IV-V patients
* patients with coagulopathy
* patient with infection at the injection site
Parent-based Intervention for Language Delayed 2 to 3 Year Olds

The aim of the study is to evaluate the impact of parent based intervention on the language of 2 to 3 year old children from socially disadvantaged populations with a clinical diagnosis of primary language delay.

This project is original in proposing to evaluate the effectiveness of a parent-based intervention for a clinical population of 2 to 3 year olds with a diagnosis of primary language delay in areas of social disadvantage. It is original in developing an interagency, integrated model of delivery in line with the health and social care agenda (NHS 5 Year Forward Plan). It is also original in examining the effect of parent attitudes on child outcomes.

Eligibility Criteria:
Inclusion Criteria:

Inclusion criteria (to diagnose primary language delay):

* The child is 24-36 months old
* The child has little or no expressive language (a vocabulary of 40 or less single words)
* The child has no known aetiology; the language delay is not secondary to sensory, structural, neurological or cognitive impairments
* The family have been assessed as having low socioeconomic status The study will use the Index of Multiple Deprivation (IMD) as a basis to determining a measure of deprivation. The IMD combines information from seven domains (income, employment, education, health, crime, housing and living environment) to produce an overall measure and it ranks how deprived areas are relative to others. This will be used to determine which areas and Children's Centres will be involved in the proposed RCT. However, as this is a geographical ranking, the RCT will include further refinement of eligibility of social disadvantage via assessment of individual measures of income deprivation, employment deprivation and education attainment. This information on employment and parent education levels will be collected via the case history taken at the initial assessment, as this is standard practice in a profile of risk for child language delay. The additional information on income will be taken at the first research assessment, as this does not form part of standard practice

Exclusion Criteria:

* The child's expressive language consists of a vocabulary of more than 40 single words
* The child's language delay is secondary to sensory, structural, neurological or cognitive impairments
* English is not the first language for the family.
* Where English is not the first language, children would be excluded. Adjustments to the protocol and delivery of intervention would be required where English is an additional language (EAL) and there is a need to test the intervention first on an English-speaking population. If effective, a longer term programme plan would be to amend the programme and evaluate the effectiveness with EAL children.
Efficacy and Safety Study of Uracyst to Treat Interstitial Cystitis/Painful Bladder Syndrome

A new device for interstitial cystitis is compared to inactive control to determine if it is safe and effective. The study lasts approximately 7 weeks with a 19-week follow-up period.

Multi-center, randomized, double-blind, parallel, 8 weekly instillations over a 7-week period with post-treatment follow-up for an additional 19 weeks for a total study length of 26 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Are a female, 18 years or older
* Have been diagnosed with IC/PBS
* Are willing to provide written informed consent and authorization to disclose after being fully informed of the risks of participation

Exclusion Criteria:

* Are lactating females
* Have previously received investigational products or devices within 30 days of screening
* Have previously received Uracyst
* Are currently receiving therapy with Interstim®
* Have any other condition/disease which, in the opinion of the investigator, could compromise subject safety or confound the interpretation of study results
* Are unable or unwilling to comply with protocol requirements
Analgesic Efficacy of Testosterone Replacement in Hypogonadal Opioid-treated Chronic Pain Patients: A Pilot Study.

The purpose of this pilot study is to test the effects of testosterone replacement on pain, fatigue, mood, cognition and libido in hypogonadal men on long-term opioid therapy for chronic pain.

Opioids are increasingly used for the treatment of non-malignant chronic pain with as many as five to ten million patients treated at the time of the most recent estimate in 2002. The side effects of opioids such as fatigue, loss of libido, Impaired cognition and sexual dysfunction have long been recognize and strikingly, resemble symptoms of hypogonadism in men. Many studies have demonstrated a high prevalence of hypogonadism in male subjects who are long-term users of opioids. The aims of this pilot study are, in hypogonadal men being treated with opioids for chronic pain, to: 1) determine the effect of TRT on pain; 2) determine effects of TRT on fatigue; 3) determine the effect of TRT on mood; 4) determine effects of TRT on cognition and 5) characterize the effects of TRT on sexual dysfunction. This study is a randomized, placebo-controlled, 6-week pilot study.

Eligibility Criteria:
Inclusion Criteria:

* Adult male patients (above 18 years old and below 60 years old)
* Receiving greater than 20 IV morphine equivalents/day with \<20% change in dosage in the last month.
* AM total testosterone \<300 ng/dL
* Report "worst pain during the past week" grater than 4 on an 11-point numeric scale.

Exclusion Criteria:

* Females
* Poorly controlled, symptomatic, active medical or psychiatric problems (e.g., HIV, hepatitis, diabetes, cancer, benign prostatic hypertrophy, substance abuse, major depression)
* Neurological or psychiatric disorder that would compromise the patient's ability to give informed consent or adhere to the requirements of the protocol.
* History of prostate cancer, abnormal findings on digital rectal exam, or PSA greater than 4.0 ng/m
* History of polycythemia
* Renal or hepatic dysfunction
* Hematocrit \>55%
* Known history of hypersensitivity to transdermal testosterone gel.
* Abnormalities during digital rectal exam.
The Prenatal/Early Infancy Project: An Adolescent Follow-up

The Nurse-Family Partnership, a program of prenatal and infancy home visiting by nurses, has been examined in a series of 3 randomized trials since 1977. It has received considerable attention in the scientific and public policy communities for its replicated effects on a variety of maternal and child health outcomes across these 3 trials, including prenatal health, childhood injuries, rates of subsequent pregnancies, inter-birth intervals, as well as its long-term effects on maternal life-course, criminal behavior, and 15-year-olds' criminal and antisocial behavior in the first trial of the program conducted in Elmira, New York.

Although this program produced positive effects on maternal and child health from pregnancy through the child's fourth year of life, its long-term effects remain unexamined. The current study was conducted to determine the extent to which the beneficial effects of the program set in motion early in the life cycle altered the life-course trajectories of the mothers and the children's adaptive functioning through the first child's 15th birthday. This study examines the long-term effects of the program on two domains of maternal functioning: 1) maternal life course (subsequent children, use of welfare, employment, substance abuse, and encounters with the criminal justice system); and 2) perpetration of child abuse and neglect; and two domains of the children's behavior: 1) their functioning in schools, and 2) their criminal and antisocial behavior. The investigators hypothesized that the program effects in these domains of maternal and child functioning, as in earlier phases of the study, would be greater for families in which the mothers experienced a larger number of chronic stressors and had fewer resources to manage the challenges of living in poverty and being a parent.

Eligibility Criteria:
Inclusion Criteria: Must be offspring of mothers who enrolled in Elmira randomized clinical trial of the Nurse-Family Partnership (known as the Prenatal Early Infancy Project) -

Exclusion Criteria:

-
The Effect of Micronutrient Supplementation on Gut Microbiome Composition and Function

The main aim of this randomized crossover study is to explore the effect of micronutrient supplementation on gut microbiota composition and function in healthy volunteers. Participants will undertake two 10-day trials with a replicated diet separated by a 15-day washout period. For one of these trials, participants will take a daily over-the-counter multivitamin supplement. Faecal and urine samples will be collected at the start and end of each trial to assess changes in gut microbiota composition, urinary and faecal metabolomics, and targeted bacterial metabolites including short chain fatty acids, sulphide, and lactate.

Exploring the effect of habitual dietary patterns on human gut microbiota and on host health is an area of scientific interest and a major funding theme in UKRI. The main aim of this proof-of-concept study is to explore the effect of micronutrient supplementation on gut microbiota composition and function in healthy volunteers.

Participants will be asked to undertake two trials with 15 day washout in-between. If the participants are allocated to the "supplementation group" they will be asked to consume an over-the-counter multivitamin supplement for 10 days (1 tablet per day) in addition to their usual diet. Participants will provide faecal and urinary samples prior to initiation of the intervention and again at the end of the 10-day supplementation. During these 10 days participants will be asked to record the meals they consume on provided food diaries. If the participants are allocated to the "control group", participants will be asked to provide the same number of samples and at the same intervals as the supplementation group (i.e. at baseline and after 10 days) but without receiving micronutrient supplementation. Participants will also be asked to replicate as close as possible the diet they had followed during the first trial they were allocated. Between the two trials, participants will follow a wash-out period of 15 days with the aim of reverting the gut microbiota characteristics back to baseline levels.

The main outcome measures of this study are to assess changes in gut microbiota composition based on 16S rRNA gene amplicon sequencing, changes in urinary/faecal metabolomics, and changes in targeted bacterial metabolites (short chain fatty acids, sulphide, lactate).

Eligibility Criteria:
Inclusion Criteria:

* Healthy adults \>18 y

Exclusion Criteria:

* History of previous major gut surgery,
* Unstable weight,
* Use of pre/probiotics, micronutrient supplements, antibiotics, or steroids the last 3 months
* Participation in other research
Study to Compare the Effect of Vytorin (Simvastatin/Ezetimibe) 10/20mg Versus Atorvastatin 20mg on ApoB/ApoA1 Ratio in Subjects With Diabetes

A single center, open label, randomized, clinical trial comparing ApoB/ApoA ratio of Vytorin 10/20mg vs atorvastatin 20mg treatment.

DM2 patients will be screened for inclusion criteria. Patients (n=66 in each arm) will be randomized to either Ezetimibe/simvastatin 10/20mg or atorvastatin 20mg after 4 week washout or TLC period. Primary and secondary endpoints will be assessed at week 12.

Primary endpoint:

1) change of ApoB/ApoA ratio at week 12.

Secondary endpoint:

1. Change of lipid parameters (TC, LDL-C, HDL-C, TG, apoB 48) at week 12.
2. Change of HbA1C at week 12.
3. Change of HOMA index at week 12

   - HOMA =\[Fasting insulin (mIU/L) × Fasting glucose (mmol/L)\] / 22.5
4. Change of hsCRP at week 12
5. Safety assessment

Hypotheses:

* Three months treatment of Vytorin 10/20mg will be superior to atorvastatin 20mg in ApoB/ApoA ratio.
* In DM patients, Ezetimibe/Simvastatin Combination will be well-tolerated.


Eligibility Criteria:
Inclusion Criteria:

1. Type 2 DM
2. Hypercholesterolemia (baseline screening LDL-C \> 100 mg/dL)
3. In case of medication, stable doses of oral hypoglycemic agents for at least three months
4. HbA1c \<8.5%
5. Age: 20-80

Exclusion Criteria:

1. Chronic renal failure: creatinine \> 3.0 mg/dL
2. Serious liver disease (\> x3 LFT UNL)
3. Congestive heart failure
4. Stroke or MI/coronary intervention during the preceding 3 months.
5. CK \> x 2.5 UNL
6. Unstable hypo/hyperthyroidism
7. Pregnant/lactating woman, or woman intending to become pregnant
8. Subject with any clinically significant condition or situation, in the opinion of the investigator, would interfere with the study evaluations or optimal participation in the study.
Epidemiology of Congenital Cytomegalovirus in a High HIV Prevalence Setting, South Africa

The aim of this project is to determine the epidemiology of congenital cytomegalovirus (CMV) infection and incidence of subsequent permanent neurological sequelae in a high HIV prevalent setting in Soweto, Johannesburg. A cross-sectional study will be conducted on mother-infant pairs, screening mothers for CMV infection and newborns for congenital CMV infection. Maternal CMV prevalence will be determined by testing for CMV specific antibodies in blood. Newborn congenital infection will be determined by polymerase chain reaction (PCR) tests on newborn saliva and urine within 3 weeks of birth. Various risk factors associated with congenital CMV such as HIV exposure, and gestational age will be assessed. The association between maternal vaginal CMV shedding postnatally with congenital CMV infection will be explored by swabbing maternal vaginal fluid and conducting quantitative CMV PCR analysis. Newborns confirmed with congenital CMV and a control group of uninfected newborns will form a cohort to be followed up until 12 months of age monitoring for various neurological sequelae such as hearing loss, neurodevelopmental impairment, ocular damage, cerebral damage and seizures.

A comparison of vaccine immune responses between cases of congenital CMV and the CMV uninfected infants to the primary series of vaccines in the National Expanded Programme on Immunisation will be compared. The contribution of CMV infection to neonatal death and stillbirths will be described by minimally invasive tissue sampling (MITS) for CMV on babies that die during the neonatal period and stillbirths.


Eligibility Criteria:
Inclusion Criteria:

* Mother's age ≥18y
* Residing in Soweto and would be available for study follow-up
* Consents to enrol self and baby in study

Exclusion Criteria:

- Mother not enrolled in V98_28OBTP (NCT02215226)
Acute Effects of Cafestol on Glucose Metabolism in Subjects With Type-2-diabetes.

Acute, double-blinded, randomized, cross-over cafestol intervention study with sixteen participants with T2D participating in two OGTTs.

The study is an acute, double-blinded, randomized, cross-over intervention study with sixteen participants with T2D. Initially, a blood sample is obtained (t=-15 min) and at time point 0, the participants will ingest a tablet containing either 12 mg cafestol or placebo. Immediately hereafter an OGTT commences with ingestion of a 75 g glucose solution. In the following 3 hours blood samples are collected at time points 0, 15, 30, 60, 90, 120 and 180 min. The samples will be used for determination of plasma glucose, insulin and cafestol, as well as GLP-1 and GIP. After a one-week washout period, the subject will undergo the same set-up again, however now with the opposite intervention / placebo.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 Diabetes defined by standard Danish guidelines
* HbA1c ≥48 mmol/mol unless successfully treated with antidiabetic drugs and/or diet/exercise intervention

Exclusion Criteria:

* In treatment with insulin
* Pregnancy
* Planned pregnancy
* Breastfeeding
* Significant comorbidity expected to unable the subject from completing visits
Phase 2 Study of TLK286 in Metastatic Breast Cancer

The purpose of this study is to determine the effectiveness of TLK286 in treatment of metastatic breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* Histologic diagnosis of breast cancer
* Metastatic disease
* Measurable or evaluable disease
* No prior chemotherapy regimens
* Age at least 18 years
* Adequate liver and kidney function
* Adequate bone marrow function

Exclusion Criteria:

* Pregnant or lactating women
* Unstable medical conditions
* Chemotherapy within 14 days of TLK286
* Radiation therapy within 14 days of TLK286
* Hormonal therapy within 14 days of TLK286
* Immunotherapy within 14 days of TLK286
* CNS metastasis unless controlled by treatment
Study on Home Obstructive Respiratory Exacerbations

Listening to breath sounds with a stethoscope/auscultation is used by pulmonary physicians in conjunction with pulmonary function, signs and symptoms, oxygen saturation and diagnostic testing to admit, follow, and discharge patients from the hospital. Of these, only auscultation routinely ceases upon discharge from the hospital. Healthcare utilization statistics have shown that for more than a decade, readmission after discharge for an exacerbation of COPD remains a major problem. The Strados RESP Biosensor has been designed to extend the range of lung sound recording both geographically and temporally to improve the standard of care when access to continuous monitoring has been replaced by periodic or no monitoring. The primary purpose of this study is to assess the associations between RESP Biosensor-acquired lung findings and subjective measures of respiratory symptoms as measured by validated measurement tools, and objective measure of respiratory physiology as determined by home pulse oximetry.


Eligibility Criteria:
Inclusion Criteria:

1. Males and females between the ages of 40 and 80 with documented physician-diagnosed COPD and FEV1/FVC\<0.70 or LLN based on post-bronchodilator spirometry
2. History of 2 moderate COPD exacerbations and/or 1 severe COPD exacerbation within the past 6 months
3. At least 30 days since hospital discharge from COPD exacerbation
4. 6-month risk of 20% for moderate exacerbation and 7.5% for severe exacerbation based on ACCEPT score (with possibility of changing to 15% for moderate exacerbation and 5% for severe exacerbation if enrollment is insufficient)
5. Tobacco History: Current or Former Smoker

1. Has smoked at least 100 cigarettes in his/her lifetime 6. Patient can follow study procedures, including instructions for self-placement and operation of biosensor

1. Patient has experience/owns a smartphone 7. Patient is accessible by telehealth/telephone for duration of the study 8. Patient is able and willing to return to study site for study visits as necessary

Exclusion Criteria:

1. Patient is unable or unwilling to provide informed consent
2. Any condition that, in the opinion of the investigator, would limit the patient's activity in the study and/or adequate lung sound capture using the RESP™ wearable device
3. Patient with end-stage medical condition with expected survival no more than 6 months
4. History of adverse reaction or allergy to adhesives such as TegaDerm®