cyrilzakka/clinical-trials huggingface dataset:
Primary Prophylaxis for Spontaneous Bacterial Peritonitis

Patient with liver cirrhosis commonly have co-existing small bowel bacterial overgrowth (SIBO) yet may be asymptomatic. It is unclear as to the value of treating SIBO in asymptomatic individuals. Cirrhosis increase permeability of the gastrointestinal mucosa. It is postulated that in cirrhosis, endotoxins translocate across the gut mucosal barrier resulting in a second hit within hepatocyte perpetuating decompensation and spontaneous bacterial peritonitis. We hypothesise that cirrhosis patients with concomitant SIBO are particularly vulnerable for endotoxin translocation and would benefit from treatment. Treatment of SIBO would reduce the risk of spontaneous bacterial peritonitis and other liver-related morbidities. We aim to treat a cohort of patients with severe liver disease and concomitant SIBO with antibiotics as prophylaxis and compare the risk of spontaneous bacterial peritonitis, further liver-related morbidity and survival against untreated asymptomatic controls.


Eligibility Criteria:
Inclusion Criteria:

* Decompensated liver cirrhosis (Childs B \& C) with ascites.
* Established diagnosis of SIBO

Exclusion Criteria:

* Known allergy to treatment drugs
* Inability to undergo test confirm the success of SIBO eradication;
* Pregnant or lactating women
* Terminal malignancy.
* Untreated Viral Hepatitis
* Alcoholic Liver disease with ongoing drinking.
* Respiratory Failure
* Recent antibiotics and proton-pump inhibitor within 30 days
Nordic Luveris Study

To study whether addition of human LH hormone (Luveris) during the final days of stimulation with recombinant FSH (Gonal-f) for controlled ovarian stimulation will be of benefit for patients undergoing in vitro fertilisation.


Eligibility Criteria:
Inclusion Criteria:

* Age below 40
* Infertility treatable by IVF or ICSI
* Regular cycles

Exclusion Criteria:

* NA
A Study of AK3280 in Chinese Healthy Volunteers

This study is a randomized, double-blind, placebo-controlled, single-center, phase I study to evaluate the safety, tolerability, and pharmacokinetics of AK3280 in healthy Chinese subjects.

This phase I study is a randomized, double-blind, placebo-controlled, single-center clinical study in healthy subjects. The objectives of the study are to evaluate the safety, tolerability, and pharmacokinetics of AK3280. Approximately, 36 healthy Chinese subjects will be recruited and randomized to orally receive AK3280 or matching placebo. The total duration of the study will be approximately 25 days for each subject.

Eligibility Criteria:
Inclusion Criteria:

* Participants who are willing to sign and date informed consent forms.
* Male or female participants between 18 and 45 years of age, inclusive.
* Have a bodyweight ≥50.0 kg (Male) or ≥45.0 kg (Female), and a body mass index (BMI) between 19.0 and 28.0 kg/m\^2, inclusive.
* Participants are in good health without any significant clinical abnormalities on the basis of medical history related to heart, liver, kidneys, gastrointestinal tracts, or mental, central nervous, and metabolic disorders; physical examination (including vital signs); baseline laboratory test and 12-lead electrocardiogram (ECG) results.
* Participants (including male participants) who have no pregnancy plan and are willing to use an effective method of contraception during the screening period and for three months thereafter without sperm or egg donation plans.
* Participants who are capable to communicate with investigators and comply with the study requirements.

Exclusion Criteria:

* Allergic to any of the study drug ingredients or ineligible determined by the investigator due to a history of food or drug allergies.
* Having an abnormal medical history in terms of clinically significant digestive, urological, neurological, hematological, endocrine, oncological, pulmonary, immunological, cardiovascular, or psychiatric diseases or having histories of use any prescription, over-the-counter, herbs, vitamins, or vaccines within four weeks prior to study drug administration.
* Intolerant to venipuncture or having difficulty in venous blood collection.
* Having a personal history of drug and alcohol abuse, use of nicotine-containing products, receiving caffeine-containing drinks, taking grapefruit or food made of it, and medications, food, or beverages such as xanthines that could affect the ADME of study medication.
* Having clinically significant abnormalities in vital sign measures and lab test results.
* Female subjects are lactating at screening.
* Previous participation in any clinical trial within 3 months prior to screening.
* Inability to meet the study requirements in the opinion of the investigator.
Pharmacokinetics of Atazanavir/Ritonavir in HIV-1 Infected Pregnant Women

To determine what dosing regimen of atazanavir (ATV) / ritonavir (RTV) produces adequate drug exposure during pregnancy compared to drug exposure in historical data in human immunodeficiency virus (HIV) infected participants.


Eligibility Criteria:
Inclusion Criteria:

* HIV-infected pregnant women
* \> 18 years of age
* Between week 12 and 32 gestation
* CD4 \> 200 cells/mm³
* Treatment-naive with HIV RNA \> 400 c/mL, on HAART with HIV RNA \<50 c/mL, or previously treated with ATV (\< 3 weeks) with HIV RNA\>400 c/mL
Nanofat Grafting as a Method of Treating Critical Limb Ischemia

This clinical trial will investigate nano fat grafting as a method for treating critical limb ischemia. The method involves the collection of adipose tissue under tumescent anesthesia through a separate incision in the anterior abdominal wall, followed by preparation and injection of nano fat into the tissues of the foot and leg without additional drug therapy. The novelty of this method lies in the use of autologous stem cells and growth factors, differing from current treatments like neovasculgen, which is a plasmid DNA-based treatment. The trial aims to assess the safety and effectiveness of nano fat grafting, including pain relief, the frequency of intraoperative complications, increased distance of pain-free walking, limb preservation, and mortality rates.

The trial will involve patients with diagnosed occlusive lesions of the femoral-popliteal-tibial segment and chronic ischemia of III-IV degree according to Fontaine and 5-6 categories according to Rutherford, excluding those with contraindications for surgical intervention on the femoral-popliteal-tibial segment, chronic heart failure of III-IV NYHA class, severe liver or kidney failure, among others.

The study design includes preoperative examinations, hospital phase activities including the surgery and post-operative assessments, and follow-up visits at 6 and 12 months post-operation to evaluate the method's safety, complications, and effectiveness based on various parameters like pain, trophic disturbances, and limb ischemia severity.

Statistical methods will involve quantitative data presented as mean ± standard deviation, with qualitative traits compared using the Chi-square test or Fisher's exact test. The planned patient number is 40, aiming to demonstrate the effectiveness and safety of nano fat grafting for critical limb ischemia treatment compared to current treatments.


Eligibility Criteria:
Inclusion Criteria:

* Patients with occlusive lesions of the femoral-popliteal-tibial segment.
* Chronic ischemia of the lower limbs of III-IV degree according to Fontaine and categories 5-6 according to Rutherford.
* Signed informed consent for participation in the clinical trial.

Exclusion Criteria:

* Absence of indications for surgical intervention on the femoral-popliteal-tibial segment.
* Patients refusing to participate in the clinical trial.
* Chronic heart failure of III-IV NYHA functional class.
* Chronic decompensated "pulmonary" heart.
* Severe liver or kidney failure (bilirubin \>35 mmol/L, glomerular filtration rate \<60 ml/min).
* Polivalent drug allergy.
* Malignant oncological diseases in the terminal stage with a life expectancy of less than 6 months.
* Acute cerebrovascular accident.
* Decompensated diseases of the endocrine organs (for diabetes, glycemia level more than 10 mmol/L).
* Pregnancy and lactation period.
* Inability to undergo examinations at control points.
* Refusal to sign informed consent for participation in the clinical trial.
Personalized Blood Pressure Management

The aim of this research project is to find out whether a personalized definition of the lower blood pressure threshold based on the individual blood pressure profile by means of preoperative 24-hour blood pressure measurement can reduce organ damage (brain, kidney, heart) through reduced blood flow during surgery.


Eligibility Criteria:
Inclusion Criteria

* age ≥ 50 years
* ASA II-IV (Classification of the American Society of Anesthesiologists for the assessment of the perioperative risk depending on the underlying diseases)
* duration of intervention in general anesthesia at least 90 minutes

Exclusion Criteria:

* Pregnancy
* Emergency procedures
* Surgery requiring controlled hypotension (e.g., aneurysm)
* Cerebrovascular events in the past medical history
* Patients of cardiac surgery, vascular surgery, neurosurgery, and transplantation surgery
* Pre-existing dementia (anamnesis)
* kidney transplant
* dialysis-dependent renal insufficiency (KDIGO criteria)
* no patient consent
* failure to meet the inclusion criteria
* Impossibility of 24-h blood pressure measurement
Carbohydrate Quality, Quality of Life, and Menopausal Symptoms in Postmenopausal Women

This study aimed to evaluate the effect of carbohydrate quality on quality of life and menopausal symptoms in postmenopausal women. Data were collected from 604 postmenopausal women using a demographic questionnaire, the Menopause-Specific Quality of Life Questionnaire (MENQOL), and the Menopause Rating Scale (MRS). Carbohydrate quality was assessed using food frequency consumption data, and the results were analyzed with SPSS 24 software.

Objective: This study aimed to evaluate the effect of carbohydrate quality on quality of life and menopausal symptoms in postmenopausal women.

Method: A total of 604 postmenopausal women participated in the study. Participants completed a demographic questionnaire, the Menopause-Specific Quality of Life Questionnaire (MENQOL), and the Menopause Rating Scale (MRS). Carbohydrate quality was assessed using food frequency consumption data and analyzed based on dietary fiber, glycemic index, solid carbohydrate-to-total carbohydrate ratio, and whole grains-to-total grains ratio. Results were divided into five quartiles, with Q5 representing the highest and Q1 the lowest carbohydrate quality. Data analysis was conducted using SPSS 24 software.

Eligibility Criteria:
Inclusion Criteria:

* Women who have not menstruated for 12 consecutive months and have no intermenstrual bleeding
* Aged between 30 and 90 years
* Must be willing to volunteer

Exclusion Criteria:

* Women diagnosed with any psychological disorder
* Cancer patients
Launching an Asthma Initiative Designed to Improve Asthma Management and Outcomes

Following on from a 10 year study conducted in Finland this study is designed to test the validity and sustainability of an enhanced asthma management model for the UK.

The British Lung Foundation (BLF) aims to work with the governments in the four UK nations to launch an asthma initiative designed to improve asthma management and outcomes. The project incorporates key learning from a 10 year programme in Finland designed to improve asthma care and cap healthcare costs for paediatric and adult populations.

The Finland programme focused on accurate diagnosis, training and education of healthcare professionals and patients and early use of anti-inflammatory therapy. The programme successfully improved medication compliance, reduced asthma hospital admissions, reduced asthma-related benefit claims and reduced the overall cost of asthma to the Finnish Government.

To test the validity and sustainability of an enhanced asthma management model for the UK, the BLF proposes to undertake a pilot initiative in England. The pilot will focus on: improving diagnostic accuracy through analysis of GP asthma registers; increasing asthma education among healthcare professionals; assessment of risk and control of patient's asthma; supportive self-management and education of people with asthma.

It is anticipated that the pilot will lead to measureable and significant improvements in asthma management, including:

* Reduced number of severe exacerbations (asthma hospitalisation, A\&E attendance and oral steroid rescue)
* Improved diagnostic accuracy (and reduction of diagnostic doubt)
* Improved implementation of recognised asthma guidelines, including appropriate step wise management of patients

The pilot will also aim to increase the proportion of patients on the asthma register with an asthma management plan and a recorded asthma control test therefore supporting higher levels of control, and will promote peer-to-peer health care professional asthma education and knowledge sharing to establish an asthma-training legacy.

The pilot model will be sustainable and reproducible across England and the devolved nations (Scotland, Wales and Northern Ireland). Whilst the core aspects of an agreed national model will be rolled out across the pilot site, it will be tailored and refined through local collaboration (primary care, secondary care and commissioners) to help attain local targets in line with regional differences, needs and priorities.

Results from the pilot will be reported 15 months after project initiation on site (July/August 2014)

Eligibility Criteria:
Inclusion Criteria:

* Motivated and driven local champions in the area
* High rates of hospital admissions (aged 3-65)
* High asthma prevalence
* High percentage of patients who have had an asthma review in the previous 15 months.

Exclusion Criteria:

-
Study of Global Coagulation Tests in Patients With Paroxysmal Nocturnal Haemoglobinuria

Paroxysmal nocturnal haemaoglobinuria (PNH) is a rare disease which results in breakdown of the red blood cells and bone marrow failure. It is associated with an increased risk of blood clots. Until recently, treatment has been with blood transfusions and in patients with a blood clot, blood thinners. A new treatment called eculizumab is now standard for patients who require regular blood transfusions. It works in the majority of patients by preventing the breakdown of red blood cells. This can eliminate the need for blood transfusion and reduce the risk of blood clots. It is not well understood why patients with PNH are at high risk of blood clots. The investigators plan to use specialised blood tests to assess the stickiness of the blood before starting eculizumab treatment and monthly after starting treatment. The investigators will compare these tests with standard tests of clotting.


Eligibility Criteria:
Inclusion Criteria:

* Presence of a PNH clone

Exclusion Criteria:

* Longterm anticoagulation for previous venous thrombosis
A Double-blinded,Double-dummy Clinical Trial of Chinese Herbal Medicine (MaZiRenWan) for Functional Constipation

The objective of this study is to evaluate the efficacy and safety of a Chinese herbal proprietary medicine, MaZiRenWan (MZRW), by comparing with stimulant laxative western medicine (WM), senna, and placebo for patients with functional constipation (FC) in excessive TCM syndrome.

Functional constipation (FC) is a common clinical complaint. Despite the effectiveness of MaZiRenWan (MZRW) for alleviating FC symptoms has been proofed in the previous study.Given the results of the dose determination study and placebo-controlled study of MZRW, we hypothesize that MZRW is more useful than senna (senokot), a commonly used WM drug for constipation, for FC patients in excessive TCM syndrome.This is a prospective, double-blind, double dummy, randomized, controlled trial. After a 2-week run-in, eligible FC patients (Rome III) in excessive TCM syndrome will randomly be assigned to CHM arm (MZRW and WM placebo), WM arm (senna and CHM placebo) or placebo arm (CHM placebo and WM placebo). Patients will undergo an 8-week treatment and an 8-week follow-up.

Eligibility Criteria:
Inclusion Criteria:

* either gender aged 18 to 65 years
* have FC diagnosed as Rome III criterial
* have diagnosis of Excessive Constipation according to the TCM theory
* complete spontaneous bowel movement (CSBM) ≦2times/w
* severity of constipation≧3pts (7 pts scale from 0 to 6pts) and the overall scoring of constipation-related symptoms≧6pts (6items in 7pts scale) for self symptom assessment in the run-in period
* normal colonic evaluation (colonoscopy or barium enema) within 12 months
* normal liver and renal function in blood test within 3 months

Exclusion Criteria:

* drug-induced constipation
* secondary causes of constipation (i.e. medical history of diabetes mellitus and thyroid disease)
* abdominal surgery (i.e. Caesarean operation)
* severe diseases (i.e. cancer and acute present asthma)
* allergy to CHM (i.e. G6PD deficiency), senna and tartrazine
* pregnancy or breast-feeding
* psychiatric or addictive disorders
The PAtient Preference Analysis of Yearly Follow-up After PCI (PAPAYA)

The purpose of this study is to determine the preference of patients regarding the approach for follow-up after percutaneous coronary intervention (PCI) procedures. We hypothesize that patients prefer questionnaires for annual follow-up assessment when compared to telephone or email.

Rationale: Assessment and reporting of long-term clinical follow-up after medical interventions is essential for transparency of medical care and its quality improvement. However follow-up adherence is a serious challenge in clinical trials. Taking the patient preference of the mode of follow-up into account is likely to enhance trial adherence, reduce withdrawals, and facilitate a longer follow-up duration. No data on patient preference of annual follow-up have been reported.

Objective: To investigate the patient preference of approach to obtain follow-up information after percutaneous coronary intervention (PCI)

Study design: Single-center, prospective, observational registry

Study population: All patients enrolled in the percutaneous coronary intervention studies TWENTE trial (a broad study population reflecting real-world PCI patients) and DUTCH PEERS trial (an all-comers population), who were treated at Thoraxcentrum Twente in Enschede between June 2008 and May 2012

Intervention: All subjects will receive a questionnaire with questions regarding their preference with regards to the approach of acquiring follow-up information after PCI.

Main study endpoints:

* The primary endpoint is the patient preference on how to be approached for annual follow-up after PCI procedures.
* Secondary endpoints include

  1. least preferred approach of follow-up
  2. the preferred number of follow-up moments per year
  3. the from the patients' perspective maximum acceptable number of questions to be answered
  4. the assessment of potential relationships between the most and least preferred approach of assessment and patient age, gender urgency of PCI treatment, and history of previous revascularizations

Eligibility Criteria:
Inclusion Criteria:

* All patients enrolled in the TWENTE trial and DUTCH PEERS trial (an all-comers population, who were treated at Thoraxcentrum Twente in Enschede between June 2008 and May 2012

Exclusion Criteria:

* Patients who had withdrawn their consent for participation in the TWENTE and DUTCH PEERS trials, respectively. Patients who passed away during follow-up could obviously not be approached for further questioning.
Human Breast Tissue Bioavailability of Topically Applied Limonene

The overall objective of this project is to determine the safety and breast tissue bioavailability of limonene following massage application of limonene containing massage oil to the breast.


Eligibility Criteria:
Inclusion Criteria:

* Women who are 18-65 years of age
* ECOG performance status 0-1
* Normal organ and marrow function
* Women of child-bearing potential must agree to use adequate contraception
* Willing to avoid consumption and use of citrus or citrus containing products throughout the study
* Have both breasts intact

Exclusion Criteria:

* Have had cancer(s) within the past 5 years
* Participated in another clinical interventional trial within the past 3 months
* Uncontrolled intercurrent illness
* Pregnant or breast feeding
* Unable to produce nipple aspirate fluid
* Have known allergic or sensitive reactions to skin care products, citrus or coconut oil
* Have ongoing skin disorders such as eczema and psoriasis
Pillow Use During Total Hip Arthroplasty

The purpose of this study is to find out whether placing a pillow between the legs during hip surgery will result in a better aligned hip replacement.

During hip replacement surgery the cup is placed on specific planned angles. Cup placement has an effect on the patients' pain-free range of movement, dislocation rates and satisfaction. However, the angles of the cup orientation (i.e. the tilt and rotation), which are preoperatively planned and postoperatively measured on radiographs, have a high variability even when an experienced surgeon is performing the surgery. One of the reasons this occurs is because the operated leg can move the pelvis to a different position in the time between set-up and actual implantation which may lead to the cup being placed in a non-optimal position. This study aims to see if the difference between planned and achieved cup angles and pelvic movement can be lessened by putting a pillow in between the legs to keep it in a stable horizontal position.

Eligibility Criteria:
Inclusion Criteria:

* Patient awaiting primary total hip arthroplasty using a posterior approach in a lateral decubitus position
* Patients capable of reading, understanding, and willing to sign the informed consent form

Exclusion Criteria:

* Total hip arthroplasty not using a posterior approach in a lateral decubitus position
* Prior hip osteotomy or fracture osteosynthesis on the index hip
Formative Usability Assessment of Wireless Thermal Anisotropy Devices

Measurements of shunt flow will be performed non-invasively. This study will generate usability data via observed tasks and comprehension questions to enable future device design improvements.


Eligibility Criteria:
Inclusion Criteria:

1. Existing ventricular CSF shunt with a region of intact skin overlying the shunt catheter appropriate in size for application of the study device
2. Signed informed consent by subject or a parent, legal guardian, health care agent, or surrogate decision maker (according to local statutes)
3. Subject or caregiver can clearly communicate and document information in English
4. Verbal assent by minors 12 years of age and older who can understand the study and communicate their decision
5. Subject is at least 5 years old but not more than 80 years old

Exclusion Criteria:

1. Presence of an interfering open wound in the device application region
2. Subject-reported history of adverse skin reactions to adhesives
Insulin Resistance in Idiopathic Oligospermia and Azoospermia

Insulin resistance in men can be the underlying major factor in reproductive abnormalities ( chronic hypospermatogenesis ) as well as metabolic abnormalities similar to polycystic ovarian syndrome ( PCOS ) in women.

During the past decade IR has been recognized as a major contributor to the pathogenesis of chronic anovulation, hyperandrogenism and metabolic abnormalities associated with PCOS . Theoretically IR in men may result in a similar reproductive abnormalities ( chronic hypospermatogenesis ) as well as other metabolic abnormalities similar to what happens in PCOS in women .

Eligibility Criteria:
Inclusion Criteria:

* sperm count less than 10 million per milliliter
* non-obstructive azoospermia

Exclusion Criteria:

* high FSH ( \> 10 mIU/ ml )
* high prolactin ( \> 36 mIU/ml )
* abnormal karyotype
* AZF