cyrilzakka/clinical-trials huggingface dataset:
First-trimester Placental Ultrasound Study

An observational cohort study to assess the clinical utility of the OxNNet Toolkit for the prediction of adverse pregnancy outcomes.

The First PLUS study is a single centre, prospective, observational study recruiting 4000 women from The Harris Birthright Centre, which provides ultrasound scanning for all women who would attend King's College Hospital NHS Foundation Trust for their pregnancy care.

This study aims to develop a tool to provide reliable measurements of placental size and estimate the blood flow within the placenta during the first trimester of pregnancy. These metrics hope to develop a screening tool for fetal growth restriction (FGR), which is a condition in which a baby fails to grow to its full potential and can cause adverse pregnancy outcomes and is the single most common cause of stillbirth. This devastating outcome could potentially be reduced by stratifying pregnancies into high risk, allowing women to undergo additional monitoring and limiting clinician resource to those in need of it most. Stillbirth is also a serious adverse pregnancy outcome that NHS England is looking to reduce the rate of as part of their long-term plan.

Women 18 years of age or older, attending their first trimester scan during 11-14 weeks of pregnancy, who has a viable pregnancy with no more than one baby with no major defects identified during the scan will be eligible to take part.

The study will take place over 24 months and participants will undergo a single study visit in which their demographics and routine medical history will be recorded, an additional research ultrasound scan will be conducted alongside their routine scan, and blood from a sample taken as part of routine care will be used to assess the level of Placental Growth Factor (PlGF). Participants will then be followed up until the completion of their pregnancy via their pregnancy records (remote follow up) and the outcome of their pregnancy will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant
* 18 years of age, or older
* Presenting for first-trimester combined test screening between 11+0 and 13+6 weeks of pregnancy
* Participant is willing and able to give informed consent for participation in the investigation.
* Able to understand written or verbal English and able to access methods of translation.
* In the opinion of the investigator, the participant is not at risk or under stress or limited in their ability to participate in the study activities.

Exclusion Criteria:

* Participant with a multiple pregnancy (more than one viable fetus) discovered at the scan
* Participant with a non-viable pregnancy discovered at the scan (no detectable heartbeat)
* Pregnancies with major defects identified during 11+0 to13+6 week scan
* Any pregnancy subsequently found to be chromosomally abnormal as a result of either prenatal or postnatal testing
The Effect of Pessary Post Vaginal Prolapse Repair, for One Month, to Reduce the Recurrence Rate of Prolapse

Genital prolapse is a common complain. 30-40% of women will complain of uterine prolapse or cystocele or rectocele, or mixed. About half of them will require surgical repair for the prolapse, with or without hysterectomy. Of these patients about 30-40% will have recurrence of the prolapse, which in some cases requires second operation.

In this study the investigators want to investigate whether a vaginal pessary inserting in the end of the primary surgery, for 4 weeks, will reduce the recurrence rate.

All patients going for vaginal surgery for genital prolapse, stage 3-4, with cystocele, rectocele or uterine cervix prominent from the vagina. These patients, after signing an informed consent, a vaginal pessary will insert at the end of the operation and will stay for 4 weeks post-op.

After 4 weeks the pessary will be removed, and the patient will followed for 2 years, for recurrence of prolapse.

Eligibility Criteria:
Inclusion Criteria:

* all healthy patients with genital prolapse grade 3-4, going for vaginal surgery
* age 30-80years

Exclusion Criteria:

* patients with pelvic inflammatory disease
* patients after pelvic irradiation
* large vaginal erosion
* vaginal bleeding uncontrolled or undiagnosed
* patients going for surgery with mesh
Body Composition and Adipose Tissue in HIV

In this study, the investigators will examine the effect of therapy with the Growth Hormone Releasing Hormone (GHRH) analog tesamorelin on body composition in patients with HIV lipodystrophy and central adiposity. This study is a single arm prospective study of tesamorelin therapy of patients with HIV lipodystrophy. Subjects will do body composition testing, adipose tissue biopsy, metabolic rate measurements and insulin sensitivity assessment before, 6 and 12 months after daily injections of tesamorelin 2 mg by subcutaneous injection.

HIV lipodystrophy is increasingly recognized as a common and clinically significant long-term sequelae of HIV treatment. In the HIV lipodystrophy lipohypertrophy phenotype, visceral adipose tissue (VAT) is increased and this is associated with reduced growth hormone (GH) secretion. Mounting evidence also links this phenotype with dyslipidemia, insulin resistance, subclinical atherosclerosis and cardiovascular (CV) disease in patients with HIV disease. The etiology of HIV lipodystrophy (HIVLD) with central adiposity is unclear, but this phenotype is increasingly common with newer, less lipotoxic combination anti-retroviral therapy (cART) use. VAT and hepatic lipid accumulation, are important health concerns for HIVLD patients. This body composition pattern may contribute to the increased cardiovascular risk that has been demonstrated in patients with HIV lipodystrophy. Patients with HIVLD and central adiposity have been shown to have reduced GH secretion. Thus, a medication has been developed to augment GH secretion. This medication is tesamorelin. GH supplementation in other clinical settings has been shown to reduce visceral adiposity and may reduce hepatic lipid content.

Eligibility Criteria:
Inclusion Criteria:

* HIV-infected subjects with HIV lipodystrophy (HIVLD)
* Abdominal fat accumulation defined as: Waist Circumference (WC) 102 cm for men, 88 cm for women, except in subjects of East/South Asian ethnicity in whom this will be defined by WC 90 cm for men and 80 cm for women.
* Weight stable for 8 weeks prior to enrollment,
* CD4 count \>100 cells/mm3
* HIV RNA load \<1000 copies/mL
* Fasting plasma glucose \<120 mg/dL
* Stable combination anti-retroviral therapy (cART) of any regimen for ≥ 8 weeks prior to study enrollment

Exclusion Criteria:

* Diabetes mellitus requiring medication
* History of any malignancy
* Abnormal renal or liver function
* Pregnancy or women of childbearing age who are not using an acceptable means of contraception
* History disorder of the hypothalamic-pituitary axis due to hypophysectomy, hypopituitarism or pituitary tumor/surgery
* Head irradiation or head trauma or adrenal insufficiency
* Systemic glucocorticoid use
* Known hypersensitivity to tesamorelin and/or mannitol
Trial to Assess Efficacy and Safety of Lacosamide in Subjects With Osteoarthritis of the Knee

The purpose of this trial is to evaluate the effectiveness, safety and tolerability of lacosamide (LCM) 400mg/day in treating the signs and symptoms of osteoarthritis of the knee.

LCM is an investigational drug that is being studied as a treatment in male and female patients who are diagnosed with osteoarthritis of the knee and require therapeutic doses of NSAIDs, COX-2 NSAIDs and/or paracetamol. This trial will be conducted exclusively in Europe.

The study has an adaptive 3-stage group sequential design.

The trial will last a total of 17 weeks. There will be a 2 week period to wean off current medication, followed by a 4 week period where the patient will receive placebo (inactive drug) or gradually increasing doses of LCM up to the target dose of 400mg/day. The target dose or placebo will be maintained for 8 weeks followed by a 1 week reduction period then a 2 week safety follow up period.

The last subject is expected to be enrolled in December 2007.

The study was terminated based on the outcome of the planned first interim analysis, which was performed as defined in the protocol in a subset of patients. It was decided not to continue the trial. No safety concerns were identified.

Eligibility Criteria:
Inclusion Criteria:

* Subject has symptomatic osteoarthritis of the knee diagnosed using clinical and radiographic evidence as well as ACR criteria with symptom duration of at least 6 months.
* Subject requires therapeutic dose of an NSAID, COX-2 NSAID, and/or paracetamol/acetaminophen for osteoarthritis pain of the index knee and has taken that medication at least 5 days per week for the last 4 weeks prior to the screening visit (Visit 1).

Exclusion Criteria:

* Subject is not able to withdraw NSAIDs, COX-2 NSAIDs and/or paracetamol
* Subject is taking analgesic other than NSAIDs COX-2 NSAIDs and/or paracetamol
* Subject is planning to begin or stop treatment with glucosamine and/or chondroitin during the trial
A Novel Method of Preoxygenation Using a Bain Circuit

The purpose of this study is to determine whether rebreathing for a short time (a bit like breathing into a paper bag) will stimulate faster breathing and thus make the giving of Oxygen more effective.

The hypothesis is that the investigators method (rebreathing) will be faster than the current method of administering Oxygen.

It is standard practice for patients to breathe oxygen before receiving a general anaesthetic. This is called preoxygenation. It is done by using a mask which fits snugly onto the face. But for how long should patients breathe oxygen? Is taking deep breaths a good idea? What is the best oxygen flow rate? These questions are important because preoxygenation is one of the things which makes anaesthesia safe, so finding the best way of doing it might help save lives. Previous research has attempted to identify the best way to give oxygen before anaesthesia. It seems that breathing pure oxygen for three minutes is enough, or if you are in an urgent situation, then taking deep breaths of pure oxygen for a minute will do. However, there is another possible way of doing it which has not yet been looked at.

Asking someone to breathe back in the air they have just exhaled seems, on the face of it, to be pointless at best. But doing just that for a very short time will make the person breathe harder. Then when you give them pure oxygen, they will breathe it in really deeply and this might make the preoxygenation quicker. That's the theory. To test it we plan to ask 40 healthy people to do the standard preoxygenation, then try our new way. We won't be giving anaesthetic, just the oxygen.

The hypothesis is that our new method will be quicker than the existing one.

Eligibility Criteria:
Inclusion Criteria:

* BMI 18-27
* Non-smoker
* No chronic cardiorespiratory or neuromuscular illness
* No intercurrent illness

Exclusion Criteria:

* Unable/unwilling to consent
Effect of Exercise on Smokers

When we look at the literature, although 202 results are found when "high intensity training" AND "aerobic" is written in the PUBMED database, 27 to 86 results are found when "high intensity training" AND "cognitive" and "high intensity training" AND "respiratory" are written and searched. 5 results are found when "high intensity training" AND "smoking" is searched, but there is no study investigating cognitive and respiratory functions, and no results are found when "high intensity training" AND "smoker" is searched. As far as is known, there is no study investigating the acute effect of high intensity aerobic exercise on respiratory functions and cognitive status in special education personnel who smoke. We aim to contribute to the literature with this original aspect of our study.

Primary objective: The primary objective of the study is to investigate the acute effects of high-intensity aerobic exercise on respiratory functions in special education personnel who smoke.

Secondary objective: The secondary objective of the study is to investigate the acute effects of high-intensity aerobic exercise on cognitive status in special education personnel who smoke.

Study questions

* Is there an acute effect of high-intensity aerobic exercise on respiratory functions in special education personnel who smoke?
* Is there an acute effect of high-intensity aerobic exercise on cognitive status in special education personnel who smoke?

Study Hypotheses:

H0: There is no acute effect of high-intensity aerobic exercise on respiratory functions in special education personnel who smoke.

H1: There is an acute effect of high-intensity aerobic exercise on respiratory functions in special education personnel who smoke.

H2: There is no acute effect of high-intensity aerobic exercise on cognitive status in special education personnel who smoke.

H3: High-intensity aerobic exercise has an acute effect on cognitive status in special education personnel who smoke.

H4: High-intensity aerobic exercise has a greater acute effect on respiratory function and cognitive status in special education personnel who smoke than low-intensity training.

H5: High-intensity aerobic exercise has a less acute effect on respiratory function and cognitive status in special education personnel who smoke than low-intensity training.

Eligibility Criteria:
Inclusion Criteria:

* Volunteering to participate in the study
* Participating in the Fageström Nicotine Dependence Questionnaire
* No comorbidities
* No comorbid diseases related to the orthopedic, neurological, cardiopulmonary system
* Participants who have not participated in another clinical trial in the last month

Exclusion Criteria:

* Participants who have had orthopedic and cardiopulmonary surgery in the last year
* Those with cardiac or pulmonary system disease
* Having sensory loss
* Participants with leg length inequality
n-3 and n-6 Fatty Acids in Rheumatoid Arthritis

Purpose: To investigate into the differential effects of polyunsaturated fatty acids as compared to standard control therapy (olive oil) on disease activity and biochemical parameters in patients with rheumatoid arthritis (RA), resp. psoriasis arthritis (PA).

Methods: Double-blinded, four-armed randomised controlled trial with 3.0 g/d of either n-3 long chain polyunsaturated fatty acids (LC-PUFA) or gamma linolenic acid (GLA), resp. the combination of 1.5 g/d of each, resp. 3.0 g/d of olive oil over 12 weeks. Outcome parameters disease activity score (DAS28), C-reactive protein, concentrations of n-3 LC-PUFA, resp. GLA in plasma lipids (PL), cholesterol esters (CE), and erythrocyte membranes (EM), and serum concentrations of arachidonic acid (AA). Conventional antirheumatic and immunosuppressive therapies could be changed only within defined limits.

Eligibility Criteria:
Inclusion Criteria:

* Rheumatoid or Psoriasis arthritis

Exclusion Criteria:

* Severe diseases of heart, liver, lung airways
* Non-compliance
Nutritional Deficiency and Recurrent Miscarriage

This prospective cohort study primarily aims to examine the association between blood niacin levels and recurrent miscarriage.

Recurrent miscarriage is affecting around 5% women at reproductive age. And the underlying causes remain undetermined in 50%-70% of cases. Although animal models and linkage analysis according to family studies have identified that niacin deficiency can lead to congenital malformations and recurrent miscarriage. Evidence based on population is lacking with regard to the effect of blood niacin levels on recurrent miscarriage. We intend to enroll 499 pregnant women confirmed by a positive blood human chorionic gonadotropin test and with history of unexplained recurrent miscarriage. By testing their blood niacin levels and following up to the end of first-trimester pregnancy, this study aims to examine the role of niacin levels in preventing miscarriages among women with history of recurrent miscarriage.

Eligibility Criteria:
Inclusion Criteria:

* 18-40years old, female
* Positive blood human chorionic gonadotropin test
* Naturally pregnant
* History of recurrent miscarriage (2 or more consecutive spontaneous miscarriage within 28 weeks of gestation)
* Willing to participate in this study with informed consent

Exclusion Criteria:

* Women whose confirmed cause of recurrent miscarriage has nothing to do with nutritional deficiencies, including chromosomal abnormalities, abnormal uterine anatomy, immune system diseases, blood diseases, etc.
* Women with Hepatitis B, syphilis, HIV/AIDS and other infectious diseases.
* Women with serious conditions, such as schizophrenia, tumors, heart failure
Novartis Everolimus Transition

Transition from tacrolimus based triple therapy with Mycophenolate Mofetil (MMF) and steroids in stable renal transplant patients to low intensity tacrolimus, everolimus and prednisone will be associated with improvement in Glomular Filtration Rate (GFR) and allograft fibrosis.


Eligibility Criteria:
Inclusion Criteria:

1. At least 18 years of age and able to give informed consent.
2. Received a first or repeat cadaveric (including ECD) or living donor renal transplant.
3. Patient has stable graft function, defined as no change of greater than 40% of baseline serum creatinine and no acute rejection during the past month.
4. Currently receiving tacrolimus, mycophenolate mofetil and prednisone as their immunosuppression regimen

Exclusion Criteria:

1. Biopsy proven acute rejection episode that occurred within the past month.
2. Malignancy within the past 3 years, except for non-melanoma skin cancer.
3. Currently enrolled in an investigational drug trial.
4. Woman of child bearing potential not utilizing an effective form of birth control.
5. Patients with uncontrolled dyslipidemia, defined at serum fasting LDL \>200 mg/dL or serum fasting triglycerides \>500 mg/dL.
6. Patients with a spot urine protein to creatinine ratio of \> 800 mg of protein per gram of creatinine.
7. WBC \< 2,000 cells/mm3
8. Platelets \< 75,000 cells/mm3
9. Patients who have received an organ transplant other than a kidney.
10. Patients with a history of biopsy proven FSGS, MPGN, or PGN.
Occluder Size Determination in Transcatheter ASD II Closure Based on 3D TEE Assessment

The aim of this study is to determine whether three-dimensional tranesophageal echocardiography (3D TEE) assessment of ostium secundum atrial septal defect (ASD II) may be as efficient as two-dimensional (2D) TEE assessment complemented by the balloon-sizing during transcatheter closure of the defect.

A total of 50 consecutive patients eligible to percutaneous ASD II closure will be enrolled in the study. 3D-TEE will be performed in the diagnostic process; the images will be recorded for further investigation, however, measurments of the defect will not be taken until after the procedure. Traditional 2D-TEE together with balloon-sizing assessment of the defect will be performed in enrolled patients in order to chose a device. Control transthoracic echocardiography (TTE) will be provided twice to evaluate the outcome of transcatheter treatment: 1 day after the procedure and 6-12 months later. The previously obtained 3D images will be retrospectively assessed by 2 independent investigators excluded from the interventionalists' team. Maximum and minimum diameter, perimeter and area of the defect will be measured to propose the assumed optimal occluder size. Correlation between proposed occluder size and the device used during the procedure will be statistically analyzed.

Eligibility Criteria:
Inclusion Criteria:

* ASD II suitable for percutaneous treatment
* free and informed consent to analyze the medical data of the person concerned
* age: patients over 16

Exclusion Criteria:

* ASD II not suitable for percutaneous treatment
* any valvular heart disease requiring cardiac surgery
* no free and informed consent to analyze the medical data of the person concerned
* age: under 16
The Trauma INtramuscular Tranexamic Acid Clinical Trial

Intramuscular injection of tranexamic acid (TXA) would increase its use in situations where administration of intravenous drugs is difficult. The investigators aim to assess the population pharmacokinetics of intramuscular TXA in trauma patients.

Primary endpoint: Serum TXA concentrations over time. Secondary endpoints: Local reactions at injection sites and adverse events

A prospective, open-label, multicentre, pharmacokinetic study conducted in the UK hospital. Potential eligible patients will have received a 1 gram IV dose of TXA at the scene of the injury or on arrival in hospital and a second dose is clinically indicated.

Eligibility Criteria:
Inclusion Criteria:

* Adult (appear to be at least 16 years old) trauma patients who have received 1 gram of intravenous TXA for the management of haemorrhage in whom a second dose is clinically indicated are eligible.

Exclusion Criteria:

* none
A Study to Compare Two Dose Strengths of CVT-301 (Levodopa Inhalation Powder) With an Oral Dose of Sinemet® (Carbidopa-levodopa) Tablets

This study will be an open-label, randomized, three-period cross-over pharmacokinetic evaluation of CVT-301 compared with the Reference Listed Drug (RLD), orally administered carbidopa/levodopa, in healthy volunteers.

The primary objective is to determine the relative bioavailability of two CVT-301 (dose levels 1 and 2) capsules compared with the Reference Listed Drug (RLD) on a per milligram basis.

Eligibility Criteria:
Inclusion Criteria:

* In good general health as determined by medical history, physical examination, electrocardiogram (ECG), vital signs, and clinical laboratory evaluation;
* FEV1/FVC above the 5th percentile of the predicted normal distribution for age and gender;
* Body Mass Index (BMI) between 18 - 30 kg/m2

Exclusion Criteria:

* No flu-like syndrome or other respiratory infections within 2 weeks prior to the Screening Visit;
* Negative drug and alcohol testing;
* Negative pregnancy test for female subjects