cyrilzakka/clinical-trials huggingface dataset:
Acute Effects of Ginger Extract Consumption on Risk Markers of Cardiovascular Disease

The primary aim of the study was to investigate the acute effect of ginger drink consumption on the risk markers of cardiovascular disease.

A randomized, single-blind human intervention study involving 22 healthy male volunteers was designed to investigate the acute effects of ginger drink consumption on risk markers of cardiovascular disease (CVD). The primary outcome measure is reduction in blood pressure while the secondary outcome measures are improvement in flow mediated dilatation (FMD) and changes in plasma biochemical profile parameters related to CVD. Participants were given 300 ml of ginger extract or water (placebo) with breakfast, followed by a lunch at 2 hours on two visits separated by 2 weeks. Blood and urine samples were collected at regular intervals as well as blood pressure measurement done during the two visits. Vascular function was measured by flow mediated dilatation (FMD) and pulse wave velocity (PWV) at baseline, 2 and 4 hours after the the consumption of the study drink and placebo. The blood and urine samples were analysed for changes in lipid profile and other markers of CVD.

Eligibility Criteria:
Inclusion Criteria:

* Apparently healthy males,
* Age (30 - 65) years,
* Not diabetic or plasma glucose \> 7 or on anti-diabetic drugs and not on anti- hypertensive drugs.
* Subjects \< 10% risk of cardiovascular disease

Exclusion Criteria:

* Women,
* Men younger than 30 years and older that 65 years,
* Men who are sick or on anti-diabetic and anti-hypertensive drugs.
* Men who have history of heart attack or stroke within the last 12 months
* Men who are on lipids lowering drugs
Transcranial Direct-Current Stimulation in Childhood Dystonia

The investigators hypothesize that transcranial direct current stimulation over the motor cortex will reduce muscle overflow and improve hand function in children with primary or secondary dystonia.


Eligibility Criteria:
Inclusion Criteria:

* dystonia affecting one or both hands
* age 4 to 21 years

Exclusion Criteria:

* metal implants in the head
* inability to cooperate with instructions
ZD4054 With Positron Emission Tomography/Magnetic Resonance Imaging (PET/MRI) for Prostate Cancer

The purpose of this research study is to assess the effects of ZD4054 on prostate cancer that has spread to the bones by using new imaging techniques. In particular, this study will use fluorodeoxyglucose (FDG) and 18F-Sodium Fluoride (NaF) PET/computed tomography (CT) and MRI scans to look for changes in bone metastasis after ZD4054 therapy.


Eligibility Criteria:
Inclusion Criteria:

1. Men \> 18 years of age.
2. Histologically proven adenocarcinoma of the prostate.
3. Presence of radiographic bone metastasis with at least one which is amenable to serial imaging using MRI/PET imaging.
4. Patients must have evidence of progressive disease by either radiographic progression or a rising PSA within 4 weeks prior to registration.
5. Patients must have had prior treatment with bilateral orchiectomy or other primary androgen-deprivation therapy.
6. For patients previously treated with flutamide (Eulexin), Nilutamide (Nilandron), or bicalutamide (Casodex): Patients must have discontinued flutamide \> 4 weeks prior to registration with continued evidence of progressive disease. For bicalutamide or nilutamide, patients must have discontinued the drug \> 6 weeks prior to registration with evidence of progressive disease.
7. Prior therapy is permitted as long as it was given \> 4 weeks prior to registration, and evidence for disease progression is met.
8. Patients must not have had prior radiotherapy \< 4 weeks prior to registration.
9. Prior use of bisphosphonates allowed only if started at least 12 or more weeks prior to registration (can continue current dose/schedule while on study).
10. Patient cannot have had prior Strontium 89, Samarium 153, or other radioisotope.
11. No concurrent use of estrogen, or estrogen-like agents
12. Patients must have adequate organ function
13. ECOG performance status 0-2.

Exclusion Criteria:

1. Use of potent CYP450 inducers (such as phenytoin, rifampicin, carbamazepine and phenobarbitone, St. John's Wort) within 2 weeks prior to start of study treatment.
2. Prior therapy with endothelin receptor antagonists or family history of hypersensitivity to endothelin antagonists.
3. History of past or current epilepsy, epilepsy syndrome, or other seizure disorder.
4. Stage II, III or IV cardiac failure (classified according to New York Heart Association (NYHA) classification), myocardial infarction within 6 months prior to study entry, or have left ventricular function (LVEF) below the institutional normal limit.
5. QT interval corrected for heart rate (by Bazett's correction) (QTcB) \>470 msec.
6. Previous history or presence of another cancer, other than prostate cancer or treated squamous/basal cell carcinoma of the skin, within the last 5 years.
7. Major surgery within 6 weeks of registration.
8. Hemoglobin (Hb) \<9 g/dL. Concomitant use of erythropoietin or blood transfusions is allowed.
9. Inability to take or absorb oral medications.
The Liver Care Trial

The goal of this clinical trial is to evaluate the efficacy of screening for liver disease with liver stiffness measurement on abstinence or light consumption after 6 months in individuals who are receiving treatment for alcohol use disorder and without a history of liver disease. The investigators will conduct a randomized controlled trial with concealed allocation comparing A) an invitation to a liver stiffness measurement, blood sampling and leaflet on alcohol-related disease (intervention) with B) an invitation to blood sampling (control). The primary outcome is 'abstinence or light consumption' (≤ 10 units/week) throughout the last months, and assessed 6 months after randomization.


Eligibility Criteria:
Inclusion Criteria:

* Attending outpatient treatment for alcohol use disorder (international classification of disease version 10: F102: alcohol dependence or F101: harmful alcohol use) at Novavi Køge or Novavi Roskilde
* Informed written consent

Exclusion Criteria:

* Not speaking Danish or English
* Severe liver disease (known by the participant)
Registry of Thiola EC Therapy

Thiola EC represents several modifications of Thiola that promise better, more efficacious therapy of cystinuria. First, pill size has changed from 100 mg to 300 mg, meaning that typical pill burden will be reduced from, on average, 10 pills per day to 3-5 pills per day. This change will be welcomed by patients whose fluid intake and administration of potassium citrate are daily impositions. Second, the preparation is now enteric-coated, formulated to offer delayed release of active tiopronin. Lastly, Thiola EC can be taken with food which is an improvement to the inconvenient dosing regimen of Thiola, which can only be taken one hour before, or two hours after meals. These changes may affect compliance and side effect profiles compared to those of Thiola. In combination with potassium citrate or other alkali preparations, adverse GI effects are relatively common in actively-treated patients with cystinuria. It is possible that GI side effects may be reduced by Thiola EC.


Eligibility Criteria:
Inclusion Criteria:

1. 18 years of age or older
2. Patients with cystinuria and a history of kidney stones
3. Taking Thiola EC
4. Willing and able to provide consent

Exclusion Criteria:

1. Unable to sign informed consent.
APSS-33-00: A Multicenter, Pilot Study of Autologous Protein Solution (APS) in Knee Osteoarthritis (OA)

This double-blind, multicenter, randomized, controlled trial (RCT) will evaluate the efficacy of a single dose of Autologous Protein Solution (APS) in patients with osteoarthritis (OA) of the knee who have failed at least 1 conservative osteoarthritis (OA) therapy (e.g. physiotherapy, simple analgesics, intra-articular injection).

A double-blind, multicenter, randomized, controlled trial (RCT) that will evaluate the efficacy of a single dose of Autologous Protein Solution (APS) in patients with Osteoarthritis (OA) of the knee who have failed at least 1 conservative OA therapy (e.g. physiotherapy, simple analgesics, intra-articular injection).

Eligibility Criteria:
Inclusion Criteria:

* Male or female ≥40 years and ≤75 years.
* Willingness and ability to comply with the study procedures and visit schedules and ability to follow verbal and written instructions.
* Diagnosis of knee osteoarthritis (OA) Grade 2 or 3 according to the Kellgren-Lawrence scale
* Body mass index (BMI) ≤ 40.
* Failed at least 1 conservative OA therapy
* Signed an independent ethics committee (IEC) approved informed consent form (ICF).

Main Exclusion Criteria:

* Intra-articular Hyaluronic (HA) injection within 6 months- On Day 1 (pre-injection), presence of active infection or abnormal effusion in the knee as noted by a physical examination (e.g., erythema, redness, heat, swelling).
* Presence of symptomatic OA in the non-study knee.
* Diagnosed with rheumatoid arthritis (RA), Reiter's syndrome, psoriatic arthritis, ankylosing spondylitis, chondromalacia, arthritis secondary to other inflammatory diseases (e.g., inflammatory bowel disease \[IBD\], sarcoidosis, or amyloidosis) or of metabolic origin.
* Diagnosis of isolated patella-femoral joint osteoarthritis.
* Valgus/varus deformity judged by the investigator to be clinically significant.
* Disease of spine, hip or other lower extremity joints of sufficient degree to affect assessment of the signal knee. Patients with TKR at the contra-lateral knee or THR in either hip may be enrolled provided sufficient pain relief after TKR or THR which does not require additional analgesic relief.
* Untreated acute traumatic injury of the index knee.
* Presence of a symptomatic meniscal tear in the index knee
* Limited daily activity for reasons other than OA.
* Presence of surgical hardware or other foreign body in the index knee.
Cardiomyopathy Arrhythmia Risk Evaluation

This study will evaluate the prognostic utility of novel ECG markers of electrical instability in patients with cardiomyopathy.

Baseline ECG markers of electrical instability will be measured in patients with cardiomyopathy. These ECG markers will be evaluated from a clinical Holter recording. All patients will have a primary implantable cardioverter defibrillator (ICD) as part of their clinical care. Patients will be followed prospectively for 2 years to evaluate the primary outcome of appropriate ICD shocks. Multivariable modelling will be performed to determine whether the ECG markers of electrical instability independently predict the primary clinical outcome.

Eligibility Criteria:
Inclusion Criteria:

* cardiomyopathy, primary prevention ICD

Exclusion Criteria:

* brady-pacing requirement
PheWAS of a Polygenic Predictor of Thyroid Function

Performing a phenome-wide association study (PheWAS) identifying clinical diagnoses associated with a polygenic predictor of Thyroid stimulating hormone (TSH) levels identified by a previously published genome-wide association study (GWAS). PheWAS will be applied in an electronic-health-record (EHR) cohort including North American (n: 37,154) and European participants using 1,318 phenotypes.

Applying a genetic predictor of thyroid stimulating hormone levels to an electronic-health-record cohort to verify associations with thyroid disorders as positive controls, and identify new associations .

Eligibility Criteria:
Inclusion Criteria:

* Being part of the eMERGE Phase I \& II Network
* Being part of the BioVU resource
* Falling within 4 standard deviations for each of the first 2 principal components based on common single nucleotide variants (SNVs) for the subset of subjects self-identified as "White, non-Hispanic"

Exclusion Criteria:

* born after 1990
Changes in Ocular Rigidity After Trabeculectomy in Patients With POAG

It has been hypothesized that the biomechanical properties of the optic nerve head and/or sclera play a role in the development of glaucoma. One approach of gaining insight into the biomechanical properties of the eye by the means of clinical studies is based on the Friedenwald equation, representing a pressure-volume relationship. This equation represents the so called ocular rigidity, which expresses the elasticity of the globe.

In order to be able to solve the equation, measurements of fundus pulsation amplitude (FPA) with laser interferometry and dynamic contour tonometric assessment of the pulse amplitude (PA) have to be performed.

In addition choroidal thickness will be assessed with OCT before and after trabeculectomy, since results in choroidal thickness measurements in patients with glaucoma are controversial.

The focus of this study lies on the changes of ocular rigidity and choroidal thickness after surgical trabeculectomy in patients with primary open angle glaucoma (POAG) or pseudoexfoliation glaucoma (PEX).


Eligibility Criteria:
Inclusion Criteria:

* Men and women aged over 18 years
* Normal ophthalmic findings except POAG or Pseudoexfoliation glaucoma (PEX)
* Patients scheduled for trabeculectomy

Exclusion Criteria:

* Participation in a clinical trial in the 3 weeks preceeding the study
* Symptoms of a clinically relevant illness in the 3 weeks before the first study day
* Presence or history of a severe medical condition that will interfere with the study aim as judged by the clinical investigator
* Other types of glaucoma, such as pigmentary glaucoma, history of acute angle closure
* History of previous glaucoma surgery
* Postoperative IOP ≤ 8 mmHg
* Ocular inflammation or infection within the past 3 months
* Topical treatment with any ophthalmic drug except anti-glaucomatous medication
Investigating the Novel Observation of Right-left Difference in Uterine Artery Vascular Resistance in Pre-eclampsia

The investigators previously demonstrated that epidural ropivacaine reduces uterine artery vascular resistance in a dose dependent manner in pre-eclampsia. The investigators also noted a marked right-left difference in vascular resistance between paired uterine arteries, which was almost completely abolished following epidural ropivacaine. However, this novel observation was not a stated outcome variable before the study began. This study assesses right-left difference in vascular resistance between paired uterine arteries as a primary end-point, assesses the dose-response effect of epidural lidocaine and compares the effect observed in pre-eclampsia with that in two control populations (term normal pregnancy and non-pregnant controls).


Eligibility Criteria:
Inclusion Criteria:

* Pre-eclampsia patients and normal pregnancy controls scheduled to receive epidural catheterization for induction of labor or Cesarean delivery. Non-pregnant controls receiving epidural catheterization for elective surgery. Pre-eclampsia group:

  1. gestational age between 35 to 40 completed weeks
  2. uterine artery notching OR evidence of reduced uterine artery blood flow
  3. resting systolic pressure \> 140mmHg or diastolic pressure \> 90mmHg measured twice at least 6 hours apart
  4. proteinuria (at least 0•1 g/l in two random samples at least 6 hours apart or at least 0•3g in a 24 hour collection).
* Normal pregnancy control group:

  1. gestational age between 35 to 40 completed weeks
  2. absence of other inclusion factors for the pre-eclampsia group. Non-pregnant control group: Non-pregnant women of reproductive age.

Exclusion Criteria:

* Active labor, resting blood pressure ≥ 160/110 (recorded on at least two occasions 6 hours apart), coagulopathy or other contraindications for epidural catheterization, abnormal fetal heart tracing, known fetal anomaly, intrauterine infection, placental anomalies, twins, and refusal of consent.
Alveolar Macrophage Proteomics in HIV-associated Emphysema

This study is being done to examine lung function changes in individuals with HIV infection and to understand why individuals with HIV have increased risk of lung damage from cigarette smoking.

To delineate the natural history of HIV associated emphysema in the HAART era. To compare the alveolar macrophage proteomes from HIV-seropositive smokers with emphysema to the alveolar macrophages proteomes of both HIV+ smokers without emphysema and HIV- smokers.

To establish whether coinfection with HIV and Hepatitis C results in accelerated lung disease manifested by decrements in forced expiratory volume and carbon monoxide diffusing capacity.

Eligibility Criteria:
Inclusion Criteria:

* Clinically stable HIV-seropositive (and HIV-seronegative) individuals
* Ages 18 years and older
* Female subjects on no oral contraception with a negative pregnancy test
* Subjects capable of giving written consent

Exclusion Criteria:

* Known medical illness that would preclude bronchoscopy/BAL (e.g. unstable angina, new cardiac arrhythmia). This only pertains to subjects involved in the bronchoscopy phase of the study.
* Pregnant females
* Prisoners
Ultrasound Screening for Developmental Dysplasia of the Hip in Newborns

The aim of the randomized controlled trial was to determine whether the addition of a general or of a selective ultrasound screening program resulted in more appropriate criteria for treatment and a reduced prevalence of late DDH compared with clinical examination alone.

This is a retrospective registration of a RCT carried out in 1988-90, with a IRB approved follow-up at skeletal maturity carried out in 2007-09. Both the RCT and the follow-up study were carried out in the same institution, by the same PI (Prof. Karen Rosendahl) and her co-workers.

Detailed information is published in the following paper:

Rosendahl K, Markestad T, Lie RT. Ultrasound screening for developmental dysplasia of the hip in the neonate: the effect on treatment rate and prevalence of late cases. Pediatrics 1994;94:47-52.

A sample of the initial RCT was invited for a maturity review/follow-up at skeletal maturity.

The follow-up at skeletal maturity is called:

Radiological indices of hip dysplasia and osteoarthritis at skeletal maturity in the Bergen Birth Cohort. Associations with neonatal hip dysplasia, childhood growth and genetic predisposition

and is included in the approval by the Regional Ethical Committee for Medical and Health Research (No 3.2006.144). All participants of the follow-up study gave written informed consent according to the 1964 Declaration of Helsinki.

The follow-up had the following main aims:

1) estimate the prevalence of radiologically defined hip dysplasia, femoroacetabular impingement and osteoarthritis assessed at skeletal maturity 2)report the frequency of 4 longitudinal dysplasia phenotypes based on sonographic assessments in the newborn and radiological assessments at skeletal maturity 3)investigate associations of dysplasia as defined in 1 and 2 above in univariate and multivariate models with clinically assessed hip joint mobility/joint hypermobility, weight, height and body mass index (BMI) at age 18/19 years, prepubertal weight, height and BMI trajectories using data from child health records, first degree family history of hip dysplasia with or without hip arthroplasty, perinatal factors, measures of OA including minimum joint space, acetabular depth ratio and reported hip pain 5) establish a genetic resource by obtaining and archiving salivary DNA samples.

Eligibility Criteria:
Inclusion Criteria:

* all babies born at our institution during 1/1988-06/1990

Exclusion Criteria:

* low birthweight \<1500 grams, severe malformations, death within first month
Dried Blood Spots for SARS-CoV-2 Serology (COVID-19).

This study aims to validate dried blood spots (DBS) for SARS-CoV-2 (Severe Acute Respiratory Syndrome 2) antibody detection in elderly individuals.

In the current SARS-CoV-2 pandemic, testing for SARS-CoV-2 specific antibodies is paramount to monitor immune responses in post-authorization vaccination and sero-epidemiology studies. However, large scale and iterative serological testing by venipuncture in older persons can be challenging. Capillary blood sampled using a finger prick and collected on protein saver cards, i.e., dried blood spots (DBS), has already proven to be a promising alternative. However, elderly persons have a reduced cutaneous microvasculature, which may affect DBS-based antibody testing. Therefore, we aimed to evaluate the performance of DBS for the detection of SARS-CoV-2 antibodies in nursing homes residents. We collected venous blood and paired Whatman and EUROIMMUN DBS from nursing home residents, and from staff as a reference population. Venous blood samples were analyzed for the presence of SARS-CoV-2 IgG antibodies using the Abbot chemiluminescent microparticle immunoassay (CMIA). DBS were analyzed by the EUROIMMUN enzyme-linked immuno sorbent assay (ELISA) for SARS-CoV-2 IgG antibodies.

Eligibility Criteria:
Inclusion Criteria:

* nursing home staff and residents

Exclusion Criteria:

* Not applicable
Wireless Physiologic Monitoring in Postpartum Women

To estimate the clinical effectiveness of wireless physiologic monitoring of women in the first 24 hours after cesarean delivery at Mbarara Regional Referral Hospital

Women in sub-Saharan Africa have the highest rates of morbidity and mortality during childbirth. Despite significant increases in facility-based childbirth, quality gaps at the facility have limited reductions in maternal deaths. Infrequent monitoring of women around childbirth is a major gap in care that leads to delays in life-saving interventions. Simple increases in staffing will not overcome this gap, thus necessitating new strategies.

This project aims to use a simple wireless monitor to improve the detection of complications immediately after childbirth and allow clinicians to provide life-saving interventions when needed. Using a hybrid clinical effectiveness-implementation approach women delivered by cesarean in Mbarara, Uganda will be recruited to wear a wireless physiologic monitor for 24 hours after delivery and their delivering obstetricians recruited to use the monitoring system, including the receipt of text message alerts should women develop abnormalities in physiologic signs. Rates of morbidity and mortality will be compared with a control group of women delivered by the same obstetricians. Clinical adoption and implementation will be assessed with the RE-AIM implementation framework and semi-structured interviews.

Eligibility Criteria:
Inclusion Criteria:

* Emergency cesarean delivery at MRRH
* Able to provide consent or have a guardian/attendant present who can consent
* Willing to wear the biosensor for 24 hours
* Willing remain in the postpartum unit for 24 hours

Exclusion Criteria:

* Admitted to ICU directly after delivery
* Allergies or hypersensitivity to device materials
Exploratory Study of MT-1303 in Systemic Lupus Erythematosus Patients

The purpose of this study is to evaluate the safety/tolerability and to explore the efficacy of MT-1303 in subjects with systemic lupus erythematosus


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of SLE based on the American College of Rheumatology (ACR) criteria
* Presence of at least one of the following items: positive anti ds-DNA antibodies, low complement levels, and so on.
* Stable doses of corticosteroids

Exclusion Criteria:

* Severe active lupus nephritis, neuropsychiatric SLE