cyrilzakka/clinical-trials huggingface dataset:
CEUS Targeted Biopsies Compared to mpMRI Targeted and Systematic Biopsies for the Detection of Prostate Cancer

The current standard for Prostate Cancer (PCa) detection remains taking 10-12 systematic biopsies of the prostate. This approach leads to overdiagnosis of insignificant PCa on the one hand and underdiagnosis and undergrading of significant PCa on the other. multiparametric Magnetic Resonance Imaging (mpMRI) has seen an increasing uptake in the clinics for biopsy targeting, but the value in biopsy naive patients remains controversial. With Contrast Enhanced UltraSound (CEUS) cancer induced neovascularisation can be visualised with the potential to improve ultrasound imaging for prostate cancer detection and localisation significantly. The past years numerous studies have been performed with CEUS, all basing their results on subjective judgement of the investigator. To overcome these difficulties CEUS quantification techniques have been used with encouraging first results. These imaging techniques have been proposed to improve the yield of prostate biopsies and possibly replacing systematic biopsies.

In this trial mpMRI imaging and CEUS + quantification are performed before primary biopsy. Using a fusion device, targeted biopsies are taken from predefined MRI lesions and CEUS lesions, together with standard systematic biopsies in the same patients by separate blinded clinicians. The main outcome measure is the per-patient (significant) prostate cancer detection rate for each of the biopsy regimens.


Eligibility Criteria:
Inclusion Criteria:

* age ≥ 18 years
* signed informed consent
* referred for mpMRI and primary biopsy

Exclusion Criteria:

* Documented acute prostatitis or urinary tract infections
* History of any clinically evidence of cardiac right-to-left shunts
* Receives treatment that includes dobutamine
* Severe pulmonary hypertension (pulmonary artery pressure \>90 mmHg) or uncontrolled systemic hypertension or respiratory distress syndrome
* Has received a biopsy procedure within 30 days before admission into this study
* Has received a biopsy procedure at the Academic Medical Center within a year before admission into this study
* Has any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study
* Is incapable of understanding the language in which the information for the patient is given
Nomad P-KAFO Study

The goal of this clinical trial is to evaluate the impact of using the Nomad powered KAFO in people who have had a musculoskeletal or neurological injury that has affected their ability to walk. The main questions it aims to answer are to quantify the effectiveness of the Nomad in improving mobility, balance, frequency of falls, and quality of life in individuals with lower-extremity impairments compared to their own brace, over three months of daily home and community use.

Participants will:

* Wear a sensor that records everyday activities and mobility.
* Perform measures of mobility and different activities of participation using their own brace.
* Perform measures of mobility and different activities of participation using the Nomad powered KAFO


Eligibility Criteria:
Inclusion Criteria:

* Regular and compliant use of a unilateral or bilateral KAFO or SCO or other passive KAFOs for impairment due to neurological or neuromuscular disease, orthopedic disease, or trauma
* Cognitive ability to understand and follow the study protocol; willingness to provide informed consent
* Willing to wear and charge an activity monitor for three-months home trials.

Exclusion Criteria:

* Flexion contracture in the knee and/or hip joint in excess of 15 degrees
* Non-correctable knee varus/valgus in excess of 15 degrees
* Severe spasticity
* Inability to stabilize the trunk with or without assistive devices (crutches, canes, etc.)
Consistency of Electrical Cardiometry and Pulmonary Artery Catheter

Currently, the gold standard method to estimate CO in patients with PAH or RV dysfunction is pulmonary artery catheter (PAC), however, the invasiveness and complexity of PAC has limited its usefulness in many clinical scenarios. By measuring the thoracic electrical bioimpedance, electrical cardiometry (EC) technique has been reported to noninvasively estimate cardiac output (CO) and other parameters related to cardiac contractility and fluid status in various cardiovascular disorders. However, in patients with pulmonary arterial hypertension (PAH) and/or right ventricular (RV) dysfunction, few study has been reported. The aim of this study is to evaluate the agreement between CO measured by PAC as the referenced method and CO measured by EC technique in patients with PAH and/or RV dysfunction.


Eligibility Criteria:
Inclusion Criteria:

* adult cardiac surgery patients
* pulmonary artery hypertension and/or right heart dysfunction
* mechanical ventilation

Exclusion Criteria:

* life threatening arrhythmia
* severe valve regurgitation
* left ventricular ejection fraction less than 30%
* patients with mechanical circulatory support
A Phase I Trial to Assess the Effects of Food and Formulation on PK of KPT-330 in Patients With Sarcoma

The purpose of this research study is to find out more information such as: to determine the effects of high and low fat foods on the pharmacokinetics (PK) of oral KPT-330 tablets and to compare PK of capsules and tablets in Arms 1 and 2; to evaluate tumor response in sarcoma participants in Arm 3; to compare the PK of 60 milligrams (mg) of the new, 2nd generation tablet formulation and 60 mg of the selinexor suspension formula to the current, 1st generation tablets.


Eligibility Criteria:
Inclusion Criteria:

1. Patients must have histologically confirmed soft tissue or bone/cartilage sarcoma. Patients with sarcoma of small round blue cell tumor types are allowed. Gastrointestinal stromal tumors (GIST) are excluded.
2. Patients must have received at least one prior anticancer regimen for metastatic disease unless there is no other therapy available and evidence of progressive disease on study entry. Patients with stable disease will be included if there has been failure to respond to another drug(s) within the previous 3 months

Exclusion Criteria:

1. Patients with known liver metastases
2. Radiation, chemotherapy, immunotherapy, any other systemic anticancer therapy or participation in an investigational anti-cancer study ≤ 3 weeks prior to initiation of therapy
3. Patients with known brain metastasis
4. Patients with any gastrointestinal dysfunctions that could interfere with the interpretation of the food effect data
5. Patients with known intolerance to low or high fat meals
6. In the opinion of the investigator, patients who are significantly below their ideal body weight
The Effect of Two Different Doses of Noradrenaline on Hypotension Caused by Spinal Anesthesia for Cesarean Section

To compare two infusion rates of norepinephrine for prophylaxis against post-spinal hypotension during caesarean delivery.

Hypotension after spinal anesthesia for cesarean delivery is common and is caused mainly by peripheral vasodilatation. Although the intravenous administration of fluids helps, it does not always prevent maternal hypotension. Usually, this hypotension is treated with phenylephrine or ephedrine.

Norepinephrine has been recently introduced for prophylaxis against post-spinal hypotension during cesarean delivery due to its α-adrenergic activity in addition to the weak β-adrenergic activity.

Although the use of norepinephrine for this purpose has shown promising results. However, no sufficient data are available with regard to its optimum dose.

The objective of this study is to compare two infusion rates of norepinephrine for prophylaxis against post-spinal hypotension during caesarean delivery.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women scheduled for cesarean section under spinal anesthesia
* Gestational age of at least 37 weeks

Exclusion Criteria:

* Patient refusal
* Contraindications of spinal anesthesia
* Allergy to the study drug
* Height\<150 cm, weight \< 60 kg, body mass index (BMI) ≥40 kg/m2.
* patients with cardiac morbidities
* Hypertensive disorders of pregnancy.
* Prepartum hemorrhage
Digital Health Intervention for Children With ADHD

To conduct an RCT to evaluate the efficacy of the system, we will recruit 60 children (ages 8-12) with ADHD who will be randomized to either immediate (n=30) or delayed (n=30) treatment (i.e., a wait-list control group). Among those randomized to immediate treatment, half will be assigned to DHI (delivered via a smartwatch and smartphone application) and half will be assigned to an active control treatment as usual (TAU) group who will receive the smartwatch with no assigned activities, applications, or interventions on the devices. The intervention period will last 16 weeks; after a participant has been in the delayed treatment group for 16 weeks and has completed the post-waiting period assessment, he or she will be assigned to either the intervention or active control group. Thus, 30 participants will complete the intervention and 30 will complete the active control, with half of the total sample also completing a wait-list period.


Eligibility Criteria:
Inclusion Criteria:

1. DSM-5TR diagnosis of ADHD through prior medical or psychological evaluations at the time of admission to the program,
2. ability to complete questionnaires and use an app in English,
3. reported IQ of at least 80 in order to ensure that the participant has the cognitive skills needed to use the app, and
4. parent/guardian available to consent and provide feedback in English.

Exclusion Criteria:

* Failure to meet any of the inclusion criteria
Study of Surgically-Induced Weight Loss on Pelvic Floor Disorders

The specific aim of this study is to evaluate the effect of surgically-induced weight reduction, as achieved by laparoscopic gastric banding or sleeve gastrectomy, on pelvic floor disorders such as stress urinary incontinence, overactive bladder, anal incontinence, and pelvic organ prolapse in severely, morbidly and super-obese women using a prospective, observational study design.


Eligibility Criteria:
Inclusion Criteria:

* surgical eligibility met by Center for the Treatment Obesity criteria
* morbid obesity (BMI \> 40 kg/m2) or severe obesity (BMI \> 33 kg/m2) in presence of NIH co-morbidities
* willing to participate in study, including completion of self-reported questionnaires

Exclusion Criteria:

* pregnancy or planned pregnancy
* recent pregnancy or pelvic surgery
* age \< 21 years
* known neurologic disease or pelvic pathology
A Study of LY3337641 in Rheumatoid Arthritis

The main purpose of this study is to evaluate the safety and effectiveness of LY3337641 in adults with rheumatoid arthritis (RA).


Eligibility Criteria:
Inclusion Criteria:

* Female subjects of childbearing potential test negative for pregnancy at screening and agree not to breastfeed
* Female subjects: agree to use a reliable method of birth control from the start of screening until 28 days after the last dose of study drug or be of nonchildbearing potential
* Male subjects: agree to use a reliable method of birth control from the start of screening until 2 weeks after the last dose of study drug or have undergone vasectomy
* Have a diagnosis of RA based on the 2010 American College of Rheumatology (ACR)/European League against Rheumatism criteria
* Have at least 1 of the following:

  * rheumatoid factor or anti-citrullinated peptide antibodies (ACPA) at screening OR
  * radiographs documenting bony erosions
* Have active RA, defined as:

  * Part A: ≥3 swollen joints (based on 66-joint counts)
  * Part B:
  * ≥6 swollen joints (based on 66-joint counts)
  * ≥6 tender joints (based on 68-joint counts)
  * hsCRP levels greater than the upper limit of normal (ULN) OR positive for ACPA
* Part B only: Have had inadequate response, loss of response, or intolerance to at least 1 synthetic OR biologic disease-modifying antirheumatic drug (DMARD)

Exclusion Criteria:

* Have received any of the following:

  * Part B only: any prior treatment with a product directly targeting Bruton's tyrosine kinase (BTK) (marketed or investigational)
  * belimumab, natalizumab, or vedolizumab within 6 months prior to baseline
  * B-cell-depleting agents (such as rituximab) or other cell-depleting biologics (eg, anti-cluster of differentiation 3 (CD3) antibody) within 12 months prior to screening for Part A or at any time prior to screening for Part B
* Have known hypogammaglobulinemia
* Have hepatitis C virus, hepatitis B virus or human immunodeficiency virus
* Have active tuberculosis (TB)
* Are at high risk of infection or have recent evidence of clinically significant infection
* Have had lymphoma, leukemia, or any malignancy within the previous 5 years except for treated basal cell or squamous epithelial carcinomas of the skin
* Have received a live (attenuated) vaccine within 28 days prior to baseline or plan to receive one during the study
Observation of Treatment With Certolizumab Pegol in Daily Practice

This is an observational, non-interventional, non-comparative, post-authorization safety study to evaluate efficacy and long-term safety of Cimzia in adult patients with RA in need of treatment with a biological product.

The purpose of this study is to assess the clinical efficacy of Cimzia in achieving clinical remission after two years of therapy. The observational nature of the study leaves the therapeutic decision exclusively within the discretion of the treating physician.

Eligibility Criteria:
Inclusion Criteria:

* Patients eligible for treatment with Cimzia as defined in EU approved SmPC

Exclusion Criteria:

* Patient previously treated with Cimzia. Patient with known hypersensitivity to any component of Cimzia
X-Ray Follow-up in Proximal Humeral Fractures Conservatively Treated

Randomly assign patients with fractures of the proximal humerus to conservative treatment to a group in which a control radiological study will be carried out after a week of evolution of the fracture and to another group in which this control radiology will not be carried out. In the evolutionary controls, it will be determined whether there are differences between the two groups in the final functional result, in the perception of quality of life, and in the number of complications derived from the fracture.


Eligibility Criteria:
Inclusion Criteria:

* patients\> 18 yo and \< 85 yo
* Fractures of the proximal humerus \<3 weeks of evolution.
* fractures treated conservatively.
* No previous pathology of the affected shoulder.

Exclusion Criteria:

* dementia
* impossibility of carrying out a rehabilitation guideline.
Anastomotic Techniques in Pancreaticoduodenectomy

There are two principal ways of draining the remnant of the pancreas back into the intestine after removal of the head of the pancreas for cancer. This can be performed either to the jejunum or to the stomach. The aim of this study is to randomly allocate consenting patients to one of the two arms to study whether the leak rates from the anastomosis and the outcomes after the surgery are affected.

Previous papers have shown similar results in both groups although non randomized data suggested that the Pancreaticogastrostomy (drainage into the stomach) may be superior


Eligibility Criteria:
Inclusion Criteria:

1. Pancreaticoduodenectomy for adenocarcinoma of the pancreatic head
2. resectable tumour

Exclusion Criteria:

1. chronic pancreatitis/benign tumours-
2. tumours extending into the body of the pancreas
3. tumours with metastasis beyond regional lymph nodes
4. requirement for sub total pancreatectomy
5. prolonged hypotension - \< 80 mm of hg for more than 30 min
The Eggs and actiVity in hEalth agiNg Pilot (EVEN-P) Trial in Older Persons

Two of the most effective lifestyle-based approaches to reduce the risk of adverse health events and enhance quality of life with aging are exercise and a healthy diet. Currently, the Canadian recommended dietary allowance (RDA) for protein is 0.8 g/kg/day, however, several expert groups have advocated for a higher RDA of protein (\~1.2 g/kg/day), along with more evenly distributed daily consumption, in older persons. Eggs are considered a nutrient-rich protein source but have recently been scrutinized. This study will compare a high-protein, egg-containing diet and a high-protein, non-egg diet in healthy older persons.

This study will examine the impacts of an egg-containing diet and a non-egg diet in healthy older persons. Briefly, participants (healthy persons, age 60-75 years old) will consume their normal diet or their normal diet plus 4 eggs completing a structured exercise program (designed to meet Canada's Physical Activity Guidelines) for a total of 12 weeks. Participants will be randomly assigned to the Egg or Control (non-egg) group. Before and after the 12-week intervention, participants' undergo assessments of diet-quality, muscle health, fitness, bone health, and vascular health.

Eligibility Criteria:
Exclusion Criteria:

1. Use assistive walking devices (e.g. cane or walker)
2. Consume any analgesic (pain-relieving) or anti-inflammatory drug(s), prescription or non-prescription, chronically
3. A history of neuromuscular problems or muscle-wasting diseases
4. Any acute chronic illness, cardiac, pulmonary, liver, or kidney abnormalities, uncontrolled hypertension, insulin or non-insulin dependent diabetes or other metabolic disorders- all ascertained through medical screening questionnaires
5. Chronic consumption of statins (particularly simvastatin/Zocor and atorvastatin/Lipitor) used to lower cholesterol
6. Be on any medications known to affect protein metabolism (i.e. corticosteroids, non-steroidal anti-inflammatories, or prescription-strength acne medications)
7. Have allergies or are not willing to consume eggs
8. Consume a vegetarian diet
9. Had significant weight gain or loss in the past 6 months
10. Have injuries preventing the safe completion of the exercise
Effects of CX516 on Functioning in Fragile X Syndrome and Autism

This study will investigate whether CX516 can improve attention, memory, language, or behavior in adults with Fragile X Syndrome and/or Autism.

CX516 is an AMPAKINE® compound. AMPAKINE compounds enhance synaptic strength. There is evidence to suggest that the synapses in the brain of an individual with fragile X syndrome are immature and abnormal. It is possible CX516 may partially correct this synaptic transmission defect and lead to improvement in cognitive and behavioral functioning.

There is also reason to believe that these changes caused by CX516 could be helpful in managing cognitive and behavioral symptoms in patients with autistic disorder.

Involvement for each participant will last 28 days. Participants will be given study medication, a physical exam, and a variety of cognitive assessment tests to study potential drug effectiveness at improving disease symptoms.


Eligibility Criteria:
Inclusion criteria:

Fragile X group

* DNA-based diagnosis of Fragile X syndrome

Autism group

* Documented diagnosis with ADOS; ADI-R; CARS and GARS

Both groups

* 18-50 years
* Measured IQ below 85
* Measured IQ \>20
* Mental age \>30 months
* Stable medication regimen for past 8 weeks
* Normal hearing
* Vision corrected to at least 20/50
* All females of childbearing age must have a negative pregnancy test at enrollment

Exclusion criteria:

* Recent history of seizure, epilepsy, or blackouts
* Unresolved medical issue impacting performance
* Behavioral dysfunction to the point that subject cannot cooperate for testing
* History of drug-induced neutropenia
* Uncontrolled hypertension
Mastopexy With Autologous Augmentation in Women After Massive Weight Loss - A Clinical, Randomized Study

The purpose of this study is to compare two different techniques of mastopexy with autologous augmentation, the Lower Pole Subglandular Advancement Mastoplasty (LOPOSAM) and Rubins Mastopexy with autologous augmentation, in massive weight loss patients to see if one technique is superior to the other.

In Massive Weight Loss (MWL) patients the breasts often appear deflated following the prominent volume decrease. The breast is not only deflated, the supportive fibrous tissue is lax and the structural properties have changed. In the typical patient the breast base has sunk along with the inframammary crease and the shape of the breast is wide and flat with a significant ptosis.

One way of helping these women is to offer a mastopexy with autologous augmentation. There are several different surgical techniques for treating the ptotic and deflated breast in MWL patients.

In this study the investigators compare the investigators own technique, LOPOSAM, with Rubins Mastopexy with autologous augmentation.

In Rubins Mastopexy, an extensive re-arrangement of the skin, fat and breast tissue is done and this is supposed to give good long term results. The procedure is however time consuming and extensive.

The LOPOSAM technique is less extensive and therefore less time consuming and the investigators hypothesis is therefore that the technique has a lower complication rate.

Women that is referred for mastopexy after MWL and meet the criteria for post bariatric surgery, set by the Danish National Board of Health, and is found to be a suitable candidate for mastopexy with autologous augmentation is invited to participate in the study.

Sample size assessment has shown that 22 women (11 in each group) is needed and this number of patients is expected to be recruited in 6-9 months.

The study design is a prospective randomized trial.

Preoperative breast measurements and clinical photographs will be compared with measurements and clinical photographs at 3, 6 and 12 months postoperative

The primary outcome is operation time but secondary outcomes include economics, breast measurements, cosmetic result and complication rates.

With this trial, the investigators hope to demonstrate whether or not one of the two techniques is superior to the other and therefore should be the preferred technique.

Eligibility Criteria:
Inclusion Criteria:

* Women that meet the Danish National Board of Health criteria for post bariatric surgery, and is found to be a suitable candidate for autologous augmentation

Exclusion Criteria:

* Severe dementia, making informed consent impossible
* Non-Danish speaking