cyrilzakka/clinical-trials huggingface dataset:
Mitoferrin-1 Expression in Erythropoietic Protoporphyria (Porphyria Rare Disease Clinical Research Consortium (RDCRC))

The purpose of this study is to identify the biochemical/genetic defects in erythropoietic protoporphyria (EPP). People with EPP have skin sensitivity to sunlight and occasionally develop liver disease. In this study, the investigators hope to learn the nature of the biochemical/genetic defects in EPP because this may help explain the severity of these clinical features.

This study examines the possibility that abnormal expression of the gene mitoferrin-1, which codes for the protein that transports iron in the mitochondria of cells, is a contributing factor to the phenotype in individuals with EPP.

Erythropoietic protoporphyria (EPP) is a human genetic/metabolic disorder in which accumulation of the compound protoporphyrin causes skin sensitivity to sunlight. Some individuals with the disorder also have mild anemia, and a few have hepatobiliary disease. Iron is joined to protoporphyrin to form heme in the mitochondria of cells, under control of the enzyme ferrochelatase. Defects in this process cause the accumulation of protoporphyrin, leading to the biochemical and clinical features of EPP. Abnormalities in the ferrochelatase gene are the major cause of the defect, but do not satisfactorily explain the severity of the phenotype in all subjects. Mitoferrin-1 transports iron to ferrochelatase in the mitochondria of cells for heme formation, and also transports iron for the formation of a compound that keeps ferrochelatase active and stable. Thus, a deficiency of this iron transporter could reduce ferrochelatase activity and contribute to the phenotype in EPP.

Eligibility Criteria:
Inclusion Criteria:

1. Enrollment in the Longitudinal Study of the Porphyrias with a diagnosis of EPP
2. An individual or parent/guardian who is able to give written informed consent or assent, as appropriate -

Exclusion Criteria:

1. Patient is not enrolled in the Longitudinal Study of the Porphyrias
2. Patient is under the age of 7
3. Patient is cognitively impaired
4. Patient refuses to have blood drawn for establishing lymphoblast line -
Complaints Associated With Use of Pre-Filled Pen B With Type 2 Diabetics on Twice-Daily Insulin

Trial of new insulin injection pen called Pre-filled Pen B by type 2 diabetics in take home situations. Patients must use insulin lispro injection \[rDNA origin\] Low Mix twice daily during the trial.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 Diabetes
* Already on Lilly insulin or beginning insulin therapy
* 25 to 75 years old inclusive

Exclusion Criteria:

* Currently using, or had used during previous month, oral diabetes medication that is NOT approved for use in combination with insulin in patient's country
* More than 3 unexplained episodes of severe hypoglycemia within 6 months prior to trial
A Study of Iguratimod in Patients With Active Rheumatoid Arthritis

This study is intended to evaluate the safety and efficacy of Iguratimod in patients with active Rheumatoid Arthritis.

This is a multi-center, open, single arm study.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with a diagnosis of RA
* Subjects who have active RA at the time of screening
* Subjects who haven't used any antirheumatic drugs or have used antirheumatic drugs for more than 3 months at the time of screening
* Written informed consent

Exclusion Criteria:

* Subjects with serious cardiovascular, renal, hematologic or endocrine diseases
* Pregnant or lactating women
* ALT\>1.5×ULN, AST\>1.5×ULN, Cr\>135umol/L
* WBC\<4×109/L，HGB\<85g/L，PLT\<100×109/L
* Subjects with uncontrolled infection
* Patients with active gastrointestinal diseases (such as gastric ulcer, etc.)
* Allergic to any of the study drugs
* History of alcoholism
* Subjects receiving live vaccines within 3 months prior to study entry
* Subjects participating in other clinical study within 3 months prior to study entry
Toward a Comprehensive Supportive Care Intervention for Older or Frail Men With mCRPC

1. Multicentre pilot study (n=90) which aims to study a prevalent population of elderly or frail patients with mCRPC whom are often excluded from clinical trial participation. (Data is sorely needed in this population)
2. The study aims to determine:

   1. if symptom monitoring (daily) is feasible using telephone or electronic means of communications in the elderly or frail patient with mCRPC
   2. The time course/pattern of symptoms important to quality of life for patients undergoing chemotherapy, abi/enza, or Radium 223
   3. If changes in physical activity (quantified by fitbit) predict for changes to ESAS in men undergoing treatment d) Qualitatively assess the supportive care needs of older/frail men with mCRPC

Study Aim:

The previous multi-centre observational study (TOPCOP), funded by Prostate Cancer Canada, demonstrated important declines in multiple areas of quality of life, and fatigue and functional decline which were common issues that often limited further treatment. Emerging data from other settings demonstrate that (a) close monitoring of symptoms may reduce treatment toxicity and improve survival; (b) improving physical activity and targeting pain and sleep may improve fatigue and function. Whether these are feasible in the setting of older or frail men with mCRPC is unclear. Incorporating what the investigators have learned from TOPCOP and emerging supportive oncology literature, our main aim is to examine the emergence of key symptoms (fatigue, pain, insomnia) and explore whether reductions in daily physical activity are early indicators of toxicity over one treatment cycle (3-4 weeks) and therefore targetable in a subsequent intervention study.

Study Design:

This is a prospective multicentre observational study. The investigators will enroll English-speaking men with mCRPC who are either age 75 or older or age 60-74 and frail using (a) chemotherapy; (b) abiraterone or enzalutamide; (c) Radium.

Daily telephone-based brief symptom screening will be done with the Edmonton Symptom Assessment Scale (ESAS). Daily monitoring of physical activity (step counts) will be done with commercial smartphone apps or a Fitbit device. Moderate or higher symptoms (\>3/10) on ESAS or a decrease in daily step count of 15% or more triggers more detailed telephone-based toxicity assessment and measures of pain, sleep, and fatigue as appropriate. The study duration is 3 weeks (1 cycle of chemotherapy) or 4 weeks (abiraterone/enzalutamide/radium). Qualitative interviews will be done to explore challenges with treatment tolerability and adherence.

Eligibility Criteria:
Inclusion Criteria:

1. Starting either chemotherapy, Radium-223, Abiraterone or Enzalutamide or starting chemo \> one year post CHAARTED
2. At least 65 years old
3. Able to provide written informed consent
4. Diagnosed with metastatic castrate resistant prostate cancer
5. Total Testosterone level 1.7nmol/L
6. Has a working smartphone OR is willing to use a study provided smartphone

Exclusion Criteria:

-
The Effects of a Tele-health Program

Frailty is a state of being vulnerable and functional disable due to age-related decline of multiple physiological systems, and is often associated with higher risk of falls, institutionalization, hospitalization, disability, dementia, and death. One of the best strategies to combat the burden of frailty is to promote physical activity in the aging population, especially to the older adults who are already in a frail condition


Eligibility Criteria:
For older adults:

Inclusion Criteria:

* aged 60 or above
* having level of frailty from "managing well" to "living with severe frailty" (Clinical Frailty Scale score 3-7) -- HK-MoCA score 23 or less (add one point to people who had less than 6 year formal education and add 2 points to people who had no formal education)

Exclusion Criteria:

* currently receiving any kind of rehabilitation service
* living with another older adult who is participating in the same study.

For young adults:

Inclusion Criteria:

* aged 17 to 35
* having educational level of secondary 5 or above

Exclusion Criteria:

- having a full-time job
Sildenafil and Exercise Capacity in Hypertension

Hypertension (persistently elevated blood pressure) is a major risk factor for heart disease and stroke. Hypertensive individuals show a reduced exercise capacity, which is present from a very early stage and contributes to their increased cardiovascular risk. Sildenafil belongs to a class of drugs called phosphodiesterase type 5 (PDE5) inhibitors, and it works by enhancing the effects of nitric oxide, a substance that dilates blood vessels and increases blood flow. We hypothesize that sildenafil, because of its effect on nitric oxide and blood flow, will improve exercise capacity in hypertensive patients. Therefore, the main aim of the study is to investigate the effects of PDE5 inhibition on exercise capacity and vascular function in hypertension, and to compare these effects in hypertensive patients and healthy controls.


Eligibility Criteria:
Inclusion Criteria:

* Male (age range: 18 - 70 years)
* Appropriate blood pressure range
* Hypertensive - Systolic BP ≥140 mmHg and/or diastolic BP ≥90 mmHg
* Controls - Systolic BP \<140 mmHg and diastolic BP \<90mmHg
* Written informed consent

Exclusion Criteria:

* Female
* History of coronary artery, cerebrovascular or peripheral vascular disease within the last 6 months
* Total cholesterol \>6.5 mmol/L
* Current alcohol abuse
* Diabetes mellitus
* Asthma
* Taking any anti-hypertensive, vasoactive or endothelial function modifying drugs which cannot be withdrawn for the purpose of the study
* ECG evidence of clinically significant arrhythmia or cardiac ischaemia
* Clinically significant abnormality on screening blood test
* Contraindication to strenuous exercise
* Current involvement in other research projects
* Other clinically relevant conditions
* Lack of written informed consent
Lessening Incontinence by Learning Yoga

The purpose of this study is to assess the feasibility of recruiting women with urinary incontinence into a randomized controlled trial of a yoga therapy program.


Eligibility Criteria:
Inclusion Criteria:

* Women aged 40 years or older who report urinary incontinence for \> 3 months prior to screening
* Self-report at least 7 urinary incontinence episodes per week on a screening 7-day voiding diary
* Self-report urgency-predominant, stress-predominant, or mixed-type incontinence on the screening voiding diary
* Willing to refrain from initiating medical treatments that may affect their incontinence or voiding pattern during the study period
* Capable of understanding study procedures and giving informed consent

Exclusion Criteria:

* Participation in a yoga class or other formal or organized yoga instruction in the past year
* Any prior yoga therapy directed specifically at improving urinary incontinence or pelvic floor dysfunction
* Current use of medical therapy or device (i.e. pessary) for incontinence or use within the previous month
* Currently pregnant, gave birth within the past 6 months, or planning pregnancy during the study period
* Current urinary tract infection or a history or 3 or more urinary tract infections in the preceding year
* Report history of neurologic conditions such as stroke, multiple sclerosis, spinal cord injury, or Parkinson's disease, or a lumbosacral spine condition associated with neurological symptoms
* Unable to walk up a flight of stairs or at least 2 blocks on level ground without assistance
* Unable to get up from a supine to a standing position in 10 seconds or less and without assistance
* Severe obesity, defined as body mass index \> 35 kg/m2 on screening examination
* Report history of interstitial cystitis, fistula or hole in bladder or rectum, or birth defect leading to urine leakage
* Report any history of prior anti-incontinence or urethral surgery (not including urethral dilation), pelvic cancer, or pelvic irradiation for any reason
* Report use of bladder botox, electrostimulation, bladder training, or pelvic floor exercise training (with certified practitioners) in the past 3 months
* Report other surgery to the pelvis (hysterectomy, oophorectomy, vaginal surgery, bladder surgery, colon surgery) within the past 3 months
* Report symptomatic pelvic organ prolapse
* Report history of vulvodynia, chronic pelvic pain, or pain when practicing pelvic floor exercises
* Report conditions that, in the judgment of the investigators, render potential participants unlikely to follow the protocol, including plans to move, substance abuse, significant psychiatric problems, or dementia
* Participation in another research study that involves investigational drugs or devices that could potentially confound the results of this study
Arthroscopy in the Treatment of Degenerative Medial Meniscus Tear

Degenerative meniscal tears are the most common etiology for knee pain, swelling and loss of function. Partial arthroscopic meniscectomy is the most common orthopaedic procedure to treat meniscal tears. Improvements have been reported both after arthroscopy and with conservative treatment, however no direct comparison exist. Accordingly, the aim of this study is to assess the efficacy of arthroscopic partial meniscectomy for the treatment of degenerative tear of medial meniscus of the knee using a double-blind, placebo controlled, randomised trial.

Middle-aged men and women with degenerative meniscal tears constitute a large group of patients presenting with knee pain, sometimes accompanied with swelling and loss of function. Many meniscal tears occur without a trauma in physically active individuals as well as in older people and could be a part of early osteoarthritis. Partial arthroscopic meniscectomy is the most common orthopaedic procedure and is used to treat patients with meniscal tears. Many patients report improvement after arthroscopy referring especially to reduced knee pain, better knee function and improved quality of life. However, similar results have also been obtained with conservative treatment (physical therapy) of patients with degenerative meniscal tears. Accordingly, the aim of this study is to assess the efficacy of arthroscopic partial meniscectomy for the treatment of degenerative tear of medial meniscus of the knee using a double-blind, placebo controlled, randomised trial. The outcome of arthroscopic partial meniscectomy (vs. sham surgery) is assessed using the Lysholm knee score and pain at rest and activity (VAS) at 2, 6 and 12 months after the operation. In addition, the functional outcome is assessed using the WOMET knee score (a disease-specific quality of life -knee score development on the assessment of meniscal pathology), the general quality of life score (15-D), and cost-effectiveness analysis.

Eligibility Criteria:
Inclusion Criteria:

1. Age: 35 to 65 years of age.
2. A pain located on the medial joint line of the knee that has persistent at least for 3 months.
3. Pain that can be provoked by palpation or compression of the joint line or a positive McMurray sign.
4. Tear of the medial meniscus on MRI.
5. Degenerative rupture of the medial meniscus confirmed at arthroscopy.

Exclusion Criteria:

1. Acute, trauma-induced onset of symptoms.
2. Locking or painful snapping of the knee joint.
3. A surgical operation performed on the affected knee.
4. Osteoarthritis of the medial compartment of the knee (determined by clinical criteria of the ACR).
5. Osteoarthritis on knee radiographs (Kellgren-Lawrence \> 1).
6. Acute (within the previous year) fractures of the knee.
7. Decreased range of motion of the knee.
8. Instability of the knee.
9. MRI assessment showing a tumor or any other complaint requiring surgical or other means of treatment.
10. Arthroscopic assessment showing anything other than a degenerative tear of the medial meniscus requiring surgical intervention.
Effects of Continuous Venous Dialysis and Hemodialysis on Fluid Dynamics by Bioreactance Method

Dialysis methods applied at the bedside and dialysis methods applied in hemodialysis unit are widely applied in patients with renal insufficiency. Especially hemodynamically affected patients are less affected by hemodynamics as a result of using dialysis methods. It is a completely non-invasive method by bioreactance method and it can be done to measure the intra-body fluid status with the help of the glued probes. The aim of this study is to investigate the effects of continuous venous dialysis and hemodialysis on the fluid dynamics applied at the bedside with bioreactance method. In this way, the patient can develop more comfortable hemodynamic changes. Patients in the Surgery, Reanimation and Postoperative Intensive Care Unit with more than 24 hours of hospitalization and bedside dialysis or hemodialysis will be included in the study. Before the dialysis, body fluid measurements will be made with bioreactance, and after dialysis in patients receiving hemodialysis, and in dialysis patients 6, 12, 24 and 36 hours.

Dialysis methods applied at the bedside and dialysis methods applied in hemodialysis unit are widely applied in patients with renal insufficiency. Especially hemodynamically affected patients are less affected by hemodynamics as a result of using dialysis methods. Dialysis in the hemodialysis unit is a method used in intensive care patients and is preferred especially in patients with stable hemodynamics. In dialysis methods, changes occur frequently in the body fluids of the patient. It is a completely non-invasive method by bioreactance method and it can be done to measure the intra-body fluid status with the help of the glued probes. The aim of this study is to investigate the effects of continuous venous dialysis and hemodialysis on the fluid dynamics applied at the bedside with bioreactance method. As a result of measurements with buioreactans method, fluid balance in patients will be understood more easily. In this way, the patient can develop more comfortable hemodynamic changes. Patients in the Surgery, Reanimation and Postoperative Intensive Care Unit with more than 24 hours of hospitalization and bedside dialysis or hemodialysis will be included in the study. Before the dialysis, body fluid measurements will be made with bioreactance, and after dialysis in patients receiving hemodialysis, and in dialysis patients 6, 12, 24 and 36 hours.

Eligibility Criteria:
Inclusion Criteria:

* patients required dialysis therapy

Exclusion Criteria:

* under 18 years old
* confirmed or undiagnosed brain death
Feasibility Study of Fiducial Markers in Oesophageal Cancer

Currently, patients of suitable fitness with non-metastatic esophageal cancer are treated with surgery, radiotherapy or chemoradiotherapy. If treated with radio or chemoradiotherapy, a Computerised tomography (CT) scan is performed and is the dataset used for planning radiotherapy. Information from the endoscopic ultrasound (EUS), performed during routine staging, is used to help localize the tumor, as tumors of the esophagus are poorly visualised on CT. This information is subjective and dependant on the clinician performing the procedure. The tumor is described in relation to common anatomical landmarks. Interpretion of this information can lead to over-compensation when attempting to cover the tumor with a radiation field, to avoid a "miss". It is thought that using fiducial markers called Visicoils placed in or adjacent to the tumor's top and bottom extent at the time of EUS, will lead to better definition of the tumor in the planning process and hence, improvement in local tumor control, and reduction in radiotherapy dose to normal tissue.


Eligibility Criteria:
Inclusion Criteria:

* esophageal adenocarcinoma or squamous carcinoma, or undifferentiated carcinoma.
* No previous radiotherapy or chemotherapy.
* Fit for radical treatment of their cancer with reasonable lung function, Fev1 \>40%, and EUS planned.
* ECOG Performance Status 0-1: 0 - Fully active, able to carry on all predisease performance without restriction 1 - Restricted in physically strenuous activity

Exclusion Criteria:

* Pregnancy or breast feeding.
* Allergy to ciprofloxacin antibiotics
SPECT-CT Vs MRI for the Diagnosis of Osteoarthritis in the Foot and Ankle

The diagnose of symptomatic osteoarthritis in the ankle, mid- and hind foot remains challenging. There is no gold standard for the work-up and various hospitals use different protocols. Current literature shows a promising role for SPECT-CT imaging in ankle, hind- and midfoot OA. In a previous study investigating the role of SPECT-CT in a reproducible group we have observed a change in diagnosis in 53% when SPECT-CT data was added to the data of conventional workup alone. In 26% of patients addition of SPECT-CT data resulted in change of the original treatment plan. To our knowledge no prospective studies are available on this subject for both SPECT-CT and MRI. In our clinic both SPECT-CT and MRI are used in the work-up for patients with ankle, hind- and midfoot pain. Although we experience good result with SPECT-CT, MRI might be able to detect symptomatic OA as well. Moreover MRI provide more information about soft tissue and is less harmful for the patient in comparison to SPECT-CT. The aim of this study is to determine the diagnostic performance of SPECT-CT and MRI when used routinely in patients with symptomatic OA of the ankle, hind- and midfoot.

Objective: The objective is to determine diagnostic performance of SPECT-CT and MRI when used routinely in patients with symptomatic OA of the ankle, hind- and midfoot.

Study design: Prospective cohort study.

Study population: All patients ≥18years old, referred to the Martini Hospital Groningen department of Orthopedic surgery with suspected symptomatic osteoarthritis of the foot and ankle and rest pain of NRS ≥4.

Main study parameters/endpoints: Main parameters will be the diagnostic performance (a.o. sensitivity and specificity, positive and negative predictive value)of SPECT-CT and MRI.

The standard work up consist of questionnaires, detailed physical examination, conventional radiographic, MRI, SPECT-CT imaging and ultrasound guided injections. There are no additional risks for participating in this study compared to current standardised hospital workup.

Eligibility Criteria:
Inclusion Criteria:

* Suspected symptomatic ankle, hind- or midfoot OA
* Informed consent
* Age ≥ 18 years
* Average NRS ≥4 over the past week.

Exclusion Criteria:

* Contraindication for surgery
* Contraindication for SPECT-CT or MRI
* Contraindication for intra-articular injections
* Isolated forefoot pathology
* Fracture, ligamentous or tendon injury of the ankle, hind- and/or midfoot trauma within one year before presentation
* History of neurological disease
* History of foot and/or ankle surgery (affected side)
* Inability to read and understand the written information