cyrilzakka/clinical-trials huggingface dataset:
Feasibility Study of Exercise in Patients With Leg Blood Clots

The purpose of this pilot study is to assess the feasibility of determining the effects of a structured exercise program started two to four weeks after diagnosis of a first episode lower-extremity deep vein thrombosis (DVT) for a period of 12 weeks in reducing the incidence of post-thrombotic syndrome (PTS).

Deep Vein Thrombosis (DVT) affects nearly 300,000 people in the U.S. each year. DVT of the leg results in PTS in up to 65% of patients,despite receiving appropriate medical management with anticoagulant therapy.

PTS, caused by persistent venous outflow obstruction and venous valvular dysfunction, may result in symptoms of leg pain, swelling, heaviness and cramping especially with prolonged standing.

All eligible patients with documented first-episode DVT interested in participating will undergo medical screening and a screening treadmill test prior to enrollment between two and four weeks post DVT diagnosis. All patients will be provided and asked to wear class II (30 to 40mmHg) knee length compression hose daily during the entire trial.

The formal exercise training includes both a supervised walking program and a home-based walking program for 12 weeks with follow-up at 26 weeks. Blood tests will be taken to measure levels of indicators of inflammation at baseline, week 4, week 12, and week 26. The primary outcomes will be the feasibility of the exercise program and the incidence of post-thrombotic syndrome at 26 weeks.

Eligibility Criteria:
Inclusion Criteria:

* First episode lower extremity DVT (proximal or distal) documented by ultrasound, CT angiogram or venogram within last 4 weeks.
* Treatment with LMWH, or unfractionated heparin (UFH) followed by warfarin adjusted to keep INR 2 to 3 for at least 3 months, or LMWH given in therapeutic doses as sole therapy.
* Age 21 to 75 years old.

Exclusion Criteria:

* Recurrent DVT.
* Treatment of DVT with systemic or catheter-directed thrombolysis Contraindications to exercise training according to the American College of Sports Medicine (e.g., acute myocardial infarction, unstable angina, etc.,).
* Life expectancy \< 1 year.
* Pregnancy.
* Geographic inaccessibility.
* Screening (pre-randomization) exercise stress test demonstrating contraindication to exercise training (see exclusion #2).
* Cognitive dysfunction assessed by mini-mental status exam (score \< 24).
* Inability to walk.
Exercise Oscillatory Breathing and Sildenafil in Heart Failure

Exercise oscillatory breathing (EOB) is a ventilatory abnormality that occurs in approximately 20% of heart failure (HF) patients and carries a very unfavourable prognosis.

Pathophysiology seems quite complex and putative mechanisms include increased pulmonary capillary pressure and pulmonary vasoconstriction, circulatory blood-flow fluctuations in the pulmonary arterial system and instability of ventilatory control.

Inhibition of the phosphodiesterase 5 (PDE5) isoenzyme favourably regulates pulmonary vascular tone and permeability through over signaling of the endothelial nitric oxide pathway. The investigators tested the hypothesis that sildenafil would reverse the EOB pattern in patients with HF and pulmonary hypertension.


Eligibility Criteria:
Inclusion Criteria:

* consent to participate in the study after detailed information about benefits and risks
* negative exercise stress test prior to study initiation
* forced expiratory volume in 1 sec/forced vital capacity ratio \>70%;
* LVEF \< 45%.

Exclusion Criteria:

* inability to complete a maximal exercise test
* resting systolic blood pressure \> 140 or \<110 mmHg
* therapy with nitrate preparations
* history of sildenafil intolerance
* significant lung or valvular diseases
* neuromuscular disorders or peripheral vascular disease
Anti-proteinuric Effect of Calcitriol in Non-diabetic Kidney Disease Patients

Proteinuria is not only a marker of chronic kidney disease (CKD) progression, but also a marker of cardiovascular disease and death. In previous studies, active vitamin D deficiency is associated with cardiovascular risk factors such as albuminuria, diabetes mellitus, and lower glomerular filtration rate (GFR). And calcitriol was shown to have a preventive effect in progressive glomerular damage in a renal ablation model. Calcitriol, an active form of vitamin D (1,25-dihydroxyvitamin-D3), is commonly used for the treatment of secondary hyperparathyroidism in patients with advanced chronic kidney diseases.

Therefore, the objective of this study is to evaluate the anti-proteinuric effect of calcitriol in non-diabetic kidney disease patients. They will be treated with calcitriol and placebo for 24 weeks and observed for 24 weeks after treatment. Proteinuria, renal function, serum and urinary inflammatory markers, and adverse event will be monitored.


Eligibility Criteria:
Inclusion Criteria:

* Nondiabetic kidney disease patients aged 19-70 years
* MDRD GFR ≥ 30 mL/min/1.73m2
* Patients with residual urine protein/creatinine ratio \> 200 mg/g
* Adequate blood pressure control as treated systolic blood pressure \<=140 or diastolic \<=90 mmHg with RAS inhibitor for more than 3 months
* Normotensive patients untreated with RAS inhibitors
* Serum intact PTH as 35-500 mg/dL and serum calcium less than 10.2 mg/dL
* Patients who have not been treated vitamin D within the 3 months prior to signing the informed consent form

Exclusion Criteria:

* Patients with nephrotic-range proteinuria (24 hour urine protein \>3.5 g/24 hr)
* Patients with rapidly progressive glomerulonephritis
* Patients requiring renal replacement therapy immediately
* Hypercalcemia (uncorrected serum calcium level \> 10.2 mg/dL) within 3 months
* Malignant hypertension
* Heart failure (New York Heart Association \[NYHA\] functional class II to IV or LVEF less than 40%)
* Severe chronic obstructive lung disease
* Decompensated liver disease
* Known allergy or hypersensitivity to vitamin D
* Current treatment with steroids and/or immunosuppressive agents
* No other active primary malignancy requiring treatment or that limits survival to ≤ 2 years
* History of noncompliance to medical regimen
* Inability to give an informed consent or to cooperate with researchers (e.g., psychiatric disorder)
Mifepristone 10 or 5 mg for 6 Months to Treat Uterine Fibroids

The objectives of this study are to estimate the efficacy and safety of the daily administration for 6 months of 5 mg versus 10 mg. A 6 month follow-up of subjects is carried out to estimate how the effects of mifepristone are kept in time.

The hypothesis of this study is that both mifepristone doses reduce the volume of the myoma up to 50% in six months treatment.

Women, in fertile age or premenopausal status, presenting symptomatic myomaswere randomly assigned to receive 5 or 10 mg of mifepristone for six months.

The decreasing in the prevalence of symptoms attributable to myomas is an important goal to achieve under both treatments. Another goal is to maintain for more than 6 months the benefits of the treatment with mifepristone.

Eligibility Criteria:
Inclusion Criteria:

* Symptomatic uterine fibroids
* Reproductive age or premenopausal
* Accepting the use of non hormonal contraception
* Conformity in keeping a monthly log of all episodes of vaginal bleeding during the treatment as well as the side effects of mifepristone
* Agreeing to have ultrasound examinations in every follow-up or evaluation visit
* Agreeing in two endometrial biopsies: one before starting treatment and another in the following 10 days after treatment termination

Exclusion Criteria:

* Pregnancy or desire to become pregnant
* Breastfeeding
* Hormonal contraception or any hormonal therapy received in the last three months
* Signs or symptoms of pelvic inflammatory disease
* Adnexal masses
* Abnormal or unexplained vaginal bleeding
* Suspected or diagnosed malignant neoplastic disease
* Signs or symptoms of mental illness
* Adrenal disease
* Sickle cell anemia
* Hepatic disease
* Renal disease
* Coagulopathy
* Any other severe or important disease
* Any contraindication to receiving antiprogestins
Effects of Growth Hormone on Difficult Ventilator Weaning Patients

Major abdominal surgeries may be followed by postoperative pulmonary complications (PPCs). These complications are common and can cause significant morbidity and mortality.

Major operations are followed by acute respiratory insufficiency (RI) in 3%-27.4%, which causes prolonged hospital stay, high patient costs, high mortality rate and lower survival rates. The most crucial pulmonary postoperative complication is the prolonged mechanical ventilation and difficult weaning.The rHGH is a synthetic metabolic hormone which improves synthesis of protein, corrects hypoalbumenia, reverses negative nitrogen balance, improves patient nutrition, improves wound healing and promotes recovery of respiratory muscle function. When used for weaning from mechanical ventilation, rHGH reducess the duration of mechanical ventilation time, ICU admission period, incidence of VAP \& ICU mortality.

Major abdominal surgeries may be followed by postoperative pulmonary complications (PPCs). These complications are common and can cause significant morbidity and mortality.

Major operations are followed by acute respiratory insufficiency (RI) in 3%-27.4%, which causes prolonged hospital stay, high patient costs, high mortality rate and lower survival rates. The most crucial pulmonary postoperative complication is the prolonged mechanical ventilation and difficult weaning.The rHGH is a synthetic metabolic hormone which improves synthesis of protein, corrects hypoalbumenia, reverses negative nitrogen balance, improves patient nutrition, improves wound healing and promotes recovery of respiratory muscle function. When used for weaning from mechanical ventilation, rHGH reducess the duration of mechanical ventilation time, ICU admission period, incidence of VAP \& ICU mortality. Felbinger et al reported a case of prolonged ventilation with failure of weaning after 42 days; the patient received subcutaneous rHGH (0.3 IU/kg/day) for 20 days in addition to intensive care standard management. They reported improvement of protein metabolism in addition to improvement of respiratory muscle strength, the patient was weaned successfully on the 75th postoperative day.this study assumes a hypothesis that rHGH would help weaning from mechanically ventilated tracheostomized patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing major abdominal cancer surgeries.
* Patients requiring prolonged postoperative ventilation.
* Patients with multiple failed trials of mechanical ventilation weaning.
* ASA I and II patients.

Exclusion Criteria:

* History of chronic cardiac,renal or respiratory illness.
* Septic or septic shock patients on inotropic supports.
* Fully alert and Conscious patients.
* ASA 3 and 4.
Thalidomide for Multiple Myeloma

The objective of this protocol is to assess therapeutic activity of thalidomide in previously untreated patients with asymptomatic multiple myeloma.

This study attempts to examine the potential efficacy of thalidomide in the treatment of patients with previously untreated multiple myeloma. The trial focuses on patients with asymptomatic and indolent disease who do not require immediate chemotherapy. We intend to treat asymptomatic patients with an initial dose of 200 mg each evening, increasing to a maximum of 800 mg.

Thalidomide is supplied as 50 mg capsules to be taken by mouth. The initial dose will be 200 mg at bedtime daily for 14 days (days 1-14), followed by an increase to 400 mg daily for 14 days (days 15-28), 600 mg daily for 14 days (days 29-42), up to a maximum 800 mg (days 43-completion) daily provided there are no side effects.

Patients who experience significant toxicity (grade 2 or more) at any time during therapy will receive a lower dose after treatment is interrupted for at least 2 days.

Once a maximum tolerated dose has been reached free of side effects, that dose will be continued for a total of 3 months from institution of therapy before definition of response or resistance. Only patients who have received at least 200 mg/d for at least 2 months will be considered evaluable for response. For patients in remission, treatment will be continued at the maximum dose free of side effects until relapse. Selected patients \<55 years of age who achieve remission may be eligible for stem cell transplant (SCT) in which case thalidomide will be discontinued prior to SCT.

Patients must be willing to return for evaluation every 4 weeks since thalidomide may only be prescribed for 28 day intervals.

Eligibility Criteria:
* Previously untreated patients with multiple myeloma and without serious or imminent complications (e.g. impending pathologic fracture, hypercalcemia, renal insufficiency). All asymptomatic patients with low or intermediate tumor mass will qualify.
* Patients with high tumor mass, symptomatic or impending fractures, hypercalcemia (corrected calcium \>11.5 mg%), anemia (Hgb \<8.5 gm/dl), renal failure (creatinine \>2.0 mg/dl), high serum lactate dehydrogenase (\>300 U/L) or plasma cell leukemia (\>1000/ul) are ineligible.
* Overt infections or unexplained fever should be resolved before treatment. Adequate liver function (including SGPT, bilirubin and LDH) is required.
* Patients must have Zubrod performance of 1 or less.
* Patients must provide written informed consent indicating that they are aware of the investigational nature of this study.
* Life expectancy should exceed 1 year.
* Patients with idiopathic monoclonal gammopathy and non-secretory multiple myeloma are ineligible. Patients whose only prior therapy has been with local radiotherapy, alpha-IFN, or ATRA are eligible. Patients exposed to prior high-dose glucocorticoid or alkylating agent are not eligible.
Open-Label Lesinurad Monotherapy Extension Study in Gout

This study will assess the serum uric acid lowering effects and safety of lesinurad over a long-term timeframe.

This is a Phase 3, open-label, uncontrolled, extension study to assess the long-term efficacy and safety of lesinurad monotherapy in subjects who completed the double-blind treatment period in Study RDEA594-303.

Eligibility Criteria:
Inclusion Criteria:

* Subject is able to understand the study procedures and the risks involved and is willing to provide written informed consent before the first study related activity.
* Subject completed the double-blind treatment period in Study RDEA594-303 and was actively receiving and tolerating study medication (lesinurad or placebo) at Month 6 visit.
* Subject is willing to adhere to the visit/protocol schedules.
* Subject is male or female; female subjects of childbearing potential must agree to use an effective non-hormonal method of birth control during the study and for at least 14 days after the last dose of study medication.

Exclusion Criteria:

* Subject has any other medical or psychological condition, which in the opinion of the Investigator and/or the Medical Monitor, might create undue risk to the subject or interfere with the subject's ability to comply with the protocol requirements or to complete the study.
* Subject has a past medical history of urolithiasis, nephrolithiasis, or kidney stone diathesis.
* Subject developed kidney stones during Study RDEA594-303
Epividian / AHF: Positive Pathways - HIV Retention in Care

The primary objective of this study is to evaluate the effectiveness of a clinical decision support system (CDSS) combined with enhanced patient contact to retain HIV+ patients in care with AIDS Healthcare Foundation. Specifically, the study aims to evaluate the effectiveness of having the patient's primary caregiver (or dedicated case manager) telephone the patient when the patient is identified as a significant risk to loss of follow-up (at-risk patients) based upon pre-defined criteria. The secondary objective Gain a better understanding about the implementation of the study's procedures in clinical practice by evaluating survey responses delivered to participating healthcare providers and AHF staff members engaging with the study's intervention.

Retention in care and re-engagement in care is a primary concern in HIV treatment today and a major obstacle in the US to reach the UNAIDS 90-90-90 goal \[1\]. The U.S. CDC supports the use of HIV surveillance data to identify not-in-care (NIC) patients and re-link them to care (Data-to-Care). The optimal strategy for identifying patients for Data-to-Care is unknown. It has been postulated that by increasing follow up of high-risk patients not meeting the retention in care measures, the number of people living with HIV being retained in care may be increased by 10%.

Multiple HIV clinics within the AHF organization in the US are eligible for study participation. "Primary" HIV provider will be defined as the primary physician or advanced care practitioner following a patient, as recorded in their respective EHRs and identified through CHORUS, a CDSS developed by Epividian. The CDSS will track patient case status as active or inactive (loss to follow-up, transferred medical care, or deceased). Providers will be informed of the study and sites will be contracted to participate in this collaborative research study.

The CDSS will generate alerts to the providers warning of suboptimal patient attendance among the population. The alerts will be generated using the following four criteria of at-risk of loss to follow-up:

* At Risk #1: No visit in the previous 4 months and no scheduled appointment in the subsequent 2 months.
* High Risk #2: Single appointment in the previous year, a missed appointment in the previous month and no scheduled appointment in the next 2 months.
* High Risk #3: Those with 2 missed sequential appointments, and no scheduled appointment in the subsequent 7 days.
* High Risk #4: Those with an attended appointment \>3 months ago and their most recent viral load \>1000 copies/ml.

Eligibility Criteria:
Inclusion Criteria:

* HIV-1+
* 18 years old or older
* Any sex
* Seen at least once in a US-based AHF clinic in the last 2 years with care documented in the EHR

Exclusion Criteria:

* Patients known to have left the practice
* Patients who choose not to be contacted about their care via telephone
CRICKET: Critical Events in Anaesthetised Kids Undergoing Tracheal Intubation

The investigators' overall objective is to assess the incidence of critical events related to tracheal intubation at all international study sites. Furthermore, the study will investigate the used intubation techniques and identify possible improvement measures to increase patient safety.

It is a prospective observational multi-centre study collecting health related patient data over a period of three months. This serves best the study's purpose to detect the incidence and nature of problems related to tracheal intubation and how such problems are handled with the aim to further improve patient safety. During the observational period the anaesthesia staff in charge will complete a screening questionnaire for critical events associated with tracheal intubation for every patient undergoing general anaesthesia with tracheal intubation. If no critical events arise there are no further requirements. If a critical event occurs, the anaesthesia provider will complete a more detailed questionnaire which includes more questions about what exactly happened.

Patient characteristics will be extracted from the anaesthesia records. The investigators will extract such data for all patients undergoing tracheal intubation and additional data for those with critical events. The research will not intervene with the clinical conduct of patient care.

The collected health related data will be transferred to an electronic research data base. In this data base data will be encoded. Every patient with a critical event will be followed up as described above.

Eligibility Criteria:
Inclusion Criteria:

* All paediatric patients requiring tracheal intubation, performed by the anaesthesia team for procedures or interventions requiring general anaesthesia
* Patients from 0 - 16 years of age.
* Informed or general consent given, according to the relevant ethics committee statement.

Exclusion Criteria:

* Refusal to give consent or withdrawal of consent if such is required by the relevant ethics committee.
* Patients \>16 years
Characteristics of Pulmonary Vascular Changes in Patients With Kidney Transplantation

The aim of the study is to investigate pulmonary hemodynamics at rest and during exercise in patients before and after kidney transplantation.


Eligibility Criteria:
Inclusion Criteria:

* Age: ≥ 18 years
* patients listed for first kidney transplantation at the Clinical Division of Nephrology

Exclusion Criteria:

* Age \< 18 years
* combined organ transplantations (heart-kidney, pancreas-kidney etc.)
* patients with prior kidney transplantation
* high calcium score on cardiac-CT (\> 160 Agatston Score)
Study of Basivertebral Nerve Ablation Treatment of Chronic Low Back Pain

Prospective, single arm, open label, multi-center study to evaluated the effectiveness of intraosseous basivertebral nerve radiofrequency ablation using the Intracept System.

This is a prospective, open-label, single-arm study of patients diagnosed with vertebrogenic low back pain for a minimum of 6 months with conservative care. Participants will receive the Intracept System procedure to ablate the basivertebral nerve within the vertebral body. Treatment is performed on all vertebral bodies with Modic type 1 or type 2 changes on MRI from L3-S1.

Eligibility Criteria:
Inclusion Criteria:

* Skeletally mature subjects at least 25 years of age
* Chronic low back pain for at least 6 months
* Failure to respond to at least 6 months of non-operative conservative management
* Oswestry Disability Index (ODI) at least 30 points
* Modic changes Type 1 or 2

Exclusion Criteria:

* Current or history of vertebral cancer or spinal metastasis
* History of a fragility fracture
* Any back pathology related to trauma, evidence of vertebral compression fracture or other spinal pathology that could affect assessment of response to back pain
* Disc extrusion or protrusion
A Study to Improve Physician-Youth Communication and Medical Decision Making

The goal of this study is improving patient-centered communication for young people with advanced heart disease.


Eligibility Criteria:
Physician Inclusion Criteria:

* Physician participants will be recruited from the Division of Pediatric Cardiology at the University of Michigan. All physicians with dedicated clinical effort will be eligible.
* Eligible physicians must anticipate remaining on staff \>1 year

Patient/Caregiver Inclusion Criteria:

* Patients 12-24 years old with heart failure symptoms meeting criteria for New York Heart Association (NYHA) Class II - IV heart failure
* One parent/caregiver of patient participants meeting inclusion criteria will also be eligible

Physician Exclusion Criteria:

- Not a physician at University of Michigan in the Division of Pediatric Cardiology

Patient/Caregiver Exclusion Criteria:

* Patients with significant cognitive/developmental delay with potential to impact study participation will be excluded from the study due to the focus on physician-youth communication.
* Parents and parent/caregivers that are non-English speaking will be excluded from this pilot study.