cyrilzakka/clinical-trials huggingface dataset:
Exercise and RP (AVAMC and Emory)

The purpose of this study is to look in humans at the relationship between moderate or little exercise and their potential effects on the retina in patients with Retinitis Pigmentosa (RP).

Human studies have shown that regular exercise may have positive effects on common degenerative diseases such as Alzheimer's disease. Exercise has also shown to improve conditions the eye such as macular degenerations, glaucoma, and cataracts. Mice with retinal degeneration which were exposed to exercise showed that it helped to slow the rate of degeneration. The purpose of this study is to look in humans at the relationship between moderate or little exercise and their potential effects on the retina in patients with Retinitis Pigmentosa (RP).

Eligibility Criteria:
Inclusion Criteria:

* Visual field no less than 10 degrees;
* VA no worse than 20/200 in the better seeing eye.

Exclusion Criteria:

* Not able to tolerate exercise due to an underlying medical condition.
Cardiopulmonary Exercise Testing as an Outcome Predictor in Coronary Artery Bypass Surgery

This is a prospective cohort study of patients undergoing coronary artery bypass graft surgery. Prior to surgery, participants will undergo submaximal cardiopulmonary exercise testing on a treadmill. Participants will be followed for one month after surgery to assess mortality and non fatal complications.

Coronary artery bypass surgery (CABG) is a complex and expensive procedure with great potential for morbidity and mortality. Preoperative evaluation is of paramount importance to optimize results. There is much evidence about the benefits of the cardiopulmonary exercise testing (CPET) in the evaluation of preoperative risk in non-cardiac surgeries. Thus, it is important to evaluate the relationship between parameters obtained in the CPET and the outcomes after cardiac surgery, especially CABG.

This is a prospective cohort study in which participants undergo submaximal CEPT on a treadmill prior to CABG. Participants will be followed up for one month after surgery to assess mortality and non fatal complications. It is expected that poor cardiopulmonary fitness is related to worse outcomes in CABG, as already observed in other cardiac pathologies and in non-cardiac surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing coronary artery bypass grafting surgery at the National Institute of Cardiology, Ministry of Health, Rio de Jnaeiro, Brazil.

Exclusion Criteria:

* Angina CCS IV, heart failure NYHA IV, inability to walk on a treadmill, severe left main coronary artery lesion.
Hemodynamic and Headache-Inducing Effect of Intravenous Vasoactive Intestinal Peptide in Migraineurs

We hypothesized that infusion of VIP may induce headache/migraine in migraineurs and that VIP-induced headache may be associated with dilation of intra- and extracranial vessels. To test this hypothesis, we performed a double blind placebo-controlled crossover study in migraineurs and studied the effect on headache and cerebral and systemic hemodynamic parameters.

We hypothesized that infusion of VIP may induce headache/migraine in migraineurs and that VIP-induced headache may be associated with dilation of intra- and extracranial vessels. To test this hypothesis, we performed a double blind placebo-controlled crossover study in migraineurs and studied the effect on headache and cerebral and systemic hemodynamic parameters. The subjects were randomly allocated to the infusion of 8pmol/kg/min VIP or placebo (isotonic saline), duration 25min. Headache intensity, mean velocity of blood flow in the middle cerebral artery (VmMCA), superficial temporal artery diameter, end-expiratory CO2 and vital signs were recorded at baseline and then every 10 min until 120 min after start of the infusion. The patients received a headache diary for the following 12 hours after infusion.

Eligibility Criteria:
Inclusion Criteria:

* migraineurs

Exclusion Criteria:

* cerebrovascular disorders, pregnancy, nursing
Observational Study to Evaluate Allogeneic HSCT Outcomes for Cerebral Adrenoleukodystrophy (CALD)

Study ALD-103 will be a multi-site, global, prospective and retrospective data collection study that is designed to evaluate outcomes of allo-HSCT in male subjects with CALD ≤17 years of age.


Eligibility Criteria:
Inclusion Criteria:

1. Provide informed consent from a competent custodial parent or guardian with legal capacity to execute a local Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved consent. In addition, informed assent will be sought from capable subjects, in accordance with the directive of the institution's IRB/IEC and all other local requirements.
2. Be male and ≤17 years of age at the time of treatment, for retrospective and partial prospective/retrospective subjects, or at the time of parental/guardian consent and, where appropriate, subject assent, for prospective subjects.
3. Have a confirmed diagnosis of CALD as defined by abnormal VLCFA profile and cerebral lesion on brain MRI.
4. Depending on the cohort, the subject must:

   * Be scheduled for allo-HSCT evaluation at a study site (prospective cohort only),
   * Have received an allo-HSC infusion and be consented in time to complete the Month 24 Visit on study (partial prospective/retrospective cohort only), or
   * Have received their most recent allo-HSC infusion on or after January 1, 2013 (retrospective cohort only).

Exclusion Criteria:

1. Previous treatment with a gene therapy product.
2. Receipt of an experimental transplantation procedure.
Protective Effect of Sivelestat Sodium on ARDS in Patients With Sepsis

Sivelestat sodium has been approved for use in patients with SIRS and ALI, but whether it can protect patients with sepsis from developing ARDS remains unknown.The aim of this study was to determine whether sivelestat sodium has a protective effect on ARDS in patients with sepsis.

The study was conducted in accordance with good clinical practice and with the guidelines set out in the Declaration of Helsinki. After approval from local and national ethics committees, patients from 3 centers in China were recruited.

All patients were randomized, in a double-blind manner, to receive either sivelestat sodium regimen or a placebo regimen for 1- 7 days in ICU.

The aim of this study was to determine whether sivelestat sodium has a protective effect on ARDS in patients with sepsis.

Eligibility Criteria:
Inclusion Criteria:

* Within 24 hours after admission, sepsis 3.0 diagnostic criteria were met;
* The patients or their family members fully understand the purpose and significance of the trial, voluntarily participate in the clinical trial, and sign the informed consent.

Exclusion Criteria:

* Patients with ARDS were identified at the time of admission;
* Patients who explicitly refused mechanical ventilation;
* Patients with 3 or more extrapulmonary organ injuries and organ failure(single organ SOFA score ≥ 3);
* Patients who need home oxygen therapy or with home mechanical ventilation (by tracheotomy or noninvasive ventilation, but excluding CPAP / BiPAP, only for patients with obstructive sleep apnea);
* The patient whose expected survival time was less than 48 hours;
* Pregnant women and lactating women;
* Other conditions judged by the researcher not suitable for inclusion.
Anakinra as a Treatment for Hydradenitis Suppurativa

This is an open-label, proof-of-concept research study to assess the effectiveness of anakinra in the treatment of patients with hidradenitis suppurativa (HS). The planned intervention is to provide about 6 HS patients with anakinra 100mg daily injections to administer subcutaneously for 8 weeks. Then, the study subjects will be followed for a further 8 weeks to monitor for relapse of HS.


Eligibility Criteria:
Inclusion Criteria:

1) Signed informed consent form with Confirmed diagnosis of hidradenitis suppurativa with moderate or severe disease activity

Exclusion Criteria:

1. Use of the following therapies:

   * Etanercept in the 4 weeks prior to the baseline visit (Day 1)
   * Adalimumab in the 8 weeks prior to the baseline visit (Day 1)
   * Infliximab in the 12 weeks prior to the baseline visit (Day 1)
   * Any other investigational biologics in the 8 weeks prior to the baseline visit (Day 1)
   * Leflunomide in the 4 weeks prior to the baseline visit (Day 1) • Thalidomide in the 4 weeks prior to the baseline visit (Day 1)
   * Cyclosporine in the 4 weeks prior to the baseline visit (Day 1)
   * I.V. immunoglobulin (I.V. Ig) in the 8 weeks prior to the baseline visit (Day 1)
   * 6-Mercaptopurine, azathioprine, cyclophosphamide, or chlorambucil in the 12 weeks prior to the baseline visit (Day 1)
   * Colchicine, dapsone, mycophenolate mofetil \& systemic antibiotics in the 3 weeks prior to the baseline visit (Day 1)
   * Corticosteroids "20mg/day or \>0.4 mg/kg, whichever applies, in the 1 week prior to the baseline visit (Day 1)
2. history of immunocompromise including HIV infection
3. positive Hep B surface antigen -
Aruba Aloë Formula F-BC-096 in the Treatment of Split Thickness Donor Sites After Wound Closure

Comparison between use of Aruba Aloë formula F-BC-096 and control.

Patients with two equal donor sites will be selected for inclusion. After wound healing one donor site will be treated with Aruba Aloë Formula F-BC-096 while a control product will be applied to the second site.

If pressure garments are applied they must be equal for both donor sites. During follow-ups objective methods will be used to evaluate elasticity and colour of the scar.

Eligibility Criteria:
Inclusion Criteria:

* Patients must have two similar donor sites, identical in depth and wound treatment.
* Healing time of both donor sites may differ by 3 days maximum.
* Flux values determined by Laser Doppler Imaging before commencement of the therapy must be approximately similar.
* If possible, the donor sites to be compared must have the same location.
* Patient compliance with therapy in relation to the protocol is necessary. In case of pediatric patiënts this depends on collaboration of the parents.
* For the two donor sites to be compared, the entire after-treatment concerning pressure garments or eventual silicone sheets must be equal for both donor sites.
* Patients must be available for regular and necessary follow-up.
* Possibility to finish all measurements during follow-up visits.
* Written authorisation of the patient, family or parents is required.

Exclusion Criteria:

* Donor sites are not similar (not identical in: depth, wound treatment, healing time and flux values)
* Children requiring sedation for LDI of donor sites
* Not following the complete treatment schedule or missing some evaluations during the follow-up period
* Patient has any condition(s) that seriously compromises the patient's ability to complete this study.
* Patient has participated in another study utilizing an investigational drug or device within the previous 30 days
* Patient has one or more medical condition(s), diabetes, including renal, hepatic, hematologic, neurologic, or immune disease that in the opinion of the investigator would make the patient an inappropriate candidate for this study
* Patients wish to terminate the study
* No informed consent before start of the trial
Elderly Urinary Incontinence Caregiver Burden

The purpose of this study is to evaluate the severity of urinary incontinence (UI) in elderly patients and its impact on the burden of care in their family caregivers.

The objective was to evaluate the severity of urinary incontinence (UI) in elderly patients and its impact on the burden of care in their family caregivers.

The study is a descriptive, cross-sectional and relationship-seeking type of research. It was conducted prospectively with 80 elderly(≥65 years of age) patients with UI and their family caregivers who applied to the urology clinic between June and December 2021. The data was collected using the "Socio-Demographic Characteristics Data Collection Form". UI was assessed by "International Consultation on Incontinence Questionnaire Short Form(ICIQ-UI-SF)" and caregiver burden by means of Zarit Burden Scale(ZBI) form.

Eligibility Criteria:
Inclusion Criteria:

* The primary caregiver family member (mother, father, spouse, sibling, child), appropriate cognitive and mental health to respond to the applied forms, constant patient care
* The patient's being 65 years and older and diagnosed with urinary incontinence.

Exclusion Criteria:

* The family member who did not volunteer to participate in the study
Impact of Dapagliflozin on DIAstolic Dysfunction in Type 2 Diabetic Patients

This study aims to assess the impact of 24-week treatment of dapagliflozin in type 2 DM(diabetes mellitus) patients on diastolic dysfunction. Primary endpoint is assessing the impact of 24-week treatment of dapagliflozin in type 2 DM patients on subclinical diastolic dysfunction assessed by supine bicycle diastolic stress echocardiography. Secondary endpoint is assessing the impact of 24-week treatment of dapagliflozin in type 2 DM patients on functional capacity, he impact of 24-week treatment of dapagliflozin in type 2 DM patients at resting diastolic function. This is single-center, randomized, double-blind, placebo-controlled, parallel-arm intervention study.

This study is planned to evaluate the impact of dapagliflozin on diastolic dysfunction assessed. The dose of dapagliflozin will be 10 mg as approved.

For assessment of diastolic dysfunction, supine bicycle stress exercise echocardiography was performed, and changes in diastolic functional reserve, VO2max, exercise time, and maximal exercise capacity were assessed before and after treatment. This study will be randomized, double blind, placebo controlled, to minimize the risk of bias.


Eligibility Criteria:
Inclusion Criteria:

* Female and male aged 19\~75 years
* Type 2 DM and had not reached adequate glycemic control with a stable dose of metformin, sulfonylurea, or both drugs before screening
* HbA1c 7.0% \~ 10% at screening (Patients who take metformin only: HbA1C 6.5-10%)
* Patients with ≥ grade 1 diastolic function (relaxation abnormality) at resting echocardiography
* Patients provided with the written, informed consent to participate in this study

Exclusion Criteria:

* Type 1 DM (Fasting c-peptide ≤ 0.78ng/dL(or 0.26 nM/L)), secondary diabetes, gestational diabetes
* History of diabetic ketoacidosis, hyperglycemic hyperosmolar status
* Estimated glomerular filtration rate \< 60 mL/min/1.73m2
* History of chronic cystitis or recurrent urinary tract infection
* Currently on loop diuretics
* Currently on medication known to affect glucose metabolism (e.g. corticosteroids, immunosuppressants)
* Abnormal liver function (AST/ALT \> x3 upper normal limit)
* On weight loss program or taking weight loss medication
* LV ejection fraction \< 50% at resting echocardiography
* Uncontrolled hypertension (systolic blood pressure \>200mmHg and/or diastolic blood pressure \>110mmHg)
* History of acute myocardial infarction, unstable angina, coronary artery bypass graft or stroke within 6 months
* Inducible ECG abnormalities at exercise
* Cardiomyopathy, significant valvular heart disease, or a significant arrhythmia
* Patients who cannot perform supine bicycle stress echocardiography
* Pregnant or lactating women
* Subjects who the investigator deems inappropriate to participate in this study
Kinesio® Tex Taping for Post Total Knee Replacement Patients

This study is designed to better understand the effect of Kinesio Taping applied using the Neurotaping technique on patients who underwent total knee arthroplasty surgery. Patients will be randomized in two groups: in the first group patients will follow a protocol of usual rehabilitation, while the second group will do the same but add the Kinesio Taping application. Main outcome will be the effect on edema, secondary outcome the effect on functionality after 13 days post surgery.


Eligibility Criteria:
Inclusion Criteria:

* Program of total knee replacement;
* Signing and accepting informed consent.

Exclusion Criteria:

* pre-operative Barthel Index score \< 70;
* program of revision of total knee replacement;
* grade III-IV heart failure;
* grade III-IV kidney failure;
* hypersensitive skin or intolerance to taping;
* Active cutaneous infection or open skin lesion on the sites of taping positioning;
* Body Mass Index \> 34,9;
* Pregnant women;
* Not accepting informed consent;
* Impossibility to follow usual rehabilitation treatment.
The Combined Effect of Mesenchymal Stem Cell, HA-CaSO4,BMP-2, and Implant in Inducing The Healing of Critical-Sized Bone Defect

This research is aimed to evaluate the combination of mesenchymal stem cell, HA-CaSO4, BMP-2, and implant in treating critical-sized bone defect.

In the presence of critical-sized bone defect whose defect size is more than 2.5 cm, bone will suffer a healing disturbance. In treating these conditions, the conventional method were vascularised bone grafting and bone transport. But the existing methods of treatment have many weaknesses Vascularized bone graft is a procedure with a high level of difficulty. Hence not every orthopaedic surgeon were able to perform it. It also takes more operating time and its failure rate is also quite high.

Meanwhile, external fixation which is applied with bone transport, was being often complained by the patient in terms of cosmetic and psychologically.

According to diamond concept of bone healing, there are four main factors that influence the bone healing. These factors are osteogenic factor (mesenchymal stem cell), osteconductive factor (HA-CaSO4), osteoinductive factor (bone morphogenetic protein-2) and mechanical component (implant). The potency of each component in fracture healing with/out bone defect has been proved in many studies. The combined effect of these components is often studied as well, but not in critical-sized bone defect.


Eligibility Criteria:
Inclusion Criteria:

* subjects with critical size defect of bone

Exclusion Criteria:

* subjects with patological fracture caused by primary or secondary bone malignancy, imunological deficit, active hepatitis or those who's under immunosuppresant therapy or other therapeutic modality that can interferes with bone healing.
Arsenic Trioxide in Treating Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of arsenic trioxide in treating patients who have relapsed or refractory acute lymphoblastic leukemia.

OBJECTIVES:

* Determine the complete remission rate of patients with relapsed or refractory acute lymphoblastic leukemia treated with arsenic trioxide.
* Determine the toxic effects of induction arsenic trioxide in this patient population.

OUTLINE: Patients are stratified according to administration schedule of arsenic trioxide (5 days a week vs 7 days a week).

Patients receive arsenic trioxide IV over 1 hour daily until bone marrow blasts are less than 5% or for a maximum of 60 days. Beginning 3-6 weeks after induction, patients achieving a complete remission receive arsenic trioxide IV over 1 hour daily either 5 days or 7 days a week for 25 days. Subsequent consolidation courses are given with 4 week treatment-free intervals between courses. Treatment continues for a maximum of 5 consolidation courses in the absence of unacceptable toxicity or disease progression.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 13-40 patients will be accrued for this study within 3 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Morphologically proven acute lymphoblastic leukemia (ALL)

  * Subtypes L1, L2, or L3
  * Bone marrow morphology with greater than 25% lymphoblasts
  * ALL morphology and cytochemistry with myeloid markers eligible
* Refractory to induction therapy or relapsed following chemotherapy or autologous blood or bone marrow transplantation

  * Any number of prior relapses allowed
  * No relapse following allogeneic transplantation
* Prior CNS leukemia allowed if treated and currently disease-free

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* ECOG 0-2

Life expectancy:

* At least 6 months

Hematopoietic:

* Not specified

Hepatic:

* Bilirubin no greater than 2.0 mg/dL
* SGOT/SGPT no greater than 2 times upper limit of normal (ULN)
* Alkaline phosphatase no greater than 2 times ULN

Renal:

* Creatinine no greater than 2 mg/dL

Other:

* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No significant active infection
* No other medical conditions that would likely decrease life expectancy
* No other prior malignancy within the past 5 years except cured basal or squamous cell skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* See Disease Characteristics

Chemotherapy:

* See Disease Characteristics

Endocrine therapy:

* At least 2 weeks since prior systemic corticosteroids

Radiotherapy:

* Not specified

Surgery:

* Not specified

Other:

* No concurrent antibiotics for active or resolving infection
Zometa and Circulating Vascular Endothelial Growth Factor (VEGF) in Breast Cancer Patients With Bone Metastasis

The primary objective of this study is to evaluate the effects of Zometa (zoledronic acid, 1 mg per week versus 4 mg every four weeks) on the circulating vascular endothelial growth factor (VEGF) levels in breast cancer patients with bone metastases. Sixty patients will be randomized into two groups.

The administration of Zometa in short intervals has been implied to be more potent in maximizing its antitumor and antiangiogenesis effects, while dosing every four weeks is an appropriate strategy for the prevention and management of bone metastases. This study was designed to explore the relationship between dosing of Zometa and level of circulating VEGF.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Female, 18 years or older
* Histologically confirmed invasive breast cancer
* Bone metastases
* ECOG Performance Status of 0 to 2
* Life expectancy of more than 3 months
* Subject must have adequate organ function:

  * Cr ≤ 3 mg/dL (265 µmol/L)，
  * CrCl (Cockcroft \& Gault) ≥ 30 mL/min，
  * Ca2+ \> 8.0 mg/dL (2.0 mmol/L) and ≤ 12 mg/dL (3.0 mmol/L)
* Negative serum pregnancy test for women with childbearing potential
* Good conditions for infusion and willing to undergo phlebotomy during the whole study
* Have ceased anti-tumor treatment including chemotherapy, endocrinotherapy and bio-targeted therapy for over 28 days

Exclusion Criteria:

* Pregnant or lactating females
* History of other malignancy. However, subjects who have been disease-free for 5 years, or subjects with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible.
* Concurrent disease or condition that would make the subject inappropriate for study participation, or any serious medical disorder that would interfere with the subject's safety
* Active or uncontrolled infection
* Current active dental problems including infection of the teeth or jawbone (maxilla or mandible); dental or fixture trauma; or a current or prior diagnosis of osteonecrosis of the jaw (ONJ); or exposed bone in the mouth; or slow healing after dental procedures
* Recent (within 6 weeks of Randomization) or planned dental or jaw surgery (e.g. extraction, implants)
* Known history of uncontrolled or symptomatic angina, arrhythmias, or congestive heart failure
* Concomitant with liver, brain or symptomatic lung metastases (symptoms such as hemoptysis, severe cough and shortness of breath)
* Accepted radiotherapy for solitary bone disease within 30 days before study
* Previous treatment with other bisphosphonates or radionuclides within one month before study
* Known hypersensitivity to bisphosphonates
* History of treatment with calcitonin, gallium nitrate or mithracin within 14 days before study.