cyrilzakka/clinical-trials huggingface dataset:
Sirolimus+Abatacept+Mycophenolate Mofetil for Prophylaxis of aGVHD in Patients Receiving Haplo-HSCT Who Are Intolerant to Calcineurin Inhibitors

Graft-versus-host disease (GVHD) is an important complication after transplantation, with an incidence of 40-60%, which can increase non-relapse mortality if poorly controlled. At present, the standard prophylaxis for GVHD is cyclosporine combined with methotrexate. However, calcineurin inhibitors (CNI) can cause some vital side effects, which are not tolerated by some patients. Therefore, this study aims to explore the safety and efficacy of Sirolimus in combination with Abatacept and Mycophenolate Mofetil for the prophylaxis of GVHD in patients with haplo-HSCT who are intolerant to calcineurin inhibitors.


Eligibility Criteria:
Inclusion criteria:

1. Primary disease: hematological malignancies (including acute leukemia, myelodysplastic syndromes), nonmalignant disorders (including severe aplastic anaemia)
2. Contraindication or intolerance to CNI

   1. Glomerular filtration rate (GFR) 60-89 ml/min/1.73m2 before transplantation or allergy to CNI
   2. Intolerance to CNI during conditioning or within +45 days post transplantation, such as CNI nephrotoxicity (creatinine higher than the upper limit of normal), uncontrolled hypertension, neurological toxicity, or other conditions deemed by physician to be inappropriate for CNI
3. Receiving haplo-HSCT for the first time

Exclusion Criteria:

1. Allergy or intolerance to study drugs
2. Active infection
3. Active GVHD
4. Transplantation-associated thrombotic microangiopathy
5. Key organ dysfunction: liver injury (total bilirubin more than 2 upper limit of normal) or heart injury (symptomatic heart failure or ejection fraction\<50%)
6. Eastern Cooperative Oncology Group (ECOG) score \>2
7. Expected survival time \<30 days
8. Patients could not cooperate
Wound Management for Sacral Pressure Ulcers With Necrotic Tissue

Evaluation of a wound care debridement product and a moisturizer on sacral pressure ulcer wounds

Pressure ulcers on the sacral area will be applied with either a wound debridement product or a wound moisturizer product plus a gentle wound dressing to manage wound closure over a 2-3 week period of treatment.

Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects of any age
* Sacral wounds with necrotic tissue

Exclusion Criteria:

* 3rd degree burns
* know hypersensitivity to products
Enhancing Blood Donation at Schools and Beyond in Malawi

First developed in Zimbabwe, Club 25 is an initiative to promote blood donation among young people, who present a low-risk population for the spread of transfusion transmissible infections (TTIs). Club 25 members in Malawi make a pledge to donate blood 25 times during their lifetime. The primary aim of this study is to compare a Club 25 donation program to the current standard procedures for student blood donor recruitment in 30 secondary schools in Malawi. Roughly half of the schools will be randomly assigned to a Club 25 intervention and the study will collect data on student blood donations in all 30 schools for three school years. Upon completion of data collection the rate of student blood donation will be compared between the intervention schools and the non-intervention schools.

Recognizing the role of youth in blood donation, Zimbabwe, a country with similar demographics to Malawi, developed "Club 25" in 1989 as a means to encourage regular blood donation among the youth. Club 25 donation programs involved students pledging to donate blood 25 times in their lifetime. In order to achieve this objective, students pledged to lead a healthy lifestyle, to avoid acquiring HIV and other TTIs and to continue donating blood after leaving school. Club 25 in Zimbabwe demonstrated a consistent drop in HIV infection among donors over time and managed to minimize blood shortages during school holidays.

This is a hybrid Type I implementation science cluster randomized clinical trial comparing an enhanced Malawian-tailored school-based Club 25 donation program to the current standard procedures (SP) for student blood donor recruitment in 30 secondary schools in Malawi. This study will be conducted for 3 years, with additional 6 months start-up and 6-month data analysis/write up (total activity period will be 4 years). The total sample size is 11,492 per year. A minimum of 5746 student voluntary non-numerated blood donors (VNRBD) from each arm (15 schools with standard procedures for blood donor recruitment (SP) and 15 Club 25 schools) will be recruited annually. Focus group discussions, in-depth interviews, and key informant interviews will be conducted with a minimum of 400 participants including student VNRBDs, key informants, and community stakeholders. Schools will be stratified by Malawi Blood Transfusion Service regional office sites (South, East, Centre, North).

Eligibility Criteria:
Inclusion Criteria:

* At least 16 years old and enrolled in a secondary school

Exclusion Criteria:

* Under 16 years of age or not enrolled in a secondary school
An Observational Study of Avastin (Bevacizumab) in Patients With Glioblastoma Multiforme in First or Second Relapse

This single-arm, open-label, multicenter, observational study will evaluate the efficacy and safety of Avastin (bevacizumab) in patients with glioblastoma multiforme in first or second relapse. Data will be collected from eligible patients initiated on Avastin treatment according to local label for up to 3 years.


Eligibility Criteria:
Inclusion Criteria:

* Adults patients, \>/= 18 years of age
* Histologically confirmed glioblastoma multiforme in first or second relapse

Exclusion Criteria:

* Patients not qualifying for Avastin treatment as per local label
Rollover Study of BMS-354825 in Patients With CML and Ph+ALL

To assess the safety of dasatinib (BMS-354825) in subjects with Imatinib resistant or intolerant chronic myelogenous leukemia (CML) and Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia (ALL) who are resistant or intolerant to treatment and will continue study drug after completing the previous Phase I/II study (CA180031/NCT00337454)


Eligibility Criteria:
Inclusion Criteria:

* Subjects who were eligible and completed the previous Phase I and II study (CA180031/NCT00337454) and for whom the principal investigator has deemed that continuation of study drug is in the best interest of the subject

Exclusion Criteria:

* Women who are pregnant or breastfeeding
* Subjects who are eligible and willing to undergo transplantation at pre-study
* Non-hematologic intolerance to Dasatinib (BMS-354825) in the previous Phase I and II study (CA180031/NCT00337454)
Penile Nerve Stimulation for Treatment of Delayed Ejaculation

The aim of this clinical trial is to test the safety and feasibility of using transcutaneous electrical nerve stimulation (TENS) of the penile nerves to reduce intra-vaginal ejaculatory latency time in men with delayed ejaculation (DE). We hypothesize that this type of stimulation, either before or during sexual activity, will reduce latency time. The primary objective of this study is to determine if TENS of the penile nerve helps men with DE subjectively reduce their ejaculatory latency time. The secondary objective is to determine whether their International Index of Erectile Function (IIEF) score improves with treatment.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Sexually active
* Diagnosed with delayed ejaculation

Exclusion Criteria:

* Less than 18 years old
* Any condition effecting the participant that would make them unable to operate the interventional device
Impact of ctDNA in Cancer Early Detection and STAS Evaluation in Patients With GGOs

The aim of the study is the early and non-invasive diagnosis of lung cancer in patients with pulmonary ground glass opacity. In particular, objective of the study is to evaluate the presence or absence of circulating tumor DNA (ctDNA) on the peripheral blood of patients with evidence of ground glass opacity(GGO) at CT scan and to evaluate the role that this can play in the diagnostic / therapeutic process. The ctDNA evaluation will be performed at the first radiological finding and subsequently correlated with the malignancy of the lesion based on the radiological / histological criteria regularly used in international protocols.

Secondary objective is the correlation, in patients with malignant GGO undergoing surgical treatment, of the ctDNA presence and tumor spread through the air spaces (STAS), and its correlation with local relapses.


Eligibility Criteria:
Inclusion Criteria:

* age\> 18 years
* radiological finding of pulmonary ground glass opacity
* absence of solid or haematological tumor

Exclusion Criteria:

* radio / chemotherapy treatment for at least 6 months
* patient unable to understand and express his consent to the study
Observational Cohort Study of Sodium, Weight and Cardiovascular Disease

To investigate cardiovascular events among individuals with low sodium intake or large weight changes in a prospective observational follow-up of subjects from the Trials of Hypertension Prevention (TOHP) study.

BACKGROUND:

Sodium reduction and weight loss lead to decreased blood pressure (BP). Among hypertensives, BP lowering leads to decreased risk of MI, stroke, and cardiovascular death. Nonetheless, concerns have been raised about increased numbers of cardiovascular events among individuals with low sodium intake or large weight changes.

DESIGN NARRATIVE:

The prospective observational follow-up of the Trials of Hypertension Prevention (TOHP) includes cardiovascular events among the 4, 507 surviving participants from the ten clinical centers involved in Phases I and II of TOHP. Phase I was a randomized trial of the effects of non- pharmacologic interventions, including sodium reduction and weight loss, on BP over 18 months of follow-up with 2,182 participants. Phase II examined the effects of sodium reduction and weight loss on BP over a longer 36-month period in a randomized 2X2 factorial design with 2,382 participants. During follow-up in Phases I and II of TOHP, several measures of both weight and sodium excretion were carefully obtained on all participants. The prospective observational follow-up specifically examines whether these values, with an emphasis on average level of sodium excretion and weight changes are predictive of later cardiovascular disease. The follow-up is conducted centrally by mail from the Division of Preventive Medicine, which served as the Coordinating Center for Phases I and II, and which has been very successful in conducting such large-scale studies by mail. Information on cardiovascular events subsequent to the trial periods is collected through June, 2003, representing an average follow-up of approximately fourteen years from the end of Phase I and eight years from the end of Phase II. This cohort provides a unique resource to address the impact in a normotensive population of salt restriction and weight change on subsequent cardiovascular events.

Eligibility Criteria:
No eligibility criteria
GDF 15 in Sickle Cell Disease and Hereditary Spherocytosis

Patients with thalassemia intermedia, congenital dyserythropoietic anemia type I , and sideroblastic anemia were found to express very high levels of serum GDF15, and this contributed to the inappropriate suppression of hepcidin with subsequent secondary iron overload.The aim of our present study is to asses the levels of GDF15 and hepcidin in patients with Sickle cell disease and hereditary spherocytosis

The identification of the ferroportin/hepcidin axis has allowed the effect of erythroid activity on iron balance to be studied and has created the basis for better defining the erythroid regulators.

In iron-loading anemias, ineffective erythropoiesis suppresses hepcidin production, which result in dysregulating iron homeostasis. Miller and co-workers showed that release of cytokines like growth differentiation factor 15 (GDF15) during the process of ineffective erythropoiesis inhibits hepcidin production, thus defining a molecular link between ineffective erythropoiesis, suppression of hepcidin production and parenchymal iron loading.

Eligibility Criteria:
Inclusion Criteria:

* non

Exclusion Criteria:

* non
Onlay and Sublay Mesh in Treatment of Ventral Hernia

Hernia is defined as aprotrusion of viscus or part of viscus usually within a peritonial sac through a defect in the abdominal wall.

Ventral abdomenal hernias include all the hernias occuring through the anterior abdominal wall excluding groin hernias ( incisinal hernia, epigastric hernias, paraumbilical hernias, umbilical and lumbar hernias)

Ventral hernia can be categorized according to their characteristic into reducible, irreducible or incarcerated , strangulated and recurrant ventral hernia.

The cause of a primary ventral hernia ia s far from completely understood, but it is undoubtedly multifactorial. familial prediposing play a role with increasing evidance of connective tissue disorders, they are considered as a leading cause of abdominal surgery and account for 2-10% of all abdomenal wall hernias .

Clinical data show that 52% of incisional hernias occur within 6 months postoperative as a result of excessive tension and inadeqate healing of aprevious incision.

The history of prothetic repair in abdominal wall hernias began in 1844 within the use of silver wire coils placed in the floor of groin to induce an inflammatory fibrosis . meny prosthetic material have been tried in hernia repair, but the two most common in current use are polypropylene mesh and expanded polytetrafluoroethylene.

The repair of ventral hernia varies from primary closure, primary closure with an onlay mesh reinforcement, sublay mesh placement, and intraperitonial mesh placement. Primary closure techniques are usually performed for smal fascial defects less than 5 cm in the greaters diameter

An onlay , usually of polyproptlene mesh is sutured to the anterior rectus sheeth after the fascial defect has been closed primary, thes type of repair has the potential advantage of keeping the mesh separeted from the abdomenal content by full abdominal muscle fascial wall thikness.

The sublay (retrorectus) placement of mesh, became popular in 1990, the recurence rates with this repair have been stated to be less than 10%.

Eligibility Criteria:
Inclusion Criteria:

* Ventral Hernia patients

Exclusion Criteria:

* Age below 18 years.
* Complicated hernia.
* Uncompensated heart or lung diseases, haemorrhagic disorders
Treatment of Pilonidal Sinus Disease Using Surgiflo as a Sealant: A New Concept

Assessment of surgiflo injection for treating pilonidal sinus disease

Evaluation of injection of Surgiflo as a sealent in treatment of pilonidal sinus, evaluation includes recurrence, infection, complications and patient satisfaction over 2 years of follow up

Eligibility Criteria:
Inclusion Criteria:

Patients included in the study had simple midline PS with single or multiple tracts and no lateral extensions. Recurrent cases of PS after previous surgery were also included in the study

Exclusion Criteria:

We excluded from the study patients with severe scarring at the natal cleft due to previous surgery or infection and patients with signs of an acute abscess.
Wireless Assessment of Respiratory and Circulatory Distress in Vascular Surgical Patients - An Observational Study

Vascular postsurgical patients have a high risk of morbidity and mortality. On top of that, patients undergoing vascular surgery usually have a high burden of comorbidities.

After a short stay in the post-operative ward, patients are usually transferred to a standard surgical ward.

Monitoring of physiological parameters by intermittent manual recordings 8-12 hours apart, is today's standard of care in hospitals. However, no effect on length of hospital stay, morbidity or mortality has been proven. This may be due to the up to 12 hours of unobserved time that can occur, where physiological deviations can progress resulting in clinical adverse outcomes such as myocardial infarction or stroke.

Vital sign micro events are occurrences when patient physiological parameters deviates significantly from what can be understood as normal physiology. Since adverse outcomes in patients rarely happens without deviating physiological parameters, it is to be investigated if micro events can be used to predict clinical adverse outcomes to patients. We acknowledge that during the observation period, the number of false alarms should be kept to a minimum to avoid the risk of 'alarm fatigue'


Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to Copenhagen University Hospital
* Patients with Peripheral Arteriel Disease(PAD)
* Patients undergoing open infraligamentary revascularization
* Emergency or subacute surgery
* Admission the day before surgery, and expected length of stay more than 2 days.

Exclusion Criteria:

* Patient expected not to cooperate
* Patients with dementia or not able to give informed consent
* Patient allergic to plaster, plastic or silicone
* Patients with pacemaker or implantable cardioverter-defibrillator (ICD) unit
* Patients in isolation
* Active therapy withdrawn
* Patients previously included in the other study branches
* Patients with \>20 mmHg in difference in systolic blood pressure between the two arms.
* Expected discharge within less than 24 hours from possible inclusion
Clinical Impact of Bacteriuria on Chronic Inflammation in Asymptomatic Hemodialysis Patients

When considering occult infections during the diagnostic workup of inflammation in Hemodialysis (HD) patients, the urine-deprived bladder is frequently dismissed as potential site of infection. The urinary tract, even in end stage renal disease (ESRD) patients on hemodialysis may represent a significant reservoir for infection. Delayed diagnosis is a relevant issue because the urinary tract is often overlooked as a source of infection in dialysis patients, especially because of absence of urinary tract infection (UTI) symptoms in HD patients. Contributing factors to asymptomatic UTI in HD patients include the presence of low urine volume, bladder stasis, and the fact that UTI symptoms are mostly related to voiding, which is reduced or absent in these patients. Persistence of asymptomatic bacteriuria and UTI may be related to higher levels of inflammatory markers in HD population. In view of the association between cardiovascular disease and cardio-vascular and all-cause mortality with inflammation, as expressed by elevated CRP and/or IL-6 levels in HD patients, the investigators questioned whether presence of asymptomatic UTI could contribute to elevated levels of inflammatory markers in patients with ESRD on maintenance HD therapy. Such a finding would provide a potential link between a treatable infection and a potential cardiovascular risk factor in this population.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female, age \> 18 years, in chronic hemodialysis treatment at least 3 months
2. Stable and adequate hemodialysis treatment three months prior to participation in study as defined by Kt/V \> 1.2 and hemodialysis performed at least 3 times weekly
3. Patients with native A-V Fistula or graft
4. Informed consent obtained before any trial-related activities

Exclusion Criteria:

1. Patients with an indwelling catheters
2. Patients with periodontitis
3. Patients with diabetic foot
4. Patients with active malignant disease or liver cirrhosis
5. Patients on chronic treatment with steroids on doses \> 10 mg/day Prednisone (or equivalent)
6. Patients treated with immunosuppressive agents
7. Patients suffering from

   * Acute vasculitis
   * Severe systemic infections
   * Heart failure (NYHA class III-IV)
A Study Comparing Trametinib and Dabrafenib Combination Therapy to Dabrafenib Monotherapy in Subjects With BRAF-mutant Melanoma

This was a two-arm, double-blinded, randomized, Phase III study comparing dabrafenib and trametinib combination therapy to dabrafenib administered with a placebo (dabrafenib monotherapy). Subjects with histologically confirmed cutaneous melanoma that is either Stage IIIC (unresectable) or Stage IV, and BRAF V600E/K mutation positive were screened for eligibility. Subjects who had prior systemic anti-cancer treatment in the advanced or metastatic setting were not eligible although prior systemic treatment in the adjuvant setting was allowed. Subjects were stratified according to the baseline lactate dehydrogenase level and BRAF genotype.

Dabrafenib and trametinib was administered orally at their recommended monotherapy doses of 150 mg b.i.d and 2 mg q.d., respectively. Subjects in the combination therapy arm received both agents; subjects in the dabrafenib monotherapy arm received dabrafenib and placebo. Treatment was continued in both arms until disease progression, death, unacceptable toxicity, or withdrawal of consent.

After treatment discontinuation, subjects were followed for survival and disease progression as applicable to collect data for the secondary objective of overall survival (OS).

Crossover to the combination therapy arm was allowed for subjects still receiving study treatment on the dabrafenib monotherapy arm after the positive result for the final OS analysis.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed cutaneous melanoma that is either Stage IIIC (unresectable) or Stage IV (metastatic), and determined to be BRAF V600E/K mutation-positive using the bioMerieux (bMx) investigational use only (IUO) THxID BRAF Assay (IDE: G120011). The assay will be conducted by a central reference laboratory. Subjects with ocular or mucosal melanoma are not eligible.
* The subject must have a radiologically measurable tumor
* The subject is able to carry out daily life activities without significant difficulty (ECOG performance status score of 0 or 1).
* Able to swallow and retain oral medication
* Sexually active subjects must use acceptable methods of contraception during the course of the study
* Adequate organ system function and blood counts

Exclusion Criteria:

* Prior treatment with a BRAF or a MEK inhibitor
* Prior systemic anti-cancer treatment for Stage IIIC (unresectable) or Stage IV (metastatic) melanoma. Prior systemic treatment in the adjuvant setting is allowed. (Note: Ipilimumab treatment must end at least 8 weeks prior to randomization.)
* The subject has received major surgery or certain tyes of cancer therapy with 21 days of starting treatment
* Current use of prohibited medication listed in the protocol
* Left ventricular ejection fraction less than the lower limit of normal
* Uncontrolled blood pressurl
* History or current evidence of retinal vein occlusion or central serous retinopathy
* Brain metastases unless previously treated with surgery or stereotactic radiosurgery and the disease has been stable for at least 12 weeks
* The subject is pregnant or nursing