cyrilzakka/clinical-trials huggingface dataset:
King's Invasive Aspergillosis Study II

Invasive fungal disease (IFD) is an important cause of mortality and morbidity in patients undergoing intensive chemotherapy or transplantation.

This current study aims to assess the impact of prophylactically using the broad-spectrum anti-fungal agent posaconazole on the incidence of IFD in high risk patients with aplastic anaemia and those undergoing intensive chemotherapy, for example for acute myeloid leukaemia, and allogeneic stem cell transplantation.


Eligibility Criteria:
INCLUSION CRITERIA

1. Adult ≥ 18 years
2. Patients with aplastic anaemia, MDS or AML undergoing: IST; or Intensive chemotherapy such as induction chemotherapy; or RIC allogeneic HSCT
3. Able to swallow and retain orally administered medication

EXCLUSION CRITERIA

1. Refusal or inability to consent
2. Autologous HSCT
3. Contraindicated medications
4. Current evidence of IFD diagnosis or treatment
5. Enrolled in another study requiring alternative antifungal prophylaxis or treatment
6. Women who are pregnant or lactating
7. Women who are unable to use and apply with effective contraception without interruption throughout the duration of study drug therapy and not willing to have further pregnancy tests during the course of the study
Uterine Closure at C-section by Stratafix Tissue Control Device: Randomized Case-Control Study

Comparative study of the surgical outcome of 2-layers closure technique of uterine incision in Cesarean section using bidirectional barbed suture (Stratafix) and conventional suture material (Vicryl) regarding the time of closure and the need of secondary additional suturing or tearing of uterine muscles during suturing.

A Randomized prospective case control study to evaluate the surgical outcome of using the new barbed bidirectional tissue controlling device in reducing the time and blood loss at uterine closure during C-Section. In addition, the need of additional sutures to control bleeding after the 2- layer closure is used and the occurrence of any tearing of the uterine muscles at the time closure of the uterine incision will be also studied. These will be the primary outcome measure and the secondary outcome measure will be factors related to the blood loss at the time of the uterine closure, surgical complications, duration of hospital stay, postoperative fever, and the number of sutures required to close the uterine incision.

Eligibility Criteria:
Inclusion Criteria:

* All pregnant patients with an indication for delivery by C section

Exclusion Criteria:

* Patient refusing to participate in the study
Comparison of Postoperative Aqueous Flare After 20G Versus 23G Pars Plana Vitrectomy

To compare postoperative inflammation and breakdown of blood-retinal barrier as measured by a laser flare-cell meter in 20G versus 23G vitrectomy.


Eligibility Criteria:
Inclusion Criteria:

age \> 18 years macular hole macular pucker willing to perform follow up written signed consent

Exclusion Criteria:

other relevant eye disease: retinal detachment, provect cataract, diabetic retinopathy, AMD, relevant glaucoma, pre-surgery except for cataract surgery
Oncologic Impact of Pancreatic Fistula

Clinically-relevant post-operative fistula is a major complication after DP, but it did not affect post-operative therapeutic path nor oncologic long-term outcomes. CR-POPF was not a predictive factor for disease recurrence and it was not associated with an increased incidence of peritoneal or local relapse.

POPF is the most common and feared complication after distal pancreatectomy (DP), increasing morbidity and mortality. Recent evidences suggest that POPF can also play a role in pancreatic cancer recurrence. Adult patients with a diagnosis of pancreatic ductal adenocarcinoma (PDAC) of the body and tail of the pancreas, undergoing curative DP, over a ten-year period in twelve European Surgical Departments were retrospectively collected from a prospective implemented database. Cohort studied included 283 patients, 139 were men (49.1%), median age was 70 years-old (range 37-88). A total of 121 POPF were observed (42.8%), 42 of them (14.9%) were CR-POPF. Median follow-up period was 24 months (range 3-120). Although poorer in the POPF group, overall survival (OS) and disease-free survival (DFS) did not differ significantly when comparing patients with and without CR-POPF (p= 0.224 and p= 0.165, respectively). CR-POPF was not significantly associated with local or peritoneal recurrence (p=0.559 and p=0.302, respectively). Less patients after POPF (76.2% versus 83.8%) benefited from adjuvant chemotherapy but the difference was not significant (p=0.228). CR-POPF is a major complication after DP, but it did affect neither the post-operative therapeutic path nor oncologic outcomes. CR-POPF was not a predictive factor for disease recurrence and it was not associated with an increased incidence of peritoneal or local relapse.

Eligibility Criteria:
Inclusion criteria:

- patient with resectable pancreatic ductal adenocarcinoma (PDAC) of the body and the tail of the pancreas undergone surgery

Exclusion criteria:

* metastatic diseases (including para-aortic lymph nodes involvement)
* PDAC arising from Intraductal Papillary Mucinous Neoplasms (IPMN)
* resection for premalignant lesions including high-grade Pancreatic Intraepithelial Neoplasia (PanIN) or adenocarcinoma in situ (Tis)
* histological diagnosis other than PDAC
* all R2 resections.
Study of Human Central Nervous System (CNS) Stem Cell Transplantation in Cervical Spinal Cord Injury

This study will evaluate the safety and efficacy of human central nervous system stem cell transplantation into patients with traumatic injury in the cervical region of the spinal cord.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects age 18 to 60 years.
* Traumatic cervical spinal cord injury (cSCI) with C5-C7 motor levels according to the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) as determined by the Investigator.
* American Spinal Injury Association Impairment Scale (AIS) Grades B or C
* Minimum of 12 weeks post-injury prior to Screening

Exclusion Criteria:

* History of penetrating SCI.
* MRI evidence of complete spinal cord interruption .
* Evidence of spinal instability, stenosis and/or persistent cord compression related to the initial trauma.
* Prior participation in another investigational study within 90 days prior to Screening.
* Previous organ, tissue, bone marrow transplantation, or gene transfer
* History of malignancy (except non-melanoma skin cancers) that require(d) radiation and/or chemotherapy
Pharmacokinetic Interactions Between Telaprevir and Un-boosted Atazanavir

Hypothesis: the Telaprevir(TVR) plasma levels (750 mg q8h or 1125 mg/12h )will not be affected when co-administered with un-boosted Atazanavir (ATV) 200 mg q12h plus two analogues (NRTIs) in HCV/HIV-co-infected patients.

Objectives

1. Primary Outcome Measures: evaluate the changes in the plasma pharmacokinetic parameters (Cmax, Cmin, AUC, t 1/2, and Cl) of Telaprevir (TVR) administered at 750 mg/8h together with un-boosted Atazanavir (200 mg/12h), taking as reference the pharmacokinetic parameters observed when TVR is administered with Atazanavir/ritonavir (300/100 mg/day)
2. To assess the changes in the plasma pharmacokinetic parameters of Atazanavir administered as 200 mg/12h with respect to its administration as 300/100 mg/day when administered together with TVR (750 mg/8h or 1125 mh/12h).

Method: open labelled clinical trial with a planned duration of 24 weeks in which 14 HIV/Hepatitis C virus genotype 1 patients under treatment with pegylated α-interferon, Ribavirin and Telaprevir will be enrolled. A 24 hours pharmacokinetic profile will be obtained after a supervised drug intake while taking TVR and ATV/rtv. Afterwards, the patients will take un-boosted ATV 200 mg bid for 7 - 10 days. Subsequently, a new pharmacokinetic profile will be obtained.

Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years old co-infected with HIV and genotype 1 HCV under treatment with pegylated α-interferon, Ribavirin and Telaprevir according to the recommendations of the Spanish Agency of Medicines and Health Products.
* Informed consent of the patient.

Exclusion Criteria:

* The usual exclusion criteria in clinical practice to start the treatment with these drugs (pegylated α-interferon, Ribavirin, Telaprevir and atazanavir) according to the Spanish and international recommendations (Spanish Agency of Medicines and Health Products,European Association for the Study of the Liver Clinical Practice Guidelines: management of hepatitis C virus infection. J Hepatol. 2011. Consensus Document of Gesida/Spanish Plan on Aids regarding the antiretroviral treatment in adults infected with the human immunodeficiency virus \[Updated January 2012\]).
* Concomitant use of drugs or medicinal products that could alter the pharmacokinetics of TVR or ATV.
* Medical records suggesting malabsorption or presence of diarrhea (\>3 depositions/day) that could interfere with the absorption of the studied drugs.
Reticular Pseudodrusen Progression Study

Age-related macular degeneration (AMD) is the leading cause of irreversible blindness in industrial countries. Reticular pseudodrusen (RPD) have been recognized as an additional phenotypic characteristic frequently observed in patients with AMD. Several studies have proven that the prevalence of RPD is associated with AMD as well as a high risk of disease progression to geographic atrophy, the late form of dry AMD. The pathogenesis of RPD is yet still incompletely understood. Retrospective studies have demonstrated that the RPD affected retinal area increases over time. Potential factors influencing progression of RPD have not been intensely studied and potentially predictive markers are yet unknown. The primary objective of this study is to characterize RPD progression in more detail and to identify predictive markers of RPD progression and development of AMD late stages.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent
* Men and women, any race, aged 60 years or older at the baseline visit
* Presence of RPD without any other type of drusen, hypo/hyperpigmentation, geographic atrophy, choroidal neovascularization
* Patient is willing to undergo ocular examinations once every 12 for up to 24 months

Exclusion Criteria:

* Presence or history of soft drusen, hypo-/hyperpigmentation, geographic atrophy or choroidal neovascularization in the study eye
* Ocular disease in the study eye that may confound assessment of the retina (e.g., diabetic retinopathy, uveitis)
* Any condition that would make adherence to the examination schedule of once every 12 months for up to 24 months difficult or unlikely, e.g., personality disorder, chronic alcoholism, Alzheimer's Disease or drug abuse
Ambroxol Spray Sore Throat Study

The development of a new Ambroxol spray formulation for the treatment of sore throat pain associated with acute pharyngitis requires an initial phase II study to be conducted in order to select the most appropriate dose for pain relief.


Eligibility Criteria:
Inclusion criteria:

1. Sore throat due to acute pharyngitis (not more than 72 hours);
2. Score of 6 or greater on an 11-point pain intensity numerical rating scale;
3. Willingness to remain at the study centre for one hour following the first dose of study medication and return one to three days later.
4. Willing to take nothing by mouth except study medication for three hours following the first intake of study medication. Patients must also not smoke during this time period.

Exclusion criteria:

1. Known allergy to and/or hypersensitivity to ambroxol, sorbitol, or Acetaminophen;
2. Patients with drug dependence and/or alcohol abuse;
3. Use of any throat lozenge, throat spray, cough drop, menthol-containing product, or any product with demulcent properties within last 2 hours;
4. Use of any analgesic/anti-pyretic within last 4 hours;
5. Use of any "cold medication" (e.g. decongestant, antihistamine, expectorant, anti-tussive) within last eight hours;
6. Use of an antibiotic for an acute illness within last 24 hours;
7. Use of inhaled steroids or beta-agonists on a continuous basis during the last week;
8. Use of any investigational therapy (including a marketed drug taken for an investigational indication) within last 30 days
9. Any sign of mouth-breathing due to nasal congestion;
10. Cough that causes throat discomfort;
11. Active pulmonary disease such as bronchopneumonia;
12. Pregnant, lactating or breastfeeding women,
13. Any medical or psychiatric condition which, in the opinion of the investigator, could increase the risks associated with participation in an investigational study or affect compliance with the protocol.
14. Patients who have previously enrolled in this study
Banca Di Materiale Biologico Per Lo Studio Di Patologie Che Interessano L'apparato Muscolo-scheletrico

Musculoskeletal disorders are an heterogeneous group of diseases that represent one of the major causes of disability. Considering the importance of studying these pathologies, it is necessary to develop research lines based on the availability of human biological material from highly clinically relevant patients. The purpose of this project is therefore the establishment of a bank of biological material (biobank) to investigate important aspects related to the pathologies of the musculoskeletal system through subsequent bio-molecular characterization studies.

Musculoskeletal disorders constitute an heterogeneous group of diseases which represent one of the major causes of disability. These include degenerative, traumatic, genetic, metabolic and primitive and secondary tumor illnesses. Among the pathologies of the musculoskeletal system are extremely widespread and rare. Among the earliest can be illnesses such as osteoarthritis and osteoporosis which, due to their high frequency in the population, have a high impact not only at the personal but also at social level. The study of these pathologies to identify new therapeutic targets is therefore a goal of great strategic importance. In the oncological field, the skeleton is also one of the most common metastatic sites along with lung, brain and liver. Bone metastases have devastating effects on the quality of life of affected patients and result from the activation of extremely complex molecular mechanisms whose comprehension would allow identification of targets for their prevention and treatment, a key goal to date still reached. Unlike secondary bone tumors, primary tumors are a rare group of tumors. As such, research into these types of pathologies has often been limited by the low availability of human samples. Further characterization of these tumors is still necessary to promote proper recognition and improve treatment.

Considering the importance of studying these pathologies, it is necessary to establish a biobank of highly valuable biological material that would be the fundamental basis for the subsequent setting up and activation of research projects. The establishment of biobanks has been a fundamental support for the development of many research projects in a wide variety of fields. Currently there isn't a biobank at IRCCS Galeazzi Orthopedic Institute. The purpose of this project is therefore the creation of a biobank to investigate relevant aspects related to musculoskeletal disorders through subsequent bio-molecular characterization studies.

Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to our Institute
* Patients aged ≥18 years
* Patients with osteoarthritis of hip or knee and rehabilitated in the institute
* Patients with primary and secondary tumors of the skeleton
* Patients undergoing prosthetic surgery following infection of the implant

Exclusion Criteria:

* Participants aged \<18 years
* Participants unable to release the Informed Consent
Melanoma Accuracy Study; Phase 2

The purpose of this study is to evaluate the process, accuracy and patient outcomes of pre-screening dermatology referrals in a clinical setting by a qualified nurse. The long-range goal of the proposed program is to improve referral wait times for patients to see a dermatologist for lesions suspicious for melanoma in comparison to normal standards of care in NS. If effective, this screening program would decrease wait times for those patients with lesions suspicious for melanoma providing earlier diagnosis and expedited treatment, and potentially reducing mortality rates.

The purpose of this study is to evaluate the process, accuracy and patient outcomes of pre-screening dermatology referrals in a clinical setting by a qualified nurse using a dermatoscope, triaging suspicious lesions vs. benign lesions. The long-range goal of the proposed program is to improve referral wait times for patients to see a dermatologist for lesions suspicious for melanoma in comparison to normal standards of care in NS. If effective, this screening program would decrease wait times for those patients with lesions suspicious for melanoma providing earlier diagnosis and expedited treatment, and potentially reducing mortality rates.

Eligibility Criteria:
Inclusion Criteria:

* New referral from a general practitioner to a dermatologist
* Males and females, over the age of 18 are eligible to participate
* Written informed consent from the patient
* Lesion or mole is new, changing color, growing rapidly or has a change in sensation
* Willing to have the lesion excised if necessary per standard of care
* Ability to complete the imaging procedure and willing to complete a basic history
* Pigmented lesion considered low, moderate or high risk for melanoma by a general practitioner

Exclusion Criteria

* Lesions which are not amenable
* Participant unable to read, understand or sign consent
* Participant under active care by a dermatologist
* Lesion \<2 mm or \>15mm in diameter
* Lesion located on areas of scars, crusts, psoriasis, eczema or similar skin conditions
* Lesion on hair covered areas (e.g. scalp, beard, mustache) where hair cannot be removed
* Lesions located on genitalia not accessible to equipment
* Lesions located in an area that has previously biopsied or subjected to any kind of surgical or ablative procedure
* Lesion with foreign matter, e.g. tattoo or splinter
* Lesion and/or reference located on acute sunburn
* Skin surface not measurable, e.g. lesion on a stalk
* Skin surface not accessible, e.g. inside ears, ears, under nails
* Skin not intact (measurement area), e.g. bleeding or with clinically noticeable ulceration
* Lesions located within 1cm of the eye
* Lesions light in pigment or thick and nodular
* Participants not willing to have the lesion excised
Phase 2 Trial of Prophylactic Rituximab Therapy for Prevention of CGVHD

To determine if rituximab administered after allogeneic transplantation decreases the incidence of chronic graft-vs-host disease (cGvHD)

To test if prophylactic anti-B-cell therapy (weekly rituximab) given within 60 to 90 days after allogeneic transplantation will decrease allogeneic donor B-cell immunity and possibly the incidence of chronic graft-vs-host disease (cGvHD).

Eligibility Criteria:
Recipient Inclusion Criteria:

* Between 18 and 76 years of age
* Chronic lymphocytic leukemia (CLL):

  * Unmutated IgG VH gene status
  * Mutated IgG VH genes (\> 2% nucleotide change compared to somatic sequence)
  * Complete remission benefit most from allogeneic hematopoietic stem cell transplant (HSCT).

(Physicians will be encouraged to provide aggressive chemotherapy prior to nonmyeloablative transplantation.)

* Mantle cell lymphoma (MCL): Transplant physicians believe subject would benefit from allogeneic HSCT.
* Adequate renal (Cr \< 2.4 mg/dL) and hepatic (Bilirubin \< 3.0 mg/dL, Aspartate aminotransferase (AST) \< 100 IU) function.
* Men and women of reproductive potential must agree to use an acceptable method of birth control during treatment and for six months after completion of treatment.
* All subjects must provide written informed consent

Donor Inclusion Criteria:

* Genotypically or phenotypically human leukocyte antigen (HLA)-identical.
* Age \< 76 unless cleared by institutional PI
* Capable of giving written, informed consent.
* Must consent to peripheral blood stem cell (PBSC) mobilization with G-CSF and apheresis

Recipient Exclusion Criteria:

* Recipient has a 9 of 10 or 10 of 10 HLA identical donor (high resolution molecular genotyping at HLA A, B, C and DrB1, and DQ)
* Pregnancy
* Lactating
* Serious uncontrolled infection
* HIV seropositivity
* Hepatitis B or C seropositivity
* Cardiac function: ejection fraction \< 40% or uncontrolled cardiac failure
* Pulmonary: Diffusing capacity - carbon monoxide (DLCO) \< 50% predicted
* Liver function abnormalities: elevation of bilirubin to ≥ 3 mg/dL and/or AST \> 100
* Renal: creatinine \> 2.4
* Karnofsky performance score ≤ 60%
* Patients with poorly controlled hypertension (systolic blood pressure \> 150 or diastolic blood pressure \> 90 repeatedly).
* Known life-threatening hypersensitivity to rituximab or other anti-B cell antibodies.
* Inability to comply with the allogeneic transplant treatment.
* Uncontrolled central nervous system (CNS) involvement with disease

Donor Exclusion Criteria:

* Identical twin to subject
* Contra-indication to subcutaneous G-CSF at a dose of 16 mg/kg/d for 5 consecutive days
* Serious medical or psychological illness
* Prior malignancy within the preceding five years, with the exception of non-melanoma skin cancers.
* HIV seropositivity
Complex Imaging Assessment of Steatosis

The main objective is the assessment of MRI (Magnetic Resonance Imaging) Spectroscopy in patients diagnosed with hepatic steatosis in treatment with combination Silimarin, Phyllanthus Niruri and Choline.

In the study will be included patients with alcoholic and non-alcoholic steatohepatitis evaluated in Research Center of Gastroenterology and Hepatology and Gastroenterology Clinic of University of Medicine and Pharmacy of Craiova. All the patients will undergo MRI and MRI Spectroscopy (3 Tesla) using PHILIPS INGENIA 3T System for exact steatosis quantification. The eligible patients will be treated with combination Silimarin, Phyllanthus Niruri and Choline (Stoptoxin Forte) for 6 months (in conformity Product Characteristics). After the treatment a new IRM Spectroscopy examination will be performed. All the acquired data will be analyzed and published.

Eligibility Criteria:
Inclusion Criteria:

* steatosis described on abdominal ultrasound

Exclusion Criteria:

* chronic viral hepatitis
* liver cancer
* abusive alcohol consumption