cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Effectiveness of Combined Intra-articular and Intra-osseus Injection VS a Single Intra-articular Injection of Bone Marrow Concentrate

Osteoarthritis (OA) is one of the most common diseases resulting in large burdens on society.

Among the emerging treatments, Bone Marrow Concentrate (BMC) intra-articular injections are a promising regenerative approach. However, they offer only a temporary benefit since they target synovial and chondral tissues but fail to address the osteochondral interface, which plays a key role in the onset and progression of joint degeneration.

This project will investigate the efficacy of combined BMC injections, targeting both intra-articular tissues and subchondral bone, to treat OA in a Randomized Controlled Trial (RCT).

The main aim is to evaluate in a RCT the potential of a new combined BMC treatment for OA, through the use of scores for the clinical outcome, the study of imaging and biological samples for tissue regeneration and systemic effects, and the identification of BMC and patient characteristics predictive of better results.

All patients will undergo an arthroscopic procedure to debride degenerated tissues (this can offer a temporary benefit but not long lasting results) before BMC intra-articular injection. Half patients will receive also the injection of BMC at the subchondral level (bone samples obtained to allow BMC placement will be sent to the Lab).

The same minimally invasive incisions will be used for all patients, ensuring patient blinding. Evaluations, performed by medical staff not involved in the treatment to ensure double blinding, will document subjective clinical improvement, functional measurements, biomarker study, and imaging with the use of modern 3TMRI and qCT technology. BMC characterization and patient features will be analysed to identify factors predictive of a better outcome.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female patients, aged between 40 and 70;
2. Arthrosis of the medial compartment (grade 2-3 according to the Kellgren-Lawrence score\> 4 months);
3. Failure after at least 6 months of conservative treatment (drug therapy with NSAIDs and painkillers, hyaluronic acid infiltration, corticosteroid infiltration, PRP);
4. Patients' ability and consent to participate in clinical and radiological follow-up;
5. Signature of informed consent.

Exclusion Criteria:

1. Patients with trauma in the 6 months prior to surgery;
2. Patients with maligncy;
3. Patients suffering from rheumatic diseases;
4. Patients suffering from non-compensated diabetes;
5. Patients suffering from uncompensated thyroid metabolic disorders;
6. Patients abusing alcoholic beverages, drugs or drugs;
7. Patients with axial deviations\> 5 °;
8. Body Mass Index\> 35;
9. Patients treated with joint infiltrations in the previous 6 months;
10. Patients treated with surgery at the same knee in the previous 12 months.
Safety and Efficacy of DIDALA Monotherapy in Patients With Type 2 Diabetes Compared With Metformin.

This is an open-label, two-group parallel study, comparing before and after treatment within the same group and between the two groups. This study is designed to collect data on the safety and efficacy of a marketed pharmaceutical product (DIDALA) compared with Metformin. The efficacy data of DIDALA will be directly compared with Metformin 1000mg/day monotherapy in this study.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older at the time of enrollment in the study.
* Diagnosed with type 2 diabetes according to the Guidelines for the diagnosis of type 2 diabetes of the Ministry of Health (2011).
* Fasting blood glucose ≤ 10.0 mmol/L.
* No previous treatment with metformin or other antidiabetic drugs.
* Ability and willingness to provide written informed consent and comply with the protocol's requirements.
* Subject who, in the judgment of the Investigator, is likely to be compliant or cooperative during the study.

Exclusion Criteria:

* The patient has been diagnosed with diabetes and has been previously treated with metformin or other antidiabetic agents.
* Patients with indications for insulin therapy or combination therapy of two or more drugs according to the guidelines for diagnosis and treatment of type 2 diabetes of the Ministry of Health.
* Pregnancy or lactation.
* Patients with contraindications to Metformin include severe liver and/or kidney disease, congestive heart failure, cardiovascular collapse, acute myocardial infarction, severe infection, and sepsis.
* Patients with conditions and circumstances that, in the investigator's opinion, are difficult to ensure adherence to study protocol.
Fluorouracil With or Without Cisplatin in Treating Patients With Advanced or Metastatic Cancer of the Pancreas

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving drugs in different ways may kill more tumor cells. It is not yet known whether fluorouracil plus cisplatin are more effective than fluorouracil alone in treating patients with metastatic cancer of the pancreas.

PURPOSE: Randomized phase III trial to compare the effectiveness of fluorouracil with or without cisplatin in treating patients who have advanced or metastatic cancer of the pancreas.

OBJECTIVES:

* Confirm the value of chronomodulated infusion with respect to survival in patients with locally advanced or metastatic pancreatic cancer.
* Test the value of adding cisplatin to fluorouracil in extending survival in these patients.

OUTLINE: This is a multicenter, randomized study.

The study design is a 2 X 2 factorial such that patients are allocated to one of 4 treatment groups involving the use or absence of chronomodulation and cisplatin (CDDP). Treatment in each of the 4 groups is repeated for 3 courses where each course is a 5-day course of treatment.

Patients in the first group receive a chronomodulated schedule based on delivery of fluorouracil (FU). Patients in the second group receive a chronomodulated schedule of FU and CDDP. Patients in the third and fourth experimental groups receive flat schedules of FU alone or FU and CDDP, respectively. Dosages of FU are increased across the three courses whereas dosages of CDDP remain constant.

Treatment is continued until disease progression, severe toxicity, or complete remission for more than 4 months occurs.

PROJECTED ACCRUAL: 200 patients will be accrued.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologic or cytologic proof of adenocarcinoma of the exocrine pancreas or of a metastasis associated with a radiologically identified pancreatic tumor
* Locally advanced and/or metastatic pancreatic cancer
* No measurable or evaluable target lesion is required
* No brain metastasis

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* Karnofsky 40%-100%

Hematopoietic:

* WBC at least 3,000/mm\^3
* Neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3

Hepatic:

* Bilirubin no greater than 3 times normal

Renal:

* Creatinine no greater than 1.24 mg/dL OR
* Creatinine clearance at least 80 mL/min

Cardiovascular:

* No overt cardiac disease

Other:

* No peripheral neuropathy
* No uncontrolled infectious or chronic disease
* No second primary except in situ carcinoma of the cervix, or basal or squamous cell carcinoma of the skin

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* No concurrent immunologic therapy

Chemotherapy:

* No prior chemotherapy allowed

Endocrine therapy:

* No concurrent hormonal therapy
* At least 2 weeks since corticoid treatment

Radiotherapy:

* No prior radiotherapy allowed except as an analgesic treatment on metastasis

Surgery:

* Not specified
Study Assessing Cognition in Relapsing Remitting Multiple Sclerosis (RRMS) Patients Treated With BG00012

The primary objective(s) of the study are to assess the BG00012 (dimethyl fumarate) treatment effect on cognition over 2 year period in RRMS patients. The secondary objectives of this study are to further assess BG00012 treatment effect on cognition, predictors of cognitive impairment, clinical efficacy, and patient reported outcomes (PRO): depression, fatigue, quality of life, and work and social life activity.


Eligibility Criteria:
Key Inclusion Criteria:

* Must have a confirmed diagnosis of RRMS according to McDonald criteria (Polman, Reingold et al. 2005).
* Must have a baseline EDSS between 0.0 and 5.0, inclusive.
* Must have experienced at least 1 relapse within the 12 months prior to randomization, with a prior brain MRI demonstrating lesion(s) consistent with MS, or show evidence of gadolinium-enhancing lesion(s) of the brain on an MRI performed within the 6 weeks prior to randomization.

Key Exclusion Criteria:

Candidates will be excluded from study entry if any of the following exclusion criteria exist at the time of screening:

* Primary progressive, secondary progressive, or progressive relapsing MS, as defined by Lublin and Reingold (Lublin and Reingold 1996)
* Severe depression (MADRS score \>34) (Montgomery and Asberg 1979)
* History of malignancy (except basal cell carcinoma that has been completely excised prior to study enrollment)
* An MS relapse that has occurred within the 30 days prior to inclusion AND/OR the participant has not stabilized from a previous relapse prior to inclusion.
Effect of Intraoperative Paravertebral Block on Postoperative Pain and Recovery in Patients Undergoing Mechanical Correction for Scoliosis

Pain management after scoliosis surgery is challenging for the anesthesiologists. This surgery causes severe postoperative pain and patients undergoing these operations are children or adolescents who are increased pain sensation compared with adults. Therefore, we aim to evaluate whether intraoperative paravertebral block (PVB) decreases postoperative pain in these patients. Thirty-two patients scheduled for mechanical correction due to scoliosis will be divided into PVB (n=16) and control (n=16) groups. Randomly selected patients of the PVB group are performed PVB with 0.2% ropivacaine on both sides. In contrast, PVB are not performed in the control group.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing mechanical correction

Exclusion Criteria:

* The subjects who cannot communicate
* The subject is a foreigner or illiterate
Different Oils For Frying and Endothelial Function

The purpose of this study is to compare the effects of the consumption of different oils (olive oil, sunflower oil, sunflower plus dimethyl-polysiloxane, sunflower plus phenols) previously submitted to heating in postprandial endothelial function, inflammation and oxidative stress in healthy young men.

To determine whether the consumption by healthy persons of an oil exposed to high temperatures, designed to have a composition of healthy fats (predominantly monounsaturated fats and with less than 10% palmitic acid) and to contain an abundance of antioxidants typically found in olive oil (phenolic compounds), will improve the vasodilatory response that depends on the endothelium, and buffer the inflammatory and postprandial oxidative response that is produced by the oils that are being used ever more frequently for frying purposes (sunflower oil and oil to which butylated hydroxytoluene (BHT) has been added), using virgin olive oil exposed to the same heating regime as a reference oil.

Eligibility Criteria:
Inclusion Criteria:

* Investigators will select obese people (BMI ranged 25 to 40).

Exclusion Criteria:

* Evidence of malignancy or severally ill (life expectancy lesser than 5 years).
Lung Function and Inflammatory Markers in Cement Dust Exposed Workers: A Cross-shifts Study

The aim of the study is to examine possible changes in lung function, nitric oxide levels and systemic inflammatory markers in cement dust exposed workers, during one shift (6-8 hours).

OBJECTIVE:

Cement dust is suspected to be one of the main factors causing increased mortality among workers not only in the cement production industry, but also in the construction industry worldwide. Our aim is to examine possible changes in lung function, nitric oxide levels and systemic inflammatory markers in cement dust exposed workers, during one shift (6-8 hours).

METHODS:

All employees from Norwegian cement plants, are invited to participate. The workers will perform spirometry, single-breath determination of carbon monoxide uptake, blood samples before and after a working shift of 6-8 hours, and again after 24 hours. Information on respiratory symptoms, allergy and former respiratory disease as well as exposure information will be given on a self-reported questionnaire. Changes in lung function indices, nitric oxide levels and serum inflammatory markers will be calculated. Nitric oxide will only be measured in non-smokers. We will compare cement dust exposed workers with low-level or non-exposed workers (controls).

Eligibility Criteria:
Inclusion Criteria:

* Employees from a Norwegian cement production plant

Exclusion Criteria:

* Exhaled nitric oxide measurements: smokers
* Substantial previous work in quarry or as a miner
A Prospective Trial on Nerve Sparing Techniques Performed in Radical Prostatectomy

The investigators propose a prospective study to assess recovery of urinary and sexual function by nerve sparing techniques after radical prostatectomy.

Subjects will be randomized in a 1:1 ratio to Retzius nerve sparing versus non-Retzius nerve sparing to compare cancer outcomes and urinary/sexual outcomes following radical prostatectomy. Using the Retzius technique, the surgeon will remove the prostate in a way that preserves a portion of the nerves and tissue structures that are typically removed during the conventional technique.

The investigators will assess recovery of urinary and sexual function of patients through questionnaires at 1 week, 1 month, 6 months, 12 months, and 24 months after surgery.

Eligibility Criteria:
Inclusion Criteria:

* clinically localized prostate cancer
* able to read and speak English or Spanish
* no previous history of head injury, dementia or psychiatric illness
* no other concurrent cancer
* estimated life expectancy of 10 years or more
* biopsy proven prostate cancer

Exclusion Criteria:

* evidence of metastases
* Prostate specific antigen (PSA) greater than 30 ng/mL
* previous major pelvic surgery
* diagnosis of another malignancy within the past 5 years, with the exception of non-melanoma skin cancer
Prognostic Value of Functional Exercise Test (EFX) in Cystic Fibrosis

The objective of study is to prospectively determine if CPET with blood gas analysis should have a prognostic value in CF. The study plans to include 300 cystic fibrosis patients. Inclusion criteria will be: age \>15 years, cystic fibrosis confirmed by chloride sweat test or genetic analysis, clinical and functional stability in the 2 month before CPET. Patients will perform a maximal exercise test on a cycloergometer during the inclusion visit, with pulmonary function testing and a six-minute walk test. The study will also include a visit every 6 months with: body mass index calculation, pulmonary function testing with DLCO (diffusing lung capacity for carbon monoxide), a six minute walk test, and antibacteriological study of sputum. The results of this study could help identify earlier the patients for referral to a lung transplantation centre, by using the usual criteria and the CPET abnormalities.

Current guidelines for referring cystic fibrosis (CF) patients for lung transplantation, based on clinical and functional resting parameters, are insufficient to predict 3-year mortality. Previous studies have shown that sex, impaired pulmonary function, undernutrition and colonization of the respiratory tract by Pseudomonas aeruginosa are associated with a poor prognosis. Current guidelines for referral to a lung transplant center include age, sex, forced expiratory volume at one second (FEV1) below 30% predicted or a rapid decline of FEV1, in particular in young female patients, increasing frequency of exacerbations requiring antibiotic therapy, refractory or recurrent pneumothorax, recurrent hemoptysis not controlled by embolization. But, despite these criteria, near that 30% of patients are still dying while on the lung transplant waiting list, or are transplanted in high emergency. Cardiopulmonary exercise testing (CPET) in CF patients would have an interest in the following of cystic fibrosis patients. A previous study, carried out on fifty one adult patients, showed that CPET with blood gas analysis may have a prognosis value in cystic fibrosis. The authors found that a BMI \< 19.8 and P(A-a)O2 peak \> 43 mmHg were independently associated with a lower chance of survival.

Eligibility Criteria:
Inclusion Criteria:

* Age more than 15 years
* Cystic fibrosis diagnosed by positive sweat chloride test or genetic test

Exclusion Criteria:

* Pregnant or breastfeeding woman
* waiting on transplantation list
Study of APG-2575 in Patients With Relapsed/Refractory CLL/SLL

The purpose of this study is to assess the efficacy and safety of APG-2575 single agent in patients with relapsed/refractory CLL/SLL.

This is an single-arm, open-label, multi-center, pivotal registration Phase II study of efficacy and safety of APG-2575 as a single agent in relapsed/refractory CLL/SLL patients.

This study plans to enroll approximately 75 CLL/SLL subjects who have failed or are intolerant to prior immunochemotherapy and BTK inhibitor therapy. Eligible subjects will receive APG-2575 600mg, orally administered once daily (QD), within half an hour of a low-fat meal, for a cycle of 28 days. Participants will continue to accept APG - 2575 until the "end of treatment" that are consistent with the provisions in the solution of the termination of any specified standards.

Eligibility Criteria:
Inclusion Criteria:

Subjects who meet each of the following inclusion criteria are eligible to participate in this study:

1. Age ≥18 years old.
2. Pathologically confirmed CLL/SLL according to the 2018 revised IWCLL NCI-WG guidelines, subject with measurable lesions or splenomegaly due to CLL.
3. Expected survival is at least 12 weeks.
4. Refractory, recurrent, or intolerant to BTK inhibitors and immunochemotherapy,or first-line treatment with BTK inhibitors fails and is not suitable for immunochemotherapy.
5. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS): 0 -2.
6. Ability to understand and willingness to sign a written informed consent form approved by EC committee (the consent form must be signed by the patient prior to any screening or study-specific procedures).
7. Willingness and ability to comply with study procedures and follow-up examination.

Exclusion Criteria:

Subjects who meet any of the following exclusion criteria are not to be enrolled in this study:

1. Prior history of allogeneic hematopoietic stem cell transplantation, adoptive cell immunotherapy or autologous hematopoietic stem cell transplantation within 24 months.
2. Failure to recover adequately, at the discretion of the investigator, from prior surgical procedures. Patients who have had major surgery within 28 days from study entry, and patients who have had minor surgery within 14 days of study entry.
3. Received Bcl-2 inhibitor treatment.
4. Invasive NHL transformation or central nervous system (CNS) involvement has occurred.
5. Pregnancy or lactation, or pregnancy is expected during the study period or within 3 months after the last administration of treatment.
6. Within 2 years before entering the study, the subject had a history of active malignant tumors other than CLL / SLL, except that:

   * Fully treated cervical carcinoma in situ;
   * Completely resected basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin;
   * Confinement and resection of previously cured malignancies (or other treatment).
7. Any other condition or circumstance that would, at the discretion of the investigator, make the patient unsuitable for participation in the study.
Pain's Treatment With Virtual Reality in Hemodialysis

Pain is a frequent and difficult to treat symptom in patients with advanced kidney disease undergoing hemodialysis. Pharmacokinetics and pharmacodynamics have complex pharmacokinetics and pharmacodynamics in these types of patients, so non-pharmacological therapies could be very useful. In this project the investigators propose to test whether the use of a virtual reality platform, designed by the company Psious and tested in other clinical settings, can reduce the pain that patients experience during connection to the dialysis session.

For this the investigators have designed a crossover clinical trial, which will be carried out on 107 hemodialysis patients, in which the intensity of pain (primary objective) and anxiety (secondary objective) that patients experience in the sessions in which participants are treated Using virtual reality, it will be compared with the intensity of pain and anxiety experienced by these same patients, in sessions in which the virtual reality platform is not used.

The results of this clinical trial can support the use of virtual reality as an adjunctive pain treatment in patients with advanced kidney disease.


Eligibility Criteria:
Inclusion Criteria:

* Hemodialysis for at least 3 months
* Pain for for at least 3 months
* Signature of informed consent

Exclusion Criteria:

* Pain from a traumatology disease
* Formal diagnose of dementia