cyrilzakka/clinical-trials huggingface dataset:
Safety and Efficacy of Autologous Bone Marrow Stem Cells for Treating Osteoarthritis

Osteoarthritis is a leading cause of chronic disability in elderly and the risk of disability attributed to osteoarthritis is as great as or greater than due to any other medical condition in that age group. Several cross sectional studies have demonstrated an age related increase in the prevalence of osteoarthritis of knee(5). Results of survey are similar with most surgeons reporting 50+ years age group being commonest at initial presentation and that the incidence increases with advancing age. Interestingly some surgeons have noticed earlier occurrence of osteoarthritis in 40+ years age group and one has to be careful to screen for secondary causes in this younger age group patients.

While pain relief is the primary treatment goal of osteoarthritis medications, localized inflammation may also be relieved by using certain drugs. Managing osteoarthritis pain can involve medications, natural remedies, exercise, weight loss, joint protection, mobility aids, assisted devices and more.

Stem cell therapy, using cells extracted from the same patient or suitable alternative human sources, targets diseases which are either incurable or with no complete or effective treatment available in the traditional healthcare system. Since this therapy is based on the concept of regenerating damaged cells in the injured or disease-affected areas of the body, it is called regenerative medicine

Autologous stem cells provide an attractive option for osteoarthritis patients and their clinicians.

In our present study we want to evaluate the safety and efficacy of autologous bone marrow derived stem cells in treatment of Osteoarthritis for therapeutic chondrogenesis through delivery of stem cells into the knee joint space in ten Indian patients.


Eligibility Criteria:
Inclusion Criteria:

1. Must be able to give voluntary written (patients may not be able to write) consent.
2. Must be able to understand study information provided to him.
3. Age 30 to 70, inclusive
4. OA Kellgren and Lawrence classification 3 \& 4
5. No ligamentous laxity i.e. stable
6. Ability to understand and willingness to sign consent form
7. The participant is able to comply with and understand the required visit schedule and all required tests and procedures.

Exclusion Criteria:

1. Serious pre-existing medical conditions like Diabetes Mellitus, Chronic Renal Failure, Rheumatoid Arthritis, Collagen vascular diseases and Autoimmune diseases
2. Pregnant or lactating woman
3. Inflammatory arthritis
4. Oral steroid, methotrexate (immune suppressants)
5. History of drug or alcohol abuse or chronic smoking
6. Poor patient compliance
7. Infectious disease test positive for HIV 1\&2, HbsAg, HCV and VDRL.
Amplitude Modulated Radiofrequency Electromagnetic Field Treatment Combined with Radiochemotherapy and Maintenance Chemotherapy in Patients with Glioblastoma (Brain-RF)

Combined chemoradiation and radiofrequency electromagnetic field treatment for patients with glioblastoma

Charité Universitätsmedizin Berlin is currently the only German University Hospital with an available capacitive radiofrequency electromagnetic field treatment device. While there is retrospective data available regarding the assumed effectiveness and low toxicity profile of radiofrequency electromagnetic field treatment for glioblastoma in the palliative setting, there is only few prospective data available on the combined effect first-line chemoradiation and radiofrequency electromagnetic field treatment. The investigators aim to conduct a feasibility trial and plan to compare the results with data of a prospective trial with a comparable patient population.

Eligibility Criteria:
Inclusion Criteria:

* Pathological evidence of newly diagnosed glioblastoma according to WHO classification criteria
* Patients 18 to 70 years of age with a WHO performance status of 2 or less
* All patients must sign written informed consent
* Adequate hematologic, renal, and hepatic function (absolute neutrophil count, ≥1,5 x 103/μL; platelet count, ≥100 x 103/μL; serum creatinine ≤1.7 mg/dL; total bilirubin \> upper limit of normal; AST or ALT ≤3 times the upper limit of normal)
* Patient must have received subtotal or gross total resection of the tumor
* MGMT-promotor methylated patients must have refused therapy according to the CeTeG/NOA-09 protocol (+ Lomustin)
* Patient must be planned for concomitant RCT with a total RT dose of 60 Gy over six weeks and temozolomide followed by six cycles of maintenance CT using temozolomide

Exclusion Criteria:

* Previous cranial RT
* Cytostatic therapy / anti-angiogenic substances / CT or radiation therapy for cancer within the past 5 years
* History of cancers or other comorbidities that limit life expectancy to less than five years
* Postoperative evidence of increased intracranial pressure (midline shift \> 5mm, clinically significant papilledema, vomiting and nausea or reduced level of consciousness)
* Technical impossibility to use magnetic resonance imaging (MRI) or known allergies against MRI and/or computed tomography (CT) contrast agents
* Technical impossibility to use AM-RF-EMF (pacemaker, defibrillator or deep brain stimulator, metal implants)
* Participants of childbearing age unwilling to use or not capable of using effective contraception
* Pregnant patients
Impact of Inflammatory Indexes and Gene Scores in Prediction of Atrial Fibrillation

Because of the high recurrence rates following electrical cardioversion and high morbidity in AF patients there is a need to explore prediction models for AF recurrence following ECV. Previous studies have primarily focused on high-sensitivity CRP (hsCRP), CRP, and IL-6, while other inflammatory indexes and gene scores might hold greater value.

This prospective cohort study is planning to include 182 patients with persistent atrial fibrillation, planned for electrical cardioversion, and \&amp;gt;18 years at two medium-sized hospitals in Sweden. Blood samples will be collected prior to electrical cardioversion and at 7-, 30-, 90-, and 180-days follow-up. Atrial fibrillation recurrence will be evaluated at follow-up or upon patient request and diagnosed with 12-lead ECG.

An interim analysis will be conducted after more than 80 patients have been included. If the results from univariate and/or multivariable logistic regression on inflammatory markers and genetic expression regarding atrial fibrillation recurrence are significant, the study will be concluded.


Eligibility Criteria:
Inclusion Criteria:

* Persistent atrial fibrillation (ICD-10 I48.1)
* Age over 18 years

Exclusion Criteria:

* Autoimmune disease
* Inflammatory diseases
* Acute or chronic liver dysfunction
* Ongoing infectious diseases
* Thyroid disorders
* Any other conditions known to impact inflammatory activity (including medication use and hematological diseases)
Adjunction of Daptomycin for the Treatment of Pneumococcal Meningitis

Pneumococcal meningitis is an infection of the membrane that covers the brain. It is a serious infection which is currently treated with a combination of corticosteroids (dexamethasone) and 3rd generation cephalosporins. Nevertheless, complications associated with meningitis are relatively frequent and severe. Recent animal studies have shown that another antibiotic, daptomycin, can reduce the mortality and long-term effects of pneumococcal meningitis. Daptomycin is widely used worldwide in humans for other diseases, with few side effects.

This study aims to evaluate the effect of daptomycin on the proliferation of the bacterial infection, and therefore on inflammation. Daptomycin will be added to the currently recommended treatment with the same dosage used for other diseases.

Roughly 130 patients with suspected pneumococcal meningitis admitted to the emergency departments of hospitals throughout France will be asked to participate in this study.

The participation period will last approximately 3 months.


Eligibility Criteria:
Inclusion Criteria:

* Persons aged over 18 years
* With Suspected pneumococcal meningitis :

  * clinical presentation evocative of pneumococcal meningitis : acute onset of ,meningeal signs, history of cranial trauma or fistula, knowledge of alteration of humoral immunity,, asplenia, alcoholism with/or
  * clearly purulent CSF with/ or,
  * presence of diplococcus on the Gram stain of CSF or positive pneumococcal antigen in the CSF, or polymorphonuclear cells in CSF \> 100
* Written consent or inclusion in an emergency
* Affiliation to a social security system

Exclusion Criteria:

* Contraindication to cephalosporin
* Immediate and severe hypersensitivity to β-lactam antimicrobial
* Contraindication to dexamethasone
* Contraindication to daptomycin
* Previous exposition to daptomycin (within one year)
* Women who are able to procreate without effective contraception and pregnant or breastfeeding women
* Patients under ward of court
* Refusal at any time after acceptation of the study from the patient or her/his legal representative.
Axitinib For The Treatment Of Advanced Hepatocellular Carcinoma

The study is designed to demonstrate that axitinib plus best supportive care is superior to placebo plus best supportive care in prolonging survival in patients with advanced hepatocellular carcinoma.


Eligibility Criteria:
Inclusion Criteria:

* Locally advanced or metastatic HCC
* Failure of one prior antiangiogenic therapy including sorafenib, bevacizumab and brivanib.
* Child-Pugh Class A or B (score 7 only) disease.

Exclusion Criteria:

* Prior treatment of advanced HCC with more than one prior first-line systemic therapy.
* Any prior local therapy within 2 weeks of starting the study treatment.
* Presence of hepatic encephalopathy and/or clinically relevant ascites.
* Presence of main portal vein invasion by HCC.
Efficacy of Leg Casts With Heel Off-loaded in Children

Assess whether by placing a "custom made" splint with heel in the immediate postoperative period until removal of the cast, the rate of pain, the number of healthcare interventions to maintain the off-loaded heel position and number of pressure sores in children wearing lower limb plaster casts is reduced.


Eligibility Criteria:
Inclusion Criteria:

* Treated by operations to the lower limbs which require immediate plaster casts that include the foot
* Treated by osteotomy, joint fusion, patella repositioning and fracture fixation
* Children with intact skin at the heel

Exclusion Criteria:

* Caregivers who cannot speak Italian
* Those who refuse to give their consent to take part in the study
* Patients with lower limb casts that are allowed to load the limb
Short-term Treatment Satisfaction in Hidradenitis Suppurativa Patients Initiated on Cosentyx in Routine Clinical Practice in Saudi Arabia

This study aims to assess the treatment satisfaction of HS patients newly started on secukinumab in Saudi Arabia, in terms of patient reported convenience, perceived safety, perceived effectiveness and global treatment satisfaction as measured by the treatment satisfaction questionnaire for medication (TSQM) at week 24 among moderate to severe HS patients.

This is a 24-week longitudinal single arm prospective study based on data collected from electronic medical records (EMRs) and patient-reported outcomes questionnaires (TSQM, DLQI, and NPRS-11) to evaluate patient-reported satisfaction and early QoL experiences among HS adult patients who are newly administering Secukinumab as per routine clinical practice.

Data will be captured from both data sources (EMRs and Questionnaires) at the following time points (+/- 1 month):

* Baseline (index date: initiation of Secukinumab),
* 24 weeks.

This is in line with the frequency of routine follow-up visits and as per the standard of care to report on pre-defined outcomes in a representative HS population across Saudi Arabia.

Eligibility Criteria:
Inclusion Criteria:

1. Male or Female adult patients ≥18 years of age at the time of data collection.
2. Patient with a confirmed diagnosis of active moderate to severe HS.
3. Secukinumab naive patients (first dose to coincide within one month of the signature of the informed consent) as per locally approved label.
4. Patients can be using antibiotics or have undergone surgery as per routine clinical practice.
5. Patients agree to sign an informed consent form (ICF) to be able to complete the questionnaires.

Exclusion Criteria:

1. Patients not fulfilling any of the above-mentioned inclusion criteria.
2. Patient's refusal to be included in the study or refusal to sign the ICF.
3. A history of off-label indication uses of biological treatment or JAK inhibitor.
Per Oral Versus Intravenous Postoperative Antibiotics After Surgery for Complicated Appendicitis.

The PIPA trial is a prospective, multicentre, cluster randomized cluster crossover non-inferiority study. We aim to test whether a three-day postoperative course of per oral antibiotics is non-inferior to a three-day postoperative course of intravenous antibiotics as standard care after laparoscopic surgery for complicated appendicitis in regards to the risk of postoperative intraabdominal abscess formation within 30-days

Complicated appendicitis increases the risk of postoperative intra-abdominal abscess. Treatment of complicated appendicitis are usually with a postoperative course of intravenous antibiotics. There is need for a study confirming the results of retrospective studies showing that a postoperative course of oral antibiotics is not inferior to intravenous antibiotics after laparoscopic surgery for complicated appendicitis.

The PIPA trial will be a prospective, multicenter, cluster randomized cluster crossover non-inferiority study designed to test whether a three-day postoperative course of per oral antibiotics is non-inferior to a three-day postoperative course of intravenous antibiotics as standard care after laparoscopic surgery for complicated appendicitis in regards to the risk of postoperative intraabdominal abscess formation within 30-days. Participating hospitals will be randomized to either a 6-month period with a per oral antibiotic regime followed by a 6-month period with an intravenous antibiotic regime, or 6-month period with an intravenous antibiotic regime followed by a 6-month period with a per oral antibiotic regime for the postoperative treatment after laparoscopic surgery for complicated appendicitis. Primary outcome will be the incidence of intra-abdominal abscess by the postoperative day 30.

The study duration has been extended by three months in both arms, totaling six months, due to insufficient patient recruitment. By addressing this challenge, the research team seeks to achieve a more representative sample size to ensure robust and reliable research outcomes.

Eligibility Criteria:
Inclusion Criteria:

* On cluster level, hospitals with emergency surgical admissions performing laparoscopic appendectomies are eligible for inclusion.
* On an individual level, participants are eligible for inclusion if they undergo a laparoscopic appendectomy for appendicitis (both uncomplicated and complicated), are ≥ 18 years of age, and provide a signed written consent form.

Exclusion Criteria:

* Exclusion criteria are specifically related to the therapy and individual participants will be excluded if they undergo any other procedures than laparoscopic appendectomy during index surgery.
Clinical Study to Examine the Effects of Erythropoietin on Left Ventricular Function After Acute Myocardial Infarction

The primary objective of this study is to establish the effects of a single bolus of EPO, administered within three hours after a primary PCI for a first acute myocardial infarction, on left ventricular function.

Erythropoetin (EPO) is commonly known as an effective treatment for anemia. However, several important extra-hematopoeitic effects of EPO are suggested which might be beneficial in the setting of an acute myocardial infarction, such as a reduction of apoptosis and stimulation of neovascularisation. Recent animal studies provided very consistent evidence for a reduced infarct size and improved left ventricular function caused by EPO administration. However, clinical studies with EPO in non-anemic patients are scarce.

We performed a safety study in our department on the effects of a single bolus of EPO in patients with an acute myocardial infarction. Serum EPO levels increased a 200-fold and EPO administration was not associated with hypertension, nor with an increase in thrombocytes or thrombotic events.

In conclusion, experimental data clearly showed that a single bolus of EPO after the onset of an acute myocardial infarction reduced myocardial infarct size, and improved left ventricular function. In our safety study, EPO administration in patients with an acute myocardial infarction was safe and well tolerated.

This will be a PROBE (Prospective, Randomised, Open label study with Blinded Endpoint) designed study, in wich one group will receive one bolus of EPO 60.000 IU) intravenously within 3 hours after the primary PCI procedure and the other group will receive standard therapy. After 6 weeks left ventricular ejection fraction will be evaluated by planar radionuclide ventriculography.

Eligibility Criteria:
Inclusion Criteria:

Successful primary PCI (TIMI 2/3) for a first acute myocardial infarction, diagnosed by:

* chest pain suggestive for acute myocardial infarction
* symptom onset \< 12 hour before hospital admission, or \< 24 hour in case ongoing ischemia
* ECG with ST-T segment elevation \> 1 mV in 2 or more leads
* TIMI flow 0/1 before primary PCI on diagnostic coronary angiography;

Exclusion Criteria:

* Hemoglobin levels \> 10.6 mmol/L;
* Anticipated additional revascularisation within 4 months;
* Cardiogenic shock;
* Presence of other serious medical conditions
* Pregnancy/breast feeding
* Malignant hypertension
* End stage renal failure (creatinin \> 220 micromol/l)
* Previous treatment with rh-EPO
* Blood transfusion \<12 weeks prior to randomisation
* Polycythemia vera
* Previous acute myocardial infarction
* Concomitant inflammatory or malignant disease
* Recent trauma or major surgery
* Unwilling to sign informed consent
* Atrial fibrillation
A Phase 1/2 Study of CS7017, an Oral PPARγ Agonist, in Combination With Paclitaxel

The Phase I/II study will be conducted as an open label, multiple center study of CS-7017, an experimental drug and paclitaxel chemotherapy in subjects with advanced anaplastic thyroid cancer. Biopsies will be obtained from patients with accessible tumor at baseline, two-weeks after the first CS-7017 dosage (prior to the start of combination therapy) and at the end of the first study cycle (week 3 of combination therapy), in order to evaluate the effects of the study drug alone and in combination with the chemotherapy agent on the tumor. Treatment will continue until disease progression or the development of intolerable toxicities.


Eligibility Criteria:
During the Phase 1 and Phase 2 portions of the study, participant eligibility criteria are identical except for prior treatment for anaplastic thyroid cancer (ATC). During Phase 1, eligible participants may have received prior chemotherapy while during Phase 2, eligible participants must be chemotherapy naïve.

Inclusion Criteria:

* Histologically or cytologically diagnosed, advanced ATC
* Measurable lesion(s)
* Lesion(s) (primary or metastatic) with viable tumor tissue accessible for repeated biopsy
* Age equal to or older than 18 years
* Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2
* Adequate organ and bone marrow function
* Agreement to use effective contraception while on treatment and for equal to or greater than 3 months after end of treatment
* Pregnant or breastfeeding

Exclusion Criteria:

* Medical history of diabetes mellitus requiring treatment with insulin or oral agents; no pleural or pericardial effusion or clinically significant pulmonary or cardiovascular disease.
* Clinically active brain metastasis, uncontrolled seizure disorder, spinal cord compression, or carcinomatous meningitis
* Clinically significant active infection requiring antibiotic or antiretroviral therapy
* Concomitant use of other thiazolidinediones (TZDs)
Comparison of Two Methods of Negative Pressure Wound Therapy

The current standard for negative pressure wound therapy is the Vacuum Assisted Closure Device (VAC), a commercial system that utilizes a computerized suction pump to apply negative pressure to an open-cell poly-urethane foam dressing sealed over a wound. The VAC system is effective but has some drawbacks:

* The system is expensive.
* There us conflicting data about the effectiveness of VAC therapy for infected wounds.
* VAC therapy is difficult to use (and frequently fails) in wounds with excess fluid drainage, and in wounds near body orifices.

Over the past 4 years, we have accumulated additional experience with negative pressure wound therapy using wall suction applied to sealed gauze dressings with about 30 patients. We call this method G-SUC and have used it when we have been unable to maintain a dressing seal with the VAC system (due to excess drainage or wound location), for management if infected wounds. We have found this method to be effective without any specific negative side effects.

Our specific aims are:

1. Compare the effectiveness of G-SUC and standard VAC therapy. Outcomes measured for each method will include the proportional change in wound size over 1 - 2 weeks.
2. Compare the effectiveness of G-SUC and VAC system in controlling wound infections as measured by the number of patients who are able to clear infection by 4 days.
3. Compare the failure of each method of therapy by documenting the number of dressing that cannot be maintained because of fluid or suction.
4. Measure and compare the cost of wound treatment with the two methods including direct cost and time spent at the bed side performing the dressing change.

Our hypotheses are:

1. G-SUC and VAC are equivalent for the treatment of uncomplicated wounds in the acute care, in-patient setting.
2. G-SUC is more effective than VAC for management of infected wounds.
3. G-SUC is more versatile than VAC, and functional G-SUC dressings can be maintained in situations where functional VAC dressings cannot.
4. Negative pressure therapy with G-SUC is less costly than VAC.


Eligibility Criteria:
Inclusion Criteria:

- Hospitalized patients at the University of Chicago Medical Center with acute wounds resulting from ether trauma, dehiscence or surgical complications

Exclusion Criteria:

* Patients with systemic sepsis caused by wound infection
* Those with grossly necrotic wounds
* Malignancy in the wound
* Wounds with untreated osteomyelitis
* Patients with allergy to sulfamylon and Dakin's (sodium hypochlorite) Patients with 2 first criteria would become eligible once their sepsis resolves and/or necrotic tissue has been debrided from the wound.