cyrilzakka/clinical-trials huggingface dataset:
Combination Chemotherapy and Rituximab With Pegfilgrastim Followed by Rituximab, in Large B-Cell Non-Hodgkin's Lymphoma

The purposes of this trial are to decrease toxicity and improve treatment effectiveness elderly patients. With a short course of chemotherapy with cyclophosphamide, mitoxantrone, vincristine, and prednisone with concurrent administration of rituximab it is likely to be as effective as longer programs, and will certainly be better tolerated by this patient group. The addition of maintenance therapy may result in substantial prolongation of remission duration.

Upon determination of eligibility, patients will receive:

* Cyclophosphamide + Mitoxantrone + Vincristine + Prednisone + Rituximab

Patients that are not considered candidates for anthracycline therapy will not receive mitoxantrone. Patients with objective response (partial or complete response) or stable disease will receive Rituximab maintenance therapy.

Eligibility Criteria:
Inclusion Criteria:

To be included in this study, you must meet the following criteria:

* Histologically documented large B-cell, CD20-positive non-Hodgkin's lymphoma
* No previous treatment
* Clinical stage II, III, or IV by the Ann Arbor Staging Criteria
* Age \> 70 years
* ECOG performance status 0, 1, or 2
* Adequate bone marrow, liver and kidney function
* Must give written informed consent prior to entering this trial

Exclusion Criteria:

You cannot participate in this study if any of the following apply to you:

* Age \< 18 years
* Central nervous system involvement with lymphoma
* Coexistent active malignancies treated within five years
* Active infection precluding the use of combination chemotherapy
* HIV infection
* Pregnant or lactating

Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
Everolimus and Octreotide in Patients With Advanced Carcinoid Tumor

The purpose of this study was to evaluate whether everolimus 10 mg / day added to treatment with depot octreotide prolongs progression free survival compared to treatment with octreotide alone in patients with advanced carcinoid tumor.


Eligibility Criteria:
Inclusion criteria:

* Advanced (unresectable or metastatic) carcinoid tumor
* Confirmed low-grade or intermediate-grade neuroendocrine carcinoma
* Documented progression of disease within 12 months prior to randomization.
* Measurable disease determined by triphasic computer tomography (CT) scan or magnetic resonance imaging (MRI).

Exclusion criteria:

* Poorly differentiated neuroendocrine carcinoma, high-grade neuroendocrine carcinoma, adenocarcinoid, goblet cell carcinoma, or small cell carcinoma.
* Hepatic artery embolization within the last 6 months or cryoablation of hepatic metastasis within 2 months of enrollment.
* Previous treatment with mammalian target of rapamycin (mTOR) inhibitors (sirolimus, temsirolimus, everolimus)
* Intolerance or hypersensitivity to octreotide, everolimus, or other rapamycins.
* Severe or uncontrolled medical conditions
* Chronic treatment with corticosteroids or other immunosuppressive agent.
* Other primary cancer within 3 years.

Other protocol-defined inclusion/exclusion criteria applied
Adding Deep Front Line Myofascial Release to Selected Exercises in Patients With Knee Osteoarthritis

the aim of the study is to investigate the effect of deep front line myofascial release to selected exercises in patients with knee osteoarthritis

: Knee osteoarthritis (KOA) also known as degenerative joint disease, is typically the result of wear and tear and progressive loss of articular cartilage.

The myofascial meridian is a new approach to the facial restriction .the knee capsules, the adductor muscles and the tipialis posterior are part of the deep front line which is a line of the myofascial meridian.

Exercise is the highest evidence in the treatment of knee osteoarthritis. The myofascial release is effective in the treatment of knee osteoarthritis so the study will investigate the effect of adding deep front line myofascial release to selected exercises in patients with knee osteoarthritis.

Eligibility Criteria:
Inclusion Criteria:

* Mild to moderate unilateral or bilateral medial tibiofemoral OA grade II-III (K/L).
* The age of the participants will range from 45 to 60 years old .
* BMI ranged from 20-30 kg/m2

Exclusion Criteria:

1. Severe knee OA (grade IV according to K/L classification).
2. Congenital or acquired inflammatory, rheumatic or neurological (systemic or local) diseases involving the knee.
3. Patients receiving oral or injected corticosteroids for the last 3 months .
4. History of knee surgery/fracture.
5. Patients with ACL and meniscus injury
Capsule Colonoscopy in Crohn's Disease and Its Correlation With Conventional Colonoscopy and Faecal Calprotectin

Aims:

* To study the feasibility of capsule colonoscopy in patients with Crohn's Disease (CD).
* To compare the results of capsule colonoscopy with conventional colonoscopy in assessing mucosal healing.
* To correlate the level of faecal calprotectin with the results of capsule colonoscopy and conventional colonoscopy.
* To document changes in clinical practice attributable to the capsule colonoscopy findings a) concordant with and b) in addition to the parallel findings at colonoscopy and ileoscopy.

Project design: Cross sectional, prospective, comparative study

Methodology: Patients of the Royal Melbourne Hospital (RMH) and other associated speciality clinics with an established diagnosis of CD who need assessment of mucosal healing and have consented to be part of the study will undergo capsule colonoscopy and conventional colonoscopy on the same day after undergoing bowel preparation. The images of both the conventional and capsule colonoscopies will be recorded. In addition calprotectin (an inflammatory marker in faeces) will be measured in a sample of faeces collected by the patients prior to the colonoscopy day.

Professor Macrae and the scholarly selective student researcher will assess the recorded images obtained from capsule colonoscopies once the images have been deidentified.

To assess the level of mucosal disease they will use the Simple Endoscopic Score for CD (SESCD).

The results of the assessment of mucosal healing obtained from conventional colonoscopy will be compared with those of capsule colonoscopy and levels of faecal calprotectin will then be correlated.


Eligibility Criteria:
Inclusion Criteria:

* Adults with established diagnosis of CD with ileal, colonic or ileo-colonic disease aged 18-75 years. Gender: both male and female
* Patients of RMH IBD clinic and other specialty clinics where assessment of mucosal healing is clinically indicated this includes: Patients who have had Anti TNF induction therapy 6-12 months prior to commencement of this study AND/OR Patients referred for colonoscopy to assess mucosal disease status with a view to treatment escalation based on the findings.

Exclusion Criteria:

Patients must not:

* Have known/suspected gastrointestinal obstruction
* Have swallowing disorder
* Have a known oesophageal stricture
* Have severe gastroparesis
* Have dementia
* Have a cardiac pacemaker or other implanted medical device
* Have sever cardiac or renal insufficiency
* Have a previous allergy or contraindication to bowel preparation
* Be pregnant
* Prior major abdominal surgery
* Colonoscopy is contraindicated
Evaluation of the Efficacy and Tolerance of Plasmapheresis by Double Cascade Filtration in a University Centre

A study is being carried out to evaluate the biological, technical and clinical/biological efficacy of this technique, the practice of which is standardized in the department, in order to evaluate our practices and to improve them if necessary. As part of this study, the investigators will ask all patients scheduled for this procedure to participate in this observational prospective study without changing usual practices.

The objective of the study is to conduct a prospective evaluation of the practice of apheresis by Double Filtration System Cascade system in a university centre in current practice with evaluation of the technical and biological effectiveness as the main objective and clinical and biological tolerance as the secondary objective for all consecutive sessions performed in a university centre over a period of 1 year.

Eligibility Criteria:
Inclusion Criteria:

Over 18 years of age I indication for plasmapheresis and hospitalized at Chu de Nimes.

Exclusion Criteria:

Under guardianship or curatorship Refusal to participate
Combination of the Immune Modulator Dimethyl Fumarate With Alteplase in Acute Ischemic Stroke

The investigators conduct this study to investigate whether oral administration of Dimethyl Fumarate, a Food and Drug Administration-approved drug for multiple sclerosis, is safe and effective in combination with alteplase in patients with Acute Ischemic Stroke.


Eligibility Criteria:
Inclusion Criteria:

1. more than 18years old
2. NIHSS score≥5
3. MRI shows anterior circulation infarction
4. Patients who meet Alteplase thrombolytic therapy within 4.5h
5. The time from onset to DMF application was less than 24 hours

Exclusion Criteria:

1. Hemorrhagic stroke
2. Patients who have received or plan to receive endovascular therapy
3. Other diseases of the central nervous system
4. Pre-existing neurological disability (mRS Score \>2)
5. Vertebrobasilar artery obstruction
6. Difficulty swallowing
7. Patients who cannot accept MRI examination
8. Abnormal liver function (transaminase higher than 2 times the normal upper limit)
9. The lymphocyte count was lower than the lower limit of normal value
10. Anti-tumor drugs, other immunosuppressive and immunomodulatory drugs are being used
11. Patients known to have hypersensitivity to dimethyl fumarate or any excipients
12. Pregnant and lactating women
Chronic Abdominal Pain After Laparoscopic Sleeve Gastrectomy

The study aims to evaluate the prevalence of postoperative chronic pain, defined as the persistence of abdominal pain for more than 3 months after laparoscopic sleeve gastrectomy.

The main goal of this study is to determine the incidence of chronic abdominal pain among patients who have undergone laparoscopic sleeve gastrectomy. Patients who underwent this type of surgery at the Department of General Surgery and Transplantology of the Medical University of Warsaw between January 2020 and August 2024 will be qualified for the study. The participants will be asked to complete an online questionnaire, including a pain scale and PainDETECT Questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent laparoscopic sleeve gastrectomy 3 months to 5 years earlier

Exclusion Criteria:

* Lack of patient consent to participate in the survey
* No possibility to contact the patient
* Revisional procedures
The Acupuncture for Pain, Opioid Use Disorder and Mood

The goal of this study is to determine how patients with chronic pain and opioid use disorder will respond to treatment with acupuncture, including whether there will be any changes in mood. Results from this study have the potential to inform future studies in patients who would consider using acupuncture as an intervention for their conditions.

In this 4-week pilot study, the feasibility of recruiting a sample of participants in a modified Battlefield Acupuncture + National Acupuncture Detoxification Association (BFA + NADA) protocol will be assessed. Utilizing a novel BFA (Battlefield Acupuncture) plus a NADA (National Acupuncture Detoxification Association) protocol, approximately 20 participants with chronic pain and Opioid Use Disorder (OUD), receiving Methadone through an Opioid Treatment Program (OTP) at Montefiore Medical Center, will be recruited. Each participant will receive a modified BFA + NADA treatment, twice per week over 4 weeks for a total of 8 treatments at the clinic. All participants will also have the small seeds placed to facilitate at-home acupressure treatment. In this feasibility study, the investigator team will collect feasibility data from each participant at every session over the course of 4 weeks. Feasibility outcomes are defined in the Outcome Measures of this registration. As part of the study, the following will also be monitored to explore preliminary efficacy: (1) pain intensity and physical functioning, (2) opioid cravings and substance use, and (3) mood, insomnia, and stress. The research team will conduct surveys assessing pain, physical functions, the changes in stress, mood, insomnia and psychological changes at baseline, and before and after every treatment.

Eligibility Criteria:
Inclusion Criteria:

1. ≥18 years old,
2. English proficiency;
3. receiving methadone treatment at an OTP through the Montefiore network for at least 12 weeks, with no dose change in 14 days to ensure treatment stability;
4. chronic pain of at least moderate pain severity (score of at least 4 on the Pain, Enjoyment of Life and General Activity (PEG) scale);
5. willingness to participate in all study components; and
6. ability to provide informed consent

Exclusion Criteria:

1. Have pending surgery or invasive pain management procedure;
2. Have a pending or planned relocation;
3. have an acutely or exacerbation of psychotic, suicidal, or homicidal conditions that preclude the ability to participate; and
4. pregnancy
Prone Position for Nonintubated Patients With COVID-19 and Hypoxemic Respiratory Failure

The aim of this observational study is to evaluate the physiological and clinical effects of prone position in awake patients with respiratory failure due to COVID-19.

The purpose of this study is to investigate the role of prone positioning in SARS-CoV-2 infected patients that are not intubated. Prone patient placement during invasive mechanical ventilation is a widespread practice in the management of severe ARDS. However, few attempts have been made to implement the prone position in patients that spontaneously ventilate with supplemental oxygen. Considering that it is a procedure that does not require additional equipment and does not represent an additional cost for its implementation, it becomes a valuable tool in the context of COVID-19 where intubation is associated with high mortality. The investigators will analyze a cohort of patients with COVID-19 and respiratory failure managed with prone position as indicated by the attending physician and register physiological variables and clinical outcomes (intubation and death).

Eligibility Criteria:
Inclusion Criteria:

* Hospitalized patients with confirmed or suspected COVID-19 pneumonia requiring more than 3 liters per minute of supplemental oxygen or a Fraction of Inspired Oxygen (FIO2) over 35% to keep Pulse Oximetry Saturation (SpO2) over 90%
* Treating physician indicated prone position as instructed by the institutional protocol
* Patient capable of changing position with minimal help from the personnel

Exclusion Criteria:

* Patient requiring immediate intubation
* Patient requiring non-invasive mechanical ventilation
* Respiratory Rate \> 40, signs of respiratory fatigue or unconsciousness with inability to protect the airway
* PaCO2 \> 50mmHg
* Hemodynamic instability (defined by Heart Rate \> 120, Systolic Pressure \< 90mmHg, Mean Arterial Pressure \< 60mmHg or requiring vasopressor support)
* Obesity with BMI \> 40 (Body Mass Index: weight in kilograms and height in meters will be combined to attain BMI in kg/m2)
* Persistent vomiting
* Facial or thoracic trauma or recent surgery contraindicating the prone position
* Pregnancy \> 20 weeks
Comparing Hydrus Microstent(TM) to the iStent for Lowering IOP in Glaucoma Patients Undergoing Cataract Surgery

This clinical trial compares two implantable devices intended to lower the pressure inside the eye of glaucoma patients. One of the two devices will be implanted immediately following cataract surgery and the placement of a posterior chamber intra-ocular lens. Only one eye (study eye) will be implanted.

This is a prospective, multicenter, single-masked, randomized clinical trial comparing Cataract Extraction (CE) + Hydrus Microstent to CE surgery + iStent implant for the reduction of intraocular pressure in patients with a positive diagnosis of primary open angle glaucoma, pseudoexfoliative glaucoma, or pigmentary dispersion glaucoma with an operable cataract. Eligible patients will be scheduled for cataract surgery. At the conclusion of successful cataract surgery and the placement of a posterior-chamber IOL, qualified subjects will be randomized to receive either the Hydrus Microstent or the iStent implant. Post-operative follow-up visits will be conducted at regular intervals.

Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of primary open angle glaucoma (POAG), Pseudoexfoliative (PXG) glaucoma, or Pigmentary dispersion glaucoma (PDG)
* An operable age-related cataract with BCVA of 20/40 or worse, eligible for phacoemulsification.

Exclusion Criteria:

* Forms of primary or secondary glaucoma not listed above
* Prior glaucoma surgery in the study eye
Neurocognitive Function After Regional and General Anesthesia (245_14 B)

Postoperative cognitive dysfunction (POCD) is a disease with restricted cognitive memory function and intellectual skills, which occurs after surgery with and without anesthesia. The POCD strongly depends on patient's age and the surgical operation type. The anesthesia procedure plays a pivotal role as well and regarding the current knowledge it is still uncertain which technique matches the lowest risk. Elevated stress level accompanied with regional anesthesia procedures are accused to cause POCD in elderly patients. The investigators address the question weather regional or general anesthesia leads to a pronounced POCD in dependence of stress incidence.

Postoperative cognitive dysfunction (POCD) is a disease with restricted cognitive memory function and intellectual skills, which occurs after surgery with and without anesthesia. The limiting cognitive ability leads to a lack of quality of life for a lot of patients. The POCD strongly depends on patient's age and the surgical operation type. In aged adults the incidence of POCD after one week following surgery is 25,8%. Risk factors for the development of a POCD is beside age less education and a reduced cognitive reserve. However, the anesthesia procedure plays a pivotal role as well and regarding the current knowledge it is still uncertain which technique matches the lowest risk. Elevated stress level accompanied with regional anesthesia procedures are accused to cause POCD in elderly patients. This fact leads to the question if a general anesthesia technique has a lower stress level and consequently leads to a reduced risk for a POCD development. Likewise the investigators address this hypothesis and analyze cognitive function following both anesthesia techniques separately in elderly patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients within 50-85 years of age both gender.

Exclusion Criteria:

* Patients under 50 years of age or older than 85 years of age.
* Preexisting neurological, neuropsychological deficits or diseases, e.g. cerebral insult or epilepsy.
* Preexisting neurological, neuropsychological medication, preexisting neuromuscular diseases.
* Alcohol- and drug abuse. Postoperative complications, pain and time shifts within the test protocol.
Fascia Iliaca Compartment Block for Pain Management in Hip Fracture Patients

BLOCKPAIN is a randomized controlled study, 80 participants. The participants will be hip fracture patients in Emergency Medicine Department in Clinical Hospital "Sveti Duh", Zagreb, Croatia. Upon patient arrival inclusion and exclusion criteria will be established. After signing the informed consent form participant will be randomized in one of two study groups. One study group is fascia iliaca compartment block (FICB), the other is placebo. All participants will be given paracetamol 1 gram IV as standard care. If needed, rescue analgesic will be tramadol 100 mg in 100 ml saline IV. The time frame is 24 hours after the FICB or placebo procedure.

Hip fractures in older patients are a major public health problem. For acute pain management, nonopioid analgesics are often not sufficient enough, and opioids have many adverse events. For this reasons fascia iliaca compartment block could be the treatment of choice. The objective of this study is to evaluate the efficacy of the fascia iliaca compartment block for pain management in the emergency department, especially the effect on stress response and the effect on the acute confusional state. The investigators intend to conduct a randomized clinical trial in hip fracture patients years 65 and older presenting in the emergency department. In addition to standard analgesia with parenteral paracetamol, the first group of patients will receive fascia iliaca compartment block and the second group placebo. The investigators will monitor the effect of treatment protocol on laboratory parameters of stress response copeptin and cortisol, frequency and severity of acute confusional state, pain intensity and the need for additional opioid analgesics. Data obtained from this research could significantly improve the standard and quality of analgesia in the older patients with hip fracture. Regional anesthesia can diminish or prevent the development of stress response and cognitive impairment and these are the factors that complicate recovery of this fragile group of patients.

Eligibility Criteria:
Inclusion Criteria:

* hip fracture after minor trauma/simple falls, confirmed by imaging technique (X-ray or CT scan or MRI)
* signed informed consent form (after a verbal explanation and written information sheet)

Exclusion Criteria:

* pathological fracture
* head injury
* body mass bellow 50 kg
* cognitive impairment (Abbreviated Mental Test Score less then 6 points)
* oral anticoagulant drugs
* prior drug allergy (paracetamol, tramadol, local anesthetics)
* prior peripheral artery bypass surgery (on the same side as hip fracture)
* skin or soft tissue infection in the groin area (on the same side as hip fracture)
* simultaneously bilateral hip fracture
* opioid analgesics prior to hospital arrival