cyrilzakka/clinical-trials huggingface dataset:
Effects of Intraarticular IL1-Ra on Pain and Inflammatory Mediators After Knee Arhroscopy

This project investigates the relation between acute pain and local inflammation. Pain reported by the patients for knee arthroscopy are compared with local changes in inflammatory mediators by using microdialysis technique. Patients with moderate-to-severe pain are included in a randomized placebo-controlled trial of anakinra given intra-articularly.

The effects of the recombinant IL-1 receptor antagonist anakinra both on acute pain and post operative inflammation will be evaluated. On inclusion, pain intensity will be measured on a five-point verbal rating scale (0= no pain, 1=mild pain, 2=moderate pain, 3=severe pain, and 4=intolerable pain), and on a visual analogue scale (0-100mm). VAS scale will be repeated at 20, 40, 60, 80, 100, 120, 140, 160, 180 and 200 minutes after inclusion / intervention. The patients will also rate pain intensity during a 5 meters walk at 200 minutes (evoked pain). The patient will rate pain at rest and evoked pain 24, 48 and 72 h after intervention.

Eligibility Criteria:
Inclusion Criteria:

1. Otherwise healthy patients (ASA 1 and 2) undergoing knee arthroscopy in general anaesthesia.
2. Being informed about and willing to participate in the study -

Exclusion Criteria:

1. Pregnancy or lactation. Fertile women will be asked if they may be pregnant, and offered a pregnancy test if there is doubt.
2. Established osteoarthritis or synovitis
3. Known intolerance to anakinra
4. Kidney failure (Creatinine clearance \<30ml/min)
5. History of frequent infectious diseases or immunodeficiency
6. Heart failure
7. History of drug -or alcohol abuse
8. Participation in other synchronous clinical trials
9. Perioperative steroid treatment, perioperative paracetamol (12 hrs), NSAIDs (24 hrs) or COX2-inhibitors (48 hrs).
10. Use of tourniquet for bloodless field
11. Strong preoperative pain (VRS ≥3)
12. Intolerable postoperative pain (VRS=4)
Domperidone for Relief of Gastrointestinal Disorders

The purpose of this study is to make Domperidone available to patients with gastrointestinal disorders who have failed standard therapy and who might benefit from it.

Domperidone is the only medication that is a true prokinetic with a low percentage of side effects that is useful in the treatment of certain GI conditions, including gastroparesis and other motility disorders.

According to recent regulations, writing prescriptions for subject to obtain domperidone outside the United States has been determined to be illegal and the FDA has issued warnings against pharmacies compounding domperidone. The legal way of administering domperidone is by obtaining an Investigational New Drug Application.

This study is an effort to both follow federal regulations and provide the medication to subjects who would benefit from it where standard therapy has failed.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* symptoms or manifestations secondary to GERD (e.g., persistent esophagitis, heartburn, upper airway signs or symptoms or respiratory symptoms, gastrointestinal motility disorders such as nausea, vomiting, severe dyspepsia or severe chronic constipation that is refractory to standard therapy
* subjects must have a comprehensive evaluation to eliminate other causes of their symptoms.

Exclusion Criteria:

* history of, or current, arrhythmias including ventricular tachycardia, ventricular fibrillation, and Torsade de pointes. Subjects with minor forms of ectopy (PACs) are not necessarily excluded.
* clinically significant bradycardia, sinus node dysfunction, or heart block. Prolonged QTc (QTc \> 450 milliseconds for males, QTc \> 470 milliseconds for females.)
* clinically significant electrolyte disorders.
* gastrointestinal hemorrhage or obstruction.
* presence of a prolactinoma (prolactin-releasing pituitary tumor.)
* pregnant or breast feeding female.
* known allergy to Domperidone.
The Effects of Physical Activity and Low-Dose Ibuprofen on Cognitive Function in Cancer Patients

This research seeks to determine if a combination of low-dose ibuprofen along with a structured home-based walking and progressive resistance exercise program, EXCAP, will be effective in reducing cognitive difficulties among cancer patients receiving chemotherapy.

To conduct a feasibility pilot to assess preliminary efficacy of a 6 week course of ibuprofen (200 mg BID with does 8 hours apart) and a structured home based walking/progressive resistance program, EXCAP, alone or together, on cognitive function and levels of inflammatory molecules among cancer patients receiving chemotherapy (beginning at cycle 2). If these interventions prove to be useful and have potential benefit, they could have a substantial impact on treating cognitive difficulties experienced by cancer patients as well as improve quality of life. Moreover, if there is an effect of these interventions on cognitive functioning and inflammation, we will gain more knowledge of a possible mechanism of chemotherapy-related cognitive difficulties.

Eligibility Criteria:
Inclusion Criteria:

* Must report cognitive difficulties of 3 or higher on a 0-10 scale
* Must provide informed consent
* Be able to read English
* Have a primary diagnosis of cancer
* Be able to swallow medication
* Women of child-bearing potential must not be pregnant or become pregnant during the 6 week study
* Agree not to take NSAIDs during the 6 week intervention period
* Be scheduled to receive at least 2 additional cycles of oral or IV chemotherapy over the 42-day study period.
* Must have the approval of their treating physician to begin the exercise program and receive the ibuprofen
* Must be over 18 years of age

Exclusion Criteria:

* Currently taking a consistent dosage of a NSAID at least 3 days a week for the last 3 months that is over 400mg daily
* Have an allergy to ibuprofen
* Be identified as in active or maintenance stage of exercise behavior as assessed by the single-item exercise stages of change short form
* have physical limitations that contraindicate participation in sub-maximal physiological fitness testing or a low to moderate home-based walking and progressive resistance program
* have a history of peptic ulcer disease within the last 12 months
* Diagnosed with a neurodegenerative disease
* Had a myocardial infraction within the past 6 months
* Patients with a neutropenic episode during the first cycle of chemotherapy or at high risk for a neutropenic episode during future chemotherapy cycles at the treating physicians discretion
* Have confirmed metastatic disease to the central nervous system
* Have been hospitalized for a major psychiatric illness within the last 5 years
Buccinator Myomucosal Flap With Furlow Palatoplasty and VPI

Nasopharyngoscopic examination of the 20 patients with secondary VPI following 2 flap palatoplasty will be done for visualization of the velopharyngeal port, allowing assessment of the pattern and grade of velopharyngeal closure during speech and the presence or absence of a velopharyngeal gap and after VPI repair by Buccinator myomucosal flap with Furlow palatoplasty


Eligibility Criteria:
Inclusion Criteria:

* 5-6 years old children with previous treated complete cleft palate with 2 flap palatoplasty technique, nonsyndromic.
* lip and palate repair performed by one craniofacial surgeon

Exclusion Criteria:

* Patients with syndromic cleft lip.
* Bilateral cleft lip
* Patient older younger 5 years.
* Associated Cardiac anomalies.
* Any systemic condition
Assessment of Proactive Treatments in Patients With Wet Age-related Macular Degeneration (wAMD) Which Have Never Undergone Treatment of This Particular Disease

In this observational study researchers want to learn more about changes in visual acuity (clarity of vision) with proactive flexible treatments over time in patients suffering from wet age-related macular degeneration (wAMD) after decision to treat with Aflibercept (Eylea) was made. Wet AMD is an eye disease that progressively destroys the macula, the central portion of the retina, impairing central vision.


Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of wAMD.
* Patients for whom the decision to initiate treatment with IVT aflibercept in a proactive regimen was made as routine clinical practice.
* Treatment-naïve in the study eye (no prior therapy for wAMD).
* Patient age ≥50 years of age.
* Written informed patient consent before the start of data collection (according to the requirements of the local authorities and laws).

Exclusion Criteria:

* Participation in an investigational program with interventions outside of routine clinical practice.
* Patients with contraindications to IVT aflibercept listed in the local marketing authorization.
* Planned treatment regimen outside of the local marketing authorization.
* Patients with eye diseases, e.g. advanced glaucoma or visually significant cataracts, likely to require surgery during the observation period in the study eye.
* Concomitant ocular or systemic administration of drugs up to 3 months before IVT aflibercept treatment that could interfere with or potentiate the mechanism of action of IVT aflibercept, including other anti-VEGF agents in the fellow eye.
* Any other retinal disease which may interfere with the treatment of wAMD.
An Open Single Centre Study To Assess Treatment of Chronic Constipation in Children

The purpose of this study was to evaluate the safety and efficacy of Movicol in the treatment of chronic constipation in children.

This was a phase III, open, single centre, non-comparative study. All patients were assigned to treatment with Movicol for a period of 12 weeks.

All patients were screened at Day 0 (Visit 1) when baseline assessment of their bowel movements over the previous 14 days were made. Patients were dispensed with Movicol to commence treatment on the following day (Day 1). During the first 5 days the dose was increased on an every second day basis until normal bowel movement was achieved. Thereafter until the end of the study the dosage was titrated according to the stool consistency (diarrhoea, loose stool, hard stools or no bowel movement for 2 days, respectively).

Four on-treatment visits were performed on Day 14 (Visit 2), Day 28 (Visit 3), Day 56 (Visit 4) and Day 84 (Visit 5). At each visit bowel movements over the previous period were assessed by the investigator using the patient's daily diary card data.

Eligibility Criteria:
Inclusion Criteria:

* children aged 24 months - 11 years old inclusive
* patients with constipation defined as:

  * ≤ 2 spontaneous complete bowel movements per week (over the previous 14 days), and one or more of the following:

    * 1/4 or more of bowel movements with straining
    * 1/4 or more of bowel movements with hard or lumpy stools
* patients in whom these symptoms have been present for ≥ 3 months
* new patients or those whose management is unsatisfactory on current laxative treatment
* patients of either sex
* patients of any ethnic origin
* hospital in-patients or outpatients.

Exclusion Criteria:

Patients with:

* history of bowel washout within the last 2 months
* intestinal perforation or history of obstruction
* recent history of urinary tract infection (within last month)
* Hirschsprungs disease
* paralytic ileus
* toxic megacolon
* severe inflammatory conditions of the intestinal tract
* clinically uncontrolled renal/hepatic/cardiac disease(s)
* clinically uncontrolled endocrine disorder(s)
* any other severe unstable co-existing disease
* hypersensitivity to macrogol or other constituents of Movicol
* encopresis
* patients who have taken any investigational drug in the last three months
* patients or patients whose parents would in the opinion of the investigator be unable to comply with the requirements of the study.
Suicide Gene Therapy for Donor Lymphocytes Infusion After Allogeneic Hematopoietic Stem Cell Transplantation

The main complications of allogeneic hematopoietic stem cell transplantation (HSCT) include graft-versus-host disease (GVHD) and poor immune reconstitution leading to severe infections and leukemia relapse. Mature donor T-cells present in the transplant facilitate T-cell reconstitution but also induce GVHD, which itself impairs immune reconstitution. We have developed a strategy of alloreactive T-cell depletion, using T-cells expressing the Herpes simplex thymidine kinase (TK) suicide gene combined with a ganciclovir (GCV) treatment. This system permits the selective elimination of dividing TK+ T-cells in vivo. To test this hypothesis in preclinical settings, we have previously developed several experimental models of GVHD using TK+ T-cells in mice. The demonstration that a preventive treatment with GCV administered close to the time of HSCT could control GVHD brought the proof of concept. We now propose a clinical trial to test whether donor lymphocytes infusion (DLI) using TK-transduced cells permits to induce a graft-versus-tumor (GVT) effect for treatment of relapse after HSCT, while GVHD can be controlled by GCV treatment.

DLI-TK is administered either after failure of 1 or several previous standard (std-) DLI of, defined after a minimal follow-up of 2 months after the last injection. To prepare DLI-TK, donor T-cells are transduced with a retroviral vector encoding TK. Transduced cells are selected using a CliniMACS device (MYLTENYI). In case of previous std-DLI received, the DLI-TK cell dose is adjusted to be below or equal to the maximal cell dose previously received in std-DLI. No comparison is planned in the analysis.

Eligibility Criteria:
Inclusion Criteria:

* Hematological malignancy.
* Previous allogeneic hematopoietic stem cell transplantation.
* Relapse diagnosed at the molecular, cytogenetic, or cytological level.
* Failure of a previous stdILD or inclusion in first intention without previous stdDLI.
* Age \> 18 years and \< 70 years at the time of inclusion. For patients between 15 and 18 years of age, a case-per case inclusion will be studied.
* Performance status considered on the score Eastern Cooperative Oncology Group (ECOG) \< 2.
* Life expectation 1-month-old superior.
* Signed written informed consent.
* Negative human chorionic gonadotropin (HCG) in the 7 days preceding the inclusion for women in age of procreation.
* Membership of the French national insurance.

Exclusion Criteria:

* Grade \>II acute GVHD or chronic extensive GVHD at the time of inclusion.
* Patient receiving an immunosuppressive treatment for GVHD treatment at the time of inclusion.
* Dysfunction of liver (alanine aminotransferase / aspartate transaminase (ALAT/ASAT) \> 5 N, or bilirubin \> 50 µM), or of the renal function (creatinine clearance \< 30 ml / min).
Safety & Effectiveness of Autologous Regenerative Cell Therapy on Pain & Inflammation of Osteoarthritis of the Hip

This is a prospective open-label clinical study of 50 patients to determine safety and treatment potential of autologous cell therapy for pain and inflammation associated with Osteoarthritis of the hip. Follow-up will consist of a larger sample including 4,000 patients.

This is a prospective open-label clinical study of 50 patients to determine safety and treatment potential of autologous cell therapy for pain and inflammation associated with Osteoarthritis of the hip. Follow-up will consist of a larger sample including 4,000 patients.

Patients will be treated for Osteoarthritis (OA) of the hip due to degeneration or chronic injury. They will be treated with autologous Stromed obtained by the Adipose Ultrasonic Cell Recovery Unit (AUCRU) and Platelet Rich Plasma (PRP) processed by the RegenLab (RegenKit BCT-3) PRP product each as direct injections to the affected joints. Patient outcomes will be tracked with laboratory tests for inflammation markers, hip disability and osteoarthritis outcome score (HOOS) questionnaires and follow up MRI's at various endpoints to 6 months. SF-36 forms (a quality of life measure) and numerical rating scales (NRS) will also be used to assess safety and efficacy of treatment, as well as any reduction in patient medication and/or delay in pending hip replacement therapy.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with indication of Osteoarthritis. Can be from degeneration or chronic injury.
2. Patients range from 18-90 years of age.
3. Patients must be able to comply with treatment plan, laboratory tests and periodic interviews.
4. Patients with adequate renal function, Creatinine ≤ 1.5 mg/dl.
5. Patients with adequate cardiac and respiratory function.
6. Patients with adequate blood coagulation activity, PT(INR) \< 1.5, APTT
7. Patients must have adequate immune system function, with no known immunodeficiency disease.
8. Greater than 6 months hip pain with the index side (left or right).

Exclusion Criteria:

1. Neoplastic cancer within 5 years prior to screening, except for cutaneous basal cell or squamous cell cancer resolved by excision
2. Presence of clinically significant acute or unstable cardiovascular and cerebrovascular (stroke).
3. Diagnosis of a transient ischemic attack in the 6 months prior to screening.
4. Patients infected with hepatitis B, C or HIV.
5. Patients with Body Mass Index (BMI) \> 40kg/m2
6. Presence of active infection.
7. Any other illness, psychiatric disorder, alcohol or chemical dependence that in the opinion of the investigator would render a patient unsuitable to participate in the study.
8. Conditions/therapies/factors which could confound or interfere with the evaluation of pain/mobility including, but not limited to:

   * Treatments with strong opioid drugs in the previous 4 weeks for other pain rather than hip osteoarthritis
   * Corticosteroid injection at treatment site within 1 month
   * Consistent use of NSAIDs within 48 hours of procedure.
A Study to Assess the Safety, Tolerability and Effects of Single Ascending Doses of ASP3652 in Healthy Subjects

The purpose of this study is to explore the safety (including the effect on cardiac intervals), tolerability, the effects on the Central Nervous System (CNS), as well as the CNS side effect profile of single ascending doses of ASP3652 in healthy, Caucasian male and female subjects.

Each subject receives 3 single ascending doses of ASP3652 and a single dose of matching placebo during one randomly selected investigational period. Randomization is conducted separately for males and females.

The washout period between dosing occasions is at least 7 days. Screening takes place from Day -22 to Day -2. Subjects are admitted to the clinic in the afternoon of Day -1 of investigational period 1, 2, 3 and 4 for pre-dose assessments.

On Day -1 of all investigational periods, subjects do not take any food or drink for at least 10 hours before the anticipated dosing time on Day 1. For the duration of their stay in the clinic, subjects are not allowed to consume caffeine or other xanthine-containing drinks.

The subjects are discharged on Day 4 of each investigational period. The End of Study Visit (ESV) is planned to take place 7-14 days after early discharge or after Day 4 of investigational period 4.

Eligibility Criteria:
Inclusion Criteria:

* Subject is white and of Caucasian origin.
* Body Mass Index more than or equal to 18.5 and less than 30.0kg/m2.
* Male subject must agree to practice an adequate contraceptive method with female sexual partners to prevent pregnancy.
* Female subject must agree to practice an adequate contraceptive method with male sexual partners to prevent pregnancy.

Exclusion Criteria:

* Pregnancy within 6 months before screening assessment or breast feeding within 3 months before screening (for females subjects only).
* Known or suspected hypersensitivity to ASP3652, or any components of the formulation used.
* A mean QTc(F) interval of \>430 ms (for males) and \>450 ms (for females) after triplicate measurements, a history of unexplained syncope, cardiac arrest, unexplained cardiac arrhythmias or torsades de pointes, structural heart disease, or a family history of Long QT Syndrome (LQTS). In case of an abnormal QTc(F) interval, the assessment may be repeated once (in triplicate). If the QTc(F) interval exceeds the limits, two additional Electrocardiogram (ECG)s can be recorded and the average of the three QTc(F) values should be used to determine the subject's eligibility.
To Evaluate the Efficacy and Safety of Inhaled Corticosteroids Combined With Bronchodilators and Programmed Death-ligand 1 (PD-L1) Inhibitor Plus Platinum-based Chemotherapy in Patients With Advanced Lung Squamous Cell Carcinoma Complicated With Chronic Obstructive Pulmonary Disease (COPD)

To evaluate the efficacy and safety of inhaled corticosteroids combined with bronchodilators and programmed death-ligand 1 (PD-L1) inhibitor plus platinum-based chemotherapy in patients with advanced lung squamous cell carcinoma complicated with chronic obstructive pulmonary disease (COPD)


Eligibility Criteria:
Inclusion Criteria:

* This project is a multi-center, randomized controlled, intentionality analysis study.

Inclusion criteria:

1. Age ≥18 years old;
2. Histological or cytological examination confirmed clinically primary squamous non-small cell lung cancer stage IIIB-IV (according to AJCC 8th Edition);
3. Patients with stable moderate to severe chronic obstructive pulmonary disease (COPD) were diagnosed according to the GOLD2021 standard and the Guidelines for Diagnosis and Treatment of Chronic Obstructive Pulmonary Disease (Revised 2021), with blood eosinophils ≤300 /ul and ≥100 /ul;
4. The gene test showed that the driver gene (EGFR/ALK/BRAF/ROS1/KRAS/ HER2/MET/RET /NTRK) was negative;
5. ECOG PS 0-2 points;
6. Clinical evaluation is suitable for suglizumab combined with paclitaxel (albumin-bound) and carboplatin anti-tumor first-line therapy, as well as chronic obstructive pulmonary maintenance therapy with long-acting bronchodilators or inhaled corticosteroids;
7. Clinical records of suglizumab treatment, chemotherapy and other treatments are available;
8. Patients who have previously used bronchodilators and inhaled corticosteroids should undergo a washout period of at least 15 days;
9. Patients voluntarily join the project and sign informed consent;

Exclusion Criteria:

* 10. Concurrent with any malignant active tumor other than squamous non-small cell lung cancer; 11. Prior systematic treatment for advanced/metastatic non-small cell lung cancer; 12. Patients with diseases requiring long-term oral or intravenous use of glucocorticoids, such as autoimmune diseases, asthma, nephritis, type 1 diabetes, hyperthyroidism, etc.; Etc.; 13. Oral or intravenous use of glucocorticoids for any reason within 1 month prior to screening; 14. The patient was assessed by the researchers as having severe liver and kidney dysfunction; 15. Accompanied by acute type I/II respiratory failure or long-term use of non-invasive or invasive ventilator assisted ventilation or frequent acute exacerbations (≥2 times/year of moderate and severe acute exacerbations); 16. Women who are pregnant or nursing, or who are planning to become pregnant; Currently receiving or planning to participate in any other clinical studies;