cyrilzakka/clinical-trials huggingface dataset:
M-ARS ACL Post-marketing Surveillance Study

The goal of this study is to evaluate the performance of Medacta Anatomic Ribbon Surgery (M-ARS) in patients requiring anterior cruciate ligament (ACL) reconstruction.

The main goal is to evaluate the survival rate of M-ARS ACL at 6 months post-operatively. The secondary goals are to assess the survival rate, clinical and functional outcomes, the quality of life, and the rate of complications at 1 month, 1 year and 2 years post-operatively.

This s a prospective, multicenter, non-controlled, observational study to evaluate the outcomes of Medacta Anatomic Ribbon Surgery (M-ARS) in the reconstruction of the anterior cruciate ligament (ACL).

Participants will be informed about the study, both orally and in writing, during a preoperative visit. The investigator will answer any questions that may arise and will collect the informed consent. During the study, enrolled participants will be able to withdraw at any time and for any reason.

The study is conducted according to the following schedule:

* V1 : Inclusion during a preoperative visit
* V2: Surgery
* V3: Follow-up visit at 1 month ± 15 days post-surgery
* V4: Follow-up visit at 6 months ± 30 days post-surgery
* V5: Follow-up visit at 12 months ± 60 days post-surgery
* V6: Follow-up visit at 24 months ± 90 days post-surgery

The following data will be collected:

* Survival rate of implants evaluating the incidence of implants failure, where implant failure is defined as revision, loosening, or any definite change in the position of components (V3-V6).
* Clinical and functional outcomes, measured with the International Knee Documentation Committee (IKDC) score (V1, V3-V6)
* Quality of Life, measured with the EQ-5D score (V1, V3-V6)
* Occurrence of intraoperative and postoperative complications (V2-V6)

Depending on standard practice, imaging assessment of implants and bone tunnels may be performed.

A web-based data collection tool will be used as Electronic Data Capture (EDC). All the information required by the protocol will be collected in electronic case report forms (eCRF).

The statistical analysis will be performed according to a pre-established statistical analysis plan. Missing values will not be replaced by estimated values but will be considered as missing in the statistical analysis.

Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18 years
* Patients with ACL rupture requiring ACL reconstruction

Exclusion Criteria:

* Patients with malignant diseases (at the time of surgery)
* Patients with proven or suspected infections (at the time of surgery)
* Patients with functional deficits of the affected extremity (at the time of surgery)
* Patients with known incompatibility or allergy to products materials (at the time of surgery)
Effect of Different Injection Speeds for Spinal Anaesthesia in Caesarean Section

The purpose of this study is to investigate if prolonging the speed of injection during spinal anaesthesia can reduce the incidence of hypotension and/or medication requirements thereby making it safer for the mother and foetus.

We plan to investigate if by varying the speed of injection during spinal anaesthesia, will there be a difference in the incidence of hypotension. Hypotension is a common complication especially for pregnant women undergoing caesarean section. A high speed of injection can theoretically cause a higher spread of anaesthetic, which may increase the incidence of hypotension. We want to know if by prolonging the injection time, will this lead to a reduction in a rate of hypotension.

Eligibility Criteria:
Inclusion Criteria:

* at least 18 years of age
* singleton term pregnancy
* American Society of Anesthesiologists (ASA) class I-II

Exclusion Criteria:

* Severe pre-eclampsia
* contraindications to spinal anaesthesia
* Height \<150cm or \>180cm
* Weight ≥100kg
* Baseline systolic BP \<90 mmHg
* Baseline systolic BP \>150mmHg
* Category 1 urgency for delivery
Oral Iron Supplementation in Pulmonary Hypertension

The purpose of this study is to investigate the effects of iron supplementation in patients with pulmonary arterial hypertension and iron deficiency.

Pulmonary arterial hypertension (PAH) is a chronic disease associated with upregulation of hypoxia inducible-factor-1alpha (HIF-1alpha) and functional iron deficiency. The investigators are proposing a prospective, single-arm, open-label intervention to determine whether oral iron supplementation in patients with pulmonary arterial hypertension reduces markers of HIF activation and improve clinical parameters of disease. After the baseline visit, patients will be given ferrous sulfate tablets to take orally for 3 months. Outcome data will be collected at the baseline visit and at the end of the 3-month study period.

Eligibility Criteria:
Inclusion Criteria:

* age 21 and older
* diagnosis of idiopathic pulmonary arterial hypertension
* iron deficiency (transferrin saturation \<20% and serum ferritin \< 100 ug/l)

Exclusion Criteria:

* active infection, malignancy, or bleeding
* hemochromatosis
* chronic inflammatory or autoimmune disease
* currently taking experimental/study medications, erythropoietin, iron supplementation, or immunosuppressants
* allergy to iron
Assessment of Clinical, Biological and Biometrological Paramaters in Adult Subjects Suffering From AD

The aim of the study is to collect different parameters (clinical, biological and biometrological) of Atopic Dermatitis (AD) in order to identify which factors are modified during the flare-up phase.


Eligibility Criteria:
Inclusion Criteria:

* Subject aged between 18 to 50 years included
* Subject suffering from Atopic Dermatitis according to the "U.K. Working Party's Diagnostic Criteria for Atopic Dermatitis" (6)
* Subject with mild to moderate Atopic Dermatitis with 20 \<= SCORAD \<= 40 at inclusion
* Subject with flare frequency ≥ 4 on the target areas over the last year
* Subject with a cutaneous target area, allowing the measurements, located on upper or lower limbs and defined as a usual AD flare area according to the subject
* Subject with a target area with 22 \<= target SCORAD signs \<= 10 following:

  * Erythema ≥ 1
  * Dryness ≥ 1 1
* Subject with a control area, allowing the measurements, located on upper or lower limbs and defined as :

  * A non- usual AD flare area according to the subject and the investigator
  * A sufficient distance from the cutaneous target area according to the investigator

Exclusion Criteria:

* Subject with a surinfected AD
* Subject having any other dermatologic condition other than AD or characteristics (e.g: tatoo) on the target area liable to interfere with the study assessments
* Subject with another dermatologic condition, acute or chronic or disease or history of disease considered by the investigator, liable to interfere with the study assessments, or hazardous for the subject or incompatible with the study according to the investigator
* Any surgical intervention on upper or lower limbs during the previous weeks or months liable to interfere with the study data according to the investigator
* Systemic immunosuppressive therapy (excepted systemic corticoids) within 3 months before the inclusion visit or ongoing at inclusion visit (except during flare period)
* Systemic corticoids taken within 4 weeks before the inclusion visit or ongoing at inclusion visit (except during flare period)
* Phototherapy performed within 4 weeks before the inclusion visit or ongoing at inclusion visit (except during flare period)
* Systemic antibiotics taken within 7 days before the inclusion visit or ongoing at inclusion visit (except during flare period)
* Moderate to high-potency topical corticosteroids applied within 7 days on upper or lower limbs before the inclusion visit or ongoing at inclusion visit (except during flare period)
* Topical immunomodulators, applied within 7 days on upper or lower limbs before the inclusion visit or ongoing at inclusion visit (except during flare period)
* Topical or oral treatment instaurated or modified before the inclusion visit or planned to be instaurated during the study or ongoing at inclusion visit, liable to interfere with the study, according to the investigator
A Study of Complex Ventral Hernia Repair Utilizing the XenMatrix™ Surgical Graft With Component Separation

This will be an observational study designed to collect early, short- and long-term clinical outcomes of the XenMatrix™ Surgical Graft for complex ventral hernia repair. Subjects will be expected to attend follow up visits at 1, 6, 12, 18 and 24 months following surgery.


Eligibility Criteria:
Inclusion Criteria:

* Be able to undergo study procedures.
* Have signed an Informed Consent form (ICF).
* Be diagnosed with a ventral or incisional hernia that cannot be closed primarily in the opinion of the investigator.
* Requires a component separation repair with the use of a biological graft.

Exclusion Criteria:

* Subject is participating in another device or drug study.
* Subject has a life expectancy less than 4 years at the time of enrollment.
* Any condition in the opinion of the investigator that would preclude the use of the XenMatrix™ Surgical Graft, or preclude the subject from completing the follow-up requirements.
* Any subject with a defect the surgeon feels he/she cannot fully close.
* Subjects with a BMI \> 50.
* Subjects with connective tissue disorders.
* Subjects with a history of cirrhosis.
* Subjects with renal failure requiring dialysis.
* Subjects on or suspected to be placed on chemotherapy or systemic immunosuppressive medications during any part of the study.
* Transplant recipients.
* Subjects taking corticosteroids for \>6 months (pre or post surgery).
* Any bowel leak or infection that would preclude the use of the XenMatrix™ Surgical Graft in the opinion of the investigator.
* The subject lives approximately 2 hours away from the study site and compliance with follow up requirements will be difficult in the opinion of the investigator.
The Efficacy of Fycompa (Perampanel) in Children With Epilepsy

Fycompa (Perampanel), a new anti-epileptic drug that uses a new mechanism-AMPA receptor antagonist. Its initial indication is for local or generalized epilepsy in children and adults over 12 years old, but its effectiveness in the treatment of epilepsy in children At present, more evidence is still needed. We will study the effectiveness of Fycompa (Perampanel) in the treatment of epilepsy in children under the age of 18. It is expected that the clinical use of Fycompa (Parampanel) in Taiwan will be able to analyze and study the effectiveness of the clinical use of Fycompa (Parampanel) in the treatment of epilepsy in children, and compare it with foreign reports.


Eligibility Criteria:
Inclusion Criteria:

* Patients under 18 years of age suffering from epilepsy
* Patients who are taking Paraampanel

Exclusion Criteria:

* Patients who are not in the above age groups and who are not using parampanel
Comparison of Effects of PEEP Levels on Respiratory Mechanics in Patients Undergoing Laparoscopic Cholecystectomy

Laparoscopic cholecystectomy is accepted as gold standard in the management of cholelithiasis. Although laparoscopic procedures have many advantages,intra-abdominal CO2 insufflation can cause decreased lung volumes and compliance, increased airway resistance and impaired ventilation-perfusion ratio. In this study, investigators aim to investigate effects of intra-operative PEEP treatment at 3 distinct levels on respiratory dynamics and elimination time of volatile anesthetic agent.

In the study, 75 ASA I-II patients aged 30-65 years will be randomized into 3 groups to receive 0 cmH2O PEEP (Group-1), 5 cmH2O PEEP (Group-2) and 8 cmH2O PEEP (Group-3) in PVC mode. In all patients underwent general anesthesia; hemodynamic parameters, Ppeak, Pplateau, compliance values as well as Fisevo/Fexpsevo ratio at 1 MAC and times from 1 MAC to 0.3 and 0.1 MAC will be recorded. In addition, preoperative and postoperative pulmonary function tests will be compared in all patients.

Eligibility Criteria:
Inclusion Criteria:

* ASA (American Society of Anesthesiologists) I-II
* BMI of 25-30
* patients scheduled to elective laparoscopic cholecystectomy.

Exclusion Criteria:

* Patients with ASA III, IV, V risk,
* Patients with comorbid diseases that may increase intra-abdominal pressure or pulmonary hypertension,
* Patients with renal and hepatic failure,
* Patients with pregnancy and
* Patients using bronchodilator or steroid were excluded.
of Myo-inositol, Melatonin and Co-enzyme q10 on Ovarian Reserve

To evaluate the role of Myo-inositol, melatonin and co-enzyme Q10 on ovarian reserve parameters and ICSI outcome in poor ovarian responder

Each patient will be subjected to:

Full history taking. Systematic clinical examination to assess the general condition, body mass index (BMI) and local pelvic physical findings and AFC by trans-vaginal ultrasound on day 2 to day 3 of menstruation. Routine labs as CBC, liver \& kidney functions to exclude general disease as a contraindication for induction or pregnancy.

Blood sample will be obtained for assessment of basal serum levels of FSH, LH, E2 on days 2- 3 of the cycle. PRL, AMH and TSH Ovarian Stimulation The patients will begin injections of recombinant FSH (rFSH, Gonal-F; Merck- Serono, Italy) from day 2-3 of menstruation, with daily dose of 300-450 IU adjusted according to individual conditions on the basis of the antral follicle count (AFC),hormonal profile, age, body mass index (BMI), and previous ovarian response, according to the standard operating procedures of the center. . For pituitary suppression, the patients will receive GnRH antagonist Cetrorelix (CETROTIDE 0.25Mg/d, Merck Serono, Germany) 0.25 mg/day subcutaneously from day 6 of induction until trigger day. The serum LH, estradiol levels as well as number and size of follicles will be monitored every two days, starting from stimulation day 6 until the day of hCG injection

Eligibility Criteria:
Inclusion Criteria:

* Infertile women who have one of the criteria of poor ovarian response as follows;

  * Antral follicle count less than 7
  * Anti-Mullerian hormone level Less than 1.2 ng/ml

Exclusion Criteria:

1. Any endocrine or metabolic disorder such as hyperprolactinemia, diabetes and thyroid dysfunction
2. Any pelvic pathology such as hydrosalpinx, uterine anomaly.
3. Any male factor infertility such as Oligo-Astheno-Teratozoospermia (OAT) or azoospermia
IV Dexamethasone for Prolongation of Peripheral Nerve Block

This is a volunteer study examining the effect of different doses of IV dexamethasone on prolongation of median nerve block in the forearm.

18 healthy volunteers aged 18-50 will be recruited (6 patients in each dosing group). Each volunteer will receive two forearm median nerve blocks separated by a two week washout period. One block will be conducted alongside an infusion of normal saline (control). The other block will be conducted alongside a randomised dose of IV dexamethasone (2, 4 or 8mg). The order of these interventions will be random. Blocks will be assessed quantitatively with cold and sharp sensation, electrical stimulation, quantitative sensory testing (thermal tolerance) and grip strength dynamometry. Measures or sensory and motor block including onset, intensity and duration will be compared between dosing groups.

Eligibility Criteria:
Inclusion Criteria:

* ASA 1 (normal healthy) volunteers.
* 18 - 50 years of age.
* 60 - 100kg weight.
* English speaking.
* Female volunteers of childbearing potential will be required to provide a negative pregnancy test before being allowed to participate.
* Females of child bearing potential must be willing to use medically acceptable birth control methods between study interventions and for a minimum of 2 weeks following the second nerve block.

Exclusion Criteria:

* Medical disorders (including bleeding disorders).
* Use of systemic steroids within 2 weeks of the study, prescription medications, live viral vaccines or any recreational drug use.
* Hypersensitivity to bupivacaine, dexamethasone or any component of saline.
* Contraindication to regional anesthetic block.
* Inability to provide informed consent.
* Baseline abnormality of hand sensation or motor function.
* Pregnancy / breast feeding.
* Individuals with mental health disorders (for example bipolar disorder or depression).
* Individuals with cataracts or glaucoma.
* Any known contraindication to IV dexamethasone as per the product monograph - bacteremia and systemic fungal infections, hypersensitivity to any of the products components, gastric and duodenal ulcers, certain viral infections i.e. varicella herpes genitalis.
Tocilizumab Dose-tapering and Interruption in Patients With Giant Cell Arteritis Achieving the Clinical Remission.

Interleukin-6 (IL-6), a pro-inflammatory cytokine, has been found to have a crucial role in the pathogenesis of Giant cel arteritis (GCA). Based on this rationale, several recent studies demonstrated the efficacy of tocilizumab (TCZ), an anti-IL-6 targeted monoclonal antibody, for the treatment of patients with refractory GCA. Confirming previous reports,in a recent retrospective study the investigators successfully treated 10 patient with refractory GCA with TCZ. All patients achieved a complete disease remission evaluated by clinical, laboratory, and positron emission tomography (PET). In a considerable number of GCA patients treated with corticosteroids (CS) the therapy may be interrupted with no disease flares. No data are available on the management of patients achieving the remission with TCZ.

Study design. Open-label, prospective, pilot study on patients with giant cell arteritis (GCA) resistant to corticosteroids (CS) .

Setting. Rheumatology department, Hospital of Prato, Prato, Italy. Treatment. All refractory GCA patients with or without involvement of aorta and its thoracic branches treated with intravenous TCZ at the dose of 8 mg/Kg/monthly or subcutaneous TCZ at the dose of 162 mg/weekly who achieved a stable remission over a 6-month period should receive reduced TCZ doses with the following schedules: intravenous TCZ tapering to 2 mg/Kg/monthly with drug withdrawal at month 4, and subcutaneous TCZ monthly reduction through the lengthening of injection intervals every 2, 3 , and 4 weeks, and with drug interruption at month 4.

Primary end-point. To investigate the maintenance of clinical remission after TCZ interruption over a 6-month follow-up period.

Secondary end-points. To assess the maintenance of clinical remission during the treatment, to evaluate the role of acute-phase reactants and PET in predicting the relapse and remission, and to assess the occurrence of adverse event (AEs).

Eligibility Criteria:
Inclusion Criteria:

- All consecutive patients meeting the 1990 ACR classification criteria for GCA.

Exclusion Criteria:

* Corticosteroid treatment during the previous 6 months.
* Uncontrolled diabetes.
* Uncontrolled hypertension.
* History of cancer within the past 5 years.
* History of frequent infections in the past.
* Positivity of screening procedures for latent tuberculosis infection.
* Uncontrolled dyslipidemia at baseline.
* Known intestinal diverticulosis.
* Concomitant hematologic disorders.
Intranasal Fentanyl for Management of Pain Associated With Cystoscopic Procedures

The purpose of this study is to assess the safety and efficacy of intranasally-administrated fentanyl pectin spray (Lazanda®)given to decrease the pain during cystoscopy (the passage of a telescopic instrument into the bladder for purpose of diagnosing the cause of blood in the urine, urinary complaints or any other problems with the urinary bladder). The current standard practice is to use Lidocaine jelly (a local anesthetic) given through the urethra to lubricate and decrease local pain. In this study, an additional medicine (Lazanda®) is used to reduce pain that occurs during and after the above procedure.

In this prospective study, twenty subjects will be enrolled. The first ten will receive a dose of 100mcg pectin fentanyl nasal spray (Lazanda®). The second ten will receive a dose of 200mcg pectin fentanyl nasal spray (Lazanda®) if the 100mcg was well tolerated in the first ten. In all cases, Lidocaine jelly is used as an local anesthetic in the urethra.

Eligibility Criteria:
Inclusion Criteria:

1. Male adult patients scheduled for cystoscopy; additional procedures (e.g. ureteral stent placement, stent exchange, bladder biopsy, retrograde pyelogram) may be included.

Exclusion Criteria:

1. History of analgesic abuse or opioid tolerance
2. Allergy to fentanyl or to any of the components of Lazanda®
3. Acute/chronic nasal problems such as rhinitis or sinusitis
4. Acute bronchial asthma / upper airway obstruction
5. Presence of bradycardia or history of seizures
6. Concomitant use of drugs that inhibit cytochrome P450 isoenzyme 3A4 (e.g., ritonavir, ketoconazole, itraconazole, troleandomycin, clarithromycin, nelfinavir, nefazodone, amprenavir, aprepitant, diltiazem, erythromycin, fluconazole, fosamprenavir, monoamine oxidase inhibitors and verapamil) or exposure to these drugs 30 days prior to placement on the study.
7. Concomitant use of vasoconstrictive nasal decongestants (e.g., oxymetazoline, phenylephrine, xylometazoline)
8. Numeric Rating Scale (NRS) pain score more than 0 at baseline
9. Any situation or condition which, in the investigator's opinion, puts the subject at significant risk, or could confound the study results.
Chemotherapy With Cordycepin Plus Pentostatin in Treating Patients With Refractory Acute Lymphocytic or Chronic Myelogenous Leukemia

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 may kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of chemotherapy consisting of cordycepin plus pentostatin in treating patients with refractory acute lymphocytic or chronic myelogenous leukemia.

OBJECTIVES: I. Evaluate the safety, maximum tolerated dose, adverse effects, and toxicities of cordycepin, given 1 hour following a fixed dose of the adenosine deaminase inhibitor pentostatin, in patients with refractory TdT positive leukemia. II. Determine the single and multiple dose pharmacokinetics of cordycepin given 1 hour following a fixed dose of pentostatin. III. Characterize selected whole blood and blast cell metabolic parameters serially in relation to cordycepin/pentostatin administration. IV. Measure and quantify any clinical responses in refractory TdT positive leukemia patients following cordycepin/pentostatin administration.

OUTLINE: This is a dose escalation study. Each treatment course is 28 days in length. On days 1-3 pentostatin is administered over 5 minutes by IV bolus and followed 1 hour later by a 1 hour infusion of cordycepin IV. An escalating dose of pentostatin is given with a fixed dose of cordycepin until the desired level of adenosine deaminase inhibition is observed. After this is determined, a dose escalation schedule for cordycepin is initiated to determine the maximum tolerated dose (MTD) when given in combination with pentostatin. The MTD is determined by the number of patients who exhibit dose limiting toxicity and the severity of the toxicity.

PROJECTED ACCRUAL: Approximately 30 patients will be accrued.

Eligibility Criteria:
DISEASE CHARACTERISTICS: TdT positive acute lymphocytic leukemia or blastic chronic myelogenous leukemia Failed at least one standard treatment

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky greater than 70% Life expectancy: At least 3 months Hematopoietic: Not specified Hepatic: Bilirubin no greater than 2.0 mg/dL Transaminases no greater than 2.5 times normal Renal: Creatinine no greater than 1.5 mg/dL Creatinine clearance greater than 60 mL/min Cardiovascular: Ejection fraction greater than 40% Other: Not pregnant or nursing No serious concurrent illness

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 3 weeks since chemotherapy No concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: At least 3 weeks since radiation therapy Surgery: Not specified