cyrilzakka/clinical-trials huggingface dataset:
Clozapine Use Pattern in the Province of Seville

CLOZAPINE USE PATTERN IN THE PROVINCE OF SEVILLE

Subjects with a diagnosis of schizophrenia (F20 of ICD-10) under treatment with clozapine in the province of Seville. The use of clozapine, variability between centers and treatment modification will be identified.

Eligibility Criteria:
Inclusion Criteria:

Patients who have been prescribed (initially or regularly) clozapine during 2018, based on the casuistry provided by the Pharmacy service of the different hospitals.

Exclusion Criteria:

* Parkinson's disease
* Dementia
Self-correction Evaluation in Scoliosis Patients

To date, there is no objective assessment method for the quality of the self-correction performed by patients with scoliosis.

The study consists of two parts, both retrospective, and distinct on the basis of the tools used to assess self-correction.

Part 1: Retrospective assessment of the radiographic variations between spontaneous position and self-correction in subjects suffering from juvenile and adolescent idiopathic scoliosis. Both measurements were performed in a single session.

Part 2: Retrospective assessment of the variations between spontaneous and self-correcting position in subjects with juvenile and adolescent idiopathic scoliosis using objective parameters deriving from non-invasive 3D ultrasound instrumentation (Scolioscan, Telefeld, Hong Kong).


Eligibility Criteria:
Inclusion Criteria for both parts:

* Diagnosis of juvenile or adolescent idiopathic scoliosis;
* Age \>= 10 years;
* Single and double curves with amplitude \>= 15 ° Cobb;
* Performing exercises according to SEAS for at least 6 months

Only for part 1 (radiographic)

* Availability of radiographic investigation in upright position and in self-correction Only for part 2 (ultrasound)
* Availability of ultrasound assessment in upright position and in self-correction
* Complete radiograph of the spine in anteroposterior projection performed in the 45 days preceding or following the medical examination.
* Risser between 0 and 2.

Exclusion Criteria:

For both parts:

* Patients with more than 2 scoliotic curves
* Patients with secondary scoliosis
* Patients suffering from learning disabilities or clinical conditions impairing neuromotor control
* Patients lacking the necessary measures to evaluate the outcome.

Part 2 only (ultrasound)

● Patients undergoing brace treatment
Registry Study on Epidemiological and Biological Disease Profile as Well as Clinical Outcome in Patients With Low Grade Gliomas

The LoG-Glio-Registry is based on a network of german hospitals gathering radiological, clinical, epidemiological and molecular data on all patients diagnosed with a low grade glioma.


Eligibility Criteria:
Inclusion Criteria:

* Patients with radiological suspected diagnosis of a low grade glioma
* Age ≥ 18 years. There is no upper age limit.

Exclusion Criteria:

* Severe neurological or psychiatric disorder interfering with ability to give an informed consent
* No consent for registration, storage and processing of the individual disease characteristics and course as well as information of the family physician about study participation
* No consent for bio-banking of patient's biological specimens and performance of analyses on stored material.
Romiplostim N01 for Platelet Recovery in Adult Hematologic Malignancies Patients Undergoing UCBT

To evaluate the efficacy and safety of Romiplostim N01 for platelet recovery after umbilical cord blood transplantation (UCBT) in patients with hematological malignancies.

Allogeneic hematopoietic stem cell transplantation (Allo-HSCT) is an important means of curing a wide range of hematologic diseases, and good hematopoietic and immune reconstitution after transplantation is one of the most important factors determining the success of the transplantation.Persistent thrombocytopenia after Allo-HSCT is one of the common post-transplantation complications.This is an investigator-initiated, single-center, single-arm, Phase II clinical trial to evaluate the efficacy and safety of Romiplostim N01 for platelet recovery after UCBT in patients with hematologic tumors. The study was conducted in patients ≥18 years of age with a diagnosis of hematological neoplasia who underwent UCBT. Subjects will be screened and receive roprostin N01 from +1 to +28 days after UCBT after signing an informed consent form, and the study will focus on the cumulative PLT implantation rate at 28 days after transplantation as the primary efficacy measure. The study is planned to enroll 34 patients.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥12 years old, male or female;
* Patients diagnosed with hematological malignancies and undergoing UCBT;
* ECOG score ≤2;
* Voluntary participation in this clinical trial, patients fully understand the trial content and sign the informed consent

Exclusion Criteria:

* Pregnant or lactating women；
* Known allergy to Romiplostim N01;
* A history of severe thrombotic events or known risk factors for thrombosis or active thromboembolism requiring anticoagulation;
* A history of platelet dysfunction or bleeding prone disease or severe bleeding (requiring more than 2 units of red blood cell infusion or a hematocrit drop of ≥10%) within 7 days prior to screening;
* Chronic active hepatitis B and C;
* Repeat or multiple transplantation or multiple organ transplantation;
* HIV positive, EBV-DNA positive, CMV-DNA positive;
* Have severe infection or complicated with serious heart, liver, lung, kidney, neurological or metabolic diseases;
* A serious adverse event (Level 4 or 5) as defined by the Standard General Terminology for Adverse Events Version 4.0 occurred during the pre-treatment period;
* Participants participate in another clinical study with any exploratory drug or device within 30 days prior to baseline visit; Observational studies are allowed;
* Subjects with cognitive impairment or uncontrolled mental illness;
* Subjects and/or authorized family members to refuse treatment with Romiplostim N01;
* Those who are judged by the researchers as not suitable for inclusion (such as accompanying medical history, which may affect the safety of the subjects or it is estimated that the treatment cannot be adhered to due to financial problems).
Conbercept Injection in Treatment of Severe Proliferative Diabetic Retinopathy

To evaluate efficacy of different intravitreal Conbercept injection therapy in the treatment of severe proliferative diabetic retinopathy.

To assess the clinical effects of preoperative, intraoperative or preoperative combined with intraoperative intravitreal conbercept (IVC) injection in pars plana vitrectomy (PPV) with silicone oil tamponade for severe proliferative diabetic retinopathy (PDR). Methods. These patients were randomly assigned to three groups: Group 1 received an IVC injection 3 to 5 days before surgery; Group 2 received an IVC injection at the end of surgery; and Group 3 received an IVC injection 3 to 5 days before PPV as well as an IVC injection at the end of PPV. Follow-up examinations were performed for at least six months after surgery.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects of either sex aged ≥ 18 years.
2. Diagnosis of diabetes mellitus (type 1 or type 2);
3. Active proliferative diabetic retinopathy was clinically evident;
4. Study eyes required a vitrectomy and silicone oil tamponade due to vitreous hemorrhage with significant fibrous proliferation, tractional retinal detachment in the posterior pole or complicated retinal detachment, which can be detected by B-scan ultrasonography.
5. Ability to give informed consent.

Exclusion Criteria:

1. Coexistent ocular disease that may interfere with visual outcome;
2. Prior vitreoretinal surgery or anti-vascular endothelial growth factor (VEGF) pharmacotherapy in either eye;
3. A macula-involving retinal detachment for \>6 months in the study eye;
4. Iris or angle neovascularization and neovascular glaucoma;
5. known allergy to any components of conbercept formulation
6. severe external ocular infection;
7. pregnancy or current oral contraceptive intake;
8. usage of anticoagulant or antiplatelet therapy;
9. preoperative or postoperative poor diabetes control \[serum hemoglobin A1c (HbA1c) \>11.0%\];
10. uncontrolled systemic diseases, such as hypertension, cardiac diseases or presenting abnormal coagulation-associated blood diseases;
11. \<6 months of follow-up post initial surgery.
Intraoperative Music Therapy in Gynecological Oncology

Background Perioperative anxiety and postoperative pain can impact surgical morbidity. We aimed to evaluate the effect of intraoperative music therapy in the reduction of immediate postoperative pain in patients undergoing gynecological oncology surgery within an Enhanced Recovery After Surgery (ERAS) protocol. Secondary objectives include reduction in preoperative anxiety, postoperative pain overtime, neurohormonal response, morbidity, length of hospital stay (LOS) and patient satisfaction.

Methods Prospective, randomized, double-blinded single-center study including patients undergoing surgery for ovarian, endometrial or cervical cancer over a period of 12 months. Patients were randomly assigned to receiving intraoperative music therapy (Group A) or undergoing standard management (Group B). A reduction in immediate postoperative pain was defined as a reduction in ≥2 points in the Verbal Rating Scale(VRS) at 4h postoperatively. Hemodynamic variables and blood samples were collected during the procedure for determination of cortisol levels. A scale of closed numeric questions (Likert-like) was used to assess patient satisfaction.


Eligibility Criteria:
Inclusion Criteria:

* All patients undergoing gynecological oncology surgery for ovarian, endometrial or cervical cancer by laparotomy, laparoscopy or robotic surgery.
* ASA grade I-III
* Signed an informed consent prior to inclusion

Exclusion Criteria:

* ASA IV
* Active ischemic cardiopathy
* Hearing impairment
* Hormonal disfunction
* Active treatment with steroids
* Ppsychiatric disorder
* Contraindication for epidural anesthesia or failure of the technique in the peri-operative period.
A Study of JNJ-63733657 in Participants With Early Alzheimer's Disease

The primary purpose of this study is to evaluate the effect of JNJ-63733657 versus placebo on clinical decline as measured by the Integrated Alzheimer's Disease Rating Scale (iADRS), a composite of cognition and function.


Eligibility Criteria:
Inclusion Criteria:

* Early Alzheimer's disease (AD): Gradual and progressive subjective decline in the participant's cognition over at least the past 6 months, as reported by the participant and informant (study partner) and Clinical Dementia Rating-Global Score (CDR-GS) of 0.5 and memory box score greater than or equal to (\>=) 0.5 at screening
* Participants must have positive tau PET results
* Able to read and write and with a minimum 5 years of formal education as reported by participant and study partner at screening
* Have a designated study partner who has adequate literacy to participate and be judged to have high likelihood of completing the study with the participant
* Male participants must agree not to donate sperm for the purpose of reproduction during the study and up to 16 weeks after receiving the last dose of study intervention

Exclusion Criteria:

* Participants with CDR GS \>=2 at predose baseline Clinical Dementia Rating (CDR) administration
* Participants who fulfill diagnostic criteria for Mild Cognitive Impairment (MCI) or dementia/mild or major neurocognitive disorder suspected to be due to any etiology other than AD (example, Parkinson's disease, cerebrovascular disease, normal pressure hydrocephalus, head injury, drug or alcohol abuse/dependence, anoxic brain injury, (Et cetera\[etc\])
* Geriatric Depression Scale (GDS) 30 score greater than (\>) 12
* Hachinski Ischemic Scale (HIS) \>4
* Has received medications that affect the central nervous system (CNS), except treatments for AD, for less than 2 months; that is, doses of chronic medications that effect the CNS should be stable for at least 2 months before the start of screening. If a participant has recently stopped a chronic medication that effects the CNS, he or she must have discontinued treatment at least 2 months before the start of screening. Chronic use of benzodiazepines is not permitted
Evaluation of Cognitive Function in a Suicidal Crisis

The aftermath of suicide is devastating, being the cause of 800 000 deaths every year worldwide. In France, suicide still causes about 10 000 deaths per year and the number of suicide attempts (SA) is estimated between 170 000 and 200 000 per year (InVS).

It is often thought that a suicidal crisis is only related to depression, as it actually is a far more complex phenomenon. A suicidal crisis can occur on various grounds like psychiatric disorders but also contextual events or somatic diseases and it has been hypothesized that suicidal ideas or inclinations could have a common and independent cognitive origin


Eligibility Criteria:
Inclusion Criteria:

* Normal or corrected vision
* Having understood the information not and having signed the form of consent
* Being hospitalized for suicidal ideas (Score with inclusion at the level of Beck \> 3) or after a suicide attempt of less than one week.

Exclusion criteria:

* Pregnant woman and/or nursing
* Diagnosed irrational pathology
* Known proven intellectual deficiency
* Patient whose physical or mental status does not allow to pass the tests of the study
* Being under supervision or trusteeship or private of freedom or in emergency
A Randomised, Blinded Study on Laparoscopic Mesh Reinforcement for Chronic Groin Pain

Chronic groin pain is a frequent cause for referral to general surgeons. In some cases this pain may be due to the presence of a hernia. However, if on clinical examination there is no palpable lump or bulge, the cause of the pain may be difficult to elucidate. Some of these patients may have the diagnosis of sportsman's groin. Other names which have been attached to this condition include Gilmores groin and sportsmans hernia. These conditions are more commonly associated with sportsmen and women but those who do not play sport may also receive this diagnosis. Sportsman's groin is thought to be a syndrome of weakness of the posterior inguinal wall without a clinically recognisable hernia. Differing explanations for sportsman's groin include avulsion of the conjoint tendon from the pubic tubercle, weakening of the transversalis fascia, tears in the internal or external oblique, superficial inguinal ring dilatation and abnormalities of the rectus abdominus insertion.

There is some evidence that pre peritoneal mesh placement in these patients may be beneficial. The theory being that the mesh prevents pressure transmission to the damages structures, allowing them to heal more rapidly.

Aim. To assess the potential benefit of pre peritoneal mesh placement using the TAPP technique in patients with chronic groin pain.


Eligibility Criteria:
Inclusion Criteria:

* Groin pain (unilateral or bilateral) for at least 4 months. In this way, patients with temporary symptoms will be excluded from undergoing unnecessary surgery.
* Tenderness over pubic tubercle or superficial inguinal ring.

Exclusion Criteria:

* Aged less than 18 years Aged more than 50 years - due to increased incidence of sacro-iliac and hip pathology.
* Bulge, lump or cough impulse consistent with inguinal or femoral hernia on clinical examination.
* Patients unwilling or unable to provide informed consent. Medically unfit for general anaesthetic
* Pregnant women
* Diabetes - due to diabetic neuropathy
* Steroid use
* QST suggestive of nerve entrapment.
Conventional MRI Versus MR Arthrography in Evaluation of Ankle Impingement Syndromes and Intra Articular Pathologies.

Chronic ankle pain is a common clinical problem with a wide differential diagnosis. Soft-tissue and osseous impingement syndromes are now increasingly recognized as a significant cause of chronic ankle pain. Ankle impingement syndromes are defined as pathologic conditions resulting in chronic, painful restriction to movement at the tibiotalar articulation secondary to soft-tissue or osseous abnormalities. Ankle impingement is classified according to its anatomic relationship to the tibiotalar joint as anterolateral, anterior, anteromedial, posteromedial, or posterior impingement.

The anterolateral impingement syndrome is caused by obstruction of the so-called anterolateral gutter (ALG) or recess secondary to an inversion injury resulting in disruption of the syndesmotic and/or lateral collateral ligaments and capsule.

In anterior impingement,Arthroscopic evaluations suggest direct microtrauma to the talus and tibia as the aetiology. The natural course of this microtraumas to form osseous spurs.

In anteromedial impingement,The mechanism is not well understood but is likely a rare complication of a supination (inversion) injury rather than a pronation (eversion) injury as initially hypothesized.During the acute injury, there is damage to the anterior tibiotalar ligament, which subsequently thickens. In addition toligament thickening, osteophytes, synovitis and fractures have been described as other possible causative factors.

In posteromedial impingement, the common precipitating injury for posteromedial ankle impingement is a plantar flexion, inversion and internal rotation trauma. This can lead to damage to the PTTL and associated synovitis.

The majority of the posterior impingement syndromes are related to the posterior talus.The secondary ossification centre of the posterolateral talus forms around 8-13 years of age and then subsequently fuses within 1 year of that. Occasionally (approximately 7%), there may be non-fusion with a resultant ostrigonum.

Conventional MR imaging can accurately detect and localize osteophytes and associated lesions. In addition, MR imaging provides an easy evaluation of any articular cartilage changes, ligamentous injury, and occult bony contusions.

Direct magnetic resonance (MR) arthrography extends the capabilities of conventional MR imaging and utilizes the natural advantages gained from joint effusion. Contrast solution distends the joint capsule, outlines intra articular structures,and leaks into abnormalities.It can detect cartilage damage, intra articular loose bodies and osteochondral talar lesions.

Eligibility Criteria:
Inclusion Criteria:

* patients in different age groups and both sex referred from orthopedic outpatient clinic with chronic ankle pain and suspected clinically to have impingement syndrome.

Exclusion Criteria:

1. Inflammatory arthritis of ankle joint, infection in ankle joint, neoplasm around ankle joint.
2. Patients with contraindications for MRI, e.g. an implanted magnetic device, pacemakers or claustrophobia.
A Post-Marketing Study of the Immunogenicity of Somatropin (Ribosomal Deoxyribo Nucleic Acid [rDNA] Origin) Injection (Nutropin AQ®) in Children With Growth Hormone Deficiency

This is a Phase IV, multicenter, open-label, single-arm study of somatropin (rDNA origin) (Nutropin AQ v1.1) in pre-pubertal children with growth hormone deficiency (GHD) naïve to prior recombinant human growth hormone (rhGH) treatment. The study is designed to characterize the immunogenicity profile of somatropin (rDNA origin) injection when administered daily subcutaneously for 12 months. The clinical impact of immunogenicity will also be assessed.


Eligibility Criteria:
Inclusion Criteria:

* Bone age less than equal to (\</=) 9 years (females) or \</= 11 years (males) as determined by X-ray of the left hand and wrist using Greulich and Pyle method and obtained within the 12 months prior to enrollment
* Prepubertal (Tanner I) males and females by physical examination
* Diagnosis of GHD (stimulated GH less than \[\<\] 10 nanograms per milliliter \[ng/mL\]) by two standard pharmacologic tests obtained up to 12 months prior to informed consent/assent
* Normal thyroid function test within the 12 months prior to informed consent/assent
* Normal complete blood counts within 12 months prior to informed consent/assent
* Documentation of prior height and weight measurements, with height standard deviation score (SDS) \</= 5th percentile for idiopathic isolated GHD participants

Exclusion Criteria:

* Any previous rhGH treatment
* Short stature etiologies other than GHD
* Acute critical illness or uncontrolled chronic illness, which in the opinion of the investigator and medical monitor, would interfere with participation in this study, interpretation of the data, or pose a risk to participant safety
* Chronic illnesses such as inflammatory bowel disease, celiac disease, heart disease, and diabetes
* Bone diseases such as achondroplasia or hypochondroplasia, intracranial tumor, irradiation, and traumatic brain injury
* Participants receiving oral or inhaled chronic corticosteroid therapy (greater than \[\>\] 3 months) for other medical conditions other than central adrenal insufficiency
* Participants who require higher (2 times or greater than maintenance) doses of corticosteroids for more than 5 days in the 6 months prior to enrollment in the study
* Participants with active malignancy or any other condition that the investigator believes would pose a significant hazard to the participant if rhGH were initiated
* Females with Turner syndrome regardless of their GH status
* Prader-Willi syndrome regardless of GH status
* Born small for gestational age regardless of GH status
* Presence of scoliosis requiring monitoring
* Previous participation in another clinical trial or investigation of GH, treatment for growth failure, or treatment with a biologic agent
* Participants with closed epiphyses
* Participants with a known hypersensitivity to somatropin, excipients, or diluent
Use of Fish Oil to Reduce Inflammation During Endovascular Abdominal Aortic Repair

The purpose of this study is to determine if high-dose PUFA supplementation in patients undergoing EVAR for infra-renal AAA reduces the peri-operative inflammation.

In this 2:1 double-blind, randomized, placebo controlled trial, subjects will be given an active drug of n-3 polyunsaturated fatty acids (PUFAs) or a placebo soybean oil for about two weeks prior to an endovascular abdominal aortic repair (EVAR) and subsequently six months after the procedure.

An EVAR is known to produce a systemic inflammatory response with an increased risk of prolonged hospitalization and complicated post-operative recovery with cardiac events, renal and pulmonary dysfunction, and multiple organ failure. The study proposed here has the potential to provide valuable insight on the role of nutritional intervention to improve outcomes related to surgical revascularization.

Eligibility Criteria:
Inclusion Criteria:

* Undergoing EVAR for infra-renal AAA and/or iliac artery aneurysm

Exclusion Criteria:

* Age \< 40 or \> 90 years
* On dual antiplatelet therapy or anticoagulation
* Evidence of active infection
* Diagnosed hypercoagulable state
* Non-atherosclerotic/aneurysmal disease as indication for procedure
* Chronic liver disease or myopathy
* End-stage renal disease (CKD 5)
* Poorly controlled diabetes (HbA1C \> 8%)
* Recent other major surgery or illness within 6 weeks
* Use of immunosuppressive medication or extant chronic inflammatory disorders
* History of organ transplantation
* Pregnancy or plans to become pregnant
* Condition in which patient life expectancy is less than one year
* Known allergy to fish or fish products
* Presence of symptomatic or ruptured AAA