cyrilzakka/clinical-trials huggingface dataset:
Long-term Outcomes After Different Management Strategies for High-level Cerebral Arteriovenous Malformation

Arteriovenous malformations (AVMs) are complex and rare cerebral vascular dysplasia. The main purpose of treatment is to avoid the neurological impairment caused by hemorrhagic stroke. The Spetzler-Martin (SM) grading system is widely used to estimate the risk of postoperative complication based on maximum AVM nidus diameter, pattern of venous drainage, and eloquence of location. Generally, grade I and II are amenable to surgical resection alone. Grade III is typically treated via a multimodal approach, including microsurgical resection, embolization, and radiosurgery (SRS). Grade IV and V are generally observed unless ruptured. However, some previous studies indicated that despite the high rate of poor outcomes for high-level unruptured AVMs, the mortality for high-level unruptured AVMs are likely lower than untreated patients. With the development of new embolic materials and new intervention strategies, patients with high-level AVMs may have more opportunities to underwent more aggressive interventions. The OHAVM study aims to clarify the clinical outcomes for patients with SM grade IV and V AVMs after different management strategies.

Follow-up: In our neurosurgical center, follow-up was conducted for all patients at the first 3-6 months and annually after discharge by clinical visit and telephone interview.

Study overview: The population in the OHAVM study will be divided into two parts. Clinical and imaging data of high-level AVM patients from 2012/04 to 2019/09 were retrospectively collected. And the high-level AVM patients from 2019/09 to 2019/12 were prospectively collected. The intervention strategies in our institution for high-level AVMs are of four categories: microsurgical resection, embolization, embolization+radiosurgery, and single-stage hybrid surgery (embolization-resection). Each participants will be followed at least for 5 year since enrollment. Finally, we will clarify the clinical outcomes and prognostic predictors for patients with SM grade IV and V AVMs after different management strategies.

Sample size: About 1000 patients will be enrolled in this study, and half of them were unruptured. The population distribution of different management strategies is expected as follows: conservative:100 cases, microsurgical resection: 300 cases, embolization:250 cases, embolization+radiosurgery: 250 cases, single-stage hybrid surgery: 100 cases.

Study endpoints: The neurological function prognosis, occlusion rate and complications were evaluated at 2 weeks, 1 year, 3 years, 5 years after the treatment and the last follow-up, respectively.

Eligibility Criteria:
Inclusion Criteria:

1. The diagnosis of AVM was confirmed with digital subtraction angiography (DSA) and/or magnetic resonance imaging(MRI).
2. The SM grade was IV and V.

Exclusion Criteria:

1. Patients with multiple AVMs.
2. Patients with hereditary hemorrhagic telangiectasia (HHT).
3. Patients with missing clinical and imaging data.
RCT of QPS vs General Information Sheet

This trial studies how well information materials work in helping communication between physicians and participants with cancer that has spread to other places in the body and their caregivers. Approaches that encourage participants to actively participate and ask appropriate questions during their visit may be important to enhance their understanding of their illness and empower them to make important decisions regarding their medical care.

PRIMARY OBJECTIVES:

I. To compare patients' perception of helpfulness in communicating with their physicians between a question prompt sheet (QPS) and a general information sheet (GIS).

SECONDARY OBJECTIVES:

I. To compare caregivers' perception of helpfulness in communicating with their physicians between the QPS and the GIS.

II. To examine the level of patients' and caregivers' overall satisfaction with the consultation with the use of the QPS versus the GIS.

III. To examine physicians' views about the information material and overall satisfaction with the use of the QPS versus the GIS.

IV. To explore how the use of QPS affects the average speaking time of patient or physician during the consultation visit.

V. To establish demographic and clinical predictors of patients' perception of helpfulness of a QPS.

VI. To examine the overall patients' preference between the QPS and GIS in an open label phase.

VII. To compare the change in patient anxiety state with the use of the QPS versus the GIS.

VIII. To explore the factors underlying patients' preferences for the QPS or GIS.

OUTLINE: Participants are randomized into 1 of 2 groups.

GROUP I: Participants receive QPS and answer questions from physician. At follow up visit, participants receive both QPS and GIS.

GROUP II: Participants receive GIS and answer questions from physician. At follow up visit, participants receive both QPS and GIS.

Eligibility Criteria:
Inclusion Criteria:

* (Patient participation) First outpatient consultation visit with a palliative care specialist
* (Patient participation) Normal cognitive status, defined as a normal state of arousal and an absence of obvious clinical findings of confusion, memory deficits or concentration deficits, as determined by the patient's physician
* (Patient participation) Ability to read and communicate in English
* (Patient participation) Diagnosis of advanced cancer
* (Patient participation) Signed written informed consent form
* (Caregiver participation) accompanied the patient to the clinic visit
* (Caregiver participation) is identified by the patient as someone who is actively involved in their overall care
* (Caregiver participation) is able to read and communicate in English
* (Caregiver participation) is willing to participate in the study and able to complete the questionnaires
* (Physician participation) a palliative medicine specialist
* (Physician participation) seeing the patient in consultation on the day of the study
* (Physician participation) willing to participate in the study

Exclusion Criteria:

* Refusal to participate in the study
Postoperative Cognitive Dysfunction: Correlations With Olfactory Dysfunction and Related Gene Changes

To study on the Postoperative Cognitive Dysfunction: Correlations With Olfactory Dysfunction and Related Gene Changes.To explore whether the olfactory dysfunction could be used as a predictor of POCD and to provide reference for POCD prevention, early detection and timely diagnosis and treatment.


Eligibility Criteria:
Inclusion criteria:

* Between 60 to 85 years old;
* Undergoing non-cardiac and non-neurological surgery under general anesthesia;
* Expected hospital stay ≥5 days;
* American Society of Anesthesiologists class I or II.

Exclusion criteria:

* Mental or neurodegenerative diseases;
* History of severe trauma or surgery within one year;
* History of nasal or sinus illness or surgery;
* Cold or influenza within 3 weeks;
* Significant history of organ dysfunction;
* Previous neuropsychological testing;
* Difficulty to perform tests (including severe visual or auditory disorders);
* Mini-Mental State Examination (MMSE) \<24 points, \<20 points if the participant only attended elementary school, or \<17 points if the participant did not go to school.
Effect of Short Term Adrenal Suppression on Androgen Overproduction in Overweight Girls With Androgen Excess

Short term hydrocortisone to test whether improves excess androgen production from adrenal gland and ovaries

This study will test whether short-term suppression of adrenal function can ameliorate androgen (male hormone) overproduction in overweight girls with androgen excess. The investigators hypothesize that one month of oral hydrocortisone administration will improve androgen levels in girls with adrenal androgen overproduction. Specifically, this intervention will improve androgen levels after adrenal stimulation testing with adrenocorticotropin hormone (ACTH).

Eligibility Criteria:
Inclusion Criteria:

* Overweight(\>85th BMI%) females
* Early to late puberty (expected age range 7-18)
* Hyperandrogenemic (free testosterone greater than 2.5 standard deviations above the mean for normal control subjects of the same Tanner Stage)
* Screening labs within age-appropriate normal range, with the exception of a mildly low hematocrit (see below) and the hormonal abnormalities inherent in obesity which could include mildly elevated luteinizing hormone (LH), lipids, testosterone, prolactin, DHEAS, E2, glucose, and insulin; and decreased follicle-stimulating hormone (FSH) and/or sex hormone-binding globulin (SHBG)

Exclusion Criteria:

* Screening labs outside of age-appropriate normal range
* Hemoglobin \<12 mg/dL and hematocrit\<36% (Subjects will be offered the opportunity to take iron supplementation for 60 days if their hematocrit is slightly low (33-36%) (suggestive of iron deficiency anemia) and will then return for retesting of their hemoglobin/hematocrit. If still \<36%, they will be excluded.)
* Morning Cortisol \<5 g/dL
* 17-hydroxyprogesterone \>295 ng/dL
* History of Cushing's syndrome or adrenal insufficiency
* Pregnant
Study of Milnacipran for the Treatment of Fibromyalgia

Antidepressants of all varieties represent a common form of therapy for many chronic states including fibromyalgia. The majority of antidepressants increase the levels of serotonin or norepinephrine in the central nervous system. Milnacipran is a dual norepinephrine and serotonin reuptake inhibitor and may be effective in the treatment of fibromyalgia.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of fibromyalgia defined by 1990 American College of Rheumatology (ACR) Criteria

Exclusion Criteria:

* Psychiatric illness
* Depression
* Suicidal risk
* Substance abuse
* Pulmonary dysfunction
* Renal impairment
* Active cardiac disease
* Liver disease
* Autoimmune disease
* Cancer
* Sleep apnea
* Inflammatory bowel disease
Trauma as a Trigger for Autoimmunity

To analyse the immunological reaction to Trauma (pertrochanteric femoral fracture with consequent osteosynthesis) in the first weeks up to one year postoperatively with focus on the development of autoimmunity.

This project represents a unique study of the influence of trauma on the immune system. It addresses the question whether an excess of apoptotic/necrotic cells can induce an at least transient autoimmune phenomena in humans. If the hypothesis of a transient induction of autoimmunity by trauma proves to be correct, this study will provide a novel insight into the pathogenesis of autoimmune diseases.

Eligibility Criteria:
Inclusion Criteria:

* pertrochanteric femoral fracture (≤7 days)
* planned gamma nail osteosynthesis
* ability to give written informed consent

Exclusion Criteria:

* Severe hepatic and renal failure
* current active oncological disease
* current immunosuppressive or biological therapy
* known systemic autoimmune disease
* foreseeable lack of complete follow-up (e.g. due to generally poor health)
* cognitive impairment (delirium, dementia, alteration of consciousness)
* insufficient knowledge of project language
* pregnancy
TAB08 in Patients With Psoriasis Vulgaris, Not Adequately Controlled With Current Treatment

Study to assess Pharmacodynamics, Safety, Pharmacokinetics and clinical effects of TAB08 during 12 weeks of treatment in patients with Psoriasis Vulgaris, not adequately controlled with current therapy.

1. To assess dynamics of the T-lymphocytes subpopulations in patients peripheral blood during 12 weeks of TAB08 treatment.
2. To assess dynamics of selected cytokines levels in patients peripheral blood during 12 weeks of TAB08 treatment.
3. To assess TAB08 concentrations in patients blood during 12 weeks of TAB08 treatment.
4. To assess frequency, seriousness and severity of adverse events during 12 weeks of TAB08 treatment.
5. To assess changes in PASI, IGA and DLQI during 12 weeks of TAB08 treatment and subsequent 4 weeks follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of Vulgar Psoriasis
* Area of Psoriasis skin damage ≥ 10%
* PASI Score ≥ 12
* Score on IGA scale ≥ 3

Exclusion Criteria:

* Other forms of psoriasis in addition to vulgar
* Prohibited treatment
* Pregnant or nursing women
* Concomitant systemic therapy dosage modification (if any) within 4 weeks before randomization
Ifosfamide, Doxorubicin and Hypofractionated Radiotherapy in Neoadjuvant Sarcoma Treatment

Prospective phase II study. Patients will be submitted to neoadjuvant chemotherapy (cT) and hypo fractionated radiotherapy (hRT) following by surgery. The remain viable cells will be analyzed and the patients whithin less than 30% will receive more 3 cycles of cT. All patients have deep high grade soft tissue sarcoma of extremity.

Prospective phase II non controlled study. Staging: All patients will be submitted to a local Magnetic Resonance (MR), Chest Tomography (CT) and Positron emission tomography-computed tomography (PET CT) previous to treatment. After the first cT cycle a new PET CT will be provided and one more at the end of the neoadjuvant treatment. Chemotherapy: cT neoadjuvant: Doxorubicin 75mg/m2 (cycles 1,2 and 3), and ifosfamide 9 g/m2 (cycles 1 and 3). Radiotherapy: RT 25 Gy / 5 x 500 cGy/day, beginning at Cycle 2/Day1. The surgery will be performed after 4-6 weeks from cycle 3. The remain of viable cells in surgical specimen will be analyzed and whether the the percentage value is less than 30% the patient will receive more 3 cycles of cT. A boost of RT is indicated if margins are considered R1 (microscopic positive margin).

Eligibility Criteria:
Inclusion Criteria:

* Patients between 18-75 years old, with non metastatic deeply high grade soft tissue sarcoma of extremities. KPS \> 70% (Karnofsky Performance Status Score)

Exclusion Criteria:

* Patients with rhabdomyosarcoma, neuroendocrine tumor (Pnet) and chondrosarcomas, or who have had received radiotherapy (RT) or chemotherapy (cT) previous, or recurrent tumors.
A U.S Post Approval Study Evaluating the SYNERGY XLV (MEGATRON) Stent System

This is a post-market, standard of care, real-world observational study to assess the clinical outcomes of the SYNERGY XLV (MEGATRON) Coronary Stent System for the treatment of subjects with atherosclerotic lesion(s) ≤ 28 mm in length (by visual estimate) in native coronary arteries ≥3.50 mm to ≤5.00 mm in diameter (by visual estimate). This Post Approval study is a cohort associated with the Evolve 4.5/5.0 (SYNERGY LV) Post Approval Study, which is registered under ClinicalTrials.gov ID: NCT03875651.


Eligibility Criteria:
Inclusion Criteria:

* Patient requires treatment with a SYNERGY XLV (Megatron) stent

Exclusion Criteria:

* Planned treatment with a non-SYNERGY stent
Study of SGN-15, Antibody-Drug Conjugate, to Treat Hormone Refractory Prostate Cancer

SGN-15 is being investigated for therapy of patients with prostate cancer in combination with the cytotoxic agent, Taxotere. The study is an open label, randomized phase II study for patients with documented hormone refractory prostate cancer who have not had any prior therapy with Taxotere or Novantrone. Both SGN-15 and Taxotere will be administered weekly over two 6 week courses separated by a 2 week rest period.

The purpose of this study is to evaluate a new class of biologic agent, the monoclonal antibody (mAb) drug conjugate SGN-15 (cBR96 - Doxorubicin immunoconjugate), used in combination with the taxane agent, TAXOTERE (docetaxel) as a strategy for targeting advanced stage, hormone refractory prostate carcinoma (HRPC). This is a randomized, open label, phase II study evaluating the immunoconjugate SGN-15 in combination with the taxane TAXOTERE in comparison to TAXOTERE alone in patients with HRPC. Based on a previous phase I study of the SGN-15/TAXOTERE combination, the weekly dose of SGN-15 will be 200 mg/m2 and the weekly dose of TAXOTERE will be 35 mg/m2. The schedule of administration for both agents will be weekly, with SGN-15 administered prior to the TAXOTERE in the patients treated with the combination. A single course of therapy will be defined as 6 weekly doses followed by a 2 week rest period for a total of 8 weeks. The study will perform an interim analysis of the data after 80 patients have completed two courses. Patients should be treated for a minimum of 2 courses of therapy. Additionally, for patients who remain eligible and have experienced tolerable levels of drug toxicity, repeat dosing with subsequent cycles is possible. Patients will be removed from study if there is evidence of tumor progression or intolerable toxicity. Follow-up assessments include adverse event reporting, clinical laboratory studies, and quality of life (QOL) assessment using a validated QOL instrument.

Eligibility Criteria:
BRIEF:

Patients must have pathologically confirmed prostate cancer, which is refractory to hormone therapy. There must be evidence of advancing disease, determined by increasing bidimensional or unidimensional measurable tumor or an increasing PSA with documented metastatic disease.

Patients must have Lewis(Y) antigen expression documented by immunohistochemistry on archived or fresh tumor specimen.
Lab School Day Study for CONCERTA of Older Children With ADHD

The purpose of this trial is to determine if the study medication, CONCERTA (methylphenidate HCl), is safe and effective in improving academic performance and behavior in children with attention deficit hyperactivity disorder (ADHD), when compared to placebo.

The hypothesis is that CONCERTA (methylphenidate HCl) is safe and effective in improving academic performance and behavior in children with ADHD, when compared to placebo as demonstrated using specified study measures. This is a double-blind (neither participant nor investigator knows the name of the assigned study drug), randomized (study drug assigned by chance), placebo-controlled, crossover study evaluating the academic, behavioral, and cognitive effects of CONCERTA (methylphenidate HCl) on older children with ADHD. This means that all eligible children will receive treatment with methylphenidate HCl throughout the study (the titration and assessment periods) and inactive pill (placebo) on one of the two laboratory classroom days. On the other laboratory classroom day they will receive their regular dose of methylphenidate HCl. The primary efficacy variable in this study is the Permanent Product Math Test (PERMP) attempted score. Secondary Measures include: SKAMP (Swanson, Kotkin, Agler, M-Flynn, and Pelham), tests of inattention, reading fluency and comprehension, and memory. Assessments will be completed during each of the laboratory assessment days (12.5 hours). Participants will be assessed for adverse events throughout the study. Patients will initiate treatment with oral CONCERTA (methylphenidate HCl) 18 mg at baseline and continue morning dosing with increases every 3 to 7 days until an optimal dose is achieved, up to the maximum of 54 mg/day. Eligible patients will remain in the study for a maximum of 8 weeks.

Eligibility Criteria:
Inclusion Criteria:

* ADHD diagnosis of all subtypes (except Not Otherwise Specified)
* Patients with total or subscale Attention Deficit Hyperactivity Disorder Rating Scale (ADHD RS-IV) scores \> =90th percentile relative to the general population of children by age and gender
* Patients currently receiving ADHD medication must be inadequately managed on their current stimulant dose and meet this criteria at the screening visit
* Ability to read and understand English
* Ability to attend school regularly.

Exclusion Criteria:

* Estimated Full Scale IQ score of 80 or below
* Severe Learning Disability
* History of, or current, primary diagnosis of: severe anxiety disorder, conduct disorder, psychotic disorders, pervasive developmental disorder, eating disorder, obsessive-compulsive disorder, sleep disorder, major depressive disorder, bipolar disorder, substance use disorder, chronic tic disorder, personal or family history of Tourette's syndrome
* Weight \< 3rd percentile for age
* History of hospitalization for treatment of a mood, anxiety, or psychotic disorder
* History of failed response to methylphenidate.
Brain Structural and Functional Connectivity Changes in the Period of Dysmenorrhea: a Prospective fMRI Study

Observational prospective study with an analysis of the changes in brain structure and related functional connectivity in women with dysmenorrhea.

Dysmenorrhea is a common gynecological disease and chronic pain disorder.Understanding the neural mechanisms of dysmenorrhea and the brain changes affecting pain factors is important for finding dysmenorrhea treatment methods. The emergence and progress of non-invasive neuroimaging technology can help us better understand pain at the neural level. Recent developments in identifying brain-based biomarkers of pain through advances in advanced imaging can provide some foundations for predicting and detecting pain. Twenty patients with dysmenorrhea and twenty matched female healthy controls were recruited from our hospital. All participants underwent the head magnetic resonance imaging scans to calculate grey matter volume and Diffusion Tensor Imaging parameters. Questionnaire assessment was also conducted.

Eligibility Criteria:
Inclusion Criteria:

* Right-handedness, as confirmed by the Edinburgh Handedness Inventory
* A regular menstrual cycle of approximately 21 to 35 days
* A history of menstrual pain longer than 6 months
* Not taking any medication or using other methods to treat dysmenorrhea in the past month
* Score of \>= 40mm on the VAS (visual analogue scale) in recent three menstrual cycles

Exclusion Criteria:

* Any psychiatric or neurological disorders, particularly premenstrual dysphoric disorder
* Using oral contraceptives, hormonal supplements, or any central-acting medication (eg, opioid, antiepileptics) within 6 months before the study
* Having a metal or pacemaker implant, claustrophobia, or any contraindications to MR
* Head injury with loss of consciousness