cyrilzakka/clinical-trials huggingface dataset:
Embolization for Meningioma

The natural course for meningioma suggests that a majority will grow over time. Treatment is usually indicated in growing or symptomatic meningiomas. Surgery is usually primary treatment, but there is a significant risk of adverse effects. Stereotactic radiotherapy is most often reserved to treat relapses after surgery, and except for surgery and radiotherapy there are no other established treatment methods. Endovascular embolization may be used in selected cases as a preoperative adjunct to reduce intraoperative bleeding. There is a need for more treatment options in patients with meningioma, both in uncomplicated, asymptomatic cases and in more complex cases. The aim of this study is to assess radiological and clinical results of therapeutic endovascular embolization for meningioma


Eligibility Criteria:
Inclusion Criteria:

* Radiological diagnose of typical intracranial meningioma (homogenous contrast enhancement or dural attachment)
* Indication for treatment due to growth, symptoms or both
* Tumor location suggestive of vascular supply via middle meningeal artery branches
* Age 18 years or older
* Karnofsky performance status of 90 or better (able to carry on normal activity and work)

Exclusion Criteria:

* Informed consent not possible (e.g. language barriers, aphasia, cognitive impaired)
* Previously treated for meningioma
* Intraosseous growth
* Tumor related brain edema
* Neurofibromatosis type 2
* Systemic cancer
* Epilepsy
* Progressive neurodegenerative disorder (eg. MS, Parkinsons disease)
* History of psychiatric disorder
* Unfit for participation for any other reason judged by the physician including patients
* Contraindications to MRI
* Allergic to contrast agents
* Relative contraindications to endovascular treatment judged from CT angiography (tortoise carotid arteries, carotid stenosis, calcified aortic arch, anatomical vascular variants/anomalies suggesting increased risk with endovascular treatment)
* DSA (Digital subtraction angiography) from carotid artery suggesting that significant vascular supply is from other vessels than the MMA.
An Open-Label, MultiCenter Evaluation of the Use of Topically Administered FP1198 in Subjects With Pain Associated With Cyclic Mastalgia

The purpose of this study is to determine the safety of topical FP1198 for the treatment of moderate to severe cyclic breast pain (cyclic mastalgia) and to examine the clinical activity of FP1198.


Eligibility Criteria:
Inclusion Criteria:

* menstruating females at least 18 years of age
* BMI less than 30
* moderate to severe breast pain associated with the menstrual cycle
* in good general health

Exclusion Criteria:

* pregnant within the last 6 months
* has taken in the last 3 months or currently taking hormonal contraception
* history of malignancy or currently being treated for cancer of the breast or genital organs
* has had breast implants or breast reduction surgery
Laser - a New Possibility in Fertility Treatment - a Pilot Study

In this study the investigators want to investigate if the pregnancy rate in conjunction with fertility treatment increases with concomitant use of laser therapy.

Furthermore the investigators want to examine the participants general mental and physical wellbeing during the experimental period using a VAS-scale.

Eligibility Criteria:
Inclusion Criteria:

1. BMI : 18-32
2. long agonist/short antagonist IVF/intracytoplasmatic sperm injection (ICSI)treatment
3. 1-2 IVF/ICSI treatments without obtaining pregnancy.
4. signed consent

Exclusion Criteria:

1. uterine malformations
2. Uterine fibroids/polyps
3. need of an interpreter.
4. D.M, epilepsy, liver-kidney-heart disease
5. endometrial biopsy
6. cancer former cancer disease
7. acupuncture
8. metal in the body
9. suspicious naevi and tatoo´s
Early RA Vascular Randomised Controlled Study

To investigate the effect of two tight-control treatment strategies, aiming at 1) 2011 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) definition of remission compare with 2) minimal disease activity (Disease Activity Index in 28 joints \[DAS28\] \<2.6), on arterial stiffness in early rheumatoid arthritis (RA) patients.

To compare the effect of two treatments on arterial stiffness in Early Rheumatoid Arthritis

One hundred RA patients with active disease (DAS28 \>/=3.2), duration of symptoms less than 2 years, and are disease modifying anti-rheumatic drug naive will participate in this 5-year prospective, hospital-based, open-label, randomized, controlled trial.

All participants will receive 1-year tight-control treatment. One hundred patients will be randomly assigned to two arms. Treatment will be adjusted according to a standardized protocol every 3-monthly aiming at remission defined by the 2011 ACR/EULAR definition (Group 1, n=50, simplified disease activity score \[SDAI\] ≤3.3) or minimal disease activity (Group 2, n=50, DAS28\<2.6). A follow up visit will be conducted at the 5th year to evulate long term effect on vascular outcomes between the two groups.

Eligibility Criteria:
Inclusion Criteria:

* fulfilled the 2010 ACR/EULAR classification criteria for RA
* have symptoms onset of less than 2 years
* have active disease (DAS28\> 3.2)
* are positive for rheumatoid factor or anti-cyclic citrullinated protein antibodies

Exclusion Criteria:

* have a history of overt cardiovascular diseases
* are on aspirin, or HMG-CoA reductase inhibitors (statins) or angiotensin-converting-enzyme inhibitor (ACEI)
* have severe renal impairment defined as a glomerular filtration rate of less than 30 ml/min/1.73m2
* have been previously treated with tumor necrosis factor alpha (TNFa) inhibitors or other biological DMARDs
* on glucocorticoids at a dose \>10mg/day
Monotherapy of an NMDA Enhancer for Schizophrenia

Previous studies found that some NMDA-enhancing agent was able to augment antioxidant activity and its adjunctive therapy was better than placebo in reducing clinical symptoms and cognitive deficits and revealed favorable safety in patients with chronic schizophrenia. Of note, a substantial portion of schizophrenia patients refuse or cannot tolerate antipsychotics due to poor response or severe side effects. Therefore, this study aims to examine the efficacy and safety of an NMDA enhancer (NMDAE) as a monotherapy for the treatment of schizophrenia.

Several lines of evidence suggest that schizophrenia is associated with accelerated aging and oxidative stress may play a role. Cognitive deficits are core symptoms of accelerated aging in patients with schizophrenia and the most difficult domain to treat. Current antipsychotics have limited, if any, efficacy for cognitive function. Previous studies found that some NMDA-enhancing agent was able to augment antioxidant activity and its adjunctive therapy was better than placebo in reducing not only clinical symptoms but also cognitive deficits and revealed favorable safety in patients with chronic schizophrenia. Of note, a substantial portion of schizophrenia patients refuse or cannot tolerate antipsychotics due to poor response or severe side effects. This study aims to examine the efficacy and safety of NMDAE monotherapy for the treatment of schizophrenia. The investigators enroll patients with schizophrenia who refuse or are unable to tolerate antipsychotics due to poor response or adverse effects into a 6-week randomized, double-blind trial to receive monotherapy of NMDAE or placebo. The investigators biweekly measure clinical performances and side effects. Cognitive functions are assessed at baseline and at endpoint of treatment by a battery of tests. The efficacies of NMDAE and placebo will be compared.

Chi-square (or Fisher's exact test) will be used to compare differences of categorical variables and t-test (or Mann-Whitney test if the distribution is not normal) for continuous variables between treatment groups. Mean changes from baseline in repeated-measure assessments will be assessed using the generalized estimating equation (GEE). All p values for clinical measures will be based on two-tailed tests with a significance level of 0.05.

Eligibility Criteria:
Inclusion Criteria:

* Have a DSM-5 (American Psychiatric Association) diagnosis of schizophrenia
* Refuse or are unable to tolerate antipsychotics due to poor response or adverse effects
* PANSS total score ≥ 60
* Free of antipsychotic drugs for at least 1 week
* Agree to participate in the study and provide informed consent

Exclusion Criteria:

* Current substance abuse or history of substance dependence in the past 3 months
* History of epilepsy, head trauma, stroke or other serious medical or neurological illness which may interfere with the study
* Use of depot antipsychotic in the past 3 months;
* Clinically significant laboratory screening tests
* Pregnancy or lactation
* Inability to follow protocol
Comparison of 1 Versus 2 Days Post-Operative Catheterization After Anterior Colporrhaphy

Patients who undergo anterior vaginal wall plastic surgery and place the bladder catheter during surgery are selected. The purpose of the study is to evaluate the presence of statistically significant differences in bladder catheter repositioning within 12 hours after bladder catheter removal in the group of patients in whom the bladder catheter is removed on postoperative day I or II.

Secondary outcomes include evaluation of the incidence of urinary tract infections, number of hospitalization days and total hospitalization costs for patients undergoing anterior vaginal wall surgery in patients in whom the bladder catheter is removed on postoperative day I or II.


Eligibility Criteria:
Inclusion Criteria:

* Women 18 years of age or older
* Patients who are candidates for cystopexy surgery
* Patients who have consented to the signing of the Informed Consent

Exclusion Criteria:

* Micturition dysfunction with preoperative bladder stagnation \> 200 cc at pessary evaluation
* History of recurrent cystitis
* Positive preoperative urine culture
* Azotemia \> 40 mg/dL or creatininemia \> 1 mg/dL
* Not collected signed consent endorsed
* Diabetes mellitus
* Contraindications to transurethral bladder catheterization
* Major protocol violations due to unforeseen intraoperative complications (bladder and/or rectal damage, severe bleeding with need for urinary monitoring)
Genetic Research of Monogenic Obesity in a Pediatric Cohort With Severe and Early Onset Obesity

Obesity is a frequent disease mainly caused by environmental/polygenic factors and more rarely caused by the alteration of a single gene ("monogenic obesity"). The diagnosis of these rare forms can lead to personalized management (new treatments, prognosis, adapted hygienic and dietary rules) and family screening. The use of a panel covering the known causes of monogenic obesity on a pediatric cohort of severe and early obesity will allow to evaluate the relevance of these analyses to adapt the management of this type of patients.


Eligibility Criteria:
Inclusion Criteria:

* Recruitment age: 2-17 years
* Body mass index, greater than the International Obesity Task Force (IOTF) 30 curve before the age of 5
* Care at the specialized pediatric obesity center (CSO) of the Bordeaux University Hospital
* Informed consent signed

Exclusion Criteria:

* no informed consent
Biological Imaging Guided Antalgic Radiotherapy of Bone Metastases (Phase II Trial)

Highly selective irradiation requires accurate target definition by high-resolution three-dimensional imaging. Co-registration of FDG-PET and high-resolution CT might be the imaging modality of choice. This choice might target radiation therapy precisely to the intra-osseous volume that is responsible for pain and to spare selectively healthy bone in the vicinity of the metastasis. This strategy could result in equal anti-pain efficacy as conventional large volume radiotherapy, but could allow bone remodeling and preservation of bone structural strength in the vicinity and could lead to reduced toxicity to neighboring organs.


Eligibility Criteria:
Inclusion Criteria:

* Painful bone metastasis of solid tumors
* A maximum number of bone metastases less or equal to 3
* Life expectancy \> 6 months
* Minimum age 21 years
* Signed informed consent

Exclusion Criteria:

* Previous radiotherapy to the painful site
* Bone metastasis from malignant melanoma or renal cell carcinoma
* Associated fracture or extra-osseous component
Continuous Positive Air Way Pressure in Cardiac Rehabilitation After CABG

Different studies reported that CPAP is effective to prevent respiratory complication in post CABG patient and have greater impact on walking time, ventilatory function and breathing pattern.

The walking time (6 minute walk test), effect on arterial blood gasses and long term effects of CPAP on cardiac activity, the previous studies focus only on the acute effects of CPAP along with specific exercises but did not tell about the long term effects. based on these finding this study is design to assess the effectiveness of CPAP in Post-op CABG patients regarding there early mobilization, walking time, ABGs and Ejection Fraction as there prognostic parameters in both phase-1 cardiac rehabilitation within hospital as well as in long-term prognosis, is of great interest.

Eligibility Criteria:
Inclusion Criteria:

* age between 35 to 60 years.
* With a clinical diagnosis of coronary artery disease, underwent elective CABG (Acute)

Exclusion Criteria:

* Low ejection friction (15%)
* Patient those who have any arrhythmias
* Unstable angina
* Patient having pace maker and implantable cardioverter defibrillator
* COPD and asthmatic patient
* Patient having BMI more then 40
Genetics Of Autoimmunity In Type I Diabetes

The purpose of this study is to gain more information about the step-by-step process that causes someone to develop type 1 diabetes. Scientists think that a person's own immune system, directed by genetic and environmental factors play a major role in its development. Participation involves a blood draw, a brief medical history questionnaire and measurements of height and weight. Some participants will be asked to return for annual follow-up visits for 10 years.

The goal of this project is to gain knowledge about the development of Type 1 diabetes (T1D), as T1D is one of the most common chronic diseases in children. There has been a rise in the number of cases diagnosed as well as a decrease in the age of diagnosis. This project aims to understand the disease progression as seen in the immune system and to define the genetic and environmental factors that affect inflammation and regulation, which could determine disease progression or nonprogression. Families that include a family member with T1D will be recruited, as well as unrelated, healthy controls as a comparison group.

Participants will have height and weight measured, complete a social \& medical history questionnaire, and have blood drawn for analysis for HLA haplotype (a genetic sequence related to type 1 diabetes susceptibility)diabetes, blood glucose, immune system response, complete blood count, and autoantibody measurements. Some family members may return for follow-up visits for up to 10 years.

Eligibility Criteria:
Inclusion Criteria (Families):

* Families where at least one first-degree family member has type 1 diabetes
* The diabetic proband in the family was diagnosed before the age of 39
* Family members must be at least 2 years old to participate

Exclusion Criteria (Families):

* Families with no history of type 1 diabetes
* Families with a history of diabetes that is not type 1 (LADA, MODY, type 2 etc.)

Inclusion Criteria (Controls):

* No family history of type 1 diabetes or other autoimmune conditions
* Age 2 or older

Exclusion Criteria (Controls):

* Personal or family history of autoimmune disease
Functional, Dynamic, and Anatomic MR Urography

This is a clinical feasibility study to assess the value of MR imaging for obtaining functional, dynamic and anatomical information in a comprehensive imaging protocol in subjects having obstructive uropathy.


Eligibility Criteria:
Inclusion Criteria:

* Males or females 18 years of age or older.
* All female patients of childbearing potential must agree to use a medically accepted method of contraception at the time of the study.
* Patients must have the ability to understand the requirements of the study, provide written and informed consent to participate, and agree to abide by the study requirements.
* Patients who have known or suspected hydronephrosis or patients with solitary kidneys.

Exclusion Criteria:

* Patients with known or suspected hypersensitivity to gadolinium-based agents.
* Patients who are pregnant or lactating.
* Patients with a condition that is a contraindication to MRI (e.g., cardiac pacemaker, epicardial pacemaker leads, cochlear implants, ferromagnetic aneurysm clip, ferromagnetic halo device, or other conditions that would preclude patient proximity to a strong external magnetic field).
* Patients with a recent history of hemolytic anemia, sickle cell anemia or other hemoglobinopathy.
* Patients with a history of significant claustrophobia.
* Patients with impaired renal function based on 24-hr urine collection (creatinine clearance \<10 ml/min or serum creatinine \>1.8 mg/dl)
Nalbuphine as an Adjuvant to Intravenous Regional Anesthesia

The effect of addition of nalbuphine to lidocaine in intravenous regional anesthesia


Eligibility Criteria:
Inclusion Criteria:

* adult patients
* American Society of Anesthesiologists (ASA) physical status I-II
* age between 20 and 50 years old
* scheduled for elective unilateral short hand surgery

Exclusion Criteria:

* allergy to study medications
* body mass index \> 35 kg/m2
* patients with sickle cell disease or Reynaud disease
* patient refusal
A Study of (LY3527727) Pirtobrutinib in Participants With Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma or Non-Hodgkin Lymphoma

Study J2N-MC-JZ01 (JZ01) is an individual-study appendix (ISA) under master protocol J2N-MC-JZNY, and represents participants from the completed originator study, clinical study LOXO-BTK-18001/J2N-OX-JZNA. Participants in the originator study will have the opportunity to continue their assigned study intervention or continue their follow-up visits by transitioning to this study. This study will evaluate the long-term safety and efficacy of pirtobrutinib.


Eligibility Criteria:
Inclusion Criteria:

* Are currently enrolled and active in the originator study, 18001. A participant is considered active in the study if they are:

  * receiving study intervention
  * in the short-term follow-up period, or
  * in the long-term follow-up period.

Exclusion Criteria:

* Were a participant in the Phase 1b cohort of Study 18001.
* Are pregnant or intend to become pregnant during the study or within 30 days of last dose of study treatment or intend to breastfeed during the study or within 1 week of the last dose of study treatment.
Use of Implanted Microstimulators for Decreasing Spasticity and Improving Motion Following Spinal Cord Injury

The primary aims of this study are to determine the safety of the RFM System (Alfred Mann Foundation, Santa Clarita, CA) in a patient with incomplete SCI and the effect of the RFM system on lower limb strength and spasticity. The secondary aim is to analyze any improvement in the participant's mobility.

Restoring mobility after spinal cord injury (SCI) is one of the most important goals of rehabilitation. Even for patients with partial lower limb motor function after SCI, many have limited mobility because of significant spasticity. Therapeutic electrical neuromuscular stimulation (TNS) has been used to improve muscle tone and strength and to enable walking and standing in patients with SCI. We propose to use the Radio Frequency Microstimulator (RFM) System, a new and novel implantable TNS system developed by the Alfred E. Mann Foundation, to improve muscle strength and reduce spasticity in a patient with incomplete SCI. The RFM System has several advantages over current TNS systems. The RFM implant devices are small enough (diameter 2.4 mm, length 16.7 mm) to be inserted using an incision approximately 5 mm long and have no lead wires passing through the skin since the microstimulator contains both the anode and cathode. Implanted RFM devices can be placed near multiple motor points and/or nerves and are controlled individually using radio frequency technology. Up to six (6) RFM devices will be inserted, two to three in each lower limb to provide stimulation to a patient's bilateral knee extensors (femoral nerve stimulation) and ankle dorsiflexors (peroneal nerve stimulation) to assess the effects on muscle strength, limb spasticity and patient mobility.

Eligibility Criteria:
Inclusion Criteria:

* an incomplete C6 ASIA C (Central Cord) spinal cord injury
* lower motor function impaired and suffers from significant spasticity (Ashworth scale 4)
* able to ambulate approximately 10-20 feet with a rolling walker and minimal assistance
* has sufficient endurance to complete at least two 20-minute therapy sessions per day
* cognitive abilities are intact

Exclusion Criteria:

* psychiatric diagnosis
* medical contraindications
* history of bleeding disorders
* allergy to anesthesia
* acute or progressive disease
* active implantable device
Effect of Water Intake and Water Restriction on Total Kidney Volume in Autosomal Dominant Polycystic Kidney Disease

The objective of this study is to measure the influence of both short term water restriction and high water intake on total kidney volume, measured by Magnetic Resonance Imaging (MRI) scan in Autosomal Dominant Polycystic Kidney Disease (ADPKD) patients.

Patients will be randomized to either water restriction for 3 hours or high water intake (20 ml/kg) for 1 hour. Before intervention and after intervention patients will have an MRI scan of the kidneys to measure the total kidney volume (TKV) (differentiated in cortex, medulla and cyst volume). The objective is to identify whether water restriction or high water load will change the TKV. Secondly investigators will analyze different biomarkers (aldosterone, renin, vasopressin/copeptin, urine- and blood-osmolarity) before and after the intervention.

Eligibility Criteria:
Inclusion Criteria:

* ADPKD
* CKD stage 1-3

Exclusion Criteria:

* Patients treated with diuretics
* Pregnancy
* Change in antihypertensive treatment \< 1 month
* Any condition contraindicating MR scan