cyrilzakka/clinical-trials huggingface dataset:
Continuous Bladder Irrigation Following Transurethral Resection of Bladder Tumors

The purpose of this pilot study is to determine if washing out the bladder with large volumes of saline after surgical removal of bladder tumors helps to decrease the number of loose cells floating within the bladder after surgery. Anticipated decrease in tumor recurrence and/or progression rates will be measured.

Bladder tumor recurrence after resection of non-muscle invasive bladder cancer (NMIBC) occurs in 50-70% of patients despite the use of adjuvant anticancer therapy after surgery. This is a single-arm, non-randomized pilot study looking to determine whether post-Transurethral Resection of Bladder Tumor (TURBT) cells counts differ significantly between continuous washout of the bladder (CBI) with normal saline compared to pre-CBI wash out. Anticipated decrease in tumor recurrence and/or progression rates will also be measured, and each participant will act as their own internal control.

Eligibility Criteria:
Inclusion Criteria:

* Patients age 18 years and older diagnosed with a bladder mass on cystoscopy or imaging study
* Primary bladder tumor occurrence

Exclusion Criteria:

* Patients with unresectable bladder tumors, as determined at the time of diagnosis or TURBT , or imaging concerning of T2 or higher disease
* Patients with bladder perforation at the time of TURBT, which is a contraindication to CBI
* Patients from vulnerable populations, including but not limited to impaired subjects, pregnant women, prisoners, family members of the study team
* Any previous history of bladder tumor resection or intravesical chemotherapy/immunotherapy
* History of previous pelvic radiation
* Bladder tumor volume \> 5 cm, involvement of prostatic urethra, or any evidence of hydronephrosis on imaging
Implicit Learning in Epileptic Children

Epileptic children suffer from impairments in various learning and memory tasks. Yet, no study investigated implicit learning in epileptic children. Implicit learning is not only underlying motor skills acquisition, but also social and cognitive ones. Because acquisition of new skills is optimal during childhood, the study of implicit learning mechanism in children is of major importance. The present study will be the first to explore implicit learning mechanisms in children with epilepsy. Implicit learning mechanisms can be preserved or altered.


Eligibility Criteria:
Inclusion Criteria:

* For Patient group only: Children with epilepsy
* For Control group only: Children without neurological, psychiatric or developmental impairments
* For both groups: Parent or tutors agreement
* For both groups: Affiliated to French social security

Exclusion Criteria:

* Neurological impairments unrelated to epilepsy
* Psychiatric impairments unrelated to epilepsy
* Developmental impairments unrelated to epilepsy
Physical Function, Health and Employment for People With Multiple Sclerosis

Employment is low in people with MS, even when physical levels of functioning are high. The purpose of this study is to investigate if an individually tailored intervention combining individualized physiotherapy and work adaptation works better than usual care in terms of reducing barriers for work and improving levels of physical activity. The utility of the intervention will be investigated in terms of quality adjusted life years, long-term employment status and work-related costs.

Physiotherapy and physical activity interventions can reduce fatigue, improve balance, walking, HRQoL, and may improve neuromuscular and physical functioning in people with MS. However, these interventions lack coordination between health care levels and sectors and rarely address vital employment adaptations. Optimizing function and physical activity, when disability is low and neuroplasticity is optimal, can be valuable for maintaining work as levels of fatigue, mobility related symptoms and cognitive disturbances are associated with current employment.

People with an MS-diagnosis who reside in the North of Norway will be identified from patient lists from the neurological out-patient clinics in the participating hospitals. Upon the provision of written informed consent, all participants will undergo baseline testing prior to randomization into either the intervention or the control group. The intervention group will receive a physiotherapy assessment at the hospitals focusing on opportunities for change. Following this assessment they will participate in group training with a municipality physiotherapist twice weekly for six weeks followed by independent training for six weeks. In addition, both participants and their employers will get access to information films on opportunities for work adaptations and the importance of physical activity. Structured meetings with a specially trained employment consultant, the participant and their employer will be held to discuss possible work adaptations. Goals will be set and formally evaluated. Retests will be carried out at week 9, 16 and 52. Registry data on employment will be obtained from the Norwegian labour and welfare administration as a part of a cost-benefit analysis of the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with Multiple Sclerosis according to the McDonald's criteria
* Extended Disability Status Scale (EDSS) 0-4
* Being employed, part time or full time, may include various degrees of sick leave, disability pension or AAP.
* Living in the participating 18 municipalities (Hammerfest, Alta, Senja, Målselv, Tromsø, Harstad, Narvik, Fauske, Bodø, Meløy, Vågan, Vestvågøy, Sortland, Hadsel, Rana, Vefsn, Alstadhaug, Brønnøy).

Exclusion Criteria:

* Pregnancy at enrolment.
* Exacerbation of symptoms (i.e. relapse) within two weeks prior to enrolment.
* Other serious conditions.
Sabril Patient Registry

The purpose of this study is to create a patient registry to collect and analyze information on subjects treated with Sabril and the prescribers of Sabril.

This prospective registry is part of the overall Risk Evaluation and Mitigation Strategy (REMS) required for Sabril by the United States Food and Drug Administration (FDA). All physicians who prescribe Sabril and all patients who take Sabril will be enrolled in a H. Lundbeck A/S-sponsored program called "SHARE" (Support, Help and Resources for Epilepsy), and the data that are collected and entered into the SHARE database will form the basis of this patient registry.

Prior to any prescription being filled by one of the specialty pharmacies, the prescribing physician and the patient must be enrolled in SHARE. A call center (SHARE Call Center) will act as the hub for a network of select specialty pharmacies. Participation in both SHARE and the patient registry is mandatory.

Information regarding prescriber specialty and location, patient demographic and disease characteristics will be collected through SHARE and entered into the database. Patients will be assigned a unique patient identifier upon entry into the registry, and all data related to that patient will be associated with this identifier.

Early in therapy (within 2-4 weeks for Infantile Spasms patients and 3 months for adult refractory Complex Partial Seizures patients), a mandatory benefit/risk assessment will occur. If the benefit of Sabril therapy exceeds the risk of vision loss, the prescribing physician will complete and submit the appropriate SHARE form and the patient will continue into the maintenance therapy phase of treatment. The outcome of this benefit/risk assessment will be entered into the database.

Regular assessments of vision are required during Sabril therapy to contribute information related to the ongoing benefit/risk assessments. The required assessments will occur at baseline, every 3 months during therapy, and about 3-6 months after stopping Sabril. The visual assessment results will be recorded and submitted using the appropriate SHARE forms, and the data will be entered into the database. A copy of the visual field will be included.

Patients will participate in the registry for as long as they receive Sabril therapy. Patients who discontinue treatment with Sabril, but are treated with it again at a later time will be treated as a single patient in the registry.

Eligibility Criteria:
Inclusion Criteria:

* All patients in the U.S. who are prescribed Sabril must participate in this patient registry in order to receive Sabril.
Correlation of Oxidative Stress and Oocyte Quality in Fertility Preservation

Whether it is for oncology or personal reasons, fertility preservation allows participants to preserve their oocytes (eggs) at their current age and condition for a better chance of having a baby in the future.

In order to proceed with fertility preservation, participants will need to undergo in vitro fertilization (IVF), which is standard practice, and take stimulation medication to stimulate production of more follicles.

The combination of both Rekovelle and Menopur for fertility preservation may increase ovarian response to stimulation and increase the number of oocytes retrieved to give better chances of embryos once the oocytes will be fertilized.

The goal in this study is to understand the effect of oxydative stress on the quality of oocytes.

For the purpose of the study and to evaluate this connection, serum levels of oxidative stress and cf-DNA in your blood will be measured.

Oocyte quality will also be assessed with Magenta, a prediction tool utilizing artificial intelligence (AI). This method is non-invasive and has no risks on the oocytes.


Eligibility Criteria:
Inclusion Criteria:

- Women 18 to 37 years of age inclusively eligible for fertility preservation for either social or oncology reason

Exclusion Criteria:

* Pregnancy and lactation
* Uncontrolled thyroid or adrenal dysfunction
* Tumours of the hypothalamus or pituitary gland
* Ovarian enlargement not due to polycystic ovarian syndrome
* Gynaecological haemorrhages of unknown aetiology
* Endometriosis stage III/IV
* Use of hormonal preparations (except for thyroid medication) during the last menstrual cycle
* Use of Coenzyme Q10 during the stimulation cycle
* Renal and/or hepatic impairment
* Hypersensitivity to any active ingredient or excipients in follitropin delta and/or HP-hMG
Compassionate Use of Omegaven to Reverse Parenteral Nutrition Induced Cholestasis

The purpose of this research study is to see if giving Omegaven (an intravenous fat emulsion containing fish oil) instead of the current lipid emulsion, which contains fat derived from soybeans, as part of your child's intravenous (IV) nutrition therapy may be tolerated better. It may reduce the harmful effects to the liver, may stop any further liver damage and may reverse damage already done to the liver because of the prolonged use of nutrition through your child's IV.

Enrollment of subjects into this study will occur for up to 4 years. Subjects will receive Omegaven at a dose of up to 1 g/kg body weight/day until they no longer require total parenteral nutrition or until their conjugated/direct bilirubin has normalized and their enteral lipid intake is sufficient to discontinue intravenous lipids.

Eligibility Criteria:
Inclusion Criteria:

* Males and females ages one month of age to 18 years of age
* Patients with intestinal failure on TPN
* Patients who have a conjugated/direct bilirubin of ≥3 mg/dl for more than weeks and in whom other causes of cholestasis have been excluded with reasonable certainty utilizing biochemical, serologic, microbiologic, and radiographic techniques. Liver biopsy is not required to rule out other disorders, but may be utilized at the clinician's discretion
* Patients in whom reduction of IV soy-based lipid to an average \<1.2g/kg body weight/day has failed to reduce the conjugated/direct bilirubin within ≥ 30 days of implementation
* Willing to use birth control during study participation for females of child- bearing potential, as determined by investigator.
* Signed informed consent for use of Omegaven® obtained

Exclusion Criteria:

* Any of the contraindications to use of Omegaven®

  * Impaired lipid metabolism (triglycerides \>1000 mg/dL) while on

    1g/kg/day or less of Intralipid
  * History of severe hemorrhagic disorders (ie. hemophilia, Von Willebrand disease, etc.)
  * Unstable diabetes mellitus
  * Collapse and shock
  * Stroke/ Embolism
  * Cardiac infarction within the last 3 months
  * Undefined coma status
  * Pregnancy (positive pregnancy test) prior to enrollment in the study for females of child-bearing potential
  * Females of child-bearing potential who are unwilling to use birth control during study participation
* Parental decision to forego the use of Omegaven®
* Known fish or egg allergy
* Pregnancy
* Causes of liver disease other than Parenteral Nutrition Associated Cholestasis
Soy and Isoflavones Effect on Bone

The purpose of this study is to test the effect of 1 year of added dietary soy protein and/or soy isoflavones on bone mineral density in late postmenopausal women.

Although soy foods contain several components (isoflavones and amino acids) that could potentially have positive effects on bone health, there are few long term, large, clinical trials using soy as a means of improving bone mineral density. The objective of this study is to provide daily soy protein and isoflavones to healthy older women in order to answer three major questions:

1. Does soy protein alone affect bone metabolism?
2. Do isoflavones, given with soy protein, affect bone metabolism?
3. What dose of isoflavones affects bone in older women?

We hypothesize that soy protein will have a beneficial effect on bone in older women compared to control protein. Further, we hypothesize that there will be an additional benefit to bone in women who receive soy protein plus isoflavones (at both doses) compared to soy protein alone.

Both control and soy proteins used in the study were isolates, meaning they were the highest concentration of protein (85-90% by weight) in order to minimize the volume of protein supplement that each woman was asked to ingest on a daily basis. The soy protein was an alcohol-washed, soy protein isolate containing 90% protein and negligible isoflavone (0.2 mg/g product). The control protein was a mix consisting of 50% protein from sodium caseinate, 25% protein from whey protein and 25% from egg white protein. The use of a mix of proteins as a control provides a more balanced level of amino acids, mimics the real life mix of proteins that humans typically consume, and avoids the unique characteristics of one source of protein. In order to maintain the dietary protein intake constant, the participant was counseled to decrease her intake of other sources of protein from primarily animal sources by approximately 3 ounces per day (the approximate equivalent of the protein powders). The isoflavones tablets each contained 57 mg of total isoflavone from primarily genistein, glycitein, and daidzein and their beta-glycosides.

Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal women 65 years old or older
* Able to travel to the clinical sites for follow-up visits

Exclusion Criteria:

* History of disease that may affect bone metabolism (including Paget's disease, primary hyperparathyroidism, osteomalacia, untreated hyperthyroidism, or multiple myeloma)
* Cancer of any kind (except basal or squamous cell of skin) in past 5 years
* Use of any of the following medications within the past 2 years: calcitonin, calcitriol, heparin, phenytoin, phenobarbital
* Use at any time of bisphosphonates, long-term corticosteroids (over 6 months), methotrexate, or fluoride
* Estimated creatinine clearance less than 50 ml/min
* History of chronic liver disease or evidence of liver disease on screening
* History of hip fracture
* Known vertebral fracture within the past year
* Vegans
Postoperative Dietary Counseling After Bariatric Surgery

This study aims to assess the changes in physical characteristics, food intake, eating behavior, vomiting, and dumping in 100 patients who undergo bariatric surgery. Patients are put into one of two conditions; they will either receive standard postoperative care or biweekly counseling sessions with a dietician that will help them with the postoperative diet. Patients who receive dietary counseling are anticipated to experience greater weight loss and report less consumption of sugar and fat as compared to patients who do not receive dietary counseling. Moreover, patients who receive dietary counseling are predicted to report less frequent nausea, vomiting, and gastric dumping, as compared to patients who do not receive postoperative dietary counseling. This is predicted to result as a consequence of increased dietary adherence evidenced by the former group.

This study aims to assess the changes in physical characteristics, food intake, eating behavior, vomiting, and dumping in 100 patients who undergo bariatric surgery. Patients are put into one of two conditions; they will either receive standard postoperative care or biweekly counseling sessions with a dietician that will help them with the postoperative diet. Patients who receive dietary counseling are anticipated to experience greater weight loss and report less consumption of sugar and fat as compared to patients who do not receive dietary counseling. Moreover, patients who receive dietary counseling are predicted to report less frequent nausea, vomiting, and gastric dumping, as compared to patients who do not receive postoperative dietary counseling. This is predicted to result as a consequence of increased dietary adherence evidenced by the former group.

Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI): 40 to 60 kg(squared) or greater than or equal to 35kg(squared) in the presence of co-morbid medical condition.
* Subjects must live within 30 minutes of the University of Pennsylvania and drive or have ready access to public transportation.
* Subjects must be able to ambulate without assistance.
* Subjects will be free of contraindications to bariatric surgery and will have been approved for surgery by both the medical staff and their insurance carrier.
* Subjects must be able to communicate with the investigator, be legally competent, and provide written informed consent.

Exclusion Criteria:

* Evidence of significant psychiatric distress that impairs daily functioning, as suggested by a Beck Depression Inventory-II (BDI-II) greater than or equal to 25. (Individuals with BDI-II scores greater than or equal to 25 will be referred for appropriate help, as per the requirements of the law in the state of Pennsylvania.)
* Any current substance abuse or dependence disorder.
* Concurrent psychiatric treatment for any DSM-IV condition
* Persons who binge eat and report purging behavior (i.e., vomiting, laxative or diuretic abuse, etc.) will be excluded from the study and referred to an eating disorders specialist.
Study of Human Monoclonal Antibody to Treat Mycosis Fungoides and Sezary Syndrome

The purpose of this study is to determine the efficacy of the drug, HuMax-CD4, in patients with mycosis fungoides(MF) and sezary syndrome who are intolerant to or do not respond to treatment with Targretin® and one other standard therapy.


Eligibility Criteria:
Inclusion Criteria:

* A biopsy compatible with the diagnosis of MF and sezary syndrome with a CD4 positive phenotype within 6 months of study entry
* Refractory to or intolerant to at least two prior therapies, one being Targretin® (or combinations hereof).
* Signed informed consent

Exclusion Criteria:

* Prior treatment with Total Skin Electron Beam (TSEB) therapy within six months
* Prior treatment with Campath (alemtuzumab)
* Prior treatment with more than three regimens of single agent chemotherapy
* Prior treatment with pentostatin within 6 months
* Treatment within 4 weeks prior to visit 2 with topical Targretin®, skin directed therapies or systemic anticancer therapies, such as, but not limited to: Targretin® , UV-light therapy, local Electron Beam Therapy (EBT), extracorporal photo chemotherapy, methotrexate, bleomycin, cyclophosphamide, combination chemotherapy, oral retinoids, systemic glucocorticosteroids , carmustine, nitrogen mustard, systemic vitamin A or etretinate
* Treatment with topical glucocorticosteroids within 2 weeks prior to visit 2
* Unwillingness or inability to avoid prolonged exposure to the sun or UV light sufficient to produce a mild erythema or thought by the investigator to likely modify the patient's disease
* Concurrent or previous malignancies within the past five years except adequately treated in situ carcinoma of the uterine cervix or basal or squamous cell skin carcinoma
* Significant concurrent, uncontrolled, or active medical condition including, but not limited to renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological, cerebral or psychiatric disease
* Known or suspected positive serology for HIV
* Known or suspected positive serology for hepatitis B or C
* Patients who are currently participating in any other trials or having received treatment with any experimental agent within 4 weeks prior to visit 1 (screening)
* Prior treatment with anti-CD4 monoclonal antibodies
* Breast feeding women or women with a positive pregnancy test at Visit 1
* Women of childbearing potential not willing to use either hormonal birth control, an intrauterine device or double-barrier method for the entire study period