cyrilzakka/clinical-trials huggingface dataset:
Treatment of Urinary Incontinence in Women With Spinal Cord Injury

The purpose of this study is to determine whether pelvic floor muscle training (PFMT) and intravaginal neuromuscular electrical stimulation (NMES) are effective in reducing urinary incontinence and improving quality of life in women with spinal cord injury (SCI).

SCI patients often experience neurogenic bladder dysfunction with neurogenic detrusor overactivity or areflexic bladder. Due to this, 40-50 % of the SCI population suffers from urinary incontinence, which often reduces the patient's quality of life.

In order to manage the neurogenic bladder dysfunction, SCI patients use specialized bladder emptying methods, most frequently clean intermittent catheterization. To reduce the symptoms of neurogenic detrusor overactivity and urinary incontinence in patients with a SCI, medical anticholinergic therapy can be assessed, but the effect is sparse and many adverse effects have been reported. Injection of Botulinum-A toxin in the bladder has shown great potential in minimizing the symptoms of neurogenic detrusor overactivity and urinary incontinence, though it is an expensive and invasive method that needs to be repeated due to its temporary effect.

PFMT and NMES of the pelvic muscles are non-invasive and cheap treatments without side effects and several studies have demonstrated the positive effect of intravaginal NMES and/or PFMT on urinary incontinence in able-bodied women as well as women with neurological disorders like multiple sclerosis.

Despite the fact that NMES of weak or paralyzed striated muscles has been used for decades in patients suffering from SCI, to our knowledge, no study has previously investigated the effect of PFMT and intravaginal NMES in women with SCI.

The aim of this study is to evaluate the effect of PFMT and intravaginal NMES on Urinary Incontinence and Quality of Life in women with SCI. In particular, we will investigate the potential additional effect of intravaginal NMES, when NMES is conducted in combination with PFMT.

This study is designed as a randomized clinical trial, investigating the effect of PFMT alone and in combination with intravaginal NMES. We will include 40 female patients with an incomplete SCI and urinary incontinence. After physiotherapeutic guidance, the patients perform PFMT or PFMT + NMES daily at home for 12 weeks with follow-up evaluations every fourth week.

Eligibility Criteria:
Inclusion Criteria:

* Incomplete SCI graded C, D og E on ASIA Impairment Scale, sustained minimum 3 months ago
* urinary incontinence, corresponding to a total ICIQ-UI-SF score ≥ 8

Exclusion Criteria:

* Regular treatment with botox bladder injections or \< 1 year since last botox injection
* Lack of urodynamic investigation after the SCI
* Pregnancy
* Pacemaker
* Lack of ability to contract the pelvic floor muscles during objective clinical examination
Effect of Medical Food on Reducing Asthma Symptoms in Asthmatic Children

To determine the effect of medical food on reducing asthma symptoms in asthmatic children.


Eligibility Criteria:
Inclusion Criteria:

* Male and female children who have had mild to moderate persistent asthma for at least 1 year and are between 6 and 14 years of age, and not currently being treated with steroids are eligible.

Each subject also has to have:

* Subject is off of controller therapy 4 wks preceding visit 1.
* Mild to moderate persistent asthma
* Methacholine responsiveness with an FEV1 PC20
* Able to perform reproducible spirometry
* Verbal assent in addition to consent
* History of prior clinical varicella or varicella vaccine.
* Nonsmoker in past year.

Exclusion Criteria:

* Asthma symptoms and/or albuterol use consistent with severe persistent asthma during the run-in period.
* Subject with FEV1 \< 80% predicted at visit 1 or FEV1 \< 70% predicted at visit 2.
* Two or more hospitalizations for asthma in the past year.
* Subject has received oral, nasal, inhaled, or IM corticosteroids during the preceding month.
* Subject has received leukotriene modifiers, theophylline derivatives, or mast cell stabilizers for asthma within 4 weeks before visit 1
* Subject is receiving one or more of the following medications:

  * Astemizole prior to 3 months of visit 1
  * Oral, inhaled or parenteral corticosteroids prior to 4 weeks of visit 1
  * Cromolyn, antimuscarinics, cimetidine, metoclopramide, phenobarbital, phenytion, terfenadine, loratadine, or anticholingeric agents prior to 2 weeks of visit 1.
  * Theophylline prior to 4 weeks of visit 1
* Subject with active upper respiratory tract infection prior to 4 weeks before visit 1
* Subject with acute sinus disease requiring antibiotic treatment within 1 week before visit
* Subject with an emergency department treatment for asthma within 1 month, prior intubation for asthma, or hospitalization for asthma within 3 months
* Subject has known bleeding disorder and/or is on medication known to have significant anticoagulant effects.
* Subject has known hypersensitivity to any of the ingredients
* Subject is taking either pill, powder, or liquid forms of nutritional and/or health food supplements within the past 4 weeks prior to visit
* Subject unable to tolerate or unwilling to take the full dose of the nutritional study formulas
* Cystic fibrosis or any other chronic lung disease other than asthma.
* Subject having gastroesophogeal reflux undergoing medical treatment
* Significant medical illness other than asthma that could require oral corticosteroids during the study.
* Subject is receiving allergen hyposensitization therapy other than an established maintenance regimen
* Subject has received IV globulins or immunosuppressants.
* Subject is known to be human immunodeficiency virus (HIV) positive.
* Pregnancy or lactation.
* If of child bearing potential, failure to practice abstinence or use of an acceptable birth control method.
* Subject is morbidly obese
Hepatic Metabolic Changes in Response to Glucagon Infusion

The objective of the study is to investigate how exogenously administered glucagon affects hepatic lipid, glucose and protein metabolism as well as appetite, food intake and resting energy expenditure.

Most research has focused on the role of the pancreatic hormone, insulin, and insulin signalling (or lack of) in the development of NAFLD. However, increasing evidence suggest that the other major gluco-regulatory pancreatic hormone glucagon is also implicated in lipid metabolism and recent human data from studies investigating the effect of glucagon receptor antagonism suggest that glucagon signalling may be essential for maintaining a fat-free liver. This, combined with observations of increased degree of hepatic steatosis in patients after total pancreatectomy, who are devoid of pancreatic glucagon and typically are lean and peripherally insulin sensitive, suggests that glucagon may play a hitherto unrecognised role in the pathophysiology of NAFLD.

The hypothesis of the study is that exogenously delivered glucagon will drive hepatic metabolism in a lipolytic direction and increase resting energy expenditure without affecting appetite and food intake.

The acute effects of exogeneous glucagon infusion on hepatic lipid metabolism will be evaluated in patients after total pancreatectomy (no endogenous pancreatic hormones), in patients with type 1 diabetes (no endogenous insulin production) and in healthy controls (preserved endogenous pancreatic hormones).

Eligibility Criteria:
Inclusion Criteria:

Pancreatectomised patients

* Patients who have undergone total pancreatectomy
* Caucasian between 30-80
* Blood haemoglobin \>7.0 mmol/l for males and \>6.5 mmol/l for females
* Informed consent

Patients with type 1 diabetes

* Patients with C-peptide negative type 1 diabetes
* Caucasian between 30-80
* Blood haemoglobin \>7.0 mmol/l for males and \>6.5 mmol/l for females
* Informed consent

Healthy controls

* Normal fasting plasma glucose (\< 7 mmol/l) and normal HbA1c (\< 6.5 %) (30,31)
* Normal blood haemoglobin (\>8.3 mmol/l for males and \>7.3 mmol/l for females)
* Caucasian between 30-80
* Informed consent

Exclusion Criteria:

All subjects

* Inflammatory bowel disease
* Gastrointestinal resection (other than the gastro-duodenectomy performed in connection with total pancreatectomy) and/or ostomy
* Nephropathy (eGFR \< 60 ml/min/1.73 m² and/or urine albumin \> 20 mg/L)
* Known liver disease (excluding non-alcoholic fatty liver disease)
* Severe lung disease
* Pregnancy and/or breastfeeding
* Uncontrolled hypertension and/or significant cardiovascular disease
* Treatment with drugs with potential steatogenic side-effects within three months prior to inclusion
* Alcohol consumption above 21 units/week for men and 14 units/week for women
* Any condition that the investigator feels would interfere with the safety of the trial participation or the safety of the subject.
Phase I Open-Label Dose Finding Study of SGN-35 for CD30 Positive Hematologic Malignancies

Phase I study to define the safety profile and pharmacokinetic parameters of SGN-35 in patients with relapsed/refractory CD30-positive hematologic malignancies. This is a single-arm, open-label, Phase I dose escalation study designed to define the MTD, PK, immunogenicity and anti-tumor activity of SGN-35 in patients with relapsed/refractory CD30-positive hematologic malignancies.


Eligibility Criteria:
Inclusion Criteria:

* Patients must have histologically confirmed CD30-positive hematologic malignancy.
* Patients with HL must have failed systemic chemotherapy either as induction therapy for advanced stage disease or salvage therapy after initial radiotherapy for early stage disease and were ineligible for, refused treatment by, or previously received stem cell transplant.
* Patients must have measurable disease of at least 10mm as documented by radiographic technique.
* Must be at least 18 years of age.

Exclusion Criteria:

* Patients with current diagnosis of pcALCL (systemic ALCL eligible).
* Patients with history of allogeneic stem cell transplant.
* Patients who have had previous treatment with any anti-CD30 antibody.
Myotonic Dystrophy Type 1 and Resistance Exercise

The purpose of this study is to investigate the response after one bout of moderate-heavy resistance exercise in patients suffering from Myotonic Dystrophy type 1. There is still doubt about if these patients could benefit from resistance exercise, or if this mode of exercise is detrimental to their mobility and health. We aim to monitor the subjects during the recovery phase and investigate recovery in several ways.

Myotonic dystrophy type 1 (DM1) is an autosomal, dominantly inherited, muscular disease and the most common muscular dystrophy amongst adults. The disease is characterized by progressive myopathy and myotonia, first evident in the distal parts of the body: calves and forearms, further progressing towards proximal parts. A recent review by Voet and co-workers (2013) concludes that exercise is safe for DM1-patients, and based on our current knowledge, DM1-patients should be able to gain positive adaptations from exercise. However, the physiological outcomes of an exercise stimulus are not well studied in this population and because of alterations in important Ca2+ handling systems the recovery processes might be significantly different from healthy muscles.

The aim of this study is to investigate the acute responses to moderate-heavy resistance exercise in DM1-patients. We aim to establish a timeline for recovery of muscle strength, measured as maximal voluntary contraction. In line with this, we want to investigate if any muscular damage has occurred with both direct and indirect measures, and possible mechanisms leading to muscle damage, i.e. impaired Ca2+ handling.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed Myotonic Dystrophy type 1-diagnosis

Exclusion Criteria:

* Non-ambulatory
* Injuries to muscle-skeletal-system that prevents resistance exercise
* Severe affection of the cardiovascular system
* Cognitive affection
* Lives more than one hour from test site
Dose-ranging Study

Dose ranging study


Eligibility Criteria:
Inclusion Criteria:

* 18 - 45 years of age inclusive
* abdominal contour defect
* BMI \<25 kg/msq
* Stable diet and exercise and body weight

Exclusion Criteria:

* Prior treatment of abdominal contour defects (liposuction, abdominoplasty, etc)
* Known hypersensitivity to study drugs
The Pre-symptomatic Familial Amyotrophic Lateral Sclerosis (Pre-fALS) Study

Pre-fALS is a prospective natural history and biomarker study of people not yet affected with ALS, but who are at genetic risk for developing ALS. The investigators aim to recruit unaffected (healthy) people from familial ALS (fALS) pedigrees in which a known genetic mutation associated with ALS has been identified; for this study, a fALS pedigree is one with two biologically related individuals who have or have had ALS and/or FTD. Individuals who may be at genetic risk for ALS and who belong to families with at least one affected family member who has tested positive for a known ALS genetic mutation may also be eligible to participate. Our goal is to study the pre-symptomatic phase, onset and progression of ALS and to learn more about genetic and environmental factors that put people at risk for developing ALS.

Healthy individuals from fALS families with a known genetic mutation will be included in this study. We encourage people who have previously undergone genetic testing and were found to carry the mutation that affects their family as well as those who do not know their genetic status to contact us. Those who wish to participate and to learn the results of genetic testing, may do so after undergoing genetic counseling. It is also possible to participate without learning the results of genetic testing. Participants eligible to complete study visits will travel to Miami (at our expense) approximately every 12-24 months for a period of 10 years or longer and will perform various biomarker procedures. Between visits, participants will complete phone calls about their health.

Eligibility Criteria:
Inclusion Criteria

* A member of a family in which a mutation in a gene associated with ALS has been identified.
* No symptoms to suggest the presence of ALS (i.e. study participants must currently be healthy).
* Having at least 50% probability of carrying an ALS associated gene mutation based on family pedigree.
* Willingness to undergo genetic testing, with the option of whether or not to learn the results.
* Willingness and availability to travel to Miami for a few days approximately every 12 to 24 months to complete biomarker procedures (e.g, MRI, blood draws, spinal tab/lumbar puncture, cognitive testing)

Exclusion Criteria

* Diagnosis of ALS
* Any condition or situation which, in the PI's opinion, could confound the biomarker data or may interfere with the individual's participation and compliance with the study protocol, including but not limited to neurological, psychological and/or medical conditions.
Effectiveness of Convalescent Plasma Therapy in 8 Non-Intubated COVID-19 Patients in Indonesia: A Case Series

This is the first Case Studies article highlight factors determine the effectiveness of Convalescent Plasma Therapy (CPT) in Indonesia, accompanied by supporting data and images before and after the patients received the therapy. This Case Studies gives a huge contribution as CPT still on going as multicentre study and apply massively as emergency approved treatment in Indonesia.

Eight non-intubated Covid-19 patients confirmed by real-time viral RNA PCR tests were included. Four patients had been administered two doses of 200 mL convalescent plasma (CP) and another four patients had been administered one dose of CP with an antibody titer of 1:320. This study has three goals included to detect the improvement of patient clinical and laboratory conditions, safety of CPT, and conversion from positive to negative results after CPT administration. Convalescent plasma applied within two weeks (13 days) from onset of illness and within a week (6.5 days) from the first day of hospital admission for all patients. Improvements in clinical symptoms, laboratory parameters, thorax photo, negative conversion of PCR, and decreased oxygen supplementation occurred within a week after CPT. Patients with two doses of CP tended to have faster recovery than those with one dose of CP. No severe adverse effects were observed in any patient. This is the first case series in Indonesia showing CPT is safe and well tolerated, and early CPT before the patient is intubated could potentially prevent disease progression, increase the recovery rate, and shorten the inpatient days.

Eligibility Criteria:
Inclusion Criteria:

* COVID-19 patients
* Severe stage
* Positive PCR swab

Exclusion Criteria:

* Non-COVID-19 patients
* No Symptoms COVID-19 patients
* Mild COVID-19 patients
Freeze All Strategy Versus Fresh Embryo Transfer After GnRH Analogue Trigger

Ovarian hyperstimulation syndrome (OHSS) is one of the most dangerous complications of assisted reproduction technology (ART), described in approximatively 3 to 10% of stimulation cycles although an underestimation of the real incidence has been suggested.

The use in clinical practice of GnRH antagonist has made it possible to perform the trigger with GnRH analogues, with the advantage of considerably reducing the risk of OHSS.

The main concerns about the trigger with analogue are about obstetric outcomes, since it may increase the Abortion Rate (AR) and reduce the Ongoing Pregnancy Rate (OPR) due to luteal phase deficiency, and on the other hand about oocyte quality and competence.

While in order to maximize the chance of pregnancy at fresh embryo transfer after GnRHa trigger, several studies have focused on the importance of luteal phase support, other authors suggest that the best strategy is freeze-all: cryopreservation of all the obtained embryos and subsequent single embryo transfers.

However, data about oocyte quality, retrieval rate, pregnancy rate and reduced occurrence of complications such as OHSS, especially on the very first embryo transfer, are still scarce.

Eligibility Criteria:
Inclusion Criteria:

* patients undergoing ART cycle with antagonist protocol stimulation and trigger with GnRH agonist
* patients are believed at risk of OHSS at time of trigger based on size and number of follicles developed (≥18 follicles with diameter 12 mm at induction).

Exclusion Criteria:

* hypogonadotropic hypogonadism
* other ART protocols
* any patient that underwent freeze-all strategy in order to perform pre-implantation genetic testing (PGT)
* oncological or deferring motherhood freezing procedures
A Study of RoActemra/Actemra (Tocilizumab) in Combination With Methotrexate in Patients With Severe Active Rheumatoid Arthritis, Comparing Tapering Versus Maintaining the Methotrexate Dosage

This randomized, placebo-controlled, double-blind study will compare the safety and efficacy of tapering methotrexate (MTX) versus maintaining MTX dosage in patients with severe active rheumatoid arthritis and an inadequate response to disease-modifying antirheumatic drugs (DMARDs) initiated on treatment with tocilizumab. Participants will receive tocilizumab 8 mg/kg intravenously every 4 weeks and MTX orally weekly throughout the study. At Week 24, participants achieving a good/moderate EULAR response will be randomized receiving the MTX Tapering arm or MTX Maintenance arm. Up to Week 56 participants will receive either tapering or stable dose MTX in combination with tocilizumab. From Week 56 to Week 72 participants will receive tocilizumab monotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, \>/= 18 years of age
* Active severe rheumatoid arthritis (DAS28 \> 5.1) according to European League of Rheumatism (EULAR)/American College of Rheumatology (ACR) criteria
* Inadequate response to a trial of 2 DMARDs, including methotrexate, a trial being defined as 6 months with 2 months at standard dose; no previous treatment with a biologic agent such as a tumor necrosis factor (TNF) inhibitor
* Oral corticosteroids must have been at a stable dose of \</= 10 mg/day prednisolone or equivalent for at least 25 out of 28 days prior to start of treatment (Day 1)

Exclusion Criteria:

* Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following randomization
* Rheumatic autoimmune disease other than rheumatoid arthritis
* Functional class IV as defined by the ACR Classification of Functional Status in RA
* Prior history of or current inflammatory joint disease other than RA
* Previous treatment with tocilizumab
* Previous treatment with any biologic drug (e.g. TNF inhibitor) that is used in the treatment of RA
* Intraarticular or parenteral corticosteroids within 6 weeks prior to enrollment
* Inadequate liver, bone marrow or hepatic function
* Positive for hepatitis B, hepatitis C or HIV infection
* Pregnant or breastfeeding women
* Females of child-bearing potential who are not using reliable means of contraception
* History of severe allergic or anaphylactic reactions to human, humanized or murine monoclonal antibodies
* Active current or history of recurrent bacterial, viral, fungal, mycobacterial or other infections
* History of, or currently active, primary or secondary immunodeficiency
Reducing Risk for Alzheimer's Disease in High-Risk Women Through Yogic Meditation Training

The purpose of this pilot study will be to test whether Kundalini yoga (KY) and Kirtan Kriya (KK) yogic meditation is superior to Memory Enhancement Training (MET) for improving cognitive functioning, health (including cardiovascular factors), and mood in women with high AD risk.

Overall, the investigators anticipate recruiting 100 women (50 or older) with MCI and high Alzheimer's disease risk. Subjects will either receive: (1) MET class for 60 minutes per week; or (2) Kundalini yoga and "Kirtan Kriya" meditation class for 60 minutes per week. Assessments will be completed immediately after the interventions at 6 and 12 weeks and follow-up visits at week 24 and 48 to monitor the overall benefit of the intervention.

Eligibility Criteria:
Inclusion Criteria:

1. Amnestic MCI, as defined by a Clinical Dementia Rating Scale score of .5.
2. High cardiovascular risk defined as at least one of the following:

   * 7.5 percentile risk or higher using ASCVD risk calculator
   * Myocardial Infarction more than 6 months ago
   * Diabetes
   * Taking medication for blood pressure \> 140/90 blood pressure
   * Taking medication for lyperlipidemia LDL \>160
3. Sufficient English proficiency and the 8th grade or higher reading level as determined by the word reading subtest of the Wide Range Achievement Test-IV (this criterion is necessary in order to ensure ability to participate in MET, which involves reading and writing and has a Flesch-Kinkaid school equivalency of 7th grade)
4. Capacity to provide informed consent

Exclusion Criteria:

1. History of psychosis, bipolar disorder, alcohol/ drug dependence, or neurological disorder
2. Recent (within three months) surgery, anticipated surgery within next year, or unstable medical condition
3. Any disability preventing participation in MET or KK+KY (e.g., severe visual or hearing impairment)
4. Insufficient English proficiency to participate in either MET or KK+KY
5. Diagnosis of dementia
6. Mini Mental Health Examination score of 23 or below
7. Currently taking any psychoactive medication
8. Participation in a psychotherapy that involves cognitive training
9. Practice of Kundalini Yoga or Kirtan Kriya within the past year
10. Myocardial Infarction within the past 6 months