cyrilzakka/clinical-trials huggingface dataset:
Megestrol and Exercise in Treating Patients With Cancer-Related Weight Loss

RATIONALE: Megestrol helps improve appetite. Exercise may decrease cancer-related fatigue, improve strength, and build up lost muscle tissue. Exercise plus megestrol may be effective treatment for cancer-related weight loss.

PURPOSE: Phase II trial to study the effectiveness of megestrol plus exercise to improve appetite, increase strength, gain lean body tissue, and decrease fatigue in patients who have cancer-related weight loss.

OBJECTIVES: I. Determine the effect of megestrol and progressive resistance training on lean body mass, total body weight, functional capacity, appetite, and fatigue in patients with weight loss due to advanced malignancy.

OUTLINE: This is a multicenter study. Patients receive oral megestrol once daily. Patients also begin progressive resistance training 3 days a week. Treatment/exercise continues for 12 weeks in the absence of unacceptable toxicity or progressive weight loss (greater than 5 pounds or 5% or more over first 4 study weeks).

PROJECTED ACCRUAL: A total of 46 patients will be accrued for this study within 1 year.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Advanced nonhormone responsive malignancy (metastatic or incurable) Nonvolitional weight loss of between 6-9% of usual body weight over past 6 months OR Decrease of 5 pounds in the past 2 months or less (not greater than 10% loss of usual body weight) No clinical or radiologic evidence of ascites or pleural effusion No lytic bone metastases

PATIENT CHARACTERISTICS: Age: Over 18 Performance status: ECOG 0-1 Life expectancy: At least 4 months Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Cardiovascular: No venous thrombosis No congestive heart failure Other: Able to participate in exercise program for 1 hour, 3 times/week No physical handicap that precludes aerobic or resistance exercise No clinical abnormality that renders exercise a risk At least 1 month since strength training of 3 hours or more per week No physical or functional obstruction to food intake No uncontrolled emesis greater than 5 episodes/week No diarrhea greater than 4 stools/day intractable to antidiarrheal medication No IV hyperalimentation No contraindications to megestrol No dementia or mental incompetence No known AIDS Not pregnant or nursing Negative pregnancy test

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: No concurrent adrenal steroids (other than for replacement), anabolics, appetite stimulants, or progestational agents Intermittent corticosteroids as antiemetic or premedication for cancer treatment allowed At least 6 weeks since prior megestrol Radiotherapy: Not specified Surgery: Not specified
Duration of ColdZyme® II

The objective of this investigation is to verify that ColdZyme® is deposited onto the throat and estimate the half-life of the ColdZyme® solution in the oropharynx of human volunteers using a log-linear mixed-effects model (LMM).

The study is an Open Label, Non-Comparative study intended to verify the method used to measure the duration of ColdZyme®. Each participant will be his own control as samples are taken before application of ColdZyme and used as an internal control. Samples will be taken from the oropharyngeal membrane using a cotton swab before application, and 1, 3, 5, 10, 20, and 60 minutes after application. Glycerol will then be extracted from the swabs using water and the concentration of glycerol will be measured.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female subjects between 18-70 years. The investigator judges the definition of healthy by medical history.
* No reported symptoms of sore throat.
* Readiness to comply with trial procedures.
* Females of childbearing potential: should use reliable method of birth control.
* Participation is based upon written informed consent by the participant following written and oral information by the investigator regarding nature, purpose, consequences and possible risks of the clinical study.

Exclusion Criteria:

* Known allergy or hypersensitivity to the components of the investigational product
* History and/or presence of clinically significant condition/disorder (self-reported), which per investigator's judgement could interfere with the results of the study or the safety of the subject.
* Any current cold symptom such as sore throat, sneezing, rhinorrhea, malaise, nasal obstruction or cough.
* Use of products, drugs, or food containing glycerol that may influence the study outcome, or concomitant medication with pharmaceuticals that might cause dry mouth (xerostomia), e.g. but not restricted to, morphine or morphine derivates, diuretics, antidepressants or other drugs with anticholinergic effect.
* Females: Pregnant or breast-feeding
* History of (in the past 12 months prior to study start) or current abuse of drugs, alcohol or medication
* Inability to comply with study requirements according to investigator's judgement
* Participation in another clinical study in the 30 days prior to enrolment and during the study
A Study Evaluating the Efficacy and Safety of ABP 959 Compared With Eculizumab in Adult Participants With PNH

This is a randomized, double-blind, active-controlled phase 3 study of ABP 959 in participants with paroxysmal nocturnal hemoglobinuria.


Eligibility Criteria:
Inclusion Criteria:

* Men and women ≥ 18 years of age.
* Historical diagnosis of PNH.
* Administration of eculizumab for ≥ 6 months and currently receiving 900 mg of eculizumab.
* Hemoglobin ≥ 9.0 g/dL for at least 6 weeks before randomization.
* Lactate dehydrogenase \< 1.5 × the upper limit of normal at screening.
* Platelet count ≥ 50 × 10\^9/L.
* Absolute neutrophil count (ANC) ≥ 0.5 x 10\^9/L (500/μL).
* Participants must be vaccinated against Neisseria meningitidis.
* Participants must sign an IRB/IEC-approved ICF before participation in any procedures.

Exclusion Criteria:

* Known or suspected hereditary complement deficiency.
* Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure \[New York Heart Association ≥ Class III\], serious uncontrolled cardiac arrhythmia), peripheral vascular disease, cerebrovascular accident, or transient ischemic attack in the previous 6 months.
* Evidence of acute thrombosis (liver Doppler ultrasound of hepatic and portal veins).
* Known to be positive for human immunodeficiency virus.
* Woman who is pregnant or breastfeeding.
* Participant is currently enrolled in or has not yet completed at least 30 days since ending other investigational device or drug study(s), or participant is receiving other investigational agent(s).
* Participant has known sensitivity to any of the products to be administered during the study, including mammalian cell-derived drug products.
* History of meningococcal infection.
* Presence or suspicion of active bacterial infection, or recurrent bacterial infection.
* History of bone marrow transplantation.
* Red blood cell transfusion required within 12 weeks before randomization.
* Participant experienced ≥ 2 breakthrough events, (ie, signs and symptoms of intravascular hemolysis, that require dose and/or schedule adjustments of eculizumab) in the previous 12 months before screening.
Induction of Migraine Aura With Cilostazol

In a double blind placebo-controlled cross-over study the effect of cilostazol on aura induction and endothelial response is tested in patient with migraine with aura.

Migraine with aura is associated to an increased risk of stroke. The mechanism behind such increased risk is not fully understood. Cilostazol induce headache and migraine in migraine patients and is used as secondary prevention of stroke. The effect on aura induction is not known. We investigate the aura inducing potential of cilostazol and associated changes in endothelial function.

Eligibility Criteria:
Inclusion Criteria:

* Migraine with aura
* Minimum of 2 attacks/year

Exclusion Criteria:

* Chronic tension type headache
* Cardiac arrhythmias
Improving Psychosocial Quality of Life in Women With Advanced Breast Cancer

Through a patient participation aid (PPA) the investigators hope to improve the psychosocial well-being of women diagnosed with metastatic breast cancer by empowering them to be active participants in clinical encounters.

The team has developed a brief Patient Participation Aid (PPA) to promote patient health literacy and encourage women to be active in the decisions that are being made about their healthcare which will lead to their satisfaction with healthcare and improves their psychosocial well-being. The paper-based PPA uses adult learning principles to limit and sequence plain language messages that have been framed from a patient's perspective. The PPA uses theory-based design to increase patients' involvement in the medical visit by modeling - through text and images - how a patient can: 1) set the visit agenda, 2) formulate questions, and 3) assert personal preferences. The specific aims of this study are to: 1- Assess the effectiveness of the PPA to increase patient involvement during clinical encounters. 2- Evaluate the effectiveness of the PPA to improve patient psychosocial outcomes. 3- Explore if the effect of the PPA varies by patients' literacy skills. To achieve this aims, the investigators will conduct a randomized controlled trial to evaluate the PPA among patients with a new diagnosis or progression of metastatic breast cancer at two cancer centers that serve diverse patient populations.

Eligibility Criteria:
Inclusion Criteria:

* female patients with metastatic breast cancer seeing one of the study physicians at one of the identified study clinics
* age 21 or older
* having suspected progression of metastatic disease

Exclusion Criteria:

* patients with an uncorrectable hearing impairment or having limited English proficiency, as this would adversely affect their ability to communicate with the physician
* patients with uncorrectable vision impairment, as this would make it impractical for the patient to read the intervention
* patients too ill to meaningfully converse with the physician
A Study of LY3202626 on Disease Progression in Participants With Mild Alzheimer's Disease Dementia

The main purpose of this study is to evaluate the safety and the effect on brain tau of the study drug LY3202626 in participants with mild Alzheimer's disease (AD) dementia.


Eligibility Criteria:
Inclusion Criteria:

* Present with mild AD dementia based on the National Institute on Aging (NIA) and the Alzheimer's Association (AA) disease diagnostic criteria as determined by a qualified clinician approved by the Sponsor or designee.
* Mini-Mental State Examination score of 20 to 26 inclusive at screening visit.
* Has a florbetapir PET scan consistent with the presence of amyloid pathology at screening.

Exclusion Criteria:

* Significant neurological disease affecting the central nervous system (CNS), other than AD, that may affect cognition or ability to complete the study, including but not limited to, other dementias, serious infection of the brain, Parkinson's disease, multiple concussions, or epilepsy or recurrent seizures (except febrile childhood seizures).
* Ocular pathology that significantly limits ability to reliably evaluate vision or the retina.
* Use of strong inducers of cytochrome P450 3A (CYP3A).
* Sensitivity to florbetapir or ¹⁸F-AV-1451.
* Contraindication to MRI or PET or poor venous access for blood draws.
Ill-health Related Job Loss

The current study aimed to estimate the one-year incidence of unfitness for the job in an occupational health service, and to describe their aetiology and the characteristics of the unfit employees


Eligibility Criteria:
Inclusion Criteria:

- to be followed-up in the occupational health center

Exclusion criteria:

- civil servants
App for Strengthening Services In Specialized Therapeutic Support

In partnership with a digital health software company, the University research team created two versions of a mobile application to help behavioral health technicians (BHT's) who work with students with autism collect data. The first version comprises a basic electronic platform for data collection. The second version has the same basic electronic platform for data collection, plus additional features designed to increase motivation to collect data and ease the burden of data collection.


Eligibility Criteria:
Inclusion Criteria:

* Participants must be working as a paraprofessionals or behavioral health technicians
* Currently providing individual support to children with autism
* Currently providing services in Philadelphia preschools, schools, day cares, or homes.

Exclusion Criteria:

* n/a
The Effect of Botox Injection on Postural Stability of Cerebral Palsy (CP) Children

Children suffer from Cerebral Palsy that willing to participate in the study will be tested with well-established measuring techniques of Balance control using force plate before 2 month after BOTOX injection in the movement and Rehabilitation Laboratory at BGU. An automated algorithm will be used to extract standardized stabilogram-diffusion parameters from each of the COP data sets collected during quiet standing. These parameters include diffusion coefficients, critical displacement, critical time and scaling exponents for both lateral and anterior-posterior sway directions (Collins \& De Luca, 1993). Each of the Times (before 3 month and 6 month after the THA) in two task conditions (eyes closed and eyes close conditions). Participants will be required to stand on the platform 5 times for 30 s For each trial, they will be instructed to sway as little as possible. In addition Gait analysis will be also examined.


Eligibility Criteria:
Inclusion Criteria:

* Cerebral palsy
* BOTOX injection

Exclusion Criteria:

* Not able to stand independently 60 seconds
* Not able to walk independently
The New Strategy for Pharmacological Treatment in People With Schizophrenia

Switching from Risperidone to Aripiprazole in early stage of pharmacotherapy will demonstrate the same efficacy as compared to risperidone continuation treatment in the treatment of schizophrenia.

It has been thought that D2 Blocking agent is necessary in acute as well as maintenance phase of pharmacological treatment of patients with schizophrenia. However, this classical strategy produces long term adverse events of drug such as TD, osteoporosis and some metabolic syndrome. To overcome these adverse events, new strategy for pharmacological treatment is needed.

Eligibility Criteria:
Inclusion Criteria:

* Schizophrenia, DSM-IV
* Acute phase

Exclusion Criteria:

* Refractory Schizophrenia
* Substance Abuse
* High risk for suicide
T1D Risk Assessment in Kids With Relatives

The purpose of this study is to determine whether early immunological markers (activation of autoreactive T lymphocytes) precede and are predictive of the appearance of autoantibodies in children born from type 1 diabetic parents.

The prevalence of type 1 diabetes (T1D) is estimated between 0.2 and 0.4% in France. The incidence in France is more than 10/105 per year, with a steady increase (\~4%/year), especially in children. Infants born to parents with T1D have a 15-fold higher risk to develop T1D compared to the general population. The appearance of autoantibodies precedes and is highly predictive of the later occurrence of T1D. The activation of B lymphocytes, which produce autoantibodies, is controlled by T helper lymphocytes. Hence, biomarkers associated with initial T lymphocyte activation are likely to precede the appearance of autoantibodies.

The aim of the TRAKR study is to determine whether the appearance of autoreactive T lymphocytes is predictive of the emergence of autoantibodies.

The secondary objectives are: 1) to evaluate whether metagenomic, metabolic, or environmental factors are associated with the appearance of autoantibodies; 2) to evaluate the incidence and the time of autoantibody appearance in a French population of genetically at-risk children; 3) to compare the incidence of autoantibodies between infants born to T1D fathers and mothers.

Eligibility Criteria:
Inclusion Criteria:

1. Mother and/or father with type 1 diabetes

   * age \> 18 years
   * type 1 diabetes : insulin-dependent diabetes positive for autoantibodies against insulin and/or GAD and/or IA-2 and/or ZnT8 at the time of diagnosis
   * planning to give birth or having given birth since less than 8 months
   * agreeing to participate upon written informed consent
   * covered by the French social security system
2. Mother/father without Type 1 diabetes

   * age \> 18 years old
   * with a spouse with type 1 diabetes : insulin-dependent diabetes positive for autoantibodies against insulin and/or GAD and/or IA-2 and/or ZnT8 at the time of diagnosis
   * planning to give birth or having given birth since less than 8 months
   * agreeing to participate upon written informed consent
   * covered by the French social security system
3. Children born to mother and/or father with type 1 diabetes

   * age \< 8 months
   * with at least one parent with T1D
   * with both parents agreeing to participate
   * both parents covered by the French social security system

Exclusion Criteria:

1) Mother/father

* secondary forms of diabetes
* monogenic forms of diabetes

  1 or 2) For the mother
* malignant neoplastic or psychiatric disease

  3 ) Newborns of mother/father with type 1 diabetes
* Severe foetal disease
* Severe congenital malformation
* Congenital measles
A Clinical Trial of the Study Medicine (Called Fosmanogepix) in Participants With Varying Degrees of Hepatic Function.

The primary purpose of this open-label study is to characterize the plasma pharmacokinetics (PK) of manogepix (active moiety of fosmanogepix) in participants with varying degrees of hepatic function following administration of a single oral dose of fosmanogepix.

All participants will receive 1 dose of fosmanogepix by mouth before breakfast on the first day at the study clinic. Serial blood samples will be collected to understand how fosmanogepix is changed and eliminated from the body. Participants will also receive physical examination and other tests. This will help to understand if fosmanogepix is safe.

Participants will be involved in this study for 4 to 9 weeks (maximum). There will be 2 to 4 study visits at the study clinic.


Eligibility Criteria:
Key Inclusion Criteria:

* Body mass index (BMI) of 17.5 to 40.0 kg/m2 (42 kg/m2 for participants of Cohort 3), inclusive; and a total body weight greater than 50 kg (greater than 110 lb)
* For participants with hepatic impairment (Cohorts 1-3): Stable hepatic impairment that meets the criteria for Class A, B, or C of the Child Pugh classification with no clinically significant change in disease status within the 28 days prior to the screening visit
* For participants with normal hepatic function (Cohort 4): No clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests
* Stable concomitant medications for the management of individual participants' medical history

Key Exclusion Criteria:

* Any condition possibly affecting drug absorption (eg, prior bariatric surgery, gastrectomy, ileal resection);
* Ongoing medical history of neurological disorders including abnormal movements or seizures (Note exception: stable history of peripheral neuropathy);
* Hepatic carcinoma or hepatorenal syndrome or limited predicted life expectancy;
* A diagnosis of hepatic dysfunction secondary to any acute ongoing hepatocellular process that is documented by medical history, physical examination, liver biopsy, hepatic ultrasound, computerized tomography scan, or MRI;
* Signs of clinically active Grade 2, 3 or 4 hepatic encephalopathy (ie, equal or greater than Grade 2 Portal Systemic Encephalopathy score)
Administration of Subanesthetic Dose of Ketamine and Electroconvulsive Treatment for Treatment Resistant Depression

In this proof of concept study, the investigators plan to administer iv ketamine interleaved with ECT days.

Patients with treatment resistant depression who are deemed to be eligible for ECT treatment will randomly be assigned to either ketamine or active placebo.

The study will compare the effects of standard ketamine dosing with an active placebo arm.

Hypothesis 1:

The investigators hypothesize that interleaved Electroconvulsive Treatment and active ketamine treatment will lead to a meaningful clinical improvement compared to Electroconvulsive Treatment and placebo treatment arm.

Hypothesis 2:

The investigators hypothesize that interleaved Electroconvulsive Treatment and active ketamine treatment will attenuate cognitive side effects.

Methods and Design:

Patients with treatment resistant depression who are deemed to be eligible for Electroconvulsive Treatment will randomly be assigned to either ketamine or active placebo

Electroconvulsive Treatments:

All patients (independent of their depression scores) will receive the same Electroconvulsive Treatment parameters: Bi-frontal brief pulse (0.5 miliseconds) Electroconvulsive Treatment administered by using Thymatron Electroconvulsive Treatment machine.

Study blinding:

Neither the patients, nor the treating psychiatrist or the nurse will be aware of the patient's assigned arm. The success of blinding will be tested after each ketamine treatment with a questionnaire given to the subject, raters, and treating physician.

Eligibility Criteria:
Inclusion Criteria:

1. Males/females at least 18 years of age but no older than 65 years of age
2. Meet Diagnostic and Statistical Manual of Mental Disorders-4th Edition (DSM-IV) criteria for Major Depression or Bipolar Disorder, depressed phase, as determined by a clinician's diagnostic evaluation and confirmed by interview using the Mini International Neuropsychiatric Interview (MINI PLUS 5.0.0)
3. A current depressive episode that has lasted a minimum of 4 weeks.
4. Have \> 3 trials of antidepressants/augmentation strategies.
5. Have a support system capable of transporting the patient post-treatment.

Exclusion Criteria:

1. Meeting Diagnostic and Statistical Manual of Mental Disorders criteria for schizophrenia, schizophreniform disorder, schizoaffective disorder, mental retardation, pervasive developmental disorder.
2. Meeting Diagnostic and Statistical Manual of Mental Disorders criteria for other substance/alcohol dependence within the past 6 months or abuse in the past 3 months.
3. Patients who meet exclusion criteria for ketamine and/or midazolam infusion.