cyrilzakka/clinical-trials huggingface dataset:
Study to Examine the Safety and Efficacy of Pimavanserin for the Treatment of Agitation and Aggression in Alzheimer's Disease (SERENE)

To evaluate the efficacy of pimavanserin compared with placebo in treatment of agitation and aggression after 12 weeks of treatment


Eligibility Criteria:
Inclusion Criteria:

1. Male or female, 50 years of age or older
2. Can understand the nature of the trial and protocol requirements and provide signed informed consent

   * from patient, if deemed competent to provide consent
   * from an appropriate person (e.g. patient's Legally Authorized Representative (LAR) with the patient's assent) if patient is deemed not competent to provide informed consent.
3. Has a diagnosis of probable AD according to the National Institute on Aging-Alzheimer's Association (NIA-AA) guidelines
4. Meets criteria for agitation according to the International Psychogeriatric Association (IPA) guidelines
5. Lives at home or in an assisted living or care facility (but has the capacity to visit the clinic as an outpatient). Subjects must have been at their current location for at least 3 weeks prior to Screening and plan to remain at the same location for the duration of the trial.
6. Has a designated study partner/caregiver who is in contact with the patient at least 3 times a week on 3 separate days
7. Female patients must be of non-childbearing potential or must agree to use an acceptable method of contraception or abstinence , for at least 1 month prior to randomization, during the study, and 1 month following completion of the study
8. The patient and caregiver are willing and able to participate in all schedule evaluations and complete all required tests

Exclusion Criteria:

1. The agitation/aggression is attributable to concomitant medications, environmental conditions, substance abuse, or active medical or psychiatric condition
2. Patient is receiving skilled nursing care for any medical condition other than dementia
3. Treatment with an antipsychotic medication within 2 weeks of Baseline visit or 5 half lives, whichever is longer
4. Patient or study partner/caregiver has a medical condition (e.g., hearing, vision impairments) that would impair the ability to perform the study assessments.
5. Has had a myocardial infarction within the last six months
6. Has a history or symptoms of long QT syndrome
7. Has a history of a significant psychotic disorder before or during the diagnosis of probable Alzheimer's disease (including, but not limited to schizophrenia or bipolar disorder)
8. Patient is bedridden or has any significant medical condition that is unstable and would place the patient at undue risk from study drug or study procedures 9. Has a sensitivity to pimavanserin or its excipients

10. Has previously participated in a clinical study with pimavanserin

11. Has a Global Clinician Assessment of Suicidality (GCAS) score of 3 or 4 based on Investigator's assessment of behavior within the last 3 months at Screening or since last visit at Baseline
Evaluation of Osteoporosis Support After a Severe Osteoporotic Fracture in Women Over 50 Years in University Hospital

Evaluate the support of osteoporosis in women over 50 years with severe osteoporotic fractures (hip, vertebral, rib, Humeral, pelvic fractures) in the Nîmes University Hospital taking prediction of treatment of osteoporosis as criterion.


Eligibility Criteria:
Inclusion Criteria:

* patients over 50 years (\> 50 years) with severe osteoporotic fractures (hip, vertebral, rib, Humeral, pelvic fractures) hospitalized in the Nîmes University Hospital

Exclusion Criteria:

* patient under 50 years
* Non osteoporotic fractures
Residual Exacerbations With Mepolizumab

This will be a two-year prospective study to characterize the nature of the remaining asthma exacerbations in patients treated with mepolizumab. Participants will be assessed every six months from pre- until two years of treatment in addition to whenever they experience an exacerbation of asthma during the study period. During these visits, various clinical, physiological and inflammatory outcomes will be assessed.

Before initiation of mepolizumab, a recording of patient's demographics, clinical, physiological and inflammatory features will be recorded. All subjects will be reassessed for the above measures at 6, 12, 18 and 24 months.

In addition to the above visits, patients will be assessed every time they experience either moderate or severe exacerbation of asthma over the treatment period.

Based on the percentage of sputum eosinophils and neutrophils, the type of inflammatory exacerbation will be determined

Eligibility Criteria:
Inclusion Criteria:

* With a proven diagnosis of severe asthma as defined by the Canadian Thoracic Society
* Eligible for mepolizumab treatment
* Able and willing to sign the informed consent form

Exclusion Criteria:

* Any respiratory disease apart from asthma
* Confounding comorbidities sur as eosinophilic granulomatosis with polyangiitis (EGPA) or hypereosinophilic syndrome
Evaluation of 3 Different Doses of IV Busulfan

Albeit the safety of the stem cell transplantation procedure has been greatly improved, further refining the intensity of the conditioning is an important issue to explore, especially in patients with poor prognosis, the goal being to maintain the very favorable safety profile and improve the disease control. This is the goal our prospective trial; we aim to prospectively evaluate in a prospective multicenter trial the efficacy of different conditioning regimens in patients with high-risk myeloid malignancies.

The study is a phase II trial randomizing patients between a prospective active control arm (BX2) and two experimental arms (BX3 and BX4). A standard group was kept in this clinical trial in order to avoid the limitations induced by the comparison with historical controls in the context of continuously improving practice. Each experimental arm will be conducted in parallel according to a standard phase II trial design.

In addition, this trial will associate four ancillary studies to the main clinical objective: 1/ a prospective assessment of the quality of life of the patients over a period of 2 years 2/ an analysis of the cost effectiveness of the procedure, assessed over a period of 2 years 3/ an observational busulfan pharmacokinetic study 4/ a busulfan pharmacogenomic study


Eligibility Criteria:
Inclusion Criteria:

1. Patients with poor prognosis myeloid malignancies:

   * Myelodysplastic syndrome,
   * Acute Myeloid Leukemia (AML) beyond Complete Response (CR1),
   * CR1 AML with poor risk cytogenetics
2. Adult patients: aged ≥ 55 years up to 65 or \< 55 years not eligible for myeloablative conditioning regimen based on Total Body Irradiation (TBI) or double alkylating agent combinations.
3. Availability of a HLA identical sibling or matched unrelated donor (10/10)
4. Affiliation to social security
5. Written Informed Consent

Exclusion Criteria:

1. History of previous Allo-Hematological Stem Cell Transplantation (HSCT)
2. HIV positivity
3. Signs of chronic active hepatitis B and/or C
4. Evolutive psychiatric disease
5. Concomitant neoplastic disease
6. Pregnant or lactating woman or without contraception (for child bearing potential wom-en)
7. Usual contra-indications for Allo-HSCT
Phase 1 Study of OLZ/SAM in Pediatric Subjects With Bipolar I Disorder

To evaluate the safety, tolerability, and pharmacokinetics of olanzapine and samidorphan in clinically stable pediatric subjects (10 to 12 years old) with Bipolar I disorder following oral administration of multiple ascending doses of OLZ/SAM


Eligibility Criteria:
Inclusion Criteria:

* Subject's parent(s)/legal guardian(s) is considered reliable by the Investigator and has agreed to provide support to the subject to ensure compliance with study treatment, visits, and protocol procedures.
* Male and female subjects between 10 and 12 years of age, inclusive.
* Subject weighs ≥70 pounds.
* Subjects who are receiving antipsychotic treatment for their medical condition, with a diagnosis of bipolar I disorder.
* Subjects must be considered stable, per investigator judgement.
* Subject is willing to abide by the contraception requirements for the duration of the study.

Exclusion Criteria:

* Subject has a comorbid neuropsychiatric disorder that could interfere with participation in the study.
* Subject poses a current suicide risk as assessed by the Investigator or as confirmed by the baseline Columbia-Suicide Severity Rating Scale by a response of "Yes" to question numbers 4 or 5 with ideation or suicidal behavior occurring in the past 12 months (assessed at Screening and at Visit 2, Day 1).
* Subject has a diagnosis of diabetes or presents with pre-diabetes lab results (hemoglobin A1c ≥6%).
* Subject has a history of use of clozapine or use of long-acting injectable antipsychotic medication within 3 months prior to Screening.
* Subject has a DSM-5 (Diagnostic and Statistical Manual of Mental Disorders-5) diagnosis of moderate to severe alcohol disorder, or moderate to severe substance use disorder, within the 3 months prior to Screening.
* Subject has taken opioid agonists within the 14 days prior to Screening, or has taken long-acting opioid agonist within the 30 days prior to Screening, or has anticipated a need to take opioid medication during the study period (eg, planned surgery, including oral surgery), or has taken opioid antagonists including naltrexone (any formulation) and naloxone within 60 days prior to Screening.
* Subject is unable to swallow oral medications, as assessed by the Investigator.
* Subject has a positive urine drug screen for opioids (assessed at Screening and at Visit 2, Day 1).
* Subject has a positive cotinine test (assessed at Screening and at Visit 2, Day 1).
* Subject has an intellectual disability, as assessed by the Investigator.
* Subject has a history of intolerance or hypersensitivity to olanzapine or opioid antagonists, or any component of the study drug.
Continuous Glucose Monitoring for Women With Diabetes Mellitus in the Intrapartum and Postpartum Inpatient Care

Diabetes mellitus affects roughly 8% of pregnancies and is associated with significant perinatal and maternal morbidity. Increasing numbers of women are either entering pregnancy with a continuous glucose monitor (CGM) or are initiating use during pregnancy, with data emerging suggesting improved outcomes among those using CGM. Since the introduction of CGM in the late 1990s, there has been slow acceptance of their validation and use in the inpatient setting. The investigators propose an observational prospective cohort study to analyze the correlation of CGM data with traditional capillary glucose readings in the intrapartum and postpartum settings.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-50 years
* Women with a viable singleton or twin intrauterine pregnancy between 22 5/7 and 41 6/7 weeks gestation based on the best obstetric estimate by ACOG criteria
* Diagnosis of insulin-dependent pregestational diabetes mellitus (type 1 or type 2 diabetes)
* Planning to deliver at OSU Wexner Medical Center
* Able to understand the study, and having understood, provide written informed consent in English

Exclusion Criteria:

* Gestational diabetes mellitus, Maturity Onset Diabetes of Young, and Cystic Fibrosis Related Diabetes
* Abnormal obstetrical ultrasound suspicious for major congenital abnormality
* Known or suspected fetal aneuploidy (by either CVS, amniocentesis, or cell-free DNA)
* Participation in another trial that may influence the primary outcome, without prior approval
* Participation in this trial in a prior pregnancy
* Higher order pregnancy
* History of severe skin allergy to adhesive products or CGM within the previous 3 months
Evaluation of the Impact of the Update SMM Criteria on the Natural History of SMM to Establish New Recommendations.

This study is a prospective open label interventional multicenter study evaluating the impact of the update multiple myeloma criteria on the natural history of smoldering myeloma in order to establish new recommendations about follow up and prognostic evaluation of smoldering myeloma.

In 2014, the International Myeloma Working Group (IMWG) proposed a revised classification of multiple myeloma (MM) and smoldering myeloma (SMM). Since the new definition of SMM proposed excludes "ultra-high risk SMM", the evolution profile of SMM will change. Therefore, investigators need to update their knowledge of SMM to optimize the management of patients. This project is expected to describe more precisely the new landscape of SMM.

The results will help to establish new recommendations for the standard care of SMM and especially for defining accurate follow-up and risk stratifying.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years.
* SMM defined by IMWG 2014 criteria

  1. Serum monoclonal protein (IgG or IgA) ≥30 g/L and/or urinary monoclonal protein ≥500 mg per 24 h and/or clonal bone marrow plasma cells 10-60%
  2. Absence of myeloma defining events or amyloidosis
* Diagnosed less than 1 year before the inclusion
* Able and willing to give valid written informed consent. Patients must give written informed consent (IC) in accordance with institutional and local guidelines.

Exclusion Criteria:

* Previous antimyeloma treatment including bisphosphonates
* Second Primary Malignancy and/or auto-immune disease treated by immunosuppressive drugs.
* Evidence of end organ damage that can be attributed to the underlying SMM:

  1. Hypercalcaemia: serum calcium \>0.25 mmol/L (\>10 mg/L) higher than the upper limit of normal or \>2.75 mmol/L (\>110 mg/L)
  2. Renal insufficiency: creatinine clearance \<40 mL/min or serum creatinine \>177 μmol/L (\>20 mg/L)
  3. Anaemia: haemoglobin value of \>2 g/dL below the lower limit of normal, or a haemoglobin value \<10 g/dL
  4. Bone lesions: one or more osteolytic lesions on skeletal radiography, CT, or Positron Emission Tomography-Computed Tomography (PET-CT)
* Presence of one of the following biomarkers of malignancy:

  1. Clonal bone marrow plasmocytosis ≥60%
  2. Involved/uninvolved serum Free Light Chain (FLC) ratio ≥ 100 (The involved free light chain must be ≥100 mg/L)
  3. Presence of one or more focal lesions on MRI studies (each focal lesion must be 5 mm or more in size)
* History of malignancy other than SMM within 3 years before inclusion
* Amyloidosis
* POEMS syndrome
* Contraindication to MRI
* Pregnancy
* Nursing mother
* Legally protected adults (under judicial protection, guardianship, or supervision)
Preoperative Administration of Lugols Solution in Toxic Thyroid Diseases (TD): A Prospective Study

Lugol's solution and other preparations containing iodide have been used as an adjuvant treatment in patients with toxic disease planned for thyroidectomy. However, no conclusive evidence supporting the benefits of preoperative treatment with LS for patients with toxic goiters. This trial aims to provide new insights into future recommendations.


Eligibility Criteria:
Inclusion Criteria:

* Patients ≥18 years of age
* Toxic thyroid disease, treated with antithyroid drugs, euthyroid and proposed for total thyroidectomy
* Written informed consent

Exclusion Criteria:

* prior thyroid or parathyroid surgery,
* hyperparathyroidism that requires associated parathyroidectomy,
* thyroid cancer that requires adding a lymph node dissection,
* iodine allergy,
* consumption of lithium or amiodarone,
* medically unfit patients (ASA-IV),
* breastfeeding women,
* preoperative vocal cord palsy and
* planned endoscopic, video-assisted or remote access surgery.
Observational Study of Safety of NovoMix® 30 Treatment for Type 2 Diabetes

This trial is conducted in Europe. The aim of this trial is to evaluate the incidence of serious adverse drug reactions when initiating insulin therapy with NovoMix® 30 in subjects with type 2 diabetes mellitus under normal clinical practice conditions in Sweden.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with type 2 diabetes
Imaging Template for Reporting Anal Fistula

Magnetic resonance imaging (MRI) is the most used diagnostic tool for pre-operative assessment of anal fistula.

However, there is lack of standardization in reporting this investigation. Moreover, reports may miss a number of key information for surgical planning.

The aim of this study is to assess the effectiveness, reproducibility, and acceptability of a new template for reporting anal fistula, which may favor standardization in clinical practice and inform surgical decision making.


Eligibility Criteria:
Inclusion Criteria:

* Adults with primary anal fistula (cryptoglandular or Crohn-related) undergoing MRI

Exclusion Criteria:

* Active cancer of the anorectum
* Recto-vaginal fistula
Effects of JNJ-53718678 in Adult and Adolescent Participants Who Had a Hematopoietic Stem Cell Transplantation and Who Are Infected With Respiratory Syncytial Virus (RSV)

The purpose of this study is to evaluate the effect of JNJ-53718678 on the development of respiratory syncytial virus (RSV) lower respiratory tract infection (LRTIs) in adult hematopoietic stem cell transplant (HSCT) recipients with RSV upper RTI.

RSV is recognized as major respiratory pathogen in infants and young children and causes upper and lower respiratory illness among all age groups, often going undiagnosed. Immunocompromised (IC) participants have a reduced ability to combat infection due to an impaired or weakened immune system. Within the IC population, HSCT recipients are generally regarded as having a particularly high risk for more severe disease caused by RSV, representing a substantial unmet need for antiviral treatment of RSV infections in this participant population. JNJ-53718678 is an investigational, potent, small molecule, respiratory syncytial virus (RSV)-specific fusion inhibitor. The study will include a Screening Period (Day -2 to Day 1), a Treatment Period (Day 1 to Day 21), and a Follow-up Period (1 year). Assessments like chest X-ray, pulse/heart rate, respiratory rate, electrocardiogram (ECG), etc will be performed. Safety and efficacy will be assessed through the study. The total study duration for each participant will be approximately 49 days.

Eligibility Criteria:
Inclusion Criteria:

* Received an autologous or allogeneic hematopoietic stem cell transplant (HSCT) using any conditioning regimen
* Absolute lymphocyte count (ALC) less than (\<) 1,000 cells/microliter (mL)
* Participant has laboratory confirmed RSV diagnosis within 48 hours of randomization
* New onset of at least 1 of the following respiratory symptoms within 4 days prior to the anticipated start of dosing nasal congestion, rhinorrhea, cough or pharyngitis (sore throat), and/or worsening of one of these chronic (associated with previously existing diagnosis, example, chronic rhinorrhea, seasonal allergies, chronic lung disease) respiratory symptoms within 4 days prior to the anticipated start of dosing
* Peripheral capillary oxygen saturation (SpO2) greater than or equal to (\>=) 92 percent (%) on room air

Exclusion Criteria:

* Admitted to the hospital primarily for a lower respiratory tract disease of any cause as determined by the investigator
* Requires supplemental oxygen at Screening or any time between Screening and randomization
* Documented to be positive for other respiratory viruses (limited to influenza, parainfluenza, human rhinovirus, adenovirus, human metapneumovirus, or coronavirus) within 7 days prior to or at the Screening visit, if determined by local SOC testing (additional testing is not required)
* Clinically significant bacteremia or fungemia within 7 days prior to or at Screening that has not been adequately treated, as determined by the investigator
Fiber Formula Study Among Radiation Oncology Patients

During radiation treatment for head and neck cancer a large percentage of patients at Mayo Clinic Rochester develop the need for tube feeding to meet nutrition and hydration needs. These patients are usually taking pain medication along with a stool softener or laxative. Currently, when these patients get a feeding tube it is our standard practice to choose a fiber-free enteral tube feeding formula as to not worsen their constipation. Currently, there are no guidelines as to which patients are good candidates for fiber containing enteral tube feeding formulas. The investigators hope this study will help determine if fiber containing enteral tube feeding formulas can be used for patients undergoing radiation for head and neck cancer without increasing rates of constipation or increasing use of stool softeners/laxatives.

Hypothesis: Participants enrolled in the study will not have increased rates of constipation on fiber-containing enteral tube feeding formula compared to historical standards on fiber-free formula.


Eligibility Criteria:
Inclusion Criteria:

* Cancer of: 1) lip/oral cavity 2) pharynx 3) larynx 4) nasal cavity/paranasal sinus 5) salivary gland 6) Thyroid according to AJCC cancer staging manual 6th edition 2002
* Current radiation therapy or starting radiation therapy in the next 2 weeks
* Patient must have a gastrostomy tube

Exclusion Criteria:

* Jejunostomy tube
* Diagnosis of Irritable Bowel Syndrome (abdominal pain and diarrhea or constipation lasting at least three months in one year)
* Short bowel (A patient is generally considered to have short bowel syndrome when less than 100 to 150 centimeters of functioning small bowel remains)
* Body max index (BMI) \<18.5kg/m2
* Gastroparesis (when the stomach retains food for longer than normal periods). This must be diagnosed with a gastric emptying study.
* Use of Metoclopramide
* Receiving 5-FU chemotherapy
Diclofenac 25mg/Paracetamol 500 mg and Diclofenac 50 mg/Paracetamol 500 mg for Patients With Pain

The purpose of this study is to collect adverse events and identify risk factors in patients that are taking Dolocordralan Extra 25® and Dolocordralan Extra Forte®


Eligibility Criteria:
Inclusion Criteria:

* Patients who are prescribed Dolocordralan Extra 25 and Dolocordralan Extra Forte at any of the participating clinics
* Patients who sign the informed consent form
* Patients who agree to comply with the study procedures

Exclusion Criteria:

* Please see the protocol for further information on exclusion criteria
Drug User Internet and Mobile Tech Use

The purpose of this exploratory study is to examine factors associated with frequency and type of internet and mobile technology use among illegal drug users, specifically use of internet and text-messaging to obtain health care information and engage in health care utilization, specifically human immunodeficiency virus (HIV) prevention and treatment services. We will target high drug activity neighborhoods in New York City and enroll participants recruited through targeted street outreach. All participants (n=336) will undergo an audio computer-assisted self-interview (ACASI) that will assess sociodemographics, health care access and utilization, sex/drug use behavior, health status, and characteristics of general and health-related internet/mobile technology use including factors that promote or hinder use. Participants identified as using the internet ≥1/month (n=151) will return for a 4-week ACASI to report on use of the pilot website (which will largely display information currently available in the community in print/ pamphlet/ video form).

At the enrollment visit participants deemed eligible after screening will be consented, and given a 30 minute baseline ACASI survey. At the end of the baseline visit, those participants who reported internet use at least 1x/month (in the past month) will be offered participation in the Pilot Website Evaluation Component. For this component, participants will be instructed on how to use an educational website with health resources. Their use of the website will be tracked. They will be given an appointment to return in 4-weeks for a follow up survey at the pharmacy and a 2-week locator call.

Eligibility Criteria:
Inclusion Criteria:

* any lifetime illegal drug use
* age \> 18

Exclusion Criteria:

* none