cyrilzakka/clinical-trials huggingface dataset:
An Exploratory Study to Evaluate the Tolerability and Safety of MWAV201 in Subjects With Wilson Disease

The primary objective of this study is to evaluate the tolerability and safety of MWAV201 in patients with Wilson disease.

This is an open-label, dose escalation study to evaluate the tolerability, safety, and preliminary efficacy of MWAV201 in patients with Wilson disease. Participants will receive a single, peripheral intravenous (IV) infusion of MWAV201. The dose escalation plan and the number of dose levels may be adjusted during study period.

Eligibility Criteria:
Inclusion Criteria:

* Male or female aged 18 and 65 years inclusive;
* Confirmed diagnosis of Wilson disease;
* Low copper diet and standardized medication for ≥ 1 year;
* Stable Wilson disease for ≥ 1 year;
* Able to understand and willing to follow study procedures.

Exclusion Criteria:

* Significant hepatic inflammation as evidenced by liver function test.
* Liver biopsy or liver stiffness measurement show progressive liver fibrosis.
* Laboratory tests or clinical symptoms indicate decreased liver reserve function.
* Other chronic liver disease (such as hepatitis B).
* Any signs of decompensated liver function (such as ascites).
* History of liver transplant or plan to receive liver transplant.
* Other diseases with clinical significance, such as cardiovascular and cerebrovascular diseases, kidney diseases, respiratory system diseases, neurological diseases, mental illnesses, active infections, etc.
* Body Mass Index ≥ 30 kg/m2.
* Other conditions that, in the Investigator's opinion, may not be suitable for the subject to be enrolled.
Long-Term Specified Drug Use-results Survey of Betanis Tablets

This study is to evaluate the safety and efficacy of long-term use of Betanis (generic name: mirabegron), and to determine the adherence to treatment with mirabegron.


Eligibility Criteria:
Inclusion Criteria:

* Patients who administer mirabegron for treatment of urinary urgency, daytime frequency, and urgency incontinence associated with overactive bladder and also who have no treatment history of mirabegron.
DEXYCU (Dexamethasone Intraocular Suspension) 9% Retrospective Study 001

Retrospective study to provide clinical outcomes with DEXYCU (dexamethasone intraocular suspension) 9%.

This retrospective study is intended to provide large-scale, real-world data on clinical outcomes with DEXYCU (dexamethasone intraocular suspension) 9%.

Eligibility Criteria:
Inclusion Criteria

* Male and Female subjects at least 18 years of age
* Subjects who underwent cataract surgery from 12Mar2019 to 15Dec2019 and received DEXYCU

Exclusion Criteria

• Subjects who underwent cataract surgery and did not receive DEXYCU
Remediation Program Via a "Serious Game" for the Cognitive Functions of Multiple Sclerosis Patients

The main goal of this study is to assess the effectiveness of a cognitive remediation program based on a "serious game" on the information processing speed evolution and the process of learning via episodic memory in multiple sclerosis patients.

Cognitive impairment affects 40 to 70% multiple sclerosis patients. This condition is characterized by slower information processing, associated with deficits in episodic memory, attention and executive functions. These disorders appear early, regardless of functional impairment, in "benign" forms and in clinically isolated syndromes of multiple sclerosis. These disruptions can have a significant impact in the socio-professional and personal life of patients and also in the quality of life (job loss risks, daily activities limitations).

Even if these disorders are now well documented, remediation strategies remain less studied. Some studies show that the "training" methods, often used, do not seem suitable for clinical monitoring, with benefits that do not persist over time. Despite their impact on daily life, no specific care for planning abilities, mental inhibition and flexibility, or even social cognition, have been well studied until today. The same is true concerning metacognitive abilities. Finally, remedial techniques are time consuming and difficult to adapt to patients still in professional activity.

Eligibility Criteria:
Inclusion Criteria:

* Relapsing-remitting or progressive multiple sclerosis people defined according to Mc Donald's criteria revised in 2005
* Age between ≥ 18 and ≤ 65 years old
* Cognitive complaint, with at least one deficient score at the initial neuropsychological examination (\<5th percentile of the reference group), one of the scores of which concerns at least one BICAMS test
* Have not had a definite relapse for at least 6 weeks
* Be at least 4 weeks away from a corticosteroid bolus
* Lack of neuroleptic treatment
* Patient with an Internet connection
* Signed informed consent

Exclusion Criteria:

* Severe cognitive deficit defined by obtaining a deficit score in more than six cognitive processes at the initial neuropsychological assessment.
* Neuropsychological care
* Inability to receive oral and written information
* Inability to use the software (due in particular to motor and / or sensory difficulties),
* Neurological or psychiatric comorbidity, other than MS and anxiodepressive syndrome
* Patient with severe anxiodepressive syndrome (BDI\> 27)
* Participation in an interventional study on cognitive functions
* Patient under legal protection, guardianship or curatorship
* Pregnant or breastfeeding women
Comparison of Veliparib and Whole Brain Radiation Therapy (WBRT) Versus Placebo and WBRT in Adults With Brain Metastases From Non-Small Cell Lung Cancer

The primary objective of this study is to evaluate the efficacy and safety of veliparib and whole brain radiation therapy in adults with brain metastases from non-small cell lung cancer (NSCLC).


Eligibility Criteria:
Inclusion Criteria:

* Subject must have cytologically or histologically confirmed non-small cell lung cancer
* Subject must have brain metastases demonstrated on a magnetic resonance imaging (MRI) brain scan.
* Subject must be eligible for treatment with WBRT
* Subject must have had adequate hematologic, renal, and hepatic function.

Exclusion Criteria:

* Subject is diagnosed with brain metastases greater than 28 days prior to Day 1
* Subject received any prior form of cranial radiation and/or neurosurgery for their brain metastases
* Subject's last dose of anti-cancer therapy or investigational therapy was less than or equal to 7 days prior to Day 1
* Subject has a Karnofsky Performance Score of less than 70
* Subject has significant dyspnea requiring supplemental oxygen therapy
* Subject has liver metastases (restaging is not required for known liver metastases)
* Subject has more than 2 sites (organ systems) of metastases from non-small cell lung cancer with the exception of intra-cranial sites of metastases from non-small cell lung cancer, thoracic sites of metastases from non-small cell lung cancer and bone metastases
* Subject has leptomeningeal metastases or subarachnoid spread of tumor
* Subject has unresolved or unstable, serious toxicity from prior administration of another investigational drug and/or prior anti-cancer treatment
* Subject has a known seizure disorder that is uncontrolled, or has seizures occurring greater than or equal to 3 times a week over the past month. Subjects presenting with symptoms of seizures from the brain metastases are eligible; however he/she should receive adequate anti-seizure medication prior to study treatment
* Subject is pregnant or lactating
* Subject has previously been treated with a poly-(ADP-ribose)-polymerase inhibitor as an investigational agent
* Subject has clinically significant and uncontrolled major medical condition(s)
* Subject has a history of another active cancer within the past 5 years except: cervical cancer in situ, in situ carcinoma of the bladder, basal or squamous cell carcinoma of the skin or other cancer in situ that is considered cured
Rehab After Hip Fracture With Wearable Device

A randomized control trial, including two intervention arms with different methods for rehabilitation after hip fracture, conducted among persons with the need of rehabilitation in their own home.

The increase of the aging population challenges health care providers. Fragility, oste-oporosis, and impaired balance are some major risk factors for hip fracture, an injury causing morbidity, mortality, and loss of independent life. This study aims to study if adding continuous measures of body positions and movements 24 hours a day with an Inertial Measurement Unit (IMU) can, compared to standard rehabilitation alone, optimize rehabilitation after hip fracture. The study is designed as a randomized controlled trial. Patients with hip fracture that require rehabilitation at home, will be invited to participate in the study. Those who accept to participate will randomly be assigned to intervention- or control group. The intervention comprises standard rehabilitation and continuous measures of body positions and movements 24 hours a day with an IMU. Standard rehabilitation comprises of home-visits by a PT, where an individualized rehabilitation plan is outlined together with the patient. The plan includes individually tailored functional exercises. The plan also includes individually tailored walking exercises, indoor and outdoor when possible. At each home visit, the PT provides feedback to the participant based on the data from the IMU, i.e. body positions (time spent in sitting, standing, lying down) and body movements (steps per day, step length, walking speed, sideway deviation during walking). The control group receives standard rehabilitation only. The primary outcome is balance, in terms of postural sway measured with the IMU, and functional balance measured with the Functional Balance test for Geriatric patients, secondary outcomes are health-related quality of life, measured with the EQ5D, functional independence in everyday activities, measured with the Barthel Index, fear of falling, measured with the Falls Efficacy Scale International, satisfaction with rehabilitation, measured with a single question, and compliance to the intervention .

Eligibility Criteria:
Inclusion Criteria:

* patients with a hip fracture, living in Malmö, and who are unable to visit a rehabilitation facility and therefore request treatment at home. Another inclusion criterion is the ability to read and understand the Swedish language or the ability to understand information through an interpreter.

Exclusion Criteria:

* the presence of major neurological diseases that have an impact on balance and walk-ing ability; a diagnosed cognitive disease, or moderate to severe cognitive impairment as assessed by a physiotherapist
Effectiveness of Adherence Therapy for Schizophrenia

When compared with those in the control (usual care) group, participants in the AT group are expected to demonstrate significant improvements immediately and at three, six and 12 months after completion of the intervention in: level of medication adherence, readmission rate, mental status, insight into treatment, and level of functioning.

When compared with those in the control (usual care) group, participants in the AT group are expected to demonstrate significant improvements immediately and at three, six and 12 months after completion of the intervention in the following aspects:

1. level of adherence to antipsychotic medication,
2. rate and length of psychiatric hospital readmission,
3. mental status,
4. insight and attitude into illness and treatment, and
5. level of functioning.

The primary outcomes are level of antipsychotic medication adherence, re-hospitalization rates and mental status; and the patients' drug attitude will be the mediating factor of the AT.

Eligibility Criteria:
Inclusion Criteria of the patients include those who:

* are Hong Kong Chinese residents;
* have a primary diagnosis of schizophrenia or its subtypes such as schizophreniform and schizoaffective disorders not more than 3 years;
* have been prescribed oral antipsychotics for at least 1 month;
* are aged 18-65 years;
* have Positive and Negative Syndrome Scale (PANSS) score \>60 and are judged by the case Community Psychiatric Nurse/psychiatrist as non-adherents; and
* are able to understand Cantonese/Mandarin.

Patients will be excluded if they have:

* only depot/intramuscular injections as regular psychiatric medication;
* co-morbidity of learning disability and organic brain disease, or clinically significant medical diseases;
* participated in adherence therapy; and/or
* visual, language or communication difficulty.
ITT-5 Mechanisms of Spermatogenesis in Man

The purpose of this investigational drug study is to determine how much male hormone, testosterone, is needed to maintain sperm production in the testis.

This is a nine-month research study examining the effects on androgen treatment on sperm production in healthy men. There are three phase to the study, a 2-month screening phase, 4-month treatment and 3-month follow-up. In this study, the investigators aim to define a quantitative relationship between intra-testicular testosterone (IT-T) and spermatogenesis in man. Hormone levels will be measured in a small amount of testicular fluid at the beginning and end of treatment and sperm concentration will be measured.

Eligibility Criteria:
Inclusion Criteria:

* Males age 18-55
* In general good health based on normal screening evaluation
* Normal serum testosterone, lutenizing hormone (LH) and follicle stimulating hormone (FSH)
* Prostate Specific Antigen (PSA) \< 3.0
* Agrees not to donate blood or participate in another research study during the study
* Informed consent
* Must be willing to use a reliable form of contraception during the study

Exclusion Criteria:

* Participation in a long-term male contraceptive study within the past three months
* History of testosterone or anabolic steroid abuse in the past
* History of or current skin disorder that will interfere with testosterone gel
* Poor general health or significantly abnormal screening blood results
* History of or current testicular or prostate disease
* History of a bleeding disorder or need for anticoagulation
* History of untreated sleep apnea and/or major psychiatric problems
* BMI \> 32
* History of or current liver disease
* Chronic pain syndrome
* Current use of terfenidine, astemizole, cisapride, budesonide, felodipine, fluticasone, lovastatin, midazolam, sildenafil, or vardenafil
* Use of glucocorticoids or underlying adrenal insufficiency
* Active drug or alcohol abuse within the past year
Effects of Parathyroid Hormone in Men With Osteoporosis

Alendronate is a drug that blocks or reduces bone loss, while parathyroid hormone (PTH) stimulates the formation of new bone. The purpose of this study is to compare the bone-building effects of PTH alone, alendronate alone, and both PTH and alendronate in men with osteoporosis over a two-and-a-half year period.

Osteoporosis causes bones to weaken and break more easily. Alendronate is used to treat or prevent osteoporosis. PTH is a protein hormone that increases the calcium and phosphorus release from bone, leading to formation of new bone. This study will examine the changes in bone density measured at multiple places in the skeleton and changes in chemicals in the body that indicate bone breakdown and bone formation. The study will indicate whether some breakdown of bone is required for PTH to have an overall bone-building effect in men.

Participants will be randomly assigned to receive PTH alone by daily injection under the skin, alendronate alone taken by mouth, or both PTH and alendronate. The study will last 2.5 years. All participants will receive some form of treatment for osteoporosis. Blood, urine, and bone density tests will be performed at 6-month intervals. During the first 6 months, participants will come in for additional study visits.

Participants who complete the initial 2.5 years of their assigned treatment will be eligible for a 12 month extension to monitor bone density and bone turnover after PTH is stopped. Participants who were receiving alendronate will continue taking alendronate. The goal of this extension is to determine what happens to bone density and turnover after PTH is stopped and whether alendronate is needed to prevent loss of PTH-induced bone gain.

Participants who complete the 12 month extension while on their assigned treatment will be eligible for a second 12 month extension in which all participants receive PTH therapy. Participants who have been receiving alendronate continue taking alendronate. The goal of the second extension is to determine if responsiveness to PTH is enhanced by a 12 month suspension of PTH treatment.

Eligibility Criteria:
Inclusion Criteria:

* Bone density of the spine or femoral neck two standard deviations below the mean of young adult men
* Normal renal and liver function tests, normal serum testosterone level, normal vitamin D and PTH levels

Exclusion Criteria:

* Significant cardiac, renal, hepatic, or malignant disease.
* Disorders (e.g., Paget's disease, hyperthyroidism, hyperparathyroidism) or drugs (e.g., steroids, anticonvulsants, lithium, bisphosphonates, calcitonin, fluoride) known to affect bone metabolism
* Active peptic ulcer disease or severe reflux
Inflammatory Biomarkers and Brain Metabolites, a Study Based on Magnetic Resonance Spectroscopy

Suicidal behaviors (SB) are a major health problem in France : 10 000 suicides and 220 000 suicide attempts every year. SB management is therefore a major public health issue.

Evidence associated dysregulation of the serotonergic system and the hypothalamic-pituitary-adrenal axis to vulnerability to SB. Recent data point to linke these abnormalities with neuroinflammatory clues, glutamatergic function and neuronal plasticity. There is a need to better understand the physiopathology and develop diagnostic and therapeutic tools in SB.

The investigators hypothesize that increased peripheral biomarkers of inflammation would correlate to a disturbance of the cerebral metabolites, such as glutamate and NAA, especially in suicidal patients.

Our aim is to compare rates of cerebral metabolites, in particular the complex glutamine/glutamate, in cerebral areas involved in suicidal vulnerability (the anterior cingulate cortex and the orbito-frontal cortex) between person with unipolar disorder with and without suicidal attempt.

69 patients : 23 with suicidal thoughts and attempt, 23 with suicidal thoughts without attempt and 23 healthy volunteers.

2 visits :

* Inclusion visit (V0) : (Day 1)

  o Clinical interview : self and hetero assessment questionnaire
* Visit V1 (as soon as possible, day 1 if available) :

  * MRI (spectroscopy)

Eligibility Criteria:
Non-specific inclusion criteria:

* Having signed informed consent
* Able to understand nature, aims and methodology of the study

Specific inclusion criteria :

* Suicidal patient with suicide attempt :

  * Persistent depressive disorder according to the Diagnostic and Statistical Manual of Mental Disorders - V (DSM-V) criteria, and evaluated by the Mini International Neuropsychiatric Interview (MINI)
  * Hamilton Depression Scale \> 7
  * Suicide attempt \< 1 week
* Suicidal patient without suicide attempt :

  * Persistent depressive disorder according to the Diagnostic and Statistical Manual of Mental Disorders - V (DSM-V) criteria, and evaluated by the Mini International Neuropsychiatric Interview (MINI)
  * Hamilton Depression Scale \> 7
  * No history of suicide attempt
* Healthy volunteers :

  * No psychiatric history
  * No history of suicide attempt

Exclusion criteria:

* Actual somatic, neurological or inflammatory pathology (C-Reactive Protein \> 10mg/L)
* Traumatic brain injury with loss of consciousness
* Antibiotic treatment or anti-inflammatory treatment
* Actual toxic abuse according to DSM-V (except tobacco and alcohol)
* Actual or passed history of psychotic disorder
* Patient on protective measures (guardianship or trusteeship)
* Deprived of liberty subject (judicial or administrative decision)
* Pregnant women or breastfeeding
* Contraindications to MRI scan
Peer Online Motivational Interviewing for Sexual and Gender Minority Male Survivors

The study will conduct a randomized comparative effectiveness trial of peer-facilitated, online, 6-week group Motivational Interviewing (MI) vs. Motivational Interviewing (MI) with a trauma-informed Sexual and Gender Minority (SGM) affirmative care approach.

Through workshops and ongoing supervision/consultation, researchers will train MaleSurvivor peer leaders to competently deliver both versions of MI and conduct a randomized controlled trial comparing the two versions of MI to enhance treatment engagement in SGM male survivors with mental health problems. All SGM male survivors who meet inclusion criteria, including significant emotional distress, will complete pre-test measures and be randomized to 6-week MI delivered by peers in online groups or 6-week MI with trauma-informed, SGM affirmative care delivered by peers in online groups. Randomization will be counterbalanced by treatment status: treatment naive versus treatment-experienced (prior treatment but not within the past 60 days).

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* English-speaking; men who have sex with men or individuals identifying as SGM males
* Individuals who report a history of sexual abuse and individuals who self-report a minimum cut-off score of 3.0 or higher on emotional distress, using a 4-question symptom inventory.

Exclusion Criteria:

* Individuals who endorse active psychosis
* Individuals who have a cognitive dysfunction
* SGM men who report that they are currently in formal mental health counseling
Phase I Study of HAL Formulations Applied to the Cervix in Healthy Volunteers

The purpose of the study is to determine the most effective formulation of HAL for release of hexaminolevulinate to the cervical epithelium at different doses.


Eligibility Criteria:
Inclusion Criteria:

* Healthy, pre-menopausal female volunteers

Exclusion Criteria:

* Acute or chronic disease which could influence the study results
Utilizing 3D Imaging for Burn Wound Assessment

The goal of this prospective cohort study is to determine if the DermaMonitor camera can accurately determine burn size in patients with 1st, 2nd, or 3rd degree burns, with exploratory aim of testing a new Artificial Intelligence (AI) program for determining burn depth. The main aims are:

1. The primary aim of this study is to assess an objective process for the classification of burn size using the DermaMonitor wound camera.
2. An exploratory aim of this study is to begin to train an Artificial Intelligence (AI) program to classify burn depth (1st, 2nd, 3rd degree) using the 3D images from this novel wound camera.

Researchers will compare DermaMonitor size classification and AI depth classification to clinician determinations. Participants will have images taken of their burn. Participation ends when the images are taken.


Eligibility Criteria:
Inclusion Criteria:

* Adults sustaining burns
* Outpatients
* No prior surgery on the wounds
* No known infection of the wounds

Exclusion Criteria:

* Burns to the face or sensitive areas (genitals)
* Burns located on or near identifying landmarks such as tattoos or birthmarks
* Non-English speaking patients
* Patients unable to sign their name
* Burn occurred greater than 7 days prior to clinic visit
* Age greater than 90 (Patient age is sent externally to IKO, to ensure no PHI is sent, patients with an age \>90 will not be enrolled)