cyrilzakka/clinical-trials huggingface dataset:
A Study to Learn About the Occurrence of ADHD in Adults With Mental Conditions and Their Quality of Life

The main aim of the study is to find out how frequently adults with at least one psychiatric condition have ADHD (but have not been diagnosed with ADHD before) and to describe the quality of life of these adults who have been diagnosed with ADHD. To find out how often ADHD is not diagnosed in these adults could provide awareness about this condition and could help to improve preventing underdiagnosis.


Eligibility Criteria:
Inclusion criteria:

Part I:

* Adult greater than or equal to (\>=)18 years of age or Canadian adult \>=19 years of age
* Ability to consent, as judged by the study investigator
* Diagnosis of at least one psychiatric disorder of at least 12 months duration, based on International classification of diseases (ICD)-10 codes registered in electronic health records
* Consecutive assessment for ADHD (as per routine clinical practice)
* Able to read and write in the first language of the respective country

Part II

* Inclusion in study Part I
* Diagnosis of ADHD during Part I, according to routine diagnostic procedure and algorithms
* Anticipated availability for being followed over 9 months

Exclusion criteria:

Part I:

* Diagnosis of any of the following at any time prior to signing informed consent: schizoaffective disorder, intellectual disability, or other cognitive disorders
* Occurrence of any of the following events within the 6 months prior to signing consent: psychotic episodes, acute intoxication, or psychotropic drug withdrawal syndrome.
* Diagnosis of ADHD at any time before study inclusion
* Serious and unstable medical condition (severe disease that limits survival to 1 year)
* Participation in a clinical interventional trial in the 12 months prior signing consent

Part II:

- Participant being followed-up for ADHD in a different site
Glycerin-Preserved, Human-Donor, Corneoscleral Patch Grafts for Glaucoma Drainage Devices

This was a retrospective, non-comparative study of 100 eyes of 100 consecutive glaucoma patients who had undergone glaucoma drainage device implantation (Baerveldt shunt) during January 2006 to December 2016. Glycerin-preserved, human-donor, corneoscleral tissue was used as a patch graft to cover the tube portion of the GDD over the sclera. The patch graft related complication was comparable to the previous reports using conventional sclera or pericardium.

This retrospective, non-comparative study was conducted at the Department of Ophthalmology, Faculty of Medicine, Siriraj Hospital, Mahidol University, Bangkok, Thailand. The medical records of consecutive patients who had undergone glaucoma drainage device implantation employing the fornix-based conjunctival flap technique and using a glycerin-preserved, human-donor, corneoscleral graft. The procedures were carried out by, or under the supervision of, one surgeon (NK) between January 2006 and December 2016 were reviewed. The study protocol was approved by the Siriraj Institutional Review Board, Faculty of Medicine, Siriraj Hospital, Mahidol University.

Eligibility Criteria:
Inclusion Criteria:

1. Consecutive patients who had undergone glaucoma drainage device implantations between January 2006 and December 2016 at Siriraj hospital by or under supervision of one surgeon (NK).
2. The GDD implantation using glycerin-preserved, human-donor, corneoscleral tissue as a patch graft

Exclusion Criteria:

1.Patients who had follow-up period less than 12 months after operation.
First in Human Study of CDR404 in HLA-A*02:01 Participants With MAGE-A4 Expressing Solid Tumors

CDR404 is a highly potent and specific T-cell engaging bispecific and bivalent antibody designed for the treatment of cancers positive for the tumor-associated antigen melanoma-associated antigen 4 (MAGE-A4). This is a first-in-human study designed to evaluate the safety, tolerability, and preliminary anti-tumor activity of CDR404 in adult patients who have the appropriate germline human leukocyte antigen HLA-A\*02:01 tissue marker and whose cancer is positive for MAGE-A4.

The CDR404-001 Phase 1 study will enrol patients with locally advanced, unresectable or metastatic tumors expressing MAGE-A4, which include advanced solid tumors, and will be conducted in multiple phases:

1. To identify the maximum tolerated dose (MTD) and pharmacologically effective dose range (PEDR) for CDR404
2. To assess preliminary evidence of anti-tumor activity of CDR404
3. To characterise the pharmacokinetics of CDR404
4. To characterise the immunogenicity of CDR404
5. To assess translational biomarkers

Eligibility Criteria:
Inclusion Criteria:

1. Provision of written informed consent
2. HLA-A\*02:01 positive
3. MAGE-A4 positive tumor
4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) \[ECOG PS\] 0 or 1
5. Selected advanced solid tumors
6. Relapsed from, refractory to, or intolerant of standard therapy
7. Measurable disease per RECIST v1.1
8. Adequate organ function
9. If applicable, must agree to use highly effective contraception

Exclusion Criteria:

1. Symptomatic or untreated central nervous system metastasis
2. Inadequate washout from prior anticancer therapy
3. Significant ongoing toxicity from prior anticancer treatment
4. Recent surgery
5. Clinically significant cardiac disease
6. Active infection requiring systemic antibiotic treatment
7. Human immunodeficiency virus (HIV) at risk of acquired immunodeficiency syndrome (AIDS)-related outcomes
8. Active hepatitis B virus (HBV) or hepatitis C virus (HBC)
9. Ongoing treatment with systemic steroids or other immunosuppressive therapies
10. Significant secondary malignancy
11. History of chronic or recurrent active autoimmune disease requiring treatment
12. Uncontrolled intercurrent illness
13. Pregnancy or lactation.
Efficacy and Safety Study of Lumiracoxib in Patients With Primary Hip Osteoarthritis

The purpose of this study is to evaluate the efficacy, tolerability, and safety of the investigational drug, lumiracoxib as compared to celecoxib and placebo in subjects with hip osteoarthritis. Both lumiracoxib and celecoxib belong to the same class of drug (COX-2 selective nonsteroidal anti-inflammatory drugs \[NSAIDs\]).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of primary hip osteoarthritis
* Qualifying pain intensity in the hip joint
* Requiring NSAID therapy

Exclusion Criteria:

* Rheumatoid arthritis or other inflammatory joint disease
* Disease or disorder that may interfere with pain assessment of the hip
* Open knee/hip surgery within the last year
* Past history of heart attack, stroke or angina (chest pain)
* Liver disorder
* History of severe adverse reactions of any kind under lumiracoxib or celecoxib treatment

Other protocol-defined exclusion criteria may apply.
Effectiveness of Accelerated Intervention With Compression Sleeve in Mild and Moderate Breast Cancer-related Lymphedema

The purpose of this study is to determine whether accelerated treatment with custom-made compression sleeve is more effective than standard procedure in the treatment of mild and moderate arm lymphedema secondary to primary cancer treatment.

Use of a custom-made compression sleeve is an initial treatment of mild and moderate arm lymphedema secondary to primary breast cancer treatment. The compression sleeve improves the flow of lymph fluid out of the arm, reduces the swelling, and prevents progression of the lymphedema in the future.

Early intervention is recommended though early is not well-defined in literature. The purpose of this study is to evaluate reduction of excess limb volume and changes in arm disability and clinical symptoms in accelerated treatment with compression sleeve compared to standard treatment.

Eligibility Criteria:
Inclusion Criteria:

* Participants must be refered for the first time due to unilateral arm lymphedema secondary to primary unilateral breast cancer treatment
* Participants must be ≥ 2 months after chemo- and radiotherapy
* Participants must have ELV ≥10% and \< 30% and/or \> 2 cm difference between the circumference of the two arms at minimum one circumference due to lymphedema
* Participants must be motivated for treatment with compression sleeve and -gauntlet
* Participants live in and around Aarhus, Denmark

Exclusion Criteria:

* Known metastatic disease
* Contraindication for treatment with compression sleeve
* Upper extremity deep venous thrombosis
* Previously use of compression sleeve
* Known contact allergy to latex
* Unable to fill in questionnaire and/or comply with treatment due to lacking Danish language skills, mental state or psychological condition
Evaluation of Single Ascending Doses of Subcutaneous Exendin 9-39 in Patients With Post-Bariatric Hypoglycemia

This study is designed to evaluate the safety, efficacy, and pharmacokinetic profile of single ascending doses of exendin 9-39 administered by subcutaneous route in subjects with post-bariatric hypoglycemia.

Post-Bariatric Hypoglycemia (PBH) is a debilitating rare disease afflicting 0.2-6.9% of post-bariatric patients, characterized by repeated severe hypoglycemic episodes with neuroglycopenic symptoms and marked disability. There are no effective medical therapies.

While the cause is not known, exaggerated postprandial secretion of glucagon-like peptide-1 (GLP-1) as a result of altered nutrient transit likely plays a major role. GLP-1 is an incretin hormone secreted primarily by the distal ileum that contributes to postprandial glucose regulation. Exendin 9-39 (Ex9) is a specific GLP-1 receptor antagonist, that when given via continuous IV infusion, has been shown to effectively prevent postprandial hypoglycemia in patients with PBH. Subcutaneous (SC) injection of Ex9 may represent a safe, effective and practical therapeutic approach to treating PBH.

Eligibility Criteria:
Inclusion Criteria:

* Post-bariatric surgery more than 6 months prior to signing the informed consent
* Reported history of Whipple's triad: the occurrence of hypoglycemic symptoms associated with blood glucose of ≤55 mg/dL, and resolution with glucose or carbohydrate administration.
* Symptomatic hypoglycemia during the baseline/screening OGTT, as defined by the presence of plasma glucose ≤55 mg/dL with concomitant autonomic and/or neuroglycopenic symptoms.

Exclusion Criteria:

* Patients currently using sulfonylureas or other medications that may interfere with glucose metabolism within 5 half-lives of drug.
* Participation in any clinical investigation within 4 weeks prior to dosing
* History of or current insulinoma
* Active infection or significant acute illness within 2 weeks prior to dosing
* Female patients who are pregnant or lactating
* Women of childbearing potential and not utilizing effective contraceptive methods
* Inadequate end organ function
Motor and Neurophysiological Changes After Ischemic Conditioning in Individuals With Stroke

The goal of this clinical trial is to test ischemic conditioning (blood flow restriction) as a neuromodulatory technique to improve gait function in stroke. Neuromodulation is emerging as a promising adjunct strategy to facilitate changes in brain activity and improve motor behavior following a neurological injury such as stroke.

The main questions this trial aims to answer are:

* Can ischemic conditioning produce neuromodulatory changes in the lower limb primary motor cortex?
* Can ischemic conditioning be used as a neuromodulatory technique to improve strength, motor control, and gait speed in individuals with stroke when compared to sham ischemic conditioning?

Participants will take part in two sessions of ischemic conditioning where a cuff (similar to ones that measure blood pressure) will be placed around the thigh and inflated to one of two blood flow restriction pressures (real or sham). Each participant will experience measures of brain activity and motor behavior testing before and after both sessions (ischemic conditioning and sham ischemic conditioning).

Researchers will investigate ischemic conditioning as neuromodulation modality in stroke to see if ischemic conditioning can produce beneficial changes in brain activity and improvements on subsequent motor behavior tasks.


Eligibility Criteria:
Inclusion Criteria:

* Single, stroke \> 6 months since onset
* Residual hemiparetic gait deficits (e.g., abnormal gait pattern)

Exclusion Criteria:

* Lesions affecting the brainstem or cerebellum
* Other neurological disorders that may interfere with motor function
* Unhealed decubiti, persistent infections that may interfere with ability to perform test procedures
* Significant cognitive or communication impairment (Mini-Mental State Examination (MMSE\<21)), which could impede the understanding of the purpose of procedures of the study
* Botulinum toxin (Botox) treatments to the lower limb within the past 6 months
* Pregnant women
* Contraindications to transcranial magnetic stimulation (TMS) or ischemic conditioning (IC) (Listed below)

TMS General Exclusion Criteria:

* Previous adverse reaction to TMS
* Skull abnormalities or fractures
* Concussion within the last 6 months
* Unexplained, recurring headaches
* Implanted cardiac pacemaker
* Metal implants in the head or face
* History of seizures or epilepsy
* Use of medications that could alter cortical excitability or increase risk of seizure (e.g., antidepressants, antipsychotics, anxiolytics, anticonvulsants)
* Current pregnancy

IC General Exclusion Criteria:

* History of thrombosis (i.e., blood clots) including venous thrombosis or deep vein thrombosis (DVT).
* Blood clots in the leg, or any condition in which compression of the thigh or transient ischemia is contraindicated (i.e., open wounds in the leg, bruising, nerve damage, etc.)
* Peripheral arterial grafts in the lower extremity
* History of uncontrolled hypertension
* History of peripheral vascular disease or hematological disease
The Effects of Topical Haemoglobin Spray in Pressure Ulcer

A prospective randomised controlled experimental study was planned to compare the effects of pressure sore dressing using topical haemoglobin and traditional gauze dressing using saline on the healing process and cost of pressure sores in patients with pressure sores.

Pressure sores are a serious health problem because they increase mortality, decrease quality of life, prolong hospital stays, increase patient care costs, impair body image, prolong the healing process, and have many other negative effects.

The European Pressure Ulcer Advisory Panel (EPUAP), National Pressure Ulcer Advisory Panel (NPIAP), and Pan Pacific Pressure Ulcer Association (PPPIA) 2019 guidelines report that the prevalence of pressure ulcers in healthcare settings ranges from 10% to 72.5%, with large variations between different clinics and geographies. In the United States, the cost of pressure sore treatment to organisations is estimated to be $11 billion annually. Pressure sores will continue to be an important public health problem today and in the future, especially due to the increasing number of elderly people in the world and in our country, chronic diseases, comorbidity, and palliative conditions.

Therefore, the study was planned as a prospective randomised controlled experimental trial to compare the effects of pressure sore dressing using topical haemoglobin and traditional gauze dressing using saline on the healing process and cost of pressure sores in patients with pressure sores.

Eligibility Criteria:
Inclusion Criteria:

1. be over 18 years of age,
2. Normal albumin and protein levels,
3. Stage 2 pressure ulcer,
4. Blood glucose level is within normal limits,
5. the consent of the patient himself or his guardian.

Exclusion Criteria:

1. being under 18 years of age,
2. Pressure ulcers in areas other than the sacrum,
3. Stage 1, Stage 3, Stage 4, unstageable pressure ulcers,
4. Albumin and protein values are lower than normal,
5. Blood glucose level is not within normal limits,
6. the patient himself/herself or his/her guardian does not authorise it.
Novel Surgical Checklists for Gynecologic Laparoscopy in Haiti

The researchers traveled to University Hospital Mirebalais in Haiti and provided a one week long laparoscopic training and simulation course to the 7 OBGYN faculty there. The researchers used novel checklists to help the faculty to set up for laparoscopic cases and care for the equipment needed. The researchers then asked the physicians their opinion of the checklists.


Eligibility Criteria:
Inclusion Criteria:

* OBGYN physician in Haiti

Exclusion Criteria:

* none
Electronic Social Network Assessment Program (eSNAP) + Caregiver Navigator

The purpose of the study is to determine if family caregivers of neuro-oncology patients feel less burdened by utilizing the Electronic Social Network Assessment Program (eSNAP) + the Caregiver Navigator.


Eligibility Criteria:
Inclusion Criteria:

* English-speaking/reading/writing
* Able to complete questionnaires (including by proxy)
* Family Caregivers (FCGs) must self-identify as being a primary FCG of a patient with a primary brain tumor, secondary (metastatic) brain tumor, or leptomeningeal disease diagnosis. A primary caregiver is a family member, friend, or other unpaid person who provides at least some care for a patient at home.
* Patients must be diagnosed with new or recurrent primary brain tumor, a secondary (metastatic) brain tumor or leptominingeal disease within the last 9 months, receiving at least some evaluation and/or care at Moffitt (i.e. at least one appointment), have a prognosis of at least 9 months

Exclusion Criteria:

* Patients may not participate without a consenting FCG, but FCGs may participate without a consenting patient
* Patients and FCGs who are experiencing acute distress will be excluded from enrollment and referred directly to social work, per Moffitt policy.
Sarcopenia and Nutritional Status in a Rehabilitation Setting

In this pilot observational study the primary outcome is to assess, in a Respiratory Rehabilitation Unit, if there is an association between sarcopenia, assessed by handgrip strenght and BIA, and a delayed decannulation time in patients who underwent tracheostomy.

Secondary outcomes are to assess if there is an association between an increased malnutrition risk (assessed by MUST), a poor nutritional status (assessed by GLIM criteria) and a delayed decannulation time and the gut microbiota composition.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent from patients or legal guardians for patients unfit to plead
* Presence of tracheostomy at admission

Exclusion Criteria:

* Refusal
* Pregnancy
* Pace maker/implantable cardioverter
* No legal guardians for patients unfit to plead
rTMS Effect in Functional Psychogenic Movement Disorders Applied Alone Then Combined With Hypnotherapy

The management of functional psychogenic movement disorders (FNPMD) is challenging for neurologists and psychiatrists and only comprehensive multidisciplinary treatment programme can be worthwhile for these patients (Moene et al 2002). Recent functional magnetic resonance imaging studies have demonstrated abnormalities in motor control at cortical level, hyperactivity of limbic system and disturbance of connectivity between these two systems leading to a lack of self-agency, (Voon et al 2010,2011).Two recent studies suggested a possible therapeutic effect of transcranial magnetic stimulation (TMS) in FNPMD (Dakotakis 2011, Garcin, 2013).

In this protocol our objectives are twofold :

1. to compare the effect of 5 consecutive daily sessions of rTMS on FNPMD in a double-blind randomized controlled study
2. to study the effect of 3 weekly hypnosis sessions combined with rTMS in FNPMD


Eligibility Criteria:
Inclusion criteria:

* Man or woman with FNPMD for at least 2 months,
* diagnosed from clinical Diagnostic and Statistical Manual V conversive somatoform troubles and Gupta \& Lang (2009) and Edwards \& Bahtia 2012 neurological clinical criteria

Exclusion criteria:

* Severe progressive psychiatric disorders
* Cardiac pace-maker
* Metallic prosthesis
* Cochlear implants
* Previous neurosurgery
* Epilepsy
* Severe cardiac disease
* Alcohol or toxic abuse for the last 12 months
* Drugs such clozapine, bupropion, methadone or theophylline
PET/CT Imaging of Small Cell Lung Cancer Using 89Zr-DFO-SC16.56

The purpose of this study is to look at how safe 89Zr-DFO-SC16.56 is, and how it is processed by the body in people with small cell lung cancer.


Eligibility Criteria:
Inclusion Criteria:

* Signed, informed consent
* Age 18 or more years
* Histologically confirmed, SCLC, (newly diagnosed or recurrent); small cell carcinoma of unknown or non-lung origin; or other types of neuroendocrine tumor OR
* Histologically confirmed prostate cancer, with suspected or confirmed NEPC based upon clinical assays obtained prior to the trial
* At least one tumor lesion on CT or MRI \>/= 2 cm

  ° For the prostate cancer patient cohort with only bone metastases, a recent PET scan (FDG or PSMA-targeted) that shows tracer-avid osseous metastases, a recent MRI that shows new osseous metastases, or a bone scan that shows new osseous metastases. The scans should have been obtained in the last 8 weeks.
* ECOG performance status 0 to 2
* Negative serum pregnancy test within 2 weeks of 89Zr- DFO-SC16.56 or women of child-bearing potential
* Adequate organ function as assessed by
* Absolute neutrophil count (ANC) \>/= 1,500 mm\^8
* Hemoglobin \>/= 8.0 g/dL
* Platelet count \>/= 75,000/mm\^3
* Bilirubin \</= 1.5 x ULN (upper limit of the norm)
* AST (GOT) \</= 3.0 x ULN (when no liver metastases are present)
* AST (GOT) \</= 5.0 x ULN (when liver metastases are present)
* ALT (GOT) \</= 3.0 x ULN (when no liver metastases are present)
* ALT (GOT) \</= 5.0 x ULN (when no liver metastases are present)
* Creatinine \</= 1.5 x ULN
* Available archival tumor biopsy material suitable for DLL3 IHC. Archival tissue is not required to have been collected within a specific time frame relative to imaging

  * For the prostate cancer patient cohort, as an alternative if archival tissue is not available, patients must be willing to undergo PET/CT guided biopsy\*\* as described in section 9.3.

    1. Patients with SCLC will be the primary study population, however patients with other types of neuroendocrine tumors may be included at the PI's discretion.
    2. Criterion is intended to demonstrate presence of imageable disease. A low-dose CT (e.g. from a PET/CT scan) may be used at PI's discretion
    3. While willingness to undergo the biopsy is required if archival tissue is not available, PET/CT guided biopsy is not a mandatory study assessment. As described in section 9.3, the guided biopsy may be waived at the discretion of the principal investigator if the DLL3 PET/CT reveals no sites of DLL3 tracer-avid tumor or if the principal investigator deems it is not in the best interest of the patient, according to best clinical judgement.

Exclusion Criteria:

* History of anaphylactic reaction to humanize or human antibodies
* Pregnant or breast feeding
* Psychiatric illness that would interfere with compliance with the study procedures
* Inability to undergo PET scan due to weight limit
Dexmedetomidine on Pediatric Heart Operation

we hypothized dexmedetomidine could reduce the reduction of renal function after cardiopulmonary bypass weaning in pediatric patients

dexmedetomidine, a2-adrenoreceptor agonist has been used for sedation or hemodynamic stability for operative procedure. It had been already reported that dexmedetomidine reduce the impairment of renal functon after cardiac operation in adult. we hypothized dexmedetomidine could reduce the reduction of renal function after cardiopulmonary bypass weaning in pediatric patients

Eligibility Criteria:
Inclusion Criteria:

* 1-6yr pediatric cardiac patients

Exclusion Criteria:

* previous renal dysfunction