cyrilzakka/clinical-trials huggingface dataset:
Efficacy of a Sensory Comfort Room in Agitation Control

In the initial approach of the study, it was considered that the comfort room would be used by all patients with GCT treated in the Functional Rehabilitation Area 1 (ARF 1) of the Álava Psychiatric Hospital. However, with the onset of the covid-19 pandemic, the service itself decided to separate the patients into two units, in order to reduce positive contacts. Consequently, the use of the comfort room will only be available for one of the two units, which will be considered as the intervention group, while the other unit will be considered as the control group. It is also important to note that the patients in the intervention group unit have a more severe mental state than those in the control group. The control group are older and more psychopathologically stable patients. So already from the initial moment of the study they are two populations with different characteristics.

Main Objective:

To determine the effectiveness of the use of a sensory comfort room in the functional rehabilitation area 1 of the HPA. It would be considered effective if mechanical restraints decrease by 5% in the intervention group with respect to the previous year.


Eligibility Criteria:
Inclusion Criteria:

* All patients admitted to functional rehabilitation area 1 presenting with questionable, mild or moderate Agitation (score less than or equal to 20 on the PEC scale) or at the patient's request.
* To have freely accepted to participate in the intervention and to have signed the informed consent. An information sheet will also be given to the patient and an information sheet to the tutor (APPENDIXES 1 and 2). Experts in easy reading are consulted to adapt this document.

Exclusion criteria:

* Severe and extremely severe agitation (score greater than or equal to 21 on the PEC scale). Immediate previous physical aggression.
* Declination of the signature of informed consent.
* Any participant who does not comply with the rules of use of the room will be excluded from the study.
Use of SGLT2i in noHCM With HFpEF

This study aims to evaluate the impact of Sodium-dependent glucose transporters 2 inhibitor Empagliflozin on the exercise capacity,symptoms of heart failure, cardiac function, myocardial remodeling and quality of life of nonobstructive HCM patients with HFpEF.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a diagnosis of nonobstructive hypertrophic cardiomyopathy;
* At least 18 years old;
* LVEF≥50%
* Elevated NT-proBNP \>300 pg/ml for patients without atrial fibrillation (AF), or \>900 pg/ml for patients with AF at Visit 1;
* NYHA II-IV
* Capable of performing cardiopulmonary exercise test with an RER≥1.0
* Signed and dated written informed consent and willing to return for clinical follow-up.

Exclusion Criteria:

* Under-went septal reduction therapy within 3 months before screening;
* Acute decompensation heart failure within 3 months before screening;
* Symptomatic low BP or SBP\<100mmHg;
* eGFR\<30ml/min/1.73m2
* LVOTG ≥30mmHg at rest or under provocation;
* Renal insufficiency with eGFR\<50mL/min/1.73m2
* ICD implantation or CRT planned within 3 months;
* Women who are pregnant, or who plan to become pregnant while in the trial;
* Currently enrolled in another investigational device or drug trial;
* Combining any other clinical condition with a life expectancy less than 1 year.
Prodromal Alpha-Synuclein Screening in Parkinson's Disease Study

The PASS-PD study is set out to screen individuals from the general population with an increased risk for the development of Parkinson's Disease (PD) and to investigate this highly enriched cohort longitudinally for five year. A special focus is placed on implementation of ethical standards for early risk disclosure in PD.

The PASS-PP Study is designed to combine the latest developments in clinical and biomarker research to

1. understand the distribution of risk profiles for PD in the general population, especially regarding non-motor symptoms
2. identify subjects with a likelihood of developing PD
3. follow individuals with a high likelihood/risk to develop PD in the future (compared to individuals with low risk and) in a prospective study
4. understand the potential of biological markers to increase prediction of progression/conversion
5. identify subtypes of PD patients, by providing a detailed clinical phenotyping with a main focus on non-motor symptoms cluster
6. provide a framework of ethical handling of early risk disclosure in PD

Eligibility Criteria:
Inclusion Criteria:

* Age between 50 and 99

Exclusion Criteria:

* Presence of clinical PD at the time of study inclusion
* Other significant neurologic diseases affecting the central nervous system (e.g. Multiple sclerosis)
* other significant diseases e.g. orthopaedic diseases affecting quantitative motor assessment
* in case of participation in the lumbal puncture substudy: contraindications for the performance of lumbal puncture (bleeding tendency, intake of anticoagulants)
LALAK for Opacities

The purpose of this protocol is to compare and develop new surgical technique of partial-thickness corneal transplantation for treating corneal opacity. A newly developed technique, "dovetail" laser-assisted lamellar anterior keratoplasty (LALAK), will be tested and compared with standard full-thickness corneal transplantation, Intralase-enabled keratoplasty (IEK). The new LALAK technique replaces only the front portion of the cornea and does not have the risks associated with conventional IEK. Additionally, optical coherence tomography (OCT) will be used to guide the depth of the graft and donor dissections.

The data will be analyzed to understand whether the new technique (LALAK) can repeatedly achieve good visual outcomes with lower risk from the operation compared to the visual outcomes and risk associated with the current standard of care, IEK.


Eligibility Criteria:
Inclusion Criteria:

* Eyes with corneal opacities that cannot be adequately or safely corrected with spectacles, contact lens or excimer laser surface ablation. The cornea must have healthy endothelium (endothelial cell density \> 1,500/mm2).

Exclusion Criteria:

1. Preoperative corneal thickness less than 400 microns.
2. Inability to give informed consent.
3. Corneal edema
4. Central guttata
5. Inability to maintain stable fixation for OCT imaging.
6. Inability to commit to required visits to complete the study.
7. Eyes with concurrent cataract, retinal diseases, glaucoma, or other eye conditions that may limit the visual outcome after surgery.
8. Patients with severe collagen vascular diseases or ocular surface disorders
Megadose of Hydroxocobalamin for the Treatment of Pernicious Anemia

Demonstrate the effectiveness of a single dose of a multivitamin complex for the treatment of megaloblastic anemia

The investigators will administrate a single intramuscular dose of hydroxocobalamin 10,000mcg, Thiamin 100mg, Pyridoxine 50mg.

To assess response to treatment, a complete blood count (CBC) will be performed weekly during the first month of treatment, after the first month a CBC will be taken monthly for 6 months.

Also to confirm the diagnosis and assess response the investigators will measure levels of methylmalonic acid, homocysteine, and hydroxocobalamin at the beginning of the study, 3 and 6 months.

Eligibility Criteria:
Inclusion Criteria:

Age \>18, All sex Clinical suspicious of megaloblastic anemia ( cytopenias and macrocytosis (CBC), hypersegmented neutrophils and elevated lactate dehydrogenase) Patients must sign an informed consent indicating that they are aware of the investigational nature of this study -

Exclusion Criteria:

Administration of hydroxocobalamin in the three years before enrollment Patients with active, uncontrolled psychiatric disorders Severe neurologic deficit Known hematologic malignancy Known coagulation disorder that contraindicates intramuscular injection End-stage kidney disease (GFR \<15ml/min) Chronic liver disease (Child-Pugh B or C) Pregnant patients Known infection of Hepatitis B or C and HIV Diagnosis of myelodysplastic syndrome

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A Study to Determine the Safety, Tolerability, and Pharmacokinetics of GDC-0310 in Healthy Volunteers

The purpose of this study is to evaluate the safety and tolerability of single and multiple orally ascending doses of GDC-0310 administered in healthy participants as 4 parts including Part 1- a single dose (SD) part using a powder-in-capsule (PIC) formulation, Part 2- a multiple dose (MD) part using a PIC formulation, Part 3- a SD part using a solution formulation, and Part 4- a MD part using a solution formulation. Effects of food on pharmacokinetics (PK) will also be explored.


Eligibility Criteria:
Inclusion Criteria:

* Female participants of non-childbearing potential must meet the criteria defined in the protocol
* Body mass index within the range of 18.0 to 30.0 kilograms per meter square (kg/m\^2), inclusive, and a minimum weight of 50.0 kg

Exclusion Criteria:

* Have a clinically significant medical condition (e.g., hypertension; diabetes; impaired cardiac, renal or hepatic function; hyperthyroidism or hypothyroidism; neurological disorder; pain condition; hematologic disorder; psychiatric disorders requiring chronic medication) including any medical condition requiring treatment with medication (other than study drugs and medications specifically allowed by this protocol) during participation in the study
* Evidence of any hepatic impairment including any abnormal levels (i.e., greater than \[\>\] 1 × the upper limit of normal) of alkaline phosphatase, gamma glutamyl transpeptidase, alanine transaminase, aspartate aminotransferase or bilirubin
* Evidence of clinically significant renal impairment defined as \>1.3 × upper limit of normal creatinine
* History or presence of alcoholism or alcohol or substance abuse (not including nicotine or caffeine) within the previous 2 years or routinely consume 2 or more alcohol-containing beverages per day or more than 10 units of alcohol per week (1 unit =150 milliliter (mL) of wine, 360 mL of beer, or 45 mL of 40 percent (%) alcohol)
* Have a positive urine drug test at screening or check-in or any other point during the study
* Are habituated to analgesic drugs (i.e., routine use of oral analgesics 5 or more times per week) or have a history of chronic pain requiring opiate use
* Have used tobacco or nicotine-containing products within 3 months before study drug administration
* Have clinically significant abnormal laboratory values as determined by the principal investigator
* Have used any prescription or over-the-counter medication or supplement within 14 days or 5 times the elimination half-life (whichever is longer) before administration of study drug and until the end of their participation in the study
* History of seizures, including in first degree relatives
* History of heritable myopathy, weakness, or paralysis, including in first degree relatives indicative of familial periodic paralysis
* Current treatment with medications that are well known to prolong the QT interval
Expanded Access Program for Aztreonam Lysine for Inhalation in Canadian Patients With Cystic Fibrosis

This program is to provide expanded access to aztreonam lysine for inhalation (AZLI) prior to its commercial availability to patients with cystic fibrosis (CF) and chronic P. aeruginosa airway infection who have limited treatment options and are at risk for disease progression.


Eligibility Criteria:
Inclusion Criteria:

* ≥ 6 years of age
* Patient has CF as diagnosed by one of the following:
* Documented sweat chloride ≥ 60 mEq/L by quantitative pilocarpine iontophoresis test, or
* Two well characterized genetic mutations in the CFTR gene, or
* Abnormal nasal potential difference with accompanying symptoms characteristic of CF
* PA present in expectorated sputum or throat swab culture within 2 months prior to consent
* Patient must be able to provide written informed consent/assent prior to any study related procedure; parent/guardian must be able to give written informed consent as necessary prior to any study related procedure
* At high risk for disease progression as defined by one of the following patient populations:
* FEV1 ≤ 50 % predicted at the time of consent OR
* Completed participation in CP-AI-006 (through Visit 20). Patients who withdraw from CP-AI-006 prior to completing all courses of AZLI and all study visits will not be eligible for this protocol.

Exclusion Criteria:

* Patients with any serious or active medical or psychiatric illness that, in the opinion of the investigator, would interfere with patient treatment, assessment or compliance with the protocol or dosing requirements
* Patients with hypersensitivity to any of the components of the drug product
* Currently enrolled in another clinical trial
* Pregnant or lactating females
Effects of Open-label Placebos on COVID-related Psychological Health

This project aimed to test the efficacy of a telehealth-administered placebo without deception intervention on stress, anxiety, and depression related to the COVID-19 pandemic. Participants were randomized into two groups (open-label placebo vs. no-treatment control). All participants received information on the impact of COVID-19 on psychological health. Participants in the open-label placebo group were instructed to watch an informational video on the beneficial effects of placebos without deception, remotely interact with an experimenter, and take open-label placebo pills twice a day for two weeks. Participants in the no-treatment control group did not receive any intervention. Instead, participants met with an experimenter and reported on their psychological and physical health. The investigators predicted that the placebo without deception group would exhibit substantially reduced stress, depression, and anxiety compared to a no-treatment control group.


Eligibility Criteria:
Inclusion Criteria:

* Individuals who have experienced moderate COVID-19 stress, as assessed by a score of ≥ 35 on the COVID-19 Stress Scale (Taylor et al., 2020).

Exclusion Criteria:

* Non-Michigan residents; self-reported diagnosis of anxiety, depression, ADHD, schizophrenia, bipolar disorder, substance use disorder; currently taking psychotropic medication including antidepressants, anti-anxiety medication or stimulants; allergies or concerns with the placebo pill ingredients; or active diagnosis of COVID-19 at the time of eligibility or enrollment.
Study of Liposomal Annamycin in Patients With Refractory or Relapsed Acute Lymphocytic Leukemia

This is a Phase I/II multi-center, open label, dose escalation study to identify the maximum tolerated dose (MTD) of liposomal annamycin and to evaluate the safety of liposomal annamycin in patients with refractory or relapsed acute lymphocytic leukemia.

This is a Phase I/II, multi-center, open-label, dose escalation, MTD study of liposomal annamycin in refractory or relapsed ALL patients. Enrollment will occur in cohorts of approximately 3 patients with 10 additional patients enrolled at the MTD. The liposomal annamycin doses will be escalated in sequential cohorts. Four dose levels of liposomal annamycin are planned: 190, 230, 280, and 310 mg/m2/day.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of refractory or relapsed ALL (acute lymphocytic leukemia)
* Age greater than or equal to 15 years
* No chemotherapy, radiation, or major surgery within 2 weeks prior to first dose of study drug and recovered from toxic side effects of that therapy, unless treatment is indicated due to progressive disease.
* No investigational therapy within 4 weeks of first dose of study drug
* ECOG performance status (PS) 0 to 2.
* Adequate liver function
* Adequate renal function
* Signed informed consent

Exclusion Criteria:

* Concommitant therapy that includes other chemotherapy that is or may be active against ALL (except central nervous system \[CNS\] therapy)
* Any condition which in the opinion of the investigator, places the subject at unacceptable risk if he/she were to participate in the study.
* Cardiac ejection fraction less than 40%
* Clinically relevant serious co-morbid medical conditions.
* Pregnant, lactating or not using adequate contraception.
* Known allergy to doxorubicin or anthracyclines.
Augmenting Response to Entecavir With Peginterferon a-2a for the Treatment of HBeAg-positive Chronic Hepatitis B

The purpose of this study is to investigate whether it is possible to augment the response of patients with HBeAg-positive chronic hepatitis B to entecavir by using a temporary peginterferon alpha-2a add-on strategy


Eligibility Criteria:
Inclusion Criteria:

* Chronic hepatitis B (HBsAg positive \> 6 months)
* HBeAg positive, anti-HBe negative at screening
* ALT \> 1.3 x ULN within 60 days prior to screening and during screening
* Liver biopsy performed within 2 years prior to screening or during screening
* Age \> 18 years
* Written informed consent
* Adequate contraception for males and females during treatment and follow up; negative pregnancy test (for women of childbearing potential)

Exclusion Criteria:

* Antiviral therapy against HBV within the previous 6 months
* Treatment with any investigational drug within 30 days of screening
* Previous treatment with lamivudine or telbivudine for more than six months
* Severe hepatitis activity as documented by ALT\>10 x ULN
* History of decompensated cirrhosis (defined as jaundice in the presence of cirrhosis, ascites, bleeding gastric or esophageal varices or encephalopathy)
* Pre-existent neutropenia (neutrophils \< 1,500/mm3) or thrombocytopenia (platelets \< 90,000/mm3)
* Co-infection with hepatitis C virus or human immunodeficiency virus (HIV)
* Other acquired or inherited causes of liver disease (i.e. alcoholic liver disease, obesity induced liver disease, drug related liver disease, auto-immune hepatitis, hemochromatosis, Wilson's disease or alpha-1 antitrypsin deficiency)
* Alpha fetoprotein \> 50 ng/ml
* Hyper- or hypothyroidism (subjects requiring medication to maintain TSH levels in the normal range are eligible if all other inclusion/exclusion criteria are met)
* Immune suppressive treatment within the previous 6 months
* Contra-indications for alpha-interferon therapy like suspected hypersensitivity to interferon or PEG-interferon or any known pre-existing medical condition that could interfere with the patient's participation in and completion of the study.
* Pregnancy, lactation
* Other significant medical illness that might interfere with this study: significant pulmonary dysfunction in the previous 6 months, malignancy other than skin basocellular carcinoma in previous 5 years, immunodeficiency syndromes (e.g. HIV positivity, auto-immune diseases, organ transplants other than cornea and hair transplant)
* Any medical condition requiring, or likely to require chronic systemic administration of steroids, during the course of the study
* Substance abuse, such as alcohol (\> 80 g/day), I.V. drugs and inhaled drugs in the past 2 years.
* Any other condition which in the opinion of the principal investigator would make the patient unsuitable for enrollment, or could interfere with the patient participating in and completing the study
A Study of the Efficacy and Safety of Pregabalin for the Treatment of Diabetic Peripheral Neuropathy or Postherpetic Neuralgia

The purpose of this study is to assess the efficacy and safety of pregabalin for the treatment of diabetic peripheral neuropathy (DPN) or postherpetic neuralgia (PHN)


Eligibility Criteria:
Inclusion criteria:

* Diagnosis of DPN or PHN
* Score on the Numeric Rating Scale of at least 4/10

Exclusion Criteria:

* Hospitalized patients
* Neurologic disorders unrelated to DPN or PHN or any severe pain that may confound the assessment of DPN- or PHN-related pain
Cryotherapy for Neuropathy in Children

This study aimed to assess the efficacy of cryotherapy in controlling Peripheral Neuropathy in cancer children

Peripheral neuropathy is a serious condition characterized by symmetrical, distal damage to the peripheral nerves that may be caused by several classes of drugs, including chemotherapeutic agents. Chemotherapy-induced peripheral neuropathy (CIPN) is an adverse effect estimated to occur in up to 40% of patients undergoing chemotherapy, with its incidence increasing in patients being treated with multiple agents. Pharmacists play a pivotal role in the prevention and management of CIPN by recommending evidence-based pharmacologic and non pharmacologic strategies appropriate for the individual patient.Peripheral neuropathy (PN) is a systemic disease characterized by symmetrical, distal damage to the peripheral nerves that negatively impacts patient quality of life (QOL). Prolonged symptoms associated with PN can cause pain, interfere with functional ability (e.g., dressing, driving, house-work), and disrupt emotional health.

Eligibility Criteria:
Inclusion Criteria:

1. Their age will ranging from eight to seventeen years.
2. Children participated in this study will from both sexes.
3. Children receiving chemotherapy as medical treatment protocol
4. All children have polyneuropathy caused by chemotherapy.

Exclusion Criteria:

1. Children with Epilepsy.
2. Children with blood clotting disorder.
3. Children have Open wounds / broken skin
4. Children with severe cardiac disease
5. Uncooperative patients.
Insulin Effects on Metabolism and Cardiovascular Function in Type 2 Diabetes

Compared to human insulins analogue insulins offer the option of optimizing metabolism also in type 2 diabetes. Especially, fast acting insulin analogues lower postprandial glucose levels more effectively than human regular insulin. However, it is not known whether therapy with analogue insulins can also improve the subclinically impaired myocardial function in type 2 diabetes. This prospective, randomized, open long term study compared the effects of a basal-bolus insulin therapy with analogue insulins versus human insulins on metabolic control and systolic and diastolic myocardial function, testing the hypothesis that optimized postprandial glucose control improves cardiac function and cardiovascular risk.

This is a single centre, long term (24-48 months), therapy controlled and randomised study with blinded analysis of the ultrasound data in 120 patients with type 2 diabetes mellitus and with previous insulin therapy. After recruitment and informed consent, patients are randomized to two treatment arms according to a randomisation protocol which takes into account age and absence or presence of cardiovascular events in each patient's history.

In one treatment arm, the intensive insulin therapy is based on human insulin (insulin NPH and regular human insulin) while in the other arm, the intensive insulin therapy is based on analogue insulin (insulin detemir and insulin aspart). Both treatment arms will be titrated to identical glycemic goals (fasting blood glucose \<110 mg/dL and post prandial blood glucose \<150 mg/dL).

All patients will be updated in their skills of self medication by the departmental diabetic teaching programme und will receive life style instructions during each visit. Furthermore, they are encouraged to keep records of any episode of hypoglycemia throughout the study. Outpatient visits for metabolic control are every 3 months and ultrasound and blood tests every 6 months.

Eligibility Criteria:
Inclusion Criteria:

* type 2 diabetes, insulin therapy

Exclusion Criteria:

* type 1 diabetes, BMI \>40, pregnancy,