cyrilzakka/clinical-trials huggingface dataset:
The Influence of Default Options in Advance Directives

The investigators aim to assess the influence of default options in advance directives on older patients selections of life- extending therapies and to determine whether alerting patients to the spectrum of possible default options in advance directives influences their selections of life-extending therapies by manipulating the default options of advance directives given to patients in with severe respiratory disease

The project is designed to document that default options influence terminally ill patients end-of-life decisions (in this case, adults with advance forms of lung disease) and that our team can recruit and retain patients in a study of advance care planning. In addition, because a larger-scale randomized clinical trial will require that the investigators alert participants to the range of possible default options, the investigators must also determine the effects that this alerting will have on their selections of life-extending therapies. Therefore, the investigators seek to achieve three aims: (1) assess the influence of default options in advance directives on patients selections of life-extending therapies; (2) determine whether alerting patients to the spectrum of possible default options in advance directives influences their selections of life extending therapies; and (3) document the feasibility of recruiting and retaining patients with advanced lung diseases from university-based clinical settings into a randomized trial of default options in advance directives.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of chronic obstructive pulmonary disease (COPD), idiopathic pulmonary fibrosis (IPF), non-small-cell lung cancer, or other interstitial or fibrotic lung disease
* Neither listed for nor considering solid organ transplantation
* Anticipated survival of less than 2 years
* Must be fluent and literate in English

Exclusion Criteria:

* Diagnosis of small-cell lung cancer or other respiratory diseases for which life extending medical therapies may be available
All-Trans Retinoic Acid in Combination With Standard Induction and Consolidation Therapy in Older Patients With Newly Diagnosed Acute Myeloid Leukemia

This is a study looking at all-trans retinoic acid in combination with standard induction and consolidation therapy in older patients with newly diagnosed acute myeloid leukemia (AML).

First Induction Therapy:

* Cytarabine 100 mg/m² cont. i.v. days 1-5
* Idarubicin 12 mg/m² i.v. days 1, 3

  * ATRA 45 mg/m² p.o. days 4-6, ATRA 15 mg/m² p.o. days 7-28

Second Induction Therapy:

* Cytarabine 100 mg/m² cont. i.v. days 1-5
* Idarubicin 12 mg/m² i.v. days 1, 3

  * ATRA 45 mg/m² p.o. days 4-6, ATRA 15 mg/m² p.o. days 7-28

First Consolidation Therapy:

* Cytarabine 1000 mg/m² bid i.v. days 1-3
* Mitoxantrone 10 mg/m² i.v. days 2, 3

  * ATRA 15 mg/m² p.o. days 4-28

Second Consolidation Therapy

* Etoposide 100 mg/m² i.v. days 1-5
* Idarubicin 12 mg/m² i.v. days 1,3

  * ATRA 15 mg/m² p.o. days 4-28

Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed AML defined according to the World Health Organization (WHO) classification (excluding acute promyelocytic leukemia \[APL\])
* Aged \> 60 years
* All patients have to be informed about the character of the study. Written informed consent of each patient at study entry.
* Molecular and cytogenetical analyses on initial bone marrow and peripheral blood specimen have to be performed at the central reference laboratories.

Exclusion Criteria:

* Bleeding independent of the AML
* Acute promyelocytic leukemia
* Uncontrolled infection
* Participation in a concurrent clinical study
* Insufficiency of the kidneys (creatinine \> 1.5 x upper normal serum level), of the liver (bilirubin, AST or AP \> 2 x upper normal serum level), severe obstruction or restrictive ventilation disorder, heart failure New York Heart Association \[NYHA\] III/IV
* Severe neurological or psychiatric disorder interfering with ability of giving informed consent
* No consent for the registration, storage and processing of data concerning the characteristics of the AML and the individual course
* Performance status WHO \> 2
Preoperative Ketorolac for Pain Control in Scleral Buckle Surgery

The scleral buckle surgery is an effective way in treating retinal detachment (RD) patients. Retrobulbar block has been proved effective in scleral buckle surgery. Though retrobulbar anesthesia saves operative time and money compared to general analgesia, the intraoperative pain is frequent and a proportion of postoperative pain is often ignored. Ketorolac has been demonstrated to be a preemptive analgesia in other diseases such as adenotonsillectomy, posterior lumbar spinal fusion, laser-assisted subepithelial keratectomy (LASEK), and so forth. The aim of the investigators study is to determine the safety and preemptive analgesic effect of ketorolac in the perioperative pain control of patients undergoing RD surgery under retrobulbar anesthesia.


Eligibility Criteria:
Inclusion Criteria:

1. consent of the patient or legal guardian
2. 18 years or above
3. normal height and weight
4. ASA class I, II
5. elective surgery
6. surgery time within 60min
7. understanding of the verbal numerical rating score (0-10)

Exclusion Criteria:

1. history of ocular surgery, trauma or infection
2. intraoperative complications
3. glaucoma or ocular hypertension (\> 20 mmHg)
4. diabetic retinopathy
5. diagnosis of asthma or coagulopathy
6. chronic pain syndromes
7. history of peptic ulceration, liver or hematologic disease
8. history of chronic use of analgesics, sedatives, opioids or steroids
9. history of drug or alcohol abuse
10. history of systemic disease
11. sexually transmitted disease (STD)
12. Pregnancy, lactation;
13. cognitive impairment or psychiatric illness;
Study to Test the Efficacy and Safety of Padsevonil as Adjunctive Treatment of Focal-onset Seizures in Adults With Drug-resistant Epilepsy

The purpose of the study is to characterize the dose-response relationship with respect to efficacy of Padsevonil administered concomitantly with up to 3 anti-epileptic drugs (AEDs) for treatment of observable focal-onset seizures in subjects with drug-resistant epilepsy.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of focal epilepsy per 1989 International League Against Epilepsy (ILAE) criteria at least 3 years before study entry
* Subject has failed to achieve seizure control with 4 tolerated and appropriately chosen prior antiepileptic drugs (AED), including past and ongoing treatment, that were individually optimized for adequate dose and duration. Prior discontinued AED treatment would need to be assessed by the Investigator considering the patient medical records and patient and/or caregiver interview. 'Prior AED' is defined as all past and ongoing AED treatments with a start date before the Screening Visit (Visit 1)
* Average of \>= 4 spontaneous and observable focal seizures (type IA1 (i.e. focal aware), IB (i.e. focal impaired awareness), IC (i.e. focal to bilateral tonic-clonic)) per month
* Current treatment with an individually optimized and stable dose of at least 1 and up to 3 AEDs for the 8 weeks prior to the Screening Visit with or without additional Vagus Nerve Stimulation (VNS) or other neurostimulation treatments

Exclusion Criteria:

* Subject has a history of or signs of generalized or combined generalized and focal epilepsy
* Cluster seizures which are uncountable in the previous 8 weeks before study entry and during 4 weeks prospective baseline
* Current treatment with carbamazepine, phenytoin, primidone, phenobarbital
* Current treatment/ use of (non-AED) prescription, nonprescription, dietary (eg, grapefruit or passion fruit), or herbal products that are potent inducers or inhibitors of the CYP3A4 or 2C19 pathway for 2 weeks (or 5 half-lives, whichever is longer) prior to the Baseline Visit
* Subjects taking sensitive substrates of CYP2C19 for 2 weeks (or 5 half-lives, whichever is longer) prior to the Baseline Visit
* Subject has been taking vigabatrin less than 2 years at study entry
* Subject has been taking felbamate for less than 12 months
* Subject taking retigabine for less than 4 years
* Current treatment with benzodiazepines (i.e. GABA-A-ergic drugs like zolpidem, zaleplon, or zopiclone, excluding GABA-A-ergic AEDs) \<3 times per week for emergencies
* Subject has a current medical condition that occurred within the last 12 months which, in the opinion of the investigator, could compromise his/her safety or ability to participate in this study
A Study of the iStent in Combo With Cataract Surgery in Newly Diagnosed Open Angle Glaucoma or OH Patients.

The purpose of this study is to evaluate the safety and efficacy of the iStent trabecular micro-bypass stent in reducing intraocular pressure (IOP) in subjects with newly diagnosed open-angle glaucoma and subjects diagnosed with Ocular hypertension.

The study will compare the reduction in IOP of those subjects implanted with two Glaukos micro-stents with the reduction in IOP for patients receiving only primary medical therapy (Xalatan - Latanoprost) or cataract surgery alone. Both groups will undergo routine cataract surgery.

Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed with open-angle glaucoma (OAG) or Ocular Hypertension with subjects not yet taking any glaucoma medications or recently diagnosed with mild open-angle glaucoma and are currently being treated with up to 2 glaucoma medications.
* All subjects must need cataract surgery.

Exclusion Criteria:

* Angle closure glaucoma
* Secondary glaucomas except pseudoexfoliative and pigmentary; no neovascular, uveitic or angle recession glaucoma
* Prior glaucoma procedures (eg trabeculectomy, viscocanalostomy, ALT, SLT, shunt implant, collagen implant, cyclo destructive procedures etc)
* Fellow eye already enrolled
Nutritional Parameters and Other Risk Factors Affecting Severity of Pneumonia in Children Under Five Years in Upper Egypt

Decrease mortality rate resulting from pneumonia

Recruiting patients with pneumonia admitted at Assiut University hospital . Then assessment of their condition and severity of pneumonia by examination and X-ray chest . After that, we aim at assessment their nutrition status and it's effect on severity of pneumonia. So we aim to investigate them by CBC, Albumin, CRP and CXR and correlate these parameters with the severity of pneumonia to assess the impact of nutrition on outcome of chest infections

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of pneumonia on day 1 of hospital admission.

Exclusion Criteria:

* patients with cardiac diseases
* patients with immune deficiency disorders
A Phase Ib Study of PRJ1-3024 for Treatment of Advanced or Metastatic Melanoma

This is a Phase Ib, open-label study to determine the safety and preliminary efficacy of PRJ1-3024 in China subjects with unresectable local advanced or metastatic melanoma

The study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of PRJ1-3024 and will determine the recommended dose in China subjects with unresectable local advanced or metastatic melanoma.

PRJ1-3024 is a small molecular Hematopoietic progenitor kinase (HPK-1) inhibitor. It will be evaluated as an oral therapeutic that tests the anti-tumor activity in patients with unresectable or metastatic melanoma and has not yet been tested in humans.

Eligibility Criteria:
Inclusion Criteria:• Histologically or cytologically confirmed locally advanced (unresectable) or metastatic melanoma (with the exception of ocular uveal melanoma). Patients who have progressed or relapsed after at least 1st-line systemic standard therapy.

* Male or non-pregnant, non-lactating female subjects aged ≥18 years.
* ECOG Performance Status 0\~1.
* Has at least 1 measurable lesion as defined by RECIST 1.1 criteria.
* Life expectancy of ≥3 months, in the opinion of the Investigator.
* Able to take oral medications and willing to record daily adherence to investigational product.
* Adequate hematologic parameters.
* Adequate renal and hepatic function
* Able to understand and willing to sign a written informed consent form.
* Consent to provide archived tissue specimen or tissue sample.

Exclusion Criteria:• History of another malignancy.

* Known symptomatic brain metastases requiring \>10 mg/day of prednisolone.
* Significant cardiovascular disease.
* Known active HBV, HCV, AIDS-related illness.
* Has received a live vaccine within 30 days.
* History of active autoimmune disorders, or ongoing immunosuppressive therapy.
* Continuance of toxicities due to prior radiotherapy or chemotherapy agents that do not recover to \< Grade 2.
* Receiving concurrent anti-cancer therapy, investigational product, strong inhibitors or inducers of cytochrome P450 3A (CYP3A) .
* Prior treatment with other hematopoietic progenitor kinase 1 (HPK1) inhibitors.
* Allergy to the ingredients of study drug, or a history of other allergies which were judged by the investigator to be unsuitable for participation in the study.
iCare ST500 Clinical Trial

Clinical validation of iCare ST500 tonometer per ANSI Z80.10:2014 standard


Eligibility Criteria:
Inclusion Criteria:

* Patients at least 18 years old

Exclusion Criteria:

1. Subjects with only one functional eye
2. Subjects having poor or eccentric fixation in the study eye(s)
3. High corneal astigmatism \>3D in the study eye(s)
4. Central corneal scarring
5. History of prior incisional glaucoma surgery or corneal surgery, including corneal refractive laser surgery in the study eye(s)
6. Microphthalmos
7. Buphthalmos
8. Contact lens use within one week of continuous wear and within one hour if lens is worn occasionally
9. Dry eyes (clinically significant)
10. Lid squeezers - blepharospasm
11. Nystagmus
12. Keratoconus
13. Any other corneal or conjunctival pathology or infection relevant to this study
14. Central corneal thickness greater than 600 μm or less than 500 μm in the study eye(s)
15. Cataract Extraction within last 2 months in the study eye(s)
Does Homebrewing Beer Affect Urinary Tract Symptoms and Bladder Cancer

In this study, investigators aim to reveal the harmful effects of increasing consumption of homemade beer in recent years on the urinary tract. The high amount of carbonyl compounds in the content of homemade beer has been proven by studies. In this study, which will be conducted in the form of a questionnaire, it is aimed to evaluate the effects of the consumption of homemade beer and the long-term exposure of the urinary system to carbonyl compounds.

Homemade and craft beers are perceived as a popular alternative to beers produced on a larger scale in recent years, due to the choice of consumers according to different taste preferences and the raw materials used for brewing. According to nationally representative survey data from the American Homebrewers Association (AHA), the U.S. had an estimated 1.1 million homebrew brewers in 2017, with annual homebrew beer production in excess of 1.4 million barrels (about 1% of annual U.S. beer production). Again in 2017, 40% of home brewers started production within the last 4 years. Due to the prohibitions that have arisen due to the pandemic all over the world, the production of homemade beer has reached its peak today. In recent years, home-made beer consumption has gained popularity in parallel with low-alcohol and non-alcoholic beers, which are prone to microbial spoilage, due to the ease of access to the material, financial returns and hobby acquisition.

Homemade beer is typically more susceptible to spoilage as it is not pasteurized or sterile filtered. The microbiota, which is associated with organic raw materials, fruits, herbs, honey, spices and vegetables, and non-traditional starch-rich ingredients added to produce different aromas and flavors, increases the risk of spoilage. In addition, home brewers often lack the advantages of a sophisticated microbiological laboratory, and optimal temperature control during brewing and storage cannot be guaranteed. In addition to the fermentation conditions (time and temperature), yeast strain and mash composition (types of grain used in malting, mashing/boiling conditions) can also affect the chemical profile of beer, resulting in a wide variety of components. Carbonyl compounds \[acetaldehyde, acrolein, ethyl carbamate (EC) and formaldehyde\] are particularly toxic compounds that can occur. Acetaldehyde, acrolein, and formaldehyde are highly reactive due to their electrophilic nature, so they easily react with biological nucleophilic targets such as proteins, RNA, and DNA.

Eligibility Criteria:
Inclusion Criteria:

* Homemade beer consumption and not consumption

Exclusion Criteria

* Bleeding disorders
Biological Investigation of Explanted Endobronchial Lung Valves Study

Rationale:

COPD is a severe, often progressive and currently incurable lung disease which affects both the upper airways (chronic bronchitis) as well as the lower airways (emphysema). In advanced stages of the disease air-trapping severely reduces the ability to breathe and subsequently the quality of life. A highly effective treatment for restoring lung mechanical functionality of these patients is the introduction of bronchoscopic lung volume reduction (BLVR), e.g. implanting small silicone/nitinol valves (EBV) inside the airways to reduce air-trapping. Although successfully investigated in a selected group of severe COPD patients, the effectiveness of the treatment can sometimes be short-lived due to fibrotic and granulation responses and tissue-material interactions.

Objective:

The main objective of this study is to study and understand the underlying biological principles of granulation and fibrotic responses limiting the effectiveness and longevity of BELVR treatment with EBVs, this to investigate the mechanism of action of tissue-device interactions.


Eligibility Criteria:
Inclusion Criteria:

* Elidgible for EBV treatment

Exclusion Criteria:

* Anticoagulation which cannot be stopped prior to the procedure
A Prospective Clinical Study of Phenylketonuria (PKU)

This is a study for adults and children ≥ 14 years old who have Phenylketonuria (PKU) with uncontrolled plasma Phe levels. No clinical intervention or study drug is provided by BioMarin in this study.


Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects with diagnosis of PKU which is a condition characterized by PAH deficiency
* Ability and willingness to maintain dietary protein intake consistent with baseline intake
* Willingness and capable per investigator opinion to comply with study procedures and requirements
* Plasma Phe Levels \> 600umol/L

Exclusion Criteria:

* Clinically significant liver dysfunction or disease
* Prior treatment with gene therapy
* Any condition that, in the opinion of the investigator or Sponsor, would prevent the subject from fully complying with the requirements of the study
Esthetic Outcome of Isolated Advancement Genioplasty With and Without Submental Liposuction in Treatment of Skeletal Chin Deficiency

This study is to measure the eshetic outcome of of isolated advancement genioplasty with and without submental liposuction in treatment of skeletal chin deficiency in double chin patients

Many methods used to treat skeletal chin deficiency in double chin patients, the aim of this study is to measure the advancement genioplasty with and without submental liposuction

Eligibility Criteria:
Inclusion Criteria:

* skeletal chin deficiency
* double chin patients
* Ages from 18 to 45
* systemic free

Exclusion Criteria:

* body mass index greater than 28
* ages greater than 45
* systemically diseased
Effectiveness and Health Benefits of a Nutritional, Chronobiological and Physical Exercise Intervention in Fibromyalgia and Chronic Fatigue Syndrome (SYNCHRONIZE +)

Chronic pain, fatigue and insomnia are classical symptoms of Fibromyalgia and Chronic Fatigue Syndrome, affecting seriously life quality. Non-pharmacological multicomponent approach is gaining relevance in Fibromyalgia treatment. However, nutrition and chronobiology are often not approached in-depth despite their potential. Furthermore, programs addressed to Chronic Fatigue Syndrome are still scare. This study aims to evaluate the effectiveness of a compact multidisciplinary group intervention based on nutrition, chronobiology and physical exercise in the improvement of lifestyle and life quality in Fibromyalgia and Chronic Fatigue syndrome.

The investigators will perform a mixed study through a randomized clinical trial in Catalonian Primary Care with patients diagnosed of Fibromyalgia (M79.7) or both Fibromyalgia and Chronic Fatigue Syndrome (G93.3). The control group will follow the usual clinical practice and the intervention group, the usual practice plus the studied intervention (12 hours in 4 days). The intervention (based on nutrition, chronobiology and physical exercise) will be designed taking into account participant's opinion through focus groups. In both groups, quality of life (EuroQol-5D), as well as MFI, VAS pain, PSQI, erMEDAS-17, BRIAN, REGICOR-Short, FIQR and HADs questionnaires will be collected, prior to the intervention, and 1, 3, 6 and 12 months post-intervention. Food intake, body composition, resistance and strength will also be evaluated. The effect size will be calculated using Cohen's d and logistic regression models will be used to quantify the impact of the intervention by adjusting for different variables. In addition, a qualitative analysis with a descriptive phenomenological perspective from post-intervention focus groups of participants and professionals will be done.

Eligibility Criteria:
Inclusion Criteria:

* People aged 18-65, recent diagnosis of Fibromyalgia (M79.1) (\<10 years), or diagnosis of Fibromyalgia and Chronic Fatigue Syndrome (M79 .7 and G93.3), with availability, motivation and interest in the intervention.

Exclusion Criteria:

* not meeting the inclusion criteria, being participating in other group interventions aimed at the treatment of these syndromes, presence of severe mental comorbidity or other relevant medical disorders or pathologies that may interfere with the evaluation of the intervention
Hypofractionated Radiation Therapy for Glioblastoma

Notwithstanding major improvements in treatment modalities, the prognosis of patients with glioblastoma is poor. Hypofractionated radiation therapy as an alternative of the standard 6-week regimen could be an attractive approach as an effort to prevent tumor cell repopulation and reduction the total treatment period promoting patient comfort and convenience.


Eligibility Criteria:
Inclusion Criteria:

* Patients 18 to 70 years of age with newly diagnosed and histologically confirmed glioblastoma.
* WHO performance status of 2 or less and adequate hematologic, renal, and hepatic function.

Exclusion Criteria:

* Prior diagnosis of cancer, unless disease free for \> 3 years
* Previous history of radiotherapy in the head and neck region (except initial larynx tumor - T1, T2 / N0M0).
* Specific severe, active co-morbidities
* Tumor located in the brainstem
* Presence of leptomeningeal carcinomatosis
* Multicentric tumor
DDI Study of BMS-663068 With Etravirine (ETR) and/or Darunavir (DVR) + Ritonavir (RTV)

The purpose of this study is to determine if there is an interaction in healthy subjects taking BMS-663068 with Darunavir/Ritonavir and/or Etravirine.

Brief title: drug-drug interaction (DDI)

Primary Purpose: Other : Phase 1 Clinical Pharmacology drug interaction study in healthy subjects

Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects with no clinically significant deviation from normal in medical history, physical examination findings, 12-lead ECG measurements, and clinical laboratory tests
* Women of childbearing potential (WOCBP) allowed. Must be practicing highly effective methods of contraception

Exclusion Criteria:

* Any significant acute or chronic medical condition
* Unable to tolerate oral medications
* Inability to be venipunctured and/or tolerate venous access
* Current or recent (within 3 months of dosing) gastrointestinal disease
* Abnormal liver function test