cyrilzakka/clinical-trials huggingface dataset:
DNA Analysis of Blood and Tissue from Patients with Lung Cancer

RATIONALE: Studying samples of blood and tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help the study of cancer in the future.

PURPOSE: This clinical trial is analyzing the DNA in blood and tissue samples from patients with lung cancer.

OBJECTIVES:

* Assess the role of genetic polymorphisms in lung-cancer risk in patients with lung cancer.
* Assess the role of germline polymorphisms in DNA repair genes, p53 pathway genes, and a matrix metalloproteinase gene (tumor invasion factor) in lung-cancer risk, after adjusting for potential confounders.
* Assess the roles of gender and age in the genetic susceptibility of lung cancer.
* Assess the role of genetic polymorphisms in modifying the diet-lung cancer risk association (gene-diet and exploratory gene-gender-diet and gene-gene-diet interactions).
* Assess the role of polymorphisms on the risk of developing specific histologic subtypes of lung cancer in case-only analyses.
* Determine whether continued exposures to mainstream and/or second-hand tobacco smoking is associated with poorer clinical prognosis in patients treated for lung cancer.

OUTLINE: This began as a case-control study, but is currently case only.

Blood samples are collected from patients and controls. Samples are analyzed by polymerase chain reaction for gene polymorphisms. Genes to be studied include GSTP1, GSTM1, GSTT1, ERCC2, XRCC1, EPHX, NAT-2, p53 gene, CYP1A1, NQO1, MnSOD, and GPX1. Tissue samples collected from patients undergoing surgery and blood samples are archived for future studies.

Patients and controls complete questionnaires about diet, medical history, and occupational/environmental history.

PROJECTED ACCRUAL: A total of 3,400 patients and 3,400 controls will be accrued for early phases of this study. Total enrollment to reach 15,000.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Patient:

  * Newly diagnosed primary lung cancer

    * Patient at Massachusetts General Hospital (MGH) or Boston Medical Center Cancer Center

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified

EXCLUSIONS:

Vulnerable populations are excluded. Patients with metastasis from another site to lung or mesothelioma are excluded.
Daily, Long-Term Intermittent Fasting for the Prevention of PSA-Recurrence in Patients With Localized Prostate Cancer After Radical Prostatectomy

This early phase I trial studies the feasibility of a daily, long-term intermittent fasting routine in preventing or delaying a rise in prostate specific antigen (PSA) levels in patients with prostate cancer that has not spread to other parts of the body (localized) and who have undergone radical prostatectomy. PSA is a protein produced by both normal and cancer cells. Following a daily fasting routine after treatment for prostate cancer may lower the risk of patients' PSA level rising above 0.4 ng/mL, which is also called PSA-recurrence. A PSA-recurrence can sometimes mean that the disease has returned and/or progressed.

PRIMARY OBJECTIVES:

I. To determine whether men treated for localized prostate cancer adhere to a long-term (months-years) daily intermittent fasting regimen.

II. To measure the levels of metabolic and prostate-cancer derived microparticles in the serum of men that practice a daily intermittent fasting regimen after treatment for localized, high-risk prostate cancer.

OUTLINE:

Beginning when patients' PSA is detectable up to 24 months after surgery, patients follow a daily intermittent fasting routine consisting of restricting the daily eating period to 8 hours (e.g. between 1PM-9PM) followed by 16 hours of prolonged nightly fasting for up to 1 year or until secondary therapy commences.

Eligibility Criteria:
Inclusion Criteria:

* Biopsy-proven histological diagnosis of localized prostate cancer (pT2 or specimen confined pT3)
* Having undergone radical prostatectomy (open or laparoscopic) with bilateral pelvic lymph node dissection
* Negative surgical margins on final specimen
* Men that decline adjuvant therapy
* Detectable serum PSA of 0.1 ng/mL or \>
* 24 months or less since radical prostatectomy at time of study screening

Exclusion Criteria:

* Unable or unwilling to provide informed consent
* Treated prior to surgery with any form of hormone, antiandrogen, or androgen deprivation therapy
* Treated prior to surgery with any form of chemotherapy or radiotherapy
* Medical conditions/history that precludes subjects from following a fasting regimen, including but not limited to:

  * Diabetes mellitus
* On hormone therapy (Casodex, gonadotrophin releasing hormone \[GnRH\] agonist/antagonist)
Lord´s Procedure Versus Sclerotherapy for Testicular Hydrocele; a Randomized Controlled Study

This study will compare a minimal invasive operation in local anesthesia with sclerotherapy for symptomatic testicular hydrocele within 6 months after randomization. Thirty days complication rates will be assessed. The hypothesis is that surgery will lead to faster cure while sclerotherapy would be cheaper and have less complications.

Testicular hydrocele is a common disorder even though it´s exact prevalence is unknown. In areas with filariasis it´s endemic.

Hydrocele is a benign condition where fluid accumulates in between two layers of tunica vaginalis (embryologically, the peritoneum), surrounding the testicle. The cause is unknown but inflammatory conditions is believed to induce these changes. The pathogenesis of hydrocele is believed to be a nonbalanced secretion and resorption of fluid.

Diagnosis of hydrocele is easy since the patient presents with an enlarged scrotum and clinical investigation including palpation and transillumination of the scrotum confirms the diagnosis. A scrotal ultrasound might be indicated to rule out a malignancy or if the diagnosis is unclear.

Treatment for hydrocele is only indicated when the patient has symptoms since all treatment modalities carries risk of complications, such as hematoma, infection, pain and even infertility concerns has been raised.

Operative management is considered the golden standard of treatment when considering recurrence but less invasive procedures such as sclerotherapy is frequently used, mainly due to cost and complications issues.

Lord´s procedure has in several series shown low frequency of complications and excellent recurrence rates. However, Lord´s procedure and sclerotherapy has not been tested head to head and the optimal treatment for hydrocele is yet to be determined.

This study aims to compare these techniques and evaluate the results within 1 year after randomization on cure, complication rates and various secondary descriptive outcomes.

The investigators aim to adhere to CONSORT.

Eligibility Criteria:
Inclusion Criteria:

* Symptomatic testicular hydrocele, with more than 2 points on a validated inguinal botherscore (Inguinal Pain Questionnaire, IPQ)
* More than 40ml of hydrocele fluid
* Age\>40 years
* Completed reproduction
* Oral and written consent to participate in the study
* American Association of Anesthesiology (ASA) grade≤ 3

Exclusion Criteria:

* Other ipsilateral scrotal disease (tumour, ongoing inflammatory disease of the scrotum,)
* Ongoing urinary infection
* Ipsilateral inguinal hernia
* Ascites
* Paternity wish
* Not possible to drain the hydrocele fully
* Opaque fluid drained on emptying the hydrocele
* Bilateral hydrocele where both sides has symptom score more than 2p on IPQ.
The Efficacy and Safety of Diluted Oral Phosphate Enema Versus Intravenous Sodium Glycerophosphate in the Treatment of Hypophosphatemia in ICU Patients

The goal of this clinical trial is to study the efficacy and safety of diluted phosphate enema in treating hypophosphatemia in adults in critical care unit in comparison to intravenous sodium glycero-phosphate as the current standard of care.

The main question it aims to answer is:

can the investigators rely on phosphate enemas as an effective and safe treatment option for hypophosphatemia in critically ill adults, in the era of global shortage of parenteral nutrition solutions and the absence of defined guidelines for treatment of acute hypophosphatemia in those population.

A Randomized Controlled Trial - Non inferiority trial of 2 groups, Eligible participants will be randomly assigned to one of two groups (Intervention Group will receive Diluted Oral phosphate enema as the repletion strategy, while Control Group will receive The Standard of care: intravenous sodium glycerophosphate) for the purpose of treatment of hypophosphatemia in critically ill patients.

Dose Calculation: as per hospital protocol and scientific reference(Crook, 2009) 0.32 mmol per kg for mild hypophosphatemia 0.64 mmol per kg for moderate hypophosphatemia

All participants will be reassessed the next day after the intervention and followed up for the occurrence of any side effects, then participants will be followed up again the day after. (Assessment of serum phosphate and sodium along with occurrence of diarrhea or any other side effects).

Eligibility Criteria:
Inclusion Criteria:

* Critically ill Patients with mild (2-2.4 mg/dl) to moderate (1.5-1.9 mg/dl) hypophosphatemia.
* Serum phosphorus level less than 2.5mg/dl - between 1.5 - 2.5mg/dl
* Patients 18 years or older

Exclusion Criteria:

* Severe hypophosphatemia
* Serum Phosphorus level less than 1.5 mg/dL
* Patients on Non-peroral status
* Ileus (as paralytic ileus, post-operative)
* Any problem in gut integrity as (intestinal obstruction, Severe Malabsorption, severe diarrhea)
* Any form of ischemic gut (as mesenteric ischemia, mesenteric gastric occlusion, arterial venous insufficiency)
* Hemodynamically unstable patients
* Severe Hypocalcemia or Hypercalcemia at the beginning of the study (when iv phosphate is deemed inappropriate at the discretion of attending physician)
Hypoglossal Nerve Stimulation Therapy in Patients With Obstructive Sleep Apnea: Belgian Registry

Hypoglossal nerve stimulation (HNS) therapy (Inspire system) is intended for the treatment of patients with moderate to severe obstructive sleep apnea (OSA) who cannot be effectively treated with the first-line treatment options. Recently, the request for reimbursement of the Inspire system in Belgium was approved.

The aim is to create a multi-center registry of OSA patients that are treated with HNS (Inspire system) within routine clinical care in Belgium.

Patients that are implanted with the Inspire system in Belgium will be invited to participate in the registry. Data will be collected from different routine clinical care visits over a period of 5 years post-implantation. All assessments of the registry are part of the standard clinical care. Data collection will include polysomnographic data, home sleep test data, therapy usage, device data and questionnaires (Epworth Sleepiness Scale, Functional Outcomes of Sleep Questionnaire-30, Visual Analogue Scale (VAS) snoring.

Data will be collected from routine visits including: pre-implant, implant, activation, titration, follow-up (6, 12, 24, 36, 48 and 60 months post-implantation).

Eligibility Criteria:
Inclusion Criteria:

Any patient implanted with or receiving the Inspire HNS system and who is able to give informed consent is eligible to participate in the registry. A patient is eligible for HNS implantation if he/she meets the following criteria:

* At least 18 years old at the time of implantation
* The patient suffers from moderate to severe OSA (15 events/h ≤ AHI ≤ 65 events/h)
* The patient has failed, not tolerated or has a contraindication for continuous positive airway pressure (CPAP) and/or mandibular advancement device (MAD) therapy
* Absence of complete concentric collapse of the level of the soft palate during Drug-Induced Sleep Endoscopy (DISE)

Exclusion Criteria:

* Body mass index (BMI) \>32 kg/m².
* Combined mixed and central AHI is more than 25% of the total AHI
* Patients with complete concentric collapse at the level of the soft palate or any other anatomical deviation that could impede the proper functioning of HNS
* Patients with severely impaired neurological control over the upper airway
* Pregnancy
* Surgery performed on the soft palate in the past three months before implantation.
ID-ClimAct. Influence of Social Motives of Clients and Staff on the Social Climate of Secure Settings

The social climate in secure settings is an essential element to successful rehabilitation. Previous studies indicate that staff characteristics are a relevant factor contributing to a beneficial social climate. Yet, secure settings form a specific and challenging work environment. Staff members are faced with clients who present a variety of difficult emotional and behavioural problems. Social motives for caring and cooperation can be blocked in a threatening environment, favouring dysfunctional interpersonal dynamics between individuals. This observational study explores the reciprocal influences of social motives between clients and staff on the social climate within secure settings.


Eligibility Criteria:
Inclusion Criteria:

* Clients who are currently incarcerated within the specified secure settings.
* Staff members currently employed in the specified secure settings.
* Individuals (both clients and staff) who are capable of providing informed consent.
* Clients who are deemed competent and not under any disciplinary restrictions that would preclude participation.
* Staff members who are directly involved with client care and management.

Exclusion Criteria:

* Clients who are not considered competent to provide informed consent.
* Staff members who do not have direct interactions with clients (e.g., administrative staff not involved in direct care).
* Clients and staff from open prisons
Evaluation of Chagas Blood Screening and Confirmatory Assays

Protocol designed to test blood samples from blood donors of whole blood and blood components using a new investigational screening test (PRISM Chagas) that detects antibody to T. cruzi (Chagas infection). Results will be compared to the current T. cruzi antibody screening assay. Specimens positive with the screening assay will be further tested with a new investigational Chagas confirmatory assay \[Enzyme Strip Assay (ESA) Chagas\]. Additional specimens collected under separate protocols or sourced from suppliers will also be provided to the clinical sites for testing with PRISM Chagas assay and ESA Chagas.


Eligibility Criteria:
Inclusion Criteria:

* Healthy donors that have consented to participate in study

Exclusion Criteria:

* N/A
Tributyrin Treatment in Mild Alzheimer Disease: Assessment of Butyric Acid Effects Via the Gut-Brain

The goal of this clinical trial is to learn if tributyrin can help prevent or mitigate cognitive decline in individuals with mild Alzheimer's disease (AD). The trial will also examine the safety and effects of tributyrin on inflammation and gut microbiota. The main questions it aims to answer are:

Does tributyrin improve cognitive function in patients with mild AD? Does tributyrin reduce inflammation and oxidative stress? How does tributyrin affect gut microbiota and intestinal permeability? Researchers will compare tributyrin to a placebo (a look-alike substance that contains no active ingredient) to evaluate its effectiveness.

Participants will:

Take tributyrin or a placebo every day for 12 weeks. Undergo assessments of cognitive function, blood markers (such as BDNF and GFAP), and gut health.

The findings are expected to provide insight into the potential of tributyrin as a preventive intervention for Alzheimer's disease.


Eligibility Criteria:
Inclusion Criteria:

* individuals diagnosed with mild AD within the past year (ICD-10: F00.1).
* voluntary consent to participate in the study in accordance with the Declaration of Helsinki.
* not currently enrolled in any other clinical trial that could confound the results.

Exclusion Criteria:

* individuals with other potential causes of dementia, such as a history of severe traumatic brain injury, brain tumours, epilepsy, or central nervous system infections.
* individuals involved in an intervention that interferes with the trial (immunosuppressive drugs, steroids, antibiotics, or received chemotherapy in the month prior to the start of the intervention).
* individuals with gastrointestinal disorders.
Routine Use of Antiretroviral Therapy to Prevent Mother-to-Child HIV Transmission in the Kafue District of Zambia

The investigators will enroll a cohort of HIV-infected pregnant women accessing PMTCT services, to better understand the incremental benefits (e.g. reduction in HIV transmission, improvements in HIV-free survival) and risks (e.g. drug toxicities) of the routine HAART strategy, in comparison to HIV-infected pregnant women accessing the Zambian Standard of Care services.

The investigators will test the hypothesis that routine use of HAART produces significant reductions in HIV transmission rates, with only minimal side effects.


Eligibility Criteria:
Inclusion Criteria:

* HIV infected
* Pregnant women
* Ability to provide informed consent.
* Meets eligibility criteria for HAART initiation

Exclusion Criteria:

* Unwillingness to provide informed consent
* Below the age of legal consent
A Non-Blinded Study Demonstrating the Effectiveness and Safety of Azilect Alone or in Combination Therapy in Parkinson's Disease

Patients with Parkinson's Disease (PD) will be divided into 2 groups at each study center at their first visit based on the drugs they are taking for their PD:

* Group 1 Patients using Azilect and no other therapy.
* Group 2 Azilect in combination with other medications like Levodopa, Mirapex, or Requip.


Eligibility Criteria:
Inclusion Criteria:

1. Idiopathic Parkinson's disease. Diagnosis previously confirmed by the presence of bradykinesia and by at least one additional cardinal sign (i.e., resting tremor, rigidity), without other known or suspected cause of parkinsonism.
2. Requiring therapy for PD symptom control

   * Azilect monotherapy.
   * Azilect as adjunct therapy..

Exclusion Criteria:

1. Patients previously exposed to Azilect
2. Patients with pheochromocytoma
3. Concomitant MAO inhibitors or medications contraindicated for use with MAO inhibitors are not allowed.
Evaluation of Dysfunction of the Basal Ganglia Before a Parkinsonian Walking in the Elderly: Risk of Falling and Confusional State

The strong relationship between falling and severity of cognitive impairment in the elderly is well established. The association premorbid gait and executive disorders suggests that they are under tension by the same mechanisms. The gait fortiori neurological are fall risk factors. Dysfunctions underlying disorders as Parkinson called march executive disorders are subcortical origin involving so the basal ganglia. This study is indeed based on the assumption that the dysfunction of the basal ganglia as observed in parkinsonian syndromes resulting in disorders of posture and walking, by dysexecutive syndrome, anxiety and the contrast vision disorders. These gait exposed to falls and dysexecutive these disorders with cognitive impairment and greater susceptibility to confusional states. The executive disorders, gait disorders, anxiety, disturbances of vision and especially saccadic eye movements, impaired vision contrasts are well established in the degenerative parkinsonian syndromes. This study proposes a new approach to assessing gait disorders to define a high risk of falling in the presence of parkinsonian walking in the elderly over 75 years.


Eligibility Criteria:
Inclusion Criteria:

* Age: 75 years,
* man or woman,
* Diagnostic Criteria for Parkinson walking: at least 3 of the following symptoms:
* Loss of swinging arms,
* Decrease in stride walking slowly,
* feet as glued to the ground,
* Trample,
* piece U-turn,
* kyphotic Attitude,
* Tolerance screw physiotherapy screws

Exclusion Criteria:

* Unrecovered delirium,
* Unable to walk for a distance of 6 meters in length without technical assistance,
* Traumatic fall phase of rehabilitation,
* Acute pathology,
* Unstabilized psychiatric pathology,
* Symptomatic orthostatic hypotension,
* Severe depressive syndrome untreated
* Subjects with a sufficient gap to explain the falls:

  * cerebellar syndrome,
  * a pyramidal syndrome with sequelae pyramidal deficit and cortical stroke
  * peripheral pathology,
  * rheumatic disease,
  * orthopedic pathology,
* Mini Metam State Examination \<18,
* Parkinsonism induced by neuroleptics,
* Not cured cancer,
* Psychotropic drugs (benzodiazepines and antipsychotics) with significant sedative effect inducing excessive daytime sleepiness namely psychotropic half long life, and high dose over 2 psychotropic
* Severe heart failure
* Severe respiratory failure,
* Associated diseases and treatments interfering
Intubation During Pediatric Resuscitation

The European Resuscitation Council (ERC) 2010 cardiopulmonary resuscitation (CPR) guidelines suggest that intubators should be able to secure the airway without interrupting chest compression. We examine the performance of the Berci-Kaplan DCI (BERCI), the GlideScope (GVL), the AirTraq, the Pentax AWS (Pentax) and the Miller laryngoscope (MIL) for endotracheal intubation (ETI) during pediatric resuscitation with and without chest compressions.


Eligibility Criteria:
Inclusion Criteria:

* give voluntary consent to participate in the study
* minimum 1 year of work experience in emergency medicine
* experienced emergency medicine personnel (physicians, nurses, paramedics)

Exclusion Criteria:

* not meet the above criteria
* wrist or low back diseases
Drug-Drug Interaction Study of HBI-3000 and Paroxetine in Healthy Adult Male and Female Subjects

Drug-Drug Interaction Study of HBI-3000 and Paroxetine in Healthy Adult Male and Female Subjects

This is a Phase 1 study in healthy volunteers to evaluate the potential effect of multiple doses of paroxetine on the pharmacokinetics and safety of HBI-3000. Each subject serves as his/her own control: Period 1 vs. Period 2.

Eligibility Criteria:
Inclusion Criteria:

Healthy adult males and females

* 18 - 50 years of age
* BMI 18 - 32 kg/m2
* Subject has no clinically significant abnormality on electrocardiogram (ECG)
* Subject has been a nonsmoker and/or has not used nicotine or nicotine-containing products for at least 4 months
* Subject is willing to comply with the study restrictions, including contraception requirements

Exclusion Criteria:

* Evidence of a clinically significant disease or abnormalities, including an active, current infection or clinically significant infection within 8 weeks prior to the first dose
* Severe allergic reaction, angioedema, or anaphylaxis to drugs, or food or latex allergies
* Subject has an estimated creatinine clearance of ≤ 70 mL
* Subject has evidence of a clinically significant deviation from normal in the physical examination, vital signs, or clinical laboratory determinations
* Subject has significant ECG abnormality, history or presence of cardiac arrhythmia or conduction abnormalities, or bradycardia (\< 45 bpm)
* Subject has a history of vasovagal syncope, or symptomatic orthostatic hypotension
* Subject has as a history of or current alcohol abuse and/or other drug addiction
* Subject has received an investigational drug (including investigational vaccines) within 5 half-lives of such drug prior to Study Day 1
* Subject has received CYP2D inhibitors (e.g., fluoxetine, sertraline, duloxetine, bupropion, chloroquine, cimetidine, diphenhydramine) less than 3 weeks prior to administration of the initial dose of study drug
* Subject has suicidal thinking and behavior (suicidality) or other significant psychiatric disorders based on self-disclosure during interview (Screening visit)
* Subject has a history of acute narrow-angle glaucoma
* Subject has as any condition that would make him or her, in the opinion of the Investigator or Sponsor, unsuitable for the study