cyrilzakka/clinical-trials huggingface dataset:
Chemoprevention of Colorectal Adenomas

The purpose of the study is to investigate if long-term treatment with three known drugs (acetylsalicylic acid, 1α 25-dihydroxy cholecalciferol, and calcium carbonate) prevents recurrence of colorectal adenomas.

This is a multicenter, randomized, parallel group, prospective, double blind, placebo controlled clinical trial of chemoprevention in patients at increased risk of developing colorectal cancer (CRC). The Colotech combination treatment (acetylsalicylic acid, 1α 25-dihydroxy cholecalciferol, and calcium carbonate) will be compared to placebo with regards to safety and efficacy during 3 years of treatment. The randomized treatment period will be preceded by a 3-week single blind placebo run-in period, which will assess patient's compliance to treatment. In order to collect data on the durability of treatment effect, follow-up data from a surveillance colonoscopy will be collected two years after the 3-year colonoscopy.

Eligibility Criteria:
Inclusion Criteria:

* Patients 40-75 years of age, both sexes.
* Colonoscopy including the cecum at trial entry
* The removed adenoma(s) have be to tubular, tubulovillous or villous, and fulfill one of the three following criteria:

  1. one adenoma with diameter ≥ 1 cm
  2. ≥ 2 adenomas of any size
  3. an adenoma of any size and familial disposition for colorectal cancer, as long as the person is a first degree relative with a colorectal cancer patient

Exclusion Criteria:

* Familial Adenomatous Polyposis Syndrome
* Member of a family with hereditary non-polyposis colorectal cancer (HNPCC)
* Proctocolectomy (colonic and/or rectum resection permitted).
* Inflammatory bowel disease (Crohn´s disease, Ulcerative Colitis).
* Ischemic cardiovascular disease.
* Patients with known gastro-duodenal ulcer at time of inclusion.
* Cancer within the past 5 years
A Safety and Dose-Finding Study of SYNT001 in Subjects With Pemphigus (Vulgaris or Foliaceus)

This was a multicenter, open-label safety study to determine the dose regimen of SYNT001 (ALXN1830) administered intravenously in participants with pemphigus (vulgaris or foliaceus).

This study planned to evaluate 2 cohorts: up to 8 participants to receive 5 weekly intravenous (IV) doses of ALXN1830 at 10 milligram/kilogram (mg/kg) (Cohort 1) and up to 12 participants to receive 3 x 30 mg/kg weekly doses of ALXN1830 IV (loading) followed by 5 x 10 mg/kg doses of ALXN1830 IV every other week or 10 weekly doses of ALXN1830 IV (maintenance) (Cohort 2).

This study was terminated after the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and efficacy were characterized in participants with pemphigus at a single dose level (10 mg/kg) in Cohort 1, before any participants were enrolled in Cohort 2.

The study consisted of 3 periods: Screening, Treatment, and Follow-Up.

Eligibility Criteria:
Inclusion Criteria:

Participants must have meet the following criteria to be included:

* Were willing and able to read, understand and sign an informed consent form
* Documented diagnosis of pemphigus vulgaris or foliaceus
* Were required to use medically acceptable contraception

Exclusion Criteria:

Participants meeting any of the following criteria were excluded:

* Were unable or unwilling to comply with the protocol
* Active non-hematologic malignancy or history of non-hematologic malignancy in the 3 years prior to screening (exclusive of non-melanoma skin cancer and cervical cancer in situ)
* Positive for human immunodeficiency virus (HIV) or hepatitis C antibody
* Positive for hepatitis B surface antigen
* IV immunoglobulin treatment within 30 days of screening
* Any exposure to an investigational drug or device within the 30 days prior to screening
* Plasmapheresis or immunoadsorption within 30 days of screening
* Participant had any current medical condition that, in the opinion of the Investigator, may have compromised their safety or compliance, preclude successful conduct of the study, or interfere with interpretation of the results
Antimicrobial Photodynamic Therapy Associated With the Conventional Endodontic Treatment: A Clinical and Microbiological Study

Microorganisms play a critical role in the etiology and pathogenesis of apical periodontitis. Enterococcus faecalis and Candida sp. are frequently associated with persistent infections. The aim of this study was evaluated the antimicrobial photodynamic therapy (aPDT) as an adjunct of the endodontic treatment. Ten uniradicular teeth \[control group (CG)=4 and test group (TG)=6\] with primary endodontic infections were analyzed. Microbiological samples were collected before and after the chemical-mechanical instrumentation (CMI), after the aPDT (for the TG) and after the temporary restorations removal (second session).


Eligibility Criteria:
Inclusion Criteria:

* Patients with teeth with: single canal with endodontic infection, intact pulp chamber walls, necrotic pulp confirmed by sensitivity pulp tests, and clinical and radiographic evidence of asymptomatic apical periodontitis

Exclusion Criteria:

* Patients with teeth with: gross carious lesions, root or crown fracture, previous endodontic treatment, gingival recession and periodontal pockets deeper than 4 mm.
* Patients pregnant, lactating, with systemic diseases that could compromise the immune system, individuals who received antibiotic therapy within the previous 3 months or in immunosuppressive treatment.
Failure Time Methods for Family Disease Studies

To develop statistical methodologies to study genetic and environmental factors in cardiovascular disease, using age at onset data from population-based family studies of disease incidence.

BACKGROUND:

In the study of chronic diseases, both environmental and genetic factors can be influential. In highly common diseases, such as coronary heart disease, genetic effects may be more influential in determining the age of onset of the disease than in determining whether or not one gets the disease. When sufficient information is available, family studies can help localize possible disease genes on the human chromosome through genetic linkage analysis, and familial aggregation of disease can help separate the effects of inheritance, environment and lifestyle on the risk of disease.

DESIGN NARRATIVE:

The study developed: (1) a general strategy for evaluating the fit of parametric dependence models for familial clustering of ages at disease-onset; (2) a computationally simple method for genetic linkage analysis of age at onset data; (3) application and illustration of recently developed additive frailty models for complex familial dependence structures. Method (1) was applied to a family study of cardiovascular disease and a twin study of appendectomy. Method (2) was applied to ongoing genetic studies conducted at the University of California at San Francisco. Method (3) was applied to a family study of coronary heart disease in Western Australia. Well-documented, user-friendly programs were developed and made publicly available.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
Buprenorphine Plus Baclofen to Increase Analgesia in Healthy Volunteers

To determine if baclofen will enhance buprenorphine analgesia for acute pain in healthy volunteers.

Abuse of opioids is a significant and growing problem in the United States. In the past two decades, opioid prescriptions have quadrupled while the age of heroin initiation has decreased, suggesting that more individuals are using opioids and transitioning to heroin and potent synthetic opioids than in the past. Further, fatal opioid overdose is now the leading cause of accidental death and is the 5th highest overall cause of mortality in the US. Engaging opioid users in opioid agonist treatments has been shown to lower rates of criminal behavior, lower rates of non-opioid drug use, and increase retention in drug treatment programs, while decreasing mortality and new HIV and hepatitis infections. However, a recent study noted that 68% of patients prescribed buprenorphine had poor medication adherence, which was associated with illicit opioid use. A Cochrane review concluded that buprenorphine was less effective at retaining patients in treatment relative to methadone. One reason for lower treatment retention may be the high comorbidity of opioid use disorder and chronic pain and/or opioid-induced hyperalgesia. Buprenorphine, as a partial mu agonist, provides lower analgesia but an improved safety profile relative to full agonists like methadone. Thus, enhancing the analgesic properties of buprenorphine will provide a safer alternative for opioid use disorder patients with chronic pain/hyperalgesia.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* general good health
* English speaking

Exclusion Criteria:

* Pregnant or nursing
* Opioid use disorder or any substance use disorder other than nicotine
* Prescribed agonist treatment for opioid dependence or prescribed opioids for a medical condition
* Prescribed naltrexone
* Known sensitivity to buprenorphine, naloxone, or baclofen
* Acute or chronic pain condition
* Trouble breathing or a pulmonary condition
* Prescribed benzodiazepines or daily use of benzodiazepines
* Positive drug screen (positive cannabis result allowed)
* Cognitive impairment or psychiatric disorder requiring treatment
* Uncontrolled hypertension
Investigating the Effects of Tube Feeds on Glycemia and Sleep in Adults With Cystic Fibrosis-Related Diabetes

The goal of this at-home, remote study is to understand how tube feeding affects blood sugars and sleep in adults living with Cystic Fibrosis Related Diabetes (CFRD).

The study is a 10-day home-based, observational study of 30 adults with CFRD receiving HEN (targeting 15 receiving overnight and 15 daytime HEN) aimed at concurrently phenotyping glucose, sleep, and circadian rhythms. The remote study is designed to reduce participant burden while allowing for safe and robust objective data and specimen collection and to inform future clinical trial design. The objective of the proposed pilot and feasibility clinical study is to assess the feasibility of remotely phenotyping glycemia, sleep, and circadian rhythms of adults living with CFRD receiving HEN and to generate preliminary data to power a future clinical trial.

Eligibility Criteria:
Inclusion Criteria:

Adult men or non-pregnant women volunteers (age 18-79) Able and willing to give consent and comply with procedures Currently on routine home enteral nutrition (at least 3 months) Known diagnosis of CF Related Diabetes (CFRD) and clinically stable with no significant changes in therapies within the prior 3 months

Concomitant Medications:

A. No initiation of an investigational drug within prior 28 days B. No initiation of new chronic therapy (e.g., ibuprofen, azithromycin, inhaled tobramycin, Cayston®) within prior 28 days C. No acute use of antibiotics (oral, inhaled or IV) or acute use of systemic corticosteroids for respiratory tract symptoms within prior 14 days D. No starting/stopping modulator therapy in the prior 3 months

Exclusion Criteria:

Blind, deaf, or unable to speak English Pregnant, nursing, or plan on pregnancy Current use of melatonin and unwilling to stop during the study With skin condition that precludes wearing sensors Within the last 4 weeks, acute CF exacerbation requiring IV antibiotics or hospitalization Major changes in diet or physical activity level in the last 4 weeks Untreated sleep and circadian disorders
Brain-Machine Interface for Freezing of Gait

Gait problems in Parkinson's disease (PD), especially freezing of gait (FOG), greatly affect quality of life. While deep brain stimulation (DBS) is a highly effective treatment for many motor symptoms of PD, it is less effective for, or can even worsen, gait issues. The primary motor cortex (M1) plays a crucial role in the network that controls gait, particularly in initiating movement. Changes in local field potentials (LFPs) from the subthalamic nucleus (STN) are associated with different aspects of gait. However, detecting abnormal brain activity related to FOG requires a method called electrocorticography (ECoG), which has revealed that during FOG, there is increased beta-gamma phase amplitude coupling (PAC) in the M1.

Brain-machine interfaces (BMIs) have shown promise in understanding motor functions by decoding brain activity. It is believed that BMIs could provide both accurate indicators of FOG and targeted treatments for it in PD.

Our objectives are to use a high-density ECoG-based BMI to both record and stimulate brain activity during real-world gait and FOG in PD patients who are undergoing standard DBS procedures. Our goals are to improve our understanding of the brain's role in FOG and normal gait in PD and to develop new treatments based on cortical stimulation.

Aim 1 - Identify gait biomarkers: brain activity from the M1/SMA cortex during different phases of walking and during FOG episodes, both with and without medication will be recorded. Machine learning will be used to identify the brain patterns linked to FOG.

Aim 2 - Use cortical stimulation to stop FOG: Cortical stimulation and its effects on leg and trunk movements will be studied by measuring muscle activity, movement, and posture during different states, such as resting, standing, walking, and during FOG episodes. The type of stimulation which is most effective at stopping FOG will be identified.


Eligibility Criteria:
Inclusion Criteria:

* PD fulfilling standard criteria for bilateral STN/GPi DBS surgery
* Debilitating FOG in the off-medication condition with only partial response to levodopa (defined as the witnessed occurrence of FOG during the on phase of the pre-DBS L-dopa challenge)
* Clinically established FOG (i.e. reported by patient/caregiver AND seen by the examiner in the clinic)
* Able to provide informed consent, comply with study protocol

Exclusion Criteria:

* Prior ischemic stroke, intracranial hemorrhage, or intracerebral mass
* Previous brain surgery
* Other disorders potentially biasing assessment
* Absence of FOG in the medication on condition (a population already manageable with current standard of treatment).
Immunogenicity nOPV2 With and Without bOPV

This is an open-label randomized clinical trial that will compare immune responses among infants who receive either novel monovalent oral poliovirus vaccine type 2 (nOPV2) alone, bivalent oral poliovirus vaccine (bOPV) alone, or co-administered nOPV2 and bOPV.

It is expected that nOPV2 would replace mOPV2 for responding to type 2 outbreaks. Outbreak response for cVDPV2 also offers the opportunity to close immunity gaps to polioviruses types 1 and 3. Furthermore, GPEI might have to respond to two poliovirus outbreaks in the same geography. For either scenario, it would be important to get data on the immunogenicity of co-administered nOPV2 and bOPV, compared to either vaccine given alone.

This clinical trial assesses and compares the immunogenicity of nOPV2 given with or without bOPV. Healthy infants 6 weeks of age will be enrolled in Dhaka, Bangladesh, and randomized to one of three study arms â " Arm A: nOPV2 only, Arm B: nOPV2 and bOPV, or Arm C: bOPV only. Infants will be followed-up until 18 weeks of age through clinic and household visits. Blood specimens will be collected to test for immunological response. Stool specimens will be collected from infant vaccine recipients and one sibling household contact each to assess viral recombinants and nOPV2 household transmission.

Eligibility Criteria:
Inclusion Criteria:

* Healthy infants 6 weeks of age (range: 42-48 days).
* Parents that consent for participation in the full length of the study.
* Parents that can understand and comply with planned study procedures.
* Infant has at least one sibling aged \<10 years living in the same household that is eligible for participation in the study.

Exclusion Criteria:

* Parents and infants who are unable to participate in the full length of the study (e.g., plan to move away from the study area during the study period).
* A diagnosis or suspicion of immunodeficiency disorder either in the infant or in an immediate family member.
* A diagnosis or suspicion of bleeding disorder that would contraindicate administration of bOPV or nOPV2 or collection of blood by venipuncture.
* Acute diarrhoea, infection or illness at the time of enrolment (6 weeks of age) that would require infant's admission to a hospital.
* Acute vomiting and intolerance to liquids within 24 hours before the enrolment visit (6 weeks of age).
* Evidence of a chronic medical condition identified by a study medical officer during physical exam.
* Receipt of any polio vaccine (OPV or IPV) before enrolment based upon documentation or parental recall.
* Known allergy/sensitivity or reaction to polio vaccine, or its contents.
* Infants from multiple births. Infants from multiple births will be excluded because the infant(s) who is/are not enrolled would likely receive OPV through routine immunization and transmit vaccine poliovirus to the enrolled infant. Even if all births from a multiple birth could be enrolled in the study, we will exclude multiple births as discontinuation of one may lead to discontinuation of multiple participants.
* Infants from premature births (\<37 weeks of gestation).
Safety and Efficacy Study of Citalopram and Lithium for the Treatment of Depressive Mood Disorder Symptoms

The investigators hypothesize that patients receiving citalopram in combination with lithium will have a greater reduction in depressive symptoms than patients receiving citalopram in combination with placebo.


Eligibility Criteria:
Inclusion Criteria:

* 18-75 years of age
* Meets criteria for Major Depressive Disorder, Dysthymia, Depression Not Otherwise Specified or Borderline Personality Disorder
* Ability to speak, read and understand the English Language and provide written informed consent

Exclusion Criteria:

* Current, unstable and significant medical condition or illness
* History of Thyroid disorder, seizure disorder, tumors or other CNS condition that predisposes the patient to risk of seizure
* Pregnant or lactating females
* Abnormal clinical laboratory test results
* Intolerance or hypersensitivity to SSRIs or lithium
* History or current diagnosis of bipolar mood disorder, psychosis, schizophrenia or dementia
* Certain mediations my not be used prior or during the study
Maturation Within Different Skeletal Growth Patterns Using Maturation Index in Males.

The purpose of the study is to evaluate the difference between the maturation stages between different skeletal growth patterns

comparing the maturation of different vertical and horizontal growth patterns using CVMI

Eligibility Criteria:
Inclusion Criteria:

* Only male patients between 8-16 years old with clear sharp cephalometric radiograph, the radiographs which have all the cervical vertebrae will be included in this study.

Exclusion Criteria:

* Previous orthodontic treatment.

  * Radiographs of poor quality.
  * Any hereditary diseases or syndromes such as Down's syndrome or cleidocranial dysostosis.
  * Any disease, trauma or fracture of the jaw that might have affected the normal growth of permanent dentition.
Multiparametric MRI for Assessment of Changes of Renal Hemodynamics After Fistula Closure in Kidney Transplant Patients

Assessment of changes of renal hemodynamics by multiparametric MRI after closure of AVF access.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Age \> 18 years
* Patients wishing to close the fistula and planned for surgical fistula closure
* eGFR CKD EPI ≥ 45 ml/min/1.73m2 at one year post transplantation
* Stable eGFR within the past 6 months
* Controlled blood pressure

Exclusion Criteria:

* Kidney Transplantation \< 12 months before fistula closure
* Proteinuria \> 500mg/d
* Presence of donor specific antibodies
* Rejection within the past 6 months
* BK virus replication within the past 3 months
* Cardiac pacemaker, which is not compatible with MRI
* Claustrophobia
Effect of High-intensity Laser Exercise Versus Moderate-intensity Aerobic Exercise on Diabetic Polyneuropathy Patients

Diabetic poly neuropathy (DPN) is a length-dependent, symmetrical sensorimotor poly neuropathy and is among the most prevalent and challenging consequences of diabetes4.

The documented prevalence of DPN varies between 13% and 55%, with 25% to 50% of these individuals experiencing neuropathic pain5. This study was conducted to find out the impact of high-intensity laser versus moderate-intensity aerobic exercises on diabetic poly neuropathy patients.


Eligibility Criteria:
Inclusion Criteria:

* Neuropathic symptoms in the lower limbs, including numbness, tingling, pain, burning, electric shock, and stabbing

Exclusion Criteria:

* sensory polyneuropathy unrelated to diabetes as
* systemic diseases,
* infections,
* inflammatory conditions,
* drug effects,
* metal exposure,
* hereditary factors
Evaluation of the "Pupillary Pain Index" in Neurological Prognosis After Cardiac Arrest

Two-thirds of patients admitted to the Intensive Care Unit after a cardiac arrest die in the context of treatment withdrawal after a multimodal evaluation that determines an unfavorable neurological outcome.

This study will evaluate the Pupillary Pain Index (PPI) in the neurological prognosis after cardiac arrest. The PPI is determined by recording of pupillary dilatation with a videopupillometer after a calibrated and incremented nociceptive stimulus on a cutaneous metamere.

Cardiorespiratory arrest is associated with high mortality and morbidity rates. The direct consequence of a cardio-circulatory arrest is the absence of blood flow allowing oxygenation of the organs and consequently formation of ischemic lesions. Anoxic cerebral lesions are common in the aftermath of a cardiac arrest and often lead to the death of patients when active therapies are stopped after a multimodal prognostication that indicates that a poor outcome is very likely.

It is of paramount importance to optimize the sensitivity of the prognostication strategy in detecting good neurological outcome. A multimodal approach to the prognostic assessment is essential, and must include at least clinical examination, electrophysiology exploration (electroencephalography and/or evoked potentials) and biomarker analysis.

Although the most reliable predictors did not give false positives in most studies, none of them, considered individually, can establish an unfavorable prognosis with an absolute degree of certitude. For these reasons it is interesting to evaluate new prognostication tools.

The videopupillometry allows precise, reproducible and repeated measurement of changes in pupil diameter in response to a painful or a luminous stimulus. Pupillary pain reflex analysis is usually used to assess the degree of analgesia in a non-communicative patient during general anesthesia and neuromuscular blockade. The PPI score is determined at the bedside by recording pupillary dilatation after a calibrated and incremented nociceptive stimulus (electrical current between 5 and 60mA) applied to a skin metamere with two electrodes.

Automated pupillometry measurement has been recently developed to help support prognostication, with a quantitative pupillary light reflex measurement. The aim of this study is to evaluate the Pupillary Pain Index in the neurological prognosis after a cardiac arrest by correlating the PPI at 48h from the patient's arrival to the CPC score at 3 months.

Eligibility Criteria:
Inclusion Criteria:

* Admission to the ICU after cardiac arrest
* Age \> 18 years
* Presenting a Glasgow score of \<8 at admission

Exclusion Criteria:

* Pregnancy
* Ocular pathology making pupillometry impossible.
* Patient under guardianship or curatorship