cyrilzakka/clinical-trials huggingface dataset:
Employment-Based Depot Naltrexone Clinical Trial II

The purpose of this study is to determine whether employment-based naltrexone treatment proves effective in promoting depot naltrexone adherence and drug abstinence.

A randomized study is planned to evaluate the effectiveness of employment-based reinforcement in promoting depot naltrexone adherence in opiate-dependent adults. Vivitrol, an extended-release depot formulation of naltrexone approved by the FDA for the treatment of alcohol dependence, will be used. Participants will be offered an inpatient opioid detoxification and oral naltrexone induction. Participants who complete the oral naltrexone induction (N=40) will be randomly assigned to one of two groups. Both groups will be invited to work in the Therapeutic Workplace and will be prescribed depot naltrexone for 6 months. Participants in the "Work Plus Naltrexone Contingency" condition will earn access to working and earning salary by taking depot naltrexone injections once per month. "Work Plus Naltrexone Prescription" participants will be encouraged to take depot naltrexone monthly, but access to working and earning salary will not be contingent on doing so.

Eligibility Criteria:
Individuals were eligible if they:

* met the Diagnostic and Statistical Manual (DSM)-IV criteria for opioid dependence,
* reported using heroin at least 21 of the last 30 days while living in the community,
* were unemployed,
* were 18-65 years old,
* were medically approved for naltrexone,
* lived in or near Baltimore, MD.

Individuals were excluded if they:

* were pregnant or breastfeeding,
* had serum aminotransferase levels over three times normal,
* had current hallucinations, delusions, or thought disorders, current suicidal or -homicidal ideation,
* expressed interest in methadone treatment,
* were required to use opioids for medical purposes,
* earned over $200 in taxable income over the previous 30 days,
* had physical limitations that would prevent them from using a keyboard, or were incarcerated or under constant monitoring by the criminal justice system.
Intracellular Counter-regulatory Mechanisms Following Low Blood Glucose

Diabetes mellitus type I (DMI) is characterized by lack of endogenous insulin and these patients are 100% dependent on insulin substitution to survive. Diabetes mellitus type II (DMII) is characterized by reduced insulin sensitivity and sometimes also reduced insulin production, thus patients with DMII might also be dependent on insulin substitution.

Insulin is produced in- and secreted from the pancreas when blood glucose concentration rises during- and after a meal. Insulin increases cellular uptake of glucose leading to lower blood glucose concentration. Substitution with insulin is/can be necessary in DM, but at the same time it induces the risk of hypoglycemia. This makes treatment with insulin a balancing act between hyper- and hypoglycemia.

A hypoglycemic episode is a dreaded consequence of insulin overdosing, and also a very frequent reason for hospital admission in patients with DM. Examples of hypoglycemic symptoms may be; shaking, a sense of hunger, sweating, irritability progressing to lack of relevant cerebral responses and eventually coma, convulsions and possibly death. People with diabetes lose the ability to sense of low blood glucose with time, because of a lack of appropriate counter-regulatory responses, hereby increasing the risk of severe hypoglycemia. Understanding normal physiologic counter regulatory mechanisms during hypoglycemia is of major importance to patients with DM and has the potential to change medical treatment in diabetes, to reduce the risk of hypoglycemia.

Hypothesis: Hypoglycemia counteracts insulin signaling via hormone-dependent intracellular counter-regulatory mechanisms, involving phosphorylation of specific signaling proteins.

Aim: To define counter-regulatory mechanisms in muscle- and fat tissue during hypoglycemia, and to investigate the effect of insulin on lipid metabolism in healthy- and type I diabetic subjects.


Eligibility Criteria:
* BMI \> 19 and \< 26
* Written Consent

Exclusion Criteria:

* Epilepsy
* Cardiac arrythmia
* Ischemic heart disease
* Other medical illness
Endolumenal Partial Myotomy for Esophageal Motility Disorders

Achalasia and esophageal spasm are primary esophageal motility disorders where the lower esophageal sphincter fails to relax in response to swallowing with no well understood underlying cause. Surgical myotomy represents an appropriate therapeutic option. The purpose of this study is to evaluate flexible endoscopic myotomy a novel therapeutic approach to overcome the need for invasive surgery.

In this study, the investigators propose the use of a recent endolumenal technique for partial myotomy in patients suffering from primary esophageal motility disorders.

Under general anesthesia patients will have upper endoscopy. Submucosal injection and mucosal incision is created for entry into the submucosal space. A submucosal tunnel is then created using a needle knife or blunt dissection as appropriate. Dissection will continue distally beyond the lower esophageal sphincter. The inner circular muscle fibers will then be divided to achieve an adequate myotomy length. The mucosal entry is then closed appropriately.

Results will be compared to historical data of conventional Heller myotomies.

Eligibility Criteria:
Inclusion Criteria:

* Candidate for elective Heller myotomy
* Ability to undergo general anesthesia
* Ability to give informed consent

Exclusion Criteria:

* Previous mediastinal or esophageal surgery
* Contraindications for EGD
Nutritional Prevention Pilot Trial for Type 1 Diabetes

The overall objective of the study is to assess whether complete avoidance of cow's milk (CM) proteins, for at least the first 6 months of life, prevents type 1 diabetes (insulin-dependent diabetes mellitus, IDDM) in genetically susceptible children who have a mother, biological father or sibling affected by type 1 diabetes.

Among the environmental factors leading to type 1 diabetes in childhood, the most important are certain viral infections and possibly some dietary factors. Among the latter cow's milk proteins are of special interest. They have been shown to be involved in the pancreatic beta-cell lesion in animal experiments. In humans there are some indications of a role of early exposure to cow's milk proteins as a risk factor for later type 1 diabetes. The hypothesis has not been confirmed, but a randomized, controlled double-blinded intervention trial should provide a definite answer.

This study aims at assessing whether one can decrease the future incidence of beta-cell autoimmunity and/or type 1 diabetes in children who have an increased genetic risk for the disease, by administering in infancy after breast feeding until the age of 6-8 months such a formula, in which the cow's milk proteins have been hydrolyzed to smaller peptides. The children in the control group, carrying a similar increased genetic risk, will receive a conventional cow's milk based formula .

This project is a pilot multicenter trial comprising 15 hospitals in Finland.

Eligibility Criteria:
Inclusion Criteria:

* the participant must have a mother, biological father or sibling with type 1 diabetes
* the participant must carry a susceptible HLA genotype(HLA-DQB1\*02 and/or DQB1\*0302 without protective alleles (DQB1\*0301, \*0602 and \*0603)

Exclusion Criteria:

* no telephone
* no accessibility to any of the research centers
* inability of parents to understand the study and instructions
* unwillingness/inability to feed the infant CM-containing food for any reason (e.g. religious, cultural reasons)
* gestational age less than 36 weeks
* Any severe illness such as chromosomal abnormalities, congenital malformations, respiratory failure, enzyme deficiencies of the newborn.
* the newborn infant has received any cow's milk-based product prior to randomization
Liver Fat Content and Bariatric Surgery

On the basis of previous research, this subject intends to evaluate the liver improvement of patients with liver disease after weight loss by MRI, and quantify it by extracting features, so as to provide a new method to judge the liver status of patients with liver disease, and to evaluate the correlation between the inflammatory status of patients and the quantitative features of MRI, and try to explain the reasons for the improvement of fatty liver status of patients with liver disease after weight loss. To provide a new theoretical basis for fatty liver and systemic inflammatory liver damage in patients with liver disease after weight loss surgery, and to link them, and try to explain the improvement of fatty liver in patients with liver disease through the reduction of systemic inflammatory level.

This study is a prospective study to explore the improvement of fatty liver and severe state of the whole body in patients with liver disease undergoing weight-loss surgery. The research object is obese patients who underwent laparoscopic sleeve gastrectomy in our hospital. According to the standard of accepting the discharge, about 50 patients were selected and divided into groups according to preoperative, postoperative one month, postoperative three months and postoperative six months.All patients underwent routine sequence examinations using a Siemens 3.0T MRI scanner (MAGNETOM Prisma, Siemens Healthcare, Munich, Germany).This study investigates alterations in NAFLD among patients with obesity who underwent bariatric surgery using MRI-PDFF and MRS techniques. Additionally, we evaluated the factors that may influence these changes in patients after the surgical procedure.

Eligibility Criteria:
Inclusion Criteria:

* 16 years old \< age \< 60 years old
* BMI \> 32kg/m2
* No previous drinking history; weekly drinking of males \< 210g and females \< 140g in 12 months
* Preoperative auxiliary examination supports the diagnosis of fatty liver, and liver MRI examination
* Previous attempts to lose weight are ineffective
* Complete case data.

Exclusion criteria:

* Secondary obesity
* History of drinking or excessive drinking (in the past 12 months, male's weekly alcohol intake was ≥210g, female's weekly alcohol intake was ≥ 140g)
* Other diseases causing abnormal liver function
* Body mass index \< 28kg/m2
* Poor compliance or self-control, unable to follow the dietary guidance after operation
* Those who cannot complete the follow-up
The Role of EGFR Mutations in Pancreatic Cancer Patients Receiving Gemcitabine With or Without Erlotinib

The purpose of this study is to investigate the influence of epidermal growth factor receptor mutations on the efficacy of erlotinib and gemcitabine in metastatic pancreatic cancer.

The influence of EGFR mutations on the efficacy of treatment with and without erlotinib in metastatic pancreatic cancer is to be determined.

Eligibility Criteria:
Inclusion Criteria:

* metastatic chemotherapy-naïve pancreatic cancer patients
* histologically confirmed
* adequate samples for analysis
* Eastern Cooperative Oncology Group (ECOG) performance status \<= 2
* absolute neutrophil count (ANC) \>= 1,500/mm3
* platelet count \>= 100,000/mm3
* serum creatinine \<= 1.5 mg/dL
* aspartate aminotransferase (AST)
* alanine aminotransferase (ALT) \< 5 times the upper limit of normal

Exclusion Criteria:

* absence of any other malignancy or serious medical or psychological illness that would preclude informed consent
Surfactant Administration Via Thin Catheter Using a Specially Adapted Video Laryngoscope

In this study the investigators intend to assess the feasibility of surfactant administration via a thin catheter using a specially adapted video laryngoscope, with a groove designed to allow insertion of an endovascular catheter without the use of other instruments in the oral cavity (forceps ect.). The laryngoscope is of Peak Medic Ltd, Netania, Israel.

A prospective study to assess the safety and efficacy of surfactant administration via thin catheter using a specially adapted VNscope, originally used for endotracheal intubation and adapted for the administration of surfactant without the placement of an endotracheal tube.

Once neonates present respiratory distress, the adapted scope will be used - clinical and outcome measures will be collected to asses the safety and efficacy of the use

Eligibility Criteria:
Inclusion Criteria:

1. - Premature infants with gestational age 30-36 weeks.
2. - Diagnosis of respiratory distress syndrome
3. - Treatment with antenatal steroids.
4. - Spontaneously breathing with non-invasive positive pressure ventilation.
5. - maximal age 3 days.

Exclusion Criteria:

1. - Apgar score at 5 min \< 5
2. - Need for chest compressions or medication upon delivery.
3. - Evident major congenital malformation, metabolic or genetic disorders.
4. - Clinical evidence of sepsis.
Prophylactic Laser Treatment of Drusen Maculopathy

To study the effect of mild laser treatment on the incidence of exudative complications in soft drusen maculopathy. We hypothesise that mild laser treatment causing a proliferation of the retinal pigment epithelium and enhancing the capacity of clearing drusen material from Bruch's membrane.


Eligibility Criteria:
Inclusion Criteria:

* \> 55 years of age,
* Soft drusen maculopathy,
* VA 0.8-1.0

Exclusion Criteria:

* VA \<0.8,
* Pigment clumps,
* PED,
* CNV,
* Atrophy,
* Haemorrhage,
* Diabetes retinopathy,
* Sign cataract,
* Glaucoma
Vestibular Pain Interactions

The goal is to establish the practical usefulness of vestibular stimulation for modulating pain perception and to describe the possible mechanisms that could underlie neural vestibular-somatosensory interactions.


Eligibility Criteria:
Inclusion Criteria:

* Weight: 50 - 100 kg
* Height: 155 - 185 cm
* Male subjects 18 years to 60 years of age
* Sufficient command of German language
* Written informed consent by the participant after information about the project
* Without any known history of neurological disease (especially motor, somatosensory disorders, peripheral neuropathies).
* Right-handedness

Exclusion Criteria:

1. Intellectually or mental impaired subjects
2. Drug abuse
3. Chronic alcohol consumption
4. No use of marihuana 24h before measurements.
5. No history of vestibular or auditory disorders.
6. Diabetes mellitus
7. Participants of other studies during study period and 30 days prior to study begin
8. Any regular concomitant medication
9. Abnormal QST parameters at the baseline measurement.
10. Absent CHEPs-Potentials at the baseline measurement.
Pencil Beam Scanning in Patients With Renal Tumors

This is a pilot study to assess acute toxicity in patients receiving flank irradiation using proton therapy for renal tumors.

Patients with renal tumors including Wilms and clear cell sarcoma of the kidney (CCSK) are treated with multimodality therapy which may include surgery, chemotherapy, and radiation. While long-term disease control is excellent, these patients remain at risk for early and late toxicities partially from radiation. There have been no significant changes to traditional photon radiation fields, which encompass the post-operative bed, anterior abdomen, and vertebral body. Proton beam radiation using pencil beam scanning, which is characterized by Bragg peak dose deposition and high conformality of dose to target regions, is ideally suited to treat the retroperitoneum. This pilot study evaluates pencil beam scanning proton therapy (PBS-PT) to:

* result in low acute gastrointestinal toxicity in patients receiving radiation therapy for renal tumors as measured by laboratory evaluations, clinician-assessed, and patient reported health related quality of life outcomes
* decrease the duration of radiation therapy
* compare doses to organs at risk (OARs) using PBS-PT as compared to traditional photon fields

Eligibility Criteria:
Inclusion Criteria:

* Less than 30 years of age
* Diagnosis

  a. Any patient with Wilms tumor or clear cell sarcoma of the kidney who would require radiation therapy as standard of care including
  1. Any patient with favorable histology (FH), stage III disease
  2. Any patient with focal or diffuse anaplasia
  3. Any patient with CCSK
* The patient is a candidate for external beam radiotherapy based on standard of care for treatment of Wilms tumor or CCSK

Exclusion Criteria:

* Prior radiotherapy to the region of the study cancer
* Chemotherapy administered for diagnosis of Wilms tumor or CCSK
* Pregnant or breastfeeding
Evaluation Genotypic, Phenotypic and Prognosis APECED Syndrome

The objective of the study will define the mutational spectrum in this French cohort, in patients with APECED syndrome genetically authenticated


Eligibility Criteria:
Inclusion Criteria:

* patients with at least 2 major criteria out of the following 3: hypoparathyroidism of autoimmune origin, adrenal insufficiency of autoimmune origin, chronic cutaneous and mucosal candidiasis.
* patients with only 1 of the 3 major criteria, associated with at least 2 of the following minor criteria: hypergonadotropic hypogonadism of autoimmune origin, atrophic gastritis, malabsorption, autoimmune hepatitis, vitiligo, alopecia, chronic keratoconjunctivitis, hypoplasia of dental enamel.
* patients whose molecular diagnosis has been established or who will be established during the inclusion visit with the genetic sample.

Exclusion Criteria:

-
Cardiovascular Imaging Registry of Canada

A multi-site, multi-modality prospective observational clinical outcomes study focussed on the development of phenotype-dirven risk prediction modelling in patients with known or suspected cardiovascular disease.

The Cardiovascular Imaging Registry of Canada (CIROC) was conceived to provide a common standardized architecture for the collection of clinically reported imaging biomarkers, demographic information, resource utilization and clinical outcomes among patients referred to non-invasive cardiac imaging. The Registry was designed to assess the feasibility of implementing personalized care strategies through automated high quality data collection and patient engagement.

The CIROC Registry was launched with inaugural focus on Cardiac MRI base phenotyping, however has evolved to encompass cardiac CTA and echocardiography. Clinically referred patients are engaged by automated, tablet-based tools to collect informed consent and deploy standardized patient health assessments. Standardized reporting of disease features are captured using bespoke reporting tools. All patients are prospectively followed for a period of 10-years using linkage to administrative health data, inclusive of ICD-coded events, laboratory test results, ECG and vital statistics.

Eligibility Criteria:
Inclusion Criteria:

* All patients referred for hospital-based cardiac imaging services

Exclusion Criteria:

* Failure or provide informed consent
Phase I Study to Evaluate the Diagnostic Performance of 89Zirconium Girentuximab PET in Urothelial Cancer Patients

The aim of this study is to determine if it is practical to use 89Zr-TLX250 PET/CT in the staging and detection of localized and metastatic urothelial carcinoma or bladder cancer.

The primary objective is to evaluate the feasibility of using 89Zr-TLX250 PET/CTas a new diagnostic and staging modality to detect urothelial carcinoma or bladder cancer.

This will be a non-randomised, non-blinded, single centre, phase 1 feasibility study comparing 89Zr-girentuximab PET with FDG PET in patients with urothelial carcinoma or bladder cancer. This study would include 2 cohorts of adult patients; those with known metastatic urothelial carcinoma and bladder cancer and those undergoing primary staging for recently diagnosed urothelial carcinoma or bladder cancer.

This study is open-label, single centre and eligible patients will receive a single administration of study drug prior to imaging on day 5 (+/- 2 days). PET scans will be independently interpreted by nuclear medicine physicians blinded to the FDG PET findings. For patients proceeding to radical cystectomy, subsequent histological confirmation of areas of increased uptake will be retrospectively correlated with both PET scans.

Eligibility Criteria:
Inclusion Criteria:

1. Patients aged 18 or older with bladder cancer or urothelial carcinoma who are able to provide informed consent
2. Negative serum pregnancy test in female patients of childbearing potential at screening. Confirmation of negative pregnancy test result from urine within 24 hours prior to receiving investigational product.
3. Consent to practise double-barrier contraception until a minimum of 42 days after 89Zr-TLX250 administration.

Exclusion Criteria:

1. Active malignancy other than urothelial carcinoma or bladder cancer
2. Administration of a radioisotope within 10 physical half-lives prior to study enrolment.
3. Administration of chemotherapy, radiotherapy, or immunotherapy within 4 weeks prior to planned administration of 89Zr-TLX250 or continuing adverse effects from such therapy
4. Planned antineoplastic therapies for the period between administration of 89Zr-TLX250 and imaging
5. Serious non-malignant disease that may interfere with the objectives of the study
6. Renal insufficiency with glomerular filtration rate ≤45 mL/min/1.73m2
7. Pregnancy or lactation
8. Exposure to murine or chimeric antibodies within the last 5 years
9. Known hypersensitivity or human anti-chimeric antibodies against girentuximab
10. Exposure to any experimental diagnostic or therapeutic drug 30 days prior to the date of planned administration of 89Zr-TLX250
11. Contraindications to FDG PET/CT
The Influence of Satiation Measures on the Portion Size Effect

The purpose of this study is to gain a better understanding of the satiation measures that influence human eating behavior in regard to intake of large portion sizes at a meal. The investigators hypothesize that satiation measures will influence the magnitude of the portion size effect at a meal. Additionally, other individual characteristics will be examined for their influence on the portion size effect. The portion size effect will be measured by serving a test meal once a week for four weeks in which the portion size of the entree will be varied.


Eligibility Criteria:
Inclusion Criteria:

* Be willing and able to travel to Penn State University Park campus weekly for meals
* Be a man or woman 18 - 70 years old
* Regularly eat 3 meals/day
* Be willing to avoid alcohol the day before and during test days
* Have a body mass index between 18.0 and 35.0 kg/m\*m
* Be willing to refrain from eating after 10 pm the evening before test sessions
* Be willing to participate in all study procedures

Exclusion Criteria:

* Must not be a smoker
* Must not be an athlete in training
* Must not be pregnant or breastfeeding at the time of screening
* Have taken prescription or non-prescription drugs that may affect appetite or food intake within the last 3 months
* Dislike or be unable to eat the test foods (because of allergies, intolerance, or dietary restrictions)
* Must not be currently dieting to gain or lose weight
* Have a health condition that affects appetite
* Have participated in a similar study in our lab in the past year
* Must not be a student, faculty, or staff member in nutritional sciences or psychology