cyrilzakka/clinical-trials huggingface dataset:
Evaluation of the Effect of Psycho-oncological Intervention on Well-being of Patients With Advanced Prostate Cancer on LHRH Analogs and Their Partners. A Randomized Controlled Pilot Study.

The purpose of the protocol, is to assess the feasibility of conducting a larger trial to evaluate the effect of a psychological intervention on the well-being of patients on luteinizing hormone-releasing hormone (LHRH) analogs in the treatment of prostate cancer and their partners.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed diagnosis of prostate cancer on biopsy
* Locally advanced or metastasised prostate cancer in need of hormonal treatment.
* On LHRH analogue treatment for a minimum of 5 months (at inclusion)
* Having a female partner
* Patients and their partner are able to fill out questionnaires, attend group sessions and give consent

Exclusion Criteria:

* Serious psychiatric difficulties
* Life expectancy \< 12 months
A Positron Emission Tomography (PET) Study Evaluating Brain Metabolism of a Medical Food in Alzheimer's Disease

This study will examine the brain metabolic effects of AC-1202 (Axona®), a medical food for Alzheimer's disease. Subjects who meet entry criteria will undergo H215O positron emission tomography prior to and 90 minutes after consumption of Axona® at baseline and then again after 45 days of treatment. Cognitive testing will also be conducted at baseline and day 45.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of probable AD (NINDS-ADRDA criteria(32))
* Age 50 - 90 (inclusive)
* MMSE range: 10 to 28
* Participants may be taking medications for AD, provided that the dose of these medications has been stable for \> 90 days
* Proficiency in English to be able to perform cognitive tests
* A caregiver must be available to monitor and administer treatment and to accompany the subject to every clinical visit.

Exclusion Criteria:

* Inability for any reason to undergo PET/CT scans
* Previous treatment with AC-1202
* Allergic to milk or soy
* Presence of neurodegenerative disease other than AD
* History of stroke or other injury that could result in cognitive impairment
* Psychiatric disorder
* Diabetes mellitus
* Recent (\<90 days) changes to medications prescribed for cognitive reasons or with the potential to impact cognition
* Irritable bowel syndrome (IBS) or other gastrointestinal conditions that could interfere with treatment compliance
* Any factor deemed by the investigator to be likely to interfere with study conduction
Cardiac SPECT With Rotating Slant Hole Collimator

The goal is to conduct a clinical pilot study to evaluate the use of a rotating multi-segment slant-hole collimator in the detection of myocardial defects.

Myocardial perfusion SPECT is recognized as an effective clinical diagnostic imaging technique in the assessment of myocardial perfusion and coronary artery diseases. It is the most important clinical application of SPECT imaging techniques.

The goal is to conduct a clinical pilot study to evaluate the use of rotating multi-segment slant-hole (RMSSH) SPECT in the detection of myocardial defects especially in very sick patients in the nuclear medicine clinics, emergence room, and intensive care units. Comparison of the clinical utilities of the cardiac RMSSH SPECT technique with conventional cardiac planar and SPECT with parallel-hole collimation will also allow us to evaluate the potential application of the technique to a wider patient population.

The objective of this study is to test the hypothesis that quantitative 99mTc myocardial perfusion RMSSH SPECT provides similar diagnostic accuracy in patients with cardiac diseases as conventional SPECT imaging techniques.

Eligibility Criteria:
Inclusion Criteria:

* Males and Females 18-80 who are scheduled for a clinical Cardiac Stress Test

Exclusion Criteria:

* Pregnant Women and Children
Language During Inhalational Induction

The aim of this study is to compare the impact of common (standard of care) language vs positive language used by clinicians during inhalational induction of anesthesia on anxiety and negative behaviors in children. This is a prospective randomized parallel group trial. Patients will be randomized 1:1 to the common/standard language group or the positive language group.


Eligibility Criteria:
Inclusion Criteria:

* ASA 1 and 2 (Healthy Patients)
* Non-emergent cases
* 5-10 year olds
* Patients receiving inhalational induction

Exclusion Criteria:

* Non-English speaking
* History of prior inhalational inductions
* Hearing difficulty
* Behavioral difficulty (Autism, Oppositional Defiant Disorder)
* Patients receiving premedication other than midazolam
Intramedullary Calcium Sulfate Antibiotic Depot

The goal of this randomized clinical trial is to study the best treatment for open lower leg fractures to prevent infection. The main questions it aims to answer is if treating tibia fracture patients with a calcium sulfate antibiotic depot is better at preventing infection that the standard of care.

This research is a randomized clinical trial aimed to reduce the frequency of fracture related infections following open tibia fracture. The proposed test methods for infection reduction is use of an antibiotic depot placed inside the bone at the time of final fracture treatment. This is in addition to standard of care wound care, fracture fixation with intramedullary nailing, and peri-operative systemic antibiotics.

This prospective randomized clinical trial will compare outcomes between patients treated with an antibiotic depot placed inside the bone at the time of final fracture fixation and those treated with traditional standard of care intramedullary nailing.

The target population for the proposed study is patients with severe open tibia fractures (Type II or III) who require definitive fixation with intramedullary nail recruited form one of the participating sites during the index hospitalization.

One group will be treated prophylactically suing a calcium sulfate antibiotic depot at the time of definitive fixation, while the second group will be treated with a standard of care intramedullary nail without the antibiotic depot.

Participants will be followed for 12 months (data capture includes patient interviews and clinical data capture from the treatment team and medical record at baseline, 6 weeks, 3 months, 6 months, and 12 months).

Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years and older
* Type II or III open tibia fracture requiring definitive fixation with intramedullary nail

Exclusion Criteria:

* Less than 18 years of age
* Allergy to vancomycin or tobramycin
* Hypercalcemia
* Unable to speak English or Spanish
* No email, phone, or other point of contact
* Pregnant and lactating women
* Prisoner
A Study of LY2599666 in Healthy Participants and Participants With Mild Cognitive Impairment or Alzheimer's Disease (AD)

The main purpose of this study is to evaluate the safety and tolerability of the study drug known as LY2599666 in different groups of people - those who are healthy, those who have mild cognitive impairment due to Alzheimer's Disease (AD), and those with mild-to-moderate AD. The study will measure how much LY2599666 gets into the bloodstream and how long it takes the body to get rid of it. It will also evaluate how LY2599666 affects the body. The study has three parts. Part A will last about 2 months. Parts B and C will each last about 23 weeks. Participants may only enroll in one part.


Eligibility Criteria:
Inclusion Criteria:

Healthy Participants Part A:

* Overtly healthy males or females as determined by medical history and physical examination
* Have a body mass index (BMI) between 18.0 and 32.0 kilograms per meter squared (kg/m²), inclusive

Participants With Mild Cognitive Impairment or Alzheimer's Disease (AD) \[Part B and C\]:

* Participants are at least 50 years old at screening
* Present with Mild Cognitive Impairment (MCI) due to Alzheimer's Disease (AD) or mild-to-moderate AD
* Have a caregiver/study informant who provides a separate written informed consent to participate
* Have adequate vision and hearing for neuropsychological testing in the opinion of the investigator
* Positive florbetapir scan

Exclusion Criteria:

All Participants

* Are currently enrolled in a clinical trial involving an investigational product or off-label use of a drug or device or are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
* Have known allergies to LY2599666, solanezumab, or any related compounds or components of the formulations, or have a history of significant atopy
* Have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study
* Have an abnormal blood pressure as determined by the investigator
* Have significant allergies to humanized monoclonal antibodies, diphenhydramine, epinephrine, or methylprednisone
* Require treatment with other monoclonal antibodies

Participants With Mild Cognitive Impairment or Alzheimer's Disease (AD) \[Part B and C\]

* Have medical or surgical conditions in which lumbar puncture and or/catheter insertion is contraindicated
* Have any contraindication for magnetic resonance imaging (MRI) studies, including claustrophobia, the presence of metal (ferromagnetic) implants, or a cardiac pacemaker that is not compatible with MRI

Participants With Mild Cognitive Impairment or Alzheimer's Disease (AD) \[Part C\]

* Have had lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years, cervical carcinoma in situ, or in situ prostate cancer with a normal prostate-specific antigen post treatment
A Multicenter Open-label Study Investigating the Pharmacokinetics and Safety of Aripiprazole IM Depot Formulation (OPC-14597 IMD) During Repeated Administration by Injection Into the Deltoid Muscle in Patients With Schizophrenia

To assess the pharmacokinetics and safety of aripiprazole intra-muscular (IM) depot formulation in patients with schizophrenia after repeated administration by injection into the deltoid muscle for a total of 5 doses of 400 mg in 4-week intervals


Eligibility Criteria:
Inclusion Criteria:

* Patients with a diagnosis of schizophrenia as defined by Diagnostic and Statistical Manual (DSM)-IV-Text Revision (TR) (295.30, 295.10, 295.20, 295.90, 295.60)
* Patients who have provided written informed consent by themselves (If the patient is a minor, written consent from a legal representative must be obtained in addition to the patient's own written informed consent.)
* Patients, both male and female, aged 18 years or older, but younger than 65 years, at the time of obtaining informed consent
* Patients with a body mass index of 18.5 or higher and lower than 35.0
* Patients whose mental condition is stable or well maintained for 2 weeks or more without any change to dosage regimen for their non-aripiprazole oral atypical antipsychotic monotherapy prior to obtaining informed consent
* Patients who have received aripiprazole in the past

Exclusion Criteria:

* Patients diagnosed as having a mental disorder other than schizophrenia, as defined by DSM-IV-TR criteria.
* Patients with a history or complication of diabetes.
* Patients with hepatic, renal, cardiac, or hematopoietic disorders.
* Female patients who are pregnant or lactating, who may possibly be pregnant, who wish to become pregnant, or male patients whose partner wishes to become pregnant.
* Patients who have a drug allergy or drug hypersensitivity
* Patients for whom clozapine has been ineffective, patients who have responded only to clozapine, or patients who are currently being treated with clozapine.
* Patients with a complication of Parkinson's Disease (excluding drug-induced Parkinsonism).
* Patients with a history or a complication of neuroleptic malignant syndrome, rhabdomyolysis, tardive dyskinesia, paralytic ileus or water intoxication.
* Patients with a history or a complication of psychological or behavioral abnormalities associated with use of psychoactive substances (abuse of alcohol, narcotics, or organic solvent, etc).
* Patients with a history or a complication of suicide attempt or self-injury within 52 weeks prior to obtaining informed consent.
* Patients with a history of or a complication of convulsive disorder such as epilepsy.
* Patients with a history of or a complication of organic brain disorder including cerebrovascular disease.
* Patients with a history or a complication of granulocytopenia or agranulocytosis.
* Patients who have received electro-convulsive therapy (ECT) within 12 weeks prior to obtaining informed consent.
Feel the Move: A Micro-Randomized Trial of a Text-Based Expectation-Setting Intervention to Increase Physical Activity

The aim of this research is to evaluate the impacts of an intervention that reminds people of the affective rewards of exercise on physical activity in adults of any activity level

The Feel the Move study tests the effects of a lightweight text-message based intervention to increase physical activity and affective attitudes towards exercise. The intervention being investigated is text messages that prime expected affective rewards of exercise, sent in advance of a time window during which participants made plans to exercise. At the start of the study, participants will write sentences about feeling good after exercise (which will be used as part of the intervention) and complete baseline questionnaires about their feelings towards exercise. For the next nine weeks, participants will be asked to plan two exercise sessions a week, and will be given a questionnaire after the time window of their planned exercise sessions to assess how it went. At the onset of each time window for their planned exercise session, participants will be micro-randomized to receive one of the following intervention options: no-message; a text message reminding them to fill out the study questionnaires; or a message about the affective rewards of exercise. The messages about affective rewards will be a mix of sentences participants wrote themselves during the baseline assessment and reflective prompts from the research team. At the nine-week mark, participants will again complete the same questionnaires about their feelings towards exercise that they initially completed at baseline. Throughout the study, participants will share data about their activity, including steps and calories burned, with the research team. These data will be automatically collected by the HIPAA-compliant CareEvolution platform from participants' Apple Watches. After the nine weeks of the study participation, a random sample of study participants will be asked to participate in exit interviews to share more details about their experiences with the intervention.

The primary hypothesis is that participants will burn more calories during their planned exercise periods when they receive messages about the affective rewards of exercise vs. when they do not. Researchers will also conduct secondary analyses examining the effects of the intervention on feelings towards exercise and qualitative data from the interviews.

Eligibility Criteria:
Inclusion Criteria:

* lives in the US
* 18 years old or older
* desires to increase activity through structured exercise
* has an iPhone that can send/receive text messages and an Apple Watch

Exclusion Criteria:

* medically advised not to exercise
PNS Vs RFA for Facet Joint Pain

Radiofrequency ablation of the medial nerve is the current surgical treatment for back pain originating from the facet joints in the spine. However, this procedure causes denervation of spinal muscles. Peripheral nerve stimulation is another treatment for facet joint pain that may not cause damage to the spinal muscles. This study will compare both treatments in terms pain relief and spine biomechanics.


Eligibility Criteria:
Inclusion Criteria:

1. Age range (18-80 years): The age range of the patient population at Hershey Medical Center with facet pain is 24 to 90 years old, with a mean age of 63 years old. Due to the physical tests planned in the study, the maximum age limit will be restricted to 80 years old.
2. English Speaking: Adults who only speak other languages will not be included because of the lack of feasibility of employing reliable instruments and interviewers fluent in other languages.
3. Facet Joint Pain: male and female patients having a diagnosis of facet joint pain based upon accepted diagnostic criteria (i.e., two positive nerve blocks) and assessed by an experienced physical therapist or physician.
4. Indication for Surgical Procedure: Physical therapy is the first line of action for facet joint pain. If PT is not effective, patients are eligible for RFA or PNS.

Exclusion Criteria:

1. Previous Spinal Conditions Surgery: We will exclude patients with other spinal conditions like scoliosis or who have received previous spinal surgeries.
2. Systemic neurological or neuromuscular disease: Such disorders (e.g., stroke, muscular dystrophy, myopathies) affect muscle and may confound muscle data and/or balance and physical performance data.
3. Allergic reaction to ultrasound gels: It is possible, although rare, that patients develop allergic reaction to ultrasound gels. Those subjects will be excluded from the study.
4. Physical Activity: Subjects will be asked to fill out the Physical Activity Readiness Questionnaire (PAR-Q), and if they answer yes to any of the questions, they need to be cleared by their physician prior to participating in the study.
5. Current infection, illness, or condition: Individuals with a current infection, illness, or condition (e.g., uncontrolled blood pressure, pregnancy) that may affect their ability to safely participate will be excluded.
6. Mental incompetency: Individuals who cannot legally consent themselves to the surgical procedure and participation in the research study, will not be considered for inclusion.
7. Patients who have a Deep Brain Stimulation (DBS) system.
8. Patients who have an implanted active cardiac implant (e.g. pacemaker or defibrillator).
9. Patients who have any other implantable neuro-stimulator whose stimulus current pathway may overlap with that of the SPRINT System.
Characteristics of Lyme Arthritis

Lyme disease is due to Borrelia burgdorferi sensu lato and is transmitted by a tick vector of the genus Ixodes. One of the clinical forms of this disease in the disseminated phase is the appearance of arthritis, classically mono or oligo-arthritis in the large joints.


Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* Diagnosis of Lyme arthritis confirmed by PCR of joint fluid at CNR Borrelia between 2011 and 2016
* Patient who has agreed to use his medical data for research purposes

Exclusion Criteria:

- Refusal to participate in the study
Evaluation of Sinetrol® Xpur in Fat Mass Reduction on Overweight and Obese Subjects

This study aims to evaluate effects of a 16-week supplementation with a polyphenol rich extract, Sinetrol® Xpur, on fat mass accumulation and body weight management improvement.Subjects were overweight or obese and received polyphenol supplement or placebo. A 4-week follow-up as performed to evaluate its effect after supplementation stop.


Eligibility Criteria:
Inclusion Criteria:

* overweight or obese (25 kg.m-2\<BMI\<42.5kg.m-2)
* healthy

Exclusion Criteria:

* metabolic or chronical disease with treatments (i.e.: diabetes, dyslipidemia, thyroiditis, inflammatory disease, immunological disease, infectious disease, asthma, anxiety and depression)
* food allergy to the ingredients of the product (grapefruit, orange, caffeine, guarana)
* involved in the prior 6 months in a chronic treatment program, eating disorders history, subjected to weight reduction by surgery
* start or quit smoking, high alcohol consumption
* pregnant, breastfeeding, wanting to have a baby,
* menopausal women
Comparison of Pain Sensation During Single Use of Two Topical Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)

Different case reports are showing that depending on the drug used for eye drops, it might provoke a painful sensation. Actually two leading NSAIDs are used in ophthalmology. This study is intended to provide information about this parameter concerning these two drugs.


Eligibility Criteria:
Inclusion Criteria:

* Patient over 21 years old
* No ocular surface pathology
* Eligible for cataract surgery

Exclusion Criteria:

* Any other eye pathology other than cataract
Immune Modulation From Trichuris Trichiura

Mucosal immunology during helminth infection

The present study investigates the effects of Trichuris trichiura on human mucosal and systemic immunity in a single self-infected individual.

Eligibility Criteria:
Inclusion Criteria:

* The included volunteer is a researcher within parasitology with main focus on Trichuris trichiura and Trichiura suis. He planned to infect himself and contacted our department with the purpose of being monitored during this infection for safety (medical supervision) and research reasons. The only clinical criterion for his inclusion in the study was that he was healthy.

Exclusion Criteria:

* N/A