cyrilzakka/clinical-trials huggingface dataset:
Melatonin Degradation Rate in Human Milk

Our long term hypothesis is that giving premature infants breast milk that was pumped during the night and has high concentration of melatonin will improve outcome of several clinical conditions related to premature infants. Prior to testing this, we need to learn the pharmacokinetics of melatonin in vitro.

In this preliminary research we would like to check the levels of melatonin in breast milk pumped during the night, and evaluate the rate of degradation of the melatonin to determine the half life of melatonin in pumped breast milk (in vitro).

The study includes 10 nursing women. Each woman will bring a frozen 5 ml sample of breast milk that was pumped at 03:00 AM. The samples will be collected at the NICU department of Carmel Medical Center and will be stored at deep freeze (-20°C). The samples will be numerically coded and will be kept anonimously. After defrosting the samples, melatonin concentration will be checked in the hospital laboratory every hour, for 4 hours. If meltonin levels will be detectable after 4 hours, continous measurements will be done at 8 hours and at 12 hours after defrosting. The samples will be tested with IBL Melatonin ELISA kit. For control we will use breast milk that was pumped at 10:00 am (when melatonin excretion is minimal). At the end of the analysis the samples will be thrown away.

Eligibility Criteria:
Inclusion Criteria:

1. Women that are breast feeding and will pump and freeze a milk sample at 03:00 AM
2. Women at least one week after delivery

Exclusion Criteria:

1. A sample that will not be freezed right after the pump
2. Women that are taking hypnotic drugs
3. Women that are taking melatonin
Impact of the Microsurgical Technique After a Theoretical-practical Course in Microsurgery

A single group study will be carried out in the Microsurgery Laboratory, Neurosurgery Department, Hospital de Clínicas, and the Center for Microsurgical Skills of the Argentine Association of Neurosurgery. The objective of the study is to evaluate the effect of theoretical-practical course learning in neurosurgery and plastic surgery residents.

Introduction: In the second half of the 20th century, the use of the surgical microscope became popular in neurosurgery. In the last twenty years, simulation has gained worldwide acceptance as a teaching tool in medicine, especially microsurgery. For this, various training models have been created.

Objective: To evaluate the effect of the theoretical-practical course learning in neurosurgery and plastic surgery residents.

Materials and methods: A single group study will be carried out in the Microsurgery Laboratory, Neurosurgery Department, Hospital de Clínicas, and the Center for Microsurgical Skills of the Argentine Association of Neurosurgery. Medical doctors of both genders will be included in the first three years of neurosurgical or plastic surgery training from any center in Argentina. The course will be theoretical-practical, lasting eight hours, divided into two meetings with a theoretical class and practical microsurgery exercises. It will be supervised by teachers microsurgery experienced. An Initial and final evaluation will be carried out and the scores obtained between both theoretical and practical evaluations will be compared. In the practical evaluations, the time and the SMART scale will be analyzed. Categorical variables will be reported as absolute and relative numbers. The normality of the data will be verified by the Kolmogorov-Smirnov test. Continuous variables will be reported as mean and standard deviations or median and interquartile ranges. Student's t test, Mann-Whitney U test will be used to compare means, when appropriate, according to the distribution of variables. The categorical variables will be compared with the χ2 test.

Eligibility Criteria:
Inclusion Criteria:

* Doctors in the first three years of neurosurgical training or plastic surgery in any center in Argentina.
* Both gender will be included without age limit.

Exclusion Criteria:

* Participants who do not complete the entire course will be excluded
Infarction Register

The Aachener Digitale Myokardinfarkt Register (ADMIRE) is a prospektive registry study which was designed in order to obtain data of patients with acute coronary syndrome and herewith control and optimize guideline conform therapy of these patients.

Aims of this registry stdy are

documentation of the characteristics of all patients representing to the RWTH Aachen University Hospital (UKA) with STEMI or NSTEMI documentation of the invasive and adjuvant medicinal therapy of STEMI and NSTEMI at UKA documentation of the in-hospital mortality documentation of the procedure-associated complications documentation of therapeutic principals for patients with STEMI or NSTEMI at UKA and investigation conformity of treatment with already established guidelines

Eligibility Criteria:
Inclusion Criteria:

* acute coronary syndrome

Exclusion Criteria:

* under age or not able to give informed consent
Role of Apathy in the Effectiveness of Weight Loss Interventions

The purpose of this study is to determine whether treating apathy with methylphenidate or medical Crisis counselling will increase adherence to weight loss programs thereby increasing their effectiveness

Title: The role of Apathy in the effectiveness of weight loss interventions in obese patients

Objective: Obesity is a major public health problem. Apathy is a common behavioral problem characterized by loss of initiative, poor motivation and persistence. Presence of apathy impairs the self-care behavior in obese patients. Lack of novelty might impair a patient's ability to seek new interactions, life styles and new treatment options for obesity. Lack of motivation might impair a patient's ability to initiate exercise regimen or diet whereas lack of persistence impairs the compliance with these regimens. Thus, apathy influences all stages of self-care. We hypothesize that the treatment of apathy will result in better adherence to weight loss interventions in obese veterans enrolled in the MOVE program.

Research Design: A prospective open label randomized study. Group 1 will have patients with obesity as defined as BMI\>30, and apathy defined as AES score of \> 40. This group will be treated with standard nutrition counseling. Group 2 will have patients with obesity and apathy as defined above and will receive the MOVE enhancement program alone (The MOVE program is a national VA weight loss program). Group 3 will be treated with methylphenidate along with the MOVE enhancement program. Group 4 will be treated with medical crisis counseling along with the MOVE enhancement program. Group 5 will be treated with methylphenidate, and the medical crisis counseling along with the MOVE enhancement program.

Methodology: 30 patients meeting the criteria will be enrolled in each of the five arms. All patients will be in the study for duration of six months. All patients in the methylphenidate arm will be started at 5mg twice daily and titrated to 10mg twice daily at two weeks. Patients will be assessed on regular intervals using the Apathy Evaluation Scale, Hamilton Depression Scale and the Patient activation measure. MOVE sessions will be held once weekly from the 2nd visit to the end of the study. Medical Crisis Counseling visits will be every week for nine sessions and then every other week till the end of the study

Clinical Relationships/Significance: The prevalence of obesity in the general population is over 30%. However the prevalence of obesity in the VA health system is almost 70%. Since obesity predisposes to several co-morbid conditions such as hypertension, diabetes and cardiovascular disease, it is important to develop interventions that are effective in inducing weight loss. Since apathy plays a large role in the self care behaviours that lead to obesity, treating apathy may improve adherence to weight loss programs

Eligibility Criteria:
Inclusion Criteria:

* BMI \>30
* Apathy score \>40

Exclusion Criteria:

* History of cancer, except basal cell
* Cardiovascular event in last 6 months
* Renal failure
Investigation of Body Awareness and Affecting Factors in Bariatric Surgery Patients

The aim of this study is to investigate the body awareness and the factors affecting the bariatric surgery.

In the treatment of obesity, bariatric surgery allows for significant and permanent weight loss and is the most effective treatment. Although the effect of changing body image on occupational and social experiences in patients undergoing bariatric surgery has been examined, there is not enough information about the body awareness and the factors affecting these patients. The aim of this study is to investigate the body awareness and the factors affecting the bariatric surgery.

In this study, body composition (with body analyzer), body awareness (with Body Awareness Questionnaire), physical activity level (with International Physical Activity Questionnaire-Short Form), joint position feeling (with photography method), quality of life (with Short Form-36), depression status (with Beck Depression Inventory) and cognition (with Montreal Cognitive Assessment Test) of all participants will be evaluated when they come routine doctor control.

Eligibility Criteria:
Inclusion Criteria:

* Having a bariatric surgery,
* At least 6 months after surgery
* Being between the ages of 18-65,
* To read and understand Turkish
* Volunteer to participate in the study

Exclusion Criteria:

* Musculoskeletal problems to prevent the tests to be applied,
* Psychiatric diagnosis,
* Drinking alcohol and / or drugs,
* Refusal to volunteer

For the control group to be included in the study, the BMI should be between 18-25 kg / m2, read and write in Turkish, and be voluntary. Those who have been included in any exercise program (plates, yoga, dance, etc.) in the last 1 year will be excluded.
DISE-HNS Effect Study

The purpose of this study is to assess the site, pattern and degree of upper airway collapse before and during hypoglossal nerve stimulation (HNS) treatment using clinical standard drug-induced sleep endoscopy (DISE) and using a novel, non-invasive method predicting site of collapse from raw polysomnography (PSG) data.

Furthermore, outcomes will be compared between responders and non-responders.

Patients who will receive hypoglossal nerve stimulation therapy will be recruited at the pre-operative consultation at the department of ENT. As part of the standard procedure, all patients who are eligible for HNS have already undergone DISE.

To be included in the study, the patient should have undergone or is scheduled to undergo a baseline PSG within two years of HNS implantation.

All patients will undergo HNS-implantation and receive HNS-therapy as part of the standard pathway.

One year after HNS-therapy, patients will undergo another PSG as part of routine practice in these patients. An additional DISE will be performed to assess the effect of HNS on the site, pattern and degree of upper airway collapse.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older.
* Eligible for HNS-therapy:
* AHI between 15 and 65 events/hour
* BMI under 32 kg/m2
* Absence of complete concentric collapse of palate (CCC) on DISE
* Intolerance or failure of continuous positive airway pressure (CPAP)-treatment
* Intolerance or failure of mandibular advancement device (MAD)-treatment
* Combination of central and mixed apneas less than 25% of total apneas on recent PSG (not older than two years)
* Scheduled for HNS-implantation at the Antwerp University Hospital
* Capable of giving informed consent
* Baseline polysomnography planned or performed in the last 2 years at the Antwerp University Hospital

Exclusion Criteria:

* Patients will not receive HNS-therapy at the Antwerp University Hospital
* Known medical history of intellectual disability, memory disorders or current psychiatric disorders (psychotic illness, major depression, or acute anxiety attacks as mentioned by the patient).
Effects of Group-based and Digitally Delivered CBT-I in Youth

Adolescence is a critical transitional stage characterised by a cascade of developmental changes in biological, cognitive, and psychological functioning. Sleep problems, particularly insomnia, are prevalent in adolescents, with a prevalence rate as high as 36%. Insomnia symptoms, presented as the problems initiating sleep or maintaining sleep, have often been reported in association with adverse outcomes in adolescents, including an increased risk of developing depression, anxiety, interpersonal problems, somatic health problems, self-harm and suicidal ideation. This study tests the efficacy of cognitive behavioural therapy for insomnia (CBT-I) in reducing insomnia severity in youth with insomnia.


Eligibility Criteria:
Inclusion Criteria:

* (1) Chinese aged 12-20 years old (an age range that was similarly adopted in the previous studies to cover a wider developmental span in adolescence);
* (2) Written informed consent of participation into the study is given by the participant and his/her parent or guardian (for those aged under 18);
* (3) Willing to comply with the study protocol;
* (4) Meeting the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) diagnostic criteria of insomnia disorder and with a score on Insomnia Severity Index (ISI) - 9 (suggested cut-off for adolescents)

Exclusion Criteria:

* (1) A current diagnosis of substance abuse or dependence; a current or past history of manic or hypomanic episode, schizophrenia spectrum disorders, neurodevelopmental disorders, organic mental disorders, or intellectual disabilities;
* (2) Having a prominent medical condition known to interfere with sleep continuity and quality (e.g. eczema, gastro-oesophageal reflux disease);
* (3) Having a clinically diagnosed sleep disorder that may potentially contribute to a disruption in sleep continuity and quality, such as narcolepsy, sleep-disordered breathing, and restless leg syndrome, as ascertained by the Structured Interview for Sleep Patterns and Disorders (DISP), a validated structured diagnostic interview to assess major sleep disorders according to the International Classification of Sleep Disorder (ICSD) criteria;
* (4) Concurrent, regular use of medications(s) known to affect sleep continuity and quality including both western medications (e.g. hypnotics, steroids) and over-the-counter (OTC) medications (e.g. melatonin, Traditional Chinese Medicine, TCM);
* (5) Having been enrolled in any other clinical trial investigational products within one month at the entry of the study;
* (6) In the opinion of the research clinician, having a clinically significant suicidality (presence of suicidal ideation with a plan or an attempt) as assessed by Mini-International Neuropsychiatric Interview (MINI);
* (7) Currently receiving any structured psychotherapy;
* (8) With hearing or speech deficit; (9) Night shift worker.
Personalized Inhibitory Control Training for Compulsive Behavior Change

Obsessive-compulsive disorder (OCD) is a severe mental illness characterized by repetitive behaviors that a person feels compelled to perform. It has been demonstrated that stimuli in the environment can trigger the compulsive urge, perpetuating the OCD cycle. The main goal of the current proposal, which is based on exciting pilot data, is to test a novel computerized training program to create an association between OCD-related stimuli, which typically trigger the compulsive urge, and the brain system responsible for stopping. The idea is that once this system is triggered, it will be easier for patients to stop the compulsive urge.


Eligibility Criteria:
Inclusion Criteria:

* OCD patients

Exclusion Criteria:

* Metal/ electronic device
* Under the age of 18
* Pregnant women
* Tattoos that cover over 10% of body mass
* Chronically ill patients
* Psychosis/ Bi-polar
* Substance abuse
* Sever depression
* Active suicide thoughts
* Hearing loss
Ambulatory Care Characteristics as Predictors of Mortality and Re-Admission

The aim of this study is to construct a prognostic model to identify risks of poor outcomes at one year following hospital discharge of patients treated in an ambulatory cate setting. The study will incorporate pre-hospitalization characteristics, hospitalization events, comorbidity burden, psychosocial measures and post-hospitalization care characteristics to predict re-hospitalization and mortality at one year.

This model will identify potentially modifiable variables in the post-hospitalization clinic setting that result in increased rates of hospital readmission and mortality. Specifically, it is hypothesized that longer time to first outpatient visit after hospitalization, multiple providers, poor follow-up with scheduled appointment and discrepancies between discharge and outpatient medication lists will be predictors of adverse outcomes. Utilizing statistical modeling methods, it will be possible to recognize at risk patients, to identify modifiable risk factors and outpatient care characteristics, and in the future, to direct patient specific interventions to improve outcomes.

Eligibility Criteria:
Inclusion Criteria:

1. All patients admitted to New York Presbyterian Hospital and followed in Cornell Internal Medicine Associated for at least one year prior to admission.

Exclusion Criteria:

1. Patients who do not wish to participate in the study.
2. Patients who are not followed in Cornell Internal Medicine Associates.
A Study Of Avelumab Alone Or In Combination With Pegylated Liposomal Doxorubicin Versus Pegylated Liposomal Doxorubicin Alone In Patients With Platinum Resistant/Refractory Ovarian Cancer (JAVELIN Ovarian 200)

A Phase 3 global study comparing avelumab alone to avelumab plus PLD and to PLD alone to demonstrate that avelumab given alone or in combination with PLD is superior to PLD alone in prolonging Overall Survival in patients with platinum resistant/platinum refractory ovarian cancer.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed epithelial ovarian, fallopian tube, or peritoneal cancer, including malignant mixed Müllerian tumors with high grade serous component.
* Platinum resistant/refractory disease, defined as disease progression within 180 days following the last administered dose of platinum therapy (resistant), or lack of response or disease progression while receiving the most recent platinum based therapy (refractory), respectively.
* Received up to 3 lines of systemic anticancer therapy for platinum sensitive disease, most recently platinum containing, and no prior systemic therapy for platinum resistant disease
* Measurable disease by investigator assessment with at least 1 unidimensional measurable lesion by RECIST v.1.1 that has not previously been irradiated
* Active autoimmune disease that might deteriorate when receiving an immunostimulatory agents. Patients with diabetes type I, vitiligo, psoriasis, hypo or hyperthyroid disease not requiring immunosuppressive treatment are eligible.

Mandatory tumor biopsy must be performed prior to enrollment for all patients (unless there is a documented clinical contraindication). In addition, availability of archived FFPE tumor tissue should be confirmed. If a patient underwent tumor tissue collection within 3 months prior to enrollment with no intervening treatment, and the sample is provided, then a new de novo tumor biopsy is not required.

Exclusion Criteria:

* Non epithelial tumor or ovarian tumors with low malignant potential (ie, borderline tumors).
* Prior therapy with an anti PD 1, anti PD L1, anti PD L2, anti CD137, or anti cytotoxic T lymphocyte associated antigen 4 (CTLA 4) antibody (including ipilimumab, tremelimumab or any other antibody or drug specifically targeting T cell co stimulation or immune checkpoint pathways).
* Known symptomatic brain metastases requiring steroids. Patients with previously diagnosed brain metastases are eligible if they have completed their treatment and have recovered from the acute effects of radiation therapy or surgery prior to study entry, have discontinued corticosteroid treatment for these metastases for at least 4 weeks prior to study entry and are neurologically stable.
* Diagnosis of any other malignancy within 5 years prior to registration, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the breast or of the cervix.
* Severe gastrointestinal conditions such as clinical or radiological evidence of bowel obstruction within 4 weeks prior to study entry, uncontrolled diarrhea in the last 4 weeks prior to enrollment, or history of inflammatory bowel disease.
PRevention of OsTEoporotiC FracTure 2 Pilot Study

With the aging of the world population, osteoporosis and fragility fractures have become global public health concerns. It has been estimated the population of people ≥60 years of age will increase from 229 million (16.2%) in 2017 to 479 million (35.1%) by 2050 in China. Because age is an important predictor of osteoporosis and fragility fracture, the incidence of fragility fracture has increased dramatically in China over the past decades. Timely treatment of osteoporosis is an effective way to decrease additional fracture risk among patients with fragility fractures, but anti-osteoporosis treatment rate is relatively low in China. Effective fracture prevention intervention is urgently needed in China.

As a potential way to achieve effective risk communication, shared decision-making allows patients to be active participants in the management of osteoporosis. The investigators designed a multifaceted intervention, which was named as "Precise Education + Shared Decision-Making" program for the secondary prevention of fragility fractures based on behavioral theories, and assessed the effectiveness for fracture prevention using a pilot cluster randomized controlled trial among several hospitals in China.

The aim of this pilot study is to test the acceptability and feasibility as well as preliminary efficacy of this program in patients with fragility fractures.


Eligibility Criteria:
Inclusion Criteria:

1. Local residents (live in the city where the hospital is located for half a year or more);
2. Hospitalized patients with fractures aged 50 years and above;
3. First fracture, without history of fracture;
4. Never diagnosed as "osteoporosis" before admission;
5. No fracture history, and never receive any bone mineral density test, and never take anti-osteoporosis medication in the 4 years before admission;
6. Hospitalized patients with the following fractures: hip fracture, thoracic spine fracture, and lumbar spine fracture;
7. New fragility fracture: fracture that occurs after minor trauma or daily activities, such as a fracture caused by a fall from standing height or less; fracture happened within 6 weeks;
8. Not living in a nursing or rehabilitation institution before fracture;
9. Possess reading ability, and can read and understand informed consent forms or medical materials independently.

Exclusion Criteria:

1. Patients with pathological fractures caused by tumor or infection;
2. Patients with cognitive dysfunction or mental disorder;
3. AIDS patients;
4. Patients who refuse to follow-up, or have poor compliance for follow-up, or fail to understand and cooperate for follow-up;
5. Hearing or visual impairment, and unable to communicate or read materials;
6. Patients who have participate in other studies;
7. Other conditions that the investigator considered inappropriate to enroll.