cyrilzakka/clinical-trials huggingface dataset:
Functional Magnetic Resonance Imaging of N-acetylcysteine in Cocaine Dependence

The objective of this research is to identify the functional neural mechanisms (as assessed using fMRI) of short-term N-acetylcysteine (NAC) administration among methadone-maintained individuals with cocaine dependence.

The objective of this research is to identify the functional neural mechanisms (as assessed using fMRI) of short-term N-acetylcysteine (NAC) administration among methadone-maintained individuals with cocaine dependence. Specifically, this application proposes to conduct a randomized, double-blind, placebo-controlled, cross-over pilot study to examine the effects of 7-day NAC administration (2400mg/day) on the neural networks engaged during response inhibition (Go/No-Go task) and affective (emotion-regulation task) processes among cocaine-dependent, methadone-maintained individuals (n=40; 20 per treatment-order condition).

Eligibility Criteria:
Inclusion Criteria:

1. enrollment in the APT methadone program and maintained on a stable dose of methadone for ≥ 2 weeks
2. males or females, aged 18-65
3. confirmed DSM-IV diagnosis of current cocaine use disorder as assessed at the screening assessment
4. for women of a child-bearing age, acceptable birth control method
5. ability to commit to 4 weeks of study participation plus 1-month follow-up
6. willingness to be randomized to NAC or placebo
7. eligibility for MRI scanning and willingness to participate in MRI scanning.

Exclusion Criteria:

1. Do not meet DSM-IV criteria for cocaine-use disorder.
2. Meet DSM-IV psychiatric classifications for lifetime schizophrenia or bipolar disorder, or exhibit significant current suicidal or homicidal plans and intent such that hospitalization is required.
3. Meet DSM-IV criteria for current alcohol or other substance-use disorder dependence (with the exceptions of nicotine, cocaine and opioids).
4. Have previously taken or currently take NAC.
5. Have asthma (due to possible complications with NAC).
6. Cannot commit to 4-weeks of study participation or are unwilling to accept randomization.
7. Have any contraindications for MRI scanning (e.g., pregnancy, color-blindness, claustrophobia, metal implants that could interfere with MRI, any other contraindication to scanning).
8. Have lab work (complete blood count, urinalysis, liver function tests, thyroid function tests) suggesting the presence of any abnormalities or have a significant or unstable medical illness.
9. Are women who are pregnant or of a child-bearing age who do not agree to adequate contraception to prevent pregnancy during the study period.
10. Are not fluent in English.
11. Do not have at least a 6th grade reading level.
12. Cannot provide written, informed consent.
The Impact of COVID-19 on the Health Care Utilization of Inflammatory Bowel Disease

The rapid spread of COVID-19 is expected to have a significant impact on medicine as well as all sectors worldwide. In particular, inflammatory bowel disease (IBD) is a chronic immune disease in which remission and activation are repeated and must be treated consistently throughout life. In addition, patients with IBD may be vulnerable to various infectious diseases due to the immuno-compromised state due to the use of immuno-suppressants or biological agents. During a pandemic, patients with IBD may postpone hospital visits due to concerns about infection with COVID-19, and if they cannot continue drug treatment, there is a concern about the flare up IBD disease activity. Therefore, in this study, we would like to investigate the current status of hospital utilization of IBD patients in Daegu, the epidemic area of COVID-19, and to investigate the effect of patient perception of COVID-19 on hospital ultilization.

Background: In the epidemic area of COVID-19, emergency treatment of chronic diseases other than COVID-19 can be limited. Therefore, it is important to reduce the risk of exposure to COVID-19 in patients with chronic immune diseases such as IBD, but it is most important to manage well so that the underlying diseases are not exacerbated at times when emergency medical treatment may be difficult. However, there is a lack of evidence on the management policy of chronic immune diseases in the current epidemic, and only expert opinions are being presented.

Aim: To investigate the current status of hospital utilization of IBD patients in Daegu, the epidemic area of COVID-19, and to investigate the effect of patient perception of COVID-19 on hospital utilization.

Material and method: This study is a multicenter, prospective, cross-sectional survey which will be consulted in Keimyung University Dongsan Medical Center and Yeungnam University Hospital. Patients with IBD aged above 18 will enrolled and surveyed about their perception about COVID-19 and status of hospital utilization during pandemic period. Patients' demographics and disease-related variables will be evaluated to identify clinical significances.

Eligibility Criteria:
Inclusion Criteria:

* Patients with inflammatory growth disease, those who agreed to participate in this study

Exclusion Criteria:

* Those who are unable to understand or answer the questionnaire
* Those who declined to participate in this study
Stress and Breast Milk Study In the Neonatal Intensive Care Unit

The overall goal of this research is to clarify the relationship between reported maternal stress, biological measures of maternal stress, breast milk biomarkers and milk quantity. Our primary hypothesis is that measures of maternal stress are associated with cortisol, cytokines, and other stress markers in the blood, which impacts breast milk quantity and composition and which may impact infant health.


Eligibility Criteria:
Inclusion Criteria:

* Baby will remain in mom's legal custody
* Intends to exclusively breastfeed during the NICU stay
* Has kept a daily log of milk expression (pump or hand expression) with date/time/quantity since birth of their child
* Less than 7 days postpartum

Exclusion Criteria:

* Baby and mother are to be separated due to legal custody issues
* Medical contraindication to breastfeeding
* Non-English speaking
* Unable to answer a written survey in English
* More than 50% of infant intake is not mother's own milk at 4 weeks postpartum
Lacosamide Versus Topiramate in Migraine

Investigators aim to compare the effect of lacosamide versus topiramate in migraine by assessing the absolute reduction in MMD in each group, the percentage of patients who achieved ≥ 50% reduction in the monthly headache days frequency compared to the baseline frequency.

Investigators will enroll 600 migraine patients who are diagnosed according to ICHD3-beta criteria in our study and will use a questionnaire to detect their demographic and clinical features (disease duration, attack frequency, and duration, pain intensity assessed by the visual analogic scale and we have two groups the first group will include 300 patients and will receive 50 mg lacosamide twice daily and Acetaminophen 500-1000 mg in acute attack, and the second group will receive topiramate100 mg per day and Acetaminophen 500-1000 mg in acute attack for at least three months. Investigators will assess The number of migraine days after three months of treatment and the percentage of patients who achieved ≥ 50% reduction in the monthly headache days frequency compared to the baseline frequency (14).. HIT-6 score reduction in each group after three months of treatment. The safety of lacosamide was evaluated by monitoring and documenting treatment-emergent adverse events (TEAE) in patients through regular follow-up procedures for three months.

Eligibility Criteria:
Inclusion Criteria:

- Naive migraine patients, according to the International Classification of Headache Disorders 3rd edition, aged 10-55 years,

Exclusion Criteria:

- Patients with major neurological disorders such as ( epilepsy, ischemic or hemorrhagic stroke, multiple sclerosis, mitochondrial diseases, brain tumors, and patients with essential tremors.

Patients with major systemic diseases such as malignancy, collagen, liver, and renal diseases.

Patients with cardiovascular diseases like hypertension (systolic blood pressure of more than 130 and/or diastolic blood pressure of more than 85 mm/Hg on at least three different occasions, diabetes (fasting plasma glucose level \>126 mg/dl and/or a casual plasma glucose \>200 mg/dl and/or HbA1C more than 6.5.

patients with valvular and ischemic heart diseases, bradycardia or heart blocks, congestive heart failure patients who received prophylactic treatment for migraine, patients with any contraindications to drugs used in the study Patients with topiramate or lacosamide contraindications
Ex Vivo Lung Perfusion : Effect of Cellular Perfusate on Mechanical Properties and Gas Exchange Function of Donor Lungs

The lungs retrieved from the brain dead multi organ donor will be placed in a lab . They will be connected to a ventilator and preservative solution will be circulated through it . Blood will be added to the fluid depending on the group to which the lungs are allocated and its effects on lung function will be seen

The lungs of a brain dead multi organ donor will be retrieved according to standard protocol. Once a decision is made not to transplant the lungs either because of not satisfying ideal criteria or in the absence of a potential recipient they will be included in the study.They will be ventilated optimally and connected to a cardiopulmonary bypass machine for circulating preservative solution through it . Red blood cells will be added to the solution either initially or later depending on the group to which it is allocated .Monitoring of mechanical and gas exchange function and pathological examination of the lungs will be performed at various time points to observe the effect of red blood cells. The lungs will be properly discarded at the end of the procedure and will not be used for transplantation.

Eligibility Criteria:
Inclusion Criteria:

* Brain death certified multi organ donor
* Absence of ideal lung donor criteria or absence of suitable lung recipient

Exclusion Criteria:

* presence of severe mechanical lung injury on visual inspection or radiography
* Presence of pneumonia
* Positive serology ( Hepatitis B,C and HIV
Understanding the Efficacy of Dietary Supplement on Fungal Mycobiota in Healthy Volunteers: A Pilot Study

The purpose of this study is to explore how the dietary supplement L-Phenylalanine affects the production of the metabolite phenylpropionic acid (PPA) and changes fungal populations of the gut microbiome.

The human gastrointestinal tract hosts a diverse microbial community that has a role in influencing the host's pathophysiological responses. Although there is an abundance of metagenomic data available, the functional dynamics of the gut microbiota still need exploration in different conditions. The microbiota produces various metabolites from dietary products, impacting both host health and pathophysiological functions. The metabolites produced by different microbiota may selectively suppress or stimulate the growth of some components of the gut microbiome, ultimately influencing the dynamic of gut bacterial and fungal populations. Our lab is specifically interested in a metabolite, known as phenylpropionic acid (PPA) produced by a human gut resident bacteria known as Clostridium sporogenes. C. sporogenes produces PPA by metabolizing the amino acid, L-phenylalanine, which is sourced from human diet. Many studies have observed the antimicrobial and antifungal effects of PPA. Our lab determined PPA holds antifungal activity of PPA in the gut of mice colonized with Candida albicans. We are interested in investigating how diversity in the mycobiota populations, which focuses on the fungi species in the human gut, are related to changes in PPA levels.

Therefore, this study will asses whether additional oral supplementation of L-phenylalanine has an effect on the way gut mycobiota responds to this amino acid. Healthy subjects received a 14-day supply of L-phenylalanine supplements and provided stool and blood samples to the study team.

Eligibility Criteria:
Inclusion Criteria:

* Male or female adults over the age of 18 years

Exclusion Criteria:

* History of a diagnosis of any gastrointestinal condition, such as inflammatory bowel syndrome or disease
* Antibiotic usage within the past two weeks
* Antifungal usage within the past month
* Allergy to L-Phenylalanine or individuals with phenylketonuria (PKU)
* Adults taking medications known to interact with L-phenylalanine supplements, such as Monoamine Oxidase Inhibitors (MOAI), L-DOPA, and some antipsychotic drugs (complete and extensive drug list will be provided to interested participants during screening)
* Pregnant or nursing women
The Impact of Greater Occipital Nerve and Stellate Ganglion Block Treatments on Sleep in Chronic Headache Management

This study aims to evaluate the effect of Greater Occipital Nerve and Stellate Ganglion block treatments on sleep in patients with chronic headaches. Patients will be assessed using the Pittsburgh Sleep Quality Index, Insomnia Severity Index, and Visual Analog Scale at the time of treatment and at 4 and 8 weeks post-procedure. The study will compare the sleep improvement effects of both treatments to help guide clinicians in selecting the most effective interventional method. Demographic and clinical data will also be collected and analyzed for statistical comparison.

The aim of this study is to evaluate the effect of Greater Occipital Nerve and Stellate Ganglion blockade treatments, used in the treatment of chronic headache, on sleep. These treatments were administered in two sessions, one week apart, for chronic headache. The goal is to compare the treatments using scales at the time of application and at the fourth and eighth weeks after the last procedure.

The improvement effect of Greater Occipital Nerve block on sleep quality scales has recently been reported in several studies in the literature. However, the efficacy of Stellate Ganglion block, a proven method for headache treatment, in these areas has not yet been studied, and its effect on sleep improvement will be investigated.

It is believed that determining the superiority of the interventional methods used on sleep, based on scales, will assist clinicians in decision-making when performing the procedure.

Patients with chronic headache (lasting more than 3 months) who undergo Greater Occipital Nerve or Stellate Ganglion blockade at the clinic will be evaluated. The Pittsburgh Sleep Quality Index and Insomnia Severity Index will be applied immediately after the procedure and at the 4th and 8th weeks following the last procedure. The Visual Analog Scale (VAS) will be obtained from clinic notes for the pre-procedure value and will be repeated at the 4th and 8th weeks post-procedure. The administration of scales will be conducted at Etlik City Hospital Algology Clinic. Patients will be evaluated either during outpatient follow-up or by phone. This study will not include sensitive or vulnerable patient groups. Demographic characteristics (age, gender, height, weight, BMI, alcohol, and smoking habits), comorbidities (obesity, restless legs, psychiatric disorders, sleep disorders, medications), and the scores from the mentioned scales will be recorded and statistically compared.

Eligibility Criteria:
Inclusion Criteria:

* Chronic headache unresponsive to conservative treatment
* Male and female population aged 18-50
* No prior interventional procedures during the treatment process

Exclusion Criteria:

* Coagulation disorders
* Infections at the procedure site
* Allergy to local anesthesia
* Socio-cultural inadequacy
* Mental retardation
* Pregnancy
* Previous interventional procedures
* Patient refusal of interventional procedure
* Use of any sleep-improving medication within the last month
A Study of the Intervention Effect of a Hybrid Exercise Program on Frail Elderly

The declining physical condition of frail elderly is becoming an ugent problem. Although the exercise intensity of Wu Qin Xi appears to be low, it is highly effective in the older individuals. Inspired by the characteristics and functions of Wu Qin Xi, we designed a brand new exercise intervention training program among frail older people, which incorporates Wu Qin Xi, strength exercises and endurance exercises to improve physical fitness, and even reverse the condition of frailty. Furthermore, to improve utility in clinical practice, we innovatively employed machine learning simulations to infer the condition of older adults and predict their level of frailty after the intervention.


Eligibility Criteria:
Inclusion Criteria:

1. a Fried frailty phenotype score of 3-5 points;
2. could walk for at least 6 min without support;
3. had not been able to walk in the past year other training.

Exclusion Criteria:

1. people who have a past mental illness or serious psychological issues which make it difficult to obey orders;
2. people who have had neurological disorders within the last six months;
3. people who must regularly participate in other training programs during the study period;
4. people who struggle to walk normally due to significant muscle and skeletal injuries and continuous joint discomfort.
Hybrid Transvaginal-Transabdominal Endoscopic Surgery

The is a pilot study to evaluate the safety and efficacy of hybrid transvaginal-transabdominal procedures. Diagnostic peritoneoscopy (visualizing the inside of the abdomen), appendectomy (removal of the appendix), and cholecystectomy (removal of the gallbladder) will be performed through a vaginal incision with an additional small incision in the umbilicus.


Eligibility Criteria:
Inclusion Criteria:

* Chronic or early appendicitis
* Symptomatic gallstones
* Suspicious abdominal mass/nodule
* Female
* Age 18-60 years
* ASA Class I or II

Exclusion Criteria:

* Pregnant women
* History of previous abdominal, pelvic, or vaginal surgery
* History of previous abdominal or pelvic radiation therapy
* History of fibroid uterus
* History of endometriosis
* History of large ovarian cyst
* History of unexplained vaginal bleeding or dyspareunia
A Multicenter, Prospective, Observational Study With PriMatrix for the Treatment of Neuropathic Diabetic Foot Ulcers

To evaluate the effectiveness of PriMatrix in the treatment of DFUs in subjects without significantly compromised arterial circulation.


Eligibility Criteria:
Inclusion Criteria:

* Type I or Type II diabetes with investigator-confirmed reasonable metabolic control
* Peripheral neuropathy
* A full thickness diabetic plantar foot ulcer of at least 1 cm2 but not exceeding 10 cm2 in area
* An ulcer which has been in existence for a minimum of 30 days, prior to the day of screening

Exclusion Criteria:

* Suspected or confirmed signs/symptoms of wound infection
* Wounds with exposed bone or tendon
* Hypersensitivity to bovine collagen
Establishing the Incidence of Tako-tsubo Cardiomyopathy in Scotland

Acute stress-induced (Takotsubo cardiomyopathy) presents like a heart attack and is triggered by intense emotional or physical stress. Although coronary arteries are unobstructed, it has been suggested that the risk of death is similar to a myocardial infarction. The purpose of the STARR study is to identify all cases of Takotsubo in Scotland since 2010 and assess its epidemiology and outcomes.

Public Health Scotland will identify all patients centrally coded under codes I42.8 (Other cardiomyopathies), I42.9 (Cardiomyopathy, unspecified) and I51.8 (Other ill-defined heart diseases), using the Community Health Index (CHI) numbers from January 2010. All identified CHI numbers will be thereafter cross-checked with their clinical data at participating health boards to confirm a diagnosis of takotsubo cardiomyopathy and a registry of all confirmed Takotsubo cases will be established.

Clinical data will be collected for all Takotsubo patients retrospectively and prospectively. This will be compared to two contemporaneous gender and age matched control populations:

1. a cohort of randomly selected individuals from the Scottish general population supplied by Public Health Scotland
2. patients with myocardial infarction (extracted through collaboration with, the High-STEACS investigators, NCT01852123).

Electronic data linkage will be performed by Public Health Scotland to assess outcomes, prescribing and scores of prediction.

Eligibility Criteria:
Inclusion Criteria:

* All patients diagnosed with Takotsubo cardiomyopathy

Exclusion Criteria:

* NA
Blood Flow Restriction Training in Patients With Lower Extremity Fractures

This study will look at the effect of using a blood flow restriction device during low load strengthening exercises on patients with tibial shaft fractures, compared to patients performing exercise without the device. The study will compare muscle strength, muscle size, fracture healing, and return to normal function between the two groups.

This study will examine the effect of blood flow restriction (BFR) training in patients with lower extremity fractures. Patients with tibial shaft fractures will be assigned to either the BFR group or control group. The BFR group will perform exercises with a blood flow restriction device, which occludes venous blood flow in the limb, while performing strengthening exercises as directed by a Doctor of Physical Therapy. The control group will perform the exercises without the device, as is current standard practice in physical therapy. Blood flow restriction training has been shown to prevent strength loss and muscle atrophy after surgery or injury, and studies suggest that it increases biomarkers of bone metabolism and tissue healing. The goal of this study is to examine the use of BFR in trauma patients using a defined protocol, and compare fracture healing, muscle strength, muscle girth, and subjective physical function between groups.

Eligibility Criteria:
Inclusion Criteria:

* Adult with closed tibial shaft fracture
* Ability to begin physical therapy treatment within 2 weeks post-operatively

Exclusion Criteria:

* History of osteoporosis or osteopenia
* Impaired circulation in the limb
* Active deep vein thrombosis
* Clotting disorders or other elevated risk of embolism
* Sickle cell anemia
* Infection in extremity
* Renal compromise
* Severe uncontrolled hypertension (SBP\>180)
* Lymphedema
* Under age 18
* Pregnancy
* Prisoner