cyrilzakka/clinical-trials huggingface dataset:
Evaluating the Impact of a Novel Cannabinoid Product for Endometriosis

Despite the proliferation of cannabis and cannabinoid products in recent years, little research has been done to determine the impact of these products on womens health conditions, including endometriosis. This study is designed to assess the impact of a custom-formulated, hemp-derived, full-spectrum, high-CBD product vs. placebo on clinical symptoms and biomarkers over the course of 12 weeks of treatment in patients with endometriosis. This project will provide information that does not currently exist on the potential efficacy of a cannabinoid-based sublingual product for endometriosis.

Despite recent increases in both medical and recreational cannabis use in the United States and globally, little research has been conducted to determine the potential applications for womens health. Endometriosis impacts approximately 10% of women of reproductive age, an estimated 176 million individuals, and is characterized by endometrial cells growing outside of the uterus, resulting in severe pain, chronic inflammation, gastrointestinal symptoms, infertility, and often, depression and anxiety (WHO, 2023). Existing treatment options are often limited in efficacy and may result in a variety of negative side effects. Previous research has indicated that cannabinoids including cannabidiol (CBD), delta-9 tetrahydrocannabinol (THC), and a number of other cannabinoids may hold potential for treating the symptoms of endometriosis, especially the chronic pain associated with the condition.

This study is a double-blind crossover clinical trial of a high-CBD product compared to placebo over a total of 12 weeks of treatment in patients with endometriosis. Participants will complete 7 visits over 12 weeks; 4 visits will be conducted in-person at McLean Hospital in Belmont, MA, and 3 visits will be conducted remotely. Visits consist of clinical ratings, assessments of conventional medication use, quality of life measures, and providing saliva, urine, and blood samples.

Eligibility Criteria:
Inclusion Criteria:

1. Subject has provided informed consent
2. Sex assigned female at birth
3. Subject is 21 or older
4. Subject is fluent in English
5. Subject endorses at least moderate levels of pain at the baseline visit
6. Subject endorses having endometriosis

Exclusion Criteria:

1. Non-fluent English speakers
2. Endorsement of current substance use disorder, psychotic disorder, or an eating disorder
3. Currently uses cannabis or cannabinoid products regularly
4. Patients will be excluded if they have a positive urine pregnancy test, are trying to become pregnant, or are currently breastfeeding
5. Presence of a serious or unstable medical illness, including liver, kidney, or cardiovascular disease (hyper/hypotension, cardiac disorders), or neurological disorder (including seizure disorder)
6. Neuropathic pain or cancer-related pain
7. Disclosure of a genetic polymorphism affecting CYP2C9 function
Effects of Oxygen Status on Hypoxia Inducible Factor 1-α and Inflammation. A Pilot Proof of Principle Study.

It has been shown in in vitro and animal models that hypoxia can have pro-inflammatory effects and hyperoxia can have anti-inflammatory effects. The pro-inflammatory effect could be the result of activation of Hypoxia Inducible Factor, a transcription factor that is known to activate many cell systems aimed at cell survival, including the inflammatory response. The anti-inflammatory effects of hyperoxia could be the annihilation of Hypoxia Inducible Factor, but also a decrease in inflammation due to oxygen toxicity resulting in a decrease in clearance of pathogens. These effects have been sparsely studied in humans. Therefore, we hypothesize that hypoxia results in an increase in Hypoxia Inducible Factor in circulating leukocytes and increases inflammatory reactions, whereas hyperoxia decreases these reactions.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 and ≤35 yrs
* Male
* Healthy

Exclusion Criteria:

* Use of any medication
* Smoking
* History, signs or symptoms of cardiovascular disease
* History of atrial or ventricular arrhythmia
* (Family) history of myocardial infarction or stroke under the age of 65 years
* Cardiac conduction abnormalities on the ECG consisting of a 2nd degree atrioventricular block or a complex bundle branch block
* Hypertension (defined as RR systolic \> 160 or RR diastolic \> 90 mmHg)
* Hypotension (defined as RR systolic \< 100 or RR diastolic \< 50 mmHg)
* Renal impairment (defined as plasma creatinine \>120 μmol/l)
* Liver enzyme abnormalities alkaline phosphatase\>230 U/L and/or ALT\>90 U/L
* Medical history of any obvious disease associated with immune deficiency
* CRP \> 20 mg/L, WBC \> 12x109/L, or clinically significant acute illness, including infections, within 4 weeks before endotoxemia day
* Participation in a drug trial or donation of blood 3 months prior to the experiment
* Pre-existent lung disease or asthma
* Use of recreational drugs within 21 days prior to experiment day
* Visit to altitude \>1500m within 4 weeks prior to the experiment
* Air travel with flight time over 3 hours within 4 weeks prior to the experiment
* History of acute mountain sickness
* Recent hospital admission or surgery with general anaesthesia (\<3 months)
* Claustrophobia
* Feelings of discomfort during a 10 minute test wearing the transparent respiratory helmet at the screening visit
Transarterial Coil Embolization of the Superior Rectal Arteries for Treatment of Stage II Hemorrhoids

This study will evaluate short , mid and long term efficacy of transarterial coil embolization of the superior rectal arteries (Emborrhoid techinque) for treatment the hemorrhoidal disease.

The 'emborrhoid' technique is the embolization of the hemorrhoidal arteries. The endovascular arterial occlusion is performed using coils placed in the terminal branches of the superior rectal arteries The emborrhoid technique has been modeled after elective transanal Doppler-guided hemorrhoidal artery ligation, which has been shown to be safe and effective for hemorrhoidal disease.

To date, there are few reports regarding emborrhoid, particularly lacking in long-term follow-up. Additionally, all procedures reported so far have used a transfemoral access route, which requires at least one day of hospital stay.

The aims of this study are:

To increase data regarding safety and efficacy of the Emborrhoid technique To report changes in the quality of life of patients at short and long-term To quantify recurrences at one-year follow-up To validate the use of the radial access for the Emborrhoid technique To validate the Emborrhoid technique as a "one-day" hospital procedure

Eligibility Criteria:
Inclusion Criteria:

* Patients with at least grade II Hemorrhoids (Banov et al. 1985), agreeing to undergo the Embhorroid technique.

Exclusion Criteria:

* Absolute contraindications to an angiographic procedure.
Dose Response Relationship for Single Doses of Corticotropin Releasing Hormone (CRH) in Normal Volunteers and in Patients With Adrenal Insufficiency

Corticotropin Releasing Hormone (CRH) is a hypothalamic hormone made up of 41 amino acids. Amino acids are proteins that when combined make up different substances, like hormones. The order of amino acids in CRH, has been determined, meaning that the hormone can now be synthetically reproduced in a laboratory setting.

When CRH is released from the hypothalamus it stimulates the pituitary gland to secrete another hormone, ACTH. ACTH then causes the adrenal glands to make a third hormone, cortisol. This process is known as the hypothalamic-pituitary-adrenal axis. Problems can occur in any of the steps of this process and result in a variety of diseases (Cushing's Syndrome and adrenal insufficiency).

Researchers hope that CRH created in a laboratory setting, ovine CRH (oCRH) can be used to help diagnose and treat conditions of the HPA axis. This study will test the relationship for single doses of oCRH in normal volunteers and patients with disorders of the HPA axis. The oCRH will be injected into the patients vein as a single injection or slowly through an IV line over 24 hours. The participants will have blood tests taken to measure hormone levels before, during, and after receiving the oCRH.

Corticotropin-releasing hormone (CRH) is a 41 amino acid hypothalamic peptide whose chemical structure has recently been determined after more than two decades of intensive research. This peptide stimulates secretion of ACTH by the corticotroph cells of the pituitary gland. As with the previously discovered hypothalamic hormones, CRH has important diagnostic and therapeutic applications. This study seeks to explore these clinical applications by determining the dose-response relationship for single doses of ovine CRH (oCRH) in normal volunteers and in patients with disorders of the hypothalamic-pituitary-adrenal axis. CRH is administered intravenously at doses up to 10 pg/kg, given as a bolus or up to 1 ug/kg/b as a continuous infusion lasting up to 24 hours. Plasma levels of ACTH, cortisol and CRH are measured before, during and after CRH administration.

Eligibility Criteria:
INCLUSION CRITERIA:

The normal volunteers are obtained through the NIH volunteer program or are NIH employees. Normal volunteers are in excellent health and are receiving no chronic medications.

We now routinely test patients with hypocortisolism or hypercortisolism in our clinic and ward.
Cardiac and Respiratory Function With Non-invasive Ventilation

To assess patients with hypercapnic respiratory failure using echocardiography,cardiac output measurements and markers of neural respiratory drive (EMGpara) prior to, during and after non-invasive ventilation (NIV) initiation, and to follow the patients for 3 months. The investigators hypothesize that the improvement in cardiac function and/or respiratory mechanics over time are associated with ongoing improvements in oxygenation, quality of life and exercise capacity.

Respiratory failure is characterized by the incapacity of the respiratory system to maintain the normal arterial blood gas homeostasis. Specifically, the overlap of hypoxaemia and hypercapnia (PaCO2 \>6 kPa) is referred to as Hypercapnic Respiratory Failure (HRF). HRF is one of the most common causes for hospital admission with high re-admission rates, therefore constitute a major burden on healthcare systems. Non Invasive Ventilation (NIV) is a well established treatment in patients with hypercapnic respiratory failure who frequently suffer with associated pulmonary hypertension (PH). NIV helps to increase arterial oxygenation and reduces hypercapnia. It is used in patients with hypercapnic respiratory failure caused by Obesity Hypoventilation Syndrome (OHS). The associated degree of PH can lead to an increased afterload of the right ventricle (RV) that causes progressive remodelling of the right heart. RV dysfunction is correlated with a reduced long term prognosis in respiratory conditions. In literature NIV is shown as effective method to treat acute hypercapnic respiratory failure in OHS.

It has not been described how NIV impacts on cardiac function and NRD in OHS.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of OHS and Overlap Syndrome
* Hypercapnic respiratory failure with the need to commence NIV
* Expected to remain an inpatient for ≥ 24 hours
* Age ≥ 18 and \<80 years
* BMI \>30 kg/m2
* Confirmed sleep-disordered breathing
* Able to give informed consent to participation in the evaluation study
* Clinically stable without exacerbations for ≥ 6 weeks

Exclusion Criteria:

* Patients established on NIV
* Inability to tolerate NIV (\< 4 hours usage at during hospital titration)
* Contraindication to NIV
* Requirement for immediate invasive mechanical ventilation at admission or any other acute critical illness
* Acute infective exacerbation
* Presence of other acute pathology or critical illness (such as pulmonary embolism)
* Presence of acute or chronic Left ventricular Cardiac Failure
* Significant Kidney or Liver disease
* Significant Anaemia
* History of Pulmonary Embolism in the previous 2 years
* Presence of cardiac congenital disease
* Presence of Primary Pulmonary Hypertension
* Presence of other severe medical problem, e.g. cancer and systemic connective tissue disease and vasculitides
* Pregnancy
* Psychological and social factors that would impair compliance with the evaluation
EXPRESON-IN : Intracerebral Recordings of P3a Responses to Expressive Own-names

Neurophysiologic evaluation of disorders of consciousness (DOC) patients in intensive care unit include late auditory evoked potentials. It allows the physicians to record cerebral responses of patients to auditory stimuli and in particularly to their own name (as the P3a response). Numerous studies try to improve the relevance of the auditory stimuli used in this paradigm and notably using more expressive stimuli.

Here the investigators investigate the intracerebral correlates of the P3a responses recorded on the scalp with neutral and more expressive stimuli.

Late auditory evoked potentials (as P3 wave) are used in neurophysiology to assess the level of consciousness in DOC (disorder of consciousness) patients. The P3 wave, elicited by listening standard and deviant stimuli, corresponds to the activation of a frontoparietal network and is considered to reflect a cognitive attention task. Using the own name of the patient as deviant stimuli improve the ability to detect the P3 wave because of the particularly relevance of this stimulus for the patient.

In human cognition, to identify the expressivity valence of a voice is essential. Neural processing of expressive voices should involves more widespread brain areas than neutral voices processing.

Here the investigators investigate the intracerebral correlates of the P3a responses recorded on the scalp to own-name stimuli uttered by neutral and more expressive voices (positive : smiling voice or negative : rough voice) in adult pharmacoresistant epilepsy patients.

Eligibility Criteria:
Inclusion Criteria:

* Intractable focal epilepsy with undergoing pre-surgical evaluation
* intracerebral electrodes implantation in auditory cortices, temporal lobe, superior temporal gyrus, limbic areas, frontal lobe
* Given Consent to inclusion

Exclusion Criteria:

* Deafness
* Pregnancy
Pain-Related Self-Efficacy in Individuals With Chronic Neck Pain

The factors affecting pain-related self-efficacy in individuals with chronic neck pain were investigated. A total of 69 subjects participated in the study. After the demographic data of the subjects were taken, pain-self-efficacy questionnaire, Timed Up and Go Test, Berg Balance Scale and International Physical Activity Questionnaire were administered, respectively.


Eligibility Criteria:
Inclusion Criteria;

1. Adults aged 30 to 65 years,
2. Adults with neck pain for at least 3 months,
3. Having a score of 3 or more on the visual analog scale for pain ,
4. To be willing to participate in the study.

Exclusion Criteria;

1. Diagnosed with neurological, vestibular, rheumatic, or endocrine disorders,
2. Had previous spinal surgery, neck trauma associated with post-traumatic amnesia or concurrent head injury, or cervical fracture or dislocation,
3. currently receiving treatment for neck pathology.
Endoscopic Characterization of Colorectal Neoplasia With the Different Published Classifications: a Prospective Comparative Study

Endoscopic characterization of colorectal lesions has become essential to predict histology and choose the best therapeutic strategy. We have created the CONECCT classification grouping all the endoscopic criteria already published in a single table. To validate this classification, we carried out this comparative study evaluating the endoscopic characterization performance of all recognized classifications and CONECCT in terms of inter-observer agreement and histological prediction.


Eligibility Criteria:
Inclusion Criteria:

* none

Exclusion Criteria:

* none
Hamstring Stretching Effective on Nonspecific Low Back Pain

Low back pain is one of the most common complaints in the world and can be considered a universal health problem for humanity. Low back pain is a multifactorial disease with multiple etiologies. Risk factors are difficult to identify. It is reported in the literature that 70-80% of the world's population has low back pain at some point in their lives, and 95% of this pain is mechanical. Mechanical low back pain (MBA) can be described as a clinical picture that develops as a result of overuse, strain, traumatization or deformation of the structures that make up the spine. In order to define low back pain mechanically, all organic causes such as inflammatory, infectious, tumoral, metabolic causes, fractures and pain reflected from internal organs must be excluded. The most common diseases that cause low back pain are; They are caused by mechanical factors and degenerative diseases. Mechanical and static stresses can lead to joint blockage, restricting the range of motion of the joint along with pain. Non-Specific many factors affect low back pain. Kim and Shin reported that asymmetry of hip extension range of motion of both hip joints was associated with nonspecific low back pain rather than simple hip extension range of motion, and they found that limiting hip extension was compensatory.


Eligibility Criteria:
Inclusion Criteria:

* Patients with complaints of low back pain,
* NLBP for at least 12 weeks,
* finger-to-ground distance greater than 0 cm; a passive straight-leg raising -(SLR) angle of less than 80°, measured with a hand-held goniometer;
* normal mobility of the hip;
* passive knee extension ≥25°,
* VAS score between 3 and 7 will be included.

Exclusion Criteria:

* People with a history of hamstring injury in the last two years,
* fractures in the spine or lower extremities,
* pregnancy,
* leg length difference of more than 2 cm,
* and obesity will be excluded from the study.
Feasibility of Lecanemab Registry and Clinical Outcome Measures

Available FDA approved treatments for Alzheimer's disease (AD) temporary alleviate symptoms but have no bearing on overall disease progression. However, recent FDA approval of lecanemab (July 2023), a disease modifying therapy based on a phase 3 clinical trial demonstrated efficacy (cognitive) in persons with AD. Delaying the disease progression may impact not only the person living with dementia (PLWD), but also their Care Partners. It may provide the ability to achieve "life goals" as a family or may increase/reduce stress and burden on the family due to the complexity of the treatment regimen. Recent secondary analysis of this Phase 3 trial suggests quality of life showed less decline in PLWD and less increase in burden in Care Partners. The investigators propose to create a registry/database for persons living with dementia who receive lecanemab infusions at HealthPartners and their Care Partners. The investigators plan to test the feasibility of collecting outcomes data for specific patient and family focused outcomes, and outcomes that are typically not included in clinic. The outcome of this study will help in the overall goal of studying the impact of lecanemab in real-world settings in a larger cohort of PLWD and Care Partners.


Eligibility Criteria:
Inclusion Criteria:

* PLWD who are eligible to receive Lecanemab infusion at our clinics.
* Care Partner who provides care for the PLWD who are eligible to receive Lecanemab infusion at our clinics.
* Age \>=18 years for PLWD and their care partners
* Provides informed consent prior to participation.

Exclusion Criteria:

* Unable to read and speak English
Adolescent Weight Management Study

Protocol #1:The goals of this study was to examine whether increased weight loss in obese adolescent is induced when the weight loss medication sibutramine is added to a family-based, behavioral weight control program.

Protocol #2: This study aims to improve the behavioral treatment of obesity during adolescence. A behavioral program using regular foods will be compared to a behavioral program using a structured meal plan (a portion-controlled approach with liquid-meal replacements \[nutritional supplements\]). This structured approach may be better for the promotion of weight loss compared to a diet of regular foods.


Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index (BMI) between 28-50 kg/m2

Exclusion Criteria:

* Severe cardiovascular problems; arrhythmias
* Hypertension, uncontrolled (blood pressure \>140/90 mm Hg)
* Diabetes mellitus (Fasting glucose \> 126)
* Other serious medical disorders that would complicate dieting such as: Ulcer disease, cancer, thrombophlebitis, liver or kidney disease
* Current use of weight loss medications, amphetamines, steroids, or aspirin; medications affecting body weight
* Mental retardation or genetic syndromes associated with obesity
* Currently pregnant or planning a pregnancy or engaging in sexual activity without using contraceptives. All females will have a serum pregnancy test at baseline and all must agree to use contraception if they are sexually active during the study.
* Glaucoma
* History of major depression, bipolar disorder, or psychosis
* History of anorexia or bulimia
* Alcoholism and other substance abuse
* Use of anti-psychotic or anti-depressant medications in the last 6 months
* Highly dysfunctional family system or parental psychopathology
* Weight loss in the preceding 6 months of 5% or more and/or participation in another weight loss program
* Cigarette smoking or recent cessation
* If taking medication for hypertension or hypercholesterolemia condition must be stable for at least 3 months prior to enrollment in the study
* Chronic use of decongestants
* Intolerance of SlimFast
The Role of Hypertonic Dextrose Spray as Endoscopic Topical Hemostatic Agent for Acute Non-Variceal Upper GI Bleeding

This study is conducted to evaluate the effectivity of hypertonic dextrose spray as an endoscopic topical hemostatic agent, compared to conventional agent (adrenaline injection, followed by hemoclip or thermocoagulation), in patients with acute non-variceal upper GI bleeding.


Eligibility Criteria:
Inclusion Criteria:

* Patients with acute non-variceal upper gastrointestinal bleeding caused by peptic or duodenal ulcer, polyps, tumors or malignancy
* Patients consented to study participation

Exclusion Criteria:

* Patients with thrombocytopenia (thrombocyte count \<100.000 cells/ul) and other forms of coagulopathy
Telephone-Based Support for Caregivers of Patients With Dementia

The purpose of this study is to develop an effective, low-cost, telephone-based intervention to reduce anxiety, depression, and feelings of burden and stress in caregivers of patients with dementia. This study will also determine whether the intervention can alter the course of dementia.

Caregivers are randomized to receive either telephone-based intervention or standard medical care. Both groups receive a resource packet containing information about caring for someone with dementia and a list of local resources. Caregivers in the intervention group also receive a series of telephone calls over 12 months, during which education, emotional support, and training in problem-solving skills are provided by trained therapists. Caregivers in the standard care group receive no additional psychosocial intervention. Participants are assessed pre-treatment, mid-treatment (6 months), post-treatment, and at a 3-month follow-up.

Eligibility Criteria:
Patient Inclusion Criteria:

* DSM-IV diagnosis of dementia (vascular, mixed, or associated with Alzheimer's disease)
* Lives in the community, including senior/retirement centers, but excluding nursing homes and assisted living centers
* 50 years old or older
* Resides in Southeastern New England

Caregiver Inclusion Criteria:

* Living with a person with dementia
* Provides care for at least 6 months for at least 4 hours a day
* English as primary language
* Telephone access
* Resides in Southeastern New England

Patient Exclusion Criteria:

* Major acute medical condition affecting independent functioning

Caregiver Exclusion Criteria:

* Acute medical illness
* Cognitive impairment as defined by an MMSE score \< 25