cyrilzakka/clinical-trials huggingface dataset:
Online Cognitive Behavior Therapy for Comorbid Sleep Problems in Alcohol Use Disorder

The main goal is to study the effects of internet-delivered cognitive behavioural therapy with minimum guidance for comorbid sleep problems in alcohol use disorder, in routine addiction care.

Alcohol use disorder (AUD) is highly prevalent and a major contributor to the global burden of disease. Insomnia symptoms are very common among individuals with AUD, including those in recovery, which may in turn promote alcohol relapse. Specialization and silo phenomena in healthcare organization, separating addiction from other types of psychiatric care, means that individuals with AUD and comorbid sleep problems often have difficulty accessing evidence-treatment for the latter. Offering online treatment for sleep problems to individuals enrolled in traditional routine addiction care is an attractive and pragmatic approach to offering parallel treatments covering the full clinical presentation, which has not yet been evaluated. This pilot and feasibility trial will recruit n=25 from patients in routine addiction care with comorbid sleep problems and AUD, who will complete an online, ten-module, CBT-based treatment program with minimum guidance for sleep problems, tailored for individuals with AUD.

Eligibility Criteria:
Inclusion Criteria:

* Enrolled patient at Stockholm Center for Dependency Disorders
* Diagnosed alcohol use disorder
* Self-rated sleep problem

Exclusion Criteria:

* Addiction to sedative or hypnotic medication
* Psychoactive medication not yet 3-month stable in dose
* Bipolar disorder
* Psychotic disorder
* Suicidality
* Periodic Limb Movement Disorder (PLMD)
* Sleep apnea
Assessment of V0018 1.5 mg Effect on Craving

The purpose of this study is to evaluate the reduction of craving after administration of V0018 1.5 mg compared to placebo in healthy moderately dependent smokers.


Eligibility Criteria:
Inclusion Criteria:

* Male and female aged 18 to 64 years
* Smoking ≥ 10 cigarettes/day and \< 20 cigarettes/day continuously for the last two years
* With a first cigarette smoked within 30 min after waking
* Not currently in the process of quitting smoking

Exclusion Criteria:

Related to pathologies

* Current or recurrent buccal lesions which, in the opinion of the investigator, would interfere with the assessment of the different parameters
* Hyposalivation or asialia
* Intolerance to lactose, or any pathology that could cause endogenous production of Carbon Monoxide (CO)

Related to treatments

* Use of antidepressants within the last three months
* Use of sedatives, hypnotics, tranquilizers or any other addictive agents within the last 3 months
* Routine use of tobacco other than cigarettes
* Regular use for more than one week of any treatment for smoking cessation (gum, patch, inhaler, lozenge, tablet, bupropion, varenicline) and other smokeless tobacco products (including e-cigarettes) within three months
* History of hypersensitivity to nicotine, peanut, soya or to any of the excipients of study treatment
* Intolerance to fructose
* History of phenylketonuria (aspartame)

For women of childbearing potential:

* Is pregnant or in post-partum period or a nursing mother
High Flow Oxygen Therapy in Patients Suffering From Chronic Obstructive Pulmonary Disease Exacerbation: Effects and Mechanisms of Action

Acute exacerbation of chronic obstructive pulmonary disease (COPD) is associated with poor outcome, especially when intubation is required, thus underlining the importance of optimizing non-invasive ventilatory support to avoid intubation. Practically, because of treatment intolerance, non-invasive ventilation (NIV) cannot be administered 24-hour a day for a long period of time and alternative solutions must be found to deliver oxygen as efficiently as possible to allow NIV interruptions. High flow humidified oxygen therapy (HFHO) consists of delivering a high-flow (15-60 L/minute) heated air-oxygen mixture (FIO2 21-100%) through a dedicated nasal cannula and can be interesting in this context. This well tolerated technique improves oxygenation and decreases respiratory rate and dyspnea in patients suffering from acute hypoxemic respiratory failure. In chronic COPD patients, using HFHO can decrease respiratory rate and PaCO2. In COPD exacerbation, using HFHO can conceptually be interesting. First, the high air-oxygen flow delivered well matches the patient's inspiratory demand and should decrease the work of breathing. Second, as during HFHO a high flow is continuously delivered in the airways, a wash-out of the anatomical dead space should occur and CO2 clearance should be enhanced. Despite this strong physiological rational for the use of HFHO in patients suffering from COPD exacerbation, the effects of using HFHO instead of conventional oxygenotherapy in combination with non-invasive ventilation (NIV) in this context has never been explored.

The main objective of the study is to explore the effects of using HFHO in combination with NIV in acute COPD exacerbation and to assess the underlying mechanisms of action.


Eligibility Criteria:
Inclusion Criteria:

* COPD patients suffering from acute hypercapnic respiratory failure (PaCO2 \> 50 mmHg) due to COPD exacerbation and requiring intermittent NIV treatment can be included in the study provided they do not require immediate intubation.

Exclusion Criteria:

* Patients younger than 18 years old
* Inability to give informed consent or denied informed consent
* Severe acute respiratory failure requiring immediate intubation defined as respiratory rate \> 40/minute, severe hypoxemia with PaO2/FIO2 ratio \< 150 mmHg despite high FIO2, severe respiratory acidosis with pH\< 7.2, altered mental status)
* Very intensive NIV treatment required defined as an impossibility to stop NIV treatment during more than one hour.
* Severe hypoxemia requiring more than 4l/minute of conventional oxygenotherapy between NIV treatments
* Poor short term prognosis (defined by the clinician in charge as a high risk of death during the next 7 days) or ongoing palliative treatment.
* Patients with "Do not resuscitate" order already established
InformationSeekingMesolimbicEngagementStudy2

Participants will complete a treasure task during neuroimaging where they have to learn which keys open a treasure chest, and then they are tested on the contents of the treasure chest.

Study 2 will use a treasure task (employed in C.2.1.1), in which participants select amongst 3 keys to learn which feature of keys unlocks the treasure chest, revealing a trial unique object image (Fig. 8b). On each encoding trial participants view three multi-featural keys and a treasure chest. Each key varies on three dimensions: color (red, blue, yellow), shape of the handle (square, circle, triangle), and number of ridges (one, two, three). On each trial, all 9 dimensions of the keys are represented, but the dimensions represented on each key are randomized across trials. During hypothesis testing runs, participants are instructed to find the feature of a key that opens the treasure chest to reveal a trial-unique image. Critically, there is one target feature of a key that deterministically opens the treasure chest. The target feature of the key randomly changes after participants successfully open the chest 4 consecutive times. This design manipulates goal-oriented exploration by allowing participants to resolve uncertainty until they identify the target feature of the key. Uncertainty resolution is the greatest after the target features switches and incrementally reduces via individuals' active hypothesis testing. During control runs, participants will be instructed to select specific keys, and key selection and outcomes will be yolked to prior hypothesis testing runs. Participants will complete 3 runs of hypothesis testing runs and 3 control runs. Trial number for each run is determined by participant behavior, in that hypothesis testing runs end when participants complete 4 rule switches (\~30 trials). Encoding is incidental in this task. Following encoding, participants will complete an immediate and delayed item memory test. On each trial, participants will view objects from the hypothesis testing and control conditions as well as new foil objects. Memory will be tested for half the stimuli immediately and at a 24-hour delay. These memory measures will be related to uncertainty resolution estimated by reinforcement learning, to determine how prior knowledge during information seeking has subsequent effects on memory.

Eligibility Criteria:
Inclusion Criteria:

* 20/40 far acuity (either corrected or uncorrected)
* In good medical health

Exclusion Criteria:

* History of head injury
* History of illness with Central Nervous Systems implications
* On Medications that Affect blood flow response and alertness
* Consumption of smoking and/or coffee 30 minutes prior to laboratory testing
* Placement of a device contraindicated for magnetic resonance imaging including cardia pacemaker, aneurysm clip, cochlear implants, pregnancy, intra-uterine device, shrapnel, metal fragments in the eyes, neurostimulators
* Weight \> 250lbs
* Claustrophobia
Efficacy of Fibrin Sealant to Reduce the Amount of Post-thyroidectomy Drain

Fibrin sealant has been studied to reduce post-thyroidectomy drain and hospital stay as well. However, no strong evidence from well-designed clinical trials is available. Harmonic scalpel is a ultrasonic vibrating scissors which makes it easy to cut and coagulate the tissues, thus reducing op time and postoperative drain, which is important to minimize hospital stay. The investigators hypothesized that fibrin sealant combined with harmonic scalpel-assisted procedure could guarantee no-drain postoperative care in total thyroidectomy with anterior compartment neck dissection.


Eligibility Criteria:
Inclusion Criteria:

* proven thyroid carcinoma
* Thyroidectomy with anterior compartment neck dissection

Exclusion Criteria:

* No use of harmonic scalpel during surgery
* coagulation abnormality
* refuse to participate
A Registry of Chinese AL Amyloidosis Patients Treated With Subcutaneous or Intravenous Daratumumab

The purpose of this protocol is to generate a registry of Chinese patients with AL amyloidosis treated with subcutaneous/intravenous daratumumab alone or subcutaneous/intravenous daratumumab combined with chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* 18 years and older
* newly diagnosed or refractory/relapsed AL amyloidosis
* treated with subcutaneous/intravenous daratumumab alone or subcutaneous/intravenous daratumumab combined with chemotherapy

Exclusion Criteria:

* co-diagnosis of multiple myeloma or Waldenström's macroglobulinemia
The Effect of Platelet-Rich Plasma-Fibrin Glue in Combination With Vitamin E and C for Treatment of Non-healing Diabetic Foot Ulcers

The aim of this study is to evaluates the chance of non-healing Diabetic Foot Ulcers repair by reducing oxidative stress caused by diabetes by taking vitamin E and C supplements along with the use of Platelet-Rich Plasma-Fibrin Glue as an effective treatment for wound healing.


Eligibility Criteria:
Inclusion Criteria:

1. DFU is classified as Wagner 1 -2 on the Wagner classification system.
2. Persons with type 1 or type 2 diabetes with a non-healing ulcer of at least 4 weeks duration.
3. If more than one non-healing wound is present, the largest of the wounds that is classified as a Wagner 1- 2.
4. The index ulcer had to be clinically non-infected.
5. Ankle Brachial Index (ABI) greater than or equal to 0.7.
6. HemoglobinA1C (HbA1c) \< 12
7. Index foot ulcer located on the plantar, medial, or lateral aspect of the foot (including all toe surfaces).
8. Wound area (length x width) measurement between 2 cm2 and 20 cm2.
9. Non-use of drugs that may interfere with wound healing, such as corticosteroids, immunosuppressive agents, and cytotoxic agents.
10. No smoking, alcohol or drug addiction.
11. Approved, informed, signed consent.

Exclusion Criteria:

1. Previous consumption of vitamin E and C supplements.
2. Index ulcer has exposed tendons, ligaments, muscle, or bone.
3. Confirmed presence of osteomyelitis, or if osteomyelitis is suspected.
4. Patients with renal deficiency, hepatic failure, has known immune insufficiency and cancer.
5. Subject is pregnant or plans to become pregnant during the duration of the trial.
6. Patient's blood vessels are non-compressible for ABI testing.
7. Patient is known to have a psychological, developmental, physical, emotional disorders.
8. Received systemic corticosteroids or immunosuppressive agents.
A 16 Week Study of HRS-7535 in Adults With Type 2 Diabetes Mellitus

The aim of this trial is to evaluate the efficacy and safety of HRS-7535 in subjects with type 2 diabetes mellitus.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female, 18-75 age years, both inclusive;
2. Type 2 diabetes mellitus diagnosed for at least 3 months before the screening visit;
3. HbA1c 7.5-11.0% (both inclusive) by local laboratory analysis;
4. Treated with conventional lifestyle intervention and stable treatment with metformin (≥1000 mg/day) at least 8 weeks prior to screening.
5. Body weight of at least 50 kg; and Body Mass Index (BMI) within the range of 19 to 40 kg/m2 (inclusive);

Exclusion Criteria:

1. Known or suspected allergy to the investigational drug or its components or excipients.
2. Diagnosed or suspected with type 1 diabetes mellitus, special types of diabetes or secondary diabetes.
3. Have a history of acute complications of diabetes (diabetic ketoacidosis, lactic acidosis, hyperglycaemic hyperosmolar state, etc.) within 6 months prior to screening.
4. Proliferative retinopathy, maculopathy, painful diabetic neuropathy, diabetic foot ulcer or intermittent claudication requiring acute treatment;
5. History or presence of vital organ primary diseases, including but not limited to neuropsychiatric, cardiovascular, digestive, respiratory, urinary, endocrine, blood, immune and other diseases, judged by researchers to be unsuitable for this study.
6. Discontinuation of previous glucagon-like peptide-1 receptor agonist therapy due to safety/tolerability reasons or lack of efficacy reasons.
7. Previous history of significant gastrointestinal disease (e.g. gastroesophageal reflux, gastric outlet obstruction, inflammatory bowel disease, active ulcers, etc.), or previous gastrointestinal surgery (except gastrointestinal polypectomy and appendectomy).
8. Pregnancy, breast-feeding, intention of becoming pregnant during the trial; or women of childbearing potential (WOCBP) or male subject not using adequate contraceptive measures.
Cytomegalovirus (CMV) Transmission and Immune Tracking (TransmIT) Study

The goal of STAGE I of the CMV TransmIT Study is to determine the prevalence of CMV shedding in children up to and including 36 months of age in large group childcare centers and in staff who regularly work at the center. Participants will complete a health survey and provide one saliva sample for CMV PCR testing. In addition, infrastructure for the study will be developed (e.g. community engagement to build the network of centers, data pipelines, digital platform, sampling workflows) and participant sample collection at home will be piloted. These activities will inform the design of STAGE II.


Eligibility Criteria:
Inclusion Criteria

Children

1. All children up to and including 36 months at time of signed consent regardless of duration of attendance at the center. Children living in the same household can each be enrolled.
2. Parent(s) has provided written informed consent for the child to be screened for CMV by saliva PCR collected at the center or at home

Center Staff

1. Individuals who regularly (average \>/= 5 weeks per year) work inside the center in any role, including employed, contracted, volunteer, and full or part time.
2. Staff member has provided written informed consent to be screened for CMV by saliva PCR collected at the center or at home

Exclusion Criteria

Children

1. \>/= 37 months of age
2. State Department of Children and Families (DCF) custody

Center Staff

1. Do not regularly (average \< 5 days per year) work inside the center
2. Work associated with but not regularly inside the center (e.g. bus drivers or food delivery staff)
Demeclocycline Fluorescence for Intraoperative Delineation Brain Tumors

This research study is studying a drug called Demeclocycline that may help brain surgeons see tumors with a microscope during surgery.

This research study is a Feasibility Study, which is the first time investigators are examining this study intervention.The FDA (the U.S. Food and Drug Administration) has not approved Demeclocycline for your specific disease but it has been approved for other uses.

In this research study, the investigators would like to determine the lowest dose of Demeclocycline that will allow surgeons to detect tumor cells during surgery. These cells will be marked through a process called fluorescence, which will cause tumor cells to glow brightly on an image in comparison to its surroundings.

Eligibility Criteria:
Inclusion Criteria:

* Participants must present with a gadolinium-enhancing brain lesion (or lesions) that are thought by the neuroradiologist and the neurosurgeon to be consistent with high-grade glioma. These may be newly diagnosed lesions or recurrent tumors.
* The patient must not be pregnant or nursing. Tetracycline (Demeclocycline, Doxycycline, Minocycline, Tetracycline, and Tigecycline) are classified as FDA pregnancy category D. Maternal ingestion of Tetracyclines during pregnancy may cause tooth discoloration, enamel defects, and other congenital anomalies. Tetracyclines are excreted in human breast milk; however, the extent of absorption of Tetracyclines by the breastfed infant is not known.
* Participants must have normal organ and marrow function as defined below:

  * leukocytes ≥ 3,000/mcL
  * absolute neutrophil count ≥ 1,500/mcL
  * platelets ≥ 100,000/mcL
  * total bilirubin within normal institutional limits
  * AST(SGOT)/ALT(SGPT) ≤ 4 × institutional upper limit of normal
  * creatinine \< 2mg/dL
* Ability to understand and the willingness to sign a written informed consent document.
* Participants must be undergoing a surgical procedure with the intention of removing more tissue than what would be taken for a biopsy.

Exclusion Criteria:

* History of allergic reactions attributed to compounds of similar chemical or biologic composition to Demeclocycline.
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
* Pregnant and/or nursing women are excluded from this study because Demeclocycline is a known Teratogenic agent, pregnancy category D. It is known to be excreted in breast milk.
* Patients taking etinoid medications by mouth (such as Acitretin, Isotretinoin), Strontium Ranelate may not take Demeclocycline because of toxic interactions
* Patients taking any tetracycline class of drug (i.e. Minocycline, etc).
Cannabidiol Effects on Blood Alcohol Level and Intoxication

The main objectives of this study were to test if 2 different doses of Cannabidiol (compared to placebo) alter 1) breath alcohol concentration, 2) craving and subjective responses to alcohol or 3) cognitive performance following a standard dose of alcohol.

Cannabidiol (CBD), is commonly found in the cannabis plant and has shown promise in treating alcohol use disorders (AUD). In this within-subjects, placebo-controlled, crossover study, the investigators explored the effects of two doses (200mg and 30mg) of plant-based CBD (compared to placebo CBD) on blood alcohol level, subjective effects of alcohol, craving and cognition over the course 4 hours after subjects consume a standardized dose of alcohol.

This pilot study was conducted at Colorado State University and volunteers were recruited from the local community. 36 individuals completed at least 1 study session and 22 completed all three sessions. At each session they received either placebo 30mg oral CBD or 200mg oral CBD prior to being given a standard dose of alcohol. They then remained in our laboratory for 4 hours and completed cognitive testing using the NIH toolbox Cognitive Battery, breath alcohol level measurements and self-reported intoxication ratings (using the The Biphasic Alcohol Effects Scale \[BAES\] and the The Subjective Effects of Alcohol Scale \[SEAS\]) and reported their craving levels using the Alcohol Urge Questionnaire (AUQ) every 30 minutes. They also provided 3 blood samples to measure blood-CBD levels at each session (prior to receiving the CBD, 25 minutes post-CBD ingestion and again 60 minutes later). Study sessions were separated by at least one week.

Eligibility Criteria:
Inclusion Criteria:

* 21-60 years old
* able to provide consent
* willing to consume CBD during the study
* report heavy drinking (\>5 drinks \[\>4 for women\] per occasion on at least 5 days/month in the past 3 months)
* not cannabis/CBD naive (i.e. THC or CBD use at least once in the past year), do not use cannabis regularly (i.e., less than monthly over past year), and no past-month cannabis use.

Exclusion Criteria:

* a regular or recent cannabis user (i.e. they used cannabis more often than monthly during the past year or used cannabis in the past month)
* were seeking treatment a substance use disorder (SUD) including AUD, taking medications to treat bipolar or psychotic disorders
* using nicotine every day
* taking blood thinning medications
* reported having a major medical condition contraindicating alcohol or CBD use (e.g., liver disease or heart disease)
* reported current suicidality
* met criteria for psychotic disorder, bipolar disorder or a current major depressive episode,
* reported using illicit drugs in the 30 days prior to beginning the study or tested positive for any illicit drugs
* were pregnant, breastfeeding or trying to become pregnant.