cyrilzakka/clinical-trials huggingface dataset:
Evolution of Psychoactive Substances Consumption in Connection With COVID-19 Containment

The current containment linked to COVID-19 will have consequences for people suffering from addiction and there is a risk of overdoses when the containment ends. So the investigators hypothesize that this health crisis is an opportunity to develop risk reduction and access to care for vulnerable people who lives with an addiction.

The main objective of this study is to describe the changes in the psychoactive substances consumption during the containment in people suffering from addiction. The secondary objectives are to describe the evolution at 1 month from the end of the containment of problematic consumption and the level of access to care of these users


Eligibility Criteria:
Inclusion criteria:

* \>18 years
* Accept study
* live with an addiction

Exclusion criteria:

- not being able to answer the questionnaire
Dignity Therapy for Terminally Ill Patients: A Randomized Controlled Trial

We conducted a randomized, controlled trial of dignity therapy for terminally ill patients with the aim of reducing dignity-related distress and demoralization and improving spiritual well-being.

Sample size assessment: A recent meta-analysis showed that dignity interventions reach on average effect sizes of -1.01 on emotional distress (Ho and Shin, 2014). Power analysis showed that with an alpha of 0.05 and a power of 0.80, we needed a sample of 26 participants to detect effect sizes of 1.01 and higher.

Plan for missing data: Occasional missing values were imputed by calculating, for each participant, the average score for each subscale and then replaced.

Statistical analysis plan: We conducted a 2 (group) X 3 (time \[pre-treatment vs. post-treatment vs follow-up\]) repeated measures multivariate analysis of variance (MANOVA) for a set of variables

Eligibility Criteria:
Inclusion Criteria:

* age over 18,
* diagnosis of life-threatening disease with a prognosis of six months or less,
* no evidence of dementia (as determined by retrospective assessments),
* the ability to read and speak Italian and provide written informed consent,
* the availability for six to seven research encounters over the period of three weeks

Exclusion Criteria:

* psychotic illness,
* dementia and severe neurological impairment
The Effects of Lactobacillus Plantarum PS128 in Self-Reported Insomniacs

To determine whether PS128 (1) reduces the severity of anxiety and depressive symptoms, (2) adjusts autonomic nervous system functioning, and (3) improves sleep quality.

Forty participants with self-reported insomnia between 20 and 40 years old were randomly assigned to two groups, the PS128 and a placebo group, under the double-blind trial. Participants took two capsules with or without PS128 after dinner for 30 days. Study measures included subjective depressive symptoms, anxiety and sleep questionnaires, and miniature polysomnography (miniature-PSG) recordings at baseline and on the 15th and 30th days after taking capsules.

Eligibility Criteria:
Inclusion Criteria:

* (1) aged 20-40 years old,
* (2) 18.5 \< BMI \< 25,
* (3) BP \< 140 mmHg/90 mmHg,
* (4) PSQI \>5, ISI\>13,
* (5) meet the DSM-5 criteria for chronic primary insomnia.

Exclusion Criteria:

* (1) used other probiotic products within the last two weeks,
* (2) antibiotic treatment within the last month,
* (3) taken sleep medication within the last two months or were on long-term use,
* (4) reported tobacco, alcohol, caffeine or drug addiction,
* (5) lactic acid bacteria allergy,
* (6) cancer, cardiovascular disease, psychiatric illness, kidney disease, diabetes mellitus or other sleep disorders,
* (7) inflammatory bowel disease,
* (8) hepatobiliary gastrointestinal tract surgery
* (9) worked the night shift.
Cognitive Training and Enhanced Supported Employment in Schizophrenia

This study will evaluate the effectiveness of a computer-based cognitive enhancement program plus a work therapy program at improving productivity, work performance, and quality of life in schizophrenic individuals.

Schizophrenia is a chronic, severe, and disabling brain disorder that affects 2.4 million people in the United States. Individuals with schizophrenia may have difficulties with cognitive functioning, including problems with attention, memory, and organizational thought processes. These factors can lead to decreased productivity and poor work performance, which may make holding a job difficult. Research has shown that certain types of psychological therapies, such as cognitive behavioral therapy, are useful in reducing the severity of schizophrenic symptoms. The purpose of this study is to determine whether a computer-based cognitive enhancement training program, in combination with a work therapy program, will enhance workplace performance, productivity, and quality of life in individuals with schizophrenia.

This study will enroll individuals with schizophrenia or schizoaffective disorder. Participants will undergo a cognitive assessment at baseline. They will then be randomly assigned to either a 12-month cognitive enhancement training program plus a 12-month work therapy program or a 12-month work therapy program alone. Participants in the cognitive enhancement training program will receive feedback on their cognitive strengths and weaknesses based on the outcomes of the baseline assessment. The training component will be comprised of 150 computer-based exercises that focus on improving memory, attention, and organizational skills. Participants will attend two weekly meetings: one will focus on providing feedback regarding goal-setting and problem-solving, and the other will focus on improving verbal skills and social information processing. Individuals taking part only in the work therapy program will attend two non-cognitive discussion groups per week. All participants will work up to 20 hours a week in an approved work environment, and will have access to appropriate support services. Following the end of the program, participants will have the option of working an additional 12 months. Schizophrenia symptoms, quality of life, and neuropsychological and rehabilitation effects will be assessed at the end of Years 1 and 2.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of schizophrenia or schizoaffective disorder

Exclusion Criteria:

* Hospitalized in the 30 days prior to study entry
* Homeless in the 30 days prior to study entry
* Changed medications in the 30 days prior to study entry
* Substance abuse in the 30 days prior to study entry
* History of head trauma
Telehealth Coaching for Families of Children With Autism

The purpose of this study is to investigate the efficacy of a 12 week telehealth intervention for families of children with autism spectrum disorders under the age of 6 years on child participation and parent efficacy.

Autism spectrum disorders (ASD) are increasingly being diagnosed in children, creating a pressing need for effective and cost-efficient models of early intervention (EI) services. Many EI systems are struggling to meet the needs of the increasing number of families of children with ASD. In rural areas, there is a shortage of EI therapists, and the distances to reach families results in an inefficient use of professional time and research shows that rural families of children with ASD receive fewer EI services, which has detrimental effects on children's developmental trajectories. If occupational therapy interventions for young children with ASD utilize innovative methods of service delivery in rural areas, investigators can increase the number of families that receive services thereby positively influencing child and family outcomes. Therefore, investigators propose to test the acceptability, cost-effectiveness, and efficacy of a 12 week telehealth intervention for families of young children with ASD.

Eligibility Criteria:
Inclusion Criteria:

* Family with a child up to 72 months old with a diagnosis of ASD and primarily spoke English in the home.

Exclusion Criteria:

* Child has significant visual or hearing impairments or has a known genetic condition associated with autism (e.g., Fragile X Syndrome).
A Study to Evaluate Ocrelizumab in Combination With Methotrexate Compared With Infliximab Plus Methotrexate in Patients With Active Rheumatoid Arthritis Currently Responding Inadequately to Etanercept or Adalimumab

This is a Phase II, randomized, active-controlled, double-blind, double-dummy, parallel-group, multicenter study in the United States enrolling patients with active RA. The study will enroll approximately 290 patients at approximately 130 sites.


Eligibility Criteria:
Inclusion Criteria:

* Age \>= 18 years
* Current treatment for RA on an outpatient basis
* Active disease
* Currently receiving 50 mg etanercept subcutaneously (SC) every week or 40 mg adalimumab SC every other week.
* Considered by Investigator to be a primary non-responder to their first anti-TNFÎ± treatment for efficacy reasons

Exclusion Criteria:

* Rheumatic autoimmune disease other than RA, or significant systemic involvement secondary to RA
* History of, or current, inflammatory joint disease other than RA (e.g., gout, reactive arthritis, psoriatic arthritis, seronegative spondyloarthropathy, Lyme disease) or other systemic autoimmune disorder (e.g., systemic lupus erythematosus, inflammatory bowel disease, scleroderma, inflammatory myopathy, mixed connective tissue disease or other overlap syndrome)
* Previous treatment with a any biologic therapy for RA (including investigational products with the exception of etanercept or adalimumab
* Treatment with more than one prior anti-TNFÎ± therapy
Safety and Immunogenicity Study of the Hepatitis B Virus (HBV) Vaccine, HEPLISAV Compared to Engerix-B Vaccine

The purpose of the study is to evaluate the safety, immunogenicity and lot-to-lot consistency of an investigational hepatitis B virus vaccine, HEPLISAV™, in healthy adults 40 to 70 years of age

The purpose of the study is to evaluate the safety, immunogenicity and lot-to-lot consistency of an investigational hepatitis B virus vaccine, HEPLISAV™, in healthy adults 40 to 70 years of age

Eligibility Criteria:
Inclusion Criteria:

* be 40 - 70 years of age, inclusive
* be seronegative for hepatitis B surface antigen (HBsAg), antibody against hepatitis B surface antigen (anti-HBsAg), antibody against hepatitis B core antigen (anti-HBcAg), and human immunodeficiency virus (HIV)
* be in good health in the opinion of the investigator, based upon medical history, physical examination, and laboratory evaluation
* if female of childbearing potential, agree to consistently use a highly effective method of birth control from screening visit through the treatment phase, for up to 28 days after the last injection

Exclusion Criteria:

* if female of childbearing potential, is pregnant, breastfeeding, or planning a pregnancy
* has a history of or is considered by the investigator to be at high risk for recent exposure to HBV or HIV; for example, current intravenous drug use or has unprotected sex with known HBV/HIV positive partner
* has a known history of autoimmune disease
* has previously received any hepatitis B vaccine (approved or investigational)
Corrective Osteotomy of the Distal Radius Without Bone Grafting

The investigators retrospectively analyzed patients who underwent extraarticular corrective osteotomy of the distal radius via a palmar approach and without the use of a bone graft, even in the absence of cortical contact after corrective osteotomy.

The goal of this retrospective observational study is to determine whether secondary dislocation or nonunion occurs after corrective osteotomy without bone grafting.


Eligibility Criteria:
Inclusion Criteria:

* malunited distal radius fracture
* extraarticular corrective osteotomy
* palmar approach
* no bone graft used
* no cortical contact after dorsal open wedge osteotomy
* signed informed consent

Exclusion Criteria:

* others reasons for malunion
* intraarticular corrective osteotomy
* use of a bone graft
* cortical contact after open wedge osteotomy
* lost to follow up
Study of the Safety and Efficacy of Adalimumab in Subjects With Moderate to Severe Chronic Plaque Psoriasis

Study of the Safety and Efficacy of Adalimumab in Subjects with Moderate to Severe Chronic Plaque Psoriasis


Eligibility Criteria:
Inclusion Criteria:

* Subject completed prior PS study

Exclusion Criteria:

* Subject has other active skin diseases
* Multiple concomitant therapy restrictions and/or washouts (topicals, UV, other systemic PS therapies)
* Poorly controlled medical conditions
* History of neurologic symptoms suggestive of central nervous system (CNS) demyelinating disease
* History of cancer or lymphoproliferative disease
* History of active TB or listeriosis, or persistent chronic or active infections
* Known to have immune deficiency or is immunocompromised
* Clinically significant abnormal laboratory test results
* Erythrodermic psoriasis or generalized pustular psoriasis
Study on the Effectiveness of AF Analysis Software in AF Rhythm Monitoring

Atrial fibrillation (AF) is a serious public health problem because of its increasing incidence and prevalence in the aging population. ECG is the most commonly used gold standard for clinical diagnosis of arrhythmias, but conventional ECG examinations are not adequate for long-term ECG follow-up measurements in patients with AF.

In this study, the AF patients will wear an watch and ECG patch to continuously monitor ECG and PPG. The software uses an integrated diagnostic mechanism of "AF burden + AF segments" to efficiently analyze ECG and PPG data, which can quickly and accurately identify the occurrence of AF and analyze AF burden in real-time, facilitating physicians' diagnosis and treatment and efficacy assessment.

PPG-AF study is a Cohort randomized observational study.The trial will include patients with AF who meet the study requirements from Beijing Anzhen Hospital within 2 months. Each participant will wear an watch and ECG monitor after admission to hospital until Radiofrequency ablation for AF, and after AF ablation until discharge. And more than 18 hours in each period.

1. Primary endpoint. The ECG and PPG data are automatically analyzed by the AF analysis software. The results are compared with expert-annotated gold standard results to verify the sensitivity and specificity.
2. Secondary endpoints. The AF burden calculated from PPG data is compared with that from ECG monitoring, to verify the feasibility of daily monitoring of AF burden using PPG analysis.

Eligibility Criteria:
Inclusion Criteria:

* Be at least 18 years of age.
* Have clear ECG-recorded atrial fibrillation in the past and will undergo atrial fibrillation ablation in the current hospitalization.
* Patients who agree to wear both the watch and the ECG recorder.

Exclusion Criteria:

* Inability to wear the watch due to limited mobility or other problems.
* Severe skin diseases such as skin allergies or skin ulcers.
* Chronic insomnia not treated with medication.
* Patients with severe cardiovascular disease who may be resuscitated at any time.
* Previous history of Parkinson's, schizophrenia, epilepsy.
* Black people and those with excessively dark skin.
RCT for Latina Mental Health Using Web-Based Apps

This study compares a choice-driven, interactive, evidence-informed storytelling web-based app intervention with links to resources and treatment (Tx) recommendations (made by a character via her blog) and Tx locator, to a web-based app with links to publicly available informational internet videos, MH resources, and a treatment locator for at least moderately anxious/depressed untreated English and Spanish speaking Latinas to determine if a story-based, character-driven approach is more effective for catalyzing mental health treatment initiation.


Eligibility Criteria:
Inclusion Criteria:

* Latina (women who are from or have family ties to Latin America)
* Currently resides in LA or Orange County
* Age 18 and older
* Able to speak, read, and write in English or Spanish
* Score 10 or higher on GAD-7 and/or PHQ-8
* Access to the internet via smartphone, tablet, or computer
* Not currently receiving mental health therapy or pharmacotherapy
* Has not accessed mental health services during the previous 6 months

Exclusion Criteria:

* Not Latina or Hispanic
* Under age 18
Behavioral Economic Treatment to Enhance Rural (BETTER) Living

The purpose of this trial is to get feedback to help develop programs delivered by phone and text messages to improve wellness and health behaviors. This study will enroll adult participants that have been seen in primary care settings and live in rurally designated areas.

This study will evaluate acceptability and feasibility of two remotely-delivered behavioral economic intervention components, alone and in combination, using remote text message delivery. The two intervention components are an episodic future thinking component and a volitional choice component. The goal of this work is to develop and determine acceptability and feasibility of a well-specified, accessible, and theory-driven mobile health intervention to reduce harmful alcohol use in people living in rural regions.

Eligibility Criteria:
Screening Inclusion Criteria:

* adults presenting in Michigan Medicine primary care
* home address in a rurally designated area (e.g., zip code, county),
* documented alcohol use in the Electronic Health Record (EHR) (e.g., alcohol use disorder diagnosis, alcohol misuse or heavy alcohol consumption).

Baseline inclusion criteria:

* an Alcohol Use Disorders Identification Test (AUDIT-C) score of ≥3 in females or ≥4 in males
* regular access to an internet-enabled device (e.g., smart phone, computer, tablet).

Exclusion Criteria:

* Does not understand English
* currently pregnant
* unable to provide informed consent due to medical/psychiatric reasons
* currently in treatment for a substance use disorder.
Non-opioid Based Pain Control After Thyroidectomy

Pain control modalities were evaluated after thyroidectomy.

Pain control modalities were evaluated after thyroidectomy. Patients were randomized to one of two pain control regimens. The control group received conventional opioid based post operative analgesia while the test group received an enhanced recovery after surgery (ERAS) based anesthesia with use of acetaminophen and non-steroidal anti-inflammatory drugs for the post operative period with opioid medications available for break through pain only. Pain scores (measured on visual analog scale) and opioid use (measured in morphine equivalent dose) were measured after completion of the operation.

Eligibility Criteria:
Inclusion Criteria:

* thyroid disease

Exclusion Criteria:

* currently on opioid pain medications
* on opioid pain meds in last 30 days
* cannot take non-opioid medications
* require more extensive operation than thyroidectomy
Reconstitution of HIV-specific Immunity Against HIV

Research Goal: To reconstitute the anti-HIV specific immunity system of the AIDS patients, so the viruses could not massively replicate when HAART was discontinued, then make HIV functional cure possible.

The research aims at establishing a new treatment strategies of HIV. It will significantly improve the clinical therapy effects and effectively reduce the morbidity and mortality by reconstituting the immune systems of HIV infected patients and combining multiple therapy strategies. Therefore, the research could develop an cloning amplification system of immunocytes in vitro, and improve the antiviral immune system severely damaged before by transfusing the clone cells modified by specific HIV antigen. So HIV infected patients could discontinue the traditional anti-viral drug, but not develop opportunistic infections,which could obviously increase the life qualities of these patients.

Eligibility Criteria:
Inclusion Criteria:

1. HIV infection confirmed
2. Receiving HAART more than 6 months
3. HIV viral-load \< 50 copies/ml
4. Without serious damage of liver and kidney
5. The subject volunteered to the research and sign the informed consent

Exclusion Criteria:

1. With serious opportunistic infections
2. With serious chronic disease such like diabetes, the mental illness,et al
3. History of suffering from pancreatitis during HAART.
4. Pregnant and breast-fed.
5. With poor adherence
Risk-Reducing Surgeries for Hereditary Ovarian Cancer

Based on studies of "Inherited Susceptible Genes Among Epithelial Ovarian Cancer" (NCT03015376, clinicaltrials.gov) and "Cohort Study of Universal Screening for Lynch Syndrome in Chinese Patients of Endometrial Cancer" (NCT03291106, clinicaltrials.gov), we provide risk-reducing surgeries of salpingo-oophorectomy with/without hysterectomy for healthy carriers with mutation genes of hereditary ovarian cancer, which is defined ovarian cancer with relevant pathogenic mutations.


Eligibility Criteria:
Inclusion Criteria:

* Carriers with known and definite mutation genes of hereditary ovarian cancer.
* With children and without further requirement of pregnancy.
* No less than 35 years for carriers with mutation gene of BRCA1.
* No less than 40 years for carriers with mutation gene of BRCA2.
* No less than 45 years for carriers with mutation genes of BRIP1, RAD51C, RAD51D and RAD51.
* No less than 50 years for carriers with mutation genes of ATM, MSH2, MLH1, SH6, PMS2, EPCAM and STK11.

Exclusion Criteria:

* Without children.
* Not reaching appreciate ages.
* With contraindications of laparoscopy.
* Refusal of risk-reducing surgeries.
Monitoring of Injection Pressure During Regional Anesthesia in Pediatric Patient

A low injection pressure is one of the safety elements to check the correct position of the needle during regional anesthesia. Subjective assessment of pressure during manual injection of local anesthetic is most commonly used. In adults, the monitoring of the injection pressure has already been evaluated and makes it possible to objectify the pressure of the injection pressure. This is possible thanks to a device named Compuflo. No study has measured injection pressures during a regional anesthesia in children. The main objective is to control the injection pressures exercised in daily clinical practice during pediatric regional anesthesia with the Compuflo. Regional anesthesia will be proposed and explained during the anesthesia consultation. The procedure will be performed according to the habits of the anesthesiologist in charge of the patient. Only the addition of the Local Anesthetic Injection Pressure monitoring (Compuflo) to the needle changes the usual setup.

The purpose of this study is to evaluate the usual practice using Compuflo, allowing the continuous measurement of the injection pressure of the local anesthetic at the needle level. On the day of the surgery, an anesthesiologist "operator" will realize the echo-guided regional anesthesia, qualifying aloud every injection realized (site or compartment of injection, and volume injected). An "observer" anesthesiologist will note the demographic data (age and weight), then the material data (minimum stimulation intensity, type and size of needles and syringes used), and finally he will note the maximum pressure levels reached during the injections performed.

Eligibility Criteria:
Inclusion Criteria:

* Minor patient (0-16 years old) with consent of the major legal representative
* Affiliated to the social security
* Informed written consent, notification on the anesthesia sheet

Exclusion Criteria:

* Patient over 16 years old
* Patient under tutorship / curatorship
* Young girl with known or suspected ongoing pregnancy
* Known allergy to local anesthetics
* Hemostatic disorder
* Local infection at the puncture site