cyrilzakka/clinical-trials huggingface dataset:
Neurobiological Mechanisms of Chess as an Add-On Treatment Against SUD

Neurobiological and neuropsychological approaches to investigate the potential mechanism of action of chess as an add-on therapy (chess based - cognitive remediation treatment, CB-CRT) to reduce cognitive deficits in individuals with alcohol use disorder (AUD) or tobacco use disorder (TUD).

The study aims to investigate the potential mechanism of action of chess as a "chess based - cognitive remediation treatment, CB-CRT" to reduce cognitive deficits in individuals with substance use disorder (SUD) seeking treatment using neurobiological and neuropsychological approaches. Furthermore, it will be assessed whether this chess intervention has a generalized positive effect on short-term abstinence. Interestingly, the functional domains and associated underlying neuronal networks observed to be affected in individuals with SUD overlap significantly with those that could be strengthened by chess-based cognitive training or formal chess. Specifically, strengthening of cortical control regions (dorsolateral prefrontal cortex, DLPFC) and brain areas relevant for decision-making (orbitofrontal cortex, OFC) could prevent future relapse. Therefore, chess as an add-on therapy to complement other standard treatments of SUD could lead to improved therapeutic outcomes.

Eligibility Criteria:
Inclusion Criteria:

* severe alcohol (AUD) or tabacco use disorder (SUD) according to DSM-5
* abstinence from alcohol for at least 72 hours (AUD)
* sufficient ability to communicate with investigators and answer questions in both written and verbal format
* ability to provide fully informed consent and to use self-rating scales
* main diagnosis AUD: inpatient or outpatient treatment in our clinic
* main diagnosis TUD: participation in 6 weeks smoking cessation treatment
* Normal or corrected to normal vision
* Signed consents for data security

Exclusion Criteria:

* severe internal, neurological, and/or psychiatric comorbidities; other Axis I mental disorders other than TUD according to ICD-10 and DSM 5 (except for other substance use disorders - if AUD or TUD is still the main diagnosis -, ADHD, remitted depression, mild or moderate depression, adjustment disorder, generalized anxiety disorder, phobias, panic disorder or other mild or moderate personality disorders) in the last 12 months
* Severe withdrawal symptoms (CIWA-Ar \> 7; Sullivan et al. 1989)
* alcohol intoxication (\>0‰)
* history of brain injury
* severe cognitive impairments
* common exclusion criteria for MRI (e.g. metal, claustrophobia, pregnancy)
* suicidality or endangerment of others
* positive Covid-19 screening
Safety and Efficacy Study of Tesofensine/Metoprolol Treatment in Subjects With Type 2 Diabetes Mellitus

Safety and Efficacy Study of Tesofensine/Metoprolol Treatment in Subjects With Type 2 Diabetes Mellitus

This is a double-blind, randomized, placebo-controlled, multiple-dose, two-center, safety and efficacy study of co-administration of tesofensine/metoprolol treatment in subjects with T2DM. Study medication will be administered for ninety (90) days (+2 days after the final assessments with half-dose of metoprolol). Following all baseline assessments, eligible subjects will be randomly assigned to one of the two arms (1:1).

Eligibility Criteria:
Inclusion Criteria:

1. Males and females
2. Confirmed diagnosis of T2DM
3. 18-70 years of age
4. HbA1c ≥7.0%

Exclusion Criteria:

1. Hypersensitivity to tesofensine/metoprolol
2. Heart failure class II or greater according to the New York Heart Association (NYHA) or decompensated heart failure
3. History of myocardial infarction or stroke within 12 months prior to enrolment
4. History of coronary revascularisation or angioplasty in the last 12 months prior to enrolment
5. Patients reporting angina in the last 6 months prior to enrolment
6. Treatment with insulin and/or other injectable anti-diabetic medications, or TZDs
7. Any clinically significant cardiac arrhythmia
Pilot Test of a Mobile App That Helps Spanish-speakers Find Mental Health Services in the US.

The goal of this observational study is to develop and test a mobile app for Spanish speakers residing in the US who seeking drug treatment and/or behavioral health services for themselves or an associate. The main questions it aims to answer are:

What are the features and content needed on this app?

How will people use and share this app?

Will they connect with treatment services?

After receiving input from focus group participants and other community stakeholders, the app was made available and its usage was tracked to determine its long-term, broad-scale feasibility.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years old
* Identify as Hispanic/Latino
* Own a smartphone, pad, or computer
* Be willing to meet with study personnel more than once

Exclusion Criteria:

* Age less than 18 or more than 75
* Evidence of significant cognitive impairment
The RIPPLE AT-PLUS Study

Atrial tachycardia is a symptomatic arrhythmia, for which an effective treatment is a catheter ablation procedure. The goal of the Ripple AT-Plus study is to evaluate two methods of performing catheter ablation for atrial tachycardia. The main outcome assessed during the study is long-term recurrence of atrial tachycardia following the catheter ablation procedure.

Catheter based mapping of the electrical signals in the heart during atrial tachycardia can identify areas that require ablation in order to treat the arrhythmia. There are numerous methods by which to map atrial tachycardia. Isthmus guided ablation using Ripple Mapping is one such method, and has recently been demonstrated to improve diagnostic accuracy of mapping and therefore improve acute procedural outcomes (termination of the tachycardia).

However, it is not known if improved acute procedural outcomes translate into long-term benefits for patients. At present, the recurrence rate following atrial tachycardia ablation is near 30%. We hypothesise that isthmus guided ablation using Ripple Mapping can reduce long-term recurrence following ablation as improved diagnostic accuracy of mapping can lead to more targeted, less extensive, ablation.

Patients referred for catheter ablation of atrial tachycardia will be randomised to undergo the procedure by isthmus targeted approach using Ripple Mapping or conventional approach using local activation time. Otherwise, the catheters used to perform the mapping and ablation will be the same in both groups. After the procedure, follow up will occur at 1 year with a further Holter Montior. Any arrhythmia recurrence will be documented and the two arms will be compared for acute success, 12 month success, ablation required and procedure time.

Eligibility Criteria:
Inclusion Criteria:

1. Referred for catheter ablation of AT by the direct care team, based on clinical indication.
2. Male or female, aged \>18 years old.
3. Able to consent for recruitment to the trial and the catheter ablation procedure.

Exclusion Criteria:

1. Contraindication to catheter ablation as deemed by the clinical team.
2. Typical atrial flutter or AF on ECG.
Cellulite and Extracorporeal Shock Wave

Hypothesis: The combination of extracorporeal shockwave and a daily gluteal muscle strength programme is superior to the gluteal muscle strength programme alone in cellulite.

Study design: Randomized-controlled trial

Analysis: Intention-to-treat

Outcome parameters: a) Photo, b) Nürnberger Score, c) circumference measurements, d) capillary blood flow, e) tissue oxygen saturation, f) postcapillary venous blood flow

Intervention: Extracorporeal shock wave for six sessions with 2000 impulses at both gluteal and thigh regions plus a specific gluteal strength exercise training

Follow-up: 12 weeks


Eligibility Criteria:
Inclusion Criteria:

Females ages 18-65yrs Cellulite 1°-4° Informed consent

Exclusion Criteria:

Pregnancy Open wounds Females \>18yrs or \>65yrs

-
Epacadostat, Idarubicin and Cytarabine (EIC) in AML

This trial assess the maximum tolerated dose (MTD) and to characterize dose-limiting toxicities (DLTs) of epacadostat when added to the anthracycline/cytarabine combination as first-line induction treatment in AML patients fit for intensive treatment

Background and Rationale:

Epacadostat (INCB024360) is an Inhibitor of Indoleamine 2,3- dioxygenase 1 (IDO1). Indoleamine 2,3- dioxygenase 1 (IDO1) is a 403 amino acid cytosolic haem enzyme encoded by the INDO gene on human chromosome 8p22. IDO1 is responsible for the catabolism of the essential amino acid tryptophan (trp) to kynurenine (kyn) within immune cells and a subset of tumor cells resulting in inhibition of antitumor cell-mediated immune responses. Increased IDO activity correlates with lower CR rates and shorter OS in AML.

Objective:

The primary objective is to determine the maximum tolerated dose (MTD) and to characterize dose-limiting toxicities (DLTs) of epacadostat when added to the anthracycline/cytarabine combination as first-line induction treatment in AML patients fit for intensive Treatment.

Study Duration:

Phase I part will last from 3 to 18 months (permitting the enrolment of minimum of 3 and a maximum of 18 patients).

Eligibility Criteria:
Inclusion Criteria:

* AML (according to the 2016 World Health Organization (WHO) classification definition of ≥ 20% blasts; Arber et al, 2016) suitable for intensive treatment (including stem cell transplantation) with a curative intent.
* Patients must be aged \> 18 years, and must have given voluntary written informed consent.
* Women of childbearing potential having a negative serum pregnancy test at screening or at least within 48 hours before start with epacadostat, and willing to use an effective contraceptive method (intrauterine devices, hormonal contraceptives, contraceptive pill, implants, transdermal patches, hormonal vaginal devices, infusions with prolonged release) during the study and for at least 6 months after the last study drug administration
* Men willing to use an effective contraceptive method (eg, condom, vasectomy) during the study and for at least 6 months after the last study drug administration.

Exclusion Criteria:

* Prior or concurrent malignancy, except for the following: adequately treated basal cell or squamous cell skin cancer, or any other cancer from which the subject has been disease-free for more than 6 months.
* Any previous AML or MDS chemotherapy (with the exception of hydroxyurea/Litalir® for leukocyte control which should be discontinued by the first day of induction chemotherapy
* Treatment with any investigational product within 4 weeks before the first administration of epacadostat (INCB024360)
* Abnormal organ function if not caused by the underlying disease as considered by the treating physician
* Use of immune-suppressive agents for the past 4 weeks before the first administration of epacadostat (INCB024360). For regular use of systemic corticosteroids, subjects may only be included after stepwise discontinuation to be free of steroids for a minimum of 5 days before the first administration of epacadostat (INCB024360)
Synthetic CBD as a Therapy for COVID-19

The study aim to test proof of concept of CBD treatment for efficacy and safety in patients suffering with mild COVID-19 infection. The CBD will be delivered via oil droplets not containing THC, compared to placebo.


Eligibility Criteria:
Inclusion Criteria:

* COVID 19 patients
* 18 Years and older

Exclusion Criteria:

* Respiratory failure requiring mechanical ventilation
* Intensive care unit admission
* Neutrophile con. \< 1000 cells/mm3
* Lymphocyte con \< 500 cells/mm3
* Liver enzymes 5 times higher then the norm
* QT interval longer then 500 ms.
* Pregnancy
* Hemodialysis renal replacement therapy
* Active or prior psychotic event
Metastatic or Refractory Soft Tissue Sarcomas and Metronomic Cyclophosphamide: Further Assessment of Efficacy and Safety

Metronomic Cyclophosphamide's use in monotherapy as a palliative treatment against non-resectable and metastatic Soft Tissue Sarcomas relies on small retrospective cohorts' data.

Current litterature needs external validation of its efficacy and safety profile in these settings of usually frail patients.

The investigators assessed further data and aimed to identify predictive factors of metronomic cyclophosphamide impact in metastatic Soft Tissue Sarcomas.


Eligibility Criteria:
Inclusion Criteria:

* patients over 18
* with inoperable or metastatic Soft Tissue Sarcoma
* treated with Metronomic Cyclophosphamide
* in 3 cancer care institutions located in 2 French regions (Bourgogne and Franche-Comté)
* between January 2005 and December 2021

Exclusion Criteria:

* patients with bone, chondral sarcomas, desmoid, or gastrointestinal stromal tumors
Study to Compare the Incidence of Biliary Complications After Liver Transplantation

A randomized prospective study will be conducted of patients at Vanderbilt University Medical Center who undergo liver transplantation from March 2014 until approximately 120 patients are randomized. Patients will be randomized to undergo biliary reconstruction with and without stent placement.

The risk of biliary complications can be related to the type of liver transplant performed and the technique used for reconstruction of the bile duct. One of the main techniques of performing biliary reconstruction is a choledocholedochostomy which can be performed over an anastomotic stent. Although placement of biliary stents is routine practice in many liver transplant centers around the country, there is no clear evidence to support their use. As of now both the placement and non-placement of a stent are essentially "standard of care". In the investigators' center, many of the transplant surgeons now perform the biliary anastomosis over a pediatric feeding tube which is used as a stent. The practice of using stents in biliary anastomosis is not uniform and there are no established guidelines to support their indiscriminate application. The investigators have designed a prospective randomized trial to evaluate the effect of stent placement on biliary complications and its effect on morbidity.

Eligibility Criteria:
Inclusion Criteria:

* 18 years and older
* will be undergoing liver transplantation
* able to give informed consent

Exclusion Criteria:

-
First Clinical Evaluation of a Novel Glucose Non-invasive Sensor Technology in Patients With Type 1 Diabetes

The primary aim of this clinical study is to find signal characteristics of VOCs detected by Sokru device during fasting, insulin injection and after glucose intake and to find the association with blood glucose variation in variant states of glycemia and hypoglycemia.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* T1D with MDI or CSII therapy \>1 year
* Age 18 - 50 (inclusive)
* Caucasian ethnicity
* BMI between 18.5 and 24.9 kg/m2 (inclusive)
* Usage of a continuous glucose monitoring (CGM)

Exclusion Criteria:

* Pregnancy or breastfeeding
* History of cardiovascular diseases
* Diabetes-related comorbidities
* HbA1c \>9 %
* Epilepsy
* Known sensitivity to medical grade adhesives or other skin-related complications, which might influence the outcome
* Known sensitivity to Latex
* Participation in another investigation with an investigational drug within the 30 days preceding and during the present investigation
REPEAT Study - A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) Therapy in Combination With COPEGUS (Ribavirin) in Patients With Chronic Hepatitis C (CHC) Who Did Not Respond to Previous PegIntron (Peginterferon Alfa-2b (12KD))/Ribavirin Combination Therapy

This 4 arm study is designed for patients with CHC who have not responded to peginterferon alfa-2b (12KD)/ribavirin combination therapy. In these patients, the effects of lengthening the duration of treatment, as well as including an initial 12-week period of high-dose PEGASYS (360 micrograms sc), are compared with the standard combination therapy of PEGASYS (180 micrograms sc) and ribavirin (1000-1200mg po). The anticipated time on study treatment is 1-2 years and the target sample size is 500+ individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients \>=18 years of age;
* CHC infection;
* liver biopsy (in \<24 calendar months of first dose), with results consistent with CHC infection;
* use of 2 forms of contraception during study and 6 months after the study in both men and women;
* Lack of response to previous treatment with peginterferon alfa-2b (12KD)/ribavirin combination therapy given for \>=12 weeks.

Exclusion Criteria:

* women who are pregnant or breastfeeding;
* male partners of women who are pregnant;
* conditions associated with decompensated liver disease;
* other forms of liver disease, including liver cancer;
* human immunodeficiency virus infection.
Minimally Invasive Surgery Techniques for One-level Degenerative Lumbar Deformities Correction

This study will be conducted at Research Institute of Traumatology and Orthopedics (NRITO) n.a. Ya.L.Tsivyan, Novosibirsk, Russia.

The current study is prospective pilot clinical study to demonstrate the possibility and effectiveness of performing modified technique of MIS TLIF, supplemented by segmental vertebrotomy, to correct segmental deformity of lumbar spine.

It is expected to enroll 10 patients aged 18-70 with segmental deformity of lumbar spine, caused by degenerative spondylolisthesis and/or degenerative stenosis.


Eligibility Criteria:
Inclusion Criteria:

* Given written Informed Consent;
* Single-level segmental deformity caused by degenerative spondylolisthesis and/or degenerative stenosis at the one level of lumbar spine L4-L5 or L5-S1;
* Mono- and/or polyradicular leg pain and/or neurogenic claudication with or without back pain;
* Symptoms persisting for at least three months prior to surgery;
* Able and agree to fully comply with the clinical protocol and willing to adhere to follow-up schedule and requirements.

Exclusion Criteria:

* Lumbar deformation of non-degenerative etiology;
* Spondylolisthesis grade II or higher (25% slip or greater) of any etiology;
* Patient that has already undergone a lumbar fusion surgery;
* Other non-degenerative spinal conditions (e.g. infectious, traumatic, metabolic, inflammatory, neoplastic, structural or other pathology) that may have an impact on subject safety, wellbeing or the intent and conduct of the study
* Concurrent participation in another clinical study that may confound study results.
Exploring Hand Function in People With Schizophrenia Based on Perspective of Sensorimotor Control

The study aims to explore the hand function in people with schizophrenia in the chronic stage.


Eligibility Criteria:
Inclusion Criteria:

* Age between 20-65 years old
* Diagnosis with schizophrenia or schizoaffective disorder by psychiatrists according to DSM5.
* Remaining the same antipsychotics and the symptom was stable for at least one month before the study.
* Be able to follow comments and have sufficient cognitive ability assessed by Mini-Mental State Examination score \>24

Exclusion Criteria:

* Substance abuse or other medical conditions that may affect movements.
* Using other non-antipsychotics that will affect movements in the same period.
Maintenance Treatment With Capecitabine Metronomic Chemotherapy and Chinese Traditional Medicine in Metastatic Colorectal Cancer

The optimum regimen of maintenance treatment after first-line chemotherapy in patients with metastatic colorectal cancer （mCRC） is unknown. This study was designed to determine the efficacy and safety of maintenance treatment with capecitabine metronomic chemotherapy plus Chinese Traditional Medicine.

In this Prospective, open-label, randomised controlled trial, the investigators will recruit 159 mCRC patients who have finished 18 to 24 weeks first-line chemotherapy and disease evaluation is SD, PR or CR. The patients will then accept Chinese traditional diagnosis and be randomised into two group, capecitabine metronomic chemotherapy only as control group and the metronomic chemotherapy plus Chinese Traditional Medicine as experimental group. This treatment regimen will be continued until progression, death, or an unacceptable adverse event.

The primary endpoint is progression-free survival (PFS). Secondary endpoints are overall survival (OS), quality of life (QOL) and toxic effects.


Eligibility Criteria:
Inclusion Criteria:

1. unresectable metastatic colorectal cancer with pathological confirmation.
2. patients have accepted 18-24 weeks first-line chemotherapy and disease evaluation is SD, PR or CR.

Exclusion Criteria:

-
To Assess the Efficacy of a Localized Focal Vibration Tool on the Muscular Response to Five Countermovement Jumps in Healthy Soccer Players

This research study aims to introduce the localized focal vibration tool. To this end, a 3-week protocol with a single session per week was created.

In the one hand, the study subject must be a soccer player, regardless of whether male or female, and must not be suffering from any active injury.

All subjects must complete an identical warm-up before beginning the noninvasive intervention using the vibration tool.

The warm-up consists of various joint mobility exercises for the legs, a brief cardio session by pedaling a stationary bicycle, and finally, jumping exercises to properly activate the main muscles of the lower limbs and thus be able to begin the intervention protocol.

In the other hand, the study subjects are divided into two groups: intervention and placebo.

Neither the study subject nor the research team knows who belongs to each group; only the person handling the focal vibration tool will know.

To begin the intervention, three surface electromyography probes are placed on the vastus medialis of the quadriceps, the tibialis anterior, and the internal gastrocnemius, and the subject is asked to perform five countermovement jumps barefoot and without moving their arms to gain momentum.

The subject then pedals at 90-100 rpm on a stationary bicycle while wearing the sensors of the 120 Hz focal vibration tool for 10 minutes.

The intervention group wears headgear to ensure tactile stimulation, while the placebo group does not wear headgear, thus ensuring that there is no tactile stimulation.

After the pedaling period, the electromyography sensors are reapplied to the lower limb in the anatomical areas described above, and the same jumping protocol is followed again.

This intervention is identical for the 3 days of recording.

This noninvasive intervention protocol aims to demonstrate the effectiveness of the 120 Hz focal vibration tool in recruiting muscle fibers in the targeted muscles through numerical improvements in muscle electrical activity and improved countermovement jump parameters.

A three-day follow-up period was established to determine when any improvement from the application of focal vibration therapy begins.

All study subjects are volunteers to participate during the official soccer season for their respective age group and may withdraw from the study at any time if they wish.


Eligibility Criteria:
Inclusion Criteria:

* Practice soccer at least three times a week.
* Do not suffer from any alterations or pathologies prior to or during the study in the area of interest for the research.

Exclusion Criteria:

* Having a lower limb disorder or pathology
* Receiving any type of lower limb treatment from a healthcare professional or receiving pseudoscientific treatments.
* Having any absolute or relative contraindications to measurement tests, surface electromyography, inertial sensor, and/or focal vibration.
* Refuse to sign informed consent.
Study of DU-176b Aged 80 Years or Older

The purpose of this study is to evaluate the efficacy and safety of edoxaban in patients with non-valvular NVAF aged 80 years or older who are ineligible for available oral anticoagulation therapy.


Eligibility Criteria:
Inclusion Criteria:

* Patients with Nonvalvular Atrial Fibrillation (NVAF) aged 80 years or older who are ineligible for available oral anticoagulation therapy

Exclusion Criteria:

* Patients with active bleeding
* Patients who have poorly controlled hypertension
* Patients who have liver dysfunction accompanied with disorder of blood coagulation