cyrilzakka/clinical-trials huggingface dataset:
CBT Treatment for Internet Gaming Disorder

For most people, gaming is perceived as a positive activity. In some cases, however, gaming may turn into an addiction with consequences for the individual health, quality of life and everyday life. Today, there is a lack of evidence-based interventions to treat this condition, called Gaming Disorder (GD). This study will evaluate a new manual for treatment of GD, divided into a number of modules and based on cognitive behavioural therapy (CBT). The study is designed as a randomized controlled trial (RCT) and will be conducted at a clinic specialized in the treatment of gambling and gaming addiction.

Participants included in the study will be randomized to one of to groups. The intervention group will receive twelve weeks of individual CBT-treatment while participants allocated to the control group will be put on a twelve-week wait-list.

The hypothesis is that the manual based CBT treatment will result in a greater reduction in symptoms of criteria for GD.

The study is designed as a two-armed randomized controlled trial. After inclusion, every participant will be offered an overview of the participant´s psychosocial circumstances. Thereafter, the participants will be randomized to one of the two arms.

The main arm includes individual CBT treatment following a module-based manual. The manual includes nine main modules and three optional modules addressing different dimensions of gaming disorder, for example thoughts, emotions, and procrastination. Between every session the participants are working with home assignments, in order to strengthen helpful behaviours. The participants also report amount of time spent on gaming and other activities every week.

Participants randomized to the control arm also report their time spent on gaming and other activities every week.The wait-list control has the same duration as the CBT-arm. After the control-period, participants in the control arm will be offered the same treatment as participants in the intervention arm.

Eligibility Criteria:
Inclusion Criteria:

* Fulfilling 5 out of 9 criteria for IGD according to DSM V
* ≥ 16 years of age
* Can read and speak Swedish fluidly.

Exclusion Criteria:

* Somatic or psychiatric disease that is contraindicating or severely complicates the implementation of the intervention (e.g., ongoing psychotic, manic or hypomanic episode or neuropsychiatric condition with severe disability)
* Ongoing increased suicide risk that is considered to make it inappropriate for the patient to participate in the study (based on evaluation at the structured clinical interview)
* have another ongoing psychological treatment with a content similar to that in the current study
* plan to start such treatment during the XX weeks that the study is ongoing or has during the last three weeks started or changed medication for any psychiatric problem.
SELF-BREATHE RCT for Chronic Breathlessness

A feasibility RCT comprising two groups:

1. Intervention (SELF-BREATHE in addition to standard NHS care)
2. Control group (standard / currently available NHS care)


Eligibility Criteria:
Inclusion Criteria:

* Adults ≥ 18 years of age, with the ability to read and type in English
* Access to a computer, or tablet or smart phone, with internet access and the ability to email
* Chronic breathlessness (CB) defined as; breathlessness that persists (\>3months) despite optimal pharmacological treatment of the underlying disease including cancer, chronic obstructive pulmonary disease (COPD),asthma, interstitial lung disease (ILD), bronchiectasis, cystic fibrosis (CF) chronic heart failure (CHF), sickle cell disease, chronic renal/ liver failure or post COVID-19
* Chronic breathlessness at rest or on exertion; MRC dysponea score \>2
* Willing to engage with short-term self-guided internet-based breathlessness intervention (SELF-BREATHE)
* Able to provide informed consent

Exclusion Criteria:

* Breathlessness of unknown cause
* A primary diagnosis of chronic hyperventilation syndrome
* Currently participating in a rehabilitation programme, e.g. pulmonary/cardiac rehabilitation
HV Electrophysiology Study In Transcatheter Aortic Valve Implantation Patients

TAVI induced LBBB is a complication that occurs between 7 and 65 % of the cases, numbers that differ considerably between devices. There is an increased risk of progression to total AV-block at follow-up, with the risk of brady-arrhythmic death.

The aim of the study is to elucidate the anatomical location of the conduction pathology of a TAVI induced LBBB. This could impact valve design and placement and thereby reduce the number of new LBBB induced by TAVI in the future. Furthermore, finding predictors for progression to a high degree AV block in the follow-up (and thus an indication for permanent pacemaker) could improve management of post-operative conduction abnormalities and prevent the risk of brady-arrhythmic death.

A prospective, single center, non-randomized pilot study in which patients will undergo an electrophysiology (EP) study during the TAVI procedure.

All patients eligible for inclusion will undergo an electrophysiology (EP) study during the TAVI procedure. For the purpose of EP measurements, a His-catheter will be placed at the beginning of the procedure and remain in the same location until the end of the procedure.

Continuous HV measurements will be collected, together with a continuous surface ECG, during the entire TAVI procedure. The different steps in TAVI procedure will be registered.

During the study, patients will undergo regular electrocardiographic examinations at the outpatient clinic (before implantation, after implantation, before discharge and after 6 weeks, 6 and 12 months post-implantation). These are part of the standard healthcare after the TAVI procedure.

The research protocol has been approved by the ethical committee (METC).

Eligibility Criteria:
Inclusion Criteria:

* All patients must provide written informed consent

Exclusion Criteria:

* Pre-existent LBBB
* Pre-existent sick sinus syndrome
* Pre-existent high-degree atrioventricular block
* Pre-existent permanent pacemaker
* Patients unable to provide written informed consent
Impact of the Comprehensive Geriatric Assessment on the Quality of Life OF Elderly Patients

Impact of the Comprehensive Geriatric Assessment on the Quality of Life of elderly onco-hematologic patients' candidates for complex antitumoral therapies: clinical and biological correlatives

The screenings for the next 2 decades indicate an exponential increase in the incidence of neoplastic diseases in the elderly population. In order to successfully balance effectiveness and low toxicity of immunochemotherapy, a treatment personalisation based on an objective evaluation of fitness is therefore needed. The use of geriatric screening is a first step to rationalize decisions in this regard, the G8 tool has demonstrated the ability to identify patients and mostly to objectively separate elderly fragile patients from those who are fit. In that consideration, the individualization of the anticancer treatment based on a Comprehensive Geriatric Assessment (CGA) is desirable in elderly fragile patients with solid or haematological malignancy. Cancer mortality is constantly increasing after 65 years and the consequent increase in life expectancy favour the processes of cellular senescence. In this context G8 fragility assessment will take place in the screening test and by using the EORTC QLQ-C30C questionnaire to assess quality of life (QoL). The evaluation of senescent cells will be done by real-time PCR. Our aims are i) to evaluate the impact of the CGA on the QoL of elderly onco-haematological patients, candidates for complex therapies, that resulted as fragile at the G8 geriatric screening and ii) to evaluate the senescent cells in the peripheral blood of the patients enrolled in the study. The study is expected to contribute to precision medicine management of elderly patients and refine the therapeutic stratifications.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged ≥ 65 years
* Diagnosis of solid or hematologic cancer
* Patients who are candidates for a first line therapy for advanced disease to be treated with biological target drugs, or candidates for integrated radiotherapy
* Patient with G8 scores ≤ 14/17

Exclusion Criteria:

* Patients aged less than 65 years
* Patients who have received or currently in treatment for solid or hematologic cancer
* Patient with G8 scores more than 14/17
A Promising Minimally Invasive Surgical Technique for the Treatment of Infected Pilonidal Sinus

Infected pilonidal sinuses are a common pathology, affecting an estimated 0.7% of the population. In France, the most commun technique is extended exeresis with an open wound, followed by directed healing. This technique reduces the risk of recurrence, albeit at the cost of daily nursing care and a long healing period involving prolonged absence from work. Closure or plasty surgical techniques aimed at reducing the duration of nursing care are more restrictive, and seem to have higher recurrence rate. Minimally invasive treatment, such as phenolization and flattening with curettage of the sinus have existed for over 50 years, albeit with disappointing long-term results and morbidity that limits their application.

Today, new minimally invasive treatments are being developed, aiming at a less constraining post-operative period. without compromising healing. These include glue, endoscopic treatment (EPSiT : Endoscopic Pilonidal Sinus Treatment or VAASP : Video-Assisted Ablation of Pilonidal Sinus) and laser treatment (SiLaT procedure : Sinus Laser Therapy or PiLaT : Pilonidal disease Laser Treatment).

Laser treatment is used since 2014 in the treatment of anal fistulas and more recently in the treatment of infected pilonidal sinus. A laser fiber is introduced, under local or general anaesthesia, into the main cavity and secondary tracts after curettage and opening of the dimples. The energy delivered by the laser is transmitted in the form of heat, in order to seal the cavity during healing of thermal lesions.

Initial results report success rates of around 90%, with a healing time of between 1 and 2 months. It also appears to be effective after failure of previous surgery. In cases of incomplete closure or recurrence, a second laser treatment can be performed with high healing rates. The investigators carried out an retrospective study including 29 patients treated with the SILAT technique. The healing rate, defined as the absence of symptoms and recurrence of suppuration, was around 70%. The procedure was painless and no serious complications were observed. The presence of one or more secondary orifices and overweight were associated with a higher risk of failure.

In order to confirm these results, to better specify the factors predictive of success, and to evaluate the efficacy of SiLaT in the longer term, the investigators will carry out a single-center study including all adult patients treated with laser between June 2018 and December 2020.


Eligibility Criteria:
Inclusion Criteria:

* Patient aged 18 or above
* French-speaking patient
* Patient hospitalized in the Proctology department of GHPSJ between 01JUN2018 and 31DEC2020 for a chronically infected pilonidal sinus
* patient presenting an recurring infected pilonidal sinus after open or closed surgical treatment

Exclusion Criteria:

* Patient hospitalized in the acute abcess stage of an infected pilonidal sinus
* Patient under guardianship or curatorship
* Patient incarcerated
* Patient under legal protection
* Patient refusing enrollment
Microalbuminuria and Allopurinol in Type 1 Diabetes

The objective is to determine if lowering serum uric acid by means of allopurinol in the course of kidney disease may be effective in preventing or improving albuminuria and renal function in Type 1 Diabetic patients. The study is a double blinded, randomised, placebo-controlled cross-over clinical trial.


Eligibility Criteria:
Inclusion Criteria:

* Albuminuria (≥30 mg/g)
* Uric Acid ≥ 0,265 mmol/l
* GFR (glomerular filtration rate) \> 40 ml/min/1.73m2

Exclusion Criteria:

* History of gout or xanthinuria or other indications for uric acid lowering therapy such as cancer chemotherapy.
* Recurrent renal calculi.
* Current use of azathioprine, 6-mercaptopurine, didanosine, tamoxifen, amoxicillin/ampicillin, or other drugs interacting with allopurinol.
* Known allergy to xanthine-oxidase inhibitors.
* Renal transplant.
* Non-diabetic kidney disease.
* Home, 24h og clinical BP\>180 or Diastolic BP \>130 mmHg at screening.
* Cancer treatment within two years before screening.
* History of hepatitis B or C.
* History of acquired immune deficiency syndrome or human immunodeficiency virus (HIV) infection.
* History of alcohol or drug abuse.
* Breastfeeding or pregnancy or unwillingness to be on contraception throughout the trial.
* Poor mental function or any other reason to expect patient difficulty in complying with the requirements of the study.
* Serious pre-existing medical problems other than diabetes, e.g. congestive heart failure, pulmonary insufficiency.
Assessment of Pelvis Diameters as a Predictor for the Mode of Delivery ,Using Non-invasive, Ultrasound Based Measurements

Assessing the relation between the Pelvis diameters measured by the LaborPro, and the mode of delivery(normal vaginal delivery/instrumental delivery/Caesarean section.

Assessing the relation between the Pelvis diameters measured by the LaborPro, and the mode of delivery(normal vaginal delivery/instrumental delivery/Caesarean section.

Eligibility Criteria:
Inclusion Criteria:

* A subject is eligible to participate in the study if she meets all of the following inclusion criteria:
* Singleton pregnancy

  * Pregnant adult woman in labor
  * Willing to participate in the study and understands the study procedures

Exclusion Criteria:

* A subject is not eligible for participation in this study if he/she meets any of the following exclusion criteria scheduled for c/s active infection
Tesetaxel in Chemotherapy-naive Patients With Progressive, Castration-resistant Prostate Cancer

Given the activity of docetaxel in patients with progressive, metastatic castration-resistant prostate cancer, this study is being undertaken to evaluate the activity of tesetaxel, an orally bioavailable taxane, in chemotherapy-naive and chemotherapy-exposed patients.


Eligibility Criteria:
Key Inclusion Criteria:

* At least 18 years of age
* Histologically confirmed prostate cancer, currently with progressive disease
* Evidence of metastatic disease
* Castrate level of testosterone (\< 50 ng/dL)
* Eastern Cooperative Oncology Group performance status 0 or 1
* Chemotherapy-naïve
* Adequate bone marrow, hepatic, and renal function
* Ability to swallow an oral solid-dosage form of medication

Key Exclusion Criteria:

* History or presence of brain metastasis or leptomeningeal disease
* Operable cancer
* Uncontrolled diarrhea
* Uncontrolled nausea or vomiting
* Known malabsorptive disorder
* Currently active second malignancy other than non-melanoma skin cancers
* Human immunodeficiency virus (HIV) infection based on history of positive serology
* Significant medical disease other than cancer
* Presence of neuropathy \> Grade 2 (National Cancer Institute Common Toxicity Criteria \[NCI CTC\]; v4.0)
* Need for other anticancer treatment
* Need to continue any regularly-taken medication that is a potent inhibitor or inducer of the CYP3A pathway or P-glycoprotein activity
* Less than 2 weeks since use of a medication or ingestion of an agent, beverage, or food that is a potent inhibitor or inducer of the CYP3A pathway or P-glycoprotein activity
* Less than 4 weeks since use of another investigational agent
Trial of Otelixizumab for Adults With Newly Diagnosed Type 1 Diabetes Mellitus (Autoimmune): DEFEND-1

The purpose of this study is to find out if an 8-day series of otelixizumab infusions leads to greater improvement in insulin secretion as compared with placebo infusion. Insulin secretion will be assessed using mixed meal-stimulated C-peptide.

Subjects will be assigned to receive either otelixizumab or placebo at a ratio of 2:1 (2/3 otelixizumab, 1/3 placebo). These study agents will be administered as an addition to insulin, diet, and other physician determined standard of care treatments.

DEFEND-1 is now closed to enrollment.

DEFEND-2 will begin early in 2010. It is very similar to DEFEND-1 and will again require subjects with new onset type 1 diabetes. Please check back here for more details.

In the meantime, established and new onset type 1 diabetes patients in North America are welcome to consider the TTEDD study:

http://www.clinicaltrials.gov/ct2/show/NCT00451321?term=TTEDD\&rank=1

The following visits are required:

* Screening Visits: 2 to 3 appointments will be conducted to determine eligibility. At 2 of these visits participants will drink a liquid meal and have blood tests done over the post-meal period.
* Dosing Visits: 8 outpatient visits on consecutive days, each lasting about 4-6 hours.
* Follow-up Visits: weekly for the first month, then every 2 weeks for 3 months, followed by monthly visits through 1 year. There will be 3 visits in the second year.
* The total duration of the study is 2 years.
* Glucose test strips, glucose monitors and PDAs to record insulin will be provided to all study subjects for the duration fo the study. Frequent glycemic monitoring will occur through lab testing and blood glucose self-monitoring to help facilitate tight glycemic control in all subjects.

Eligibility Criteria:
Inclusion Criteria:

* Ages 12-45
* Diagnosis of diabetes mellitus, consistent with ADA criteria
* No more than 90 days between diagnosis and administration of study compounds
* Requires insulin for type 1 diabetes mellitus, or has required insulin at some time between diagnosis and administration of study compounds.
* Stimulated C-peptide level greater than 0.20 nmol/L and less than or equal to 3.50 nmol/L
* Positive for one or more of the autoantibodies typically associated with T1DM: antibody to glutamic acid decarboxylase (anti-GAD); antibody to protein tyrosine phosphatase-like protein (anti-IA-2); zinc transporter autoantibodies (ZNT8); insulin autoantibodies (IAA). A subject who is positive for insulin autoantibodies (IAA) and negative for the other autoantibodies will only be eligible if the subject has used insulin for less than 7 days total.

Exclusion Criteria:

* Other, significant medical conditions based on the study doctor's evaluation
Proteomic Approach Using Matrix-assisted Laser Desorption/Ionization Tandem Time-of-flight (MALDI-TOF/TOF) of Tumor Response in Rectal Carcinoma After Radiochemotherapy

Treatment for locally-advanced rectal adenocarcinoma includes preoperative radiochemotherapy before surgery with total mesorectal excision in order to reduce tumor infiltration, facilitate oncologic surgery and improve survival. About fifty percent of these patients are good responders i.e. their tumor infiltration reduces in the rectal wall and regional lymph nodes in order to be graded ypT0 to T2 N0 after pathologic assessment (so called downstaging). At the opposite, bad responders (ypT3-4 and/or N+) are not sensitive to standard preoperative radiochemotherapy, and their survival is poor than good responders. Until now, response to preoperative radiochemotherapy cannot be anticipated before pathological assessment of surgical specimen. Proteomic analysis of sera from good and bad responders to preoperative radiochemotherapy could allow identification of early biomarkers of tumor response, and subsequently adaptation of treatment to increase preoperative treatment efficiency and survival in most patients.

Good or bad responders to preoperative radiochemotherapy for locally-advanced rectal adenocarcinoma cannot be anticipated before pathological assessment of rectal specimen. The purpose of this prospective monocentric study is to look for early seric biomarkers predictive of tumor response (good and bad responders) in patients treated by preoperative radiochemotherapy (45 Gy) for rectal adenocarcinoma using a proteomic approach. All patients with locally-advanced rectal adenocarcinoma will be enrolled. Sequential samples of sera will be collected before, during preoperative treatment and before surgery, and analysed using a MALDI-TOF-TOF method. Proteomic analysis will be correlated to pathological response in order to identify potential early biomarkers of tumor response.

Eligibility Criteria:
Inclusion Criteria:

* T3T4 or N+ M0 rectal carcinoma
* histologically-proven adenocarcinoma
* from 0 to 15 cm from the anal verge
* patient is at least 18 years of age
* ECOG performance status \</= 2
* Patient and doctor have signed informed consent

Exclusion Criteria:

* Metastatic disease
* T1-T2 N0 rectal carcinoma
* Contra indication of radiotherapy or chemotherapy
* History of cancer
* Severe renal insufficiency
* Symptomatic cardiac or coronary insufficiency
* Patient included in a trial
* Previous radiotherapy or chemotherapy for this cancer
* No contraceptive treatment
Study Evaluating the Efficacy and Safety of Topical Diclofenac Spray in Osteoarthritis of the Knee: Trial II

The objective of this study is to evaluate the efficacy and safety of TDS-943 (topical diclofenac spray) compared to oral celecoxib and placebo in subjects with osteoarthritis of the knee. The main hypotheses are that TDS-943 will be better than placebo and no worse than celecoxib.

This is a multicenter, outpatient, multiple-dose, placebo- and active controlled, double-blind, double-dummy parallel group, randomized (stratified by unilateral vs. bilateral knee OA) trial. The trial will enroll subjects who have been diagnosed with OA of the knee (confirmed by weight-bearing x-ray) and whose condition is in flare at baseline. Subjects who qualify to enter the study will be randomized to topical TDS-943 40 mg bid, oral celecoxib 200 mg qd, or placebo in a 3:2:2 ratio.

Eligibility Criteria:
Inclusion Criteria:

* Males or females in generally good health at least 40 years of age
* Osteoarthritis (OA) of at least one knee, verified by a weight-bearing radiograph
* Subject has taken an oral NSAID or analgesic at least 3 days during the past 30 days to treat knee OA pain

Exclusion Criteria:

* Females who are pregnant or lactating or who may become pregnant
* Hypersensitivity (exacerbations of asthma, rhinitis, or urticaria) to sulfonamides, acetaminophen, diclofenac, celecoxib, aspirin, or any other NSAID
* History of myocardial infarction, congestive heart failure, stroke, coronary-artery bypass graft surgery, or any other significant cardiovascular disease, or is on any form of anticoagulation therapy other than low-dose aspirin (no more than 325 mg/day)
Bioavailability Study of MLDL1278A After Subcutaneous and Intravenous Administration in Healthy Subjects

This is a study in healthy volunteers designed to investigate the PK following intravenous and subcutaneous administration of MLDL1278A (also known as BI-204). The bioavalialbility of MLDL1278A after subcutaneous administration will be determined.


Eligibility Criteria:
Inclusion Criteria:

* Adult males/females aged 18 to 55 years inclusive at screening;
* Subjects who are between 18.0 and 30.0 kg/m2 body mass index (BMI) inclusive and weigh between 55.0 and 100.0 kg inclusive;

Exclusion Criteria:

* Any clinically relevant disease or disorder (past or present), which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the results of the study, or the subject's ability to participate in the study;
* Any clinically relevant abnormal findings in physical examination, clinical chemistry, haematology, coagulation, urinalysis, vital signs or ECG at baseline, which, in the opinion of the investigator, may put the subject at risk because of his participation in the study;