cyrilzakka/clinical-trials huggingface dataset:
Relationship of Addictions to Obesity, Physical Activity and Vascular Ageing in Young Adults

This is a cross-sectional observational study whose objective is to analyse the relationship between behavioural addictions and drug addictions with obesity, physical activity, sedentary lifestyle, arterial stiffness and vascular ageing in young adults, since many of the lifestyles of adulthood are established early in life, and it is easier to prevent them before they start than to achieve their abandonment once they are established as unhealthy lifestyles

Behavioural addictions. Brief Questionnaire of Pathological Gambling (CBJP), Lie/Bet scale, Compulsive Internet Use Scale (CIUS), Smartphone Dependence and Addiction Scale (EDAS-18), Questionnaire of Experiences Related to Video Games (CERV). Drug addictions: Alcohol, Smoking and Substance Involvement Screening Test (ASSIST V3.0), Drug Abuse Screening Test (DAST-20), Alcohol Use Disorders Identification Test (AUDIT) and Fagerström test. Obesity and body composition: Weight, height, waist circumference, hip circumference and Inbody 230®. Diet: Mediterranean Diet Adherence Questionnaire. Physical activity: International Physical Activity Questionnaire (IPAQ), Actigraph GTX3 accelerometer and Marshall questionnaire. Analysis of vascular structure and function and target organ lesions. Pulse wave analysis (PWA) and femoral carotid pulse wave velocity (VOPcf) (Sphygmocor System). Cardio Ankle Vascular Index (CAVI), ankle-ankle pulse wave (VOPbt) and ankle-ankle index (ABI) (Vasera VS-2000®). Retinal vascular injury (TOPCON TRC NW 200). Cardiac lesion (General electric 5000). Kidney Injury: analytical variables. Brain Injury: Montreal Cognitive Assessment (MoCA). Vascular ageing (VOPcf and VOPbt). Other variables. Basal glycaemia, HbA1c. TSH, lipid profile, creatinine and creatinine albumin index and Vit D. Measurement of blood pressure and drug consumption.

Eligibility Criteria:
Inclusion Criteria:

* Patients between 18 and 34 years of age who agree to participate in the study and do not meet any exclusion criteria.

Exclusion Criteria:

* Subjects who are terminally ill, who are unable to travel to health centres for the corresponding examinations, and who do not sign informed consent.
Concomitant Association of Ultrafractionated Brain Irradiation - Temozolomide in Inoperable Primary Glioblastoma Multiforme

The main purpose of this study is the evaluation of concomitant association of ultrafractionated irradiation and Temodal® in patients with inoperable primary glioblastoma multiforme; study of tolerance and objective response rate.

The secondary purposes of this study are the evaluation of progression free survival, global survival and tolerance through toxicity study. The therapeutic response according to methylation or not of MGMT is also evaluated.


Eligibility Criteria:
Inclusion Criteria:

* giving their informed consent
* having a supratentorial malignant glioma, either grade 4 of St. Anne/Mayo grading, or glioblastoma multiforme according to WHO classification
* having an inoperable brain tumor (diagnosed by stereotactic biopsy)
* having a general status, evaluated by Karnofsky scale, \>60
* having a life expectancy \>3 months
* not having previously had a brain irradiation and/or adjuvant or neo-adjuvant chemotherapy
* potentially having another cancer, if histology and clinical history are available for comparison
* being able to take oral tablets
* no HIV disease
* satisfactory hematology, hepatic and renal functions: polymorphonuclear neutrophils \>1500/mm3, platelets \>100000/mm3, Hb \>8g/dl, creatinemia ≤1.5 times upper normal value, total bilirubin \<1.5 times upper normal value, ASAT and ALAT \<3 times upper normal value
* for women of childbearing potential, a contraception is given

Exclusion Criteria:

* having an under tentorial malignant glioma (brain stem and/or cerebellum), grade 4 of St. Anne/Mayo grading
* having a Karnofsky score \<60
* having a life expectancy \<3 months
* having had a brain irradiation or an adjuvant or neoadjuvant chemotherapy
* refusing any additional therapy
* having a non-malignant but serious systemic disease or uncontrolled active infection
* having a severe psychiatric disorder
* not having signed the informed consent
* pregnant or breastfeeding woman
Dose-dense ABVD First Line Therapy in Early Stage Unfavorable Hodgkin's Lymphoma

Prospective, multicenter, Phase II trial designed to assess whether intensification of ABVD (dd-ABVD) is feasible and can improve the outcome of patients with early stage Hodgkin Lymphoma.

Dose-density has been shown to be an important factor for complete remission rate and longterm survival in lymphomas.

The aims of this study were to find out whether intensification of ABVD (dd-ABVD) is feasible and can improve the outcome of patients with early stage Hodgkin Lymphoma. In view of emerging data on the role of early PET in defining prognosis in Hodgkin Lymphoma patients, the percentage of FDG-PET (fluorodeoxyglucose positron emission tomography) negativity after two cycle was chosen as the parameter to evaluate dd-ABVD activity.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-70 years
* Histologically confirmed Hodgkin Lymphoma stage I, II unfavorable according to EORTC (European Organisation for Research and Treatment of Cancer) criteria, with exclusion of stage II B bulky.
* Previously untreated
* ECOG (Eastern Cooperative Oncology Group) performance status 0 - 2
* Staging with FDG-PET (fluorodeoxyglucose positron emission tomography)
* Written informed consent
* Adequate liver and renal function (total serum bilirubin \< 2.5 x ULN, AST/SGOT and/or ALT/SGPT ≤ 2.5 x upper limit of normal (ULN) or ≤ 5.0 x ULN if the transaminase elevation is due to disease involvement, serum creatinine \< 2.5 x ULN)

Exclusion Criteria:

* Concomitant cardiac, pulmonary, neurologic, psychiatric or metabolic severe disease.
* Uncontrolled diabetes mellitus (with fasting glucose levels above 200mg/dl)
* Other prior malignancies except for adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, carcinoma in situ of the cervix, carcinoma in situ of the breast or other cancer from which the patient has been disease-free for ≥ 3 years
* Patients with a known history of HIV seropositivity
* Active HCV infection (PCR + ; AST\> 1.5-2x UN)
* Woman who is pregnant or breast feeding. Fertile patients not willing to use effective contraception during the study and 3 months after the end of treatment. Women of childbearing potential (WOCBP) are defined as sexually mature women who have not undergone a hysterectomy or who have not been naturally postmenopausal for at least 12 consecutive months.
* Negative pregnancy test at baseline is required (serum β HCG).
* Male patient whose sexual partner(s) are WOCBP who are not willing to use a effective contraception during the study and 3 months after the end of treatment
* Nodular lymphocyte prevalence histological subtype
Safety and Immunogenicity Study of HIV-MAG Vaccine +/- IL-12 and Ad35-GRIN/ENV in HIV-uninfected Volunteers

The purpose of this study is to evaluate the safety, tolerability and immunogenicity of multiantigen HIV (HIV-MAG) plasmid DNA (pDNA) vaccine co-administered with recombinant human IL-12 pDNA (GENEVAX® IL-12) followed or preceded by recombinant Ad35-GRIN/ENV HIV vaccine in low-risk for HIV-uninfected healthy adults.

The study is a randomized, double-blind placebo-controlled trial assessing the safety and tolerability of HIV-MAG with or without co-administered GENEVAX® IL-12 given intramuscularly by in vivo electroporation (IM/EP) using the Ichor Medical Systems TriGrid Delivery System (TDS-IM) followed by Ad35-GRIN/ENV in each of four different regimens. An additional group will evaluate the safety and tolerability of Ad35-GRIN/ENV followed by HIV-MAG with co-administered GENEVAX® IL-12 given intramuscularly by in vivo electroporation (IM/EP) using the Ichor Medical Systems TriGrid Delivery System (TDS-IM).

Volunteers will be screened up to 42 days before the 1st vaccination and will be followed for 12 months after the first vaccine administration. It is anticipated that it will take approximately 3 months to enrol the study. Approximately 75 volunteers (60 vaccine/15 placebo recipients) will be included in the study.

Eligibility Criteria:
Inclusion Criteria:

* healthy male or female adults,
* 18 to 50 years of age (21 to 50 years of age for volunteers in Rwanda),
* who do not report high-risk behaviour for HIV infection,
* who are available for the duration of the trial,
* who are willing to undergo HIV testing,
* use an effective method of contraception, and
* who, in the opinion of the principal investigator or designee, understand the study and who provide written informed consent.

Principal exclusion criteria:

* confirmed HIV infection,
* pregnancy and lactation,
* significant acute or chronic disease,
* clinically significant laboratory abnormalities,
* recent vaccination or receipt of a blood product,
* previous receipt of an HIV vaccine, and
* previous severe local or systemic reactions to vaccination or history of severe allergic reactions.
MAXIMA Study: A Study of Maintenance Therapy With MabThera (Rituximab) in Patients With Non-Hodgkin's Lymphoma.

This single arm study will evaluate the safety and efficacy of MabThera maintenance therapy following a MabThera-containing induction regimen in first line or relapsed patients with follicular non-Hodgkin's lymphoma. All patients will receive MabThera 375mg/m2 body surface area, as an intravenous infusion, every 8 weeks. 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;
* histologically confirmed grade 1, 2 or 3a follicular non-Hodgkin's lymphoma;
* patients who have received adequate (\>=8 cycles) induction therapy with MabThera as first line treatment, or treatment for relapsed disease;
* demonstrated partial or complete response to induction therapy.

Exclusion Criteria:

* stable or progressive disease after most recent induction therapy;
* transformation to high grade lymphoma;
* patients with prior or concomitant malignancies, except non-melanoma skin cancer or adequately treated in situ cancer of the cervix.
Evaluation of HRCT Patterns in Systemic Sclerosis-associated Interstitial Lung Disease

Systemic sclerosis (SSc) is a heterogeneous systemic autoimmune disease with distinct prognosis according to patients. Interstitial lung disease (ILD) concerns almost 50 % of SSc patients and represents the main cause of mortality. SSc-ILD is variable: from limited forms (with asymptomatic patients) to extensive lesions. Disease course in SSc-ILD is also highly variable: patients can experience stable disease, slow or fast progression. Investigators performed unsupervised clustering analysis to classify SSc-ILD according to elementary radiological lesions on HRCT scan.


Eligibility Criteria:
Inclusion Criteria:

* Patients with systemic sclerosis according to 2013 ACR/EULAR criteria
* Patients with interstitial lung disease on HRCT chest

Exclusion Criteria:

* Patients with an alternative diagnosis of SSc-associated ILD (silicosis, sarcoidosis, lung cancer or other significant lung abnormalities)
Serial Progesterone Level Measurements During the Menstrual Cycle in Subfertile Women

Ovulatory dysfunction is identified in 15% of all infertile couples and it accounts for 40% of female infertility. Ovulatory dysfunction may be more subtle in women with regular menses. Detecting the day of ovulation is necessary for optimizing natural conception, diagnosis of cycle disturbances and also timing for embryo transfer in natural cycle frozen-thawed embryo transfers. In order to diagnose ovulatory dysfunction, ovulation physiology and change of reproductive hormones during the menstrual cycle should be understood. In the present study we aimed to evaluate serial serum hormonal cut-off levels referenced to ovulation in subfertile women with regular menses.


Eligibility Criteria:
Inclusion Criteria:

* women that have regular menses (menstrual cycle length 21-35 days)
* women who will come visits regularly
* women that are trying to conceive more than 1 year if women age is less than 35 years or more than 6 months if women age is \>35 years

Exclusion Criteria:

* women who do not menstruate regularly
* women that use hormonal contraception
* women who take drugs that will interfere with steroid hormone metabolism
Association Between Mitochondrial DNA Content and Risk of Acute Leukemia

Compelling epidemiological evidence indicates that alterations of mitochondrial DNA, including mutations and abnormal content of mitochondrial DNA (mtDNA), are associated with the initiation and development of acute lymphoblastic leukemia (ALL).The aim of this study was to explore association between mtDNA content in peripheral blood cells could be used as a risk predictor for ALL.


Eligibility Criteria:
Inclusion Criteria:

* 1.histological confirmed chronic lymphocytic leukemia; 2.preparing for chemotherapy; 3.no preoperative anticancer treatment.

Exclusion Criteria:

* 1.history of other malignancy; 2.blood transfusion within one month or prior bone marrow transplantation; 3.patients who reluctant to sign informed consent.
Two-stage Hybrid Ablation or Thoracoscopic Epicardial Ablation for Long-standing Persistent Atrial Fibrillation

Hybrid ablation, as an emerging strategy for atrial fibrillation (AF) in recent years, shows encouraging outcomes in many medical centers. A lot of cases demonstrated hybrid ablation has higher success rate than surgical ablation on patients with persistent AF, especially long-standing persistent AF (LSPAF). But it is still lack of high level evidence to prove it.

This study focus on patients with long-standing persistent atrial fibrillation (LSPAF). In order to compare the efficacy and safety of hybrid ablation (two-stage) versus thoracoscopic surgical ablation, a randomized, controlled clinical trial will be performed in the population of LSPAF patients.

In this study, all selected LSPAF patients will receive thoracoscopic surgical ablation. After 3 months of blanking-period, patients off antiarrhythmic therapy freedom from atrial arrhythmia (including atrial tachycardia, atrial flutter and atrial fibrillation) will be divided into Hybrid group and Surgical group randomly and equally. Patients of Hybrid group will receive transcatheter endocardial electrophysiological mapping and catheter ablation after randomization subsequently. In followed 2 years, cardiovascular risk control will be recommended to 2 groups' patients.

During the 2-year follow-up, 7d-Holter will be used to monitor patients' rhythm and cardiac conditions will be confirmed by transthoracic echocardiography (TTE). Physical examination and examinations mentioned above will be performed in 3 months, 6 months, 12 months, 18 months, 24 months and suspected recurrence.

Eligibility Criteria:
Inclusion Criteria:

* Older than 18 years old.
* Nonvalvular and long-standing persistent atrial fibrillation confirmed by echocardiography and electrocardiography respectively.
* Written informed consent

Exclusion Criteria:

* Secondary atrial fibrillation caused by other reversible diseases.
* Left atrial diameter \>55mm confrimed by Transthoracic echocardiography.
* Intracardial mass or thrombus.
* Previous cardiac surgery.
* Uncontrolled heart failure or LVEF less than 30%.
* Severe chest wall deformity.
* Possibly pleural adhesion or pericardial adhesion caused by previous thoracic surgery, tuberculosis or constrictive pericarditis.
* Severe comorbidities (e.g. severe CAD, severe renal failure, severe liver failure).
* Life expectancy less than 2 years (e.g. patients with MODS or cancer)
* Unsuitable for radiation exposure (e.g. pregnancy)
Pilot Testing PREschooler Care, Community Resources, Advocacy, Referral, Education (PRE-CARE)

The goal of this proposed study is to pilot test a novel treatment model (PRE-CARE) addressing unmet social needs for families of preschool-age children with Attention Deficit/Hyperactivity Disorder (ADHD) symptoms. The investigators will conduct an adaptive, pilot randomized controlled trial (RCT) of the intervention with parents of 60 low-income children age 3-5 (36-71 months) with ADHD symptoms in order to: optimize intervention delivery; field test study logistics (e.g., recruitment, enrollment, randomization, retention); explore putative intervention mechanisms; and obtain estimates of study parameters to plan an appropriately powered RCT of the intervention.

The PRE-CARE intervention is adapted from Well Child Care, Evaluation, Community, Resources, Advocacy, Referral, Education (WE CARE), a screening and referral intervention that has been shown to be feasible and effective in addressing the family psychosocial stressors of low-income families seen in pediatric medical homes. Given the negative impact that socioeconomic stressors can have on the health and development of young children with ADHD symptoms, tailored interventions such as PRE-CARE may serve as a vital early intervention strategy to promote long-term well-being.


Eligibility Criteria:
Inclusion Criteria:

* Legal guardian and primary caregiver of a child aged 36-71 months
* Legal guardian or primary caregiver is age 16 years or older
* Child receives pediatric care at Boston Medical Center or at one of the participating Boston HealthNet clinics
* Able to understand informed consent procedures in English or Spanish
* Participant has a child aged 36-71 months with an ADHD diagnosis, OR one elevated total or subscale score at the 80th percentile on the ADHD-Rating Scale-IV Preschool Version. 80th percentile cut-offs on the ADHD-Rating Scale-IV Preschool Version are as follows:

  * For male children, a total score ≥ 25 OR subscale score (inattention and/or hyperactivity) ≥ 12
  * For female children, a total score ≥ 13 OR subscale score (inattention and/or hyperactivity) ≥ 6 for female children

Exclusion Criteria:

* There are no specific exclusion criteria for this study
Validation of Kaihani Score for Gambling Addiction

The Kaihani Score is a blood based means of assessing molecules believed to be associated with gambling addiction.

The current clinical trial will assess the Kaihani Score in 3 groups:

Group 1: 10 patients with no personal or family problems with gambling as assessed by the PG-YBOCS (obsessions-compulsions scale Yale-Brown (Y-BOCS), adapted for pathological gambling) (PG-YBOCS).

Group 2: 10 patients with moderate gambling addiction as assessed by the PG-YBOCS (obsessions-compulsions scale Yale-Brown (Y-BOCS), adapted for pathological gambling) (PG-YBOCS).

Group 3: 10 patients with severe gambling addiction as assessed by the PG-YBOCS (obsessions-compulsions scale Yale-Brown (Y-BOCS), adapted for pathological gambling) (PG-YBOCS).

The goal of the study is to confirm preliminary efficacy of the Kaihani Score as a blood based means of assessing gambling propensity.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a diagnosis of pathological gambling (DSM IV criteria)
* First-time consultants.
* Without psychotropic treatment or treatment with a stable and unchanged for over a month.

Exclusion Criteria:

* Pregnant women and patients with hearing disorders
* Epilepsy (untreated or poorly balanced)
* Focal brain injury, whatever its origin (vascular, traumatic, tumor or infectious)
* History of head trauma with loss of consciousness,
* Administration of drugs or substances lowering the seizure threshold
* Sleep deprivation, jet lag, or drug withdrawal.
* Participants with a problem of uncorrected visual acuity.
* Other current addiction.
Assess the Blood-Oxygen-Level-Dependent (BOLD) Signal Changes in the Brain by Paracetamol as Measured by Functional Magnetic Resonance Imaging (fMRI) in Subjects With Osteoarthritis (OA)

Blood-Oxygen-Level-Dependent (BOLD) responses to painful mechanical stimulation of the OA knee following treatment with four consecutive doses (at 8 hour intervals) on giving sustained released paracetamol treatment or placebo will be compared. The fMRI and pain assessments will occur approximately 2-5 hours after taking the final dose.

The objective of this study is to investigate if functional magnetic response imaging (fMRI) can detect the effects of a known pain medicine at over-the-counter doses in people with osteoarthritis (OA) of the knee. The fMRI is a harmless and painless technique that is used in the current study to collect images of brain activity to see if is changed when feeling pain. In this study, BOLD response to mechanical stimulation via pressure stimuli applied to the tibio-femoral joint and patello-femoral in participants with knee OA following four treatment doses of any of three treatment will be compared.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of osteoarthritis of at least one knee for 3 months
* Male or female at least 45 years of age
* Score a minimum of 4 out of 10 on the numerical pain rating and a maximum of 8 at screening

Exclusion Criteria:

* If female, is pregnant, lactating, or breast feeding
* Has secondary cause of knee arthritis
* Lower extremity surgery in the last 6 months
* Prior injury in the last twelve months to the index knee
* Used any analgesics (NSAIDs, COX2 inhibitor, etc) within 5 half lives of study start
* Recently used oral or injected glucocorticoids
Prevalence and Risk Factors for Pelvic Floor Disorders

Pelvic floor disorders (PFD) can adversely affect the quality of life of a woman and they can occur during different stages of female life such as during pregnancy, early postpartum period or during menopause. It is well known that pregnancy and vaginal birth are significant risk factors in the etiology of PFD and predicting models like UR-CHOICE score were developed for this reason to provide mothers-to-be with sufficient information regarding their subsequent risk of PFD. Pregnancy, childbirth and the immediate postpartum period, where the demands on the pelvic floor and the incidence of pelvic floor trauma are particularly high, offers an optimal opportunity for such counseling and prevention.

Pelvic floor disorders (PFDs) can adversely affect the quality of life (QoL) of a woman and they can occur during different stages of female life such as during pregnancy, early postpartum period or during menopause. The reported prevalence of PFDs varies widely both during and after pregnancy and reported up to 30-50%. Besides, the term PFD includes a broad spectrum of conditions such as urinary incontinence (UI), pelvic organ prolapse (POP) or anal incontinence (AI). Many risk factors seem to be involved like the pregnancy itself, mode of delivery, parity, the use of episiotomy, obesity, increased age and so on. It is well known that pregnancy and vaginal birth are significant risk factors in the etiology of PFDs and predicting models like UR-CHOICE score were developed for this reason to provide mothers-to-be with sufficient information regarding their subsequent risk of PFD. The identification of women during their pregnancy who are at higher risk for PFD remains a key element in targeting of prevention and planning health of resource allocation strategies. Pregnancy, childbirth and the immediate postpartum period, where the demands on the pelvic floor and the incidence of pelvic floor trauma are particularly high, offers an optimal opportunity for such counseling and prevention. The validated German pelvic floor questionnaire modified for pregnancy and postpartum period is thus an important tool identifying such symptoms and helping clinicians assess patient's quality of life. The aim of the present study was to evaluate the prevalence of PFDs in a cohort of Egyptian women during pregnancy. Furthermore, we searched for clinical risk factors that correlate with the occurrence of PFDs during pregnancy in the investigator's population.

Eligibility Criteria:
Inclusion Criteria:

* age over 18 years
* any trimester of pregnancy
* planned delivery at our institution.

Exclusion Criteria:

* Women with the inability to complete the questionnaire