cyrilzakka/clinical-trials huggingface dataset:
A Comparison of the Perception of a Needle Injection Pain Between Cancer Patients Receiving Opioid Therapy Versus Opioid-naive Patients

Opioid-induced hyperalgesia (OIH) is most broadly defined as a state of nociceptive sensitization caused by exposure to opioids. In humans, the evidence of OIH is strong but conflicting. Previous clinical studies mostly used experimental or non-standardized surgical stimuli to assess OIH. We therefore sought to certify a presence of OIH using a standardized, clinical pain stimuli in cancer patients receiving opioid therapy and opioid-naive patients.


Eligibility Criteria:
Inclusion Criteria:

* age 20-80
* cancer patient
* patient whom receiving opioid treatment, any acute or chronic pain condition amenable to a diagnostic/therapeutic nerve block or neuromodulation,and a regular analgesic regimen.

Exclusion Criteria:

* patient who has any change in opioid or other analgesic medications less than 14 days prior to the scheduled procedure
* an inability to understand English or adequately respond to the relevant questions
Effectiveness of Indo-SURFT in Reducing Addictive Substance Use in Women With Substance Use Disorders

Relapse in women was associated with depression, interpersonal stress, and relationship conflict with others when compared with men. The differences in gender profiles with substance use disorders (SUD) leads to the need for management strategies that are sensitive to each gender. This is a challenge to build a new module that can be applied continuously by collaborating CBT and several other psychosocial interventions, such as motivational enhancement therapy. The investigators compiled Indonesia Substance Use Reduction for Female Therapy (Indo-SURFT). By implementing this module, it is hoped that it can provide short and long term effects and reduce the relapse rate in women with SUD.


Eligibility Criteria:
Inclusion Criteria:

* women aged 18-59 years old
* diagnosed with substance use disorders based on DSM-V or ICD-10

Exclusion Criteria:

* subjects with severe mental disorder or intellectual disability
Study to Compare Efficacy and Safety of TEV-45779 With XOLAIR (Omalizumab) in Adults With Chronic Idiopathic Urticaria

The purpose of the study is to compare the efficacy, pharmacokinetics, pharmacodynamics, safety, tolerability, and immunogenicity of TEV-45779 compared to XOLAIR in patients with Urticaria (CIU)/Chronic Spontaneous Urticaria (CSU) who remain symptomatic on H1 antihistamine treatment.

This is a multicenter, randomized, double-blind study to demonstrate similar efficacy and safety of TEV-45779 compared to XOLAIR administered sc at doses of 300 mg or 150 mg every 4 weeks for 24 weeks (6 treatments) in patients with Chronic Idiopathic Urticaria (CIU)/Chronic Spontaneous Urticaria (CSU) who remain symptomatic despite antihistamine (H1) treatment. This study will consist of a screening period (up to 2 weeks), a 24-week treatment period consisting of a 12-week double-blind main treatment period and a 12-week double-blind transition period, which is followed by a 16-week follow-up period. The total duration of the study is up to 42 weeks.

At baseline, patients will be randomized in a 2:2:1:1 ratio to receive the first 3 treatments of TEV-45779 300 mg, XOLAIR 300 mg, TEV-45779 150 mg or XOLAIR 150 mg (main treatment period). At Week 12, prior to receiving their fourth dose of study medication, patients in the XOLAIR 300 mg and the XOLAIR 150 mg treatment groups will be randomized 1:1 to receive 3 additional doses of XOLAIR (at the same dose level as prior to randomization, or switch to 3 doses of TEV-45779 (transition period) at the same dose level as prior to randomization. All patients in the TEV-45779 groups will continue to receive TEV-45779 at the same dose levels.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of CIU refractory to H1 antihistamines for ≥3 months

Exclusion Criteria:

* Chronic urticaria with clearly defined underlying etiology
* Other skin disease associated with itch
* Evidence of parasitic infection on stool evaluation for ova and parasites
* History of anaphylactic shock
* Hypersensitivity to omalizumab or any component of the formulation
* Required background therapy with other than protocol-defined antihistamines
* Any medical condition that could jeopardize or would compromise the patient's safety or ability to participate in this study
Safety Study of Shenmai(a Chinese Medicine Injection) Used in Hospitals in China

The purpose of this study is to make a cohort event monitoring to see whether and how Shenmai injection in hospital results in adverse events or adverse drug reactions.

Safety surveillance on Chinese Medicine injection is an important problem that needs to be sorted out ,because in mainland China hospitals ,Chinese Medicine Injection are used widely. Population for taking medicine characteristics,the incidence rate of ADR and other uncertain factors influence can not be found now.

A registry study for shenmai injection safety surveillance with 30000 patients will be conducted from Jan.2012 to Dec.2015.

Eligibility criteria Patients who will use shenmai injection in selected hospitals.

Eligibility Criteria:
Inclusion Criteria:

* all inpatients use Shenmai injection in 30 selected hospitals during their hospital stay

Exclusion Criteria:

* none
Training of a Artificial Intelligence Model to Detect Venous Diseases Using PPG Technology

This clinical research aims to evaluate the effectiveness of using Photoplethysmography (PPG) signals combined with Artificial Intelligence (AI) algorithms, for the precise classification and diagnosis of Venous Diseases of the lower limb. This study invites a group of participants who currently undergoing investigations for venous disease at The Whiteley Clinic (hereinafter referred to as TWC). The Participants will be classified into control (healthy individuals with no significant venous disease) and chronic venous disease (CVD) (diagnosed with proven venous disease) groups. Prospective participants who express an interest in being included in the study will be given a patient information sheet and will undergo a briefing of the pilot study. If they consent and sign the relevant consent forms, the participants will perform a series of standardized exercises under the supervision of a consultant vascular surgeon. Throughout the exercises, a data acquisition device attached to the ankle records the PPG signals, capturing the changes in blood volume due to the reflected PPG signals from the red blood cells during the movement. Thus, once the data is collected and recorded, this allows for the analysis of the data of the control group and CVD group against each other. During the analysis of the two groups' PPG signals, the objective lies within the capability to detect subtle nuances in the patterns of the PPG signals during the performed movements using AI algorithms. The AI algorithms will distinguish patterns or features indicating the presence or absence of venous disease. This study seeks to contribute valuable insights into enhancing the diagnosis of venous disease using PPG and AI algorithms, paving novel approaches to Venous healthcare.


Eligibility Criteria:
Inclusion Criteria:

* Patients are attending for investigation of suspected venous disease. Patients must be able to walk and mobile normally and have good skin integrity of the lower leg, where the PPG is attached.

All patients attending TWC are 18 years or older.

Exclusion Criteria:

* Subjects with known arterial occlusive disease or physical disability affecting gait or ankle movement will be excluded.

Patients unable to have a PPG attached to the lower leg (ie: active ulceration) will be excluded.

Patients unable to give consent. Pregnant female.
Cost Effectiveness of Combined Contingency Management and Cognitive Behavioral Therapy for Alcohol Use Disorder

Alcohol contributes to 88,000 deaths and costs an estimated $223 billion annually in the United States. Alcohol use disorder (AUD) is highly prevalent in veterans. The positive public health impact of reducing heavy drinking among veterans with AUD would prevent significant medical morbidity and mortality. Contingency management (CM) is an intensive behavioral therapy that provides incentives to individuals for reducing substance use. Monitoring alcohol abstinence usually requires daily monitoring. Because of this difficulty, CM approaches for treatment of AUD are not currently available to people with AUD. Our group has developed a mobile smart-phone application that allows patients to video themselves using an alcohol breath monitor and transmit the encrypted data to a secure server. This innovation has made the use of CM for outpatient AUD treatment feasible. The aim of the current study is to evaluate the effectiveness and cost effectiveness of CM as an add-on to cognitive behavioral therapy for AUD. The trial will also explore the potential usefulness of a long-term abstinence incentive ontreatment utilization and alcohol outcomes. Proposed is a trial in which 140 veterans with AUD will be randomized to receive either CM as an add-on to evidence-based CBT or CBT alone. Veterans will also be randomized to one of two long-term incentive conditions (i.e., receipt of a monetary incentive for abstinence/low-risk drinking at 6- months vs. no incentive). This project aims to advance AUD treatment by 1) testing the effectiveness of a mobile health approach that makes CM for AUD feasible, and 2) providing highly needed cost-effectiveness data on the use of behavioral incentives as an adjunct to CBT for the treatment of AUD. These aims are designed to address two significant barriers to the implementation of CM for AUD.


Eligibility Criteria:
Inclusion Criteria:

* are an enrolled veteran at the DVAHCS for primary care,
* have current AUD (meeting past month DSM-5 criteria), and
* are willing to make a quit attempt and/or reduce alcohol use to low risk levels.

Exclusion Criteria:

* have fewer than 3 days of abstinence,
* have a history of clinically significant alcohol withdrawal, as indicated by a score of 10 or more on the Clinical Institute Withdrawal Assessment of Alcohol (CIWA), or
* are currently receiving professional behavioral treatment for AUD.
A Study to Evaluate Safety, Efficacy, and Tolerability of TEZ/IVA in Orkambi® (Lumacaftor/Ivacaftor) -Experienced Subjects With Cystic Fibrosis (CF)

Study VX16-661-114 (Study 114) is a Phase 3b, randomized, double-blind, placebo-controlled, parallel-group, multicenter study in subjects aged 12 years and older with CF who are homozygous for the F508del mutation on the cystic fibrosis transmembrane conductance regulator gene (CFTR) gene and who discontinued treatment with Orkambi due to respiratory symptoms considered related to treatment. This study is designed to evaluate the safety and efficacy of Tezacaftor/Ivacaftor (TEZ/IVA).


Eligibility Criteria:
Inclusion Criteria:

* Willing and able to comply with scheduled visits, treatment plan, study restrictions, laboratory tests, contraceptive guidelines, and other study procedures.
* Prior discontinuation of Orkambi, with at least 1 respiratory sign or symptom considered related to therapy.
* Resolution or stabilization of qualifying event(s) \>28 days prior to Screening.
* Discontinuation of Orkambi therapy must have occurred within approximately 12 weeks from the first dose of Orkambi.
* Homozygous for F508del mutation in the CFTR gene as documented in the subject's medical record. If genotype documentation is not available in the medical record, genotyping will be performed during screening.
* FEV1 ≥25% and ≤90% of predicted normal for age, sex, and height.
* Stable CF disease as judged by the investigator.
* Other protocol defined inclusion criteria could apply.

Exclusion Criteria:

* History of any comorbidity that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the subject.
* Recent rapid or progressive deterioration in respiratory status.
* Receiving continuous oxygen at \>2L/min or on face-mask ventilation.
* Any protocol-defined exclusionary laboratory values at Screening.
* Child-Pugh Class B or C hepatic impairment.
* An acute upper or lower respiratory infection, pulmonary exacerbation, or change in therapy for pulmonary disease within 28 days before Day 1.
* Documentation of colonization with organisms associated with a more rapid decline in pulmonary status.
* History of lung transplantation since most recent initiation of Orkambi.
* History of alcohol or drug abuse in the past year as deemed by the investigator.
* Participation in an investigational drug study or use of a CFTR modulator within 28 days or 5 terminal half-lives of the investigational drug or modulator (whichever is longer).
* Use of restricted medications or foods within the specified window before the first dose of study drug, or an anticipated need or use of restricted medication or foods after the first dose of study drug.
* Pregnant or nursing females: Females of child-bearing potential must have a negative pregnancy test at Screening and Day 1.
* Other protocol defined exclusion criteria could apply.
Role of Carbohydrate Modification in Weight Management Among Obese Children

The purpose of this study is to test the hypothesis that a low-carbohydrate diet and a low-glycemic load diet will improve body mass index and result in more body fat loss than a control diet among overweight children ages 7 to 12. In addition this study is also designed to test the safety of diets with modified carbohydrate content as compared to a conventional weight management diet among younger overweight children.

The treatment of pediatric obesity supported by the medical community is a moderate restriction in calories by modifying intake of fat and simple sugars, along with an increase in energy expenditure through more physical activity. However, this approach is associated with only limited success. As a result, overweight children and adolescents are seeking alternative approaches to weight management, such as diets that modify the type and amount of carbohydrates. However, at this time there is limited data on the safety and efficacy of these diets, particularly with younger children. This study is a controlled clinical trial that compares the safety and efficacy of a low carbohydrate and reduced glycemic load diets to a more standard dietary intervention for the management of pediatric obesity (i.e. portion-controlled, moderate fat, high carbohydrate diet). This study will involve 150 overweight children (ages 7 to 12) who will be randomly assigned to one of the three diet groups for 12 months. The effects of each diet will be determined by measuring changes in anthropometric measures (body weight, height, body mass index, waist circumference, body composition), other cardiovascular risk factors (blood pressure, fasting lipid profile, fasting glucose and insulin, and inflammatory markers of cardiovascular disease), and measures of psychological well-being and mental status. The results of this study will provide needed information to the public in their quest for safe, effective, and health-promoting weight management strategies for obese children. Such information is vital if we are to address the obesity epidemic in the United States.

Eligibility Criteria:
Inclusion Criteria:

* Age 7-12 years
* Body mass index \>95th percentile and BMI z-score no greater than 2.65
* Normal fasting blood glucose of less than 100 mg/dL
* Age-appropriate cognitive and behavioral skills
* Absence of developmental or physical disabilities
* Capability to function independently in group exercise sessions
* Commitment of parent/guardian to attend scheduled meetings for 12-month period

Exclusion Criteria:

* Active cardiac, pulmonary, renal, liver, or gastrointestinal disease (pancreatitis, cholelithiasis, inflammatory bowel disease), diabetes, untreated thyroid disease, hypertension, hyperlipidemia
* Chronic infections
* Uncompensated or labile mental illness
* Chronic or intermittent use of corticosteroids
* Specific medications that may alter lipid, glucose, bone metabolism or appetite
Predictive Value of 18F-FAZA in Rectum Cancer

The primary purpose of the study is to investigate 18F-FAZA-PETs role as predictor of response to neoadjuvant chemoradiation of locally advanced rectum cancer.


Eligibility Criteria:
Inclusion Criteria:

* Histopatologically verified adenocarcinoma in the rectum
* T4 tumor eller T3 tumor \< 10 cm from the anus and \< 5 mm from the mesorectal fascie measured by MR scan. At the distal part of the rectum the distance to the mesorectal fascie is \< 5 mm and therefore all T3 tumors are included in this area
* Suitable for preoperative radiation and chemotherapy
* No distant metastases
* Age \>18 years
* Hematology ANC ≥1.5x10\^9/l. Thrombocytes ≥ 100x10\^9/l.
* Biochemistry Bilirubin ≤ 3 x UNL. ALAT ≤ 5 x UNL
* Creatinine ≤ UNL
* Contraception for fertile women
* Written and orally informed consent

Exclusion Criteria:

* Other malignant disease within 5 years, excl. non-melanotic skin cancer
* Previous radiation treatment of the pelvis
* Pregnant or breastfeeding women
* Surgery within 6 weeks prior to enrollment
* Serious concurrent medical disease
* Enrollment in study "A prospective observational study of patients with rectum cancer after concomitant radiation and chemotherapy", where the patients are potientially not operated.
Behavioral Economics-Based Online Lifestyle Balance Program

The objective of this project is to design a Behavioral Economics Based Online Lifestyle Balance Program that employs behavioral economics to engage and motivate adherence to an Internet-based program. The investigators compare the effects of two financial incentives on inducing weight loss: a direct financial incentive for weight loss and a financial incentive for health literacy.

This project investigates whether participants in an online weight loss program can be induced to achieve weight loss using financial incentives. The study is a 3-arm randomized controlled trial (RCT) stratified by gender. The goal is to examine how overweight individuals respond to two different types of financial incentives. The first type of incentive, incentive for weight loss (IW), is a cash award of approximately $150 given for achieving 5% weight loss over 12 weeks. The second type of incentive, incentive for education (IE), is a $150 award for passing quizzes that test the participants' health literacy about weight loss and the techniques required for maintaining a healthy lifestyle. The investigators compare the effectiveness of IW to IE in promoting weight loss in overweight individuals and investigate whether the two incentives work equally well for men and women.

Eligibility Criteria:
Inclusion Criteria:

* BMI between 23 and 33
* Age between 40 and 60 years old

Exclusion Criteria:

* History of diabetes
* History of significant cardiovascular disease
* Family history of atherosclerosis
* High blood pressure
* Significant lung disease
3-year Study of Menostar Versus Evista to Prevent Osteoporosis in Post-menopausal Women

The aim of this trial is to investigate whether the Menostar patch is as safe and effective in the prevention of bone loss in postmenopausal women as raloxifen, a drug already registered for prevention and treatment of osteoporosis.

The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor of the trial.

Eligibility Criteria:
Inclusion Criteria:

* Last (regular) menstrual period more than 5 years ago
* Relative good state of health
* Intact, normal uterus

Exclusion Criteria:

* Bone and musculoskeletal diseases
* Clinically significant vertebral fracture within the last 12 months
* Pre-existing cardiovascular disease (e.g. uncontrolled high/low blood pressure, stroke, thromboembolic event etc)
* Uncontrolled diabetes mellitus (or treated with insulin)
* Uncontrolled thyroid disorders
* Relevant renal disorder or significant liver dysfunction (including cholestasis)
* History of alcohol or drug abuse
* History of immobilization of more than 2 months in the last 6 months
* Smoking of more than 10 cigarettes per day
* Unexplained uterine bleeding
* Known or suspected malignant or premalignant disease (e.g. cancer of breast or uterus, melanoma)
Emotion Regulation Training Via Telehealth During the COVID-19 Pandemic

This study is an open trial designed specifically to address the need for evidence-based treatment delivered via telehealth to individuals that are currently struggling with mental health issues during the COVID-19 pandemic, with the overarching goal of helping residents of New York adversely impacted by the pandemic to effectively manage their anxiety, stress, and depression during this unprecedented time in human history.

The present study is evaluating whether this ERT treatment program delivered via telehealth demonstrates efficacy in: 1) reducing symptoms of psychological distress (e.g., anxiety, depression, worry, rumination); 2) improving outcomes specific to the ERT mechanism-based model (e.g., attentional control, decentering, reappraisal); 3) improving quality of life and functioning, for adults aged 18-65 years old.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18-65 years during the time of participation
* Endorses distress and worry/rumination exacerbated by the COVID-19 pandemic
* Access to a mobile device (e.g., smartphone, personal computer, laptop, tablet) connected to the Internet

Exclusion Criteria:

* Active suicidal intent
* Current substance dependence disorder (within the past year)
* Current or past psychotic disorder, Bipolar-I disorder, or dementia
* Primary DSM-5 diagnosis of borderline or narcissistic personality disorder
* Currently receiving any other form of psychosocial treatment
Early MRI Detection of Myocardial Deterioration as a Preventive, Disease Staging, and Prognostic Biomarker in Insulin Resistance

The purpose of this study is to evaluate the relationship between insulin resistance (IR) and myocardial tissue abnormalities. The study will focus on a patient population, South Asians, with a high prevalence of IR.

Cardiac fibrosis has been linked to adverse outcomes in non-ischemic cardiomyopathy. Fibrosis is also detectable in diabetic patients, but does not appear to closely track with insulin sensitivity. Hence, fibrosis may be an independent risk factor for adverse outcomes in IR and diabetic patients. As a result, a critical need exists to develop a non-invasive tool to identify and treat the highest-risk patients. Early detection of cardiac fibrosis and other CMR- detectable abnormalities in IR patients may help to 'stage' a patient's disease process and future risk of events, ultimately leading to an adjustment in the aggressiveness of their medical management and long-term monitoring accordingly. This project is aimed at reducing the mortality and morbidity associated with insulin resistance and diabetes, and the investigators believe this project could have a transformative impact on long-term diabetic care and shed new light upon the biology of diffuse cardiac fibrosis in insulin resistance and diabetes and its role in shaping the long-term cardiovascular risk for these patients.

Eligibility Criteria:
Inclusion Criteria:

- South Asian

Exclusion Criteria:

* Pregnant women
* Patients with prior diagnoses of diabetes
* Patients on insulin therapy
* Patients with known coronary heart disease or other non-ischemic cardiomyopathies