cyrilzakka/clinical-trials huggingface dataset:
Implementing Technology-Assisted Drug Treatment and Relapse Prevention in Federally Qualified Health Centers (FQHCs)

Implementing a mobile-phone based system for drug use disorders in primary care settings.

The purpose of the research is to study the impact of a recovery support system called Seva on primary care organizations, where issues such as coordination of care, job satisfaction, and the cost of adopting and operating new technologies are critical. The study will also investigate how to best implement this kind of technology into health care delivery systems that care for people diagnosed with substance abuse.

Eligibility Criteria:
Inclusion Criteria:

Patient subjects must be 1) age 18 or older 2) meet criteria for Substance Use Disorder (SUD) according to the clinic. Clinician subjects referring patients will ensure that patients: 3) have no current psychotic disorder severe enough to prevent participation, 4) have no acute medical problem requiring immediate inpatient treatment, 5) are willing to use Seva, and 6) can understand and sign a consent form in English.

Clinician subjects include MDs, behavioral health providers, nurses and management staff from the clinics' primary care and behavioral health departments. Clinician must have an interest in the research objectives.

Exclusion Criteria:

* Failure to meet inclusion criteria above will exclude patients and clinicians from participating.
A Feasibility Study of a Support Program for Building New Parent-child Behavioral Habits

This study evaluates the feasibility and preliminary impacts of a new parent support program consisting of a series of educational videos, delivered via a popular texting platform. For this pilot project, the program content is focused on teaching parents strategies to better manage one of the commonly reported challenges children face, a transition to a non-preferred activity. Parents with children demonstrating inattentive, hyperactive and impulsive behavior and experiencing difficulties with daily transition routines are invited to participate in the study.

This pilot study employs a pre-post, open trial design with the primary aim to investigate the feasibility of delivering parenting educational materials in an accessible format, i.e., a widely used testing platform. The training videos demonstrate the applications of antecedent- and reinforcement-based behavior management techniques in a specific situation and encourage parents to build positive parenting habits. The program usability and satisfaction will be assessed through participant ratings. The study targets parents of children demonstrating inattention, hyperactive, and impulsive behavior. These families frequently experience difficulties managing everyday routines at home, yet the access to psychosocial treatment is limited. The investigators expect parents to engage well in the program delivered via digital media. Based on the existing literature on the effectiveness of behavior parent training delivered in traditional in-person format, a moderate effect size is expected in the pre-post measures of parenting practices and the child target behavior for this study.

Eligibility Criteria:
Inclusion Criteria:

Parents with children aged 4-10, who experience difficulties with transitions. The program will be advertised that it was developed targeting children demonstrating behaviors consistent with ADHD, and the ADHD symptoms will be measured pre-post. However, children are not required to have a diagnosis of ADHD or show elevated levels of ADHD symptoms for the parents to sign up.

Exclusion Criteria:

Parents who do not understand Japanese (the language the program is offered in).
Continuos Subcutaneous Insulin Infusion in Italy

This is an observational, multicenter, cross sectional study, collecting clinical and metabolic informations about patients treated with CSII in Italy.

The aim of the study is to collect clinical and metabolic characteristics of patient treated with CSII in Italy.

Data will be collected through a questionnaire sent by e-mail to CSII experienced Diabetes Centers ( both adult and pediatric patients) . The questionnaire assessed: (1) number of CSII-treated patients; (2) patients and pump characteristics; (3) structure and organization of Diabetes Centers providing CSII therapy; (4) metabolic control.

Eligibility Criteria:
Inclusion Criteria:

* all patients treated with CSIIin Italy

Exclusion Criteria:

* none
Coca-Cola Zero (®) Consumption on Night-call Inpatient Course and Mortality

The purpose of this study is to determine the effect of coke zero consumption by night-call staffs on inpatient admission and mortality, and total sleep duration during the night-call duty. Coke Zero is a soft drink that is widely popular within the medical community, carrying the meaning of "zero", which to some, signifies the minimal level of morbidity and mortality that will occupy the on-call the night staffs.

Previous studies have demonstrated that superstitions among the medical community have been prevalent and staffs regularly engaged in conforming to the superstitions because of their associations with workload, inpatient admissions and mortality. As such, the current study aims to evaluate whether the consumption of Coke Zero has an effects on patient admissions and mortality and the eventfulness of the night-call duties.

Eligibility Criteria:
Inclusion Criteria:

• Doctors on the night-call roster at Singapore General Hospital

Exclusion Criteria

• Other allied health professionals or medical students
IgA Nephropathy, Lymphocyte Homing and IgA Class Switch

IgA nephropathy (IgAN) is the most common primary glomerulonephritis in the world and it represents an important cause of end-stage kidney failure. This disease was described as a distinct entity in 1968 by J Berger and N Hinglais. The aetiology and the pathogenesis remain still obscure. Clinical observations and immunisation studies indicate that IgAN represents a dysregulation of the immune system, rather than an intrinsic renal abnormality. Twenty years ago, some authors proposed the mucosa-bone marrow axis to explain the pathogenesis of the disease. Mucosal IgA plasmocytes are displaced and take up residence in systemic sites. The unusual characteristics featured by the IgA produced by these cells (charge, size, glycosylation) drive their accumulation, deposition and mesangial activation characteristic of IgAN.

Evidence is emerging that altered lymphocyte homing may ultimately explain this aberrant localization.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 and \< 70 years
* IgA nephropathy documented by the kidney biopsy in the six months preceding the inclusion
* Glomerular filtration rate (MDRD formula as simplified) \< 90 ml/mn and \> 30 ml/mn/1,73 m2
* Consent form signed

Exclusion Criteria:

* Patients with cirrhosis or chronic liver disease
* Patients with a history of Crohn's disease or celiac disease
* Patients who received treatment with corticosteroids or affiliates for six months
* Patients who received a live attenuated vaccine during the past 4 weeks
* Patients with a known infection such as HIV, hepatitis B or C
* Patients who presented with a serious infection during the last month
* Breastfeeding women
* Patients not affiliated with a social security scheme
* Under guardianship patient
Pilot Study of Strength and Balance Training Program for Persons With Oxaliplatin Induced Neuropathy

The purpose of this study is to evaluate the effects on strength, balance, and neuropathic symptoms (numbness, tingling, pain, weakness) of a 12 week, bi-weekly, 60 minute, group exercise program designed to improve lower extremity strength and balance with persons with oxaliplatin induced peripheral neuropathy.


Eligibility Criteria:
Inclusion Criteria:

* Prior history of colon cancer
* Completed oxaliplatin based chemotherapy at least 6 months prior to enrollment
* Report numbness, tingling, or pain of the lower extremities ≥ 4 by chemotherapy induced peripheral neuropathy (CIPN) Visual Analog Rating
* Karnofsky performance status of at least 60%
* Able to read, write, and understand English

Exclusion Criteria:

* Patients will be excluded from the study if they live outside of a 30 mile radius of the University of South Florida, if they are currently undergoing chemotherapy or radiation therapy, or if they regularly (at least once a week) participate in strength or balance training exercises. The investigators will not exclude participants if they are participating in aerobic exercise, but we will collect that information so that the investigators may control for aerobic exercise in our data analysis.
A Study to Investigate the Effect of JNJ-67953964 on Gastric Mucosal Integrity in Healthy Male and Female Participants

The main purpose of the study is to investigate the upper gastro-intestinal (GI)-related safety and tolerability in healthy participants by gastroscopy and gastric biopsies after treatment with 25 milligram (mg) JNJ-67953964 once daily (QD) over 4 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index (BMI) between 18 and 30 kilograms per meter square (kg/m\^2). Minimum body weight should be 50 kilogram (kg)
* Healthy on the basis of clinical laboratory tests performed at screening. If the results of the serum chemistry panel, hematology, or urinalysis are outside the normal reference ranges, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant or to be appropriate and reasonable for the population under study. This determination must be recorded in the participant's source documents and initialed by the investigator
* Non-smokers (not smoked for 3 months prior to screening)
* A woman of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test before the first dose
* A male participant must wear a condom when engaging in any activity that allows for passage of ejaculate to another person until 90 days after receiving the last dose of study intervention

Exclusion Criteria:

* History of malignancy within 5 years before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy, which is considered cured with minimal risk of recurrence)
* History of any gastric surgery, documented gastric disease (including peptic ulcer disease, gastritis, achlorhydria, upper gastro-intestinal (GI) bleeding, esophagitis, or any GI precancerous condition), current clinically evident GI complaints including functional gastrointestinal disorders (FGID)
* Is positive for helicobacter (H.) pylori antigen in a stool test at screening
* Is diagnosed to have any gastric disease (macroscopic) as visually assessed by gastroscopy at screening
* History of human immunodeficiency virus (HIV) antibody positive, or tests positive for HIV at screening
Comparing Safety and Efficacy of Combigan® and Lumigan® With Lumigan® Alone in Glaucoma or Ocular Hypertension Subjects Treated With Xalatan®

Comparing Safety and Efficacy of Combigan® and Lumigan® with Lumigan® Alone in Glaucoma or Ocular Hypertension Subjects Treated with Xalatan®.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with glaucoma or ocular hypertension.
* Visual Acuity 20/100 or better in both eyes

Exclusion Criteria:

* Any active ocular disease
* History of any intraocular surgery or glaucoma laser surgery within 3 months
* Contraindication to pupil dilation
* Use of topical, periorbital, intravitreal, or systemic steroid within 3 months
Heart to Heart: Testing a Sexual Health Training for Foster and Kinship Caregivers

Heart to Heart is a brief pregnancy prevention training program delivered to foster and kinship caregivers to prevent unintended pregnancy in foster youth. The training delivers easy to understand information on sexual health, contraception, and adolescent development. It also includes a brief behavioral training, and information on effective communication, monitoring strategies, and social support. The curriculum was piloted in Los Angeles. Investigators will test the intervention in a randomized control trial.

Dr. Ahrens and her team will evaluate the effectiveness of this training using a randomized stepped wedge study design with a target enrollment of 100 foster and kinship caregivers. Recruitment will be carried out in collaboration with the Los Angeles Department of Child and Family Services, foster family agencies and support groups. After completing a baseline survey, participants will be randomly assigned to either the intervention group or the waitlist control group. (With a target 1:1 ratio of controls to intervention subjects, but in consideration of greater levels of attrition in the waitlist control group due to the 6-month wait before being offered the training, participants will be randomized in a ratio of 4:3 to control vs intervention group). The intervention group will receive the training soon after enrollment, and will then complete 3 follow-up surveys over the following 6 months. Participants assigned to the waitlist control group will first complete 3 surveys over 6 months, receive the intervention at the 6 month mark, then take 3 follow-up surveys over the following 6-month period. Dr. Ahrens and team will use these survey data to measure the effectiveness of the training based on the outcome measures. Participants will be surveyed at multiple timepoints both because the different outcomes are expected to occur within different time intervals (e.g. knowledge may change right away, while behaviors will take longer), and to assess whether these outcomes change over time (e.g. whether knowledge gained in the training is lasting).

Eligibility Criteria:
Inclusion Criteria:

* Is a foster or kinship caregiver in Los Angeles County.
* Has a youth age 11-21 who has lived with them for at least 3 months in the past year.
* Anticipates that at least one youth age 11-21 will continue to live with them for the next 12 months.
* Is available for either training group (immediate or in 6 months).

Exclusion Criteria:

* Does not anticipate youth will stay in their home for 12 months
* Does not have a youth age 11-21 in their home
* Cannot commit to being randomized to either training group.
Dose-Escalating Multiple Dose Study of PD-0360324 in Combination With Methotrexate in Patients With Rheumatoid Arthritis

This study is designed to evaluate the safety and tolerability of multiple intravenously administered doses of PD 0360324 in patients with rheumatoid arthritis receiving methotrexate.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of RA for at least 6 months based upon the American College of Rheumatology (ACR) 1987 Revised Criteria.
* Must have been treated with methotrexate (≥7.5 mg/week to ≤25 mg/week) for at least 16 weeks immediately prior to enrollment. The dose of methotrexate must be stable for at least 6 weeks prior to enrollment.
* Females of childbearing potential are required to simultaneously use 2 effective contraceptive methods, 1 of which must be a barrier (condoms, diaphragm or cervical cap) with spermicide. Non-vasectomized men must be willing to abstain from sexual intercourse or willing to use a condom in addition to having their female partner use another form of contraception, if the woman could become pregnant from the time of the first dose of study medication until completion of follow up procedures
* Contact your local site for more inclusion criteria.

Exclusion Criteria:

* Diagnosis of any other inflammatory arthritis (eg, spondyloarthropathies); or a non-inflammatory arthritis or musculoskeletal condition (eg, osteoarthritis, fibromyalgia) that, in the investigator's opinion, may interfere with clinical assessments.
* Evidence of active or latent infection with Mycobacterium tuberculosis (TB).
* Use of etanercept, anakinra, or oral DMARDs with the exception of methotrexate, within the 4 weeks prior to enrollment. Use of biological DMARDs within the 8 (adalimumab or infliximab) or 12 (abatacept) or 56 (rituximab) weeks prior to enrollment. Use of oral corticosteroids, acetaminophen, NSAIDs, and opioids are permitted within the dose ranges defined in the protocol.
* Contact your local site for more inclusion criteria.
The Effect of Three Different Fluids(Albumin 5%, Normal Saline, Hydroxyethyl Starch 130 kD) on Microcirculation in Severe Sepsis/Septic Shock Patients

Major microvascular blood flow alterations have been documented in patients with severe sepsis. It was also demonstrated that the microcirculation improved in survivors of septic shock but failed to do so in patients dying from acute circulatory failure or with multiple organ failure after shock resolution. Early, effective fluid resuscitation is a key component in the management of patients with severe sepsis and septic shock with the goal of improving tissue perfusion. The best fluid in this early resuscitation phase has been and still is under debate. The aim of this study is to evaluate the effect of Three different Fluids(Albumin 5%, Normal Saline, HES 130 kD) on microcirculation in severe sepsis/septic shock patients using Sidestream Dark Field (SDF) Microscopy and Near-Infrared Spectroscopy (NIRS) analysis.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients will be enrolled within 24 hrs of onset of severe sepsis/septic shock with an indication for fluid bolus administration.

Exclusion Criteria:

* Liver cirrhosis
* shock from other causes
* Oral injuries (precluding SDF imaging)
* Severe peripheral vascular disease, dialysis fistula, or mastectomies precluding safe forearm occlusion
* Age \< 18 years
An Observational Study to Evaluate Neoadjuvant Nivolumab (OPDIVO®) in Combination With Platinum-Based Chemotherapy in Non-Metastatic Non-Small Cell Lung Cancer Participants in Germany

The purpose of this observational study is to collect and evaluate real-world data to assess the effectiveness of neoadjuvant nivolumab when given in combination with platinum-based chemotherapy in participants with early-stage, resectable non-small cell lung cancer (NSCLC) in Germany


Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years or older
* Diagnosis of non-metastatic non-small cell lung cancer with tumor Programmed death-ligand 1 (PD-L1) expression level of 1% or more (tumor proportion score (TPS); according to label approved in the European Union)
* Decision to initiate a neoadjuvant treatment with nivolumab plus platinum-based chemotherapy for treatment of non-small cell lung cancer according to current Summary of product characteristics and independent of the study
* Willing to complete patient-reported outcome questionnaires and sufficient understanding of the German language
* Signed written informed consent
* Other criteria according to current Summary of product characteristics

Exclusion Criteria:

* Current primary diagnosis of cancer other than non-small cell lung cancer that requires systemic or other treatment
* Other contraindications according to current Summary of product characteristics
The Effect of Human Placental Explants and Pregnant Women Sera on Cancer Cells

Maternal malignancy during pregnancy is estimated to occur in 1 out of 1000 pregnancies. Controversy exists regarding the effect of pregnancy on cancer prognosis. Gestational hormones and pregnancy-related growth factors may induce a more aggressive behavior in malignant cells. However, metastasis to the products of conception is rare. In the current study investigators wish to analyze the effect of placental explants on cancer cells (cervical, ovarian, thyroid, melanoma, lymphoma, leukemia and breast)phenotype (cell death, proliferation, migration , invasion), signaling pathway, mRNA, miRNA and protein expression.

In the Oncogenetic laboratory cancer cells will be exposed to first trimester human placental explants or to serum collected from pregnant women. As a control cancer cells will be cultured alone or in the presence of sera collected from young (18-45) non pregnant women.

Placentae, 6-9 weeks gestational age, will be retrieved from terminated normal pregnancies. The placenta will be taken after pregnancy termination, thus, no harm will be caused for the women.

The sera will be collected from the women by an authorized physician. It will be taken from: 1. the vein of the non pregnant women and volunteered pregnant women. 2. from the same branula that will be introduced into the pregnant women as a routine during pregnancy termination procedure.

Following culture investigators will analyze the cancer cells phenotype (cell death, proliferation, migration, and invasion), signaling pathway, mRNA, miRNA and protein expression.

Sera will be collected from 50 pregnant women and 50 non pregnant women. Placentae will be collected from 50 pregnant women.

Eligibility Criteria:
Inclusion Criteria:

* Healthy women
* Age 18-45.
* Pregnant (6-9 weeks) and non pregnant women.

Exclusion Criteria:

• Placentae that were destroyed during pregnancy termination.
Evaluating a Strategy to Improve Pre-Anesthesia Care Discussions (My Anesthesia Choice-Hip Fracture)

The objective of this study is to assess the implementation process for and the effectiveness of a quality improvement (QI) strategy to increase shared decision-making around anesthesia options for hip fracture surgery at 6 US hospitals. The QI strategy is to be facilitated by a clinician-administered 1-page bedside conversation aid designed to improve the quality of physician-patient communication, paired with brief clinician training. The evaluation will occur via a stepped wedge, cluster randomized trial to be carried out over a period of 27 months.

The objective of this study is to assess the implementation process for and the effectiveness of a quality improvement (QI) strategy to increase shared decision-making around anesthesia options for hip fracture surgery at 6 US hospitals. The QI strategy is to be facilitated by a clinician-administered 1-page bedside conversation aid designed to improve the quality of physician-patient communication, paired with brief clinician training. The evaluation will occur via a stepped wedge, cluster randomized trial to be carried out over a period of 27 months.

Activities at each site will be divided into three phases: Pre-Implementation; Active Implementation; and Sustainment. Data collection will occur across all study phases at each site, although specific data elements collected will vary across phases. To facilitate evaluation, sites will be randomly assigned to one of three possible timing sequences (A, B, C) for project implementation (2 sites/sequence). The duration of the active implementation phase will be the same for each sequence (12 months); however, the duration of pre-implementation and sustainment phases will vary across sequences.

During the pre-implementation phase, data collection on selected outcome variables will occur but no interventions will be delivered. During the implementation phase, site clinicians will undergo training in use of the My Anesthesia Choice-HF tool and the tool will be made available for use in clinical areas with eligible patients. Data collection on key outcomes will continue over this period, and clinicians will receive reminders to encourage tool use. During Sustainment, the tool will remain available for use and outcomes will continue to be measured to assess sustainment of the intervention over time.

Eligibility Criteria:
Inclusion:

Age 50 and older Planned surgery to treat a hip fracture

Exclusion:

Contraindication to spinal anesthesia: current anticoagulant therapy or coagulopathy Contraindication to spinal anesthesia: critical aortic stenosis Contraindication to spinal anesthesia: skin infection over the lumbar spine