cyrilzakka/clinical-trials huggingface dataset:
Fetal Alcohol Syndrome/ARND Research Consortion

Children will receive comprehensive evaluations through the UOHSC ABC program The assessment for the child will include: medical issues (including medication), dysmorphic examination, intellectual assessment, academic achievement, language, and motor skills. This program will provide appropriate non-study services and referrals. Eligible families will be randomly assigned to treatment group or control group. Treatment group will receive Parent Child Interaction Therapy (PCIT). The Control group will receive standard referrals and services through the ABC program and the parent education/advocacy component of the project.

PCIT has been adapted by the applicant for group administration. The intervention will consist of 90-minute sessions of PCIT once a week for 14 weeks. During PCIT sessions parents and children will participate in activities that promote interactions. A behavior specialist who will be observing through a two-way mirror assists parents in development of appropriate behaviors and interaction techniques. Parents will be prompted by use of in-ear devices (i.e., bug in the ear). This intervention has been shown to be effective in other populations. For each family, individualized goals for parent-child interactions will be set and reviewed each session. Homework assignments also will be given.

Parent Component: Three 90-minute sessions conducted in a group format. Topics will include: FAS/ARND education, impact of FAS/ARND on families, specific development of a child with FAS/ARND, and FAS/ARND social skills and deficits.

Evaluation Plan: Treatment and control groups will be compared using pre- and post-tests measures. Post-tests will be at the conclusion of the intervention and at a 6, 12, and 18-month follow-ups. Process (e.g., parent satisfaction, compliance, etc) and outcome (e.g., behavior, family functioning, etc) measures will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Children ages 3 to 7 years
Comparison of Two High Performance Guidewires in ERCP

In ERCP guidewires are used for the insertion of endoprostheses and the cannulation of stenosis. This leads to two essential requirements for the wire systems: The use of a (highly) flexible, hydrophilic wire to achieve successful and rapid passage of the narrow passage; for additional intervention, modern wires are equipped with a stable shaft with which e.g. bougies, dilatation catheters, or stents can be introduced. Guidewires are available with angled or straight tips whose use differ regionally. Guidewires with angled tips are used predominantly in Japan, whereas in the Western world incl. Germany straight wires are commonly used. In a recently published study examining the intubation of the native papilla, successful intubation of the papilla was faster with guidewires with angled tips than with guidewires with straight tips. However, this did not result in an effect upon the time-independent rate of the successful papilla intubation.

The investigators test the hypothesis that 1) a higher success rate of the ERCP can be achieved with the use of an angled guidewire than with a straight guidewire and 2) a higher success rate of the ERCP can be achieved with the use of a type 1 guidewire than with a type 2 guidewire

This is a randomized, multicentric study.

Eligibility Criteria:
Inclusion Criteria:

* Obstruction of the biliary tract (cross sectional imaging or ultrasonography/lab data

Exclusion Criteria:

* Operatively alternated anatomy of the patient
A Study to Evaluate the Consistency of Oscillometry and Spirometry Test Results in Patients With Confirmed or Suspected Asthma or COPD

The study to evaluate the consistency of oscillometry and spirometry test results in patients with confirmed or suspected asthma or COPD, it is a multi-centre clinical study. sponsor by Astrazeneca Investment(China) Co.,LTD.

800 patients, including suspected or confirmed asthma, suspected or confirmed COPD, will be enrolled in nationwide multiple study centres. Enrolling suspected and confirmed subject in an approximate1:1 rate in centre-level. About 100 subjects were enrolled at the leader site, while about 14 subjects were enrolled at other sites.

To evaluate the consistency of oscillometry and spirometry test results in patients with confirmed or suspected asthma or COPD.

Eligibility Criteria:
Inclusion Criteria:

Participants are eligible to be included in the study only if all of the following criteria apply and signed informed content :

Suspected and confirmed asthma

1. Participant must be≥18 years old.
2. Present symptom such as wheezing, cough, chest tightness, shortness of breath, but not confirmed-asthma (without evidence of variable airflow restriction) or confirmed-asthma with evidence of variable airflow restriction (such as positive bronchodilation test, positive bronchial challenge test, variability \>10% in twice daily PEF over 2 weeks, et al) Suspected and confirmed COPD

1 Participant must be ≥40 years old. 2 Present symptom such as chronic cough, sputum production, dyspnoea, but not confirmed-COPD (without evidence of persistent airflow restriction) or confirmed- COPD with evidence of persistent airflow restriction (post-bronchodilator FEV1/FVC\<0.7)

Exclusion Criteria:

Participants are excluded from the study if any of the following criteria apply:

1. Any diseases that influence lung function result such as lung cancer, pneumonia, active pulmonary tuberculosis, pulmonary embolism and interstitial lung disease, etc; history of recent surgery that affect lung function results, including thoracotomy surgery, pneumothorax surgery, thoracic drainage, etc
2. Contraindication to spirometry or oscillometry test, or allergic to bronchodilator.
3. Currently pregnant or breast-feeding women
4. Judge by the investigator if the participant is unlikely to comply with study procedures, restrictions, and requirements, will not be enrolled .
Adaptation of Work in a Hospital and Assessment of Feelings of Quality of Life at Work, Teleworking and Face-to-face

The ADAPTAWORK_2 study is a follow-up to the first qualitative study, to evaluate the feelings of hospital workers in all occupations about teleworking. This involves measuring the variation between three periods: before the COVID-19 pandemic, during the first lockdown an after the pandemic.

Secondary objectives were: 1) to evaluate wich factors were associated to the feelings towards teleworking, 2) to assess musculo-squeletal disorders among teleworkers and the other participants, 3) to assess psycho-social risks among teleworkers and the oher participants, and 4) to evaluate teleworking costs

This is a quantitative study carried out at the Clermont-Ferrand University Hospital and in the Hospital Centers of the Homogenous Territorial Group (HTG). The target population was made up of all hospital workers in these establishments who agreed to participate and complete the online questionnaire, regardless of their function or grade in the work establishment.

Eligibility Criteria:
Inclusion Criteria:

* all hospital workers in the University Hospital Centre of Clermont-Ferrand, and the hospitals belonging to the same HTG who agreed to participate and complete the questionnaire, regardless of their function or grade in the work establishment

Exclusion Criteria:

N/A
Clinical Evaluation of 3D Printed Versus CAD/CAM Milled Onlays

The digital workflow in dentistry has proven in the past decades to be a time-efficient, multifunctional, effortless, and accessible approach. The inherited shortages milling machines represented by the incapability to produce accurate complex hollow structures may give preference to modern 3D ceramic printing.

Computer-aided-design/computer-aided-manufacturing (CAD/CAM) in dentistry is a digital subtractive approach for manufacturing indirect restorations. Nevertheless, waste materials and milling burs wearing are considered as key disadvantages of CAD/CAM technology, and are the main drive to improve 3D printing technology (additive manufacturing) as the latter has shown considerable efficiency in minimising wasted materials.

Although additive manufacturing has been known since the 1980s, its application in dentistry is relatively new and not fully studied with limited research and in vivo studies on their clinical performance.


Eligibility Criteria:
Inclusion Criteria:

Age: 25-45 years.

* Males or females.
* Participants with carious vital ower molars indicated for onlay (one or two missing cusps)
* Patients with at least 20 teeth under occlusion.
* Good oral hygiene.
* Co-operative patients approving to participate in the trial.
* Have sufficient cognitive ability to understand consent procedures.

Exclusion Criteria:

* Participants with parafunctional habits or bruxism.
* Participants with systemic diseases or disabilities that may affect participation.
* Heavy smoking.
* Pregnancy.
* Lack of compliance.
* Severe or active periodontal disease.
* Cognitive impairment.
Wolman/CESD Natural History Chart Review and Longitudinal Follow-Up

The purpose of this study are: to characterize and understand the natural history of disease progression in WD and CESD, and to provide historical controls for WD and CESD for developing clinical treatment trials. The hypothesis is that the variability and clinical progression in WD and CESD is large and represents a continuum of severities from a lethal infantile to near normal adults with only "fatty livers".

This is a single institution historical cohort study of patients with Wolman (WD) or Cholesteryl Ester Storage Disease (CESD). Retrospective data will be collected and abstracted from the medical records of both living and deceased patients. Additionally prospective data from living patients will be collected and abstracted annually until the end of the study. Literature sources will be used as secondary source data and will be screened to minimize/eliminate duplicative reports.

Eligibility Criteria:
Inclusion Criteria:

* male or female of any age;
* a clinical diagnosis of WD or CESD as defined by:

  * documented LAL enzyme deficiency OR
  * LAL gene mutations OR
  * a clinical course and tissue biopsy consistent with CESD or WD;
* written informed consent
Chamas for Change Validation

This team has shown that chamas can be tailored to increase the uptake of health services in pregnancy and infancy, sustain themselves beyond the period of funding and become integrated within a county's health strategy. However, further investment is warranted to validate this intervention in a new region to ensure the positive effects on MNCH are a result of chamas and can be replicated. The purpose of this study is to demonstrate that chamas are an effective service-delivery platform for improving women's and children's health and well-being in western Kenya.

The objectives are:

To test the effectiveness of chamas as an intervention on improving:

* Health services uptake (Facility delivery, attendance of 4 or more ANC visits, Visit by a CHV within 48 hours of birth, immunization uptake at 6 months-of-age, long-term FP uptake)
* Health behaviors and care practices (exclusive breastfeeding to 6 months)
* Women's Empowerment, peer support, parental stress, and harsh punishmennt within the home
* Maternal and infant morbidity (low birth weight, diarrhea in the last month, preterm deliveries)
* Maternal, perinatal, neonatal and infant mortality

To perform a qualitative evaluation to better understand women's and CHV's experience with chamas and understand how chamas affect peer support

To perform a process evaluation

To perform a cost effectiveness analysis on chamas.

The investigators plan to use a cluster randomized controlled design because the intervention is delivered in groups that are based within Community Units (CUs). We know that some of the positive effects of chamas expand to the community surrounding the chama. By randomizing clusters, we will hope to isolate these communities in order to understand the individual effects of chamas. The unit of randomization and implementation will be Community Units (CU). Because there are only 77 of the 163 CUs with active Community Health Workers trained by AMPATH, we will draw our intervention and control groups from these active units. By doing this, the control group is receiving the standard of care per the MOH and AMPATH community strategy. We will randomly assign each of the 77 active CUs in the four sub-counties to the chama intervention (arm 1) or to act as a control region (arm 2). We will evaluate individual outcomes on women enrolled in the study. The CUs that do not participate in the study will serve as buffer areas.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women \< 28 weeks, and their newborn infants following birth

Exclusion Criteria:

-
Heart Math Resilience Program on Jail Staff

The study is a multiple cohort, staggered-entry, waitlist randomized controlled trial evaluating the effectiveness of a comprehensive resiliency-based program in reducing stress for correctional officers employed by the Leon County Sheriff's Office in Tallahassee, FL.

The primary objective of the study is to implement and evaluate the effectiveness of a comprehensive resiliency-based intervention, HeartMath, designed to reduce stress for correctional officers (COs) currently employed with the Leon County Sherriff's Office in Tallahassee, Florida. The study will also examine whether the intervention 1) improves perceptions of job satisfaction, workplace safety, and occupational stress; 2) improves CO retention and decreases absenteeism; 3) results in less punitive attitudes and greater apprehension to employ use of force.

Eligibility Criteria:
Inclusion Criteria:

* Leon County Sheriff's Office jail correctional officers.
* Attending a defensive tactics training by Leon County Sheriff's Office
* Age 18 years or older
* Conversational English
* Being willing and cognitively able to provide consent.

Exclusion Criteria:

* Not meeting Inclusion Criteria
HealthCall:Brief Intervention to Reduce Non-injecting Drug Use in HIV Primary Care Clinics

Among HIV-infected individuals, non-injection drug use (NIDU) is associated with poor HIV medication adherence, greater HIV/AIDS risk behaviors, and increasing non-AIDS mortality. Thus reducing NIDU among HIV infected individuals is critical to their survival and to limiting the spread of HIV. We propose to study the efficacy of a technologically enhanced brief intervention (HealthCall) to reduce NIDU in HIV primary care patients that demands little from busy medical staff and is well accepted by patients. In a 3-arm randomized clinical trial will test the efficacy of (a) Motivational Interviewing (MI)+HealthCall; (b) MI-only; and (c) a control condition (advice + DVD HIV health education) in reducing NIDU.


Eligibility Criteria:
Inclusion Criteria:

* All research volunteers will be 18 and older and HIV positive. We will include participants whose primary drug is non-injection use of cocaine, opioids including heroin, or methamphetamines and current use in the past 30 days \> 4 days. Participants will need to complete a medically supervised detoxification if such detoxification is required.

Exclusion Criteria:

* Excluded are research volunteers for whom participation would not be clinically appropriate, who clearly could not participate. Psychotic, suicidal or homicidal patients require clinical management that is too intensive for this study, and we have no evidence that MI+HealthCall would be effective among injection drug users. Leaving New York precludes follow-up. Gross psychomotor/cognitive impairments that may hinder patients' HealthCall use. Hearing and severe vision impairments that preclude telephone use precludes randomization to MI+HealthCall.
Study to Determine the Safety, Maximum Tolerated Dose, Pharmacokinetics of Sorafenib (BAY43-9006)

The primary objective of the study was to define the safety profile and maximum tolerated dose (MTD) of sorafenib tablets in combination with carboplatin and paclitaxel chemotherapy in patients with advanced, refractory solid tumors.

The secondary objectives were evaluation of pharmacokinetics (PK) and tumor response of these patients being treated with sorafenib in combination with paclitaxel and carboplatin.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed solid tumors
* Evaluable disease
* Eastern Cooperative Oncology Group (ECOG) 0 or 1
* Life expectancy minimum 12 weeks

Exclusion Criteria:

* Congestive heart failure
* Serious arrhythmias
* Coronary artery disease (CAD) or ischemia
* HIV (human immunodeficiency virus)
* Hepatitis B or C
* Serious active infection
* Metastatic brain or meningeal tumors
Growth of Infants Fed Hydrolysate Formulas

Effects on weight and weight gain will be monitored in healthy term infants fed assigned infant formulas.


Eligibility Criteria:
Inclusion Criteria:

* Infants in good health.
* Singleton, term birth with a gestational age of 37 to 42 weeks.
* Birth weight of 2500 g (5 lb 8 oz) or greater.
* Between 0 and 9 days of age at enrollment.
* Not receiving vitamin or mineral supplements.

Exclusion Criteria:

- Maternal, fetal or perinatal medical history with potential for adverse effects on growth or development.
Coping Intervention After Embryo Transfer

Background of the study:

Undergoing an IVF or ICSI treatment is an emotional and physical burden for both the woman and her partner. Most stressful for the couple is waiting for the result of the treatment, the period after the embryotransfer until the pregnancy test or menstruation and an unsuccessful treatment. Symptoms of anxiety and depression have been identified in couples during the waitingperiod after an embryotransfer. For this waitingperiod a short selfhelp copingintervention has been developed based on the stress theory of Lazarus for women to use at home. Goal of the instrument is to stimulate the copingstyle positive reappraisal. Research has demonstrated that using this copingstyle can have a positive impact in health related circumstances.

Objective of the study:

To investigate if a short copingintervention reduces anxiety in patients undergoing an IVF or ICSI treatment in the UMCU during the waitingperiod after an embryotransfer.

Study design:

In this research a randomised controlled trial (RCT) will be used for three groups. The choice for three groups has been based on earlier research with a daily record keeping (DRK). The DRK is a daily measurement for emotions, copingstyle and physical complaints. Previous research with the DRK showed an increase of anxiety. More research must be done of the impact of the DRK. Group 1: Positive Reappraisal Coping Intervention (PRCI) \& DRK \& questionnaires Group 2: DRK \& questionnaires Group 3: Standard care \& questionnaires

Study population:

Patients undergoing an IVF or ICSI treatment in the UMCU.

Intervention (if applicable):

A selfhelp coping intervention

Primary study parameters/outcome of the study:

Anxiety

Secondary study parameters/outcome of the study (if applicable):

Risk of emotional problems copingstyle depression vital pregnancy quality of life

Nature and extent of the burden and risks associated with participation, benefit and group relatedness (if applicable):

Using the coping intervention may reduce anxiety for the patient. The use of this instrument is not a burden for patients. The burden for patients is to complete questionnaires before, during and six weeks after the embryotransfer. Partners are asked to fill in a questionnaire at three times.

Eligibility Criteria:
Inclusion Criteria:

* Patient in IVF/ICSI treatment

Exclusion Criteria:

* Patient who do not speak the dutch language
A Study to Evaluate Efficacy and Safety of GW117 Tablets in Major Depressive Disorder

The study aims to evaluate the efficacy and safety of GW117 Tablets compared to placebo in adults participants with MDD over a period of 8 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Outpatients aged 18 to 65 years (including both limits), either male or female;
* Meet the diagnostic criteria for depression in DSM-5 (the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders), without psychotic symptoms;
* Have a total score of ≥ 22 on the 17-item Hamilton Depression Rating Scale (HAM-D17) at both screening and baseline visits;
* Have a Clinical Global Impression - Severity (CGI-S) score of ≥ 4 at both screening and baseline visits;
* Voluntarily participate in this trial and sign the informed consent form, and be able to comply with the planned visits, treatment plan, laboratory tests and other research procedures.

Exclusion Criteria:

* Allergic constitution (such as those allergic to two or more drugs or foods) or known to be allergic to similar products like agomelatine;
* Have previously received adequate and full-course treatment with agomelatine but showed no effect, or treatment-resistant depression (those who have used at least two antidepressants in adequate and full-course treatment but still showed no effect);
* HAM-D17 scale score reduction rate is ≥25% compared to the baseline period;
* High suicide risk; history of suicide attempts within one year before screening; suicidal or self-harming behavior during the screening period; score of ≥3 on item 3 (suicide item) of the HAM-D17 scale;
* Diagnosed with any disease other than depression according to DSM-5, including anxiety disorders, neurodevelopmental disorders, schizophrenia spectrum and other psychotic disorders, bipolar and related disorders, obsessive-compulsive and related disorders, trauma and stress-related disorders, dissociative disorders, anorexia or bulimia nervosa, personality disorders, etc.;
* Depression secondary to other mental or physical diseases. Note: Other inclusion/exclusion criteria may apply
Prospective Evaluation of Cast Bivalving for Pediatric Distal Radius Fractures

Pediatric patients with distal radius fractures are most commonly treated non-operatively with fracture reduction and cast immobilization. In order to prevent complications from increased swelling after the injury (or fracture manipulation) casts may be split along their length to relieve pressure. However, this can compromise the casts' structural integrity, predisposing fractures to loss of reduction. The goal of this study was to investigate if cast bivalving, or splitting the cast longitudinally on both sides, resulted in any immediate change to bony alignment and to assess if bivalving effected cast parameters associated with loss of reduction.

Displaced pediatric distal radius fractures are treated with fracture reduction and cast immobilization. Currently, at our institution (and many others) radiographic assessment to determine acceptable fracture alignment and cast parameters is done immediately after cast application. However, afterward casts are often split on both sides along their length, in a process known as bivalving, prophylactically treating for post-traumatic soft tissue edema. While bivalving is felt to relieve pressure from the cast, it may also diminish the structural integrity of the cast. Although it is well-established that loss of fracture alignment is most common in the first few weeks after fracture reduction there have been no studies to evaluate any immediate changes to fracture reduction or cast parameters that may occur after bivalving. Thus, the goal of this study was to assess if pediatric distal radius fracture alignment was affected by cast bivalving by obtaining post-bivalve radiographs in addition to standard post-cast radiographs.

Eligibility Criteria:
Inclusion Criteria:

* Guardian must be present
* Able/eligible to complete follow-up
* Initial injury within 72 hours
* Distal Radius fracture with or without distal ulna fracture
* Requiring non-operative management with molded cast

Exclusion Criteria:

* Open fractures
* Re-fractures
* Pathologic fractures
* Fractures associated with neurovascular injury
* Poly trauma incident
* Intubated patients or unable to verbalize symptoms of pain
* Preexisting medical history that effects musculoskeletal health