cyrilzakka/clinical-trials huggingface dataset:
Yoga-CBT Group Intervention for Adolescents With Chronic Pain and Their Caregivers

Clinical symptoms that are often found to be comorbid with pediatric chronic pain include anxiety, depression as well as increased stress, obesity, and decreased physical conditioning. Integrative therapies have been increasingly offered at children's hospitals as part of an integrated approach to treatment. Limited research exits on the efficacy of mind-body practices (e.g., yoga) utilized in conjunction with evidenced-based non-pharmacological treatments like cognitive behavioral therapy (CBT) to treat pediatric pain. Hence, this 7-week interventional pilot study was conducted to evaluate the impact of combining yoga and CBT for both pediatric patients with chronic pain and their caregivers.


Eligibility Criteria:
Inclusion Criteria:

* Established Children's Hospital of Philadelphia (CHOP) patients 14-18 years old, of any gender, race, or ethnicity
* English speaking
* Has received a diagnosis related to the primary symptom of chronic pain
* For adolescents who are less than 18 y/o, parental or guardian permission (informed consent) and adolescent assent (patient)
* Parents or legal guardians of adolescents enrolled, who speak English
* Parents or legal guardians' permission (informed consent) of their own participation

Exclusion Criteria:

* Current medical status or cognitive functioning precludes completing assessment instruments (e.g., cognitive or intellectual disability such as diagnosis of autism spectrum disorder)
* Physical limitation, handicap, or injury that would prevent participation or risk further injury or harm (e.g. physical assistance required from a device)
* Non-English speaking
* For adolescents who are less than 18 years of age, parental or guardian permission (informed consent) and/or adolescent (patient) assent declined
* Patient, who in the opinion of the investigator, may be non-compliant or unable to complete the study procedures
* Parents or legal guardians of adolescents enrolled, who do not speak English
* Parents or legal guardians' permission (informed consent) for their own participation or if the adolescent is less than 18 years of age and assent has been declined
* Parents or legal guardians, who in the opinion of the investigator, may be non-compliant or unable to complete the study procedures (If the dyad or triad includes a primary caregiver who has a developmental delay, intellectual disability, or communication challenge that prohibits completion of questionnaires or participation in study sessions)
Innovative Approaches to Tuberculosis Control

This study is designed as a cluster-randomized trial. The cluster unit is at the community level. Communities will be randomized to 1 of 2 study arms: DOTS+ACF or DOTS. Communities in the DOTS+ACF arm will receive door-to-door symptom screening of the entire population by health care workers between 2 and 4 times over a 9-month period. Those communities in the DOTS-arm will receive the current standard of care in those communities (PCF). All study communities will be receiving between 4 and 6 visits by community health workers annually as part of a program to assess and follow-up illnesses in each household. Households with ill residents will be visited more often. The intervention for this study is simply adding 3 to 5 simple questions to the current protocol. For subjects responding positively to these questions, results will be returned to the subject at their home and routine, standard of care follow-up diagnostic and treatment algorithms will be followed.

Despite free ARV drugs and free TB treatment, and an expanding DOTS program, TB rates have not diminished in this city overall (29), suggesting that DOTS alone will not be sufficient to turn the tide. Nevertheless, an elemental ACF strategy did appear to work well in this city. A prior International Collaborations in Infectious Disease Research (ICIDR), in one area of Rio de Janeiro, evaluated the use of the WHO's directly observed therapy, short course (DOTS) strategy versus an enhanced DOTS strategy (DOTS-A), which included household contact investigation as a means of identifying cases. A statistically significant reduction in incidence rates between DOTS versus DOTS-A communities was seen from 2000 to 2002 (Figure 2), suggesting that ACF strategies can be instrumental in reducing incidence rates if subjects are detected and treated. Treatment completion rates among new TB cases were not significantly different statistically in the 2 study arms, however treatment completion rates overall increased from 68% to 77% over the course of the study. Overall, the DOTS communities exhibited little change (+7%) in TB incidence over the 5-year period, while DOTS-A communities showed a combined decrease (-14%) (P\<0.05). The difference suggests that a large scale ACF campaign at a more intensive level (ie, door-to-door case finding) could have a significant impact on long-term TB incidence in a community.

Eligibility Criteria:
Inclusion Criteria:

* All residents of the study communities will be eligible to be surveyed at their homes, regardless of gender, age, or ethnicity.
Investigation of the Effectiveness of Muscle Inhibition and Space Correction Techniques of Kinesiotaping Method in Female Patients With Myofascial Pain Syndrome Related to Upper Trapezius Active Trigger Points

To investigate the effectiveness of muscle inhibition and space correction techniques of kinesiotaping (KT) method; on pain, functional status and quality of life in female patients with myofascial pain syndrome (MPS) related to upper trapezius active trigger points (TP) in comparison to control group and to determine the advantage of each technique over another.

The investigators conducted a prospective, randomized, controlled trial involving 93 female patients with MPS related to upper trapezius TPs and randomized the patients to KT treatment group with space correction technique and home exercise program (KSCT, n=20), KT treatment group with muscle inhibition technique and home exercise program (KMIT, n=24) and control group (CG, n=27) which received home exercise program only. Patients were evaluated by numerical rating scale (NRS) for their average and maximum pain intensity, Turkish version of neck disability index (NDI), and short form-36 (SF-36) scales. Statistical tests were conducted at the 0.05 significance level for all outcome measures.

Eligibility Criteria:
Inclusion Criteria:

* being female
* being aged between 18 and 45 years old
* not being in menopausal period
* having pain in upper trapezius region
* determining a taut band in examination
* having at least one active TP in this taut band
* the pain produced by palpation of this TP is the pain that the patient complains
* painfull restriction of cervical lateral flexion
* having pain score 4 or more according to NRS
* signing informed consent.

Exclusion Criteria:

* having major surgery or trauma related to the musculoskeletal system (primarily including the spine and upper extremity)
* having any operative history including the head and neck region
* having a neuromuscular disease
* having an active rheumatic disease
* having a systemic disease (diabetes, hypothyroidism, infection, malignancy...)
* having any pathology related to musculoskeletal diseases -especially including the cervical region- (cervical discopathy, cervical spondylosis, pathologies related to shoulder joint and surrounding soft tissues, scoliosis, kyphosis, limb length discrepancy, polio sequelae, developmental hip dysplasia...)
* having serious psychological problems (having score of 30 or more from Beck Depression Inventory)
* being obese (Body Mass Index≥30 kg/m2)
* having allergy to kinesiotapes
Triple P With Pediatric Residents

The objective of this study is to conduct a randomized control trial to evaluate the impact of Triple P on the clinic practice of pediatric residents and on select parent and child outcomes. This study will accomplish that overarching goal through addressing two specific aims.

Aim 1. Triple P's Effect on Pediatric Resident's Practice: test the effect of Triple P training on practice of pediatric residents in addressing and managing psychosocial problems.

Hypothesis 1: At the completion of the trial, residents assigned to the intervention group, compared to residents exposed to the control condition, will have:

1. increased skill levels,
2. increased confidence, and
3. increased satisfaction in dealing with and managing psychosocial issues

Aim 2. Triple P's Effect on Parent and Child Outcomes: test the effect of Triple P interventions on parent's feelings of self efficacy, parent's discipline strategies and on children's externalizing behavior.

Hypothesis 2: At the completion of the intervention, parents and children receiving the intervention, compared to those receiving the control condition, will have:

1. greater reduction in targeted child behavior problems,
2. greater reduction in dysfunctional parenting practices,
3. increased use of appropriate discipline and positive parenting strategies, and
4. greater confidence in parenting ability.


Eligibility Criteria:
Inclusion Criteria for Pediatric Resident:

* Assigned to a participating continuity clinic

Exclusion Criteria for Pediatric Resident:

* Not assigned to a participating continuity clinic

Inclusion Criteria for Parent:

* Parent of an eligible child.
* Speaks English

Exclusion Criteria for Parent:

* A parent of an ineligible child
* Non-English speaking

Inclusion Criteria for Child:

* Treated by a participating resident
* Between 18 months and 12 years old
* Does not have any mental health diagnosis
* Is not receiving medication or therapy from a professional

Exclusion Criteria for Child:

* Not treated by a participating resident
* Age falls outside of eligible range
* Has a mental health diagnosis
* Currently receiving medication or therapy from a professional
Intrapartum Oxytocin Administration Affects Primitive Neonatal Reflexes

The aim of this study was to assess whether administration of oxytocin intrapartum (Oxt) has any effect on Neonatal Primitive Reflexes (RNP) and if dose dependent. The secondary objective is to assess the effects on exclusive breastfeeding at 3 months

Patients and Methods Prospective case-control study performed in a tertiary hospital. Cases: mother-child dyads in which Oxt had been administered during the birth process (n = 53). Controls: mother-child dyads without Oxt (n = 45). The RNP were recorded with a camcorder in biological nurturing position. An observer blinded to the group and the dose of Oxt codified the RNP (reach/not reached). To assess the type of breastfeeding telephone call was made at 3 months old RN.

Eligibility Criteria:
Inclusion Criteria:

* Healthy singleton term infant delivered vaginally with Apgar at 5 min\> 7;
* Expressed desire to administer during pregnancy breastfeeding;
* Signed informed consent

Exclusion Criteria:

* Preterm neonate;
* Fetal chromosomal or other abnormalities diagnosed in utero to modify their adaptation to extrauterine environment;
* Hospitalization of the mother in ICU;
* Hospitalization in the following 48 hours neonate at birth;
* Wish to artificial feeding before parturition;
* Language difficulties;
* Completion of caesarean delivery
Efficacy Study of Water Drinking on PKD Progression.

This is a prospective 5-year study to compare the change in total kidney volume (TKV) before and after tolvaptan therapy, as the primary endpoint, in patients with ADPKD.

Tolvaptan was approved in Japan for the treatment of autosomal dominant polycystic kidney disease (ADPKD) in March 2014. This is a prospective 5-year study to compare the change in total kidney volume (TKV) before and after tolvaptan therapy, as the primary endpoint, in patients with ADPKD. Study results will be summarized, analyzed, and compiled into a research paper at 3 years (data cut-off, March 31, 2018) and at 5 years (data cut-off, March 31, 2020)

Eligibility Criteria:
Inclusion Criteria:

* The patients with ADPKD
* The patients who consent to the study protocol
* Estimated glomerular filtration rate (eGFR) or Creatinine Clearance greater than 50ml/min/1.73m2

Exclusion Criteria:

* Patients who might be danger to drink large amount of water such as having heart failure or past history of cerebrovascular or cardiovascular disorders.
* The patients who take habitual medication which affects the AVP action such as selective serotonin reuptake inhibitors (SSRI ), tricyclic antidepressants or diuretics.
* The patients who is considered inappropriate by physicians.
Adverse Drug Events at Emergency Department

Emergency departments (EDs) are a crucial element of the health care systems at interface between hospital and communities. The goals of the ED are to make an initial diagnosis and deliver urgent and critical care 24 hour per day and 365 days a year. Also, many Adverse Drug Events (ADEs) are not identified by emergency physicians. ADEs are injuries resulting from a drug related medical intervention. Their detection, documentation and reporting are essential for adequate medical care and knowledge of risk/benefit profiles of medication throughout their lifecycle. However, a number of studies indicate that in clinical practice the under-reporting of ADEs is a pervasive and widespread problem. The main reasons for under-reporting were difficulty in determining the cause of the ADE, lack of time, poor integration of ADE-reporting systems and uncertainty about reporting procedures. Successful treatment of ADEs depends on the ability of physicians to attribute ADEs to a medication. Some studies have reported that pharmacists but also student pharmacists were one of the best health care providers to establish medication history. Consequently, the aims of our study were to assess prevalence and characteristics of ADEs identified in an emergency department and to identify factors associated with ADEs in ED patients.

This prospective observational study is conducted at the ED of a tertiary care hospital (University hospital of Montpellier). This department supports 80 000 patients every years. Patient were not included if they were less than 18 years old, present acute psychological disturbance or they did not agree to participate at this study.

For each patient included, a pharmaceutical team conducted: medication reconciliation process to establish medication history and a structured interviews to determine self-reported adherence and self-medication. ADEs were attributed to a medication by the treating senior emergency physician: directly during patient consultation or after being alerted by the pharmaceutical team.


Eligibility Criteria:
Inclusion criteria:

- Patients aged above 18 years old, admitted to the department during the study period

Exclusion criteria:

- Patient presenting acute psychological disturbance or they did not agree to participate at this study
Alvopem® (Pemetrexed) Safety Assessment

The present study was a phase IV, post-marketing, observational study for safety evaluation of Alvopem® use in Iranian patients with non-small cell lung cancer and malignant pleural mesothelioma. No control groups were included in the study design.

The primary objective of this study was safety assessment, including the incidence of adverse events (AEs).

The present study was a phase IV, post-marketing, observational study for safety evaluation of Alvopem® use in Iranian patients with non-small cell lung cancer and malignant pleural mesothelioma.

Data was gathered in one booklet, which had 6 different periods. The patients' information assessed after each injection, every 3 weeks. These booklets were completed by designated physicians.

The primary objective of this study was safety assessment, including the incidence and intensity of AEs and serious adverse events (SAEs).

This study was single arm and the sample size of this study was 199 patients.

Eligibility Criteria:
Inclusion Criteria: Patients diagnosed with non-small cell lung cancer and malignant pleural mesothelioma under chemotherapy regimens with Alvopem® were enrolled in the study.

Exclusion Criteria: There were no exclusion criteria for this study.
An Observational Study of Cholesterol in Coronary Arteries

In April 2008, a coronary catheter based imaging system, LipiScan, was cleared by the FDA for use in detecting lipid core containing containing plaques of interest (LCP). These plaques are rich in cholesterol. The way that cholesterol and other lipids deposit with the coronary artery is unique to each patient. This study is an organized attempt to observe the LCP and the variety of ways that it presents in patients as detected by this recently approved device. This information will be used for physician training and to observe the behavior of the LCP in response to no therapy and currently approved therapies. The purpose of this project is further medical knowledge of the LCP and its treatment.


Eligibility Criteria:
Inclusion Criteria:

* Subject is at least 18 years of age.
* Subject is scheduled for elective coronary catheterization.
* LipiScan CIS, LipiScan IVUS Imaging System, or TVC Imaging System use is not contra-indicated.
* At least one chemogram from a native coronary artery is available for submission to the registry.
* Able to read, understand and sign the informed consent.

Exclusion Criteria:

* Subject is pregnant or nursing.
* Subject life expectancy is less than 2 years at time of index catheterization.
* All submitted chemograms are obtained with the LipiScan, LipiScan IVUS, or TVC(R) Imaging Catheter positioned within a coronary artery bypass graft.
* Unable to give informed consent
Study of Addiction Criteria in the Elderly

Patients over 65 years old who are exposed to alcohol or benzodiazepines will be recruited through the Fragility Assessment and Addictions Prevention Day Hospital, the Addiction Service and the Geriatric Post-Emergency Department. Toulouse University Hospital.

The investigators will study descriptively the frequency of substance use disorder and the frequency of DSM-5 criteria associated with this diagnosis in a population of elderly subjects.

The hypothesis of this research is that some of the DSM-5 criteria for substance use disorder are more appropriate than others in people over 65 years of age. This study therefore aims to describe the frequency of the DSM-5 criteria for the substance use disorder in a population over 65 years of age and to link it secondarily to the severity of the addiction.

The study is a descriptive study of a population of subjects over 65 years old. It aims to search for addiction criteria in this population by formulating the hypothesis of an addictive vulnerability relating to certain risk factors.

To sensitize the detection of criteria, we chose among older subjects those who are most at risk because they are more exposed to the vulnerability factor relative to this population (physical disability, loss of autonomy, loneliness).

Eligibility Criteria:
Inclusion Criteria:

* To be over 65
* Have given your non-oral opposition to participate in research
* Mini-Mental State Examination (MMSE) greater than or equal to 24
* Be part of one of the 3 inclusion services of the University Hospital of Toulouse
* For 12 months, have daily consumption of benzodiazepine (at least once a day) and / or have excessive alcohol consumption as recommended by the American Geriatric Society (more than one unit of alcohol per day) ).

Exclusion Criteria:

* Patient refusing to participate in the study
* MMSE less than 24
* Acute decompensation of a psychiatric disorder
* Impossibility to understand or speak French
* Patient under the protection of justice
Effect of Nafamostat on Postreperfusion Syndrome (PRS)

This study intends to see the effect of nafamostat on the attenuation of postreperfusion syndrome (PRS) that frequently occurs during liver transplantation.


Eligibility Criteria:
Inclusion Criteria:

* \>= 18 year old scheduled to undergo liver transplantation

Exclusion Criteria:

* Previous history of pulmonary, cardiovascular, or renal disease
* Previous history of allergic reactions to nafamostat
The Effect of Adenosine on Cranial Hemodynamic, Headache and Migraine Induction Properties.

Adenosine is a nucleoside that plays a role in both vascular and nociceptive systems, and it has been proposed that adenosine may cause headache in particularly sensitive subjects.

Thus, considerable evidence implied that adenosine plays a role in migraine pathophysiology, it is still unknown if intravenous adenosine infusion provokes migraine attacks in healthy subject or in migraine patients. Furthermore, adenosine's effects on the cerebral hemodynamic remains unknown.

This study aims to clarify a possible coherence between adenosine and headache/migraine. In general, the study will contribute to a greater understanding of migraine pathogenesis and possibly lead to development of specific migraine treatment.


Eligibility Criteria:
Inclusion Criteria:

* Migraine patients without aura who fulfill criteria in the international classification of headaches. This does not apply to healthy volunteers.
* 18-60 years.
* 50-90 kg.
* Women of childbearing potential must use adequate contraception

Exclusion Criteria:

* Headache less than 48 hours before the tests start
* All primary headaches, except migraine without aura for migraine patients, according to international classification of headache
* Daily consumption of drugs of any kind other than oral contraceptives
* Pregnant or nursing women.
* Cardiovascular disease of any kind, including cerebrovascular diseases.
The Application of a Wireless Sensor Technology for Vital Statistics in CHILDREN AND ADULTS

The primary outcome for this project will be the development of a small, non-invasive wireless sensor that is linked to a conventional computer that can be used in health care for monitoring of acute and chronic health problems. The advantages of developing this technology are threefold. First, monitoring can be conducted for a fraction of the cost of a bedside nurse. Second, monitoring can be done in real time and stored so that we can diagnose and manage critical events in a more timely manner. Lastly, many patients can be monitored simultaneously. The wireless sensors will be fitted to healthy volunteers of various ages. The data gathered from the sensor with respect to their vital signs will be compared to that of conventional tools such as nursing assessments and pulse oximetry.


Eligibility Criteria:
Inclusion Criteria:

* Adults with controlled and non-controlled hypertension (hypertension defined as \> 130/90 on two separate occasions and history of hypertension)
* Adults with known chronic obstructive pulmonary disease in respiratory distress with oxygen saturations \< 90%
* Febrile adults (temp at triage \> 38 C) with no significant co-morbidities
* Elderly (\>70 years) patients with no significant co-morbidities
* Obese adults (BMI \> 30)
* Febrile (temp at triage \> 38 C) and non-febrile children (age \< 18 yrs)
* Obese children (BMI \> 30)
* Neonates (age \< 6 weeks)
* Children with corrected cyanotic congenital heart disease
* Children in respiratory distress that present with oxygen saturations \< 90%

Exclusion Criteria:

-Subjects with unstable vital signs will be excluded.