cyrilzakka/clinical-trials huggingface dataset:
My Care My Call: Peer-Led Health Empowerment Training in Chronic Spinal Cord Injury

My Care My Call (MCMC) is an innovative, peer-led telephone intervention designed to empower adults with chronic spinal cord injury (SCI) in the self-management of their primary health care needs to prevent secondary conditions. In a randomized controlled trial, participants assigned to the MCMC intervention receive tapered calls from a Peer Health Coach (PHC) for six months. PHCs are experienced, empathetic peer mentors living with SCI who act as supporters, role models, and advisors, providing goal-setting support, motivation, education, and resource referral to participants. Participants complete surveys at baseline, 2, 4, and 6-months, as well as qualitative exit phone interviews.

It is hypothesized that MCMC will: 1) Increase participants' self-advocacy in health care interactions as reflected in increases in three domains of self-advocacy: assertiveness, illness education, and potential for mindful non-adherence, 2) Increase participants' self-efficacy for health care navigation, preference for involvement in, and satisfaction with their primary care physician (PCP), and 3) Increase health related quality of life and medical social support compared with those receiving usual care. Additional secondary hypotheses state that the MCMC intervention will increase access to primary care and use of preventive screening services compared with those receiving usual care.


Eligibility Criteria:
Inclusion Criteria:

* Self-report of physician-confirmed traumatic spinal cord injury diagnosis
* Injured one year ago or more
* Telephone access for at least 9 months
* Speaks and understands conversational English
* Have a current health issue to address

Exclusion Criteria:

* Moderate to severe cognitive impairment
* Surgery scheduled for a 2-week or longer duration during the months of the study
Early Airway Response to Allergen in Asthmatics (MK-0000-176)

This study will assess the Early Airway Response (EAR) associated change in forced expiratory volume in one second (FEV1) and plasma 9α-11ß-PGF2 ('9P') after single dose pretreatment of nedocromil, montelukast, and mometasone.


Eligibility Criteria:
Inclusion Criteria:

* History of mild to moderate Asthma
* In good general health (except for asthma)
* Stable and free of respiratory infection
* Nonsmoker
* Females highly unlikely to conceive (surgically sterilized, postmenopausal, or agrees to use 2 acceptable methods of birth control)

Exclusion Criteria:

* Nursing mother
* Recent or ongoing upper or lower respiratory tract infection
* Unable to refrain from or anticipates the use of any prescription and non-prescription drugs
* Consumes excessive amounts of alcohol or caffeine
* History of stroke, chronic seizures, or major neurological disorder
* History of cancer
* Received a vaccination within the past 3 weeks
Long-term Clinical Effectiveness of the Delta Xtend Reverse Total Shoulder

This post-marketing study is designed to collect data relating to the use of the Delta Xtend™ Total Shoulder Replacement System in shoulder with rotator cuff deficiencies. This allows for continued monitoring of the performance and safety of the prosthesis in a broader range of clinical situations.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects, aged less than 85 years inclusive.
* Subjects who have cuff tear arthropathy, osteoarthritis with cuff deficiency, rheumatoid arthritis, post traumatic injury, or a need for revision surgery of a failed anatomic prosthesis in the left or right shoulder, which requires (total) shoulder arthroplasty.
* Subjects with radiographic evidence of sufficient bone stock to seat and support the Delta XtendÔ Reverse Total Shoulder System.
* Subjects who in the opinion of the Clinical Investigator are considered suitable for treatment with the Delta Xtend Reverse Total Shoulder System.
* Patients with a life expectancy of greater than 12 months.
* Subjects who are able to give voluntary, written informed consent to participate in this clinical investigation and from whom consent has been obtained.
* Subjects who, in the opinion of the Clinical Investigator, are able to understand this clinical investigation, co-operate with the investigational procedures and are willing to return to the hospital for all the required post-operative follow-ups.

Exclusion Criteria:

* Male and female subjects aged 86 years or older.
* Subjects with complete deltoid muscle palsy in the target joint as determined by clinical evaluation.
* Subjects with active local or systemic infection or with a history of general or local infections in the target joint over the past 12 months.
* Subjects with severe deformities, or tumours, that would impair fixation or proper positioning of the implant.
* Subjects with no significant muscle, nerve or vascular disease.
* Subjects with a pathology that, in the opinion of the Clinical Investigator, will adversely affect healing.
* Known allergic reactions to implant materials (e.g. bone cement, metal, polyethylene) implant corrosion or implant wear debris.
* Subjects with a known history of poor compliance to medical treatment.
* Subjects who, in the opinion of the Clinical Investigator, have an existing condition that would compromise their participation and follow-up in this clinical investigation.
* Women who are pregnant.
* Subjects who are known drug or alcohol abusers or with psychological disorders that could affect follow-up care or treatment outcomes.
* Subjects who have participated in a clinical investigation with an investigational product in the last month.
* Subjects who are currently involved in any injury litigation claims.
Bolster: Caregiver App to Reduce Duration of Untreated Psychosis

The proposed research project aims to develop and test a mobile health intervention designed to improve caregivers' illness knowledge and caregiving skills through interactive cognitive-behavioral modules, and through these improvements, reduce distress, improve coping, improve family communication, increase caregiver treatment facilitation and reduce duration of untreated psychosis. This clinical trial will involve a remote pilot randomized controlled trial comparing this new intervention to existing online caregiving support resources. Analyses will determine whether this approach is acceptable and feasible, as well as explore its effectiveness and impact on key components of the cognitive model of caregiving.


Eligibility Criteria:
Inclusion Criteria:

* 18 years old or older
* Live in the United States
* Caregiver to a young adult with early psychosis, wherein early psychosis is defined as: (1) Being between the ages of 18 and 30, and (2) Within the past five years, the young adult first experienced: (2A) Presence of psychotic symptoms represented by one or more of hallucinations, delusions, marked thought disorder, psychomotor disorder or bizarre behavior, as well as (2B) Definite change of personality or behavior manifesting as two or more of the following: serious deterioration of function, marked social withdrawal, persistent self-neglect, episodic marked anxiety.
* A positive screen according to the Caregiver Prime Screen - Revised (endorsed two or more responses of five or six ("somewhat"/"definitely" agree))
* Own an Apple iPhone
* Self-identify as a caregiver of the affected person
* The affected person is not enrolled in specialty mental health services (i.e. a program wherein the affected person can access psychiatry and counseling/therapy services), and has not been enrolled in such services for at least three months prior to screening. If an affected person is receiving one of these services, the caregiver reports that this is an inadequate level of care.

Exclusion Criteria:

* Incarceration or long-term care setting for either the caregiver or identified affected young adult.
* Participant failed to demonstrate understanding of study details in comprehension screening process.
* The affected person is unengaged in services, but only as a result of having completed or "graduated" from a specialty treatment program for psychosis.
Early Iron Exposure on the Gut Microbiota in Young Infants

This study will look at the amount of iron in infant formula and how that affects a child's gut development. The children of mothers who plan to formula feed their children will be randomized to receive either high iron or low iron formula from birth until 4 months of age. Infants will consume only the study provided formula during enrollment. Blood and stool samples will be collected at birth and end of study to measure the effects of the iron exposure. The overall object is to compare high iron versus low iron exposure in formula-fed infants during the first months of life. Aims include determining the types of bacteria that are present in the infants' fecal microbiome, determining the effect of high iron exposure on gut microbiome and sleep patterns, and comparing iron status and homeostasis between the low and high iron formula groups.

Disturbance of the gut microbial colonization during infancy may result in long-term programming impact of metabolism and disease risks of the host. The early gut microbial colonization coincides with the maturation of the infant's mucosal innate immune system and research showed that the gut microbial dysbiosis is associated with impaired innate immune development. Thus, ensuring proper microbial colonization early in life is critical to the maturation of the immune system and long-term health.

Iron fortification can increase the abundance of pathogenic bacteria and induce inflammation in older infants. However, it is still not known what the effect of iron is on a more vulnerable population: the newborn infant, who has immature immune system. Infants 0-4 months are at a low risk for iron deficiency due to the iron endowment at birth, which is compatible with the very low iron content (\<0.5mg Fe/L) in breastmilk. However, commercial infant formulas are all fortified with ≥12mg Fe/L. Whether this striking difference drives adverse health effects is unknown/unexamined, especially on early colonization and immune homeostasis. The overall objective is to determine the impact of high vs. low iron exposure in formula-fed infants during the early post-natal months on gut microbiome.

Eligibility Criteria:
Inclusion Criteria:

* Healthy new born infants

Exclusion Criteria:

* Newborn infants with conditions that prohibit cow-milk based formula consumption
Assessment of the Stability of Immediately Loaded All-on-four Dental Implants in FFF Used for Reconstruction of the Jaws

The use of free vascularized fibula flaps for bony reconstruction has proved its success as a substitution for the resected bone and in some instances, the surrounding soft tissues

The aim of this case series study is to evaluate the stability of the dental implants placed in free fibula flaps substituting a resected mandible and/or maxilla when they are immediately loaded with the All-On-Four technique along with the patient satisfaction.

• Preoperative phase :

Patients will be subjected to:

* Case history including personal data, medical, surgical and family history.
* Clinical examination
* Radiographic examination using computed tomography (C.T) bony and soft tissue window.
* Diagnostic studying casts.
* Operative phase :

All cases will undergo surgery under local regional anesthesia. Injection of local anaesthesia (Articaine 4% and 1:100000 epinephrine) for regional infiltration. Sequential drilling then insertion of the dental implant fixtures and abutments on which the prefabricated temporary prosthesis will be fixed.

• Postoperative care Proper postoperative instructions will be given to the patient such as strict oral hygiene measures and soft diet for 1 month, in addition to the postoperative medications including antibiotics (amoxicillin 1g capsules b.d.s ) and analgesics (diclofenac potassium 50mg as needed). Adherence to follow ups will be also instructed

Eligibility Criteria:
Inclusion Criteria

* Patients with reconstructed jaws with free fibula flaps in either or both jaws.
* Age group : from 15 to 60 years old
* No sex predilection
* Patients with no contraindications to surgical intervention Exclusion Criteria
* Patients with systemic condition counteracting with the surgical procedure.
Distribution and Prognostic Impact of Oncogenic Drivers in Metastatic Lung Adenocarcinoma : a Retrospective Monocentric Study in Nancy University Hospital Center

The recent discovery of oncogenic drivers has revolutionized the management of advanced lung cancer by development of tyrosine kinase inhibitors targeted therapies. Prevalence of daily tobacco use is evaluated at 31,3 % in Grand-Est region, the only French region with a statistically significative difference for smoking habits. This region shows a higher incidence (+ 13 %) and mortality for lung cancer in comparison to the average for other French regions. The objectives of our studie were to estimate the distribution of oncogenic drivers and analyse their prognostic impacts in the Nancy University Hospital Center metastatic lung adenocarcinoma's population.


Eligibility Criteria:
Inclusion Criteria:

* Lung adenocarcinoma
* Patients diagnosed at a metastatic stage
* Patient who benefited an oncogenic driver research on their histologic samples
* Medical follow-up entirely done in Nancy Central Hospital

Exclusion Criteria:

* Patients with double histology
* Synchronous cancer
* Patients with surgical care
Stress Reduction Program Based on Mindfulness for Patients With Discopathies

This study evaluates the influence of stress on inflammation and the symptomatology of the patient with back pain. Mindfulness Based Stress Reduction (MBSR) will be used in half of participants, a validated psychopedagogical intervention for stress reduction, and the participants assigned to the control group will follow the usual treatment, according to their diagnosis.

The Mindfulness based stress reduction (MBSR) is a psycho-educational program of stress reduction based on mindfulness. It consists of a program of 30 hours of duration divided into 9 sessions with a weekly frequency of 2.5 h and an intensive session between the week 6 and 7 of the program with a duration of 7.5 hours. Each week, the theoretical contents that are necessary to understand the attention development practices will be covered. In addition, basic concepts of the psychobiology and psychology of stress and pain will be explained. The subjects will have a homework load of approximately 45 minutes per day during the intervention program.

Eligibility Criteria:
Inclusion Criteria:

* To be diagnosed with symptomatic disc disease (Participants must provide a medical report that certifies the discopathy).
* Normal or moderate mobility
* Normal cognitive state
* Patients who have previously read and signed the informed consent.
* Patients that are capable and willing to comply with the study procedures.

Exclusion Criteria:

* Serious psychopathologies
* Suicidal thoughts.
* Deep depression
* Psychosis
* Drug addiction
* Very limited functional capacity and cognitive impairment: Patientsconfined in a bed or a chair. They need the help of a third person.
* Do not incorporate during the program any clinical, psychological or pharmacological treatments different from those ones that are normally used to controlled the pain, or any drastic changes in lifestyle.
Anti-adhesion Effect of GUARDIX-SGⓇ in Gastric Cancer Surgery

This study is to evaluate the efficacy of GUARDIX-SGⓇ for patients with gastrectomy in Korea and the investigators hypothesized applying of adhesive preventing agent would reduce incidence of adhesive obstruction after gastrectomy.

Adhesive bowel obstruction is relatively often complication in patients after abdominal surgery

Gastric cancer is the most frequent cancer in Korea.

The incidence of adhesive bowel obstruction would be increased in patients with gastric cancer, especially associated radical lymphadenectomy.

The causes of postoperative adhesive obstruction include adhesion of the wound, adhesion of small intestine to small intestine, adhesion of the small intestine to other abdominal organs, and internal hernia.

Several studies reported efficacy of adhesive preventing agent after colorectal resection.

Gastrectomy is associated with a high risk (incidence, 11.7%-38.5%) of bowel obstruction.

To date, however, no randomized study has shown that GUARDIX-SGⓇ reduces the rate of small bowel obstruction after gastrectomy with radical lymphadenectomy for gastric cancer.

Eligibility Criteria:
Inclusion Criteria:

* Patients with gastric adenocarcinoma who scheduled to undergo open gastrectomy
* Informed consents

Exclusion Criteria:

* Pregnant
* Ascites
* Liver dysfunction
* Renal failure
* Past history of abdominal operation or small bowel obstruction
A Study on Analgesia and Related Outcomes for Patients With Tabacco Smoking

Numbers of postoperative PCA(Patient-Controlled Analgesia) related side effects among current, past and non smokers are determined by comparing and analyzing frequency distributions. To determine whether smokers require more post operative opiate analgesics than others. Multivariate analysis will be performed to identify the major and the minor factors predicting the use of postoperative pain therapy. Our previous related study showed that the smoker male patients consumed more analgesics than those without smoking, but the female group showed the similar findings. However, the case number, especially the female cases, is underpowered. Investigators hope to increase the case number to have a better statistical and clinical significance.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing elective general surgery are assigned to current smokers（n=100） or past smokers（n=100） or never smokers（n=100） according to the questionnaires "Fagerstrom test for nicotine dependence" 1 day prior to the surgery.

Exclusion Criteria:

* the patients undergoing major thoracic cardiovascular surgery
* the patients with significant lung lesion
* the patients with conscious disturbance
* the patients with allergic history to morphine
Evaluation of the Percutaneous SCS Trial Using the DSSEP Collision Testing

This study is to objectively evaluate the success of a spinal cord stimulator (SCS) trial using testing (DSSEP) to determine if the paresthesia (tingling sensation) or pain reduction achieved correlates with the degree of stimulation.

The SCS trial leads will be placed as per standard of care, using fluoroscopic guidance and leads will be checked for proper positioning. Leads will be tested for appropriate paresthesia coverage of the patient's painful area(s), using multiple electrode configurations and lead positions (dependent on the location of the pain). After the leads are secured, the patient will be sent to the recovery room where the DSSEP test will be performed. A technologist will glue/tape recording electrodes to the patient's head, neck, back or legs. One or two stimulating electrodes are also placed on the patient's leg. Each electrode is checked with a meter to ensure proper functioning. Pulsing stimulus will start in one of the stimulating electrodes. Each time a different area is tested, the pulsing will be started again. Each area tested will take 10-15 minutes. The painful dermatomal distribution area, specific to each patient will be used for dermatomal SSEP stimulation. Placement will be correlated with nerve roots involved with the corresponding dermatomes. Measurements will be obtained to determine collision criteria.

Eligibility Criteria:
Inclusion Criteria

A subject will be eligible for inclusion in this study only if all the following criteria apply:

A. Subject understands the procedures, agrees to participate in the study, and has signed and dated the informed consent form prior to the initiation of any study-related activities.

B. Subjects are male or female greater than 18 years old at the time of screening visit.

C. Pain in one or both lower extremities. D. Pain is not responding to conservative treatment such as physical therapy or medications.

E. Average pain rating of at least 4 on a scale 0 to 10, on average, prior to enrollment in the study.

F. Patient is mentally competent to make decisions.

Exclusion Criteria

A subject will not be eligible for inclusion in this study if any of the following criteria apply:

A. Female subject with childbearing potential (a premenopausal female, who is not surgically sterile).

B. Subjects who poorly cooperate or have any cognitive impairment. C. Patient with severe concomitant depression. D. Inability to communicate adequately with physician and /or study coordinator.

E. Patient is diagnosed with a psychiatric condition that will likely interfere with diagnostic accuracy of the workup protocol or with recovery following the anticipated procedure
A Study to Evaluate AAV9 Neutralizing Antibody Seroconversion in Household Contacts.

This study will include male and female participants who live or work in the same household as a patient in one of the fordadistrogene movaparvovec interventional studies. Up to 5 participants from the same household may be enrolled. The objective is to estimate the likelihood of NAb seroconversion to AAV9 in household contacts of a patient in one of the interventional studies who is treated with fordadistrogene movaparvovec gene therapy.

This single center study will include approximately 50 to 250 participants and is designed to estimate the likelihood of NAb seroconversion to AAV9 because of exposure to shed viral vector material released by a DMD patient treated with fordadistrogene movaparvovec in an interventional study. Eligible participants will undergo a blood draw provided by a Home Health Care Vendor at three home visits.

The total duration of participation in this study is about 4 months, including up to 48 days for the screening/baseline period and about 56 days after the DMD patient of the same household is dosed with the investigational gene therapy in the interventional study.

To maintain the blind in the blinded interventional studies, all C3391007 study participants and investigators as well as the sponsor will remain blinded to the Cohort assignment of the interventional study patient until the interventional study becomes unblinded.

Eligibility Criteria:
Inclusion Criteria:

* Males or females who weigh at least 9 kg.
* Anticipated to be living or working in the same household as a patient in one of the fordadistrogene movaparvovec interventional studies for at least 4 months.
* Anticipated to have \> 10 hours of contact per week and expected to have direct contact with the interventional study patient.
* The interventional patient is dosed in the interventional study.

Exclusion Criteria:

* Prior treatment with gene therapy utilizing AAV vectors of any serotype.
Reactions to Warnings on Hookah Ads

The purpose of this study is to help us better understand what kinds of waterpipe tobacco advertisements appeal to young adults as well as to help evaluate and create health warnings that can be placed on waterpipe tobacco advertisements to inform young adults of the risks associated with smoking hookah tobacco.


Eligibility Criteria:
Inclusion Criteria:

* Young adults who are susceptible to or who are current tobacco smokers (which is defined as at least once in the past month, and using hookah tobacco on at least a monthly basis).
* Must have Internet access for Phase 1 and Phase 2 and have a Turkprime account.
* English speaker

Exclusion Criteria:

* Anyone who is not susceptible to waterpipe tobacco smoking or is not a current waterpipe tobacco smoker
* Anyone who does not have Internet access or a Turkprime account