cyrilzakka/clinical-trials huggingface dataset:
Effect of Teriparatide, Vibration and the Combination on Bone Mass and Bone Architecture in Chronic Spinal Cord Injury

Spinal cord injury (SCI) results in marked acute loss of bone. This study evaluates the effect of teriparatide (PTH) and the use of vibration as a form of mechanical stimulation on bone mass.

The aim of this study is to evaluate PTH with vibration in a group of individuals with chronic SCI and loss of bone mass in their lower extremities. A convenience sample of 60 subjects with SCI will be enrolled into a 12 month study assessing the effects of PTH (20 ug/day) and vibration (10 min/day) individually or in combination on BMD and bone markers. Subjects will be evaluated at 3, 6, 9, and 12 months after initiating treatment with measurement of bone density as well as bone markers of formation and resorption.

Eligibility Criteria:
Inclusion Criteria:

Age \>21 years (must have closed epiphyses; PTH contraindicated if epiphyses open)

* Both males and females
* SCI with inability to ambulate independently
* Capable of positioning to have DXA performed
* Low bone mass at the total hip by DEXA (Z score \< 1.5; T score \< 2.5 or T score \<-2.0 plus preexisting fragility fracture)
* Capable of reading and understanding informed consent document
* Able to self-administer teriparatide or have someone in the family who can do so
* No known endocrinopathies
* Normal TSH levels
* Normal 25-OH vitamin D levels (\> 30ng/ml)
* Normal calcium levels
* Normal renal function (creatinine \<2.0mg/dl)
* Able to return for all follow-up visits

Exclusion Criteria:

Surgical or other intervention resulting in metal or anatomy precluding obtaining DXA measurements (e.g., cardiac pacemakers, ferromagnetic implants or brain aneurysm clips).

* Had had an allergic reaction to Teriparatide (FORTEO) or one of its ingredients.
* Have Paget's disease of the bone
* Have unexplained high levels of f alkaline phosphatase in blood
* Any active Gastrointestinal condition that results in malabsorption
* History of presence of alcoholism or drug abuse within the 2 years prior to study screening
* Other medical conditions that in the opinion of the investigator would preclude the subject from completing the study
* History of malignancy. Patients having had basal cell carcinomas successfully removed will be allowed to enroll in the protocol.
* History of radiation therapy
* Unable to self-administer PTH or have it administered
* Elevated liver function tests \>2x normal
* Currently being prescribed anti-convulsants
* Currently being prescribed glucocorticoids, other than inhaled glucocorticoids
* Currently being prescribed any bone-active agents, including any bisphosphonate, raloxifene, hormone therapy (estrogen and estrogen/progestin), calcitonin or strontium-containing compounds. Bisphosphonate use will be allowed up the time of initiation of study medication but not during the dosing with study medication.
* Previous history of PTH use
* Pregnant, planning to become pregnant, or lactating
Identifying and Overcoming Barriers to Diabetes Management in the Elderly: A Cost-effective Intervention Study

The purpose of this study is to find ways to identify barriers that affect self care in older adult with diabetes and to provide cost effective coping strategies to improve clinical, functional and psychosocial measures.

This is a study to evaluate whether short term focused intervention by a geriatric diabetes team to help overcome barriers to diabetes care in older adults will result in improved clinical, functional, and quality of life measures compared to usual care in a cost effective manner. In addition, we will assess whether the support network formed during intervention by the geriatric diabetes team will empower patients, resulting in long lasting improvement in parameters after intervention is completed.

Eligibility Criteria:
Inclusion Criteria:

* Age 70 years and older
* Diagnosis of type 1 or type 2 diabetes
* Seen at Joslin Clinic or Beth Israel Deaconess Medical Center for at least one year
* HbA1c 8% X 2 in past 6 months without fluctuation of more than 0.5% (i.e. stable poor control)
* No major change in medications in past 3 months, e.g. addition of insulin or another hypoglycemic agent

Exclusion Criteria:

* Patients with terminal diseases, e.g. malignancy with expected life expectancy of 12 months or less
* Patients who live more than 25 miles from Joslin Clinic/Beth Israel Deaconess Medical Center
* Patients who live in an institutional setting (e.g. nursing home, group home, etc)
* Patients who are not able to complete outcome assessments, (e.g. poor vision, diminished mental capacity/severe cognitive decline, unable to speak/read/write English
DAME: Induction of Labor or Waiting for Suspicion Fetal Macrosomia

Aim of the study :The major aim is to evaluate the effectiveness of the induction of labor in case of fetal macrosomia on the reduction of neonatal traumatism risk. The secondary aims are to evaluate maternal morbidity and the risk of Caesarean in case of induction of labor, compared to a spontaneous labor.

A clinical trial multicentric randomized controlled will be organized. A total of 1000 women will be recruited between 36 and 38 weeks of amenorrhoea (GW) if the pregnancy is single, in cephalic presentation and the fetus is estimated macrosomic for the gestational age (\> 90e percentile clinically and \>95° percentile sonographically).All agreeing patients will be randomized in one of the two following groups: - 1. Induction of labor between 37+0 and 38+6 GW and within 3 day after the randomization. - 2. Expectancy until the spontaneous beginning of labor or up to 41 GW.The measurement of principal exit is the neonatal traumatism (criterion composite associating: dystocia of the shoulders, fractures osseous, paralysis/paresis of the plexus brachial or intracerebral haemorrhage).The secondary criteria are neonatal asphyxiation (arterial pH \< 7.10 or Apgar \< 7 to 5 minutes), the maternal traumatism (tear of 3rd or 4th degree) and the Caesarean. The long-term after-effects for the mother and her child will be also evaluated

Eligibility Criteria:
Inclusion Criteria:

* Agreed women Sonographic estimation of begin of pregnancy \<20GW Single pregnancy in cephalic presentation Macrosomic fetus :
* clinical estimation : 36GW : ≥3350g or 34cm 37GW : ≥3550gor34cm 38GW : ≥3750g or 35cm
* sonographic estimation : 36GW : ≥ 3500g 37GW : ≥ 3700g 38GW : ≥ 3900g

Exclusion Criteria:

* Typical diabetes I or typifies II or diabetes gestational treated by insulin.
* Antecedents of tear of the anal sphincter or severe urinary or faecal presence of an incontinence.
* Antecedent of dystocia of the shoulders or neonatal traumatism.
* Antecedents of caesarian or uterine scar.
* contraindication in the release of the work or in the childbirth by low way.
Clinical Benefits of Additional Complex Fractionated Atrial Electrogram Targeted Catheter Ablation for Longstanding Persistent Atrial Fibrillation

1. Purpose of the study

1) To compare clinical outcome, procedure time, complication rate of persistent atrial fibrillation patients between conventional additional linear ablation and additional complex fractionated atrial electrogram targeted catheter ablation.

2. Scientific evidence of the study

1. In atrial fibrillation patients, the maintenance of normal sinus rhythm showed significant reduction of mortality.
2. drug therapy with anti-arrhythmic drug showed many complications and side effect, thus non-drug therapy such as catheter ablation is developed.
3. catheter ablation has been performed for 10years world-wide, and showed superior treatment outcome compared with drug therapy.
4. However, there are no consensus for proper ablation strategy in longstanding persistent atrial fibrillation.
5. additional ablation make extent of myocardial injury and paradoxically increase recurrence rate, thus still controversial.
6. Therefore, we will compare conventional linear ablation with additional complex fractionated atrial electrogram targeted catheter ablation.

3. Methods

1. Treatment of All patients with atrial fibrillation is performed according to the standard treatment guideline of atrial fibrillation.
2. there is no additional blood sampling, imaging study, or any other invasive procedure according to the inclusion of the study.

4. study contents

1. to evaluate superior ablation strategy in longstanding persistent atrial fibrillation

   * compare conventional linear ablation with additional complex fractionated atrial electrogram targeted catheter ablation. both strategies are conventional ablation strategies being performed world-wide.
2. compare complex fractionated atrial electrogram before and after linear ablation.


Eligibility Criteria:
Inclusion Criteria:

1) patients who undergoing catheter ablation of atrial fibrillation due to symptomatic, drug refractory atrial fibrillation

Exclusion Criteria:

1. patients who do not agree with study inclusion
2. permanent AF refractory to electrical cardioversion
3. AF with valvular disease ≥ grade 2
4. Patients with left atrial diameter greater than 60mm
5. patients with age less than 19
Indirect Evaluation of Lithium Level in Blood Using Non-invasive Sweat Biosensors

Indirect evaluation of the accuracy and the efficacy of biosensors developed for Li+ detection in sweat.

Lithium (Li+) is one of the most widely used and studied medications for treating of Bipolar Mood Disorder, resistant cases of Major Psychiatric Disorders and especially Major Depressive Disorder.

After administration, more than 95% of administered dose of Li+ is eliminated unchanged in the urine, less than 5% - in the saliva, sweat, and feces. Up to 40% of patients that are on Li+ therapy encounter adverse effects that can be explained by drug involvement in various biochemical processes. Li+ efficacy and side effect manifestation are obviously determined by the drug concentration in blood. The optimal way to prevent manifestation of side effects is to control that Li+ serum level is within therapeutic range. A blood test is often ordered to monitor the serum level of Li+ to ensure target serum levels are reached. The available methods for blood Li+ are invasive, time consuming, and cause of discomfort for patients, yet are of a great importance as levels of drug in blood outside the therapeutic range may dramatically affect patient health. It is especially of importance for Li+ treatments it has a narrow therapeutic window - 0.6-1.5 mmol/L. Thus, there is a growing need for a reliable, comfortable, and inexpensive method for detection of Li+ in blood that can be performed easily in an in-patient setting and automatically whenever necessary without the need for a clinic visit out-patient setting.

Spectrophon LTD has developed an algorithm that allows calculation of levels of various compounds contained in sweat using standard PPG sensors with special coating and thus to estimate the levels of corresponding chemicals in the bloodstream. This algorithm has proven useful and accurate in clinical trials on detection of dehydration level, blood sodium level, and blood glucose level. We suggest that Spectrophon biosensors can be used to detect the levels of Li+ in sweat that will allow non-invasive estimation of the level of corresponding medication in blood in real-time.

Eligibility Criteria:
Inclusion Criteria:

* Meeting Diagnostic and Statistical Manual 5th edition (DSM-V) criteria for MDD, BMD, Schizoaffective Disorder, Schizophrenia;
* Patients must be on constant Li+ treatment or prior their first drug administration.
* Ability and willingness to sign an informed consent form for participation in the study.

Exclusion Criteria:

* Evidence of serious disorder;
* Unstable chronic disease;
* Kidney disease
* Pregnancy;
* Contraindication for Li+ treatment.
A Pediatric Safety and Pharmacokinetics Study of Ha44 Gel Administered Topically for Treatment of Head Lice Infestation

The primary purpose of the study is to evaluate safety and tolerability of a single application of Ha44 Gel 0.74% w/w for the treatment of head lice. Secondary purpose is to evaluate PK of Ha44 and benzyl alcohol under conditions of maximal exposure in pediatric population.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female, 6months \< 3years of age
2. Good health
3. Active head lice infestation defined as the presence of at least 3 live lice
4. Dermatological condition of scalp (at least G2 erythema or pruritus with evidence of excoriation/inflammation)
5. Parent/guardian agrees to allow PK samples collected
6. Signed Informed Consent Form

Exclusion Criteria:

1. Condition or illness that in the opinion of the investigator may interfere with the study results.
2. Current dermatological disease that may compromise the health of subject or the assessment of safety. Subjects with scalp ulceration or evidence of scalp infection should not be enrolled.
3. Prior reaction to product containing piperonyl butoxide, pyrethrin, or pyrethrum extract.
4. Receiving systemic or topical medication that may interfere the study results.
5. Received an investigational agent within 30 days prior to Day 0.
Enhanced Outpatient Symptom Management to Reduce Acute Care Visits Due to Chemotherapy-Related Adverse Events

This clinical trial studies if enhanced outpatient symptom management with telemedicine and remote monitoring can help reduce acute care visit due to chemotherapy-related adverse events. Receiving telemedicine and remote monitoring may help patients have better outcomes (such as fewer avoidable emergency room visits and hospitalizations, better quality of life, fewer symptoms, and fewer treatment delays) than patients who receive usual care.

PRIMARY OBJECTIVE:

I. Determine the efficacy of remote patient monitoring (RPM) on improving clinical outcomes.

SECONDARY OBJECTIVE:

I. Evaluate the following patient-centered outcomes: treatment delays, health-related quality-of-life (HRQOL), patient activation, and family caregiver-experience.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive standard of care consisting of oncology care provided via telemedicine.

ARM II: Patients receive standard of care consisting of oncology care provided via telemedicine. Patients also undergo remote monitoring.

Eligibility Criteria:
Inclusion Criteria:

* Adults (≥ 18 years)
* English- and Spanish-fluent participants with thoracic and/or gastrointestinal cancers who are scheduled to initiate or continue outpatient chemotherapy at either MDACC (Texas Medical Center campus and any Houston-area location) or MDACC oncology clinic at Lyndon B Johnson (LBJ) hospital
* Their adult (≥18 years) patient-identified or self-identified primary caregivers (MDACC only)
* Participants on combination chemotherapy and immunotherapy or combination chemotherapy and biologic will also be eligible for inclusion.
* Participants may participate if they do not have a caregiver, or if their caregiver declines participation; however, caregivers of MDACC participants may participate only if the participant consents.

Exclusion Criteria:

* Participants who are receiving investigational new drug treatments or concurrently enrolled in a phase 1 clinical trial will be excluded due to the associated structured reporting and regulatory requirements.
* Participants with a requirement for inpatient infusion (i.e. CAR-T cell therapy), living in institutional settings (i.e. prison, nursing homes), with a history of dementia, physical disability or neurological deficits that prohibit ability to report symptom burden will also be excluded.
Heart Spare the Nephron (STN) Study - A Study of CellCept (Mycophenolate Mofetil) and Rapamune (Sirolimus) in Heart Transplant Recipients

Heart transplant patients on a standard care regimen of CNI, MMF, and corticosteroids will enter the study 4-6 weeks post-transplant. At 3 months after transplant, patients will be randomized to either continue this regimen or CNI therapy will be discontinued and replaced by sirolimus therapy (in combination with MMF and corticosteroids). The effect of these 2 regimens on efficacy, safety and renal function will be evaluated.The anticipated time on study treatment is 1-2 years and the target sample size is 500+ individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult (\>=18 years of age) heart transplant patients (4-6 weeks post-transplant);
* receipt of first heart (single-organ) transplant;
* standard care regimen of CNI, MMF, and corticosteroids since transplantation.

Exclusion Criteria:

* positive donor-specific cross-match at time of transplantation;
* history of malignancies, other than non-melanoma skin cancer that has been totally excised with no recurrence for 2 years;
* patients participating in another interventional clinical trial or requiring treatment with unmarketed investigational drugs.
Bundle Consent and Expectation Setting in Pediatric Intensive Care Unit

The purpose of this research study is to find out about how obtaining consent for procedures in the PICU affects parental/caregiver stress. The researchers think that alleviating some of the uncertainly of a PICU stay by discussing types of procedural support offered and obtaining informed consent prior to their immediate necessity may help decrease stress experienced by caregivers. This study will allow the researchers to learn more about it.

Having a child admitted to the Pediatric Intensive Care Unit (PICU) is a deeply challenging and stressful experience for parents and caregivers. Despite the high survival when compared to adult ICUs, a PICU admission can have meaningful long-term, negative health consequences for adult caregivers including symptoms of depression, anxiety and PTSD. There is little known in regards to what specific factors impact the mental health of parents/caregivers of PICU patients. However, research into stress and anxiety has suggested that uncertainty is a significant contributor to stress when faced with a new environment.

Usual informed consent for procedures performed in the PICU is obtained immediately prior to the procedure. Participants will be randomly assigned (like the flip of a coin) to either usual informed consent prior to each procedure or to a single consent form obtained upon admission to PICU for possible procedures their child may undergo. In this study participants will be asked to complete a survey at two separate times during the child's PICU hospitalization- 48-72 hours after admission and again upon transfer or discharge from the PICU. Data will be collected about the child from the medical record including age, diagnosis/reason for PICU admission, length of stay, and any procedures performed in PICU requiring consent.

Eligibility Criteria:
Inclusion Criteria:

* Parents/caregivers (\>18 years) of children admitted to the Pediatric ICU during the designated study period

Exclusion Criteria:

* Anticipated length of PICU stay \< 24 hours
* Non-English speaking parents/caregivers
KYSA-7: A Study of Anti-CD19 CAR T-Cell Therapy, in Subjects With Refractory Primary and Secondary Progressive Multiple Sclerosis

A Study of Anti-CD19 Chimeric Antigen Receptor T-Cell (CD19 CAR T) Therapy, in Subjects with Refractory Primary and Secondary Progressive Multiple Sclerosis

Multiple sclerosis (MS) is an autoimmune and neurodegenerative disease in which lymphocytes at first attack the myelin sheaths within the central nervous system (CNS), accompanied or later followed by axonal damage. B cells play a central and multifunctional role in the immunopathogenesis of MS. B cells present antigen to T cells in stimulating a pro-inflammatory immune cascade, secrete pathogenic cytokines, moderate T cell and myeloid cell functions, form structural B cell meningeal follicles within the human central nervous system and produce pathogenic antibodies upon evolution to plasma cells.

CD19-targeted chimeric antigen receptor (CAR) T cells harness the ability of cytotoxic T cells to directly and specifically lyse target cells to effectively deplete B cells in the circulation and in lymphoid and potentially non-lymphoid tissues. KYV-101, a fully human anti-CD19 CAR T-cell therapy, will be investigated in adult subjects with refractory primary and secondary progressive multiple sclerosis.

Eligibility Criteria:
Key Inclusion Criteria:

1. Subject must have a history of diagnosis of primary progressive or secondary progressive MS.
2. History of treatment with anti-CD20 mAb with continuing evidence of worsening physical disability over a period of ≥6 months, with documented clinical disability progression within the 2 years prior to inclusion.

Key Exclusion Criteria:

1. Monophasic disease, radiologically isolated syndrome, clinically isolated syndrome, progressive solitary sclerosis or relapsing-remitting disease as defined by the 2017 McDonald criteria.
2. History of CNS or spinal cord tumor, metabolic or infectious cause of myelopathy, genetically inherited progressive CNS disorder, sarcoidosis, non-MS progressive neurologic condition or PML.
3. Prior treatment with cellular therapy (CAR-T) or gene therapy product directed at any target
4. History of allogeneic or autologous stem cell transplant
5. Evidence of active hepatitis B or hepatitis C infection
6. Positive serology for HIV
7. Primary immunodeficiency
8. History of splenectomy
9. History of stroke, seizure, dementia, Parkinson's disease, coordination movement disorder, cerebellar diseases, psychosis, paresis, aphasia, and any other neurologic disorder investigator considers would increase the risk for the subject
10. Impaired cardiac function or clinically significant cardiac disease
11. Previous or concurrent malignancy with the following exceptions:

    1. Adequately treated basal cell or squamous cell carcinoma (adequate wound healing is required prior to screening)
    2. In situ carcinoma of the cervix or breast, treated curatively and without evidence of recurrence for at least 3 years prior to screening
    3. A primary malignancy which has been completely resected, or treated, and is in complete remission for at least 5 years prior to screening