cyrilzakka/clinical-trials huggingface dataset:
Tai Chi Chih and Varicella Zoster Immunity

A randomized control trial testing whether a relaxation response based intervention, Tai Chi Chih, will affect Varicella Zoster Virus (VZV) specific immunity measures of psychological adaptation and health function in the older adult.

Both the incidence and severity of Herpes Zoster (HZ) or "Shingles" increase markedly with increasing age, is a painful condition, due to a decline in Varicella Zoster Virus (VZV) specific immunity. Considerable evidence further shows that psychological stresses salient in the older adult correlate with impairments of cellular immunity.

The investigators have observed that Varicella Zoster Immunity is always decreased in individuals with major depression. Moreover, our preliminary data indicates that the presence of depressive symptoms in older adults is associated with a decline of VZV responder cell frequency (VZV-RCF). Taken together, the untoward effects of age and depressive symptoms on VZV immunity raise the question as to whether an alternative medicine intervention might augment VZV specific immunity in the older adult. We have preliminarily shown that administration of a relaxation-response based intervention, Tai Chi Chih (TCC), results in improvements in health functioning and VZV immunity in older adults as compared to controls. TCC is a slow moving meditation comprised of twenty separate standardized movements for use in elderly populations.

This proposed controlled clinical trial aims to: 1) determine whether the practice of TCC for 16 weeks influences Varicella Zoster Virus (VZV) immunity; 2) demonstrate that TCC can produce significant changes in psychological adaptation, health behaviors, and health functioning and well-being; and 3) assess whether changes in psychological adaptation, health behaviors, and health functioning correlate with changes in VZV immunity following TCC in older adults.

We hypothesize that this behavioral intervention that prioritizes treatment of excessive physiological arousal can influence one's affective state with effects on cellular immunity. By standardization of training and practice schedules, TCC offers an important advantage over prior relaxation response based therapies. Focus on older adults at increase risk for HZ and assay of VZV specific cellular immunity has implications for understanding the impact of behavioral factors and an alternative medicine intervention on a clinically relevant endpoint and the ability of the immune system to respond to antigens of infectious pathogens.

Eligibility Criteria:
History of Varicella or long-term resident (greater than or equal to 30 years) in the continental United States.
Incidence and Prognostic Implication of Acute CV Events in Patients Hospitalized for CAP in Internal Medicine Units.

FADOI-ICECAP is a observational, prospective, multicenter study involving 20-25 nationwide Units of Internal Medicine. The study foresees the participation of 26 Internal Medicine Operative Units, and for each of them a prospective registration of data relative to at least 50 patients admitted with CAP (in total, at least 1300 evaluable subjects) is foreseen.

Phase 1 - Patients enrollment (October 2016 - February 2018) Each Investigator have recorded data concerning 50 patients. It will be collected general characteristics of patients, clinical parameters and conditions, diagnostic imaging and blood tests,

Phase 2 - Database review and validation (April 2018 - October 2018) The data collected will be analysed to process the endpoints.

Eligibility Criteria:
Inclusion Criteria:

1. Age \> 18 years
2. Diagnosis of pneumonia defined by the presence on chest X-ray or CT-scan of lung of new infiltration associated with at least two of the following clinical features:

   * fever \> 37.8°C
   * typical symptoms (dyspnea, productive cough, pain)
   * typical clinical signs on chest examination (crepitation, bronchial breathing, pleural effusion)
   * leukocytosis

Exclusion Criteria:

* patients with Hospital-Acquired Pneumonia (HAP) (i.e. those patients with pneumonia acquired in hospital more than 48 hours after admission)
* patients with tuberculosis in active phase
* patients with cystic fibrosis
* patients who refuse to participate in the study and/or to give the written informed consent.
Remote Ischemic PreConditioning Effect on Postsurgical Pain

Remote Ischemic PreConditioning (RIPC) will improve the postoperative pain experience in patients undergoing abdominal surgery. Although abdominal surgery can be a lifesaving procedure many people have a significant amount of postsurgical pain. Severe postsurgical pain may lead to chronic pain in some people. "Remote Ischemic Preconditioning" may reduce the amount of postsurgical pain. Remote ischemic preconditioning is done by inflating a balloon (very similar to a blood pressure cuff) on the leg until it blocks blood flow for a few minutes. The cuff is then deflated and blood flow resumes. The process is repeated up to three times. This procedure causes the body to increase its natural pain relief system that may help to decrease the amount of postsurgical pain.


Eligibility Criteria:
Inclusion Criteria:

1. Ages 30-80
2. Undergoing elective open intra-peritoneal surgery
3. Able to provide written informed consent to participate
4. Laparoscopic abdominal surgery

Exclusion Criteria:

1. Ongoing Workman's Compensation claim
2. \>50mg/day of oral morphine or morphine equivalent
3. Currently being treated for lower extremity DVT
4. Known intracranial hypertension (not excluding patients with a functioning VP shunt)
5. Known Hypercoagulable state (e.g. factor V Leiden, protein s or c deficiency)
6. Ongoing localized thigh pain
7. Planned epidural analgesia
8. Pregnancy
9. Any DSM IV-R Axis I psychotic disorders
10. Unable to understand English
11. Unable to understand the consent form
Discontinuation or Continuation of Immunosuppressive Therapy in Participants With Chronic Graft Versus Host Disease

This randomized trial studies how well discontinuation or continuation of immunosuppressive therapy works in treating participants with chronic graft versus host disease. Continuation of immunosuppressive treatment may prevent graft-versus-host disease worsening.

PRIMARY OBJECTIVE:

I. Assess feasibility of enrolling and randomizing patients with chronic graft versus host disease (GVHD) to discontinuation (standard of care) versus continuation (investigation) of immunosuppressive therapy (IST).

SECONDARY OBJECTIVES:

I. Assess feasibility of enrolling and randomizing patients who are not local, and evaluate the quality of data received for those patients.

II. Assess whether prolonged IST decreases the need for pulses of high dose IST.

III. Evaluate the effect of prolonged IST on chronic GVHD manifestations and severity, risk of relapse, infection and organ toxicity.

OUTLINE: Participants are randomized to 1 of 2 arms.

ARM I: Participants have their IST tapered and discontinued per the plan.

ARM II: Participants continue to receive a fixed dose IST for an additional 9 months with no taper.

After completion of study treatment, participants are followed up annually.

Eligibility Criteria:
Inclusion Criteria:

* Prior first allogeneic stem cell transplant, with any graft source, donor type, and GVHD prophylaxis
* Patients who are on one systemic immunosuppressive agent for chronic GVHD with a plan to withdraw all systemic IST; hydrocortisone or prednisone continued for treatment of adrenal insufficiency is not considered a systemic IST
* No evidence of malignancy at the time of enrollment
* Agree to be evaluated at the transplant center or by local provider every 3 months for 12 months after randomization
* Agreement to be contacted by phone or e-mail for health status evaluation for up to 3 years
* Signed, informed consent

Exclusion Criteria:

* Inability to comply with study procedures
* Pregancy
Measuring Sweat Glucose of Patients With Diabetes - The ENGAGE Study

This pilot clinical trial will explore the accuracy and acceptability of a non-invasive, wearable glucose sensor in patients living with DM. This study will compare needleless glucose sensor readings from sweat with glucometer measurements from patients with any type of diabetes at fasting, and after a meal.

There is an unmet need for a non-invasive glucose monitoring device. UCSD nanoengineers developed a flexible, ultra-thin sensor adherent to the skin, similar to a temporary tattoo. Sweat glucose correlates with blood glucose. This proposed study would be the first to examine this needle-free glucose sensor to measure glucose in endogenous sweat in individuals with DM, and would serve as the basis for future development of a continuous, non-invasive sensor. The investigators hypothesize that compared with a glucometer, a tattoo sensor can accurately measure sweat glucose in patients with DM.

Eligibility Criteria:
Inclusion Criteria:

* Individuals with an existing diagnosis of diabetes mellitus, of any type, defined as having a fasting plasma glucose (FPG) \> 126 mg/dL, or hemoglobin A1c (HbA1c) \> 6.5%.
* Ability to provide informed consent for participation.

Exclusion Criteria:

* Individuals who do not have diabetes.
* Those who have an allergy to pilocarpine.
* Frequent episodes of low blood sugar (hypoglycemia), have no warning symptoms of hypoglycemia (hypoglycemia unawareness), or are at high risk of having hypoglycemia.
* If taking any of the following medications: any beta-blockers (including atenolol, carvedilol, metoprolol, and propanolol), chlorthalidone, hydrochlorothiazide, oxybutynin, and tiotropium.
* Individuals who have the following conditions, for which it is not safe to take pilocarpine, including:

Known or suspected gallstones or gallbladder disease

Kidney stones

Conditions that affect your thinking and/or memory, including Parkinson's disease and Alzheimer's disease

Asthma

Chronic obstructive pulmonary disease (COPD)

Glaucoma

Irritable Bowel Syndrome

Pregnancy - a pregnancy test will be obtained for each woman of child-bearing age.
A Study of GFH925 in Combination with Cetuximab in Previously Untreated Advanced NSCLC Harboring KRAS G12C Mutation

This is a Phase Ib/II study. The objectives are to evaluate the safety/tolerability and efficacy of GFH925 in combination with Cetuximab in advanced KRAS G12C mutant NSCLC, to characterize pharmacokinetics (PK) of GFH925 in combination with Cetuximab in advanced KRAS G12C mutant NSCLC


Eligibility Criteria:
Inclusion Criteria:

1. Patient has provided informed consent form (ICF).
2. Males or females aged ≥ 18 years.
3. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0\~1.
4. Life expectancy \> 3 months judged by the investigator.
5. Have histologically or cytologically confirmed advanced KRAS G12C-mutated NSCLC.
6. Have at least one measurable lesion per RECIST 1.1.
7. Have sufficient organ functions.
8. With toxicities left from prior anti-tumor therapy resolved to baseline or CTCAE Grade 1 (neurotoxicity or alopecia ≤ Grade 2).
9. Women of childbearing potential (WOCBP) and male patients with WOCBP partners must agree to use effective contraception method during the study specified period.

Exclusion Criteria:

1. With clinically significant cardiovascular diseases.
2. With active central nervous system (CNS) metastases and/or carcinomatous meningitis.
3. With clinically significant gastrointestinal diseases.
4. With active infections.
5. With uncontrollable or symptomatic pleural effusion, ascites, or pericardial effusion.
6. With uncontrolled systemic diseases, such as hypertension or diabetes.
7. Prior treatment with an inhibitor specific to KRAS G12C.
8. Major surgery within 4 weeks prior to initiation of study treatment.
9. With known allergies to the study drugs or components.
10. Pregnant or lactating females, or female patients intend to become pregnant during participation.
Interval Training in Bipolar Disorder

Our main objective will be to evaluate the chronic effects (12 weeks) of high-intensity interval training compared to moderate intensity (same total work) on reducing the symptoms of bipolar disorder, cortical changes, as well as on the VO2max. In addition, the investigators will establish what influence of gain to VO2max has on reducing symptoms.

Physical exercise has significant effects on health promotion and the consequent reduction of the severity of bipolar disorder (BD). This review establishes a pattern of response of exercise and potential impact on the pathophysiology of BD; , as well as, produces hypotheses on how acute and chronic effect of exercises may act differently; and provides future perspectives with the focus of the exercise as an important and innovative model of treatment for BD and mental disorder. A critical evaluation of the literature was undertaken including the influence of exercise on health promotion in patients with mental disorders, neurochemical behavior exercise-induced, as well as reflective introduction of news perspectives of training control in severe exercise domain. The exercise induces significant changes in monoaminergic after, and with long-term training, and work with a threshold of exercise can modulate positive effects on mood. Fast adaptive effects from the high intensity interval training should be considered in BD patients. However, there must be caution in his administration. We speculate that exercise may be a way of maintaining euthymia in the case of BD, making it less vulnerable patient to stay longer at a time of neutrality. Future research is needed to adopt a training strategy that is both time efficient in the different areas and adequate for the population in question.

Eligibility Criteria:
Inclusion Criteria:

* Bipolar Criteria (DSM-IV),
* sedentary lifestyle

Exclusion Criteria:

* 60 and over,
* Cardiovascular Disease,
* Panic disorder,
* Metabolic syndrome Diagnosis
Primary Stability of Immediate Implant Using Versah Versus Conventional Burs

This study is designed as a Prospective Randomized Clinical Trail, Evaluate the effect of osseodensification technique on primary stability in comparison to the conventional drilling technique in immediate single fresh extraction sockets.

In this study, 30 dental implants inserted immediately after tooth extraction (not a multi-rooted tooth) as a two groups according to bur drill technique and measure the primary stability by osstell devise based on resonance frequency analysis (RFA) value which is scaled from 1-100, after 16 weeks measuring the secondary stability.

Eligibility Criteria:
Inclusion Criteria:

* Healthy and medically fit patients
* Patients age ≥18 years for both gender
* Apical bone ≥ 2mm from vertical structure showed in x-rays.
* Patient has tooth or teeth with single root anterior and\\or posterior area cannot
* restored by another dental treatment procedure.

Exclusion Criteria:

* Patient with active periodontal disease.
* Pregnancy or lactation.
* A local or systemic disorder that is contraindicated for the minor surgical procedure
* and may affect healing process.
* Any irradiation in head and neck area.
* Heavy smoking habit.
Maternal Hypotension During Cesarean Section and Short Term Neonatal Outcome.

About 20-25% of deliveries are by cesarean section. Most are elective with use of regional anesthesia (spinal/epidural). Drop of blood pressure after regional anesthesia is common. It have the risk of reduction of blood flow to the placenta and the fetus.

No studies had followed the newborns their first days of live,of mothers who developed hypotension in durins CS.

A reterospective study of all full term babies, born in elective cesarean section with use of regional anesthesia. Two groups will be define rgarding maternal hypotention following regional anesthesia - maternal hypotention (study group) or normal maternal BP. The definition of Maternal hypotension: decrease in 10% or more in mean BP in compared to first BP taken at admition.

Data will colect from mothers and neonates records as well as operation data. Maternal data: gravida, parity, diseases, medications, demographics, and all data regarding the operation (blood pressures, Heart rates, saturation, treatment given etc.).

Infant data: gestational age, birth weight, sex, Apgar, cord pH, clinical manifestations, medications, time of hospitalization.

Eligibility Criteria:
Inclusion Criteria:

* fullterm infants, born by elective cesarean section using regional anasthesia.

Exclusion Criteria:

* preterms, urgent CS, CS using general anasthesia, Multiple pregnancy, Congenital malformations.
Decision Support AMPATH

Computer-generated clinical reminders offered to providers will improve compliance with care guidelines and impact outcomes in resource-limited clinics.

The investigators will assess the effects of computer-generated reminders for the 3 cohorts of patients: (1) pregnant women; (2) HIV-exposed infants; and (3) adults and children co-infected with TB and HIV identified from the AMPATH clinics. Patients will be randomized to either receive the reminders as part of a paper summary, or to not have any of the reminders in their summary. Reminders implemented will vary by type of patient population. Comparisons will be made between the intervention and control groups.

Eligibility Criteria:
Inclusion Criteria:

* All pregnant women, children born to HIV+ mothers, and TB/HIV co-infected patients visiting these clinics during the this study will be included.

Exclusion Criteria:

-
A Phase II Trial of Intermediate Radiation Dose For Lymphoma

The purpose of this study is to determine the optimal radiation dose fractionation regimen for low grade follicular lymphoma.

It is hypothesized that the complete response rate with the use of 12 Gy in 6 daily fractions is 80% (10% total width of the confidence interval) at 3 months.

This phase II study will evaluate whether an intermediate dose for follicular lymphoma is associated with excellent response rates while minimizing acute and late toxicity.


Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years or older
* Pathology review at Sunnybrook Health Sciences Centre showing low grade (grade 1- 2) follicular lymphoma
* Previously un-irradiated stages I-IV low grade follicular lymphoma
* Radiation indicated for local disease control (radical or palliative)
* Able to give informed consent
* Non-bulky targets (less than 7cm)

Exclusion Criteria:

* Systemic therapy (including steroids) for lymphoma within 3 months before or after radiotherapy
* Prognosis less than 3 months
* Pregnancy
Brexpiprazole as Combination Therapy With Sertraline in the Treatment of Adults With Post-traumatic Stress Disorder

This will be a 12-week, multicenter, randomized, double-blind trial evaluating the efficacy, safety, and tolerability of fixed-dose brexpiprazole + sertraline combination treatment in adult participants with post-traumatic stress disorder.


Eligibility Criteria:
Inclusion Criteria:

* Male and female outpatients 18 to 65 years of age, inclusive, at the time of informed consent.
* Participants who have post-traumatic stress disorder (PTSD), diagnosed according to Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5), and confirmed by the Mini International Neuropsychiatric Interview (MINI).
* Onset of symptoms meeting the DSM-5 criteria for PTSD symptoms for a minimum of 6 months prior to screening.

Exclusion Criteria:

* The index traumatic event that led to the development of PTSD took place \> 9 years before screening.
* The index traumatic event occurred before age 16.
* Participants who have experienced a traumatic event within 3 months of screening.
* Participants who are receiving disability payments because of PTSD or any other psychiatric disorder; unless the disability payments will not be impacted by potential improvements demonstrated in the trial.
Gender Disparity in Burn Injury Survival

Hypothesis 1: A quantifiable difference in inflammatory cytokines exist in women with burn injury and this correlates with clinical markers of outcome

Hypothesis 2: The amount of adipose tissue contributes to the severity of cellular immune response (CMI) dysregulation in response to burn injury

Skin-fold caliper measurements will be taken on consented patients (both male and female) to determine body fat percentage. Serum samples will be obtained from these patients. The level of inflammatory cytokines in the serum will be measured to determine if there is a link between body fat percentage, pro-inflammatory cytokines and the ability of women to survive burn injury.

Consented patients admitted to University Medical Center with greater than 15% total body surface area burns will participate in this study. A skin-fold caliper measurement will be performed to determine body fat percentage. Serum samples will be obtained and assayed for inflammatory cytokines to establish whether or not a link between obesity in women and pro-inflammatory cytokines exists. If so, obesity may be a factor which contributes to the gender disparity in burn wound survival.

Eligibility Criteria:
Inclusion Criteria:

* Men and women ages 18 to 65 years
* Admitted to University Medical Center with greater than 15% total body surface area burns
* Able to provide informed consent or has authorized representative to give informed consent

Exclusion Criteria:

* Prisoners or pregnant women
* Individuals with injuries that preclude taking caliper measurements
Postpartum Care in the NICU (PeliCaN) Transitions

This is a randomized controlled trial of a dyad-centered, doula support and healthcare coordination model of care in a large urban neonatal intensive care unit (NICU), which serves a high-risk, low-income, majority Black population. In addition to doula support and coordination of care in the NICU, there will be a warm handoff to a community doula to continue the support once infants leave the Hospital of the University of Pennsylvania (HUP) NICU.


Eligibility Criteria:
Inclusion Criteria:

* HUP postpartum patients who are at least 16 years old at the time their newborns' birth
* Infant born at HUP
* Preterm birth \<34 weeks
* English language speaking

Exclusion Criteria:

* Unable to read or sign informed consent
* Parents of infants transferred into HUP NICU
* If the medical team believes that the infant may not live or be transferred to another hospital in upcoming weeks
* HUP postpartum patients who are less than 16 years of age at the time of their newborns' birth