cyrilzakka/clinical-trials huggingface dataset:
RCT of ACP for Transplant

We aim to examine the effect of an online advance directive on decisional conflict and quality of life in patients undergoing stem cell transplant. We also aim to assess the effect of palliative care at the time of a sentinel event on quality of life.


Eligibility Criteria:
Inclusion Criteria:

The inclusion criteria for Phase I (primary objective) are as follows:

* Age ≥ 18 years
* Hematologic malignancy diagnosis including any subset of myeloma, lymphoma, leukemia, or myelodysplastic syndrome
* Currently scheduled for autologous or allogeneic transplant at the Hospital of the University of Pennsylvania

The inclusion criteria for Phase II (secondary objective) are as follows:

* Age ≥ 18 years
* Hematologic malignancy diagnosis including any subset of lymphoma, leukemia, or myelodysplastic syndrome
* Received an autologous or allogeneic stem cell transplant at the Hospital of the University of Pennsylvania and experienced a sentinel event of either 1) disease relapse,2) severe (Grade III or IV) graft-versus-host disease, or 3) unplanned hospital admission with length of stay greater than 72 hours.

Exclusion Criteria:

The exclusion criteria for Phase I include:

* Inability to read and write English
* Not serving as the primary decision maker for their health-related decisions
* Having a non-hematologic malignancy reason for undergoing transplantation (e.g. aplastic anemia)

The exclusion criteria for Phase II include:

* Not completing participation in Phase I of the study
* Myeloma diagnosis
3D Thyroid Education Model for Student

The purpose of our study is to develop a high-fidelity thyroid education model, that can be utilized for medical students/ PGY doctors/ residents training. This model can help them better understand the structure of thyroid, learn about what are thyroid nodules, and practice thyroid fine needle aspiration examination with the model. The investigators would also evaluate the efficacy of using this model in student teaching.

Background： Thyroid nodular disorder is prevalent in Endocrine clinics, and while thyroid fine needle aspiration examination is crucial for evaluating nodules, conveying the procedure to students is challenging. The investigators propose a high-fidelity 3D model to enhance education, especially for hands-on practice. Our study aims to assess the model's education efficacy.

Study Design： This is a prospective study.

Methods： In our study, 3D scanning and 3D printing technology will be used to create the thyroid high-fidelity model. The investigators plan to choose 3D printing materials that enable the practice of thyroid fine needle aspiration produce with No.22 or No.23 needles.

Effect： The investigators hope to assist students understand the structure of thyroid and thyroid nodules better. And students will be able to practice thyroid fine needle aspiration examination with the 3D high-fidelity model. The outcome of our study may be utilized in medical schools or hospitals to facilitate student education.

Key words： 3D printing; medical education model; high-fidelity simulation; thyroid; fine needle aspiration

Eligibility Criteria:
Inclusion Criteria:

* Medical students, medical interns, PGY physicians, and resident physicians training at Fu Jen Catholic University Hospital

Exclusion Criteria:

* Refused to participate in the study
Study to Assess the Efficacy and Safety of SK-MS10 in Subjects With Acute and Chronic Gastritis

The purpose of this study is to Assess the Efficacy and Safety of SK-MS10 in subjects With acute and chronic gastritis.


Eligibility Criteria:
Inclusion Criteria:

1. Have been diagnosed as erosive gastritis by endoscopy within 1 weeks before enrollment.
2. Patients who voluntarily signed written informed consent may participate in the study.

Exclusion Criteria:

1. Pregnant or lactating female.
2. Patients have gastric ulcer, duodenal ulcer and GERD.
3. Use of any proton pump inhibitor, H2-receptor antagonist, muscarine receptor antagonist and gastrin receptor antagonist within 2 weeks before initiating study drug therapy
4. Patients requiring corticosteroid therapy
5. Severe neurological or psychological disease
6. History of allergic reaction to the medications used in this study
7. Use of other investigational drugs within 30 days prior to the study.
8. Patients that investigators consider ineligible for this study
Correlation of Pain, Obesity and Fertility Potential.

The overall aim of the study is to investigate if patients with musculoskeletal chronic pain have reduced semen quality in comparison with age matched healthy controls. Secondly, the aim is to investigate whether overweight with or without chronic pain are related to reduced semen quality. We will investigate semen quality in obese chronic pain patients, normal weight chronic pain patients and in obese and normal weight healthy controls.

Obesity is associated with several disorders including chronic musculoskeletal pain. For example obesity has been implicated in the development or progression of low back pain and knee osteoarthritis. The mechanism by which obesity causes lumbar back pain is poorly understood, but the contribution of both mechanical and system factors is likely. Direct mechanical stress on the intervertebral discs and adjacent structures are suspected to be mechanisms through which obesity affects the spine, leading to subsequent low back pain. The link between obesity and knee osteoarthritis has also been demonstrated, but potential factors underlying the association of obesity with knee osteoarthritis has not entirely been elucidated.

It is a well-known fact that obesity leads to an excess load on the joint, increased cartilage turnover, increased collagen type 2 degradation products and increased risk of degenerative meniscal lesions. Although all of these factors have been proposed to lead to knee osteoarthritis, no causal relationship has been demonstrated.

Eligibility Criteria:
Inclusion Criteria:

* Men between 18-45 years with low back pain or knee pain recruited among referees to the orthopaedic outpatient clinics at Aalborg University Hospital
* Pain more than 3 months
* Patients can be on a daily use of Paracetamol 1 gram x 4, NSAID x 3-4 or combined
* Patients will be included regardless of their BMI but will be put in their respective BMI subgroup after the required measurements have been taken
* Regarding low back pain the LBPRS \>9, knee pain the KOOS \<75 (0-100, i.c. 100 = no problems)
* Healthy men in the age 18-45 years (matched with enrolled patients)

Exclusion Criteria:

* Malignancy
* Ongoing infection
* Drug addiction defined as the use of cannabis, opioids or other psycho drugs
* Previous neurologic, musculoskeletal or mental diseases
* Lack of ability to cooperate
* Pain rating
* Patients with a pain rate below 3
* Medication
* Patients taking Morphine drugs
Stress Management Among Latinos With Type 2 Diabetes

The primary aims of this study are to:

1. Tailor a diabetes stress management intervention for delivery by community health workers (CHWs) serving an urban Latino population.
2. Investigate the efficacy of the stress management intervention on glycemic control.

   Secondary aims of this study are to:
3. Investigate the efficacy of the stress management intervention on stress hormones, psychosocial functioning, and stress-glucose reactivity.

Study hypothesis:

A CHW-led group-based diabetes education model enhanced with stress management education will improve glycemic control more than CHW-led group-based diabetes education alone.


Eligibility Criteria:
Inclusion Criteria:

* Latinos age 18 or older that are ambulatory
* Spanish speaking
* Diagnosed with type 2 diabetes for at least 1 year
* Hemoglobin A1c levels greater than 7.0

Exclusion Criteria:

* Medical instability or medical treatment requiring inpatient care
* Diagnoses of bipolar disorder or thought disorder (or taking medications prescribed for either); current substance abuse or dependence disorder
* Current suicidality or history of suicide attempt
* History of psychiatric hospitalization
* Taking antidepressant medications prescribed for the treatment of depression accompanied by either a) changes to the antidepressant regimen within previous 6 weeks, or b) anticipated changes to the regimen during period of study. Such patients will be deferred and re-evaluated for eligibility after 6 months
Study on the Effect of Transcranial Magnetic Stimulation in Mild to Moderate Alzheimer's Disease

The investigators will compare cognitition, mood (depression), ADL, and brain structural and functional MRI before and after 4-week transcranial magnetic stimulation in patients with mild to moderate Alzheimer's disease.

The investigators also compare the change of cognitition, mood (depression), ADL, and brain structural and functional MRI between TMS group and sham coil group.

Each 16 patients will be allocated to TMS group and sham coil group. Before TMS/sham coil stimulation, the investigators will take fMRI of each patient, and figure out which focus has strongest connectivity to hippocampus among lateral parietal regions of the brain. The investigators will fix the TSM transduced and apply accurate TMS stimulation to the focus using personalized frames. The investigators will make the frame using 3D printing technology.

After 4 week- TMS stimulation, the investigators will compare cognitition, mood (depression), ADL, and brain structural and functional MRI beween baseline and after intervention. The investigators also compare the change of cognitition, mood (depression), ADL, and brain structural and functional MRI between TMS group and sham coil group.

Eligibility Criteria:
Inclusion Criteria:

* patients who visited memory clinic of Samsung Medical Center
* aged 55 \~ 90
* diagnosed as probable Alzheimer dementia according to NIA-AA guideline 2011, or MCI patiens with amyloid PET positivity
* below -1SD in SVLTdelayed recall test and RCFT delayed recall test
* K-MMSE \>=18
* no epileptic discharge in EEG
* no history of epilepsy
* no arrhythmia or MI in ECG
* can read and write Korean (literate)
* volunteer and agree to the registration

Exclusion Criteria:

* no other neurologic deficit which can cause dementia except for Alzheimer's disease
* paitient who has severe cerebral white matter hyperintensities. (deep white matter \>=2.5cm and caps or band \>=1.0 cm)
* patients with severe medical disease including caner and ishemic heart disease
* claustrophobia or allergic to contrast of MRI
* medical deviced which is not removable (e.g pacemaker, cochlear implantation, dental prosthesis)
* history of brain surgery, and intervension or surgery of intra/extracranial artery(e.g. carotid artery stent insertion, CEA)
* patient with dyspnea during resting
* history of loss of consciousness for more than 1 hour except for general anesthesia
* patients who cannot read written material because of poor visual acuity
* patients who cannot communicate because of severe hearing difficulty
* history of ototoxicity medication or exposure severe noises
* determined as inapropriate to participate clinical trial
Micropulse Laser for Geographic Atrophy

Geographic atrophy (GA) causes the loss of the retinal pigment epithelium (RPE) cells in broad areas of the retina. The application of subthreshold micropulse laser spots in healthy RPE in the vicinity of the area of GA may restore the imbalance in survival factors caused by the disease (ie, the laser may decrease vascular endothelial growth factor and RPE-derived transforming growth factor beta, upregulation of pigment epithelium-derived factor). This may slow or even stop the enlargement of atrophy secondary to GA, and therefore, avoid further vision loss.


Eligibility Criteria:
Inclusion Criteria:

* GA \> 0.5 disk areas secondary to AMD in both eyes
* 50 years or older
* The periphery of the atrophic lesions must demonstrate increased autofluorescence
* Best corrected visual acuity between 20/20 and 20/400 inclusive
* Clear ocular media
* Ability to provide informed consent and attend all study visits

Exclusion Criteria:

* GA secondary to other causes aside from AMD
* Evidence of choroidal neovascularization in either eye
* Any prior treatment for AMD, aside from antioxidants
* Any other ocular condition that would progress in the study period and confound visual acuity assessment
* Any ocular or systemic medication known to be toxic to the lens, retina or optic nerve
* Presence of idiopathic or autoimmune-associated uveitis
* Any intraocular surgery 3 months of entry
* Any prior thermal laser in the macula
* History of vitrectomy, filtering surgery, corneal transplant or retinal detachment surgery
* Previous therapeutic radiation in the ocular region in either eye
* Any treatment with an investigational agent in the previous 60 days before study entry
Development of a Lifestyle Physical Activity Intervention to Reduce Risk for Perinatal Cannabis Use

This study will recruit 20 women who are high risk for prenatal cannabis use for a 12-week program of using the tracker and receiving a Lifestyle Physical Activity program. The primary outcomes will be self reported percent days of cannabis use and physical activity. Secondary outcomes include self -reported measures of depression and anxiety symptoms, adaptive coping, and self-efficacy for cannabis abstinence.

This study will recruit 20 women in an open trial who are high risk for prenatal cannabis use for a 12-week program of using a Fitbit activity tracker and receiving a Lifestyle Physical Activity program. The primary outcomes will be self reported percent days of cannabis use and physical activity. Secondary outcomes include self -reported measures of depression and anxiety symptoms, adaptive coping, and self-efficacy for cannabis abstinence. The investigators will clinically monitor all participants in the study for safety and clinical deterioration, and measure a variety of symptom outcomes over the course of the intervention period during pregnancy, as well as at a postpartum follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Women aged 18+
* 12-25 weeks gestation with a healthy singleton pregnancy
* Medically cleared for moderate physical activity
* Self-report of cannabis use at least once/week in the 3 months prior to the pregnancy desire to not engage in prenatal cannabis use
* Elevated depression (EPDS\>=7) or anxiety (GAD7\>=5)
* English-speaking
* Owns a smartphone to enable use of the Fitbit app
* Current physical activity does not meet health recommendations (150 min/week mod intensity activity)
* Expresses interest in reducing or discontinuing cannabis use

Exclusion Criteria:

* Current DSM-5 diagnosis of moderate/severe substance use disorder other than CUD or nicotine use disorder
* Use of illicit substances in the last 3 months (other than cannabis)
* Acute psychotic symptoms
* Current or recent suicidality or homicidally
* Current anorexia or bulimia
* Cognitive impairment
* Physical or medical problems that would not allow safe participation in moderate intensity PA (i.e., not medical cleared by Ob/Gyn)
* Has a plan to relocate away from the area during study period
* Recently started new mental health or substance use treatment within past 4 weeks.
A Study of Mircera in Anemic Patients With Chronic Kidney Disease Not Yet on Dialysis.

This study will evaluate the efficacy and safety of different subcutaneous starting doses and dosing frequencies of Mircera in anemic patients with chronic kidney disease not yet on dialysis. The anticipated time on study treatment is 3-12 months and the target sample size is \<100 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients \>=18 years of age;
* chronic renal anemia;
* not receiving renal replacement therapy.

Exclusion Criteria:

* women who are pregnant, breastfeeding or using unreliable birth control methods;
* administration of any investigational drug within 30 days preceding the screening visit and during the run-in period.
Assessment of Family Planning and Immunization Service Integration in Malawi

This is a mixed methods process evaluation of a programmatic intervention to integrate family planning and immunization services at health facilities and through outreach services in Dowa and Ntchisi districts of Malawi. The study involved qualitative methods (in depth interviews and focus group discussions with service providers, mothers and fathers of infants \<1 year, and supervisors and program managers) as well as secondary analysis of service statistics for family planning and immunization services and of supervision reports.


Eligibility Criteria:
Inclusion Criteria:

* All health facilities and associated outreach sites in Ntchisi and Dowa districts implementing the integrated approach with support from the USAID-funded Maternal and Child Survival Program

Exclusion Criteria:

* All health facilities and associated outreach sites not implementing the integrated approach with support from the USAID-funded Maternal and Child Survival Program
Evaluation of Corneal Temperature by Infrared Thermography in Glaucoma Patients

Measurement of corneal temperature gives indirect information about the ocular blood flow. For this reason corneal temperature can be used as a surrogate to quantify ocular blood flow. It can be measured by means of infrared thermography. This test, however, is not used in an everyday clinical routine so far. In this study is investigated if ocular blood flow disturbances in glaucoma patients can be diagnosed by means of infrared thermography.

Corneal temperature are measured in normal tension glaucoma patients and healthy controls before and after cold provocation test. In the group of patients and the group of controls, subjects with and without a primary vascular dysregulation (PVD) are included. This will allow to analyze and compare the influence of cold provocation on corneal temperature (and indirectly ocular blood flow) in these study Groups.


Eligibility Criteria:
Inclusion Criteria for Patients:

* Glaucoma
* Age 18-65

Exclusion Criteria for patients:

* No Glaucoma
* Alcohol consumption
* Smoking

Inclusion Criteria for Control:

* No Glaucoma
* Age 18-65

Exclusion Criteria for control:

* Alcohol consumption
* Smoking
Evaluating the Use of Grip Exercises to Decrease Deep Vein Thrombosis in Adult Patients With PICC Lines

Patients who have a peripherally-inserted central catheter (PICC) placed are at a risk of developing a deep vein thrombosis (DVT). At TriHealth, approximately 2-4 patients per month who have a PICC placed experience a subsequent DVT. One innovative way to possibly mitigate the risk of DVTs is hand grip exercises. The current study will be the first study to evaluate hand grip exercises for the prevention of DVTs in adult patients hospitalized in the United States.


Eligibility Criteria:
Inclusion Criteria:

* Had a PICC placed in the past 24 hours by the Vascular Access Team
* Patient is admitted to either Bethesda North Hospital or Good Samarian Hospital

Exclusion Criteria:

* Under 18 years old
* Does not speak English
* Unable to consent to involvement in the research study
* Has a bleeding disorder/diagnosis
* Has a severe limb disfunction whereby they would be unable to perform the grip exercises
Serum-Free Thymus Transplantation in DiGeorge Anomaly

The study purpose is to determine if thymus tissue cultured in a serum-free (SF) solution is a safe and effective treatment for atypical and typical complete DiGeorge anomaly. \[Funding Source - FDA OOPD\]

Complete DiGeorge anomaly is a congenital disorder characterized by athymia. Without successful treatment, patients remain immunodeficient and usually die by age 2 years. In "typical" complete DiGeorge subjects who have no T cells, thymus transplantation without immunosuppression has resulted in diverse T cell development and good T cell function. In "atypical" complete DiGeorge subjects who have no thymus, a rash, and some T cells that presumably developed extrathymically, thymus transplantation with immunosuppression has resulted in diverse T cell development and good T cell function. Thus far, thymus transplantation studies have used thymus cultured in fetal bovine serum (FBS medium). This protocol's purpose is to determine whether transplanted thymus cultured in serum free medium can safely support thymopoiesis and T cell reconstitution as does FBS medium cultured thymus tissue in DiGeorge anomaly subjects. This protocol includes 2 arms: atypical DiGeorge subjects who will receive immunosuppression and thymus transplantation; and, typical complete DiGeorge subjects who will receive thymus transplantation without immunosuppression. Serum free medium use would reduce concerns of animal product exposure including potential exposure to bovine spongiform encephalopathy(BSE).

Eligibility Criteria:
Thymus Recipients Inclusion:

Complete DiGeorge anomaly diagnosis

Must have one of following:

* congenital heart disease
* hypocalcemia requiring replacement
* 22q11 or 10p13 hemizygous
* CHARGE

Atypical Arm:

* Must have, or have had, rash. If rash present, skin biopsy must show T cells. If rash resolved, must have \>50/cumm T cells; \& \<50/cumm naive T cells or \<5% total
* PHA response must be \<40000 counts per minute(cpm) on immunosuppression; or, \<75000cpm off immunosuppression. PHA test must be done 2x
* CD45RA+CD62L+ CD3+ T cells must be \<50/mm3; or, \<5% of total CD3. Test must be done 2x

Typical Arm:

* PHA response \<20 fold or \<5,000cpm
* Circulating CD3+CD45RA+CD62L+T cells \<50/mm3 or \<5% total T cells
* 2 tests of T cells \& PHA response must show similar results

Biological Mother Inclusion:

-Must be recipient's biological mother

Thymus Recipient Exclusion:

* Heart surgery \<4 weeks pre-transplant or within 3 months post-transplant
* Rejection by surgeon or anesthesiologist as surgical candidates
* Lack of sufficient muscle tissue to accept transplant
* Medical condition does not allow to undergo a biopsy
* HIV
* CMV(\>500 copies/ml blood by PCR on 2 tests)
* Ventilator dependence
* GVHD
* Maternal T cells \>20% of total T cells
* Prior immune reconstitution attempts (e.g., BMT, prior thymus transplant)
* Hypoparathyroidism meeting criteria for combined thymus/parathyroid transplant \& parents desiring it
* RSV or parainfluenza virus
* Enterovirus or Adenovirus in stool

Biological Mother Exclusion:

-Unwillingness to sign consent or provide blood/buccal samples
Platelet Function in Patients With an Acute Coronary Syndrome

The aims of the study are to:

* explore whether platelet reactivity in patients treated wih novel platelet inhibitors is associated with clinical outcome
* investigate whether a therapeutic window exist for novel platelet inhibitors
* investigate the incidence of adverse events under treatment with novel platelet inhibitors in the real life clinical scenario
* investigate the association between genetic polymorphisms, inflammation, platelet reactivity and clinical outcome
* investigate synergistic effects between aspirin and novel platelet inhibitors


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Acute coronary syndrome at admission
* Planned treatment with novel platelet inhibitors
* Age \>18

Exclusion Criteria:

\* Participation in interventional trials