cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Rectal Cancer Treatment Response Using PET/MRI

The investigators will be using the combination of FDG-PET and multiparametric MRI in pre- and post-adjuvant chemoradiation therapy in order to attempt to predict pathologic response on surgical resection.


Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of histopathologically confirmed rectal adenocarcinoma.
* Locally advanced disease as determined by ERUS or pelvic MRI. Endoscopy reports should clearly state both the T and N stage.
* Patients with cT2N1-3M0 or cT2-4NxM0 will be considered eligible for participation.
* Age ≥18.
* Ability to understand a written informed consent document and the willingness to sign it.
* Tumor must be determined to be surgically resectable. Surgical resection is planned to take place at Univeristy of California, San Francisco (UCSF).
* Neoadjuvant chemoradiation prior to resection is planned..
* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.

Exclusion Criteria:

* ERUS tumor state of T1.
* Radiographic evidence of metastatic disease
* Weight in excess of limitations of the scanner or girth that prohibits entry into the bore of the PET/CT scanner due to size.
* Any medical condition which impairs the ability to lie flat and without movement for 15 minutes (e.g. cough, severe arthritis, etc.)
* Prior receipt of any therapy, including local excision, radiation or chemotherapy, for the diagnosed rectal adenocarcinoma.
* Prior history of pelvic radiation.
* Uncontrolled hyperglycemia (defined as inability to achieve a glucose of \<250 mg/dL at time of fluorodeoxyglucose (FDG) injection).
* Impaired renal function (CKD 4 or 5: estimated glomerular filtration rate (eGFR) \< 30 mLs/min), which is a contraindication to gadolinium containing contrast.
* Known allergy to gadolinium containing contrast agents.
* Contraindication to use of fluoropyrimidines as a radiosensitizing agent.
* Pregnancy or nursing. Women of child bearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 72 hours prior to randomization. This is because of the potential teratogenic effects of the involved imaging modalities, radiation, and chemotherapy.
Data Analysis for Drug Repurposing for Effective Alzheimer's Medicines (DREAM)- Dihydropyridine Calcium Channel Blockers Versus Hydrochlorothiazide

This study aims to evaluate the comparative risk of dementia/Alzheimer's disease onset between patients treated with medications that target specific metabolic pathways and patients treated with alternative medications for the same indication.

This is a non-randomized, non-interventional study that is part of the DREAM Study of Brigham and Women's Hospital. DREAM is led by Dr. Madhav Thambisetty, MD, PhD, Chief of the Clinical and Translational Neuroscience Section, Laboratory of Behavioral Neuroscience, National Institute on Aging (NIA) intramural research program. This study aims to evaluate the comparative risk of dementia/Alzheimer's disease onset between patients treated with medications that target specific metabolic pathways and patients treated with alternative medications for the same indication using healthcare claims data.

Eligibility Criteria:
Please see https://docs.google.com/spreadsheets/d/1VlyY3zcxoRp0tH7yv8rSOEggSO6WQ0VYEjq-6KlSSt8/edit?usp=sharing or Appendix A for full code and algorithm definitions.

Medicare timeframe: 2008 to 2018 (end of data availability).

Inclusion Criteria:

* 1. Aged \> 65 years on the index date
* 2. Enrollment in Medicare Part A, B, and D with no HMO coverage for 365 days prior to and including cohort entry date
* 3. At least two claims with hypertension diagnosis recorded in 365 days prior to cohort entry date

Exclusion Criteria:

* 1. Prior history of dementia measured anytime prior to cohort entry date
* 2. Prior use of dihydropyridine CCBs, hydrochlorothiazide, or other antihypertensives anytime prior to cohort entry date
Proof of Concept Study of IMMUNOadsorption Therapy in Patients With Idiopathic Pulmonary Arterial Hypertension

This clinical investigation is a medical device trial to examine the safety and efficacy of TheraSorb® Ig flex adsorber treatment (as an add-on to conventional treatment) used exclusively with the LIFE 18® apheresis system for extracorporeal application for IA therapy (5 treatments) performed over 5 to 8 consecutive days in patients with Idiopathic Pulmonary Arterial Hypertension and WHO functional classification III.


Eligibility Criteria:
Inclusion Criteria:

* Able to understand and willing to sign the Informed Consent Form
* age \> 18 and \< 80 years at time of informed consent
* Idiopathic pulmonary arterial hypertension diagnosed by right heart catheter
* WHO functional classification III
* Application of conventional IPAH therapy, which has been stable for the prior 8 weeks
* Able to perform a 6-minute-walk test (MWT)
* Negative pregnancy test (β-HCG) at the start of the trial and appropriate contraception throughout the trial for women with child-bearing potential.

Exclusion Criteria:

* Pregnancy and/or lactation
* PAH of any cause other than permitted in the inclusion criteria, e.g. concomitantly to portal hypertension, complex congenital heart disease, reversed shunt, HIV infection, suspected pulmonary veno-occlusive disease
* Contraindication for right heart catheterization
* Any change in disease-targeted therapy within 8 weeks prior to inclusion
* Walking impairment due to causes other than IPAH that would preclude performance of a 6MWT
* Any patient who has received any investigational medication within 8 weeks prior to the start of this trial or who is scheduled to receive another investigational drug during the course of the trial between visits V1 and V9
* Known intolerance to immunoadsorption in general or to one of the excipients (e.g. sheep antibodies or agarose) or other supporting agents
* Hemoglobin concentration of \< 75% below the lower limit of normal
* Systolic blood pressure \< 85 mmHg
* Lack of compliance or other similar reason that, in the judgment of the Investigator, precludes satisfactory participation in the trial
* Concurrent severe or uncontrolled medical disease (i.e. uncontrolled diabetes, congestive heart failure, myocardial infarction within 6 months prior to the study, unstable and uncontrolled hypertension, chronic renal disease, or active uncontrolled generalized viral, bacterial and/ or mycotic infection) which by assessment of the treating Investigator could compromise patients safety or participation in the study
* Drug or alcohol abuse within the last 5 years
* Hypercoagulability
* Known severe immunodeficiency (e.g. AIDS)
* Severe lung disease: FEV1/FVC \< 50%, total capacity \< 60% of normal value
* Indications that prohibit transient anticoagulation using Heparin and/or ACD-A-solutions
Advanced MRI Sequences for Radiation Therapy Treatment Planning

The purpose of this study is to determine if it would be helpful to use advanced MRI imaging techniques to take additional views of the tumor target for radiation treatment planning or treatment follow-up MRI.

The results of this research project will be used to establish a standard MRI protocol specific to each tumor or disease site. An MRI protocol is a list of MR image types that are acquired for each disease site. These images are used to generate the patient's treatment plan.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 years older of any race or gender with anal canal, brain, breast, cervix, esophagus, gynecology, head and neck, lung, pancreas, primary liver or liver metastases, prostate cancer or sarcoma either undergoing MRI scan for radiation treatment planning or a post treatment MRI
* Voluntarily signs an IRB approved consent form

Exclusion Criteria:

* Inability to obtain informed consent from the patient or their medical power of attorney
* Patients who are not undergoing MR for radiation treatment planning
* Patients who will not have MRI scans after treatment
* Patients with pacemakers or other non-MRI compatible metallic implants
* Pregnant women, by self report using a standard MRI questionnaire
* Patients who will not receive contrast agent as part of their standard MR, will participate only in the non-contrast portion of the study
Efficacy and Safety of Crinone Versus Combination Medication (ACCESS)

The study to compare to the efficacy and safety of Crinone versus combination medication in infertile women receive frozen-thawed embryo transfer (FET) in artificial cycles (AC).


Eligibility Criteria:
Inclusion Criteria:

Participants are eligible to be included in the study only if all the following criteria apply:

* Participants who will receive artificial frozen-thawed embryo transfer (FET) cycle study interventions
* Participants who have no more than two Day 5 embryos are planned to be transferred (follow the clinical practice of the study site)
* Participants have received estradiol valerate for no more than 20 days
* Participants have a transitional-endometrium of greater than or equal to 8 millimeter
* Participants have normal uterine cavity
* Participants can give signed informed consent
* Participants are willing to follow the study protocol and able to complete the study

Exclusion Criteria:

* Participants are willing to follow the study protocol and able to complete the study
* Participants with greater than or equal to three previously failed cycles of ET
* Participants with diseases that cannot tolerate pregnancy
* Hydrosalpinx
* Severe endometriosis (Endometriosis American Society for Reproductive Medicine (ASRM) criteria from 1996)
* Known hypersensitivity to progesterone, the excipients of Crinone and Duphaston Vaginal bleeding of unknown origin
* History of recurrent miscarriages
* Vaginitis
* Thromboembolic diseases (thrombophlebitis, thromboembolic disorder, or cerebral apoplexy) or participants with a history of these conditions
* Known or suspected progestogen-dependent neoplasm
* Participation in another clinical trial within the past 30 days
* Contraindications of both Crinone and Duphaston
Investigation of Physical and Emotional Status the Elderly Infected and Non-Infected With COVID-19

The aim of this observational study is to evaluate individuals in terms of balance, functional mobility, influences in activities of daily living, fear of COVID-19, moods, quality of life parameters in order to investigate the effects of COVID-19 on elderly individuals.

This study was carried out to investigate the status of elderly individuals who survived the COVID-19 in terms of different parameters such as balance, functional mobility, activities of daily living, quality of life, fear of COVID-19, depression. A total of 107 elderly individuals aged 65 and over were included in the study, including 52 elderly individuals who survived the COVID-19 and 55 elderly individuals who non-infected COVID-19. The sociodemographic information of the participants was recorded. The Berg Balance Scale was used to evaluate the balance levels, the Timed Up and Go Test was used to evaluate the functional mobility levels, and the Functional Independence Scale was used to evaluate the activities of daily living. The World Health Organization Quality of Life Instrument-Older Adults Module (WHOQOL-OLD) was used to evaluate the quality of life, the Fear of COVID-19 Scale was used to evaluate the COVID-19 Fear levels, the Geriatric Depression Scale was used to evaluate the symptoms of depression.

Eligibility Criteria:
Inclusion Criteria:

* Being an individual aged 65 and over voluntarily to participate in the study
* Not having a problem affecting understanding and speaking, having the ability to walk without any help

Exclusion Criteria:

* Having any musculoskeletal or neurological problem that may affect walking and balance
* Have a known mental problem
Impact of a built-in Insulin Calculator Feature on Diabetes Control - Pilot Study

The purpose of this study is to investigate the effect of using FreeStyle InsuLinx (a blood glucose meter with a built-in insulin calculator) on glucose control in people with type 1 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Subject with Type 1 diabetes on MDI (3 or more insulin injections per day (U100 insulin)) for at least 1 year and insulin adjusting
* HbA1c between 7.0% and 9.5% (53 to 80 mmol/mol) inclusive
* Age 18 and over
* In the investigator's opinion, thought technically capable of using masked CGM
* Subject self reporting a minimum of 21 SMBG tests per week prior to study enrolment
* Willing to perform a minimum of 4 SMBG tests per day during study

Exclusion Criteria:

* Subject has any concomitant disease or condition that, in the investigator's opinion, may compromise patient safety
* Subject is participating in another study of a glucose monitoring device / drug that could affect glucose measurements / management
* Subject is pregnant / planning to become pregnant within the planned study timeline
* Subject is known to require a dose of more than 50 units of U100 insulin in any one bolus injection
* Subject is currently on an insulin pump
* Subject is currently using the FreeStyle InsuLinx
* Subject is currently using the FreeStyle Freedom Lite
* Subject is currently using CGM
* Subject has an allergy to medical grade adhesives
Beta-blocker Administration for Cardiomyocyte Division

Heart failure is a common long-term complication in patients with congenital heart disease (CHD). Medical treatments to promote regeneration of new healthy heart muscle cells have the potential to provide new heart failure treatments for these patients. The development of such therapies is limited by the poor understanding of the ways in which heart muscles grow after birth. Investigators have learned that humans without heart disease generate new heart muscles cells up to the age of 20 years old and that this is decreased in patients with congenital heart disease like Tetralogy of Fallot. Investigators are trying to determine if treatment with a medicine called Propranolol can increase heart muscle cell proliferation and, with that, normalize heart growth. Investigators will examine discarded heart muscle tissue that is obtained during surgery for the presence of new heart muscle cells. Propranolol is approved by the Food and Drug Administration (FDA) to treat a certain kind of benign tumor in infants (hemangioma), but it is not currently approved by the FDA to increase heart muscle growth.


Eligibility Criteria:
Inclusion Criteria:

* Male and female infants \< 45 days of age with a diagnosis of tetralogy of Fallot with pulmonary stenosis or double outlet right ventricle, tetralogy type by echocardiogram, who weigh greater than 2 kg at the time of consent and are tolerating enteral feeds.
* DORV variant

Exclusion Criteria:

* congenital atrio-ventricular block on EKG (PR interval \> 120 ms),
* concomitant medication administration that interacts with propranolol,
* patient family is, in the opinion of the investigator, unable to comply with the requirements of the study protocol or is unsuitable for the study for any reason,
* gestation age \< 35 weeks,
* infants of diabetic mothers, asthma or underlying respiratory disease,
* presence of metal implants in infants.
Preliminary Study on the Metastatic Rate and Clinical Significance of the Anterior Leaf of Vesicouterine Ligament in Early Stage Cervical Cancer

The purpose of this study is to preliminarily explore the metastatic rate and clinical significance of the anterior leaf of vesicouterine ligament resection for early stage cervical cancer, so as to further improve the postoperative quality of life of patients and reduce the incidence of postoperative urinary complications.

The patients with cervical cancer who underwent abdominal radical hysterectomy（type C）plus pelvic lymph node dissection by the same surgical team at the Department of Gynecological Oncology, Sun Yat-sen Memorial Hospital, Sun Yat-Sen University, were included. According to the resection range of the anterior leaf of vesicouterine ligament (VUL), patients were divided into type C resection group (near the bladder wall) and B type resection group (above the ureter). The anterior leaf of the VUL in the type C resection group was sent to pathological biopsy separately, and the metastasis rate was further clarified by the pathological "ultrastaging" method. By comparing the clinicopathological characteristics of patients with metastasis and non-metastasis, the potential risk factors of VUL metastasis were analyzed. The oncological outcomes of patients with different resection range of the anterior VUL were compared. At the same time, the Functional Assessment of Cancer Therapy-Cervical（FACT-Cx）cervical cancer patient quality of life score table was used to evaluate cervical cancer patients after surgery. The relevant factors that may affect the quality of life score are included in the multiple linear regression analysis to obtain independent risk factors that affect the quality of life of the patient after surgery.

Eligibility Criteria:
Inclusion Criteria:

1. Histological confirmation of squamous, adenocarcinoma, or adenosquamous cervical carcinoma (even neuroendocrine or clear cell carcinoma)
2. Radiographically confirmed tumor limited to the cervix or upper third vagina, but without evidence of lymph node metastasis
3. Stage IA2-IIA2 ( FIGO 2018)
4. Treated initially or just underwent cervical conization before
5. Underwent the abdominal type C (Q-M classification) radical hysterectomy with pelvic lymph node dissection by the same team
6. Underwent the bilateral type C AL-VUL resection during the surgery
7. The Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Exclusion Criteria:

1. Not stage IA2-IIA2 ( FIGO 2018)
2. History of abdominal or pelvic radiotherapy
3. Evidence of metastatic disease detected by PECT, MRI or CT
4. The surgeon evaluated the patient as unsuitable for abdominal radical hysterectomy or the patient as refusing abdominal surgery
5. Patients with other mailgnant tumors except cervical cancer
6. Incompetence of the clinical, surgical and pathological data
Impact of Extended CPAP on Bronchopulmonary Dysplasia

The purpose of this pilot study is to compare if keeping infants on CPAP (continuous positive airway pressure) support for an extended period of time until they are 32 weeks corrected gestational age or 1250 grams (approximately 2 pounds and 12 ounces) will decrease their degree of lung disease as compared to weaning their respiratory support to HFNC (high flow nasal cannula).

There are two ways to help premature babies breathe. Both HFNC and CPAP are commonly used in our NICU. CPAP, which helps your baby breathe without a tube in their windpipe (intubation or ventilator), delivers oxygen and air by pressure through either small prongs in the nose or a nose mask, keeping your baby's airways open. HFNC provides heated and humidified oxygen and air by small prongs in the nose that does not use high pressure to the airways. Our goals are to reduce long term complications such as lung disease of prematurity, also called Bronchopulmonary Dysplasia (BPD). BPD causes "lung damage/scarring, need for a ventilator or oxygen, brain/neurological impairment etc. In recent years, HFNC has become a common choice for care. There is no clear agreement in previous research which way may be best to reduce BPD.

Eligibility Criteria:
Inclusion Criteria:

* babies born at \<30 weeks' gestation
* babies who are extubated to non-invasive ventilation by 32 weeks postmenstrual age

Exclusion Criteria:

* babies born at \<30 weeks' gestation
* requiring less than 2L NC at birth or
* those who are extubated after 32.0 weeks' postmenstrual age
* congenital anomalies
* skeletal disorders
* neuromuscular disorders
* genetic syndromes
Efficacy and Safety of Prescription Omega-3 Fatty Acid Added to Stable Statin Therapy in Patients With Type 2 Diabetes and Hypertriglyceridemia

Assess efficacy and safety of Omacor® 4g with statin treatment for lowering TG levels in subjects with type 2 Diabetes combined with hyperlipidemia


Eligibility Criteria:
Inclusion Criteria:

* LDL-C \< 100mg/dL, TG \> 150mg/dL, patients on statin treatment for at least 6 weeks prior to randomization.
* Type 2 Diabetes
* HbA1c ≤ 10.0

Exclusion Criteria:

* Type 1 Diabetes
* Patients with PPAR gamma agonist therapy
* Patients with acute MI, Unstable angina within 6 months
* History of malignant tumor within 2 years
* Women with pregnant, breast-feeding
A Comparative Study of Adding Ipratropium to Salbutamol for the Treatment of Asthma Attack in Children

The goal of this clinical trial was to determine if adding ipratropium bromide to salbutamol improves asthma treatment in children.

The main question this study aimed to answer was:

Does combining ipratropium with salbutamol improve asthma symptoms more effectively than salbutamol alone?

Researchers compared salbutamol alone to a combination of salbutamol and ipratropium in children with acute asthma.

Participants:

(i) Received either salbutamol alone or salbutamol with ipratropium via nebulization for 4 hours

(ii) Had their asthma symptoms assessed before and after treatment

(iii) Were discharged with continued treatment and counseling if stable

This study was conducted in the Department of Pediatric Medicine, Children's Hospital Multan, over six months. A total of 60 children with acute asthma were included.

Children presenting with asthma exacerbation were assessed for eligibility. Eligible participants had their baseline characteristics recorded including age, gender, history of parental asthma, duration of asthma diagnosis, use of asthma controllers (inhaled corticosteroids, Long Acting Beta Agonist (LABA), Montelukast) \& baseline pulmonary asthma score. Through lottery method using sequentially numbered sealed opaque envelopes children were assigned to group A and group B treatments. At the end of 4-hours of therapy, pulmonary asthma score was re-assessed by pediatrician not aware of treatment assigned. Once stabilized, the children were discharged on regular nebulization therapy with controller medication after proper counseling.

Eligibility Criteria:
Inclusion Criteria:

* Children with acute asthma exacerbation (presenting with wheeze, labored breathing with ronchi audible on auscultation)
* Within 12 hours of symptom onset

Exclusion Criteria:

* Children with known pulmonary and/or cardiac congenital malformations
* Bronchopulmonary dysplasia
* Cystic fibrosis
* Post infectious bronchiolitis obliterans
* Altered mental status on presentation with imminent respiratory failure (pulmonary asthma score ≥ 10, cases needing PICU care)