cyrilzakka/clinical-trials huggingface dataset:
SEMS Placement Followed by Chemotherapy and Surgery for Obstructing Left-sided Colonic Cancer

This study aimed to evaluate the safety and feasibility of SEMS followed by neoadjuvant chemotherapy prior to elective surgery for obstructing left-sided colon cancer.

Stoma is reported to be frequent in self-expanding metallic stent (SEMS) treated patients with obstructing left-sided colon cancer than in those with non-obstructing surgery. Retrospective study reported worse overall survival with SEMS and elective surgery than with emergency surgery in patients with left-sided malignant colon obstruction. In practice, intestinal wall edema following stent placement increases the difficulty of surgery, and this could be a major problem if the interval between stent insertion and surgery is short (1-2 weeks). The patients with obstructing left-sided colon cancer received SEMS treatment, and the recevied neoadjuvant chemotherapy prior to elective surgery.

Eligibility Criteria:
Inclusion Criteria:

1. histologically proven adenocarcinoma located in the left colon (between the splenic flexure and 15 cm proximal to the anal margin)
2. Eastern Cooperative Oncology Group (ECOG) performance status of from 0 to 2

Exclusion Criteria:

1. history of any other cancer
2. multiple primary colorectal cancers
3. distant metastases
4. hereditary nonpolyposis colorectal cancer
5. familial adenomatous polyposis
A Study to Compare the Impact of a School Based HPV Program on Vaccination Uptake and Completion Rates

The purpose of this study is to evaluate the impact of a school-based Human Papillomavirus (HPV) vaccination program to determine if the combination of increased disease and vaccine education coupled with the removal of barriers will positively impact the HPV vaccination uptake and completion rates among students.

The purpose of this study is to evaluate the impact of a school-based HPV vaccination program. The intervention will consists of: provision of HPV vaccine information and consent forms for parents delivered in the back-to-school packets; school-nurse delivered student education; removal of barriers (scheduling, transportation and parental presence); changing of social norms; and the provision of free HPV vaccine.

Eligibility Criteria:
Inclusion Criteria:

* Must have not completed three dose series of HPV vaccine
* Must be a student at Wayne County or Monticello High School in KY

Exclusion Criteria:

* Completed three dose series
* Pregnant
* Contraindication to vaccine ingredients
Comparison of Small Colorectal Polyp Removal Using Cold EMR With Hot EMR

This study evaluates the efficacy of small colorectal polyp removal using cold endoscopic mucosal resection with hot endoscopic mucosal resection. Half of the participants will receive cold endoscopic mucosal resection, while the other half will receive hot endoscopic mucosal resection.

Colorectal polyps are considered as precancerous lesions and endoscopical resection is currently the treatment of choice when it is possible.

Colorectal polyps are classified into diminutive polyps (\<5mm in diameter), small polyps (6-9mm in diameter), and large polyps (\>1cm in diameter). There are several endoscopical treatment methods: cold biopsy forceps polypectomy, cold snare polypectomy, hot biopsy forceps polypectomy, hot snare polypectomy, and endoscopic mucosal resection. Cold polypectomy means mechanical removal of the polyp with snare or biopsy forceps without the use of electrocautery, and hot polypectomy means removal of the polyp with the use of electocautery.

Eligibility Criteria:
Inclusion Criteria:

* Patients with colorectal polyps that are \<1cm in diameter who need endoscopic mucosal resection.

  * Patients who gave informed consents to this study.

Exclusion Criteria:

* Patients under the age of 19
* Patients who are receiving antiplatelet or anticoagulant therapies
* Patients with hypercoagulability (i.e., liver cirrhosis, hemophilia, end-stage renal disease, or chronic kidney disease)
Self-management for Dual Sensory Impaired

This study aims to determine the effectiveness of a self-management program for elderly with an acquired and concurrent hearing and visual impairment due to age-related disease processes.


Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of hearing loss and low vision
* at least one sensory loss acquired after the age of 55
* living in a home for the elderly

Exclusion Criteria:

* congenital deaf persons
* a dual sensory loss before the age of 55
Medtronic Genetic Arrhythmia Markers for Early Detection (GAME Study)

To generate a list of potential genetic markers that correlate with an increased risk of life-threatening arrhythmias.

To evaluate ECG-based risk markers such as heart rate variability and T-wave Alternans for their association with arrhythmic events.

The primary objective is to establish the role of genetics in life-threatening arrhythmias leading to sudden cardiac death (SCD) and the potential utility of genetic markers in risk stratification of patients to receive an implantable cardiac defibrillator (ICD). The successful accomplishment of this goal would serve as the basis for future work on a specific diagnostic test that can be used to assess risks of threatening arrhythmias in order to quality patients for implantation of an ICD.

* to identify single nucleotide polymorphisms (SNPs) that can be used to identify individuals in need of an ICD.

The secondary objectives involve more detailed analysis to search for potentially unidentified genetic markers of risk for SCD.

1. to identify genes associated with SCD susceptibility.
2. to identify risk factors associated with SCD as found in the case report form (CRF).
3. to correlate SNPs with co-morbidities in the subjects as found in the CRF information.
4. to study the association between parameters derived from Holter recordings and predictors of life-threatening arrhythmias.

Eligibility Criteria:
Inclusion Criteria:

The following criteria apply to all subjects:

* Subject has an ICD or CRT ICD implanted
* Subject must be on optimal medical therapy
* Subject is a Caucasian with all 4 grandparents believed to be Caucasian
* Subject has had a myocardial infarction (MI) prior to ICD implantation
* Subject is willing and able to comply with the study protocol
* Subject is willing and able to sign and date the study Informed Consent and HIPAA Authorization (US)

Case Inclusion Criteria:

The following criteria apply to case subjects only:

* Subject is at least 40 years of age at time of ICD implantation
* Subject has at least one documented life-threatening arrhythmia (LTA) on their ICD that can transferred as a save-to-disk or has had an LTA documented in their medical history. LTA is defined as a true VT/VF episode with cycle length less than or equal to 400ms that was terminated by the device.

Control Inclusion Criteria:

The following criteria apply to control subjects only:

* Subject is currently at least 70 years of age
* Subject has haad currently implanted Medronic ICD for a minimum of three years

Exclusion Criteria:

The following criteria apply to all subjects:

* Subject has received a bone marrow or heart transplant at any time
* Subject has a previously identified cause for arrhythmias (Brugada, LQT, HCM)

Control Exclusion Criteria:

The following criteria apply to control subjects only:

* Subject has had a potentially LTA documented on their ICD
* Subject was previously identified as having a LTD at any time in life
* Subject has had the memory on their ICD cleared at any time in the past three years.
Bilirubin Neurotoxicity (BN) and Neurodevelopmental Impairment (NDI) in Extremely Preterm (EP) Infants: Avoidable by Reducing the Usual Intravenous Lipid (UL) Administration

The purpose of this study is to evaluate the effect of usual versus reduced lipid intake on unbound bilirubin levels, brainstem auditory evoked responses, and neurodevelopmental outcome at 2 years in extremely preterm infants.


Eligibility Criteria:
Inclusion Criteria:

* no major congenital anomaly or overt nonbacterial infection
* mother has consented to inclusion of the infant for the Neonatal Research Network (NRN) Cycled Phototherapy Trial

Exclusion Criteria:

* has received Intralipid
Smartphone-based Mindfulness Training for Chronic Pain

The purpose of this study is to test a smartphone-based mindfulness training program for chronic pain. Research participants use a 20 minute app-guided audio program six days per week. The study hypothesis is that training in this technique over a period of four weeks will reduce pain interference with daily life activities. This study does not require any travel or in-person contact with research staff-- all elements of the study are completed on the participant's smartphone.

This is a randomized, waitlist controlled trial. Smartphone users who download the research app complete an electronic informed consent before the app content is made available. Subjects meeting inclusion criteria are then prompted to complete baseline questionnaires. Submission of questionaires triggers randomization to one of two groups-- active treatment or waitlist. Subjects have equal chance of entering either group.

The active treatment group is instructed to use the app-guided "body scan" exercise daily for six days per week. The waitlist group is instructed that the research intervention will be made available to them in four weeks time. On a weekly basis, all subjects complete a Brief Pain Inventory scale. At the end of four weeks, subjects again complete a Brief Pain Inventory as well as the questionnaires measuring secondary outcomes. Upon completion of the control condition, waitlist subjects are invited to begin using the "body scan" exercise as described above. From this point forward, subjects receive the same protocol as the active treatment group. This study involves no face-to-face contact between participants and study investigators/staff.

Eligibility Criteria:
Inclusion Criteria:

* English speaking
* Pain duration at least 3 months
* Access to smartphone

Exclusion Criteria:

* Pain from active cancer
* Pain from active cardiac disease
A Clinical Evaluation of a Steroid-Coated Sinus Stent When Used Following Functional Endoscopic Sinus Surgery in Patients With Chronic Sinusitis

The purpose of this study is to assess the safety and efficacy of the Propel mometasone furoate implant when used following Functional Endoscopic Sinus Surgery (FESS) in patients with Chronic Sinusitis (CS).

The purpose of this study is to assess the safety and efficacy of the Propel mometasone furoate implant when used following Functional Endoscopic Sinus Surgery (FESS) in patients with Chronic Sinusitis (CS). The Propel implant is designed to provide a mechanical spacing function within the sinus anatomy to separate mucosal tissues, provide stabilization of the middle turbinate, and thereby prevent tissue adhesions from forming. The implant is coated with a small amount of mometasone furoate (a corticosteroid) in order to help minimize post surgical inflammation within the supported tissues.

The study utilizes an intra-patient control design to assess the safety and efficacy of the drug-coated implant compared to the non-drug coated implant that is identical in appearance.

Eligibility Criteria:
Inclusion Criteria:

* Patient has bilateral chronic sinusitis confirmed by CT scan and defined as inflammation of the mucosa of the nose and paranasal sinuses of at least 8 consecutive weeks' duration.
* Patient is indicated for and has consented to FESS.
* FESS successfully completed without significant complication that in the opinion of the physician would confound study results and the patient's anatomy remains amenable to Sinus Stent placement.

CT Imaging Inclusion Criteria:

* CS diagnosis confirmed and documented by CT Scan within 6 months of the procedure.
* Patient has minimum total CT score (Lund-Mackay method) of 6. • Patient has bilateral ethmoid sinus disease confirmed by CT.

Exclusion Criteria:

* insulin dependent diabetics
* oral steroid dependent condition
* glaucoma, ocular hypertension, posterior subcapsular cataracts
* middle turbinate resection
Comparison Between Aesthetic Functional Appliances and Twin Block in Correction of Skeletal Class II

The goal of this is to evaluate the skeletal, dental and soft tissue effects between aesthetic functional appliance and Twin block appliance in treatment of skeletal class II in ( growing male/female patients)

The sample will be randomly divided into 2 equal groups according to the appliance will be used:

Group 1: Aesthetic Functional appliance Group 2: Twin block

Methods:

\*Radiographs (CBCT) will be taken before starting the treatment (T1) and after obtaining Class I occlusion and normal overjet (T2) by sequential appliances.

appliances.

* Lateral cephalograms -extracted from CBCT- will be used to evaluate the effect of the two appliances.
* CBCT will be used to evaluate root resorption and bony changes in the condyle .

Eligibility Criteria:
Inclusion Criteria:

* Skeletal Class II pattern with ANB angle exceeding 6° and Wits appraisal of 2 mm or more.
* Mandibular deficiency (SNB angle less than 77°).
* Growing patients.
* No prior orthodontic intervention.
* The vertical skeletal classification shows a horizontal or neutral growth pattern.
* Overjet ≥ 8mm.

Exclusion Criteria:

* Developmental abnormalities with atypical or irregular patterns of growth and maturation.
* Any indications or manifestations, as well as any prior medical records, of Tempro-Mandibular Joint (TMJ) disorders, such as the presence of clicking, pain, limitations, or deviations.
Assessment of Initial Efficacy and Safety of High Intensity Focused Ultrasound 'ExAblate 4000 Type 2' for Blood Brain Barrier Disruption in Patients With Alzheimer's Disease

The proposed study is to evaluate initial efficacy and safety of the BBB disruption with transcranial MRI-guided focused ultrasound (ExAblate 4000 type 2.0) in patients with Alzheimer's disease.

This study iw designed as a prospective, single-site, single-aarm, nonrandomized study. Assessments will be made before and three months after 2 sessions of BBB disruption with radiologic, nuclear medicine imaging and neurophysiological examinations. Relative safety will be evaluated using a common description of Significant Clinical Complications for patients treated in this study.


Eligibility Criteria:
Inclusion Criteria:

* Age between 50 and 85 years, inclusive.
* Total score of 23 or less on the Korean version of Mini Mental state Exam (K-MMSE)
* FBB (18F-Florbetaben)-PET test result positive
* FDB (18F-Fluorodeoxyglucose)-PET test results suspected of Alzheimer disease-induced neurodegeneration
* Mild cognitive impairment or dementia caused by Alzheimer's disease
* A participant who has been given a drug at a stable dose for at least three months to improve symptoms of Alzheimer's disease
* Able to communicate during the ExAblate BBB disruption procedure
* Able and willing to give informed consent
* Able to attend all study visits

Exclusion Criteria:

* CGA-NPI (Caregiver-Administrated Neuropsychiatry Inventory) severity score of more than 2 points for any of "Delusion", "Hallucination" or "Agitation/Aggression"
* Known sensitivity/allergy or contraindications to MRI contrast agent(Gadovist®) or the ultrasound contrast agent (Definity®)
* Contraindications to MRI such as non-MRI compatible implanted devices.
* Any of the following items in MRI

  1. severe ischemic changes
  2. active or chronic infection/inflammation
  3. acute or chronic hemorrhage
  4. tumor/space occupying lesion
  5. meningeal enhancement
  6. intracranial hypotension
* More than 30% of the skull area traversed by the sonication pathway is covered by scars, scalp disorders (e.g., eczema), or atrophy of the scalp
* Active seizure disorder or epilepsy (seizures despite medical treatment)
* History of a bleeding disorder, coagulopathy
* Cardiac disease or unstable hemodynamics
* Severely impaired renal function with estimated glomerular filtration rate \<30 mL/min/1.73m2
* Severe brain atrophy
* HIV (Human immunodeficiency virus) positive, who have a high probability of developing HIV encephalitis due to the influx of HIV in to the brain parenchyma
* Subjects with evidence of cranial or systemic infection
* A homozygosity of Apolipoprotein E allele (ApoE4) known to have a thin blood-brain barrier
* Positive pregnancy test (women of childbearing potential)
* A participant in other clinical trials or have experience in other clinical trials within 90 days from the screening date
BHCG Level in Day 4,7, in Comparison to Day 10 as an Indicator for Treatment Success

The investigators want to compeer BHCG levels after Methotrexate ( MTX). treatment for Ectopic pregnancy in days 4 and 7 after MTX. to day 10 . The hypothesis is that "BHCG" level in day 10 is the best indicator for treatment success , superior to day 4 and 7 . According to the investigators impression BHCG level rises in days 4 and 7 due to destruction of the trophoblast tissue , and only day 10 is an indicator for treatment success


Eligibility Criteria:
Inclusion Criteria:

* patients with ectopic pregnancy
* healthy
* hemodynamic stable
* first ectopic

Exclusion Criteria:

* hemodynamic non-stable
* abnormal liver or kidney function
* allergy reaction to MTX
A Clinical Study of GZR33 and GZR101 in Healthy Subjects

This study evaluates the safety, tolerability, pharmacokinetics, and pharmacodynamics of GZR33 and GZR101 in healthy adult male subjects.This study consists of Part A and Part B.

Part A is a randomized, open-label, single-dose, two-sequence, two-period, cross-over design comparative study evaluating the PD and PK characteristics of GZR33 and Insulin Degludec Injection.

Part B is a randomized, double-blind, placebo-controlled, multiple-dose, parallel-group design study evaluating the safety, tolerability, immunogenicity, and PK of GZR33 and GZR101.


Eligibility Criteria:
Inclusion Criteria:

* 1. Voluntarily participated in the study and signed the informed consent form (ICF);
* 2.Chinese healthy male adult subjects aged 18-45 years old (including 18 and 45 years old as of the date of signing the ICF);
* 3.During screening period, the body mass index (BMI) between 19.0 and 24.0 kg/m2, inclusive, and a body weight\>50 kg (not containing 50kg).

Exclusion Criteria:

* 1.History of drug abuse within one year prior to screening.
* 2.History of alcohol abuse within 6 months prior to screening (alcohol abuse is defined as more than 14 units weekly: 1 unit of alcohol equals to 360 mL of beer, 150 mL of wine, or 45 mL of 40% alcohol).The subject who smoke more than 5 cigarettes per day within 3 months prior to screening, smoke within 48 h prior to the use of the investigational drug, and is unwilling to refrain from smoking and drinking during the trial period.
* 3.Allergic constitution, or history of bronchial asthma, hives, eczema and other allergic diseases (except mild asymptomatic seasonal allergy), or known allergy to the investigational drug or its excipients, hypersensitivity or intolerance.
* 4.Hepatitis B surface antigen (HBsAg), hepatitis C antibodies, syphilis spiral test or human immunodeficiency virus (HIV) antibodies positive.
* 5.History of needle and blood sickness, and subject couldn't tolerate venipuncture for blood collection, or be difficult to collect blood.
Efficacy and Safety of SHR-1314 by Subcutaneous Injection in Active Moderate to Severe Graves' Orbitopathy Patients

This is a single-arm, prospective, open-label, Phase II study that explored the efficacy and safety of SHR-1314 in active moderate to severe Graves' Orbitopathy. The study consists of a 6-week screening period, a 16-week treatment period, and a 12-week follow-up period. Eighteen adult patients with active moderate to severe Graves' Orbitopathy will be enrolled. Eligible subjects will receive SHR-1314 subcutaneously. The primary endpoint was the proptosis responder rate and will be evaluated at 16weeks.


Eligibility Criteria:
Inclusion Criteria:

1. Patient must be able to understand and communicate with the investigator and comply with the requirements of the study and must give a written, signed and dated informed consent before any study assessment is performed.
2. Male or female between the ages of 18 and 70 (including boundary values)
3. Onset of active GO symptoms fewer than 9 months prior to baseline.
4. Clinical diagnosis of Graves' disease associated with active GO with a CAS ≥ 3 (on the 7-item scale) for the most severely affected eye(study eye) at Screening and Baseline.
5. Moderate-to-severe active GO (not sight-threatening but has an appreciable impact on daily life).
6. Does not require immediate surgical ophthalmological intervention.

Exclusion Criteria:

1. Pregnant or lactating women.
2. allergy to the study drug or to any component of the study drug.
3. Significant abnormalities in laboratory and ECG.
4. Decreased best corrected visual acuity due to optic neuropathy as defined by a decrease in vision of 2 lines on the Snellen chart, new visual field defect, or color defect secondary to optic nerve involvement within the last 6 months.
5. Corneal decompensation unresponsive to medical management.
6. Decrease in CAS of ≥ 2 points between Screening and Baseline.
7. Decrease in proptosis of ≥ 2 mm between Screening and Baseline.
8. Previous orbital irradiation or surgery for TED.
9. Any other ophthalmic disease that might interfere the study or the study result confirmed by investigator.
10. Patients with serious, progressive and uncontrolled cardiovascular, liver, kidney, lung, gastrointestinal, hematopoietic, endocrine, nervous and psychiatric diseases, or other conditions that considered inappropriate for patients to participate this study.
Classification of Adult-onset Diabetes in Five Subgroups in Pakistani Population

This study aims to classify adult-onset diabetes patients into distinct data-driven clusters, such as severe insulin-deficient, severe insulin-resistant, mild obesity-related, and mild age-related diabetes, based on clinical and biochemical characteristics. Using a cross-sectional design, data will be collected from individuals attending outpatient diabetes clinics at tertiary care hospitals in Pakistan. The study will analyze the distribution of metabolic and demographic characteristics within each cluster and assess subgroup-specific risks for diabetic complications. Additionally, the relationship between clustering variables and the risk of complications will be evaluated to enhance the understanding of diabetes heterogeneity and its impact on patient outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Patients of both genders whose age of disease onset was older than 16 years
* Patients newly diagnosed with or previously diagnosed with T2D
* Able and willing to provide written informed consent and to comply with the study

Exclusion Criteria:

* Patients with other medical comorbidities (not a complication of diabetes), such as malignancies.
* Pregnancy