cyrilzakka/clinical-trials huggingface dataset:
Abdominal Muscle Exercises on Nocturia and Sleep Quality in Women With Type 2 Diabetes

Nocturia is the leading cause of sleep disruption with its subsequent negative impact on general health and QoL for a large proportion of the adult population. Nocturia is prevalent in men and women of all ages but may be particularly bothersome in younger adults, in whom the consequences of sleep disturbance may be more detrimental for daytime functioning and possibly for health and mortality.The underlying causes of nocturia obviously influence the efficacy of different treatment options. Because a major cause of nocturia is overproduction of urine at night, nocturia may not respond to treatments designed to reduce urgency and increase bladder capacity or increase urine flow, such as agents for the management of bladder outlet obstruction.

Nocturia may be more than simply a patient inconvenience, in view of its association with increased risk of morbidity and mortality. Clinicians often underestimate the consequences of nocturia, however, and thus fail to perform a thorough evaluation of the condition and its causes. Patients with nocturia deserve full consultation and implementation of an appropriate management strategy to ensure that the specific underlying medical conditions associated with nighttime voiding are addressed. Investigators should help women with nocturia as to improve their sleep. Participants will strengthen their pelvic floor muscles and abdominal muscles to control voiding so their sleep will not disturb to decrease their sufferance.

Eligibility Criteria:
Inclusion Criteria:

* Female Patients have had type II diabetes mellitus for more than 5years.
* HbA1c value from 6.5% to7.5%.
* Sleep deprivation for more than one month.
* Medically stable patients
* Blood glucose level from 130 to 150
* Patients are not pregnant
* Body mass index is 25 to 29.9 kg / m

Exclusion Criteria:

* Unstable medical condition.
* On antidepressors or anxiety treatment.
* With ant musculoskeletal or neurological conditions that might interfere with the execution or the assessment of the exercise.
* Cushing's disease (hypercortisolism) or Addison's disease (hypocortisolism).
Electrolysis Percutaneous Therapeutic (EPTE) for Supraspinatus Tendinopathy

Therapeutic management of supraspinatus tendinopathy is conflicting. There is evidence that eccentric exercise protocols can be effective for this condition. The inclusion of other therapeutic modalities could help to the management of these patients. A new therapeutic approach, called Electrolysis Percutaneous Therapeutic (EPTE) has been clinically developed. The objective of this randomized clinical trial is to determine the effectiveness of the inclusion of EPTE into a eccentric exercise protocol for the management of patients with unilateral supraspinatus tendinopathy


Eligibility Criteria:
Inclusion Criteria:

* Unilateral supraspinatus tendinopathy
* Shoulder pain from at least 3 months
* Shoulder pain of more than 4 points on a NPRS
* Positive findings of supraspinatus tendinopathy on MRI

Exclusion Criteria:

* bilateral shoulder symptoms
* younger than 18 or older than 65 years
* history of shoulder fractures or dislocation
* cervical radiculopathy
* previous interventions with steroid injections
* fibromyalgia syndrome
* previous history of shoulder or neck surgery
* any type of intervention for the neck-shoulder area during the previous year
A Study of Technology to Improve Glucose Control in Participants With Type 1 Diabetes

The main purpose of this study is to determine whether combining meal, glucose, and insulin data in a web-based system will improve management of type 1 diabetes (T1D). No study drug will be given. The study will last about 18 weeks.


Eligibility Criteria:
Inclusion Criteria:

* T1D by clinical diagnosis for \> 3 years
* Insulin pump use \> 3 months: must use one of the following pump types: Animas Ping and Vibe, Insulet Omnipod, Medtronic 523/723 and 530G, Tandem t:slim and t:flex
* Continuous Glucose Monitor (CGM) \> 3 months and current use of Dexcom G5 at least 6 out of 7 days per week
* HbA1c 7.0-9.5%
* Must have iPhone (meal-tagging app has been built on iOS)
* Personal computer for uploading of pump and CGM devices
* Willingness to follow study protocol including tagging food data
* Comfort speaking, reading, and writing English

Exclusion Criteria:

* Individuals currently using a hybrid closed-loop system (e.g., Medtronic 670G)
* Individuals planning to follow a specific diet plan for weight loss
* Inability to consume "common meals"
* Gastroparesis;
* Eating disorder
* Evidence of missed insulin meal-time insulin boluses on pump download
* Use of medications that can affect blood glucose levels (such as SGLT inhibitors, steroid, beta agonists)
* Use of medications that affect gastric emptying (such as GLP agonists, pramlinitide)
* Alcohol abuse
* Pre-conception, pregnancy, or lactation
PENG vs. FIC Blocks in Hip Fractures in the ED

This study is a prospective, randomized clinical trial assessing the efficacy of physician-performed ultrasound-guided pericapsular nerve group (PENG) block vs fascia iliaca compartment (FIC) block for pain control in acute hip fracture.


Eligibility Criteria:
Inclusion Criteria:

* Adult (\>= 18 years of age)
* Isolated proximal hip fracture (defined as Intertrochanteric or more proximal) as identified by X-ray, Computed Tomography (CT) scan or Magnetic Resonance Imaging (MRI) scan
* Glasgow Coma Score (GCS) = 15
* Subjective pain score of \>= 5 on a scale of 0 to 10 just prior to the nerve block placement

Exclusion Criteria:

* Patients who are unable to give consent due to altered mental status or dementia
* Clinically intoxicated patients
* Patients who are unable to communicate their numeric level of pain
* Open fracture or penetrating hip trauma
* Signs of infection or laceration at injection site
* Patients with multi-system trauma
* Painful distracting injury (injury causing significant pain that distracts the patient from having reliable scoring of hip fracture pain, e.g. humerus fracture, dislocated joint)
* Requiring immediate surgical intervention (\< 1 hour)
* Deemed clinically unstable by treating physician
* Abnormal vital signs (Pulse\>120bpm, Systolic blood pressure \< 100 mm Hg, Pulse O2 \< 95%)
* Patients on long-acting systemic opioid analgesia
* Allergy to amide local anesthetics
* Vulnerable populations including pregnant patients, prisoners, children, elderly dementia patients. All precautions will be taken to avoid coercion, harm and exploitation of these vulnerable populations, thus they are to be excluded from this study. They will receive pain medications as deemed appropriate by their treating physician.
Gene Expression Following Short Term Exposure to Neoadjuvant Endocrine Therapy in Invasive Breast Cancer

The purpose of this pilot study is to see if taking anastrozole (Arimidex) for 10 days causes changes in breast cancer cells. Anastrozole (Arimidex) is a drug used in the treatment of a type of breast cancer that depends on estrogen to grow. This type of breast cancer is called estrogen receptor positive breast cancer. Anastrozole (Arimidex) works by blocking an enzyme in your body called aromatase. Aromatase is found in your muscles, fat, liver and in breast tumors. This enzyme is important for making estrogen in women who are no longer having menstrual periods. Anastrozole decreases levels of estrogen in the body. We are interested in seeing if taking anastrozole for 10 days will cause changes in breast cancer cells. We will study cell processes such as how they make new blood vessels, how quickly the cells multiply, and how soon they die. We will also study which genes in the breast cancer tissues are turned on or off by taking anastrozole for 10 days.

This is an exploratory study utilizing micro-array technology and immunohistochemistry to test the hypothesis that changes in gene expression occur as an early event in response to endocrine therapy and that these changes can be correlated with changes in surrogate biological markers.

Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal patients, defined as one or more of the following criteria:

Documented history of bilateral oophorectomy, Aged 60 years or more,

Aged 45-59 years and satisfying one or more of the following criteria:

Amenorrhea for at least 12 months and intact uterus Amenorrhea for less than 12 months and follicle stimulating hormone (FSH) concentrations within postmenopausal range including: patients who have had a hysterectomy and patients who have received hormone replacement therapy in the past.

* Clinically palpable or non-palpable T1c or greater, ER positive invasive breast cancer diagnosed by outside core biopsy.
* Outside diagnosis of invasive breast cancer confirmed at MSKCC
* Palpable or non-palpable breast mass \> 1cm highly suspicious for invasive breast cancer based on mammographic, ultrasound and/or physical examination findings and amenable to diagnostic core biopsy.
* Core biopsy diagnosis of ER positive invasive breast cancer performed at MSKCC
* Breast conserving surgery or mastectomy scheduled at MSKCC.
* Informed consent obtained.

Exclusion Criteria:

* Co-morbid conditions which would preclude use of aromatase inhibitors such as: previous hypersensitivity, severe hepatic insufficiency (SGOT or SGPT three times the upper limit of normal), severe renal insufficiency (creatinine clearance \<10ml/min).

Prior radiation therapy to chest wall / breast.

* Neoadjuvant chemotherapy
* Hormone replacement therapy, tamoxifen or raloxifene treatment within past 3 months
* ER negative breast cancer
* History of active malignancy within the previous 5 years (except for nonmelanoma skin cancer and breast cancer)
Pulsenmore ES Device, Efficacy and Safety Assessment

This is a multicenter, prospective, investigational device study designed to evaluate:

The safety, feasibility, and accuracy of the device, when used by pregnant individuals


Eligibility Criteria:
Inclusion Criteria:

* Singleton gestation.
* Gestational age \>14 weeks with a prior scan demonstrating fetal viability and confirming dates.
* English or Spanish speaking.
* Ability to understand and sign the informed consent (available in English and Spanish).
* Ability to read and understand instructions that are required for equipment use (instructions available in both languages).

Exclusion Criteria:

* Multiple gestations.
* BMI \>40.
* Known fetal and genetic anomalies.
* Subjects with skin problems in the abdominal area (such as wounds, cuts in the skin, and skin rash).
* Subjects allergic to the ultrasound probe materials.
* Non-English/ non-Spanish speaking.
* Unable to provide consent.
Metformin and Insulin to Pancreatic Cancer Related Diabetes (Type 3c)

About 80% of patients with pancreatic adenocarcinoma have aberrant fasting blood glucose at the time of diagnosis. The consistent association between pancreatic cancer and diabetes mellitus has long been recognized and even been termed as "chicken and egg". Many reports have found that pancreatic cancer can result in diabetes, which is called type 3c diabetes. New-onset diabetes is commonly observed in pancreatic cancer patients and has been considered as a potential screening sign. Moreover, diabetes has been found as a predictor of poor outcome in pancreatic cancer.

Pancreatic cancer cells have a strong dependence on glucose and they are well-known for their sweet teeth. High glucose is associated with impaired immunologic reaction, intolerability to chemotherapy, radiotherapy and other major treatments, an increased risk of pancreatic surgery. Given the linkage between pancreatic cancer and diabetes or high blood glucose, a clinical trial is needed to validate the effect of metformin and insulin on regulating blood glucose in type 3c diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed content obtained prior to treatment
* Age ≥ 18 years and ≤ 80 years
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Patients must have histologically confirmed pancreatic adenocarcinoma
* History of diabetes mellitus, or newly diagnosed diabetes mellitus according to the American Diabetes Association criteria
* The expected survival after surgery ≥ 3 months

Exclusion Criteria:

* Active second primary malignancy or history of second primary malignancy
* Patients who have received any form of anti-tumor therapy including surgery, chemotherapy, radiotherapy, interventional chemoembolization, radiofrequency ablation, and molecular targeted therapy
* Inflammation of the digestive tract, including pancreatitis, cholecystitis, cholangitis, etc
* Pregnant or nursing women
* Patients who are unwilling or unable to comply with study procedures
Intraoperative Lung Ultrasound in Pediatric Patients

Investigators hypothesized that perioperative lung ultrasound would be beneficial in pediatric patients undergoing cardiac surgery compared to those who did not receive lung ultrasound.


Eligibility Criteria:
Inclusion Criteria:

* Acyanotic congenital heart disease patients undergoing cardiac surgery under general anesthesia

Exclusion Criteria:

* History of surgery on the lungs
* Cyanotic congenital heart disease
* Abnormal preoperative chest radiograph findings including atelectasis, pneumothorax, pleural effusion, and pneumonia
* Considered inappropriate by the investigator
Remote Monitoring of Home Exercise in Peripheral Arterial Disease

Many patients with blockages in the arteries in their legs (peripheral arterial disease, "PAD") suffer from pain in their legs when walking. Exercise therapy is known to decrease pain levels as well as increase the distance that patients with PAD can walk. The purpose of this study is to understand whether home exercise using a digital exercise monitoring system (LIVMOR) with provider supervision/ feedback will improve walking distance compared to those undergoing home exercise using the same monitoring system but without provider supervision/ feedback.


Eligibility Criteria:
Inclusion Criteria:

* Age \>18
* Diagnosis of PAD (based on ABI \<0.9 in either leg or prior intervention) with mild/moderate claudication

Exclusion Criteria:

* Prior above ankle amputation
* Wheelchair bound
* Inability to walk \>200m during 6 min walk test
* Use of walking aid other than cane
* Walking impairment for reason other than PAD
* Critical limb ischemia
* Planned vascular surgery within next 3 months, recent surgery within past 3 months
Pain and Schizophrenia

The aim of the investigators project is to explore the mechanisms of pain insensitivity in patients with schizophrenia, in order to prevent its invalidating consequences. The investigators will couple methods of experimental psychology with EEG and blood samplings, in order to distinguish the role of non-painful perception, attention, aversive effects, and pain expression, and the investigators will explore an original neurobiological hypothesis regarding the activation of opioid receptors.


Eligibility Criteria:
Inclusion Criteria:

* Patients with schizophrenia (criteria DSM IV) or healthy controls matched with patients on age, sex and education level
* 18-55 years old

Exclusion Criteria:

* Past history affecting CNS
* Intake of psychotropic drugs, except for patients
* Metabolic disorder affecting sensory processing (diabetes)
* Intake of benzodiazepines
Compassionate Use of REGN-COV2 for the Treatment of COVID-19

Compassionate Use requests will be considered for individuals who test positive for SARS-CoV-2 and where there is reasonable basis to believe that the patient is infected with a susceptible variant.

Compassionate Use requests are only being considered in response to Individual Patient Investigational New Drug (IND) applications.

Eligibility Criteria:
Blind Elderly Melatonin Treatment Study

The primary focus of this five-year study will be to optimize the melatonin dosing regimen for synchronizing the body clocks of elderly blind individuals to the 24-hour day.

The investigators intend to study as many as 26 subjects through up to four melatonin treatment regimens, all of which involve a dose step-down in which the melatonin dose will be reduced gradually to find the lowest effective dose. The 4 treatment plans differ only in the start dose and the time of administration. Successfully treated subjects will enter a one-year intensive assessment of the safety and efficacy of melatonin treatment in which the subject will take the same dose for one year and complete biweekly assessments of efficacy and side-effects. The final phase of the study involves a placebo discontinuation, in which the subject's circadian rhythm will be returned to the baseline rhythm (this may take up to 6 months for some subjects).

Eligibility Criteria:
Inclusion Criteria:

* Adults 55-100 years old
* Blindness for at least one year, verified by an ophthalmologic exam
* Ability to comply with the requirements of the experimental protocol
* No clinically significant abnormalities (other than blindness) on a general physical examination
* Subjects must be competent to sign informed consent

Exclusion Criteria:

* Abnormal heart, liver or kidney function; a current Axis I psychiatric or substance abuse disorder according to the DSM-IV Manual
* A diagnosis of obstructive sleep apnea (apnea index \> 10) or nocturnal myoclonus (\> 10 associated arousals/hour)
* External demands that limit the ability to maintain a regular schedule, e.g., night shift work
NALIRIFOX Combined With PD-1 Sequential Radiotherapy Versus AG Combined With PD-1 Sequential Radiotherapy as First-line Treatment of Locally Advanced Pancreatic Cancer

The purpose of the study is to evaluate the efficacy and safety of NALIRINOX combined with PD-1 synchronous sequential SBRT or AG combined with PD-1 synchronous sequential SBRT as first line systematical therapy in patients with ocally advanced pancreatic cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Histologically or cytologically confirmed pancreatic cancer;
2. ECOG performance no more than 2;
3. Radiographically assessed as locally advanced pancreatic cancer according to NCCN guidelines;
4. No previous anti-tumor therapy；
5. Able and willing to provide a written informed consent;

Exclusion Criteria:

* 1. Prior anti-tumor therapy of any kind; 2. Severe infection (\>NCI CTC grade 2); 3.Patients with autoimmune disease or immune deficiency who are treated with immunosuppressive drugs; 4.Patients with bleeding tendency; 5. Pregnant or lactating women.
Effect of an Early Mobilization Program on Outcomes After Major Cancer Surgery

The aim of this study is to evaluate the effect of an early postoperative physical rehabilitation program on the functional capacity and incidence of postoperative complications in patients undergoing major elective surgery for treatment of a neoplasm


Eligibility Criteria:
Inclusion Criteria:

* Patients who will be submitted to major surgery for cancer treatment.
* Age ≥ 18 years
* Reading and signing the informed consent

Exclusion Criteria:

Acute myocardial infarction (within the last 30 days)

* Unstable Angina
* Cardiac arrhythmia uncontrolled
* symptomatic severe aortic stenosis
* Congestive heart failure NYHA III or IV
* infarction or acute pulmonary thromboembolism
* pericarditis or myocarditis
* Acute Endocarditis
* Acute aortic dissection
* Active infection
* Acute renal failure
* Thyrotoxicosis
* Refusal to participate in the study
* Inability to ambulate independently and / or inability to exercises
* Presence of bone metastasis
* musculoskeletal and neurological conditions that preclude the achievement of an exercise program designed for this study
Study to Assess the Efficacy & Safety of KHK4951 in Patients With Neovascular Age-Related Macular Degeneration

The purpose of this study is to evaluate efficacy and safety of KHK4951 eye drops in patients with nAMD.


Eligibility Criteria:
Inclusion Criteria:

* Voluntary written informed consent to participate in the study
* Active subfoveal MNV (any subtype) or juxtafoveal/extrafoveal MNV secondary to AMD with a subfoveal component related to the MNV activity in the study eye as assessed by FA (evidence of leakage) or SD-OCT (presence of fluid) judged by the central reading center at screening
* BCVA ETDRS letter score of 78 letters to 35 letters in the study eye as measured by the ETDRS visual acuity chart at screening
* CST ≥ 450 μm at screening

Exclusion Criteria:

* Subretinal hemorrhage, fibrosis, or atrophy of \> 50% of the total lesion area and/or that involves the fovea in the study eye
* Uncontrolled glaucoma in the study eye
* Aphakia or pseudophakia with AC-IOL in the study eye
* Active intraocular inflammation in the study eye
* Any current ocular condition for which visual acuity loss would not improve from resolution of macular edema in the study eye
* History of rhegmatogenous retinal detachment in the study eye
* Any current or history of ocular disease other than nAMD in the study eye that may confound assessment of the macula or affect central vision
* History of the following therapies in the study eye:

  * History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD
  * Prior treatment PDT with Visudyne®, external-beam radiation therapy, transpupillary thermotherapy, or panretinal photocoagulation
  * Periocular or intraocular (sub-Tenon or IVT) corticosteroids within 12 weeks prior to Day 1
  * Previous intraocular device implantation except PC-IOL
  * Previous laser (any type) to the macular area
  * Previous treatment with IVT anti-VEGF drugs other than ranibizumab, bevacizumab, aflibercept 2 mg, and their biosimilars;
  * Treatment with ranibizumab, bevacizumab, aflibercept 2 mg, or their biosimilars within 12 weeks prior to Day 1. Previously treated patients who received these medications more than 12 weeks prior to Day 1 can be enrolled, but the patients should be diagnosed with nAMD within 3 years prior to Day 1
* Any current or history of endophthalmitis in either eye
* History of idiopathic or autoimmune-associated uveitis in either eye
* Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye
Total Shoulder Arthroplasty Near-infrared Spectroscopy

The purpose of this study is to measure cerebral oxygenation and cardiac output of total shoulder replacement patients undergoing general anesthesia (GA) and positive-pressure ventilation (PPV).

We hypothesize that cerebral desaturation occurs frequently during GA with PPV, but is rare during GA and spontaneous ventilation. We also hypothesize that cardiac output usually is well maintained under GA in the sitting position when epinephrine is used, but that decreased cardiac output increases the risk of cerebral desaturation.


Eligibility Criteria:
Inclusion Criteria:

* Patients 18-99 undergoing total shoulder arthroplasty
* Planned general anesthesia + brachial plexus nerve block
* Planned arterial catheter

Exclusion Criteria:

* Patients younger than 18 years older and older than 99
* Patients not intending to receive general anesthesia and peripheral nerve block
* Indication for endotracheal tube
* BMI ≥ 30
* Ejection Fraction (if known) \< 50%
* Known significant restrictive or obstructive pulmonary disease
* Patients with a history of transient ischemic attack (TIA) or stroke
* Patients with recent signs or symptoms of myocardial ischemia

  * Current stress test positive for ischemia
* Intolerance to study medications
* pre-existing contraindication to regional anesthesia

  * infection at block site
  * pre-existing neurological injury to operative limb
* Non-English speaking patients