cyrilzakka/clinical-trials huggingface dataset:
Intraoperative Protective Ventilation for Obese Patients Undergoing Gynaecological Laparoscopic Surgery

Background. The use of a comprehensive strategy providing low tidal volumes, peep and recruiting maneuvers in patients undergoing open abdominal surgery improves postoperative respiratory function and clinical outcome. It is unknown whether such ventilatory approach may be feasible and/or beneficial in patients undergoing laparoscopy, as pneumoperitoneum and Trendelenburg position may alter lung volumes and chest-wall elastance.

Objective. The investigators designed a randomized, controlled trial to assess the effect of a lung-protective ventilation strategy on postoperative oxygenation in obese patients undergoing laparoscopic surgery.


Eligibility Criteria:
Inclusion Criteria:

* scheduled for gynaecological laparoscopic surgery in the Trendelenburg position
* Obesity with body mass index\>35 kg/m\^2
* written informed consent

Exclusion Criteria:

* Clinical history or signs of chronic heart failure
* history of neuromuscular disease
* history of thoracic surgery
* pregnancy
* chronic respiratory failure requiring long-term oxygen administration
Sleep Extension and Blood Pressure

Emerging evidence suggests that approximately 30% of the US adult population sleeps less than 7 hours per night, and those who do exhibit 20-52% enhanced risk to develop cardiovascular diseases and particularly hypertension. Since sleep curtailment is largely voluntary, sleep deficiency can be corrected and its detrimental health consequences potentially reversed. The purpose of the present proposal is to investigate the cardiovascular and metabolic effects of sleep extension in prehypertensive and stage 1 hypertensive subjects who report habitual short sleep.


Eligibility Criteria:
Inclusion Criteria:

* Age: 18 to 65 (inclusive)
* Gender: both males and females
* Body mass index (BMI): 18.5-34.9 kg/m2
* Habitual sleep duration: \<7 hours
* Presence of either:

  * Prehypertension: office systolic BP (SBP) 120-139 mmHg and/or diastolic BP (DBP) 80- 89 mmHg;
  * Stage 1 hypertension: office SBP 140-159 mmHg and/or DBP 90-99 mmHg
* Either on no prescription medications (other than oral contraceptive pills, or intrauterine devices) or on stable medical regimen for at least 1 month, if taking prescription medications for chronic conditions
* Not pregnant or breast feeding and not intending to become pregnant or breast feed
* Not a current smoker or tobacco user
* Ability to provide written informed consent

Exclusion Criteria:

* Vulnerable study populations will be excluded
* Pregnancy
* Smoking
* Presence of overt cardiovascular diseases, diabetes, chronic kidney disease, cancer, sleep disorders, psychiatric disorders
* If taking prescription medications for chronic conditions, change in therapy (type, frequency and/or dosage) over the previous month
* Habitual sleep duration ≥7 hours
* Excessive alcohol (≥15 drinks/week in men and ≥8 drinks/week in women) and/or excessive caffeine intake (\>400 mg)
* Currently on a diet and/or actively trying to lose weight
* Currently or previously (during the past 2 months) participation in any other research study at the discretion of study personnel
* Blood/plasma donation during the past 2 months
* Unwillingness or inability to adjust sleep schedule.
Raltegravir Kaletra Pharmacokinetics

This will be an open-label, 3-period, fixed sequence study in young, healthy, male and female subjects of the pharmacokinetic interaction between raltegravir and Kaletra.

This will be an open-label, 3-period, fixed sequence study in young, healthy, male and female subjects. The initial cohort, to be studied simultaneously, will be 15 subjects with intention to collect complete data from 12 subjects. Replacements will be subsequently enrolled if necessary. Subjects will be reimbursed.

The periods will be

* Period 1: Raltegravir (RAL) 400 mg q12h for 4 days (7 doses of RAL).
* Period 2: Kaletra 200 mg 2 pills bid for 10 days (19 doses of Kaletra).
* Period 3: both regimens for 4 days (7 doses of both drugs). All morning doses will be observed at Prism Research, Inc. Evening doses will be distributed each morning. 12 hour PK studies will be done on the last day of each period. Specimens will be obtained 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12 hours after the morning dose of the last dosing day of each period.

Eligibility Criteria:
Inclusion Criteria:

* Healthy, male or female, age 18-55.
* Anti-HIV, anti-HCV, HBsAg negative.
* Normal history and physical at screening.
* Normal complete blood count, creatinine and ALT at screening.
* Negative urine pregnancy test at screening.
* BMI 18-30.

Exclusion Criteria:

* Donated blood in the month before Day 1.
* Participated in another research study in the month before Day 1.
* Tobacco use in the 3 months before Day 1, unwillingness to avoid tobacco use during the study.
* Use of any illegal drug in the year before Day 1, positive drug screen for an illegal drug at screening.
* Unwillingness to restrict coffee use to 6 or fewer cups of coffee during the study.
* Unwillingness on the part of fertile female subjects to be abstinent or to use two effective birth control methods, one of which is a barrier method, for any vaginal intercourse.
* Unwillingness to avoid use of any prescribed medication during the study
* Allergy to RAL, lopinavir or ritonavir.
Prevalence of Thrombophilic Gene Polymorphism (MTHFR C677T) in COVID-19patients

Aim of the study is to find the prevalence of thrombophilic gene methylene tetrahydrofolate reductase (MTHFR) gene polymorphism in a sample of COVID-19 patients, aiming at early detection of MTHFR mutant patients and guiding preventive therapy.

The inflammatory component of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) creates a prothrombotic state that necessitates a thrombophylactic strategy for hospitalized patients. Such strategies are difficult to be standardized because certain individuals can have prothrombotic conditions, such as inherited thrombophilia, which predispose them to an additional coagulative risk. Whether outside the hospital or when admitted, patients with inherited thrombophilia need special anticoagulant attention. Identifying such patients, especially in susceptible populations like the Egyptian people, will aid primary providers in risk stratification for choosing the optimal anticoagulation plan. Case-control study which will be conducted on 33 patients who had been diagnosed as COVID-19 at Ain-Shams University isolation Hospitals and 13 healthy controls. Patients will be subjected to: Thorough history taking, Thorough clinical assessment,COVID-19 PCR+/- radiological data collection, Assessment of MTHFR C677T genotypes were determined by RT- PCR of 2 ml EDTA blood sample, Follow up patient for 28 days as regard development of vascular thrombotic manifestation (D. dimer, LL duplex, or CT chest with Pulmonary angiography if needed).

Eligibility Criteria:
Inclusion Criteria:

* All adult patients diagnosed as COVID -19 by RT-PCR will be included

Exclusion Criteria:

* Patients younger than 18 years old Patients on Antithrombotic treatment before COVID-19.
Evaluation of the Prophylactic Efficacy of tDCS in Chronic Migraine

The purpose of this study is to determine whether TDCS is an effective prophylactic therapy of chronic migraine.

Consenting patients will report on a book, all of their migraine attack for 1 month. Then they will be randomized to the active tDCS group or sham tDCS group. Patients will have one session of tDCS per day during the first week, then one session per week for a month and finally a session every 15 days for 1 month. After tDCS sessions, patients will be followed for 3 months. Throughout their participation in the study, patients will complete their migraine record (1month of base line before tDCS, 2 months during tDCS, 3 months after tDCS).

Patients will have 5 evaluation examinations:

* The first, one before tDCS,
* The second, 1 month after the beginning of tDCS
* The third, immediately after the end of tDCS
* The fourth, 1 month after the end of tDCS
* And the last one, 3 months after the end of tDCS.

The physician responsible for conducting tDCS sessions will make the randomization via a website.

The physician in charge of the evaluation examinations will don't know the allocated treatment.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of chronic migraine for more than 1 year
* Stable treatment since 1 month
* Frequency of migraine crisis is above 8 per month during last month
* chronic migraine that has not been improved over the previous year by at least 3 different prophylactic treatments recommended and well conducted
* Patient agreeing not to try other migraine prophylactic treatment, throughout the study
* Patient's written consent

Exclusion Criteria:

* History of drug addiction, epilepsy, or severe head trauma with bone break
* History of psychiatric illness (psychosis and severe cognitive disorders) may interfere with the proper conduct of the study
* Presence of intracranial ferromagnetic material or an implanted stimulator
* Introduction of a new treatment for less than a month
* Pregnant women, parturient women, breast-feeding mother. Lack of effective contraception
* Person not understanding the study protocol
Early Interventional Treatment for Cancer Pain

The purpose of the study is to evaluate how feasible and beneficial it is to refer patients with cancer pain to a doctor who specializes in pain management, including procedures to relieve pain, and whether this is helpful to patients with pain related to their cancer.

This is a single arm pilot study evaluating a new system of referral and pain evaluation for patients with advanced solid tumors and moderate-to-severe pain who are not already on high-dose opioids to an anesthesia-trained interventional pain management specialist .

A variety of interventional treatments for pain have been proven effective for cancer patients. Often without early referral patients do not get evaluated for interventional procedures for their pain unless the pain is very severe, or they are admitted to the hospital. It is expect this intervention will work by providing effective pain treatments to patients sooner than they might normally be referred and will be evaluated by how many patients are candidates for interventional treatments for their pain, whether patients choose to receive these treatments, and whether patients find the pain specialist referral acceptable and helpful

The research study procedures include screening for eligibility, study interventions including evaluations and follow up visits, as well as surveys at the beginning, middle, and end of the study. Participants will be followed on the study for 4 months.

It is expected that about 30 people will take part in this research study.

Medtronic and is providing funding for this research study

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of a metastatic, or locally advanced unresectable malignancy
* Anticipated prognosis of more than 6 months according to the primary oncologist
* Age greater than 21 years
* Persistent pain with an average pain rating of 4 or greater on an 11-point numeric rating scale (NRS) from 0-10 where 10 is considered the most severe.
* Pain has persisted for at least 2 weeks
* Pain is due to cancer or sequelae of cancer treatment

Exclusion Criteria:

* Primary pain syndrome is sensory peripheral neuropathy
* Patient is taking more than 200 morphine milligram equivalents (MMEs) per day on average, at the time of recruitment.
* Currently cared for by interventional pain management specialist
* Receipt of prior pain intervention (e.g. celiac neurolysis)
* Bleeding diathesis, uncontrollable infection, or other contra-indications to pain interventions
* History of opioid misuse disorder
* Inability to speak English
* Cognitive impairment or any other disorder that would impede study participation and survey completion
* If patients are unable to complete the baseline survey, they will no longer be considered eligible for the study; this will serve as an indication of barriers to participation that would make them unable to comply with study procedures.
Continuous Glucose Sensor Profiles in Non-Diabetic Subjects

The Juvenile Diabetes Research Foundation (JDRF) Glucose Sensor Study group is carrying out a large, randomized clinical trial to assess the efficacy, safety and cost-effectiveness of use of real-time continuous glucose monitors (RT-CGM) as an adjunct to standard meter plasma glucose testing. Although the primary outcome in the \>= 7.0% cohort is differences in HbA1c levels, important secondary outcomes are differences in the percent of glucose sensor values either above or below the target glucose range of 70-180 mg/dl and differences in glucose variability. Prevention of biochemical hypoglycemia is a particularly important outcome in the low HbA1c cohort. Since CGM systems measure interstitial rather than plasma glucose and CGM values differ from simultaneous plasma glucose values by up to 18%, it would be extremely useful for comparative purposes to establish a reference range of sensor values in healthy, non-diabetic control subjects for this study and other future investigations. The objective of this protocol is to establish such reference sensor glucose ranges in each of the 3 devices being utilized in the JDRF study.

1. After initial eligibility is determined, informed consent and assent are obtained from the parent/guardian and subject.
2. Subjects will have the following tests performed:

   * Hemoglobin A1c (using the DCA2000 or equivalent device)
   * Oral glucose tolerance test to obtain fasting and 2 hour plasma glucose levels
   * Anti-GAD, anti-IA2 and anti-insulin antibodies

     * Subjects with an HbA1c \>6.0% and/or fasting glucose levels \>100 and/or 2 hour glucose levels \>140 will be discontinued from the study.
3. Subjects with normal A1c and glucose levels will be provided with an RT-CGM and home glucose meter (HGM)
4. An RT-CGM sensor will be inserted and initiated by study personnel.
5. Subjects who would like to wear 2 sensors will be given 2 of the same type of RT-CGM.
6. Subjects will be instructed to wear the sensor for 3-7 days (depending on the type of device) and measure the blood glucose on the HGM as needed to calibrate the sensor.
7. Subjects will return to the clinical center after the 3-7 days of sensor wear to return the RT-CGM and HGM.

   * If the subject has less than 48 hours of sensor data he or she will be asked to wear another sensor and return 3-7 days later.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 8 years
* Body mass index (BMI) between the 10th to 90th percentile for age and sex (based on CDC, 2000 nomogram) and \< 28 kg body weight/meter in adult subjects
* No significant chronic illness or taking any acute or chronic medications that might affect glucose metabolism.

Exclusion Criteria:

* History of diabetes or positive islet cell antibody testing
7T MRI to Evaluate Cartilage Defects in the Knee

The investigators propose to prospectively evaluate the accuracy of a novel 7-Tesla (7T) knee MRI protocol for the detection and grading of cartilage lesions in the knee, which is a significant limitation of current MRI techniques.

The investigators hypothesize that 7T MRI will be \~ 80% sensitive for detection of cartilaginous lesions. This will be tested in a prospective multi-reader study of 100 patients who are scheduled to have knee arthroscopy. Patients will have two MRIs of the knee: one standard of care and one experimental 7T MRI. Subjects will visit at one time point prior to scheduled knee arthroscopy, for a session time of \~1-2 hours for a single 7T MRI scan.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed Knee Symptomatology
* Scheduled Arthroscopic Treatment of Knee
* Adult (equal or greater than 18 years of age)

Exclusion Criteria:

* Active infections
* Less than 18 years of age
* Pregnant
Effect of Pioglitazone Therapy for Type 2 Diabetes on Vision

We are studying patients with diabetes who under proper medical care and administer an approved drug. Our interest is if this drug has any sideeffect on vision and if this drug may cause swelling of the retina.

To evaluate the safety of pioglitazone treatment for diabetes. Recent reports suggest that oral glitazone treatment may cause or exacerbate retinal edema. We hypothesized that glitazone treatment may cause subclinical edema evidenced by increased retinal thickness. We will conduct a double-masked, prospective safety study of 19 subjects undergoing placebo-controlled treatment with pioglitazone. Patient treatment consisted of either insulin with placebo or insulin with pioglitazone. The main outcome measures are ETDRS visual acuity and retinal thickness measured with optical coherence tomography.

Eligibility Criteria:
Inclusion Criteria:

* Male or female patients with type 2 diabetes mellitus on insulin therapy, 30-75 years of age with Hgb 1c values between 7.5 - 10% and a BMI of \< 40kg/m2.
* Patients were enrolled if they have been on a stable anti-hypertensive and lipid regimen for 90 days prior to study randomization.
* Patients must have had the ability to understand the requirements of the study, provide written consent and agree to abide by study requirements.

Exclusion Criteria:

* Prior treatment with sulfonylurea, or metformin within 21 days before study entry, prior treatment with NSAIDs, or diuretics within 21 days of screening, serum creatinine levels above 1.5 mg/dl for males or above 1.4 for females or creatinine clearance less than 70 ml/min by Cockcroft and Gault, or serum albumin levels of less than 2.5 gm/dl.
* Other exclusion criteria were elevated hepatic enzymes (aspartate aminotransferase or alanine aminotransferase more than 2.5 times upper limit of normal) or uncontrolled or untreated significant pulmonary, neurological condition, or cardiovascular disease, including hypertension, congestive heart failure (specifically New York Heart Association Type III or IV patients), angina, peripheral vascular disease, or greater than +1 peripheral edema.
* Furthermore, any patients with any condition that would jeopardize their safety or affect the validity of the trial results were excluded from this study.
A Real-world Study of Selinexor-based Regimens for Treatment of Non-Hodgkin Lymphoma

This study aims to observe and explore the efficacy and safety of selinexor-based regimen in patients with Non-Hodgkin lymphoma

this study aims to observe and explore the efficacy and safety of selinexor-based regimen in patients with DLBCL or T cell lymphoma. This study is a non-interventional real world, observational study and all registered data are collected from real clinical practice cases. The medical data includes patient demographic, tumor characteristics, laboratory examination, history of treatments, adverse reactions, efficacy results and possible prognostic factors.

Eligibility Criteria:
Inclusion Criteria:

* Know and voluntarily sign the Informed Consent Form (ICF)
* Clinically confirmed DLBCL, T or NK cell lymphoma
* Patients with DLBCL or T or NK cell lymphoma who have used selinexor-based therapy in the past 3 months are included
* Cooperate with clinical diagnosis and treatment management, and provide disease-related past medical history materials

Exclusion Criteria:

* Previously received selinexor
* Poor patient compliance
* physicians evaluate that patients are not suitable for enrollment
Study of the KinexConnect Telerehabilitation System (KCTRS)

A randomized, single-blind study comparing telerehabilitation at home with continuous passive motion (CPM) and a tablet-based patient engagement application (KinexConnect) versus traditional outpatient physical therapy (PT) following total knee arthroplasty (TKA).

The Randomized Study of the KinexConnect Telerehabilitation System is a 1:1 randomized, single-blind, prospective cohort study to be conducted at one investigational site in the United States. The study compares at-home telerehabilitation system versus traditional outpatient PT following total knee arthroplasty (TKA). The telerehabilitation system involves a tablet-enabled patient engagement application, the KinexConnect App, to be used in conjunction with a continuous passive motion (CPM) machine.

Eligibility Criteria:
Inclusion Criteria:

1. Planned for a primary unilateral TKA.
2. At least 21 years of age.
3. Capable of understanding the study requirements and giving written informed consent.
4. Willing and able to comply with either therapy program.
5. Has easy access to caregiver support.

Exclusion Criteria:

1. Active range-of-motion (ARoM) \< 80 degrees in target knee.
2. Unable to read and write in English.
3. Lack of email capability to receive recovery trend information.
4. Previous knee intervention in target knee.
5. Previous knee joint infection in either knee.
6. Received a revision TKA (opposite knee).
7. Planned for bilateral TKA.
8. Self-reported pregnancy.
9. Reason for arthroplasty being for the treatment of fracture, infection or malignancy.
10. Other physical or mental impairments or medical conditions that may affect ability to complete therapy as prescribed.
11. Unwilling to participate.
Crossing the Divide: Piloting Integrated Care to Reduce Amputations Among Rural Patients With Diabetic Foot Ulcers

This project directly addresses the escalating national rate of major (above-ankle) amputations due to diabetic foot ulcers; it focuses on rural patients, who face 37% higher odds of major amputation compared to their urban counterparts. The project pilots the first integrated care model adapted to rural settings, an approach that has reduced major amputations in urban settings by approximately 40%. Pilot data will be used to improve recruitment and retention strategies and provide preliminary evidence of efficacy needed to conduct a robust, statewide efficacy trial.


Eligibility Criteria:
Inclusion Criteria:

* Healthcare worker inclusion criteria:

  * Willing to provide informed consent
  * Willing to comply with study procedures
  * Rural providers (primary care physicians at the UW Health Belleville Family Medicine Clinic, diabetes and wound care specialists at Sauk Prairie Healthcare Diabetes and Wound Care Clinic) and schedulers placing referrals.
  * Employed at a participating clinic
  * For rural providers, confirm understanding that they will retain clinical discretion to deviate from the integrated care model if they think it would best serve the patient.
  * Available for the duration of the study
* Patient inclusion criteria:

  * Able and willing to provide informed consent.
  * Willing to comply with study procedures and be available for the duration of the study.
  * 18 years of age and older.
  * Patient with either type 1 or type 2 diabetes at a participating rural clinic.
  * Develops diabetic foot ulcer during enrollment period.

Exclusion Criteria:

* Healthcare worker exclusion criteria:

  * Insufficient overlap in work schedules between rural providers and scheduler based on clinic manager determination.
* Patient exclusion criteria:

  * receiving palliative care such that referral to urban centers for aggressive limb salvage would be inappropriate, as assessed by patient rural provider
  * insurance does not cover referral to the University of Wisconsin's specialty clinics
  * Not suitable for study participation due to other reasons at the discretion of the investigators.