cyrilzakka/clinical-trials huggingface dataset:
Post-Operative Urinary Retention (POUR) in Thoracic Surgery Patients Receiving Prophylactic Tamsulosin

Post-Operative Urinary Retention (POUR) in Thoracic Surgery is a prospective interventional study aiming to test the hypothesis that the prophylactic use of tamsulosin prior to thoracic surgery in high risk patients leads to reduce the rates of POUR.

Post-operative urinary retention (POUR) is one of the most common post-operative complications encountered by most surgical specialties. The incidence of POUR can vary from five to 70%.

Post-operative urinary retention is a prevalent complication. Patients who undergo thoracic surgery have greater urinary retention rates compared to others. Data on effective methods to reduce the risk of POUR in this high-risk group are limited.

All subjects who meet inclusion and exclusion criteria will be invited to participate. There will be no randomization. All will receive tamsulosin in the pre operative period.

Eligibility Criteria:
Inclusion Criteria:

* All male patients \>=60 years old who undergo inpatient thoracic surgery for major resections.

Exclusion Criteria:

* - Prisoners
* Adults unable to consent
* End stage renal disease on hemodialysis
* Indwelling urinary catheter
* Child-Pugh class C hepatic failure
* Usage of the following medications prior to surgery: strong CYP 3A4 inhibitors, strong CYP2D6 inhibitors, other alpha-adrenergic blocking agents, PDE5 inhibitors, and cimetidine
* patients known to be CYP2D6 poor metabolizers
* History of prostatectomy or cystectomy
* Patients with contraindications to tamsulosin and those at high risk for side effects: hypersensitivity to tamsulosin HCl or any component of FLOMAX capsules, hypersensitivity to sulfonamides. History of known glaucoma, hypotension, plan to undergo cataract surgery in the next 2 weeks
Comparative Study of Calculating the X-ray Dose to the Skin of the Patient Exposed

The main objective is to estimate the precision of the calculation by the software DoseMap ® towards the in vivo measure by gafchromic movie.

The procedures of Interventional Cardiology are realized under exposure in the X-rays which can be sometimes important for the patient according to the nature of the procedure.

The estimation of the dose in the skin following a procedure of interventional cardiology is difficult. The knowledge of this dose allows to anticipate the appearance of determinist effects, and so to activate a dermatological follow-up of the exposed patient in case of overtaking of a dose threshold. Unfortunately, it is impossible to measure it directly and the thresholds of exposures are fixed from the measure of the kerma in the air accumulated at the exit of the tube with X-ray, what remains very indistinct.

Since a few years the manufacturers propose tools allowing an estimation of the dose the skin of the patient. The DoseMap software ® allows to consider this dose from the data of exposure supplied by the system. To do it, it uses a modelling simplified of the patient to feign the deposit of dose in the latter.

It seems to us interesting to verify the precision of this simulation by comparing it with a measure of the in vivo dose.

Eligibility Criteria:
Inclusion Criteria:

* Procedure of Interventional Cardiology potentially more irradiant (angioplasty of the circumflex artery , or of several vessels)
* Body mass index \> 25
* Collection of the Non-opposition of the patient

Exclusion Criteria:

* Diagnostic coronarography,
* Emergency procedures,
* Minor patients
Effects of Dextrose on Knee Osteoarthritis

Using double blind, randomized controlled design to study the immediate, short-term and intermediate-term therapeutic effects of ultrasound guided hyaluronic acid injection and hyaluronic acid combined dextrose injection to patients with knee osteoarthritis.

A total of 106 patients will be collected. The participants will be randomized into two groups, including hyaluronic acid group and hyaluronic acid combined dextrose group.

The hyaluronic acid group will receive 3 times of hyaluronic acid injection per week in three weeks; the hyaluronic acid combined dextrose group will receive 3 times of hyaluronic acid combined dextrose injection per week in three weeks.

The pain, physical activity, and functional performance will be evaluated.

All the evaluations will be re-evaluated at one week after injection, one month after injection, three months after injection, and six month after injection.

Subjects and the evaluator will be both blinded to the group's classification during the whole course of study.

Eligibility Criteria:
Inclusion Criteria:

* knee osteoarthritis with Kellgren/Lawrence grade II or III

Exclusion Criteria:

* who have neurological deficit, such as stroke who have implant in knee
An Exploratory Investigation of a Male Focused Skincare Supplement

Most skincare products on the market are topical and do not take a holistic approach to understanding skin health. This trial will examine a dietary supplement designed to support the gut microbiome and promote skin health from an internal perspective. Research has previously supported the link between the gut microbiome and skin health and the supplement tested in this trial will further the knowledge on the effectiveness of supporting gut health to improve skin outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Male
* Between the ages of 18-55
* Frequently experience different forms of acne
* Frequently experience breakouts
* Must be in good health with no long term health conditions
* BMI must be under 40
* Must follow a consistent dietary regimen
* Must be willing to stop any oral supplementation targeting their skin while in the trail

Exclusion Criteria:

* Anyone who does take prescription medication (oral or topical) targeting their skin including reinoid, over the counter retinol, or retinal
* Not willing to stop any oral supplementation targeting their skin
* Severe chronic conditions, including oncological and psychiatric disorders
* Previous severe allergic reactions
* Unwilling the follow the study protocol
A Proof-of-concept Study to Examine QUC398 in Participants With Knee OA

The purpose of the study is to find out if the investigational treatment named QUC398 has beneficial effects on osteoarthritis knee pain and knee cartilage, and if it is safe and well tolerated.

This is a phase IIa study to establish the effect of QUC398 on pain and cartilage preservation in participants with symptomatic knee OA

Eligibility Criteria:
Inclusion Criteria:

* Weight ≥ 50 kg and body mass index 18 -35 kg/m2 at Screening 1
* Kellgren-Lawrence grade 2 to 4 in the tibio-femoral compartment in the target knee confirmed by radiography in standing weight-bearing fixed flexion position and posterior-anterior view, at Screening 1
* mJSN 1-2 in the medial tibiofemoral compartment of the target knee, confirmed with Xray by central reader at Screening 1
* Symptomatic OA with moderate to severe pain (corresponding to Pain NRS ≥ 5 to ≤ 9) in the target knee for the majority of days in the last 3 months prior to Screening 1, as per participant's judgement
* Symptomatic OA with moderate to severe pain (corresponding to Pain NRS ≥ 5 to ≤ 9) in the target knee at Screening 1 and 2

  . Moderate to severe OA pain (corresponding to Pain NRS ≥5 to ≤9) in the target knee during the last 7 days prior to Screening 3, confirmed by: Completed pain diary for at least 6 of the last 7 days prior to Screening 3, AND Diary reported Pain NRS ≥5 to ≤9 for at least 6 of the last 7 days prior to Screening 3
* KOOS pain subscale ≤ 60 in the target knee at Screening 1, Screening 2, and Screening 3

Exclusion Criteria:

* Painful ipsilateral hip OA defined as a Pain NRS ≥3 on the majority of days in the last 3 months prior to Screening 1, as reported by the patient
* Symptomatic, patello-femoral pain in the target knee as per investigator's examination at Screening 1
* Severe malalignment \> 7.5º in the target knee (either varus or valgus), measured using standardized knee X-ray at Screening 1
* Patient unable or unwilling to undergo MRI or presenting absolute contraindications to MRI
* Previous exposure to any ADAMTS-5 drug, including QUC398.
* History or current diagnosis of ECG abnormalities

Other protocol-defined inclusion/exclusion criteria may apply
Validity And Reliability of Wearable Motion Sensors in Knee Joint Range of Motion Measurement

Objective: The aim of this study is to examine the validity and reliability of a wearable motion sensor, which is an inertial measurement units (IMUs) sensor, in measuring knee joint active flexion movement angles.

Methods: The study included 70 Health Sciences Faculty students between the ages of 18-25. The dominant knee joint range of motion of the participants was measured by two raters with a digital goniometer (Meloq EasyAngle) and wearable motion sensors (MetaMotionRL). A 10-minute rest was given between each measurement. The data were analyzed using the IBM® SPSS® Statistics for Windows software (Version 27.0). Mean ± standard deviation (Mean ± SD) and percentage (%) were used for the descriptive variables. Intra- and inter-rater reliability was tested with intraclass correlation coefficient (ICC) and Bland-Altman analysis. ICC values less than 0.5 were classified as poor, values between 0.5 and 0.75 as moderate, values between 0.75 and 0.9 as good, and values greater than 0.90 as excellent reliability. Paired samples t test was used to compare test-retest measurements. Concurrent validity was determined by Pearson correlation coefficient. The significance value was accepted as p\<0.05.

Before knee range of motion measurements, all participants were given verbal information about the measurements. Participants were asked to wear shorts that exposed their knees. While the participants were lying in the prone position on the examination table, their dominant knee range of motion was measured with both EasyAngle and MetaMotionRL by two different physiotherapists.

EasyAngle digital goniometer and universal goniometer measurement results were compared and it was concluded that EasyAngle is a valid and reliable evaluation tool.

MetaMotionRL (MBientlab Inc., San Francisco, USA); Includes 9-axis inertial measurement units and environmental monitoring sensor. It features gyroscope, accelerometer, magnetometer and sensor fusion. Real-time communication is provided via BluetoothLE. Data can also be saved to 8 megabyte NOR flash memory. There are free, open-source applications and applications for fast data collection.

Eligibility Criteria:
Inclusion Criteria:

* being between the ages of 18-25
* volunteering to participate in the study

Exclusion Criteria:

* a history of orthopedic surgery or trauma to the lower extremity
* knee pain felt during joint range of motion measurement
* inability to maintain a prone position
Impact of Muscle Afferent Feedback During Exercise in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Recently, direct evidences point to the contributing role of peripheral muscle fatigue in exercise tolerance among patients with COPD. However, the physiological mechanisms by which peripheral muscle fatigue impairs exercise tolerance are still unknown, as factors regulating peripheral muscle fatigue in COPD may be complex. One possible link between limb muscle fatigue and exercise intolerance could be enhanced afferent signals from the active limb muscles to the central command, thereby limiting central motor output and eventually leading to exercise termination.

A direct method to investigate the regulation of peripheral muscle fatigue during exercise in patients with COPD is the blockade of peripheral neural afferents via lumbar anesthesia. Consequently, investigating the interplay between the peripheral muscular component and the central motor command during self-paced exercise could shed light on the regulation of peripheral muscle fatigue in COPD and its implication in exercise intolerance.

The aim of the study is to characterize the role of peripheral muscle afferents on the development of muscle fatigue, cardiorespiratory response and exercise tolerance to constant-workrate endurance cycling exercise in patients with COPD.

In a double-blind randomized design, patients with GOLD stage II-III COPD will be recruited and will complete a constant-workrate cycling test following either the injection of a placebo \[NaCl, interspinous L2-L3\] or an opioid \[Fentanyl 25 µg, intrathecal L2-L3\] inhibiting central feedback of peripheral muscles sensory afferents. Quadriceps force (TwQ) will be measured by magnetic stimulation of the femoral nerve and central chemoreceptors response will be assessed by CO2 rebreathing, both performed before and after the injection. Finally, TwQ will also be measured after the endurance cycling test to assess the magnitude of quadriceps fatigue induced by symptom-limited exercise.

Eligibility Criteria:
Inclusion Criteria:

* Smoking history \> 15 pack-years
* COPD GOLD II-III (30 % predicted \< FEV1 \< 80 % predicted; FEV1/FVC \< 0.70)

Exclusion Criteria:

* Unstable condition
* Recent exacerbation (\<3 months)
* Recent cancer (\<3 months)
* Myopathy, neuromuscular disease
* Unstable cardiac disease
* Hepatic, kidney, intestinal disease
* BMI \> 35
* PaCO2 \> 45 mmHg
* PaO2 \< 60 mmHg
FLuoresence Image Guided Surgery With A VEGF-targeted Tracer in Soft-tissue Sarcomas in Humans Approach With Bevacizumab-IRDye 800CW

There is a need for better visualization of resection margins during surgery for soft tissue sarcoma. Optical molecular imaging of soft tissue sarcoma associated biomarkers is a promising technique to accommodate this need. The biomarker Vascular Endothelial Growth Factor (VEGF-A) is overexpressed in soft tissue sarcoma versus normal tissue and has proven to be a valid target for molecular imaging. VEGF-A can be targeted by the monoclonal antibody bevacizumab. Monoclonal antibodies can be labeled by the near-infrared (NIR) fluorescent dye IRDye800CW (800CW). The investigators hypothesize that bevacizumab-800CW accumulates in VEGF expressing cancer, enabling soft tissue sarcoma visualization using a NIR intraoperative camera system. In this pilot intervention study the investigators will determine the optimal dosage of bevacizumab-800CW (10, 25 or 50mg) to detect soft tissue sarcoma intraoperatively.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years.
* Patients with soft tissue sarcoma who are scheduled to undergo surgical intervention with curative intent
* World Health Organization (WHO) performance score 0-2.
* Signed written informed consent

Exclusion Criteria:

* Medical or psychiatric conditions that compromise the patient's ability to give informed consent.
* Other invasive malignancy
* Pregnant or lactating women. Documentation of a negative pregnancy test must be available for woman of childbearing potential. Woman of childbearing potential are pre- menopausal women with intact reproductive organs and women less than two years after menopause.
* History of infusion reactions to bevacizumab or other monoclonal antibody therapies.
* Inadequately controlled hypertension with or without current antihypertensive medications
* Within 6 months prior to inclusion: myocardial infarction, Transient Ischemic Attack, Cerebral Vascular Accident, pulmonary embolism, uncontrolled chronic hepatic failure, unstable angina pectoris.
Safety and Efficacy of a Glaucoma Drug Delivery System

The purpose of this study is to evaluate the ocular safety and efficacy of a glaucoma drug delivery system in open-angle glaucoma or ocular hypertension.


Eligibility Criteria:
Inclusion Criteria:

* Man or woman 21 years of age or greater
* must have open angle glaucoma or ocular hypertension.
* Corrected visual acuity in each eye of 20/200 or better.

Exclusion Criteria:

* Previous glaucoma intraocular surgery or refractive surgery.
* Planned contact lens use during the study.
* Clinically significant ocular or systemic disease that might interfere with the study.
* Use of chronic corticosteroids by any route.
Aripiprazole and Lexapro Drug Interaction Study

The purpose of this clinical research study is to learn whether aripiprazole has effect on the steady-state pharmacokinetics of escitalopram in healthy subjects. The safety and tolerability of aripiprazole and escitalopram co-administration will also be studied.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female subjects, ages 18 to 45. (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 4 weeks after the study in such a manner that the risk of pregnancy in minimized.
* Body Mass Index (BMI) of 18 to 33 kg/m2 inclusive.

Exclusion Criteria:

* Subjects with a decrease in SBP of \>=20 mm Hg and increase in HR of \>=20 bpm after 2 minutes standing vs. 2 minutes supine at screening or with frank orthostatic hypotension at screening.
* Supine BP of 90/50 mm Hg or lower at screening.
MATCH: The Mexican-American Trial of Community Health Workers

The MATCH study (Mexican-American Trial of Community Health Workers) tests the hypothesis that the use of indigenous Community Health Workers (CHWs), recruited from the target community and trained to provide culturally appropriate diabetes education, can promote pro-active self-management among inner-city dwelling Mexican-Americans with Type 2 diabetes mellitus. The study aims are to demonstrate that a CHW, compared to an attention control, will: 1) result in improvement in short term physiologic outcomes (Hemoglobin A1c levels and blood pressure), and 2) result in increased frequency of self-management behaviors (daily self blood-glucose monitoring, medication adherence, adherence to diet and physical activity recommendations). The study design is a single site, partially blinded, randomized controlled trial of 144 patients with Type 2 diabetes mellitus.

Eligibility criteria include a diagnosis of Type 2 diabetes, residence in target community areas in the Chicago area, and Mexican or Mexican-American ethnic heritage. Participants are randomized to either an experimental group receiving 36 home visits over a two year period in which a CHW delivered diabetes education and self-management skills training, or to an attention control consisting of 36 bilingual diabetes education newsletters covering the same curriculum as the CHWs. The curriculum covers recommended diabetes self-management behaviors including glucose self-monitoring, responding to abnormal blood glucose levels, working effectively with health care providers, medication adherence, foot care, daily physical activity, and reducing fat content of diet. CHWs also deliver training in behavioral skills of self-monitoring, environmental restructuring, engagement of social support, stress management, and problem-solving skills to facilitate the self-management activities. Consistent delivery of the CHW intervention is documented by audiotapes and Documentation of Intervention worksheets.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of type 2 diabetes mellitus
* Taking at one oral medication daily to control diabetes
* Self-identified as Mexican or Mexican-American
* Resident in target community within Chicago, Berwyn, or Cicero, Illinois.

Exclusion Criteria:

* Diabetes controlled with diet or insulin only
* Advanced end-organ complications, including: end-stage renal disease, stroke with paresis, Congestive Heart Failure (NYHA class 3 or 4), or other major end-organ complication of diabetes
* Receiving treatment for a major psychiatric disorder (i.e. schizophrenia)
* Are unable to understand and give informed consent in either English or Spanish
* Live in a household with someone who is already a randomized study participant or know of family members who are already study participants.
* Have lived in Mexico for more than four months in the past two years, or are anticipating extended travel to Mexico in the next year.
* Are under the age of 18
Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX07+HLX10 +mFOLFOX6 or HLX07 Monotherapy in Patients With mCRC

This is An Open-label, Multicenter, Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX07 (Recombinant Humanized Anti-EGFR Monoclonal Antibody Injection) + HLX10 (Recombinant Humanized Anti-PD-1 Monoclonal Antibody Injection) + mFOLFOX6 or HLX07 Monotherapy in Patients with Metastatic Colorectal Cancer.


Eligibility Criteria:
Inclusion Criteria:

* Age\>=18Y and ≤75Y
* Good Organ Function
* Expected survival time ≥ 3 months
* mCRC that have been diagnosed histologically
* KRAS/NRAS/BRAF WT verified by PCR or NGS of tumor tissue
* ECOG score 0-1;

Exclusion Criteria:

* HIV infection
* Active clinical severe infection;
* A history of other malignancies within two years, except for cured carcinoma in situ of the cervix or basal cell carcinoma of the skin.
Acupuncture for Vulvodynia: A Pre-pilot Study

Vulvodynia is a women's pain condition. Women have pain in their vulva, the area in their genitals between the vagina and labia (lips of the vagina). They also have pain when they have sexual intercourse or insert anything in the vagina. Sometimes they have so much pain, that they cannot have sex.

This research is being done for two reasons. The first reason is to test a set of special needles called double-blinded acupuncture needles to give acupuncture treatments (one is a real needle and the other is a fake needle). The second reason is to develop a protocol (checklist) that will be used in this and future studies, and to identify and resolve any procedural problems. The protocol will be first tested by the principal investigator who is also an acupuncturist. The investigator will perform acupuncture using the protocol, if necessary change the protocol, and then teach a second acupuncturist using the modified protocol how to use the double-blinded acupuncture needles.

The real needle called the penetrating needle penetrates the skin. The fake needle called the non-penetrating placebo touch needle does not penetrate the skin but it touches the skin so it feels like a needle is being inserted. It has a blunt tip.

Participants can't see which needle they are getting acupuncture with because the needles are housed in a double-blinded needle device which has two tubes (an inner and an outer) that neither the acupuncturists nor the participants can see through.

If a fake acupuncture needle can be used in acupuncture research like a sugar pill is used for drug studies to see how well the real medicine works, the investigators can see how effective acupuncture is. The investigators will be testing these needles to treat participants with vulvodynia.


Eligibility Criteria:
Inclusion Criteria:

* women previously diagnosed with generalized vulvodynia
* women previously diagnosed with localized vestibulodynia,

Exclusion Criteria:

* pregnancy
* menopause
* interstitial cystitis
* irritable bowel syndrome
* untreated vaginitis
* cervicitis
* pelvic inflammatory disease
* any other pelvic pathology causing pain
* concomitant physical therapy
* concomitant biofeedback
* concomitant massage
* additional acupuncture