cyrilzakka/clinical-trials huggingface dataset:
Treatment of Knee Osteoarthritis (KOA) by Injection of Autologous Adipose-derived Vascular Matrix Components (SVF) Into Joint Cavity

The purpose of this study was to analyze and study the efficacy and safety of autologous adipose-derived vascular matrix components (SVF) in patients with knee osteoarthritis before and after treatment through clinical evaluation, radiation index, and metabolic index comparison between plasma and irrigation solution before and after SVF injection.


Eligibility Criteria:
Inclusion Criteria:

* The age range is 20-70 years old
* Patients with unilateral or bilateral knee degenerative inflammation (KOA) with Kellgren-lawrence rating of level 3 or lower
* The physical health status is mainly in the ASA grade Ⅰ, Ⅱ and Ⅲ
* Subjects had no active tumors, no active inflammation, no treponema pallidum, HIV, hepatitis B virus, or hepatitis C virus
* The subject shall provide the physical examination report of knee X-ray examination, MRI examination and other items

Exclusion Criteria:

* Patients with nonunion or displaced fractures around defective cartilage
* Pregnant or lactating women
* Autoimmune disease
* Subjects with diabetes (exceptions are patients whose blood sugar levels remain within the normal range and diabetes has not caused other complications)
* The patients had severe neurological diseases affecting the evaluation of postoperative results
Colorectal Screening Strategies in Underserved Populations

Research efforts are necessary to identify strategies to increase colorectal screening in underserved patient populations. Racial, ethnic minorities and medically underserved individuals continue to experience disparities in colorectal cancer mortality despite the availability of screening tests that can detect tumors early when treatments are most effective.

To determine the effectiveness of completion of colorectal cancer screening through fecal testing for blood and/or colonoscopies as a screening intervention utilizing digital reminders versus telephone prompts and reminders in economically disadvantaged minority communities as part of a colorectal screening outreach program.

Eligibility Criteria:
Inclusion Criteria:

* Any Gender
* 45-64 years of age
* Able to sign the informed consent form
* Meets eligibility criteria to participate in New Jersey Cancer Education Early Detection Community Outreach Program

  * Uninsured/underinsured
  * Household income \<250% Federal Poverty Level
  * Must be New Jersy resident
* Must have Smart phone
* Must speak English or Spanish

Exclusion Criteria:

* History of colon cancer, colon/rectal polyps and rectal bleeding
* Individuals with Dementia
* ECOG Performance Status 3-4
* Prior Colonoscopy within past 10 years
Genetic Causes of Discrepant Clinic in Monogenic Twins

In the DISCO-TWIN study (prospective, open-label molecular-genetic study), twin pairs with one healthy and one affected twin with molecularly undiagnosed diseases will be analysed by means of omics technologies and/ or re-analysed using existing datasets. Phenotype and omics data will be shared within the University Hospital Tübingen and with external collaborators to improve the diagnostic rate of the subjects included in the study.


Eligibility Criteria:
Inclusion Criteria:

* Twin pair monozygotic clinically (phenotypic) discordant twins
* Unclear diagnosis
* Suspected (mono-)genetic cause of the disease in one twin

Exclusion Criteria:

* Missing informed consent of both twin/ legal representative
* No distinct phenotype
Combination Dexamethasone and Bupivacaine Pain Control in Reduction Mammaplasty

The addition of dexamethasone to non-liposomal bupivacaine in perineural blocks has been shown to enhance pain control and prolong the time until first request for postoperative narcotics in the fields of orthopedic, thoracic, and gynecologic surgery. This has not been investigated in any types of breast surgery. The investigators assessed if the combination of dexamethasone to bupivacaine in the preoperative field block prior to bilateral breast reduction surgery resulted in improved pain control relative to bupivacaine alone.

The investigators conducted a double-blind randomized controlled trial to determine whether the addition of dexamethasone to bupivacaine in a preoperative Pecs II block resulted in improved pain control, relative to bupivacaine alone, in patients undergoing bilateral reduction mammaplasty.

Using a preassigned randomization list, patients were randomized to experimental and control groups in a ratio of 1:1 upon enrollment. Both groups received PECS II bupivacaine field blocks in the preoperative holding area, performed by an acute pain fellowship-trained anesthesiologist. The experimental group received 29mL of 0.5% bupivacaine mixed with 1mL 4mg/mL dexamethasone per side. The control group received 29mL 0.5% bupivacaine mixed with 1mL 0.9 saline solution per side. To maintain the blinded aspect of the study, the anesthesiologists were given pre-mixed vials labelled uniformly for the trial, regardless of the patient's treatment arm.

The patients all underwent bilateral breast reduction with a single surgeon. Postoperative pain regimens were standardized. Subjective pain scores, narcotic consumption, 4-hour interval vital signs, anti-emetic usage, and postoperative quality of life via an sf-36 questionnaire were all recorded per patient.

Eligibility Criteria:
Inclusion Criteria:

* Female
* Age 18-80
* Bilateral reduction mammaplasty
* American Society of Anesthesiologists (ASA) physical status classification 1, 2, or 3
* Must choose to receive preoperative nerve block as part of pain management strategy

Exclusion Criteria:

* Allergy to dexamethasone or bupivacaine
* History of postoperative nausea and vomiting following anesthesia
* History of chronic pain conditions
* History of narcotic abuse or dependency
* History of chronic renal disease
* History of chronic liver disease
Neuromuscular Mechanisms of Specific Trunk Interventions in Children With CP

Determine the effect of repeated pelvis perturbation training on trunk posture and locomotor function in children with CP.

We will determine whether repeat exposure to pelvis perturbation during sitting astride will induce functional improvements in trunk postural control and locomotion in children with CP.

Eligibility Criteria:
Inclusion Criteria:

* Children with a diagnosis of bilateral spastic CP attributed to complications of prematurity, intracranial hemorrhage and periventricular leukmalacia according to the definition of Bax.
* Children aged 4 to 12 years old without Botulinum toxin treatment within 6 months, and without surgeries (such as selective dorsal rhizotomy) within 12 months before the onset of the training.
* Subjects will be able to remain seated without help for ≥10s.
* GMFCS levels will be I to IV.
* Children must be able to signal pain, fear or discomfort reliably.
* Children with mild scoliosis (Cobb angle \< 20 °).
* Children with CP who have no prior hippotherapy experiences within 6 months.

Exclusion Criteria:

* severe lower extremity contractures, fractures, osseous instabilities, osteoporosis.
* severe disproportional bone growth.
* unhealed skin lesions in the lower extremities.
* thromboembolic diseases, cardiovascular instability.
* aggressive or self-harming behaviors.
MOM NEST Study: Maternal Opioid Medication: Naltrexone Efficacy Study

This is a multi-center prospective comparative cohort study examining the safety, efficacy, pharmacokinetics, and pharmacogenomics of naltrexone for pregnant women with opioid use disorder. Pregnancy, delivery, and maternal and infant outcomes to 12 months post-delivery will be examined and compared with a cohort treated with buprenorphine/naloxone.

Fifty pregnant women stabilized pre-pregnancy on oral or extended-release naltrexone (XR-NTX) and 50 comparison women on buprenorphine/naloxone (BPH) from Boston Medical Center and the University of North Carolina will be enrolled in this multi-center prospective comparative cohort study. The specific aims of this project are: 1) Safety and Efficacy: To compare maternal outcomes (safety, relapse, retention in care), fetal outcomes (growth, fetal distress), and infant outcomes (neonatal abstinence syndrome, growth, neurodevelopment) during pregnancy until 12 months post- delivery; An exploratory part of this aim is to collect safety and efficacy data on women receiving NTX for alcohol use disorder (AUD). We will collect maternal, fetal and infant outcomes related to prenatal alcohol exposure. 2) Pharmacokinetics: To determine the pharmacokinetics of NTX in pregnant and postpartum women; 3) Genetics and Epigenetics: To examine the association between genetic variants and epigenetic modification in the mu-opioid receptor (OPRM1) gene, as well as global DNA methylation changes after treatment with NTX and BPH within the mother, placenta, and infant; and 4) Breast milk: To measure breast milk concentrations of NTX and corresponding infant relative dose to determine safety for lactating women.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women between 6 - 30 6/7 weeks gestation, receiving prenatal care at Boston Medical Center (BMC) or the University of North Carolina (UNC)
* Plan to deliver infant at BMC or UNC
* Diagnosis of opioid use disorder (OUD) or alcohol use disorder (AUD) in the current pregnancy on prescribed oral or extended-release naltrexone; or buprenorphine/naloxone for the treatment of OUD
* English speaking
* Singleton pregnancy

Exclusion Criteria:

* OUD on prescribed methadone, or no maintenance medication
* OUD on Subutex formulation of buprenorphine
* Severe psychiatric illness or cognitively impairing ability to provide informed consent
* Current maternal incarceration
* Women who present for care \>31 0/7 weeks
* Multiple gestation pregnancy
The UK ADAPTIS Study

An ankle replacement procedure consists of replacing the worn-out joint surfaces of the ankle with metal and plastic components that are shaped to allow continued movement of the ankle. There are several different types of ankle replacement available. Infinity ankle implants are already routinely used in NHS hospitals. The INFINITY™ with ADAPTIS™ and EVERLAST™ ankle replacement system is a development of the Infinity ankle implant, designed to attach to the bone better and to wear out more slowly.

The purpose of the UK ADAPTIS™ Study is to assess the performance and function of the newly introduced INFINITY™ with ADAPTIS™ and EVERLAST™ technology Total Ankle System for total ankle replacement (TAR) or arthroplasty (TAA) and EVERLAST™ Poly Insert that modernises and streamlines Stryker's TAA/TAR portfolio.

UK ADAPTIS is a prospective multi-centre cohort series of INFINITY™ with ADAPTIS™ and EVERLAST™ Technology with Poly Insert for patients requiring primary total ankle replacement (TAR) i.e. Total Ankle Arthroplasty (TAA).

Patients meeting the criteria for the study will be asked to enrol by providing written informed consent.

The patients will be monitored clinically by post-operative follow-up examinations and Patient reported outcome measures (PROMs) (Manchester Oxford Foot \& Ankle Questionnaire (MOXFQ), Ankle Osteoarthritis Scale (AOS), EQ5D-5L).

Intended use:

It is intended to give a patient limited mobility by reducing pain, restoring alignment, and replacing flexion and extension movement in the ankle joint.

Indications for use:

* Patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis.
* Patients with a failed previous ankle surgery.


Eligibility Criteria:
Inclusion Criteria:

1. Male or non-pregnant female over the age of 21 years with a diagnosis of end stage ankle arthritis and requiring primary TAA/TAR and is suitable for the use of the ADAPTIS TAA/TAR
2. Patients who are physically and mentally willing and able to comply with the post-operative follow-ups and an appropriate rehabilitation schedule.
3. Patient can understand and provide written consent.

Exclusion Criteria:

1. Patients with previous ankle arthrodesis or Patients who require revision of previously implanted TAA/TAR.
2. Any patients presenting with clinically relevant conditions prior to implantation, that would contraindicate implantation of a TAA/TAR
Inflammation Markers in Fluid Aspirate From a Scarred Uterine vs. a Normal Uterine Cavity

A prospective study that will take place in the hydrosonography clinic, comparing patients with an intact uterus to those who had a caesarean section. Eligible patients will preform a transvaginal ultrasound for evaluation of presence of a niche. After fixation of the transcervical catheter, we will flush 2 ml sterile NaCl 0.9% into the uterine cavity and aspirate the fluid. After collecting all samples, the samples will be snap frozen and stored at -80o C, until they undergo an immunological analysis.


Eligibility Criteria:
Inclusion Criteria:

- Patients suffering from infertility and assigned for a hydrosonography exam for assessment of the integrity of the uterus and fallopian tubes.

Exclusion Criteria:

1. Patients with hydrosalpinx/pyosalpinx/sactosalpinx
2. Patients who went through surgical correction of a niche
3. Hormonal treatment- estrogens or progestins.
4. Immunosuppressive/immunomodulating medication
Dexmedetomidine in Sonographic Guided Erector Spinae Plane Block

to investigate the postoperative analgesic effect of dexmedetomidine addition with different doses as an adjuvant to bupivacaine to Erector spinae plane block after renal surgeries.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 70 years.
* Both sexes, males and females.
* Patients with the American Society of Anesthesiologists (ASA) physical status I/II.
* Body mass index (BMI) of 18-35 kg/m2
* Patients scheduled for elective Renal or Percutaneous Nephrolithotomy.

Exclusion Criteria:

* Patients under 18 years.
* Patient refusal of nerve block.
* Infection at the site of injection.
* Coagulopathy.
* Allergy to used medications.
* Psychiatric disorder or chronic pain syndromes.
* Chronic opioid use or substance abuse.
* Quadriplegic patients.
LXRs, Cholesterol Metabolism and Uterine Dystocia

Despite the fact that a link between cholesterol and the myometrium has been clearly established, no study investigating aspects of cholesterol metabolism and uterine dystocia currently exists. This study is a pilot study whose aim is to test the hypothesis that an association between uterine dystocia and single-nucleotide polymorphisms (SNPs) in the genes coding for the LXRs.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing C-section for a dystocia: 2 to 3 hours of stagnation in labor progress are observed (ie no increasing dilation, and uterine contractions less that 3-5 per 10 minutes) in spite of measures taken to overcome dystocia (oxytocin injection and artificial breaking of waters)
* the child is alive
* the child does not have apriori known malformations that could interfere with a vaginal birth
* foetus in cephalic position
* full term pregnancy (\>= 37 weeks of amenorrhea)
* single birth
* patient has signed consent
* patient is affiliated with a social security system

Exclusion Criteria:

* vaginal birth
* programmed C-section
* C-section is chosen because the fetus has a cardia rhythm problem, and there is no stagnation in the labor process
* multiple pregnancy
* the child is in a breech position
* premature birth (\<37 weeks amenorrhea)
* in utero fetal death
* fetal malformation known before birth that could interfere with a vaginal birth
* non french-speaking patient (impossible to correctly inform the patient)
* patient under guardianship
Chronic Non-Malignant Pain in Cancer Patients at a Supportive Care Clinic

The goal of this research study is to learn how frequently cancer patients in the Supportive Care Center have chronic, non-malignant pain. Chronic, non-malignant pain is pain that is neither related to cancer nor its treatment and lasts beyond the normal tissue healing time of 3 months.

If participant is found to be eligible and agrees to take part in this study, participant will be asked to complete 3 questionnaires about participant's pain, pain level, and what drugs participant takes to treat participant's pain. Participant will also be asked a few questions about tobacco use. These questionnaires should take about 20 minutes to complete.

Researchers will also collect information from participant's medical record such as participant's date of birth, sex, race, marital status, economic background, and medical history.

Length of Study:

Participation on this study will be over after participant has completed the last questionnaire.

This is an investigational study.

Up to 200 participants will be enrolled in this study. All will take part at MD Anderson.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of cancer with or without active disease
2. Consultation visit at an outpatient supportive care clinic
3. Age 18 or greater
4. Report of having pain within the last 3 months

Exclusion Criteria:

1) Memorial Delirium Assessment Scale \>13
Detecting Early Onset Pre-eclampsia and Use of Placental Growth Factor (PlGF) for Marker of Trisomy 21

This is a study for the evaluation of the benefits of 1 st Trimester risk markers in detecting Early Onset Pre-eclampsia and the use of the Placental Growth factor(PIGF) as a potential marker for Trisomy 21 and other aneuploidies.

Aim of this prospective nonprofit study is to analyze the benefits of early onset pre eclampsia risk assessment in the 1st trimester (measuring biochemical markers \[PIGF\], blood pressure and Doppler ultrasound), and how the results can permit to modify or influence the course of the preeclampsia during the pregnancy. The investigators will also evaluate the potential use of the PIGF as a marker to improve the prenatal screening with the currently used nuchal translucency, serum Pregnancy-associated plasma protein A (PAPP-A) and free beta subunit of human chorionic gonadotropin (fBhCG) parameters.


Eligibility Criteria:
Inclusion Criteria:

* Singleton pregnancy
* Nulliparous pregnancy
* Gestation age between 6.0-13.6 weeks by last menstrual period verified by ultrasound
* Blood sample provided at gestational age 6.0-13.6 weeks
* Informed Consent

Exclusion Criteria:

* Multi-fetal pregnancy
* Primiparous or multiparous pregnancy
* Mental retardation or other mental disorders that impose doubts regarding the true patient's willingness to participate in the study
* Gestation age below 6.0 or above 13.6 weeks by last menstrual period verified by ultrasound.
* Lack of blood sample at the specified enrollment period
* Known major fetal anomaly or fetal demise
* Lack of demographic data
Revlite Laser System Compared to the Candela Alex TriVantage System Refractory Mixed Type Melasma

This proof of concept study will be conducted to assess the aesthetic improvement in refractory mixed type melasma in subjects treated with two FDA 510K approved devices: Q Switched Nd: YAG Laser vs. Alex TriVantage


Eligibility Criteria:
Inclusion Criteria:

1. Subjects with Fitzpatrick Skin Type III-VI
2. Subjects with mixed (epidermal and dermal) type melasma diagnosed by Wood's Lamp.
3. Subjects who are over the age of 18 years of age
4. The subject is willing and able to comply with study instructions and return to the clinic for required visits.
5. The subject's melasma has persisted for greater than 6 months and has failed to respond to conventional treatment with hydroquinone cream or other topical lightening agents.

Exclusion Criteria:

1. The subject is female and pregnant, has been pregnant within the last 3 months, is currently breast feeding or planning a pregnancy during the study period.
2. The subject has a history of cutaneous photosensitization, porphyria, and hypersensitivity to porphyrins or photodermatosis.
3. The subject has any skin pathology or condition that could interfere with the evaluation or requires the use of interfering topical or systemic therapy.
4. The subject has an uncorrected coagulation defect or is currently using anti-coagulation medication (including but not limited to heavy aspirin therapy).
5. The subject has any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in this research study.
6. The subject is currently enrolled in an investigational drug or device trial, or has received an investigational drug or been treated with an investigational device within 30 days prior to entering this study.
7. The subject has used photosensitizing drugs (e.g., Declomycin, sulfa antibiotics, phenothiazines, etc.) within a timeframe where photosensitization from these drugs may still be present.
8. The subject has the need to be exposed to artificial tanning devices or excessive sunlight during the trial.
9. The subject has had prior treatment with parenteral gold therapy (gold sodium thiomalate).
10. The subject has Diabetes Type 1 or 2.
11. The subject has a sensitivity to hydroquinone or Retin-A.
12. The subject has evidence of a compromised immune system or hepatitis.
13. Has had microdermabrasion in past 3 months, other laser or Intense Pulsed Light treatment or chemical peels to the face in past 6 months, injectable fillers, topical retinoids, over-the-counter anti-aging products past 2 weeks.
14. Has a history of keloids or hypertrophic scarring
15. Has permanent make-up and/or is unwilling to refrain from using semi-permanent cosmetics during study
Monitoring Treatment Response With On-board DWI During Neo-adjuvant Chemo-radiation for Rectal Cancer Using Magnetic Resonance-guided-radiotherapy Systems

feasibility of using a diffusion sequence of a MRgRT system as an early marker of treatment response during nRCT of rectal adenocarcinoma.

feasibility of using a diffusion sequence of a MRgRT system as an early marker of treatment response during nRCT of rectal adenocarcinoma.

Eligibility Criteria:
Inclusion Criteria:

1. Patient over 18 years old.
2. Diagnosis of histologically confirmed rectal adenocarcinoma for which nRCT has been indicated.
3. Karnofsky Index (KPS) ≥ 70 or ECOG = 0 or 1
4. Signed consent to participation.
5. For women of childbearing age, effective contraception must also be agreed for the duration of treatment.
6. Affiliation to a social security regimen, or beneficiary of such a regimen.

Exclusion Criteria:

1. Predominant mucinous component on initial MRI, biopsy and / or definitive pathology. Mucin may lead to overestimation of ADC values on DWIs.
2. Contraindications to the MRI procedure (non compatible pacemaker or other metallic foreign body, severe claustrophobia).
3. Exclusive radiation therapy.
4. Other associated neo-adjuvant treatment.
5. Delayed completion of the surgery (more than approximately 10 weeks after the end of the nRCT) or cancellation of the surgical procedure.
6. Contraindications to capecitabine: Severe hepatic impairment, severe renal impairment (creatinine clearance \<30 ml / min),
7. Known deficiency of Dihydropyrimidine dehydrogenase (DPD), known hypersensitivity to 5-FU / capecitabine and / or its excipients.
8. Participation in a protocol with concurrent treatment.
9. Pregnant or likely to be pregnant (without effective contraception) or breastfeeding
10. Person in emergency situation, person of legal age subject to a legal protection measure, or unable to express his / her consent.
11. Impossibility of attending the medical examination of the test for geographical, social or psychological reasons.