cyrilzakka/clinical-trials huggingface dataset:
Adipose Tissue Injection in Perianal Fistulas in Crohn´s Disease

This randomized and placebo controlled study investigates the efficacy of injections with freshly harvested autologous adipose tissue in CD patients with complex perianal fistulas refractory to standard surgical and/or medical treatment. 140 CD patients will be included and randomized to either treatment with freshly harvested autologous adipose tissue or placebo (saline). Primary outcome measures are clinical healing 6 months after treatment evaluated by clinical examination and pelvic MRI.

Injection with freshly harvested autologous adipose tissue has been reported to be an efficient treatment of perianal fistulas in patients with Crohn´s Disease (CD). In a prospective observational study 57 % of 21 patients with complex fistulas refractory to combined surgical and/or medical treatment achieved complete clinical healing of the treated fistulas from one to three injections.

This randomized and placebo controlled study aims to confirm the efficacy of injections with freshly harvested autologous adipose tissue in CD patients with perianal fistulas. 140 CD patients with complex perianal fistulas refractory to standard surgical and/or medical treatment will be included and randomized to either treatment with freshly harvested autologous adipose tissue or placebo (saline). Clinical evaluation of the treatment efficacy will also be performed in a blinded manner.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with Crohn´s Disease
* Perianal fistula with out branching or cavities with one external and one internal opening, which due to the risk for development of incontinence is not suitable for lay-open procedure, meaning: 1) all anterior interspinchteric and low transpinchteric (involving\<1/3 of spinchter) in women 2) high interspinchteric fistulas 3) high transspinchteric (\>1/3 of sphincter), suprasphincteric and ekstrasphincteric fistulas 4) intersphincteric or low transsphincteric fistula in patients with fecal incontinence and/or fecal urge.
* no or minimal luminal disease activity by colonoscopy \< 3 months before treatment defined by Simple Endoscopic Severity for Crohn´s Disease\<3
* Prior optimal medical treatment for fistulas (immunmodulators, antibiotics and/or anti-TNF-alfa treatment) with out achieving fistula healing
* Treatment with seton for a minimum of 6 weeks
* Speaks and understand Danish

Exclusion Criteria:

* Pregnancy
* Changes in immunmodulator or anti-TNFalfa treatment \< 12 weeks
* Anovaginal fistulas
* Rectal or anal stenosis
* Active proctitis
* Stoma
* Previous surgery for fistulas besides simpel drainage or seton
* Smoker
* Insulin-dependent diabetes, conditions inducing defective immunity, pelvic radiation
* pelvic MRI contraindicated
The Post Intensive Care Syndrome Follow-up and Management Study: the ICU Recovery Answers Project

Critically ill survivors develop mental health, cognition, and mobility sequelae known as Post-Intensive Care Syndrome (PICS). Clinically significant symptoms of post-traumatic stress, depression, anxiety, and cognitive impairment are frequently observed at short- and long-term after ICU, impacting quality of life of the survivors and their relatives.

The main objective of the project is to optimize, implement and evaluate the impact in quality of life of a digital platform (ICURA) specifically designed for following-up and managing the mental health sequelae related to PICS in ICU survivors and their relatives during the one-year recovery phase.

Methods: Observational, prospective and multicenter study including two cohorts: 1) ICU patients' cohort (ICUcohort), and 2) ICU patients' family cohort (ICU-F-cohort). After ICU discharge, patients will be randomized to participate in a follow-up with ICURA vs. the standard follow-up.

Expected results: Critically ill survivors in the APPICS program after ICU will show better levels of functionality and quality of life than those participants in the usual follow-up. APPICS will contribute to enhancing the prognosis of emotional alterations during the 12 months after ICU both, in ICU survivors, and relatives. Analyzing risk factors, based on demographic and clinical data, will help to the early detection of long-term mental health difficulties in ICU survivors.


Eligibility Criteria:
Inclusion Criteria:

* Adult (≥18 years old) critically ill patients admitted to the ICU with or without need of invasive mechanical ventilation (IMV).

Exclusion Criteria:

* Non-authorization of the relatives and/or patient to inclusion in the study; neurocritical ICU patients.
* Severe neurological pathology (including dementia or focal brain damage with functional and cognitive impairment) prior to admission to the ICU.
* Severe psychiatric pathology (schizophrenia, bipolar disorder, major depressive disorder)
* Intellectual disability (IQ \<80).
* Patients who develop secondary complications (infections, stroke, TBI or any non-transient acquired brain damage) after ICU discharge, that may compromise the results of the emotional and neuropsychological evaluation during the recovery phase
* Moderate-severe cognitive impairment (Short-IQCODE \>85) that impair ICU patients an independent participation in the telematic follow up and accompaniment program
* Readmission to ICU within 12 months after discharge from ICU
* Idiomatic barrier (non spanish and/or catalan speaker)
* Patients with life expectancy \<1 year or not subsidiaries of active treatment measures.
Preventing Urinary Tract Infection Post-Surgery

Approximately 10-27% of patients undergoing gynecologic surgeries develop a catheter associated urinary tract infection (CAUTI) in the post operatory period, as bladder catheterization is a common practice in gynecologic surgery. Cranberry products provide alternative means for preventing CAUTI and could result in decreased use of antimicrobials. In this pilot study we will enroll 200 women post gynecologic surgery and randomize them to take either cranberry powder capsules or placebo powder capsules. The low risk of harm associated with using cranberry to reduce UTI coupled with its potential benefit makes it a desirable intervention for the prevention of CAUTI. The conduct/ results of this pilot /feasibility study will prepare us for the conduct of a large scale clinical trial.

Cranberry products prevent bacteria that cause UTI, especially Escherichia coli, from adhering to bladder cell wall thus preventing infection. Adherence of type 1 pili is inhibited by the fructose and of p pili by the proanthocyanidins present in cranberry.

Eligibility Criteria:
Inclusion Criteria:

1. Presenting at the gynecology clinic for a pre-operatory visit
2. Ability to give informed consent
3. Willing to take cranberry capsules for up to 6 weeks
4. 18 of age or older

Exclusion Criteria:

1. Pregnancy
2. History of nephrolithiasis
3. History of allergy to cranberry
4. Patient on anticoagulant medicine to be re-started during the 4-6 weeks after surgery
5. Less than 18 years old
Efficacy at One Year of Combined Injections of Plasma Rich in Platelets and Hyaluronic Acid in Knee Osteoarthritis

The French Society of Rheumatology cannot rule on the value of intra-articular injections of PRP due to the lack of hindsight and insufficient data. In fact, the injection protocols are very heterogeneous in terms of preparation method, the presence or not of leukocytes, the number of centrifugations, the volume injected, the ultrasound guidance, which makes it difficult to analyze the literature. The investigator objective is therefore to evaluate the effectiveness of combined injections of PRP and hyaluronic acid.


Eligibility Criteria:
Inclusion Criteria:

* age : \> 18 years old
* Patients benefiting, in the context of knee osteoarthritis, from viscosupplementation alone or from two injections of PRP, in combination with HA, at the Amiens University Hospital.

Exclusion Criteria:

* Patient refusal to use the data
* Language barrier
* Age less than 18 years old.
A Multicenter Trial Comparing Multi-course Chemotherapy in Locoregionally Advanced Nasopharyngeal Carcinoma

Locoregionally advanced nasopharyngeal carcinoma (NPC)(stage III, IV in UICC 2002 Classification) can be divided into two groups according to the risk of metastasis: high-risk metastasis group (T4 or N2-3) and low-risk metastasis group (T3N0-1). In low-risk metastasis group, concurrent chemoradiotherapy (CCRT) might decrease local recurrence and distance metastasis, which benefits overall survival. On the other hand, neoadjuvant chemotherapy is also associated with lower distance metastasis of advanced stage NPC. Nevertheless, CCRT alone or neoadjuvant chemotherapy alone leads to unsatisfactory results regarding to distance metastasis in patients with high-risk metastasis group. In this case, it is utmost important to investigate the new treatment combining neoadjuvant chemotherapy plus CCRT in order to improve overall survival of locoregionally advanced NPC with high-risk metastasis.

In our study, in order to investigate the effect and adverse reaction of neoadjuvant chemotherapy plus CCRT on distance metastasis and locoregionally relapse, four hundred patients with high risk of distance metastasis will be randomly divided into two groups, comparing neoadjuvant chemotherapy (DDP+5FU) plus CCRT (DDP) and CCRT (DDP) alone. We aim to find out the best therapeutic regimen with lowest adverse reaction for NPCS with high risk of distance metastasis.


Eligibility Criteria:
Inclusion Criteria:

* Patients with newly histologically confirmed nasopharyngeal carcinoma, including WHO II or III
* Original clinical stage must be T4 or N2-3 （UICC 2002）
* Male and no pregnant female
* Age between 18-60
* WBC ≥4,000/mm3 and PLT ≥ 100,000/mm3
* With normal liver function test (ALT、AST≤2.5×ULN)
* With normal renal function test (Creatinine ≤ 1.5×ULN)
* Performance status scale ECOG grade 0，1
* Without radiotherapy or chemotherapy
* Patients must give signed informed consent

Exclusion Criteria:

* Patients have evidence of relapse or distant metastasis
* The presence of uncontrolled life-threatening illness
* Receiving other ways of anti-cancer therapy
* Receiving radiotherapy or chemotherapy
* Investigator consider the patients can't finish the whole study
Lifting and Tightening of the Face in Subjects With Skin of Darker Color

This prospective, multi-center, single treatment clinical trial evaluates the clinical outcomes associated with non-invasive treatment to obtain lift and tightening of facial tissue and improve jawline definition in subjects with darker skin color utilizing the Ulthera® System to deliver focused ultrasound energy below the skin surface.

The primary objective of this clinical trial is to demonstrate the effectiveness of the Ulthera® System for the non-invasive treatment to obtain overall lift and tightening of facial tissue and jawline definition improvement.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, aged 30 to 65 years.
* Subject in good health.
* Subjects who desire lift and tightening of cheek tissue, improvement in jawline definition and/or submental skin laxity.
* Fitzpatrick skin phototypes of 3 through 6.
* Provide written informed consent and HIPAA authorization

Exclusion Criteria:

* Pregnant or lactating.
* Presence of an active systemic or local skin disease that may affect wound healing.
* Severe solar elastosis.
* Excessive subcutaneous fat on the cheek.
* Excessive skin laxity on the lower face and neck.
* Significant scarring in areas to be treated.
* Significant open facial wounds or lesions.
* Severe or cystic acne on the face.
* Presence of a metal stent or implant in the facial area to be treated.
Supplemental Hydrogen Plus PQQ for Mitochondrial Biomarkers and Brain Function in Elderly With Mild Cognitive Impairment

The goal of this randomized controlled double-blind parallel-group interventional trial is to evaluate the effects of dietary supplementation with molecular hydrogen and pyrroloquinoline quinone in elderly. The main questions it aims to answer are: (1) whether the supplementation affects biomarkers of mitochondrial function in serum, and (2) whether the supplementation affects cognition and brain metabolism. The participants will be subjected to take the dietary supplement during 6 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 65 years
* MMSE scores ranged from 23-27
* Informed consent signed

Exclusion Criteria:

* Take part in exercise on a regular basis
* Severe chronic disease and acute injuries
* History of dietary supplement use during the past 4weeks
* No consent to randomization
* Participation in other studies
Study to Assess the Safety, Tolerability, and Efficacy of IDX-1197 in Combination with XELOX or Irinotecan in Patients with Advanced Gastric Cancer

This is an open-label, Phase 1b/2a study to evaluate the safety and tolerability of IDX-1197 and determine the MTD and RP2D in combination with XELOX or irinotecan in patients with advanced gastric cancer.


Eligibility Criteria:
Inclusion Criteria:

* Group 1, patients with treatment-naïve recurrent or advanced metastatic gastric cancer including gastroesophageal junction or upper part of the stomach.
* Group 2, patients with recurrent or advanced metastatic gastric cancer including gastroesophageal junction or upper part of the stomach, who were treated ≥2 times with palliative chemotherapy before screening.
* At least 1 evaluable lesion for the dose escalation part and at least 1 measurable lesion according to RECIST v1.1 for the dose expansion part.
* Eastern Cooperative Oncology Group (ECOG) performance status ≤1.
* Group 2 Part C, patients should have UGT1A1 genotype tested during or prior to screening.

Exclusion Criteria:

* Symptomatic central nervous system or uncontrolled brain metastasis
* Carcinomatous meningitis or its history.
* For Group 1, patients who are HER 2 positive.
* Any other concurrent uncontrolled illness including, but not limited to, active or ongoing symptomatic infection requiring IV antibiotic treatment, uncontrolled diabetes, hepatic, renal, or respiratory illness.
* Severe or unstable angina, myocardial infarction or ischemia, symptomatic congestive heart failure, arterial or venous thromboembolism requiring coronary artery bypass graft or stent within the past 6 months or clinically significant cardiac dysrhythmia or New York Heart Association class II \~ IV heart disease within 6 months of randomization.
* Uncontrolled hypertension
* Immunocompromised patients, such as patients known to be serologically positive for HIV.
* Patients with known active Hepatitis B or C infection.
* Patients with known active or symptomatic pneumonitis, or history of non-infectious pneumonitis requiring steroids.
* Diagnosis of a myelodysplastic syndrome/acute myeloid leukemia or its suspicious characteristics.
* Any unresolved clinically significant Common Terminology Criteria for Adverse Events (CTCAE) Grade ≥2 toxicity
* Resting ECG with measurable QTcF \&gt; 470 msec on 2 or more time points within a 24-hour period or family history of long QT syndrome.
* Current use of a cytochrome P3A4 inhibitor or inducer and strong uridine diphosphate (UDP)-glucuronosyltransferase 1A1 (UGT1A1) inhibitors.
Riluzole Effects on Hippocampus Biomarkers

To examine the clinical efficacy of the anti-glutamatergic medication riluzole in posttraumatic stress disorder (PTSD), and its effect on hippocampus biomarkers that our laboratory previously has identified using MRS.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female age 18-65.
2. Right handed
3. Able to provide written informed consent.
4. Meets DSM-5 criteria for PTSD (current month and past 3 months).
5. If already receiving psychiatric intervention(s), must be on a stable regimen.
6. Has normal physical examination, laboratory test results, and electrocardiogram results at pre-treatment visit.

Exclusion Criteria:

1. Unwillingness or inability to provide written informed consent.
2. Unable to swallow pills.
3. Unable to tolerate blood draws.
4. Currently enrolled in another intervention study.
5. Imminent risk for self-harm (assessed by a licensed clinician)
6. Active psychotic symptoms.
7. Current panic disorder.
8. Lifetime history of schizophrenia spectrum disorder, bipolar disorder, obsessive compulsive disorder, anorexia nervosa, seizure disorder, or neurologic disorder.
9. Urine toxicology positive for drug(s) of abuse.
10. Evidence of any clinically significant medical disease.
11. Women who test positive for ß-HCG, self-report as pregnant, or are nursing.
12. Substance or alcohol abuse within 3 months of Visit 1. Substance or alcohol dependence within 6 months of Visit 1.
13. Excessive caffeine use, defined as regular consumption of \>700mg caffeine per day.
14. Treatment with an antipsychotic, valproate, other anticonvulsant, reversible MAOI within 4 weeks of Visit 1. Other excluded medications will be those with (1) known glutamatergic effects, (2) previous MRS evidence of effects on brain glutamate, (3) potential effects on riluzole levels or (4) risk of neutropenia - used within 4 weeks of the first study visit.
15. Previous exposure to riluzole or ketamine.
16. Treatment with any investigational medicine within 30 days of Visit 1.
17. Treatment with electroconvulsive therapy (ECT) within 3 months of Visit 1.
18. Uncorrected thyroid disease.
19. Any screening laboratory assay that is deemed to be a clinically significant abnormality by the investigator, with the exception of liver function tests (AST, ALT, alkaline phosphatase), which must be within 1.5 times the upper limit of normal.
20. Any contraindications to having an MRI scan.
Premenstrual Syndrome and Physical Activity Self-Worth

Premenstrual syndrome (PMS) negatively affects the quality of life of millions of women. PMS is a common cyclic disorder characterized by somatic, cognitive, emotional and behavioral symptoms that usually occurs in young and middle-aged women, lasts during the luteal phase of the menstrual cycle and ends with the onset of menstruation.Studies have shown that women with high PMS symptoms are more inactive. Physical activity participation in women affects a wide spectrum of self-perceptions, including knowledge, social, and emotional self-perceptions. By determining which physical, emotional, social and academic/knowledge areas are affected by women, increasing their participation in physical activity can be achieved. The subject of the study is to determine the symptom severity of women with and without premenstrual syndrome and to examine how premenstrual syndrome affects physical activity self-worth.

Premenstrual syndrome (PMS) negatively affects the quality of life of millions of women. PMS is a common cyclic disorder characterized by somatic, cognitive, emotional and behavioral symptoms that usually occurs in young and middle-aged women, lasts during the luteal phase of the menstrual cycle and ends with the onset of menstruation.Studies have shown that women with high PMS symptoms are more inactive. Physical activity participation in women affects a wide spectrum of self-perceptions, including knowledge, social, and emotional self-perceptions. By determining which physical, emotional, social and academic/knowledge areas are affected by women, increasing their participation in physical activity can be achieved. The subject of the study is to determine the symptom severity of women with and without premenstrual syndrome and to examine how premenstrual syndrome affects physical activity self-worth.

A total of 296 women age of 18-35 participate in the research. Participants were divide into two groups with and without premenstrual syndrome.

Eligibility Criteria:
Inclusion Criteria:

* Volunteer to participate in the study
* Being 18-35 years old
* Being women
* To be menstruating

Exclusion Criteria:

* Evaluation form missing
* Not menstruating for 12 months or more
* Having any psychological diagnosis
* Being pregnant
Multiple Dose Pharmacokinetics of Intranasal Ketamine

This is an open label, single-center study of the pharmacokinetic and safety profile of repeat doses of PMI-150 (intranasal ketamine) 30 mg in healthy adult volunteers.

To examine safety and characterize the repeat dosing plasma profile, effect on absorption, and accumulation following repeated administration of 30 mg doses of PMI-150 (intranasal ketamine) to healthy adult volunteers.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adults

Exclusion Criteria:

* under 18 years
Deferoxamine for the Prevention of Cardiac Surgery-Associated Acute Kidney Injury

Multiple lines of evidence support a central role of iron in causing acute kidney injury (AKI), including the finding that prophylactic administration of iron chelators attenuates AKI in animal models. Patients undergoing cardiac surgery may be particularly susceptible to iron-mediated kidney injury due to the profound hemolysis that often occurs from cardiopulmonary bypass. The investigators will test in a phase 2, randomized, double-blind, placebo-controlled trial whether prophylactic administration of deferoxamine decreases the incidence of AKI following cardiac surgery.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years
2. Undergoing coronary artery bypass graft and/or valve surgery with cardiopulmonary bypass
3. AKI risk score ≥6 at the time of screening
4. Written informed consent from the patient or surrogate

Exclusion Criteria:

1. AKI, defined as any of the following:

   * Increase in serum creatinine ≥0.3 mg/dl in 48h
   * Increase in serum creatinine ≥50% in 7d (if no value available in last 7d, use most recent value in last 3 months)
   * Urine output ≤0.5 ml/kg/h x 6 consecutive hours (only assessed in patients with hourly monitoring via Foley catheter)
   * Receipt of renal replacement therapy (RRT) within 7d
2. Advanced chronic kidney disease (eGFR \<15 ml/min/1.73m2 or end-stage kidney disease receiving RRT)
3. Hemoglobin \<8 g/dL (closest value in the prior 3 months)
4. Fever (temperature ≥38⁰C) in the last 48h
5. Suspected or confirmed bacteremia, endocarditis, or pyelonephritis
6. Pneumonia, aspiration, or bilateral pulmonary infiltrates from an infectious etiology reported on chest x-ray or CT scan in the last 7d
7. Positive COVID-19 test within previous 10d
8. Chronic iron overload (including conditions such as hemochromatosis and beta thalassemia major) or previous iron chelation therapy (including prior participation in DEFEAT-AKI)
9. Known hypersensitivity to deferoxamine
10. Taking prochlorperazine
11. Severe hearing loss
12. Pregnant or breastfeeding
13. Prisoner
14. Concurrent participation in another interventional research study in which the intervention has potential interaction with deferoxamine
15. Surgery to be performed under conditions of circulatory arrest
16. Receiving extracorporeal membrane oxygenation
17. Durable ventricular assist device (VAD) prior to surgery (does not include Impella device or intra-aortic balloon pump)
18. Any condition which, in the judgement of the investigator, might increase the risk to the patient
19. Conflict with other research studies