cyrilzakka/clinical-trials huggingface dataset:
Identification of Multimorbid Patients With a Higher Probability of Readmission and Mortality

A prospective qualitative quantitative study was designed to create predictive models of readmission in multimorbid patients.

Social determinants have been shown to be related to the probability of readmission and death in multimorbid patients. These are increasingly older, which makes them more likely to be readmitted when their preferences are usually to be at home. Objective: To create and validate prediction models for readmission and mortality during home transitional period (1 month) and up to a year, in multimorbid patients, including variables related to the patient and their social environment. Design: Quali-quantitative. 4 hospitals from 3 regions (Andalucia, Catalonia and the Basque Country) will participate . Patients presenting at least 2 of the Ollero's categories will be included. Variables will be identified by means of nominal groups of professionals and focal groups with patients and caregivers. These variables will be included in the final models join to clinical variables, PROMS (health related quality of life, burden of the caregiver , social support). Logistic/ Cox regression models will be developed and validated internally to identify the risk of readmission and death which will be validated in an external cohort. Expected results: We hope to provide the health system with stratification tools for polypathological patients that help in identifying those patients with the greatest need for individualized interventions.

Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years of age
* Patients discharged from the Internal Medicine departments of the participating centers due to acute pathology, de novo or decompensation of a chronic pathology who also present at least 2 of the cathegories of Ollero et al.

Exclusion Criteria:

* Patients admitted for end-of-life treatment, scheduled admissions, exacerbation of rheumatic pathology or systemic disease, study of anaemia in patients with no-known comorbidity, search for neoplasia and acute processes without associated comorbidity. -
* Failure to sign the informed consent form.
Pharmacological Approach to Improve the Outcome of Social Cognition Training

This study will evaluate whether oxytocin will facilitate the learning of social cognitive skills in schizophrenia patients who receive 12 sessions of Social Cognitive Skills Training (SCST). The primary hypothesis is that schizophrenia subjects who are treated with oxytocin will demonstrate greater improvements in a summary measure of social cognition than subjects treated with placebo over the course of SCST.

Individuals with schizophrenia often have serious deficits in their abilities to perceive and interpret socially relevant information. These deficits in social cognition can lead to misunderstanding the intentions of others and failing to interpret social signals that are important for successful social interactions. The relationship between social cognition and functioning has led our group to develop a research agenda that includes understanding the neural underpinnings of social cognitive deficits, measuring these impairments using brain-based biomarkers and clinical assessments, and enhancing our Social Cognitive Skills Training program to improve social cognition and promote recovery.

Oxytocin, which is a hormone and neurotransmitter, is believed to impact social cognition through increased orienting toward and attending to socially salient visual features. There is also evidence that oxytocinergic signaling is impaired in schizophrenia. With this research, we hope to learn whether administration of oxytocin will improve different aspects of social cognition by examining the effects of oxytocin versus placebo administered intranasally before each of 12 sessions of a social cognitive skills training program on measures of independent living, work and social functioning.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders 4th edition
* Stable on an antipsychotic medication
* No change in antipsychotic dose of \>10% during the past 3 months

Exclusion Criteria:

* Unable to provide informed consent
* History of epilepsy
* Active medical conditions that would make the study unsafe
* History of serious head injury
* History of hyponatremia
Improving ACL Reconstruction Outcomes: CBPT

The overall objective of this study is to conduct a two-group randomized trial to examine the efficacy of cognitive-behavioral based physical therapy (CBPT) for improving knee function, return to sport, and quality of life outcomes in patients following ACL reconstruction (ACLR). The study consists of two treatment groups: telephone-based cognitive-behavioral based physical therapy for ACLR (CBPT-ACLR) and telephone-based Education. The central hypothesis is that the CBPT-ACLR participants relative to the Education group will demonstrate significantly greater improvement in postoperative outcomes at 12 months following surgery.


Eligibility Criteria:
Inclusion Criteria:

1. English speaking (due to feasibility of employing study personnel to deliver and assess the study intervention);
2. 14 to 35 years of age (children 14 and older have skeletal maturity and adults 35 and younger are less likely to have symptoms of knee osteoarthritis);
3. no previous surgery to either knee;
4. time from injury to surgery 12 months or less;
5. active participation in a sport on a weekly basis prior to injury

Exclusion Criteria:

1. bilateral simultaneous ACL reconstructions;
2. revision ACLR;
3. any concurrent ligament (MCL, LCL, or PCL) surgical procedures;
4. concurrent osteotomies or meniscus transplantations;
5. surgery secondary to trauma, tumor, or infection;
6. having workman's compensation insurance for surgery;
7. on active military duty;
8. medical history of schizophrenia or other psychotic disorder; and
9. unable to provide stable address and access to a telephone
5fluorouracil for Advanced Photoaging

It is well known the efficacy of 5% 5-fluoruracil for multiple and superficial actinic keratosis (AKs)treatment. Recently its additional benefit for advanced and severe photoaging while treating Aks was reported.

The aim of this study is to compare the efficacy and safety of the two modalities of 5% 5-FU use for forearms photoaging.

The use of 5% 5-fluorouracil (5-FU) cream, twice a day, during 3 weeks represents a classic treatment for multiple and superficial AKs. The main adverse event is the severe skin irritation leading to interruption of the treatment in some cases. In the last decade a superficial pulse-peeling using it as agent in sequential applications was described. This modality of treatment has been demonstrated efficacy and better tolerability.

The improvement of the overall aspect of photodamaged skin is observed while treating multiple AKs.

There are no comparative study between the two types of 5% 5-FU use. So that is the purpose of our clinical trial.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy Men and women, aged from 50 to 75 anos;
2. Phototype I a III (Fitzpatrick Classification);
3. Advanced photoaging on forearms, with multiple superficial actinic keratosis;
4. Agreement with no sun exposure during the study and
5. Agreement with study conditions,capacity to understand and follow the orientations and form consent signature.

Exclusion Criteria:

1. Topical treatment with:

   * tretinoin in the last 6 months ;
   * other retinoids, alpha-hydroxyacids, poli-hydroxyacids, beta-hydroxyacids and ascorbic acid in the last 3 months;
2. Treatment by chemical peeling, microdermabrasion and non-ablative laser in the last 3 months;
3. Treatment with systemic retinoid in the last 6 months ;
4. Chemotherapy in the last 3 months;
5. Hypersensibility to parabens;
6. Infectious or inflammatory dermatosis on forearms;
7. Clinical evidence of immunosuppression and
8. Presence of photodermatosis
Character Traits and Stress in Suspected Prostate Cancer

It has previously been reported that men with prostate cancer are 1 ) reduced quality of life after diagnosis and treatment, 2 ) neuroticism increases the reduction in QoL related to treatment side effects, and 3) often have very involved and active spouses who seems to have been handed over / taken over parts of the men's responsibility for their own health. We postulate herein a new hypothesis that the stress level is elevated when harbouring undetected prostate cancer. We will investigate whether those who are diagnosed with prostate cancer already in beforehand have an increased degree of masculine stress ( experience of not living up to their own perception of the ideal man ) and neuroticism in the typology. We will examine different personality and QoL questionnaires for patients with elevated PSA, and compare those whose clinical assessment later reveals prostate cancer, with three control groups: 1) men with elevated PSA who are not diagnosed with prostate cancer, 2) men with normal PSA treated for benign prostate enlargement and 3) patient with substantial risk of colorectal cancer (CRC) who undergo colonoscopy, with regard to increased level of masculine stress and the personality trait neuroticism.

Inclusion criteria:

1. Men who are being referred as new urological outpatient and meet the following criteria:

   1. Wanted clinical examined because of elevated PSA
   2. Not strong family history of prostate cancer
   3. It is taken biopsy as part of routine investigation.
2. Control groups: Men being referred to urological / gastroenterological outpatient clinic, and which meet the following criteria:

   1. urination complaints, normal PSA, and study shows prostate size\> 40cc
   2. Or melena and cancer suspicion in colorectum
3. Age\> 18 years and \<75 years

Outcome measures:

Together with statistician look for patterns / covariance in replies from those who are diagnosed with prostate cancer in the questionnaires personality evaluation adapted to normal population (Neo-FFI), gender differentiated stress response questionnaire (MGRSS) and questionnaires related to resilience, relationship and quality of life index, compared with the control groups.

Eligibility Criteria:
Inclusion Criteria:

1. Men who be referred a new urological outpatient and satisfy the following:

   * Wanted examined because of elevated PSA
   * Not strong family history of prostate cancer
   * It is taken biopsy as part of routine investigation.
2. Control group: Men referred to urological outpatient clinic, and who satisfy the following

   * urination complaints
   * Normal PSA
   * examination shows prostate size\> 40cc
3. Control group: Men first time referred urological / gastroenterological outpatient clinic, and which satisfy the following

   -- symptoms that might indicate cancer suspicion in colorectum
4. Age\> 40 years and \<75 years

Exclusion criteria:

1. known prostate cancer
2. Reduced consent

4 Familial occurrence of prostate cancer (one or more 1st degree relatives with CaP)
Safety and Efficacy Study of Botulinum Toxin Type A for the Treatment of Forehead and Frown Lines

This study evaluated the safety and efficacy of botulinum toxin Type A compared to placebo for the treatment of forehead lines (facial rhytides) when also administered to frown lines (glabellar rhytides).


Eligibility Criteria:
Inclusion Criteria:

* Moderate to severe forehead lines

Exclusion Criteria:

* Current or previous botulinum toxin treatment of any serotype within one year
* Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis
* Prior facial cosmetic surgery (e.g. prior periorbital surgery, facial lift, brow lift, eyelid lift or eyebrow surgery)
* Facial laser or light treatment, microdermabrasion, or superficial peels within 3 months
* Oral retinoid therapy within one year
Study of Iron Accumulation Measured in MRI in Non-pathological Aging

To study the correlation between the iron load in brain, measured in MRI, and the age of healthy subjects Secondary objectives are to study the correlations between the iron load in cortical brain regions and (i) the cognitive performances, (ii) markers of aging (MRI, EEG, OCT, biology),and (iii) demographical factors involved in iron load.


Eligibility Criteria:
Inclusion Criteria:

* Men or women between 18 and 95 years old
* French speaker with capability to understand the instructions
* Health insurance

Exclusion Criteria:

* Pregnancy
* minor subject
* no informed consent agreement
* subject enrolled in pharmaceutic study or exclusion period
* MRI contra-indications
* Neurological or psychiatric disorders
* MOCA \< 26
* Psychotropic drugs
* More than 3 MRI exams
* More than 1 neuropsychological assessment (same cognitive tests) in the last 12 months
* Unable to follow the entire protocol according to the investigator
A Placebo-Controlled Study to Investigate the Onset of Action of Paroxetine in Premenstrual Dysphoria

The objective of this study is to explore the onset of action when serotonin reuptake inhibitors are used to treat premenstrual dysphoric disorder

Whereas serotonin reuptake inhibitors (SRIs) usually require weeks of treatment to effectively counteract depressed mood or anxiety, several studies suggest that they may reduce the symptoms irritability and anger more rapidly. In line with this, SRIs have been shown to reduce certain symptoms, including irritability, in women with premenstrual dysphoric disorder (PMDD) when the drug only is administered from ovulation to menstruation only, which indicates an onset of action of 10 days or less. How fast this effect appears in terms of hours or days is, however, not known. The objective of this study was to explore this issue.

Eligibility Criteria:
Inclusion Criteria:

* The patient should have participated in an ongoing placebo-controlled trial regarding the effect of paroxetine in PMD; to be included in that trial, she must have fulfilled the diagnostic criteria A-C of PMDD in DSM-IV and certain other inclusion and exclusion criteria which are listed in appendix 1.
* The patient should a) have been given paroxetine during the previous trial, b) have reported that she has been "much improved" or "very much improved" by this treatment, c) have displayed a marked reduction in VAS-rated irritability during treatment, and d) have reported that she has found the side-effects tolerable.
* The patient should display at least a 50% increase in VAS-rated irritability during the luteal phase (mean of last five days prior to menses) as compared the follicular phase (days 6-10) during one cycle of pretreatment symptom rating (without medication).
* The patient should have given written informed consent to participate in the study.

Exclusion Criteria:

* Any concomitant psychiatric disorder for which SRIs are known to be effective.
* Any other concomitant psychiatric disorder that, in the investigator's opinion, would render the patient unsuitable for the study.
* Any somatic disorder that, in the investigator's opinion, would render the patient unsuitable for the study.
* Any ongoing medication which, in the opinion of the investigator, would render the patient unsuitable for the study. Examples of medications that preclude participation in the study are: 1) any psychotropic drug, with the exception of the occasional use of hypnotics, 2) any hormonal preparation, with the exception of thyroid hormone, 3) anti-coagulants, and 4) 5HT1D agonists. Occasional use of analgesic compounds does not preclude participation.
* Patient characteristics which, in the opinion of the investigator, are likely to reduce compliance with the protocol.
Measurements of Sexual Steroids' Concentrations in Prostatic Tissue

In the investigators's previous work, measurements of intra-prostatic concentrations of sex steroids were determined on samples taken from the operating room using a punch.

In order to study the in-vivo intra-prostatic concentrations of sex steroid, it is necessary to validate a measurement technique performed on samples obtained by a biopsy needle used in standard care for prostate biopsy punctures allowing the diagnosis and follow-up of prostate cancer.

The aim of this project is to validate this measurement technique carried out on samples obtained by the biopsy needle and to define the optimal number of carrots obtained by biopsy offering dosage results comparable to the punch.


Eligibility Criteria:
Inclusion Criteria:

* Patient aged ≥ 18 years
* With a bladder cancer
* Should be operated by total cystoprostatectomy at Foch Hospital
* Affiliated to a health insurance scheme
* Having expressed the non-opposition for the participation to the study

Exclusion Criteria:

* Patient receiving or has received a treatment by analog or antagonist of Luteinizing Hormone Releasing Hormone (LHRH), antiandrogens (steroidal or non-steroidal), 5 alpha-reductase inhibitor, docetaxel or cabazitaxel chemotherapy, abiraterone acetate, enzalutamide or corticosteroids
* Patient who does not understand French
* Patient deprived of liberty or under guardianship
Blood Flow Path Reconstruction in Rectal Cancer

89 patients with distal sigmoid and rectal cancer were referred in our observation and underwent MS-CTA between June 2020 and March 2022. We classified the distribution of LCA and confirmed whether there exists AMCA (accessory middle colic artery). Then we planned blood flow path based on the classification of LCA branches before operation. High ligation was applied in regular radical surgery. During operation, we carefully protect the bifurcation of ascending and descending LCA. Then we compared the planned blood flow path with the actual postoperative blood flow path to verify the mechanism we proposed previously.


Eligibility Criteria:
Inclusion Criteria:

* (1) patients with distal sigmoid colon and rectal cancer; (2) cTNM stage was confirmed to be I-III on MRI or CT; (3) Laparoscopic anterior resection (LAR) was performed.

Exclusion Criteria:

* (1) The starting time of arterial phase scanning is earlier； (2) The anatomic structure is not clear; (3) No enhanced CT after operation (only 5 cases).
Clinical Outcomes Maxilla: Buffered 1% Lidocaine vs. Non-buffered 2% Lidocaine

Anecdotal data suggest that the buffered form of the local anesthetic is more potent at equal dosages, and a lower dosage of the buffered drug might be used with an effect equal to higher dosage not buffered. Clinical data are needed to confirm these anecdotal data. No published data exist comparing buffered local anesthetics at lower drug concentrations to current dosages commonly used in dental and oral surgical procedures

Specific Aims:

Compare clinical depths of pulpal anesthesia for maxillary molar and canine teeth at 30min intervals post injection after maxillary field block anesthesia with buffered 1% lidocaine with 1/100,000 epinephrine as compared to non-buffered 2% lidocaine with 1/100,000 epinephrine.

Hypotheses:

No differences exist in anesthetic depth for pulpal anesthesia after intraoral injection for maxillary field block anesthesia between buffered 1% lidocaine with 1/100,000 epinephrine as compared to non-buffered 2% lidocaine with 1/100,000 epinephrine.

Study Time Frame: 6 months: Month One Recruit 24 volunteers as subjects, Prepare case-books. Months Two-Three Clinical Study. Months Four-Five Analyze Lab data. Month Six Prepare Abstracts, Papers Methods: Blinded, Randomized Clinical Design, Recruit subjects with Institutional Review Board approved consent at University of North Carolina. Subjects will serve as their own controls in a cross-over AB/BA study design which is uniform within sequences, uniform within periods, and balanced. Randomized subjects to be injected orally for maxillary field block (Posterior alveolar, Anterior alveolar, Palatal sensory nerves) alternatively with 4cc of buffered 1% lidocaine with 1/100,000 epinephrine and 4cc non-buffered of 2% lidocaine with 1/100,000 epinephrine.

Assessment: pre, and post-anesthetic administration for pulpal anesthesia with cold, electronic pulp test at maxillary molar and canine at 30 minute intervals.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists Risk Classification I Willingness to participate in two sessions

Exclusion Criteria:

* Allergy to lidocaine class of anesthetic drugs Local anesthetic drug use in past week Current symptoms teeth or oral mucosa
A Multicentre Observational Study to Assess Long-term Outcome of Participants in the EXCELLENT Clinical Trial

The PERFECT study is an observational study designed to follow patients randomised in the EXCELLENT study (NCT02669810) for 10 years.

The aim is to assess the long-term clinical outcomes for patients randomised to the Standard of Care arm or the ProtheraCytes arm.


Eligibility Criteria:
Inclusion criteria :

* Completion of the last visit in the EXCELLENT interventional clinical trial.
* Participation must be within 10 years after the randomization in the EXCELLENT trial

Exclusion criteria :

* Patients randomized to the ProtheraCytes® group who did not receive the product of the EXCELLENT Trial are excluded.
* Any other coexisting conditions that will preclude participation in the study or compromise ability to give informed consent
Study Comparing the DOVER Silver Foley Catheter to a Standard of Care Catheter and a Marketed Silver Coated Foley Catheter

The purpose of the study is to determine if the commercially available device called the DOVER™ Silver Foley catheter prevents infections of the urinary tract.

Over 1 million catheter-associated urinary tract infections (CAUTIs) occur annually in U.S. healthcare facilities and account for approximately 40% of the nosocomial infections. This investigation is a multi-center, blinded, prospective, randomized, controlled, parallel comparison of the intervention catheter (Tyco Healthcare DOVER Silver Foley catheter) to a usual care catheter and another commercially available silver-coated catheter. 1000 subjects total will be randomized at the multiple study centers.

Eligibility Criteria:
Inclusion Criteria:

* Subject is at least 18 years of age.
* Subject is expected to be catheterized with a 14, 16 or 18 French Foley catheter for at least 72 hours.
* Subject or his/her legally authorized representative is able to grant informed consent to participate in this investigation.

Exclusion Criteria:

* Subjects who present with ongoing, active, symptomatic UTI.
* Subjects with a known or suspected allergy to silver or silver compounds causing delayed hypersensitivity reactions or contact dermatitis.
* Subjects with a known or suspected allergy to natural rubber latex or natural rubber latex compounds causing delayed hypersensitivity reactions or contact dermatitis.
* Subjects known to be pregnant.
* Prisoners.