cyrilzakka/clinical-trials huggingface dataset:
Individual Differences in Placebo Analgesic Effects

This study examines the effects of placebo suggestions tailored to match or mismatch individual participants' motivational styles-an issue of person-situation 'fit' with important effects in public health settings, but which has been ignored in past research.


Eligibility Criteria:
Inclusion Criteria:

* Healthy participants
* Dominant promotion focus or dominant prevention focus (based on our screening)

Exclusion Criteria:

* Currently or recently suffered from chronic pain (based on screening)
* Cannot tolerate heat pain applied to the forearm, based on a calibration task at the beginning of the experiment
Home-based Computerized Cognitive Rehabilitation in Chronic Stage Stroke

This study evaluates the effectiveness of Guttmann NeuroPersonalTrainer (GNPT), a tele-rehabilitation platform developed as a tool for the cognitive rehabilitation of chronic stroke patients. All patients will receive this treatment but in different order: half will receive GNPT and the other half will receive sham cognitive training; after a washout period of three months, crossover will occur and participants from the GNPT condition will receive sham cognitive training, while participants originally from the control intervention will receive GNPT.


Eligibility Criteria:
Inclusion Criteria:

* to be over 18 years old,
* to have been diagnosed with stroke
* an occurrence of the injury of 12 month period ore more (chronic stage)
* cognitive impairment confirmed by pre-intervention neuropsychological assessment

Exclusion Criteria:

* diagnosis of language deficits or aphasia
* motor impairment concerning upper limbs that may incapacitate them for the use of the computer
* severe alteration of the visual field or perceptual problems
* health status that may require further intervention or admission to a medical center during the study;
* neurological or psychiatric history
* substance abuse.
Randomized Clinical Trial of Bisacodyl Versus Placebo on Postoperative Bowel Motility in Elective Colorectal Surgery

Postoperative bowel dysmotility is a frequent condition after colorectal surgery. The influence of colon stimulating laxatives have not been studied. This prospective, randomized, double blind, placebo controlled study assesses the influence of bisacodyl on postoperative bowel motility in patients undergoing elective colorectal surgery. The hypothesis of this trial was that bisacodyl has a beneficial effect on the duration of postoperative ileus.

All adult (\>18 years) patients admitted for elective colorectal resection were evaluated for eligibility.

Patients were randomized using a computer programme and received either 10mg of bisacodyl in non-transparent capsules or identical placebo capsules, containing glucosemonohydricum. The capsules were administered twice daily, starting one day before surgery and ending on postoperative day three.Patients and all involved medical personnel were blinded.

Bowel preparation was not routinely used in open surgery, whereas in patients undergoing laparoscopic resection two litres of sodium-sulfate / macrogol solution (Cololyt®, Spirig Pharma AG, Switzerland) was administered. Standard colorectal surgery was performed in all patients. In open surgery a midline incision was used for laparotomy. In laparoscopic resections a four-port technique with removal of the specimen through a small transverse incision in the lower abdomen was used. All patients received perioperative single shot antibiotics, cefuroxime 1.5 g and metronidazole 1g. Nasogastric tube (NGT) was scheduled to be removed at the end of surgery. Postoperative treatment was not changed during the study. All patients received postoperatively a basic analgesia of 500 to 1000 mg oral paracetamol every 6 h; additionally, metamizol was administrated intravenously or orally as needed.

The primary endpoint was the time to recovery of gastrointestinal function, defined as the mean time to the occurrence of the following three events (GI-3): first flatus passed, first defecation and first solid food tolerated. We did not include the presence of bowel movement, as they may be present before recovery of the colon due to small bowel activity24. Secondary endpoints were the incidence of NGT reinsertion, duration of NGS reinsertion, incidence of postoperative vomiting and length of hospital stay. Additionally, consumption of analgesics and pain, cramping and nausea scores (assessed with a visual analogue scale \[VAS\]) during the first 8 postoperative days were monitored. Other variables recorded were patients' demographics, use of epidural anaesthesia, type and duration of surgery and morbidity.

Eligibility Criteria:
Inclusion Criteria:

* elective colorectal resection
* age \>18 years

Exclusion Criteria:

* preoperatively planned stoma formation
* emergency surgery
* pregnancy
* known hypersensitivity for bisacodyl
Image-Guided Biopsies in Identifying Mechanisms of Resistance in Participants With Metastatic Castration Resistant Prostate Cancer Undergoing Radioligand Therapy

This trial studies image-guided biopsies work in identifying mechanisms of resistance in participants with castration resistant prostate cancer that has spread to other places in the body and who are undergoing radioligand therapy (RLT). Tissue sample collected from a biopsy may help determine why response to RLT varies among patients, and this may help researchers to find better treatments for advanced prostate cancer.

PRIMARY OBJECTIVES:

I. Proportion of metastatic castration resistant prostate cancer (mCRPC) patients with altered signaling pathways after radioligand therapy assessed by phospho-proteomics of biopsy samples.

SECONDARY OBJECTIVES:

I. Generation of patient derived xenograft (PDX) models to determine if tumor levels of activity for individual adaptive pathways are related to the best prostate specific antigen (PSA) response.

II. Sequencing to identify frequently mutated genes such as TP53 and ATM.

OUTLINE:

Participants undergo image-guided biopsy over 45 minutes prior to first RLT course and 1-2 days after the third RLT course.

Eligibility Criteria:
Inclusion Criteria:

* Volunteer patient
* Histologically confirmed prostate cancer
* Enrolled in Lu-PSMA-617 treatment trial (Institutional Review Board \[IRB\]# 17-000330)
* Based on positron emission tomography (PET)/computed tomography (CT) images: evidence of lymph node or soft tissue metastatic disease amenable to image-guided biopsy
* Platelets \> 75,000/ul within 14 days prior to biopsy
* Prothrombin time (PT) or international normalized ratio (INR) and a partial thromboplastin time (PTT) \< 1.5 times the institutional upper limit of normal (ULN) within 14 days prior to biopsy
* Patients on warfarin, aspirin, or other anti-coagulants are eligible provided they are deemed able to tolerate discontinuation of anti-coagulation for one week prior to the biopsy. Conversion to low molecular weight heparin prior to biopsy is permitted per local standard operating procedures, provided there is agreement regarding the procedure between the treating physician, the interventional radiologist and the principal investigator (PI)

Exclusion Criteria:

* Patients with significant congenital or acquired bleeding disorders (e.g. von Wildebrand's disease, acquired bleeding factor inhibitors) are not eligible
Autologous Adipose-Derived Stromal Cells Delivered Into the Corpus Cavernous in Patients With Erectile Dysfunction

This will be an open-label, non-randomized, multi-center, patient sponsored study of Adipose-Derived Stromal Vascular Fraction cells (AD-SVF) implantation delivered into the corpus cavernous in patients with Erectile Dysfunction.

The intent of this clinical study is to answer the questions: 1) Is the proposed treatment safe and 2) Is treatment effective in improving the disease pathology of patients with diagnosed Erectile Dysfunction.

AD-SVF will be collected from the patient's adipose-derived tissue (body fat). Using local anesthesia, Liposuction will be performed to collect the adipose tissue specimen. The adipose tissue is then transferred to the laboratory for separation of the adipose tissue derived stem cells. In addition, peripheral blood will be collected for isolation of platelet rich plasma, which are then combined with the ASC's for direct injection to the Corpus Cavernosum (Penis).

Eligibility Criteria:
Inclusion Criteria

* Males Age 18 and 80 years.
* Penile arterial insufficiency and or venous leakage (doppler) at the time o inclusion: PSV \<25 cm/sec, PSV \>25 cm/sec, EDV\>5cm/sec, RI\<0,75.
* Up to date on all age and gender appropriate cancer screening per American Cancer Society

Exclusion Criteria

* Severe co-morbidities like cardiac insufficiency, congestive cardiac failure (NYHA ≥ III), malignancy, infection, sepsis and bed sores.
* Life expectancy \< 6 months due to concomitant illnesses.
* Exposure to any investigational drug or procedure within 1 month prior to study entry or enrolled in a concurrent study that may confound results of this study.
* Active infectious disease. Patients known to have tested positive for HIV, HTLV, HBV, HCV, CMV (IgM \> IgG) and/or syphilis will be evaluated by an expert as to patient eligibility based on the patient's infectious status
* Any illness which, in the Investigator's judgment, will interfere with the patient's ability to comply with the protocol, compromise patient safety, or \\ interfere with the interpretation of the study results
* Patients on chronic immunosuppressive transplant therapy
* Systolic blood pressure (supine) ≤90 mmHg or greater than 200mmHg
* Resting heart rate \> 100 bpm;
* Active clinical infection within one week of enrollment.
* Known drug or alcohol dependence or any other factors which will interfere with the study conduct or interpretation of the results or who in the opinion of the investigator are not suitable to participate.
* History of cancer (other than non-melanoma skin cancer or in-situ cervical cancer) in the last five years.
* Unwilling and/or not able to give written informed consent.
Improving Genetic Counseling for BRCA+ Mothers

Genetic counseling and testing for hereditary breast cancer may reveal that you, and possibly your blood relatives, are at increased risk for the disease across the lifespan. This includes biological children, both male and female. We do not yet know the best ways to educate mothers who have a risk gene (are BRCA+) about whether, when, and how to share genetic information with their children or manage their thoughts and feelings. The purpose of this study is to help mothers make more informed choices about talking with children about hereditary breast cancer, provide them with age-and gender-appropriate information and emotional support, and improve their psychological well-being.


Eligibility Criteria:
Inclusion Criteria:

* Mothers/primary caregivers to adolescents/young adults ages 13-24 years-old.
* Participating in genetic testing for hereditary breast cancer.
* Adequately speak/read English.

Exclusion Criteria:

- Does not meet inclusion criteria.
Health Status and the Need for Social Return of Drug Abusers in Guangdong Province

This study intends to conduct a secondary analysis of the data from the investigation on the status quo of anti-drug rehabilitation work and management needs in Guangdong Province.

The drug problem is a major problem that threatens individuals' physical and mental health, family happiness, national security, regional stability and world peace. In recent years, anti-drug departments in various regions of Guangdong Province have adhered to the arrangement and deployment of the National Anti-Drug Office, the provincial Party committee and the provincial government and the Party committee of the Public Security Department, focused on preventing the harm of synthetic drugs, improved the system, implemented responsibilities, and innovated methods, and constantly improved the anti-drug and drug rehabilitation work in Guangdong.

Nowadays, with the improvement of the level of social and economic development, the personnel structure and characteristics of drug abusers in Guangdong Province have undergone corresponding changes, and the effect of the existing control policies on drug abusers has also shown a weak stage, which needs to be adjusted and updated in time.

In this context, Guangdong Provincial Public Security Department has carried out research on anti-drug management countermeasures, and actively discussed the status quo, difficulties and reform direction of anti-drug management in the new era.

This study intends to conduct a secondary analysis based on the data obtained from the investigation and research on the status quo of drug control and detoxification work and management needs in Guangdong Province, aiming to describe the demographic and sociological characteristics of drug abusers in Guangdong Province, as well as their psychosocial experience of receiving interpretation intervention and the status quo of social regression needs. What's more, this study also devoted to forming a practical multi-department co-management model of community comprehensive management of drug addicts in Guangdong Province in the new era, to comprehensively improve the management level of drug abusers in Guangdong Province, serving grassroots communities, and build a harmonious society.

Eligibility Criteria:
Inclusion Criteria:

* Cities in Guangdong Province are selected according to the geographical distribution, development level, economic level and population distribution of the cities.
* Drug abusers who registered in any of a streets or townships of Guangdong Province would be selected.
* Drug abusers who have abstained for more than 3 years.
* All age groups under 30 years old, between 30 and 50 years old and over 50 years old were covered.

Exclusion Criteria:

* Eliminate more than 20 questions missed or not answered questionnaires.
* The questionnaires which be filled out by the same respondent repeatedly.
Assessment of Cognitive Function After Surgery in Two Types of Anesthesia in Patients Operated for Breast Cancer

The emergence of cognitive disorders after surgery under general anesthesia (GA) is the second leading cause of patient complaints (after dental debris caused by intubation techniques). These cognitive disorders can range from simple reversible confusion (26%) with postoperative cognitive dysfunction without actual recovery (10%).

The hypnosedation is an ancient technique of anesthesia expanding its effects on cognitive function remain to this day unknown, but appear promising.

For twenty years, hypnosedation is offered to patients who underwent surgery as an alternative to other anesthetic techniques (general anesthesia and locoregional), in some European and Anglo-Saxon hospitals for specific surgical indications (surgery area). It is commonly used in some hospitals.

The hypnosedation is little used in oncology

The hypnosedation is a hypnosis technique suitable for anesthesia, namely the one associated with intravenous conscious sedation and local anesthesia hypnosis. This derived from medical hypnosis Ericksoniene technique is divided into three stages:

1. induction
2. Deepening trance
3. Déhypnotisation.

This technique is currently being validated and used at national and international level, in fact it is based on 500 references and appears in the national nomenclature of the Common Classification of Medical Procedures in the code ANRP 001, states: hypnosis referred to analgesic.

Eligibility Criteria:
Inclusion Criteria:

* Female, over 18 and under 80 years
* Diagnosis of breast cancer established (Pathology)
* Life expectancy greater than 6 months
* Surgery of breast lumpectomy with or without lymph node dissection, mastectomy with or without lymph node dissection, dissection isolated
* ASA 1 (healthy patient) or 2 (patient with moderate to high function) according to the classification of the American Society of Anesthesiologist,
* Affiliation to a social security scheme,
* Information on the study, signed informed consent

Exclusion Criteria:

* Presence of major psychiatric disorders or psychotic behavior addiction, evaluated by neuropsychologist at the first preoperative consultation, through the test MINI (MINI\> 4 positive responses for each module)
* Presence of neurological disorders known untreated or evaluated by neuropsychologist at the first preoperative consultation, with the MMSE test (MMSE \<24)
* Patient treated morphine orally for 3 months or more
* Patient is pregnant or nursing, or of childbearing potential and not using adequate contraception,
* Patient included in another clinical study
* Inability to undergo medical monitoring study for geographical, social or psychological
* Patient deprived of liberty and most subject to a measure of legal protection or unable to consent
Lifestyle Interventions for Long Term Diabetes Control

Lifestyle interventions have been shown to reduce heart disease risk and improve blood sugar control in clinical trials. This project will investigate whether those lifestyle interventions can be implemented long-term, in usual practice settings, by using dietitian case managers to coordinate lifestyle change in cooperation with fitness instructors and primary care clinicians.

The proposed randomized trial investigates the effectiveness of lifestyle case management to encourage long-term lifestyle modifications in diet and physical activity, improve control of type 2 diabetes, reduce risk factors for progression of type 2 diabetes and cardiovascular disease, and improve quality of life, among health plan enrollees with type 2 diabetes and obesity. Patients agreeing to participate are randomly assigned to one of two conditions: 1) lifestyle case management, in which initial 12 month intensive diet and physical activity intervention is followed by 30 months of active maintenance directed by dietitians and physical trainers (the "lifestyle case management" group); 2) lifestyle intervention, in which there is no formal maintenance following the intensive lifestyle intervention (the "lifestyle intervention" group). Because the lifestyle case management intervention incorporates the content of the lifestyle intervention, we will be able to assess the incremental effectiveness of providing post-intervention lifestyle case management on glycemic control, cardiovascular risk, body composition, diet and physical activity habits, and health care utilization.

Eligibility Criteria:
Inclusion Criteria:

* treated for type 2 diabetes within one year prior to their entry into the trial, have a BMI at or above 30, and are 18 years of age or older

Exclusion Criteria:

* 1) end-stage renal disease (defined as being on dialysis), 2) active foot ulcers or infections (defined as an open wound or requiring drug therapy), 3) pulmonary, cardiac, renal, hepatic, neurologic, psychiatric, infectious, neoplastic and malignant disease (other than non-melanoma skin cancer) that precludes diet and physical activity changes
Primary-care-provider Identification And Notification

New York-Presbyterian Hospital has created a system that notifies its primary care providers whenever their patients are admitted to the hospital. In this study, the investigators want to evaluate how accurate this system is and how it is affecting the primary providers and their health care delivery.

The investigators will interview the participating providers to understand if they were aware of the admission of their patients, and how they want to get involved in the care of that patient while he/she is in hospital. The investigators will also look at the data in the Electronic Health Record system to understand how providers are acting in response to the notifications.

Lastly, the investigators will determine if the notifications have resulted in any change in the care of the patients, specifically in terms of the number of days from discharge until the next clinic visit.

Eligibility Criteria:
Inclusion Criteria:

* Primary Care Provider at the New York Presbyterian.

Exclusion Criteria:

* No clinic rotation during the study period
A Study to Assess Efficacy and Safety of Two Different Dose Regimens of Risankizumab Administered Subcutaneously in Japanese Subjects With Generalized Pustular Psoriasis or Erythrodermic Psoriasis

The purpose of this study is to investigate the safety and efficacy of two different dose regimens of risankizumab for Japanese subjects with generalized pustular psoriasis (GPP) or erythrodermic psoriasis (EP).

Safety and efficacy data through 14 December 2017 are included in the interim analysis, which was conducted after all participants completed the Week 28 visit or discontinued from the study.

Eligibility Criteria:
Inclusion Criteria:

For GPP

* Have a diagnosis of GPP for at least 60 days prior to informed consent based on the diagnostic criteria of the Japanese Dermatological Association (JDA). Subjects not fulfilling one of the diagnostic criteria i.e., "accompanying systemic symptoms including fever or malaise" at the time of screening can be entered.
* Subjects with an erythema area with pustules accounting for ≥ 10% of the body surface area (BSA), and with a severity assessment criteria score (JDA total score) specified by the JDA of less than 14.
* Must be candidates for systemic therapy or phototherapy for GPP, as assessed by the investigator.

For EP

* Have a diagnosis of EP prior to informed consent.
* Subjects with an inflammatory erythema area accounting for ≥ 80% of the BSA at screening and at the time of the first administration of the study drug.
* Must be candidates for systemic therapy or phototherapy for EP, as assessed by the investigator.

Exclusion Criteria:

* Previous exposure to risankizumab.
* Currently enrolled in another investigational study or less than 30 days (from screening) since completing another investigational study (participation in observational studies is permitted).

For GPP

* Subjects with active ongoing inflammatory diseases other than GPP that might confound trial evaluations according to investigator's judgment.

For EP

* Subjects with active ongoing inflammatory diseases other than EP that might confound trial evaluations according to investigator's judgment.
* Subject diagnosed with medication-induced or medication-exacerbated EP.