cyrilzakka/clinical-trials huggingface dataset:
F-CaST for Individuals With Substance Use Disorder

Examining the effectiveness of the F-CaST based on a controlled randomized trial in patients with SUD residing in a therapeutic community.

Background and Aims: Substance use disorder (SUD), an urgent public health concern, is a chronic relapsing brain disorder caused by psychoactive substances, characterized by cognitive, behavioral, and physiological symptoms, severely impacting every life domain. Repeated substance use leads to impairments in higher cognitive abilities, termed executive functions (EF), and leads to SUD chronicity. Furthermore, EF deficits are associated with difficulties in sensory processing, severely limiting daily functions and with reported high incidence in SUD. However, to date both are not addressed therapeutically. This translational study aims to enhance rehabilitation success in patients with SUD residing in a therapeutic community (TC) by employing sensory and EF strategies utilizing the Functional Cognitive and Sensory Treatment (F-CaST), an innovative personalized therapy.

Methods: A qualitative study will be nested in a single-blind, controlled randomized trial, comparing two groups: (i) Experimental group- F-CaST - in which therapy is individually tailored for successful task performance and where the focus is on strategies for improving sensory and EF deficits and (ii) Control group - Standard Care - the typical treatment given in the therapeutic community. Measurement will be conducted by assessors blind to group allocation at 4 time points: T1- pre-intervention; T2- post-intervention; T3- at a 1-month follow-up; and T4- at a 3-month follow-up.

Population: Forty-eight adults diagnosed with SUD, aged 18-45 years, with no significant cognitive deficits, and residing in a TC for SUD.

Tools: Both objective and subjective measures to evaluate TC performance will be applied. Additionally, interviews will be conducted to provide a deeper understanding of the perceived performance and difficulties.

Expected Results: F-CaST will lead to improved rehabilitation success and treatment duration, better compliance with TC requirements, and greater satisfaction, compared to control group.

Eligibility Criteria:
Inclusion criteria:

* Diagnosed by a psychiatrist and meeting the DSM-V diagnostic criteria for severe SUD
* Admitted to the therapeutic community (TC) for full-length SUD rehabilitation and with no more than 3 previous rehabilitation trials in this TC
* Abstained from drugs and alcohol for at least 14 days (verifying minimum withdrawal effects); and no more than 21 days of TC residency (to ensure familiarization with the facility)
* Without a significant cognitive deficit \[the Montreal Cognitive Assessment (MoCA)≥19/30 points) and adequate language skills

Exclusion Criteria:

* Relapsing substance use in the TC
Efficacy and Safety of High Absorption Pad in Split-thickness Skin Graft Donor Site Wound

High absorption pad for blood and pus with natural antimicrobial agent or gauze dressing impregnated with paraffin, containing 0.5% chlorhexidine acetate (Bactigras) will be randomly covered on half of split-thickness skin graft donor site wound. The another will be cover on another half of split-thickness skin graft donor site wound. Then, they will be covered with gauzes and bandage. Time to wound healing, amounts of covered dressing gauzes, signs of infection, pain score, erythema index, melanin index, trans epidermal water loss index, and adverse events will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Have split-thickness skin graft donor site wound on thigh
* Age 18-60 years
* Can read and write
* Can follow the study protocol
* Available on appointment date

Exclusion Criteria:

* Systemic infection
* Chronic skin diseases
* Immune deficiency
* Allergic to cellulose, chitosan, sericin, and chlorhexidine
* Psychotic disorders
* Pregnancy or breast feeding
Prevention of Contrast Nephropathy During Diagnostic Coronary Angiogram or PCI With Hydratation Based on LEVDP

The goal is to determine if prehydration based on LEVDP is superior to a standard hydratation with NaCl 0.9% or NaHCO3 for the prevention of contrast nephropathy related to a diagnostic coronary angiogram or to PCI.

The goal is to determine if prehydration based on LEVDP is superior to a standard hydratation, independant of volemic status, with NaCl 0.9% or NaHCO3 for the prevention of contrast nephropathy related to a diagnostic coronary angiogram or to PCI.

Eligibility Criteria:
Inclusion Criteria:

* minimum 18 years old
* chronic renal insufficiency with a calculated creatinine clearance below 60 cc /min. (estimated with the MDRD formula)
* hemodynamically stable

Exclusion Criteria:

* Acute renal failure or in recuperation of acute renal failure
* urgent coronary angiogram
* moderate to severe valvulopathy or presence of a valvular prosthesis
* diagnostic of multiple myeloma
* dialysis before test
* having had a test with contrast product in the 2 weeks preceding
* receiving a nephrotoxic in the last month.
Reconstruction Method and Delayed Gastric Emptying After Pancreatic Surgery

Pancreaticoduodenectomy (whipple procedure) is the standard operation for tumors of the pancreatic head, uncinate process, distal common bile duct as well as the papilla of vater. For reconstruction, pylorus-preservation (PPPD) has been shown to be technically and oncologically equivalent to the traditional whipple operation. One issue with this technique is delayed gastric emptying (DGE), which occurs in 25-70% of patients, usually emerging between day 4 and 14 after surgery. Patients with severe DGE can not only experience prolonged length of hospital stay, but are also at increased risk for other complications like aspiration or other issues related to the inability to ingest nutrition.

There is vast retrospective evidence and one prospective study indicating that antecolic reconstruction of the duodenojejunostomy can improve the rate and severity of delayed gastric emptying.

The investigators have conducted a prospective randomized trial in order to test this hypothesis. Patients were randomized to either undergo antecolic or retrocolic reconstruction after PPPD. On day 10 after surgery, DGE was assessed by clinical criteria. In addition, a test meal including 1g paracetamol was administered to check for clinically inapparent DGE. Of these serum samples, kinetics of intestinal peptides like GLP-1, PYY and glucagon was alos measured.


Eligibility Criteria:
Inclusion Criteria:

* verified cancer of the pancreatic head/neck/uncinate process or distal bile duct, radiographically suspicious tumor requiring pancreaticoduodenectomy
* pylorus-preserving reconstruction planned
* no evidence of distant metastases
* written informed consent

Exclusion Criteria:

* age \<18 or \>90 years
* status post surgical resection of stomach or duodenum
* locally unresectable:
* invasion of the hepatic artery/superior mesenteric artery
* \>180 deg invasion of portal vein/superior mesenteric vein
* gastric invasion
* hypersensitivity to paracetamol
* clinically significant anastomotic dehiscence
* postoperative pancreatitis \> day 10
* preoperative evidence of gastroparesis
Colonic Stent and Tumor Cell Dissemination

This study aims to examine the hypothesis of tumor cell dissemination after colonic stenting for obstructing colorectal cancer by measuring the level of plasma circulating tumor cell before and after the procedure of successful colonic stenting in patients.

1. Patient recruitment:

   Patients will be recruited from the Division of Colorectal Surgery, Department of Surgery, the University of Hong Kong, over a 12 - 18 months period. Our institution is a tertiary referral center for colorectal cancer patients in Hong Kong. Informed consent will be obtained from the patients after the inclusion criteria are met.

   The study plans to recruit 25 patients in the colonic stenting group to compare with 15 patients in the control group.

   Inclusion criteria:

   Colonic stenting group
   1. Patients with obstructive colorectal cancer that requires colonic stenting as treatment
   2. Age \> 18 years and is able to give informed consent
   3. Informed consent for blood collection obtained

   Control group
   1. Patients with colorectal cancer who have colonoscopy without stenting
   2. Age \> 18 years and is able to give informed consent
   3. Informed consent for blood collection obtained
2. Blood collection and examination for circulating tumor cell

About 10ml of EDTA blood will be collected for examination before the procedure (colonoscopic stenting or colonoscopy in the control group) and blood collection daily will be repeated for 3 days after procedure. Blood will be sent to the laboratory for processing within 2 hours of withdrawal. Circulating tumour cells, which are characterized by CD45- (to exclude hematopoietic cells), CD326+ (to mark epithelial cells), CK18+ and CK19+ (to mark intestinal cells), i.e. cells expressing CD45-CD326+CK18/19+, will be detected by fluorescence activated cell sorting (FACS).

For each ml of blood, 1 ml of FCM Lysing solution will be added and allowed to incubate for 5 minutes to lyse the red blood cells, followed by centrifugation at 1000 RPM for 5 minutes. Supernatant will then be aspirated, and the pellet resuspend in approximately 1 ml cold 1X PBS. 10 µl of the appropriate antibody will be added into the tubes, vortexed and incubated for 15 in dark and room temperature. After incubation, cells will be washed with PBS and then incubated with the second antibody. The process is repeated until all 4 antibodies have been labelled to the cells. Cells will then be analysed on a FACS machine (MoFlo, Beckman Coulter).

Eligibility Criteria:
Inclusion Criteria:

* Colonic stenting group

  1. Patients with obstructive colorectal cancer that requires colonic stenting as treatment
  2. Age \> 18 years and is able to give informed consent
  3. Informed consent for blood collection obtained

Control group

1. Patients with colorectal cancer who have colonoscopy without stenting
2. Age \> 18 years and is able to give informed consent
3. Informed consent for blood collection obtained

Exclusion Criteria:

* Patients who refuse or who is unable to give informed consent on blood taking for the study.
Establishment and Clinical Assessment of a Prostate Cancer (PCa) Risk Model Based on the Updated Circulating Tumor Cell (CTC) Detection Technique

1. To elucidate the role of CTC detection in the evaluation of risk level in PCa patients, and establish a mathematic model for predicting the pathological status.
2. To explore the possible subtle change in CTC condition after radical prostatectomy.

1. Detect and evaluate the CTC status (a total of 3 times: 1 day before sugery, 3/12 months after surgery) for all of the PCa patients enrolled. Analyze the CTC result with PSA level, needle biopsy and radiological imaging information.
2. Analyze the difference in CTC amount/Epithelial-Mesenchymal ratio between patients in different D'Amico risk level(low/intermediate/high).
3. Establish a mathematic model based on the CTC results and pathological condition observed in operation (OC, organ confined; EPE, extraprostatic extension; SVI, seminal vesicle invasion; LNI, lymph node invasion), and compare this model with the latest version of Partin table.
4. Detect and compare the CTC and PSA level 3/12 months after surgery. Evaluate the radiological condition in 12 months after blood draw.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed with PCa by biopsy, for the first time.
2. Clinical assessed suitable for radical prostatectomy
3. Age ≥ 18 years, able to provide written informed consent
4. No prior systematic or regional treatment for PCa.
5. No neuro-endocrine differentiation or small cell PCa pattern.
6. ECOG status 0-1
7. Expected life span ≥ 12 months.
8. Multiorgan function (heart, lung, liver, kidney) able to tolerate radical prostatectomy, and meet the standard of this study.

Exclusion Criteria:

1. Severe concomitant disease or infection.
2. ALT or AST \> 2.5 ULN, or total bilirubin \> 1.5 ULN; Creatinine \>177umol/L(2.5mg/dL)；Plt \< 100,000/uL, Neutrophil \<1,500/uL.
3. Known or suspected brain metastasis or leptomeningeal carcinomatosis.
4. Another malignancy in the last 5 years, excluding completely cured melanoma.
5. Severe cardiovascular disease, including:

   Myocardial infarct within 6 months; Uncontrolled angina pectoris within 3 months; Congestive heart failure; Ventricular arrhythmia history with clinical significance; Morbiz type Ⅱ or complete heart block
6. Major surgery (general anesthesia) within 4 weeks.
Effect of Natural Compounds on the Severity of HPV-induced Cervical Lesions

To test the efficacy of a newly-commercialized formula, 40 HPV-positive women displaying chronic cervicitis, mild dysplasia or moderate dysplasia. Women in the study group took one tablet per day containing 200 mg of EGCG, 400 mcg of Folic Acid, 1 mg of Vitamin B12 and 50 mg of Hyaluronic Acid for twelve weeks. Women in the control group received no treatment.


Eligibility Criteria:
Inclusion Criteria:

* HPV infections
* Occurrence of low-grade cervical lesions

Exclusion Criteria:

* Diagnosis of malignancy or severe cervical lesions
* Concurrent uterine pathologies
* Pregnancy or intended to seek pregnancy in the next three months
* Cancer
Observations From Long Term Responders in the Gefitinib (Iressa) Expanded Access Program (EAP)

The purpose of the study is to determine patient characteristics from patients that have used Iressa for a period of minimal 3 years.


Eligibility Criteria:
Inclusion Criteria:

* Participation in the gefitinib Expanded Access Program
* Patient still uses gefitinib in September 2009
Nurse Assisted Post-discharge Intervention in Decompensated Cirrhosis

In a randomized controlled trial, the effects of a nurse-driven post-discharge intervention for patients with liver cirrhosis compared with standard follow-up will be investigated.

Since 1970 the mortality from cirrhosis has increased with 26.7 %, with a 50% mortality rate within 2 years of diagnosis. Grave complications result in functional impairment and reduced quality of life. 20-37 % of patients with liver cirrhosis are readmitted less than 30 days after a hospitalization for decompensation. These patients have a higher 90-day mortality rate than those who avoid readmission. Re-admissions have great personal-, societal- and economic consequences.

In a randomized controlled trial, the effects of a nurse-driven post-discharge intervention for patients with liver cirrhosis, compared with standard follow-up will be investigated.

The intervention, based on concepts from Family Nursing, will comprise three home-visits within eight weeks after discharge including therapeutic conversations focusing on strengthening participants' family relationships and social networks, disease education and help to initiate contact to municipal offers. After 12 weeks the participants will be followed-up by telephone.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with liver cirrhosis and one or more complications hereto during admission to the Gastro Unit, AHH. Complications include, but are not limited to: hepatic encephalopathy, infection, ascites, edema, kidney failure, upper or lower GI bleeding.
* Patients must read and understand Danish.
* Adults \>18 years.

Exclusion Criteria:

* When the diagnosis of liver cirrhosis is questioned with reasonable doubt or the diagnosis of liver cirrhosis is disproved by histology or relevant imaging.
* Patients with comorbidity as the primary diagnosis and where an independent rehabilitation or post-discharge program is offered, for example hip fracture, chronic obstructive pulmonary disease etc.
* Patients diagnosed with an active and invasive malignant disease.
* Residency outside the catchment area of Amager Hvidovre Hospital.
Occurrence of Selected Vitamins in Saliva and Blood

There is an interest to assess nutritional status of vitamins in humans in a non-invasive way, i.e. by avoiding taking blood samples. Saliva could potentially be an alternative to blood for this purpose. The suitability of saliva for status determination will be investigated by analysis of (forms of) vitamins A and E, B1, B2, B3, B6 and C in both saliva and blood.

There is an interest to assess nutritional status of vitamins in humans in a non-invasive way, i.e. by avoiding taking blood samples. Saliva could potentially be an alternative to blood for this purpose. However, literature data on vitamins in saliva is scarce. The occurrence is best demonstrated for 25-hydroxy-vitamin D3 where already indications for a correlation to blood levels have been observed in a small scale supplementation study. Occurrence of (forms of) vitamins A and E, B1, B2, B3, B6 and C has been reported but is less well documented. Some information is somewhat ambiguous and for none of these latter vitamins blood levels have been investigated in parallel to saliva.

Eligibility Criteria:
Inclusion Criteria:

* Generally healthy males and females
* Age: 20-65 years
* Non-smokers
* No recent or recently (within the last four weeks) started intake of vitamin supplements; long-term intake of supplements on regular base is o.k., but needs to be documented (type of supplement and dosage)
* Subjects willing and able to give written informed consent and to understand, to participate and to comply with the biomedical research project requirements.

Exclusion Criteria:

* Any condition that, in the investigator's opinion would impact volunteer safety and/or a volunteer's ability to complete all study related procedures. (e.g. psychiatric illness, drug addiction, alcoholism, etc.)
* Known infection with human immunodeficiency virus (HIV) or hepatitis.
* Chronic intake of substances affecting blood coagulation (e.g. acetylic acid, anticoagulants, diuretics, thiazides), which in the investigator's opinion would impact volunteer safety
* Allergy or known hypersensitivity against disinfection solutions
* Women: pregnancy, or during lactation
* Currently participating in another study
A Pilot Study Using Rocuronium to Prevent Intermediate Syndrome After Organophosphorus Insecticide Poisoning

Organophosphate pesticide poisoning causes close to 300 000 deaths per year worldwide. Many patients who ingest organophosphates require ventilation; of these patients approximately 50% die. Much of the mortality in these ventilated patients is secondary to intermediate syndrome. This is because OP pesticides inhibit acetylcholinesterase, causing an excess of acetylcholine at nerve synapses and the neuromuscular junction (NMJ). At the NMJ, the excess acetylcholine causes overstimulation and damage, which may lead to sudden respiratory arrest or prolonged ventilation and its associated complications.

The investigators believe that blocking these receptors using a neuromuscular blocking agent such as Rocuronium will protect the NMJ from damage and thus prevent intermediate syndrome and reduce number of intubated days and mortality.

In this pilot randomised controlled trial Rocuronium, a competitive nicotinic receptor antagonist, will be used to bind to the receptor at the neuromuscular junction and to block the effects of the accumulated acetylcholine. The effects of OP pesticide on cholinesterase in the blood will then be monitored and Rocuronium withdrawn using Sugammadex as the OP is eliminated from the body.

Primary outcome: Number of days intubated

Eligibility Criteria:
Inclusion criteria:

* Male or female
* Age over 16
* Clinical diagnosis of OP insecticide poisoning
* Admission to Intensive Care Unit for Ventilation
* Informed consent from family
* Train of four measurement \> 50%

Exclusion criteria:

* Age 16 or under
* Pregnant
* Consent not obtained from patient or patient's family
Seroprevalence of Leptospirosis in Val Müstair, Switzerland

Human leptospirosis is a zoonotic disease caused by bacteria of the genus Leptospira. Due to its frequent inapparent course or mild severity with unspecific symptoms and limited availability of diagnostic laboratories the incidence of leptospirosis is likely to be underestimated. The hospital of Val Müstair is the major healthcare provider of a rural mountain valley in the canton of Graubünden/ Switzerland with approximately 1500 inhabitants. A relevant prevalence of Leptospira spp. antibodies in the population of the Val Müstair due to its geographic and social risk profile for Leptospira infection, namely the close contact of the population to both livestock and wildlife in agriculture and hunting is estimated. The aim of this study is to analyze the burden of this disease in order to evaluate the need of preventive measures. In addition, seroepidemiological data for the Hepatitis E virus (HEV) and for tularemia will be collected.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent as documented by signature
* Aged 18 years or older
* Living for at least one year mainly (\>6 months per year) in Val Müstair (including Taufers and Rifair, Italy)

Exclusion Criteria:

* Inability to give consent
* Inability to follow procedures
* Acute infections/inflammatory disease
Knee Pain Nurse Led Package of CareTrial

1. To develop a training package for nurse-led management of knee osteoarthritis (OA), incorporating information about OA and core non-pharmacologic and pharmacologic principles of management of OA as recommended in the National Institute for Clinical Excellence and Health (NICE) guidelines for management of OA
2. To evaluate fidelity of delivery of individual components of this complex package of care for knee pain
3. To assess the acceptability of the intervention by exploring participant satisfaction with nurse-led complex package of care of knee pain.
4. To explore and resolve possible challenges to delivery of individual components within a complex package
5. To examine the feasibility of a definitive cohort randomised controlled trial of nurse-led care versus usual care of knee pain in terms of recruitment rate, drop-out rate, reasons for dropping out and completeness of outcome data
6. To explore whether such a trial should provide analgesia before non-pharmacologic interventions or vice versa


Eligibility Criteria:
Inclusion Criteria:

* Knee pain on most days of the previous month
* At least moderate pain on two of the five WOMAC knee pain domains in the most painful knee
* Knee pain present for longer than 3 months

Exclusion Criteria:• House-bound or care home resident

* Dementia
* Dialysis
* On home oxygen
* Serious mental illness
* Inability to communicate in English
* Unable to give consent
* Terminal cancer
* Known diagnosis of autoimmune rheumatic diseases or psoriasis
* Knee or hip replacement, or on waiting list for knee or hip replacement
* Asthma or COPD requiring regular daily oral corticosteroids
* Unstable angina or heart failure
* Known peripheral vascular disease
* Pregnant