cyrilzakka/clinical-trials huggingface dataset:
Autologous Dendritic Cell Vaccine in Patients With Soft Tissue Sarcoma

The purpose of this study is to achieving a six-month progression free survival (PFS) of patients receiving autologous dendritic cell vaccine (ADKV) loaded with allogeneic tumor lysate expression of cancer-testis antigens (CTA) in patients with soft tissue sarcomas

Vaccination is carried out on the planned days ± 3 days

1. All examinations must be performed before the vaccine is administered.

   * Full physical examination.
   * Assessment of vital signs (blood pressure, temperature, heart rate), the general condition of the patient and physical activity.
   * Evaluation of concomitant therapy.
   * Assessment of vital signs.
   * Laboratory safety and immunological indicators
   * Assessment of adverse events, symptoms and syndromes of the disease.
2. Introduction of CV in accordance with the dose determined for a given vaccination (see section 9.2. - procedures for delivery and use)
3. After administration, patients are observed for at least 1 hour. An assessment of vital indicators. Undesirable effects detected at the introduction are recorded.

Eligibility Criteria:
Inclusion Criteria:

* age of 18 or older
* ECOG performance score 0 or 1
* Histologically proven soft tissue sarcoma
* Unresectable or metastatic soft tissue sarcoma
* Ability to give written informed consent
* Objective measured and measurable tumor lesions
* The failure of standard therapy
* Adequate amount of material for genetic research
* No active or chronic infection with HIV, Hepatitis B or Hepatitis C
* Men/Women of childbearing potential must use adequate contraception
* Hematology, liver function and renal function lab tests within required parameters

Exclusion Criteria:

* Untreated or uncontrolled brain metastases.
* History of other active malignancy within last 2 years, except adequately treated other soft tissue sarcoma.
* Autoimmune disease (vitiligo is not a basis for exclusion).
* Serious uncontrolled medical disorder or active infection that would impede treatment.
* Underlying medical or psychiatric condition that would cause administration vaccine
* Any non-oncology vaccine therapy up to 1 month before or after any dose of vaccine
* Concomitant therapy with IL-2, interferon, other non-study immunotherapy, or cytotoxic chemotherapy; immune-suppressive agents within 30 days of registration; other investigational therapies; chronic use of systemic corticosteroids (however, a low stable dose steroid for mild brain edema or adrenal insufficiency is allowed; topical and inhaled standard dose corticosteroids are allowed).
* Dementia or significantly altered mental status that would prohibit understanding or rendering of informed consent and compliance with protocol requirements.
* Pregnant or breastfeeding women.
* Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g. infectious) illness.
EpiRetinal Membrane Peeling and Internal Limiting Membrane

To study and compare visual acuity in patients undergoing removal of the epiretinal membrane with and without the removal of the internal limiting membrane at baseline versus 6 month.

This prospective cohort study includes 2 arms : with and without internal limiting membrane (ILM) peeling.

Each patient undergo the same procedure : first of all pars plana vitrectomy, then internal limiting membrane peeling is performed and facilitated by the use of dye, which aids in better visualization of the ILM.

If the ILM is removed in same time : the patient is ranked in the "ILM peeling" group If the ILM is not removed : the patient is ranked in the "non ILM peeling" group.

If the ILM is partially removed, the patient is not enrolled.

The outcomes are recorded for 6 months : at baseline, day 15, 1, 3 and 6 months.

Eligibility Criteria:
Inclusion Criteria:

* adult up to 18 years old,
* diagnosed and treated surgically

Exclusion Criteria:

* proliferative diabetic retinopathy,
* ocular trauma,
* central veinous occlusion,
* intra-ocular tumor, total retinal detachment,
* central visual field loss in glaucomatous patients
A Randomized Clinical Study Comparing a Fully-Coated Cementless Stem Versus a Cemented Stem for Total Hip Replacements

The purpose of this study is to answer the question as to whether or not a fully coated cementless stem is equal to or better than a cemented stem in patients over 72 years with good bone quality.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients undergoing surgery for total hip replacements, including diagnosis of osteoarthritis, rheumatoid arthritis, traumatic and post-traumatic arthritis, avascular necrosis and congenital dislocation of the hip. Congenital dislocation of the hip will be included where small but anatomical acetabuli are present, ie., the acetabuli located near the tear-drop
* Revisions of failed osteotomies may be included
* Bone quality felt to be acceptable to the surgeon for cementless arthroplasty preoperatively in patients \> 72 years of age

Exclusion Criteria:

* Patients with active infection
* Revision cemented total hip replacement
* Charcot joints
* Patients with primary or secondary bone tumors in the vicinity of the joint to be replaced
* C.D.H. with abnormally placed acetabuli or femoral canals
* Fibromyalgia patients
oVRcome Self-guided Virtual Reality for Specific Phobias

Specific phobias: fear of flying, heights, spiders, dogs and needles are the extremely common and exposure therapy (ET) is the first line of treatment. Using Virtual Reality (VR), participants will have control in gradual exposure to their fears. oVRcome (https://www.ovrcome.io/ Virtual reality app), is a self-help VRET for specific phobias, that is delivered through a smartphone application (app) in combination with a low cost headset that holds the smartphone and uses 360º video. The investigators hypothesize that oVRcome is effective in reducing specific phobia symptoms.


Eligibility Criteria:
Inclusion Criteria:

In order to be eligible to participate in this study, a subject must meet all of the following criteria:

* are between 18-64 years old
* Have a fear of flying, heights, spiders, dogs, needles and score above 4 on the Brief Standard Self rating scale for phobic patients (Marks, I. Matthews ,A (1979) Behaviour Research and Therapy)
* have access to a smart phone and internet
* willing to participate in the research study and providing informed consent

Exclusion Criteria:

A potential subject who meets any of the following criteria will be excluded from participation in this study:

* present with symptoms of severe depression or suicidality respectively as measured with the PHQ-9; total score \> 19
* have insufficient knowledge of the English language
* are under current treatment for specific phobia or psychotropic medication (unless on stable dosage for the previous 3 months and no changes planned during the study period).
Cryocompression After Total Knee Arthroplasty

The overall aim of this study is to evaluate the effectiveness of a cryocompression device after total knee arthroplasty (TKA) compared to standard therapy.

The aim of this study is to investigate the effect of cryocompression after total knee arthroplasty (TKA) compared to a control group without cryocompression. The effect on the following parameters will be evaluated: knee and osteoarthritis outcome score (KOOS), patient satisfaction, knee girth, skin temperature, knee range of motion, morphine consumption, pain perception, the length of stay, the 10-metre walk test and the timed-up-and-go.

Eligibility Criteria:
Inclusion Criteria:

* Signed Informed Consent
* Diagnosed Arthritis of the Knee
* Planned implantation of a primary total knee arthroplasty by the Regionalspital Surselva AG

Exclusion Criteria:

* Decompensated hypertension in the affected area
* Acute inflammatory phlebitis in the affected area
* Patients with acute paroxysmal cold hemoglobinuria, or cryoglobulinemia
* Significant vascular disruption in the affected area
* History of pulmonary embolism or risk factors for deep vein thrombosis or pulmonary embolism in the affected area
* No increased venous or lymphatic return in the affected leg is desired due to e.g. carcinoma
* Raynaud's disease
* Hypersensitivity to cold
* Fear of cold/compression
A Trial of High Intensity Versus Low Intensity Neoadjuvant Chemoradiotherapy in Locally Advanced Rectal Cancer

Neoadjuvant chemoradiotherapy (CRT) has been the standard therapy for local advanced rectal cancer. Pathological complete response (pCR) is an important prognostic factor for local control and survival. A high intensity CRT increases not only the pCR rate, but also toxicity, especially diarrhea. Compared with traditional RT technique, intensity-modified radiation therapy (IMRT) can decrease the toxicity of diarrhea because of low volume of high dose for small bowel. Therefore, IMRT technique provides an opportunity to improve the dose intensity of neoadjuvant CRT. The investigators hypothesize that a higher treatment dose induces a high rate of pCR and design a two-arm trial. in this trial, low intensity CRT includes the whole pelvic irradiation of 50Gy together with Oxaliplatin and Capecitabine weekly. While in high intensity group, additional concomitant 5Gy for primary tumor and a cycle of Xelox are prescribed. All patients will receive a total mesorectal excision (TME) 8 weeks after CRT.


Eligibility Criteria:
Inclusion Criteria:

* Patients with rectal adenocarcinoma
* Clinical staged T3/4 or any node-positive disease
* Age: 18-75 years
* Karnofsky Performance Status \> 80
* Adequate bone marrow reserve, renal and hepatic functions
* Without previous antitumoural chemotherapy
* No evidence of metastatic disease
* Written informed consent before randomization

Exclusion Criteria:

* Previous pelvis radiotherapy.
* Previous antitumoural chemotherapy
* Clinically significant internal disease
Ability of Mayo Clinic High-performance Liquid Chromatography (HPLC) Method to Measure Fecal Bile Acids

The investigators' hypothesis is that therapy with Colesevelam, reduces fecal bile acid excretion in patients with Irritable Bowel Syndrome (IBS)-diarrhea with prior evidence of increased fecal 48 hour total bile acid excretion. The investigators aim to study the ability of the HPLC assay for fecal bile acids to demonstrate responsiveness after treatment with Colesevelam.

This study will evaluate whether Colesevelam, a bile acid sequestrant, is able to reduce fecal bile acids and improve bowel function in patients with IBS-diarrhea and Mayo's HPLC method can demonstrate a response to the Colesevelam.

The study design will be a single center, unblinded, single dose trial to study the ability to identify the effect of taking 1875 mg (3 tablets \[625 mg/tablet\]) of Colesevelam orally twice daily for ten days on fasting serum 7alphaC4 and total 48 hour fecal bile acid excretion. Stool and fasting serum samples will be collected predose and during final 48 hours' dosing for assessment. Participants will also fill out an 8-day stool diary assessing frequency, consistency, ease of passage of bowel movements before and during treatment with Colesevelam.

Eligibility Criteria:
Patients with IBS-diarrhea with prior evidence of increased fecal 48 hour total bile acid and increased fasting serum 7alphaC4 who meet the following:

INCLUSION CRITERIA

* Bowel disease questionnaire (BDQ) - IBS symptoms: Positive by Rome lll criteria
* No restrictions on Hospital Anxiety/Depression Score (HADS).
* Gender: Men or women. Women of childbearing potential will have a negative pregnancy test before initiation of medication.

EXCLUSION CRITERIA

* Use of drugs or agents within the past 1 week or planned use in the subsequent 2 weeks during the study period (Birth control pill, estrogen replacement therapy, and thyroxine replacement are permissible exceptions):

  * Agents that alter GI transit including opioids, narcotics, anticholinergics, tricyclic antidepressants, serotonin-norepinephrine reuptake inhibitors (SNRI) antidepressants.
  * Analgesic drugs including opiates, nonsteroidal anti-inflammatory drugs (NSAID), cyclooxygenase-2 (COX 2) inhibitors
  * Intake of medication that could interfere with the interpretation of the study.
* Female subjects who are pregnant or breast-feeding. Females must be either surgically sterilized, postmenopausal (\>12 months since last menses), or, if of childbearing potential, using reliable methods of contraception as determined by the physician.
* Abdominal surgery (except Appendectomy)
* Patients with known chronic liver disease or history of elevated aspartate aminotransferase (AST)/ alanine transaminase (ALT) 2.0 X upper limit of normal.

  * Bile acid (BA) synthesis and possible false positive or negative fecal bile acid or serum 7alpha-hydroxy-4-cholesten-3-one (7alphaC4) result. If there is no AST or ALT values in the medical record, the study physicians will determine if the tests need to be run.
To Assess the Pharmacokinetics and Safety and Tolerability of Efanesoctocog Alfa (BIVV001)in Adults With Type 2N and 3 Von Willebrand Disease (VWD)

Primary Objective:

-To characterize the pharmacokinetics (PK) of BIVV001 after a single intravenous (IV) administration, as assessed by factor VIII (FVIII) activity determined by the one-stage activated partial thromboplastin time (aPPT) clotting assay, as well as, BIVV001 capture chromogenic Coatest FVIII activity assay

Secondary Objective:

-To assess the safety and tolerability of a single IV dose of BIVV001 in adult patients with type 2N and 3 VWD

Duration of each part of the study for one participant:

Total study duration: Up to 57 days.

* Screening: up to 28 days.
* Up to 29 days of safety observation following the IV BIVV001 dose administration (this period includes PK sampling up to the first 10 days following administration).

Eligibility Criteria:
Inclusion criteria :

-- Male and/or female participant, between 18 and 65 years of age, inclusive at the time of informed consent.

* The participant has been diagnosed with hereditary type 3 VWD or type 2N VWD as documented in historical medical records OR a documented genotype known to produce VWD type 3 or 2N VWD.
* Type 3 VWD participants are included if they have a medical history of at least 25 exposure days to VWF and factor VIII-containing coagulation factor concentrates
* Type 2N VWD participants are included if the use of DDAVP is deemed insufficient or contraindicated, as assessed by the Investigator, or if they have required prior use of VWF- and FVIII- containing coagulation factor concentrates.

Exclusion criteria:

* Hereditary or acquired coagulation disorder other than VWD (including qualitative and quantitative platelet disorders, and thrombocytopenia \< 100,000 cells/uL at Screening)
* The participant has a FVIII activity levels \>20 IU/dL, at Screening
* History or presence of a VWF inhibitor or clinical suspicion of a VWF inhibitor
* History of a positive FVIII inhibitor test, defined as ≥0.6 BU/mL (by Nijmegen modified Bethesda assay) or a clinical suspicion of a FVIII inhibitor
* Positive FVIII inhibitor test, defined as ≥0.6 BU/mL, at Screening
* History of hypersensitivity or anaphylaxis associated with any FVIII- or VWF- containing product
* The participant has received or anticipates receiving systemic immunosuppressive or immunomodulatory treatment within 12 weeks prior to Baseline.
* The participant requires the use of acetylsalicylic acid, non-NSAID anti-platelets, and NSAIDs above the maximum dose product
* Patients currently on a prophylaxis regimen for the treatment of VWD that, in the Investigator's opinion, would preclude participation in the study due to the possible increased risk of bleeding associated with the requirement to withhold prophylaxis during the study.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Early Neurocognitive Rehabilitation in Intensive Care

The purpose of this project is to assess the efficacy of an early neurocognitive intervention for ICU patients, in terms of psychopathological, neuropsychological and functional improvement. The treatment is supported in an interactive advanced computing platform that includes the continuous biomedical registration of the patients and a virtual reality software specifically designed for critical patients.

The investigators expect an improvement in neuropsychological, psychopathological and functional status at hospital discharge and 3 months follow-up in those patients that have received the early neurocognitive intervention comparing with patients treated as usual. Furthermore the investigators expect a decrease of episodes and/or duration of delirium in ICU patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged between 18 and 80 years
* Patients receiving mechanical ventilation for at least 24 hours
* Patients scoring more than 8 on the Glasgow Coma Scale (GCS) and more than 2 on the Sedation Agitation Scale (SAS)
* Patients haemodynamically stable
* Informed consent signed by the closest relatives.

Exclusion Criteria:

* Patients with previous neurologic pathology or focal brain injury before ICU admission
* Patients with serious psychiatric pathology (major depression, psychosis, bipolar disease) or mentally retarded
* Patients with sensorial alterations needed to interact with the neurocognitive stimulation programme
* patients whose closest relatives refuse the subject to be included in the study.
Acoustic Radiation Force Impulse-Imaging in Comparison to Transient Elastography for Liver Fibrosis Staging in HCV

This study will evaluate the effectiveness of Acoustic Radiation Force Impulse (ARFI)- Imaging compared to Transient Elastography (FibroScan) in differentiating liver fibrosis in patients with chronic hepatitis C. Patients who are scheduled to have a liver biopsy will also undergo ARFI and FibroScan testing. The liver biopsy will be used as the reference method. The target sample size is 433.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, 18-79 years old
* Written consent
* Chronic Hepatitis C infection
* Liver biopsy planned or performed within the last six months
* In addition, 10 patients/center with proven liver cirrhosis without present liver biopsy can be included

Exclusion Criteria:

* Consuming illness (HIV infection, malignoma)
* Comorbidities associated to HCV (HBV, NASH, hemochromatosis, primary sclerosing cholangitis, primary biliary cirrhosis
* Antiviral therapy between liver biopsy and study inclusion
* Pacemaker or heart defibrillator
* Pregnancy or lactation
* Liver transplantation
The Effect of Exposure to an Informative Video on Maternal Anxiety

Stress and anxiety during childbirth have negative consequence on both mother and fetus. Previous studies have learned the effect of several intervention to reduce anxiety during labor- such as music and foot reflexology. Nevertheless, data for informative video before labor for reducing stress and anxiety are sparse. The present study aimed to review and determine the effect of informative video on anxiety, pain and outcomes of the labor in primigravida women.

A randomized control trial studying the effect of exposure to an informative video regarding labor and possible obstetrics emergencies on maternal anxiety and postpartum satisfaction

Eligibility Criteria:
Inclusion Criteria:

above 18 years of age Nulliparus women Informed consent Reads and understand Hebrew \>37 weeks of gestation

Exclusion Criteria:

Refuse to participate Contraindications for vaginal delivery
Computer Assisted Quality-monitoring for Magnet-controlled Capsule Endoscopy: a Prospective Case-control Study.

During the past several years，MCE（magnet controlled endoscopy）has made great process in detecting lesions of gastric as well as screening. Compared with conventional endoscopy, magnetically controlled capsule endoscopy can be further optimized in gastric examination. So we make an AI for operators to help improve the quality of MCE and record the mucosa visibilty of gastirc.

We developed a new artificial intelligence for quality improving during the operation of magnet controlled endoscopy. The AI can help operators screen every part of gastric and then evaluate the visibilty of gastic. Also, It can be record time of the opration. Other than that ,we compared the performancce of AI with experts.

Eligibility Criteria:
Inclusion Criteria:

* patients between 18 and75
* patients who can sign informed consent

Exclusion Criteria:

* patients who are unsuitable to accept the check
Integrated Alcohol and Sexual Assault Intervention for College Men

This research will evaluate a new intervention that integrates evidence-based alcohol intervention strategies and promising sexual assault prevention strategies with the goal of decreasing sexual aggression among men who report heavy drinking; a particularly high risk group. Specifically, this study will conduct a randomized controlled pilot trial with college men who report heavy drinking to demonstrate the feasibility and acceptability of the proposed intervention. The main questions the study will answer are: 1) what is the feasibility of the recruitment plans, research design, intervention training methods, and delivery of the program?; and 2) does the intervention, relative to a mindfulness-based control condition, produce reductions in the quantity and frequency of alcohol use, perpetration of sexual aggression, and attitudes associated with sexual aggression over the 2- and 6-month follow-up. Follow-up assessments are completed at 2- and 6-months following the program. The intervention is compared to the mindfulness-based control group.


Eligibility Criteria:
Inclusion Criteria:

* Engaging in binge drinking, defined as 5 or more drinks per day for men on the same occasion by the Substance Abuse and Mental Health Services Administration on two or more occasions in the past month.
* Engaging in oral, vaginal, or anal sexual intercourse with a female partner one or more times in the past four months

Exclusion Criteria:

* Displaying symptoms consistent with alcohol use withdrawal
* Reporting current suicidal or homicidal ideation
* Meeting criteria consistent with a diagnosis of Antisocial Personality Disorder
Calmodulin Gene Mutations in Patients With Ventricular Arrhythmia of Unknown Origin - A Screening Study

The aim of this study is to screen a well characterized patient population with ventricular tachycardia of unknown origin and treated with an implantable cardioverter-defibrillator (ICD) for mutations in the calmodulin genes.

Patients with ventricular tachycardia of unknown origin and treated with an implantable cardioverter-defibrillator (ICD) will be asked to participate in the study. For patients with results showing mutations in the calmodulin genes, family members (parents, siblings and children) will also be asked to participate in the study. For under age patients and relatives who agree to participate, informed consent will also be taken from their custodian.

Eligibility Criteria:
Inclusion Criteria:

* Patients with ventricular tachycardia of unknown origin that have been treated with an ICD
* Signed and dated informed consent

Exclusion Criteria:

- Inability to provide informed consent