cyrilzakka/clinical-trials huggingface dataset:
Development of a Questionnaire Based on Patients' Messages on an Internet Forum for Flare Detection in IBD

Crohn's disease and ulcerative colitis, the two major forms of inflammatory bowel disease (IBD) are chronic disabling conditions characterized by flares followed by periods of remission. However, IBD patients are seen every 3 to 6 months in the outpatient clinic, and the occurrence of a flare between two outpatient visits is not captured. In the current state of knowledge, there is no validated patient-reported outcome (PRO) tool to measure the phenomenon of flare in IBD. This study aimed to use an innovative methodology to collect messages posted by patients in an Internet forum for developing and validating a PRO measuring flare in IBD.

The design involves 1) Engineering sciences for scraping extraction of messages posted in an Internet forum and for Identification of messages related to flare, 2) Qualitative methods for thematic content analyze of the messages posted, for candidate items generation, for items selection (Delphi process) and for items adjustment ("think aloud" interviews), 3) Quantitative methods for psychometric validation of the PRO.


Eligibility Criteria:
Inclusion Criteria:

* Every patient consulting the gastroenterology unit of Nancy University Hospital with a confirmed IBD diagnosis, regardless of the patient's state or treatment will be considered for inclusion

Exclusion Criteria:

* patients with a diagnosis \< 3 months.
* Protected persons (minors, adults under guardianship, pregnant or breastfeeding women, people living in a public health or social institution, patients in an emergency situation, incarcerated individuals)
The Effect of Methods of Self-regulation of Mental State on Pain Perception in the Postoperative Period in Colon Cancer Patients

In this study, it will be investigated whether the methods of self-regulation of mental state have an effect on postoperative pain perception in colon cancer patients.

According to the assumptions of psychoneuroimmunology, the improvement of mental state affects the physical improvement of patients. Numerous studies confirm the effectiveness of hypnosis and learning autohypnosis in improving the functioning of patients in terms of reducing pain and anxiety, improving the quality of sleep and mood. The study is a Prospective Randomized Controlled Trial consisting of two groups. Patients in the study group will receive a voice recording with hypnotic instructions with a suggestion to improve the psychophysical state. Patients in the control group will receive a recording with relaxing music. Depending on the randomization, patients will listen to the selected recording before being admitted to the surgical department. They will then be given a recording to listen to whenever they want. The patients will be examined four times using the Activity Change Scale, ie. before randomization, on the first day after surgery, on the 7th day after surgery and 1 month after surgery. Simultaneously the total analgesic consumption will be recorded.

Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent to participate in the study
2. Age \>= 18 years
3. Histopathological diagnosis of primary colon cancer without distant metastasis
4. Planned surgical treatment
5. Fluency in Polish

Exclusion Criteria:

1. Severe comorbidities with pain disorders
2. Regular use of analgesics
3. Coexistence of another neoplastic disease
4. Use of non-pharmacological pain management (including autohypnosis) prior to the study
5. Poor general condition
6. Previous colorectal surgery
7. Hearing disorders
8. No possibility of playback of the received recording
Outcomes and Discharge of Long-stay Psychiatric Patients

An increasing number of severely ill patients require long-term care in non-hospital Residential Facilities (RFs). Despite the magnitude of this development, only a few detailed longitudinal studies on fairly larger samples of residents have provided important information about this population. The PERDOVE study is the first study carried out in Italy aimed at obtaining comprehensive data about the course and outcome of patients living in RFs, and test whether discharge to independent accommodations is a real option for many patients. The major aims are three: (1) to describe the sociodemographic, clinical, and treatment-related characteristics of patients treated in RFs during an index period in 2010; (2) to identify predictors, and characteristics associated to discharge at 1-year follow-up; and (3) to evaluate clinicians' predictions about the likelihood of home discharge for each individual patient. The primary endpoint was discharge within one year as a measure of good outcome. The PERDOVE study is an observational cohort study, involving 23 RFs all belonging to the St John of God Order, located in Northern Italy. The first step involves the evaluation of all RFs with a Structure Schedule, which assesses the following areas: logistics structure, general organization: internal rules, meals, clothing and personal hygiene; staff and users' characteristics and meetings, documentation system and evaluation activities; rehabilitative activities provided inside the RF itself. In the second step a research assistant completed a standardised assessment of each resident with the manager and staff; clinical diagnoses were made by treating clinicians. A number of standardised instruments were administered. At one year follow-up, changes in clinical and life conditions of the patients were evaluated and selected rating scales were administered again. For patients discharged to the community or to other RFs, a research assistant contacted the patient's psychiatrist and asked him/her to fill out the follow-up documentation. With regard to residents' discharge, investigators hypothesised that the likelihood of community discharge would be associated both with the level of social support outside the facilities, and with the degree of patients' psychological and social impairment.


Eligibility Criteria:
Inclusion Criteria:

* psychiatric diagnosis
* age \< 65
* staying in september 2010 in any of 23 RFs located in Northern Italy

Exclusion Criteria:

* elderly patients (over 65 yrs)
* primary diagnosis of organic mental disorder
* refusal of signing an informed consent
Surgical Treatment for Trapeziometacarpal Osteoarthritis Eaton & Glickel Stage 2-3

Trapeziometacarpal osteoarthritis is a common cause of pain and loss of hand function in postmenopausal women. Many surgical treatments have been described and recent literature has show that the relatively simple trapeziectomy gives equal results and less complications, when compared to other techniques such as ligament reconstructions and interpositions. A relatively new treatment modality, which has been further developed in recent years is the total joint arthroplasty. Randomized prospective trials and long-term results are lacking, but prospective cohorts show a faster recovery and good results after one year, without an increase in complication rate.

We hypothesize that a total joint arthroplasty gives a better objective and subjective result after one year than a trapeziectomy.


Eligibility Criteria:
Inclusion Criteria:

* Women.
* 40 years of age or more.
* Symptomatic trapeziometacarpal osteoarthritis.
* Eaton \& Glickel stage 2 and 3.

Exclusion Criteria:

* An operation for trapeziometacarpal osteoarthritis on the same hand in the past.
* Participation in randomized clinical trial for trapeziometacarpal osteoarthritis with contralateral hand.
* Secondary trapeziometacarpal osteoarthritis as result of trauma, rheumatoid arthritis, systemic lupus or gout.
* Symptomatic carpal tunnel syndrome in same hand.
* Symptomatic Quervain's tenosynovitis in same hand.
* Neurological or other disorders of the affected side that can influence postoperative rehabilitation.
* Insufficient knowledge of Dutch language.
Low Molecular Weight Heparin in Recurrent Implantation Failure

Recurrent implantation failure is the failure to achieve a pregnancy after multiple attempts with in vitro fertilization treatment. The reason is usually obscure. Many empirical treatments have been offered without substantial evaluation. Heparin is thought to play a role in the embryo implantation process beyond its anticoagulation effects. The proposed study aims to assess the effectiveness and safety of empirical administration of low molecular weight heparin in patients undergoing a new IVF treatment cycle after multiple failed attempts.


Eligibility Criteria:
Inclusion Criteria:

* History of at least two previously failed fresh embryo transfer cycles
* All previously failed cycles to be performed in the American Hospital of Istanbul
* Female age ≤ 38 years
* Fresh ejaculate sperms to be used for ICSI
* No hormonal, coagulation, or immunological disorders detected
* Normal uterine cavity, as assessed by diagnostic office hysteroscopy or saline infusion sonography
* Normal female and male peripheral karyotype
Total Parenteral Nutrition-Associated Liver Disease

This is a study to determine whether choline, when added to total parenteral nutrition (TPN), can help prevent the development of hepatic steatosis, a liver disease, in patients on TPN.

Choline deficiency-induced hepatic steatosis occurs in patients that require long-term TPN and may progress to significant hepatic disease and death. Initial studies indicate choline-supplemented TPN may reverse TPN-associated hepatic steatosis.

Choline chloride or placebo will be added to each patient's TPN for 16 weeks by the hospital or pharmacy providing their usual TPN. Patients will receive their TPN in the hospital until they are medically stable for discharge. If patients are discharged before study completion, the pharmacy will deliver the TPN supply to them. Evaluation of hepatic steatosis is done by CT scans and blood analyses. Blood will be drawn on a biweekly basis during the first 4 weeks and at Week 8, 12, 16 or withdrawal. CT scans will be done at Week 4, 8, 16, or withdrawal.

Completion date provided represents the completion date of the grant per OOPD records

Eligibility Criteria:
Inclusion criteria:

* Underlying pathology may include, but is not limited to: short bowel syndrome, chronic pancreatitis, pancreatic pseudocysts, pseudo-obstruction, enterocutaneous fistula, entero-enteric fistula, or malabsorption syndrome.
* Requirement for TPN to supply greater than 85 percent of nutritional needs for at least 16 weeks.

Exclusion criteria:

* Not receiving lipid emulsion with TPN regimen
* Albumin less than 2.5 g/L
* Renal failure requiring hemo- or peritoneal dialysis
* Hepatic failure (PT greater than 2 times control)
* Diabetes
* Hepatitis C
* AIDS
* Concurrent hospitalization for organ transplantation or rejection treatment
* Concurrent cholinergic medication
* Positive pregnancy test
* Refusal to use an acceptable method of birth control
* Ethanol abuse
* More than 40 kcal/kg/day ideal body weight
* Obesity with ensuing weight loss
* Use of IV tetracycline, valproic acid, corticosteroids, methotrexate, or amiodarone
Effect of Doxium on High Sensitivity CRP and Endothelin-1 Serum Levels in Patients With Diabetic Retinopathy

Diabetic retinopathy (DR) is a highly specific vascular complication of type 1 and type 2 diabetes mellitus. Calcium dobesilate(CD) or Doxium has been tested in the treatment of diabetic retinopathy showing a slowdown of the progression of the disease after long-term oral treatment,as a potent antioxidant. Endothelin-1 (ET-1) Besides being a very potent vasoconstrictor,acts as a mitogen on the vascular smooth muscle and play the main role in the failure of autoregulation that it is an important and often early feature of diabetic retinopathy.several studies have been confirmed that inflammation besides oxidative stress are the main mechanisms,in the pathogenesis of DR and hsCRP can play a sensitive role in detecting inflammation in these patients. The aim of this study was to determine the effects of CD on decreasing ET-1 and hsCRP serum levels in patients with diabetic retinopathy.


Eligibility Criteria:
Inclusion Criteria:

* BS 120-200 mg/dl
* Age 40-70
* Severe NPDR(non proliferative diabetic retinopathy) or PDR(proliferative diabetic retinopathy)
* type II diabetes
* no history of doxium consumption

Exclusion Criteria:

* Allergy to doxium
* incidence of active hepatic disease or rising of hepatic enzymes during the intervention
The Effect of Home Blood Pressure Measurement on the Management of Hypertension

Home blood pressure measurement has been reported to be associated with better clinic blood pressure and daytime blood pressure control. However, no study has evaluated the association between home blood pressure measurement and control of 24-hour ambulatory blood pressure in real world practice.

The purpose of the present study is to investigate the effect of home blood pressure measurement on the control of ambulatory blood pressure in the real world.

The detailed purposes of the present study are (1) to investigate the effects of home blood pressure measurement on the appropriate control of 24-hour ambulatory blood pressure in hypertensive patients treated with antihypertensive drug, (2) to evaluate the effect of home blood pressure measurement on the occurrence of cardiovascular events and target organ damage, (3) to investigate the status and appropriateness of home blood pressure measurement in the real world, and (4) to investigate factors of home blood pressure measurement methods affecting the treatment of hypertension.


Eligibility Criteria:
Inclusion Criteria:

* Patients with hypertension and taking antihypertensive drugs more than 1 year

Exclusion Criteria:

* Secondary hypertension
* Hypertensive emergency and urgency
* Severe heart failure (NYHA III and IV)
* Angina with 6 months
* Myocardial infarction within 6 months
* Peripheral artery disease within 6 months
* Significant arrhythmia (i.e. ventricular tachycardia and fibrillation, atrial fibrillation, atrial flutter)
* Pregnancy
* Night labor, shift worker
* Those who are currently participating in other clinical studies
* Those who have taken other clinical trial drugs within the past month
* According to the opinion of the researcher, those who have or may have a disease that may interfere with the completion of the study
* History of drug or alcohol dependence within 6 months
ORN Study: Curative Treatment of Osteoradionecrosis (ORN) With Hybrid Bone Substitution

The main objective of the study is the cure of osteoradionecrosis (ORN) at 12 months.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (between 18 and 75 years) affiliated with an appropriate social security system, diagnosed as suffering from symptomatic ORN, radiologically confirmed, for which surgery is indicated
* Presence maximum of 2 outbreaks of ORN
* Oncological remission of the original tumor site for 1 year and for 3 years if the ORN is in the contact or close to the initial tumoral site
* ECOG performance status 0, 1 or 2
* ORN symptomatic accessible to the conservation of at least one cortical mandibular basilar
* Signed informed consent

Exclusion Criteria:

* Oncological treatment
* Haematologic background
* Current bone necrosis consecutive or concurrent to taking bisphosphonates
* Extension of ORN does not allow the retention of a mandibular rod (bicortical form)
* Presence of fracture complicating ORN
* Bisphosphonates during the last year
* Contraindications to the removal of iliac or sternum bone marrow
* Contraindication for general anesthesia
A Rehabilitation Tool to Determine Patient's Stay in Hospital After Joint Replacement

SPARTA force plate is used as rehabilitation tool in this study. The device is Force Plate coupled with SPARTA scan software that enables quick assessment of individual movement and balance within minutes. The magnitude as well as efficiency of force production is analyzed to determine an patient recovery graph.

The investigator hope to learn co-relation between the rehab tool and clinical findings and analyse association if any. In this study, force plate is rehab tool, which will optimize care according to the patient's specific needs and provided insights to patients length of stay in the hospital. these data driven insights will be used to observe correlation between machine and clinic data

Eligibility Criteria:
Inclusion Criteria:

* Patient scheduled for Primary unilateral total joint replacement
* Patient age should be more than or equal to 18 years.
* Patient must speak English

Exclusion Criteria:

* Patients undergoing bilateral primary knee replacement surgery
* Patients undergoing revision knee replacement surgery
* No uncorrectable deformity
* No deformity greater than 15 degree
* No hip arthritis
* No wheelchair dependency

Patients not willing and capable to sign the written informed consent
Re-examination Study For Varivax (V210-059 AM2)

This survey is conducted for preparing application materials for re-examination under the Korean Pharmaceutical Affairs Laws and its Enforcement Regulation; its aim is to reconfirm the clinical usefulness of VARIVAX through collecting the safety information according to the Re-examination Regulation for New Drugs.

This post-marketing survey was conducted in the usual routine practice and the investigator enrolled participants vaccinated with VARIVAX continuously after study start. The purpose of the study was to assess the occurrence of adverse events and to identify factors that may affect the safety of the vaccine under real-life, post-marketing conditions. No hypothesis testing was conducted in this survey.

Eligibility Criteria:
Inclusion Criteria:

* Participants must be vaccinated with VARIVAX as a standard of care

Exclusion Criteria:

* Participants who have been previously vaccinated with VARIVAX
* Contraindication with VARIVAX
Study of the Safety and Effectiveness of HIFU Combined With REGOTORI for Metastatic Colorectal Cancer

This study intends to perform high-intensity focused ultrasound combined with REGOTORI in patients with multiline drug-resistant metastatic colorectal cancer to explore the safety and efficacy of patients. Patients receive HIFU local treatment combined with REGOTORI treatment, and receive corresponding clinical data collection at different follow-up points, including necessary data from various laboratories, CT/MRI, and immune function tests that are exactly the same as before surgery collection.


Eligibility Criteria:
Inclusion Criteria:

* The subject has metastatic colorectal cancer, and the first and second-line standard treatments have failed
* There is at least one target lesion that can be treated with HIFU
* Voluntarily accept this treatment clinical research, and sign the "Subject Informed Consent"
* 18-75 years old, no gender limit
* The level of physical strength of the Eastern Cooperative Oncology Group (ECOG): PS\<=2
* The expected survival time is greater than 3 months
* No chemotherapy or radiotherapy within 21 days before enrollment
* The function of major organs is basically normal

Exclusion Criteria:

* Pregnant or lactating women
* People infected with HIV, hepatitis C virus and Treponema pallidum
* There is an active infection that requires systemic treatment (such as active tuberculosis)
* Severe infection within 4 weeks before starting the study treatment
* Subjects who have received allogeneic tissue/solid organ transplantation
* The patient suffers from major vascular disease or irregular bleeding disease
* Suffer from physiological or pathological malnutrition diseases, chronic diarrhea, cachexia, etc.
* The patient has autoimmune diseases, such as (but not limited to) multiple sclerosis, systemic lupus erythematosus and inflammatory bowel disease, vitiligo
* The patient has a history of serious drug or food allergy (for example, allergy to protein)
* The patient has serious heart disease (including but not limited to: myocardial infarction, cardiomyopathy, valvular disease, malignant arrhythmia, etc.), severe liver and kidney damage, uncontrolled blood sugar and blood pressure (the subject's blood pressure, After using antihypertensive drugs, it still cannot be controlled within the normal range; fasting blood glucose is still \>10mmol/L after using antihypertensive drugs)
* The patient has uncontrollable seizures or loss of insight due to mental illness
* In the 12 months before screening, the patient has a history of drug abuse, drug abuse, and long-term alcoholism
* Within 3 months before screening, the patient is participating in other clinical studies
* Other situations that cannot participate in clinical research.
Using Diagnostic Tools to Stage Breast Cancer

This project is aimed at investigating the relative diagnostic and synergy of four state of the art breast imaging techniques (magnetic resonance imaging (MRI), full-field digital mammography (DMAM), ultrasound, and positron emission tomography (PET)) with respect to determining the extent of breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* Women recently diagnosed with Breast Cancer
* Will be undergoing surgery (after study) at the Hospital of the University of Pennsylvania

Exclusion Criteria:

* Contraindications to MRI
* previously diagnosed with breast cancer (in the smae breast) within the past 5 years
* Patients with known locally advanced cancer (prior to study entry) being treated with preoperative adjuvant therapy.
* Pregnant women
Assessing the Feasibility of a Novel Non-Invasive Sensor for Guiding Wounded Warrior Rehabilitation

The purpose of this study is to test a low cost, non-invasive, wearable near-infrared spectroscopy (NIRS) sensor, previously validated for able-bodied athletes as a rehabilitation aid for war-fighters with lower extremity limb loss. This sensor can record real-time physiologic data that relates to total fitness capacity and exertion levels and may help develop individualized programs on a per-patient basis. The uniqueness of this NIRS measurement system is that it provides real-time muscular oxygenation, dehydration, and iron status during whole-body exercise, as well as training-induced adaptations. Currently, no technology like this has been tested in an amputee population. Successfully validating this technology in a wounded warrior population would provide vital information regarding tissue perfusion after injury and new opportunities for improving rehabilitation outcomes.


Eligibility Criteria:
Inclusion Criteria:

1. Military health care beneficiary and veterans for enrollment.
2. Between 18 and 45 year old.
3. Possess a unilateral transtibial or transfemoral amputation.
4. Low risk for cardiovascular disease.
5. Ambulatory without assistive ambulatory device.

Exclusion Criteria:

1. Exclusion criteria includes individuals outside of our age range or if over the age of 18 and under the age of 45 will be excluded if found at risk according to the ACSM/AHA pre-participation screening questionnaire for exercise testing.
2. Told by a doctor that they should not exercise.
3. Orthopedic injury/surgery of the lower extremity within the last year
4. Less than 5" x 2.5" of soft tissue proximal to the prostheses (since the sensor will need to be placed on the soft tissue proximally)
5. Hip or shoulder disarticulation.
6. Regular use of medications designed to alter cardiovascular function;
7. Unwilling to comply with the study protocol.
8. Individuals with a fat layer greater than 10mm in correspondence of the location of the NIRS probe (thigh).
9. Allergic reaction to latex, cotton, or polyester, which are the primary materials of an ace bandage.