cyrilzakka/clinical-trials huggingface dataset:
Analysis of the Quality of Life, the Clinical Effectiveness and Cost-effectiveness of a Novel Educational Programme in Patients With Psoriasis and Atopic Dermatitis

'OnderHUIDs' is an educational program (Department of Dermatology, University Hospital, Gent) for patients with psoriasis and atopic dermatitis. We want to stimulate the patient to actively participate in their therapeutic approach by enhanced self care. We call the hypothesis that this program will help the patients learn to cope with their disease and to be loyal to their treatment, which will result in a better quality of life, better clinical outcome and cost effectiveness.


Eligibility Criteria:
Inclusion Criteria:

* Patients who have given written informed consent
* Women or men of any race
* Patients who are 18-75 years of age
* Diagnosis of psoriasis or atopic dermatitis

Exclusion Criteria:

* Patients with a cognitive disorder (not able to understand, speak, read or write..)
* Patients with a significant underlying medical cause (i.e. severe infection, haematologic disease, malignity, severe renal or hepatic disease, major depression) in the last 3 months
* Patients under experimental pharmaceutical medication
The Effect of Cognitive Behavioral Therapy on the Outcome of Spinal Surgery

This study is designed to examine the efficacy of Cognitive Behavioral Therapy (CBT) on the outcome of spinal surgery.

The goal of this treatment is to change the coping style, thoughts, behavior and adaptive perception of the patient, and to replace them with an adaptive style.

The patients in this study will be randomly divided into two groups. One group will undergo Cognitive Behavioral Therapy (CBT) before having spinal surgery. The other group will be a control group, and will not have any psychological intervention.


Eligibility Criteria:
Inclusion Criteria:

* patients who intended to undergo spinal surgery

Exclusion Criteria:

* patients who does not speak Hebrew language
Comparison of Imaging Characteristics of uEXPLORER and Conventional PET/CT in Patients With Lung Cancer, Lymphoma, and Melanoma

To determine the minimum scan duration for fluorine-18 positron-emitting radioactive isotope-fluorodeoxyglucose (18F-FDG) positron emission tomography (PET)/computed tomography (CT) scans performed on a total-body PET/CT scanner that results in non-inferior image quality to 18F-FDG PET/CT scans performed on a conventional PET/CT scanner. The subject population will be patients being staged for lung cancer, lymphoma, or melanoma.


Eligibility Criteria:
Inclusion Criteria:

1. Ability to understand and willingness to sign an informed consent form.
2. Ability to adhere to the study visit schedule and all protocol requirements.
3. Men and women ≥18 years of age.
4. Diagnosis or suspected diagnosis of lung cancer, melanoma or lymphoma.
5. Patients who have been referred for a PET/CT scan.

Exclusion Criteria:

1. Pregnant women.
2. Claustrophobia.
3. Any significant medical condition that in the opinion of the investigator would prevent the subject from participating and/or adhering to study related procedures or interfere with subject safety.
Long-term Prevention of Recurrent Gastric or Duodenal Ulcers Caused by Low-dose Aspirin With Rabeprazole (E3810) Treatment (Planetarium Study)

The primary objective of this study to examine the long-term safety of rabeprazole 5 mg or 10 mg tablets administered once daily in participants who were confirmed to have no recurrence of gastric or duodenal ulcer by endoscopic examination at the end of 24 weeks of treatment in the E3810-J081-308 (NCI01397448) \[Double-Blind Phase\] study. From a total of 420 participants who completed the E3810-J081-308 study, 328 entered the E3810-J081-309 (NCT01398410) study.

The E3810-J081-309 consisted of two arms: the long-term rabeprazole groups (participants from the rabeprazole 5 or 10 mg arm of the E3810-J081-308 study who entered the rabeprazole 5 mg or 10 mg arm of the E3810-J081-309 study) and the newly-initiated rabeprazole groups (participants from the teprenone 150 mg arm of the E3810-J081-308 study who entered the rabeprazole 5 mg or 10 mg arm of the E3810-J081-309 study).

Eligibility Criteria:
Inclusion Criteria

* Confirmed to have no recurrence of gastric or duodenal ulcer by endoscopy at the end of 24 weeks of treatment in study E3810-J081-308.
* Need to continue receiving low-dose aspirin (81 mg/day or 100 mg/day) during this study.

Exclusion Criteria

-Confirmed to have a recurrence of gastric or duodenal ulcer at the end of 24 weeks of treatment in study E3810-J081-308 (at the start of this trial) and thus are withdrawn from the trial.
Severe Pandemic H1N1 Infection in ICU: Comparative Resource Utilization

The main purpose of this study is to review the resource utilization of severe adult H1N1 pneumonia undergoing antiviral and oxygen therapy, mechanical ventilation and support with pulmonary rescue therapies ( nitric oxide, ECMO, HFO) in critically ill patients in Winnipeg. Secondary objectives include, comparison of resource utilization to other similar disorders (viral pneumonia, bacterial pneumonia, septic shock, ARDS). The investigators will also look at the percentage of patients that required ICU care as compared to those who could be cared for on medical wards. The investigators will determine the resources used by both groups and compare. Finally the investigators will record the frequency of chronic comorbidities in hospitalized adult H1N1 patients.


Eligibility Criteria:
Inclusion Criteria:

1. \> 18years,
2. Suspected or confirmed influenza (Appendix A)
3. Requirement for ICU admission due to respiratory distress or critical illness defined as one of:a) Inspired oxygen need of \>50% for at least 4 hours (For FiO2 for non-intubated patients see Appendix B) b) mechanical ventilation c) Patient is receiving inotrope or vasopressor

Exclusion Criteria:

1. Age less than 18 years
Evaluating a Caregiver SMS Reminder Intervention to Reduce Immunization Drop-out in Arua, Uganda

Faced with high rates of immunization drop-out, Uganda's immunization program requires innovative approaches to address this weakness. Building upon Uganda's growing mHealth infrastructure to pilot a scalable short message service (SMS) system to remind caregivers of their children's upcoming vaccination visits, it was hypothesized that the SMS intervention will increase immunization coverage in a cost-effective and affordable manner that would make it scalable. The study design was an investigator-blinded, multi-center, parallel groups randomized controlled trial with randomization occurring at the caregiver level in select health facilities of Arua District in Uganda. Enrollment took place at the time of Pentavalent 1 vaccination, and both arms included standard of care provided by the health worker. However, in the intervention arm, caregivers also received SMS text messages reminding them to return for their children's second and third doses of Pentavalent vaccine (four and eight weeks after the first dose of Pentavalent vaccine) and measles-containing vaccine (9 months of age). The primary outcome of interest is vaccination coverage at 12 months of age among children enrolled in the study and will be measured by comparing Penta3 and MCV coverage between arms. The study will also examine the SMS impact on timeliness of vaccine receipt, as it is hypothesized that those children receiving the SMS intervention will be more likely to have timely vaccination than those in the control group. The study will also assess caregiver acceptability and cost-effectiveness of the SMS intervention. In addition to assessing its impact on strengthening the immunization program, this intervention has implications for strengthening other programs of the health system through similar health messaging directed toward caregivers.


Eligibility Criteria:
Inclusion Criteria:

* Is a caregiver of a child between the ages of 6 weeks and 6 months of age and presents at one of the study sites for child's Penta1 vaccination
* Access to a personal or household cell phone that can receive text messages
* Lives in Arua district

Exclusion Criteria:

* Does not have access to the cell phone number at time of registration
* Does not agree or is unable to consent to participate in the study
* Does not anticipate being the caregiver through the child's first birthday
* Plans to move out of Arua district in the upcoming year
* Prior enrollment of the caregiver with a different child
Effect of Smoking on Activated Clotting Time Values During Coronarography and Angioplasty

analyzing influence of smoking on patients anti-coagulation status as assessed by ACT measurements during coronary angioplasty

During angioplasty, activated clotting time (ACT) measurements are recommended to attest the correct anticoagulation level and if anticoagulation levels are suboptimal after the two first boluses, additional unfractionated heparin (UFH) injections are recommended until obtention of a therapeutic ACT values (250-350s).

The study hypothesis was that the procoagulant effect of the tobacco may be responsible of reduced anticoagulation levels after standardized UFH administrations and thus presenting an UFH resistance requiring increased UFH dosages to obtain a therapeutic ACT values.

Eligibility Criteria:
Inclusion Criteria:

* any patient older than 18 years needing a diagnostic coronarography was eligible for enrollment

Exclusion Criteria:

* unconscious patient
* any patient presenting with one of the following characteristic known to impact either on ACT or aPTT measurements as: oral anticoagulation medication (anti-vitamin K and non-vitamin K antagonist oral anticoagulants \[NOAC\]), fondaparinux or LMWH usage, coagulopathy defined as prothrombin time \< 50 % or thrombopenia \< 50 000 G/L, declared or observed thrombophilia defined as antithrombin \< 50%, baseline aPTT values with a ratio patient/control \> 1.2 presence of lupus anticoagulant, connective tissue disease, active cancer
* a person as defined by the law articles L. 1121-5, L. 1121-7 et L1121-8 of the Code de la santé publique, France (pregnant, parturient women or breastfeeding women, legally adult patient under legal protection measure \[tutelage, protection of vulnerable adults\]),
* a person as defined by the law articles L. 3212-1 et L. 3213-1 of the Code de la santé publique, France (legally adult patient unable to consent, person with legal or administrative freedom restriction or person under psychiatric treatment)
Sintilimab With P-GemOx Regimen for Newly Diagnosed Advanced Extranodal Natural Killer/T-cell Lymphoma, Nasal Type

The purpose of this multi-center,single arm,phase Ⅱ clinical trail is to determine the safety and efficacy of Sintilimab with P-GemOx (pegaspargase, gemcitabine and oxaliplatin) regimen for newly diagnosed advanced extranodal natural killer/T-cell lymphoma, nasal type (ENKTL)


Eligibility Criteria:
Inclusion Criteria:

* biopsy proved extranodal natural killer/T-cell lymphoma, nasal type;
* newly diagnosed stage III/IV patients;
* at least one evaluable lesion；
* ECOG PS 0-2;
* 18-75 years; without other malignancy;
* proper functioning of the major organs.

Exclusion Criteria:

* hemophagocytic syndrome or aggressive NK cell leukemia;
* involvement of central nervous system;
* previously received treatment of chemotherapy, radiotherapy, immunotherapy or biotherapy for lymphoma；
The Safety & Efficacy of Intravitreal Aflibercept Injection in Patients With Persistent Central Serous Chorioretinopathy

A preliminary study to determine the safety and efficacy of intravitreal aflibercept injection in patients with persistent central serous chorioretinopathy.

Intravitreal Aflibercept Injection for Persistent Central Serous Chorioretinopathy: A Prospective Pilot Study

Eligibility Criteria:
Inclusion Criteria:

* Pre-treatment acuity of 20/40- 20/320
* Macular fluid on optical coherence tomography for greater than 3 months
* Leakage on fluorescein angiography
* Willing and able to comply with clinic visits and study-related procedures
* Provide signed informed consent

Exclusion Criteria:

* Treatment for CSCR in the study eye (anti-VEGF, PDT, or laser) within three months prior to study enrollment
* Presence of choroidal neovascularization on enrollment imaging
* Prior vitrectomy in the study eye
* Presence of any substantial ocular disease (other than CSCR) that may compromise vision in the study eye and /or confound interpretation of the data; e.g. substantial cataracts, advanced glaucoma, optic neuritis, optic neuropathy or atrophy, marked macular atrophy, ocular vascular occlusion, history of retinal detachment, uveitis, viral or other forms of chorioretinitis, etc.
* History of rhegmatogenous retinal detachment or macular hole (Stage 3 or 4) in the study eye
* Uncontrolled glaucoma in the study eye (defined as IOP ≥ 25 mmHg despite treatment with anti-glaucoma medication)
* Active ocular infection or inflammation in the study eye
* Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye
* Prior treatment with systemic anti-VEGF agents
* Cerebrovascular accident or myocardial infarction within the preceding 6 months.
* History of allergy to fluorescein, povidone iodine (Betadine) or aflibercept
* Participation in a study of an investigational drug or device within 30 days prior to potential enrollment into the study
* Pregnant or breast-feeding women Sexually active men\* or women of childbearing potential\*\* who are unwilling to practice adequate contraception during the study (adequate contraceptive measures include stable use of oral contraceptives or other prescription pharmaceutical contraceptives for 2 or more menstrual cycles prior to screening; intrauterine device \[IUD\]; bilateral tubal ligation; vasectomy; condom plus contraceptive sponge, foam, or jelly, or diaphragm plus contraceptive sponge, foam, or jelly)

  * Contraception is not required for men with documented vasectomy.

    * Postmenopausal women must be amenorrheic for at least 12 months in order not to be considered of child bearing potential. Pregnancy testing and contraception are not required for women with documented hysterectomy or tubal ligation.
Recovery of Walking in Persons With Complete Spinal Cord Injury

We documented the impact of 1 year of underwater treadmill training and supplemental overground walk training in five adults with chronic motor-complete SCI (cSCI) who had not undergone programmed epidural spinal cord stimulation (eSCS).

Regular exposure to self-initiated treadmill walking in water, a unique sensorimotor exercise setting that makes stepping movements easier to perform, may capitalize on the adaptability of the neuromuscular system and enhance locomotor function in persons with cSCI who have not undergone eSCS. In our study, a combined aquatics- and land-based approach to gait training was employed over a 12-month period that featured underwater treadmill training and supplemental overground walk training.

Eligibility Criteria:
Inclusion Criteria

* At least 21 years of age
* Presence of traumatic or non-traumatic spinal cord injury for at least 1 year
* Medical diagnosis of paraplegia (T1 or below)

Exclusion Criteria

* Presence of complex comorbidities that could limit involvement in training activities
* Surgical implantation or removal of a medical device six months prior to training
* Skin breakdown
* Use of electrical implants to promote ambulation
Safety and Efficacy Study of High Dose Colistin

Colistin is a rapidly acting bactericidal antimicrobial agent that possesses a post antibiotic effect against MDRO Gram-negative bacteria, such as as Pseudomonas aeruginosa, Acinetobacterbaumannii, and Klebsiella pneumonia.


Eligibility Criteria:
* Inclusion Criteria:

  1. Patient age more than or equal 18 years old.
  2. Patient has clinical signs and symptoms of infection with suspected or proven infection due to Carbapenem resistant microorganism.
  3. Patient was started with Empirical therapy of Colistin and positive MDRO within 5 days of empirical therapy.
* Exclusion Criteria:

  1. Patient age less than 18 years.
  2. Pregnant patient.
  3. If received Colistin treatment for less than 72 hours.
  4. Renal Replacement Therapy.
A Phase I Study to Evaluate the Safety, Tolerability and Efficacy of MEDI4736 (Durvalumab) With Tremelimumab in Head and Neck Cancer

This is a multicenter, open-label, dose-exploration and dose-expansion study to evaluate the safety, tolerability, antitumor activity, PK, pharmacodynamics, and immunogenicity of MEDI4736 in combination with tremelimumab in subjects with recurrent/metastatic squamous cell carcinoma of the head and neck.


Eligibility Criteria:
Inclusion Criteria:

1. Male and female subjects
2. 18 years and older
3. Histologically or cytologically confirmed recurrent or metastatic squamous cell carcinoma of the head and neck (oral cavity, oropharynx, hypopharynx or larynx) that is incurable by local therapy.
4. Subjects who are treatment-naive or pretreated (prior anti-PD-1 or anti-PD-L1 required) in the recurrent/metastatic setting.
5. Subject eligibility will be based on PD-L1 expression as determined by a specified IHC assay.

Exclusion Criteria:

1. Any concurrent chemotherapy, immunotherapy, biologic, or hormonal therapy for cancer treatment, receipt of last dose of an approved anticancer therapy within 21 days
2. Concurrent or prior use of immunosuppressive medication within 14 days
3. Active or prior documented autoimmune or inflammatory disease within 3 years with some exceptions.
A Study of Sleep Patterns to Determine Predictive Markers Due to Cardiovascular Disease in Elderly Patients

The purpose of this study is to learn if there are predictive markers of hospitalization or death that can be found from data gathered from a Sleep Number® bed. This is a prospective observational cohort study that will follow participating subjects in the Masonic Homes/Acacia Creek Retirement Community in Union City, California.


Eligibility Criteria:
Inclusion Criteria:

* Subjects living at Masonic Homes/Acacia Creek Retirement Community who use a Sleep Number® bed and are cognitively able to consent on their own accord.

Exclusion Criteria:

* Subjects who do not have a Sleep Number® bed.
* Subjects without an internet connection to transmit nightly SleepIQ® data.
Kidney Damage In Patients With Severe Fall In eGFR

This is a pilot study using a randomized, double blinded, comparison of two iodinated contrast agents used during percutaneous coronary intervention (PCI). All patients enrolled must have and estimated glomerular filtration \[eGFR\] \< 30 mL/min/1.73 m2. Statistical summaries will be presented to analyse the various laboratory tests for the two groups.


Eligibility Criteria:
Inclusion Criteria:

* Provides written Informed Consent
* Is at least 18 years of age;
* Is scheduled for or likely to undergo percutaneous coronary intervention;
* Has documented estimated glomerular filtration rate \[eGFR\] \< 30 mL/min/1.73 m2 calculated with the MDRD formula within 72 hours prior the enrolment.

Exclusion Criteria:

* Is a pregnant or lactating female
* Has a history of severe congestive heart failure
* Has a history of hyperthyroidism
* Has unstable renal function
* Has a history of hypersensitivity to iodinated contrast agents
Safety and Immunogenicity of a New Inactivated Poliovirus Vaccine in Infants

A new inactivated polio vaccine based on attenuated poliovirus strains was developed to transfer the technology to manufacturers in low- and middle-income countries. This vaccine was produced in different dosages and in different formulations. In healthy adults the safety of the highest dose was comparable to that of the existing inactivated polio vaccine. The purpose of this trial is to determine the safety of the different dosages and formulations of the vaccine in infants. The second goal of this study is to analyse the immune response after three doses in infants.

The goal of this study is to assess the safety and immunogenicity of Sabin-IPV and adjuvanted Sabin-IPV produced with the production process set up for technology transfer by the National Institute for Public Health and the Environment (RIVM, formerly the Netherlands Vaccine Institute (NVI).

* The primary objective is to evaluate safety (local and systemic reactions) of intramuscular injection with Sabin-IPV and adjuvanted Sabin-IPV in healthy infants.
* The secondary objective is to evaluate immunogenicity of three doses Sabin-IPV and adjuvanted Sabin-IPV in infants.

Eligibility Criteria:
Inclusion Criteria:

* Age 8 weeks (56-63 days) at the time of first vaccination
* Infants in good general health, eligible to be vaccinated according to the Polish national vaccination program. The same health criteria apply as used in well-baby clinics when a child receives a vaccination, e.g. also children with a small increase in temperature (\< 38.5° C) or with a common cold (runny nose etc) are seen as children with normal health.
* The parent(s)/legally representative(s) have to be willing and able to allow their child to participate in the trial according to the described procedures
* Presence of a signed informed consent in which the parent(s)/legally representative(s) have given written informed consent after receiving oral and written information (signature from one parent in case of single-parent family).

Exclusion Criteria:

* Any IPV or OPV dose
* Known or suspected allergy against any of the vaccine components
* History of unusual or severe reactions to any previous vaccination administration of plasma (including immunoglobulins) or blood products prior and during the study
* Any vaccination less than 14 days before or after each vaccination with the IMP
* History of any neurological disorder including epilepsy or febrile seizures
* Any infectious disease at the time of screening and/or inclusion that might interfere with the results of the study
* Present evidence of serious disease(s) demanding immunosuppressive medical treatment, like cytostatics and prednisolones, that might interfere with the results of the study
* Any known or suspected primary or secondary immunodeficiency
* Communication problems interfering in the study realization according to the judgment of the investigator
* Bleeding disorders and use of anticoagulants
* Premature birth (\<37 weeks)
* Participation in another clinical trial