cyrilzakka/clinical-trials huggingface dataset:
Ustekinumab Plus UVB-311nm in Psoriasis

Ustekinumab, an IL-12/23 antibody has been approved in the E.C. and U.S.A. for the treatment of moderate to severe psoriasis. The aim of this study is to determine in a randomized half-side comparison whether additional narrowband UVB-311nm phototherapy accelerates and improves the clearance of skin lesions in Ustekinumab-treated patients.

Patients with moderate to severe psoriasis who receive standard treatment with Ustekinumab (45 mg at week 0, 4, and every 12 weeks) are exposed to UVB-311nm phototherapy on a randomized body half (left or right; head exempt) 3 x per week for six weeks and/or until complete response (defined as reduction in PASI to \< 3). PASI score, patient visual analogue score (VAS) for therapeutic response, and patient VAS for severity of skin lesions is assessed weekly; and at follow-up visits at month 3, 6, and 12. Paired Wilcoxon testing for differences in PASI and patient VAS scores is done; Fischer exact test is applied to determine differences in complete remission, PASI reduction \> 90%, \> 75% and/or 50% between body sites.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Psoriasis patients who receive treatment with Ustekinumab

Exclusion Criteria:

* Age below 18 years
* Pregnancy or lactation
* History of malignant melanoma
* History of invasive squamous cell carcinoma of the skin
* Dysplastic melanocytic nevus syndrome
* Antinuclear antibodies (ds-DNA, Ro/SSA, La/SSB)
* Autoimmune disorders such as Lupus erythematosus or Dermatomyositis
* Photosensitive diseases such as porphyria, chronic actinic dermatitis, Xeroderma pigmentosum, basal cell nevus syndrome, and others
* General poor health status
A Phase 2 Study of Tomudex & Iressa as Second Line Chemotherapy in Subjects With Colorectal Carcinoma

The primary objective of this study is to compare the activity of raltitrexed and ZD1839 versus raltitrexed alone as second line chemotherapy in subjects with colorectal carcinoma by estimating progression free survival (PFS) in each treatment arm.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, aged 18 to 75 years, inclusive
* histologically-confirmed metastatic colorectal carcinoma; measurable lesion according to the Response Evaluation Criteria in Solid Tumours (RECIST)
* relapsed after treatment with a fluoropyrimidine-based chemotherapy
* prior chemotherapeutic regimen for metastatic or locally advanced disease with an interval of at least 4 weeks between the last administration of chemotherapy an the first administration of study treatment
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
* life expectancy of at least 12 weeks

Exclusion Criteria:

* Known severe hypersensitivity to raltitrexed or any of the excipients of this product
* known severe hypersensitivity to raltitrexed or any of the excipients of this product
* active infection or uncontrolled diarrhoea
* cerebral metastasis or meningeal carcinomatosis
* any evidence of clinically active interstitial lung disease (patients with chronic stable radiographic changes who are asymptomatic need not be excluded)
* simultaneous antitumoral treatment
* radiotherapy within 2 weeks before entry into the study
* other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ
* any unresolved chronic toxicity greater than common toxicity criteria (CTC) grade 2 from previous anticancer therapy (except alopecia)
* significant clinical disorder or laboratory finding (leukocyte count less than 3.0 x 109 /litre (L) or platelets less than 100 x 109 /L; serum total bilirubin more than 2.0 mg/dl; as judged by investigator, any evidence of severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic, or renal disease); creatinine clearance ≥ 65ml/min (according to Cockcroft-Gault formula); alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 2 times the upper limit of the reference range (ULRR) if no demonstrable liver metastases, or greater than 5 times the ULRR in the presence of liver metastases)
* pregnancy or breast feeding (women of child-bearing potential)
* concomitant use of phenytoin, carbamazepine, rifampicin, barbiturates, or ST John's Wort;
* Treatment with a non- approved or investigational drug within 30 days before Day 1 of study treatment
Cognitive Behavioral Therapy for Health Anxiety: Internet Treatment Versus Face-to-Face Therapy

Background

Severe health anxiety is a highly distressing, often debilitating, psychological problem. Since the release of the Diagnostic and Statistical Manual of Mental Disorders 5 (DSM-5) its clinical manifestations are increasingly often referred to as Somatic Symptom Disorder (SSD) or Illness Anxiety Disorder (IAD). Despite often being overlooked in routine care, several treatments for severe health anxiety have shown great promise, the most well-established being Cognitive Behavioral Therapy (CBT). Traditionally, CBT - like most other psychotherapies - has typically been delivered face-to-face. That is, the patient physically meeting with the therapist once a week for the whole of the treatment. Internet-delivered CBT does not rest on this requirement, but has nevertheless been shown to be efficacious for severe health anxiety (see for example NCT01673035).

Aim of the study

The present study aims to compare the effects of Internet-delivered CBT and CBT face-to-face for severe health anxiety in a randomized controlled trial. A non-inferiority criterion is applied to determine if Internet-delivered CBT is at least as efficacious as its well-established predecessor.


Eligibility Criteria:
Inclusion Criteria:

* A primary diagnosis of severe health anxiety (somatic symptom disorder or illness anxiety disorder) according to the Diagnostic and Statistical Manual of Mental Disorders 5 (DSM-5)
* Registered citizen of Stockholm county
* At least 18 years old

Exclusion Criteria:

* Other primary axis-I disorder
* Substance abuse or addiction during the last 6 months
* Current or previous episode of psychosis or bipolar disorder
* Severe major depressive disorder
* Suicide risk
* Personality disorder making the treatment procedure very difficult
* Non-stable psychiatric pharmacotherapy (dosage changed during the last 2 months) and the drug is likely to affect outcome measures
* Ongoing concurrent psychological treatment for severe health anxiety
* Having received previous high quality Cognitive Therapy or Cognitive Behavioural Therapy during the recent year
* Ongoing serious somatic disorder, precluding CBT
The Effects of Disease Management Programs for Prevention of Recurrent Ischemic Stroke

It has been reported that stroke is the first cause of becoming bedridden, and its cumulative recurrence rate in 5 years is approximately 35%. There is a high probability that patients reduce or discontinue medications by self-determination, leading to a high risk of stroke recurrence in these patients. Comprehensive and long-term patient educations ameliorating their self-management are important making patients possible to be managed according to the guidelines for their risk factors. Using disease management programs created for each of risk factors according to clinical practice guidelines, the influence of those programs were evaluated for the prevention of stroke recurrence in this Disease Management Program Stroke Trial.


Eligibility Criteria:
Inclusion Criteria:

* Ischemic stroke onset \[including transient ischemic attack (TIA)\].
* Receiving regular consultation with their primary care physician.
* modified Rankin Scale (mRS) score from 0 to 3 at discharge.

Exclusion Criteria:

* modified Rankin Scale (mRS) score 4 and over at discharge .
* Patient having severe complications and the physical symptom that the contents of the program cannot carry out.
* They had medical care in medical/nursing care institutions.
* Patients with pregnancy or under terminal care.
* Dementia (scores of ≤20/30 on the Revised Hasegawa's Dementia Scale) However, when a care-giving family member living with the patient could provide self-management, patients were included even if they had dementia.
Effect of Mindfulness Based Treatment for Obsessive-compulsive Disorder

Hypothesis of this study is that mindfulness meditation would decrease the severity of obsessive-compulsive symptoms.

Before and after 8 weeks of mindfulness program, We will measure Y-BOCS scores in OCD patients. As a control program, relaxation and psychoeducation will provided to OCD patients.

Eligibility Criteria:
Inclusion Criteria:

* obsessive-compulsive disorder
* age 17-55

Exclusion Criteria:

* currently undergoing Cognitive Behavioral Therapy, psychotherapy
* other medical disease
Evaluation of the PreCursor-M+® in CIN2

The goal of this observational study is to to evaluate the accuracy and sensitivity of PreCursor-M+ on a post-aliquot of liquid-based cytology (LBC) cervical samples (biopsy) obtained by physicians in a group of women with histologically-proven diagnoses of CIN2.

The PreCursor-M+® assay is a multiplex real-time methylation specific PCR test that identifies the level of promotor methylation of the host cell genes FAM19A4 and miR124-2, known biomarkers associated with cervical carcinoma and transforming CIN in cervical cells.

To evaluate the clinical course of CIN2 at 2 years after the first diagnosis, with an interval evaluation at 6 months.

After enrolment, women will be divided into two groups: "active surveillance" and "immediate treatment". In the first group, clinical outcomes to be assessed, in relation to the PreCursor-M+ result at baseline, will include regression to \<CIN2, persistence of CIN2, and progression to CIN3+. In the second group, we will evaluate the histological diagnosis at cone specimen (downgrading or upgrading) and the 2-year cumulative incidence of CIN2+ recurrence based on the PreCursor-M+ result at baseline.


Eligibility Criteria:
Inclusion Criteria:

1. age at diagnosis of 18 years or older;
2. histological confirmation of CIN2 after colposcopic-guided cervical biopsy or conservative surgical treatment, including loop electrosurgical excision procedure (LEEP) and laser conization;
3. known HPV test result at baseline;
4. ability to understand and sign the informed consent;
5. written informed consent given.

Exclusion criteria:

1. unknown HPV test result at diagnosis;
2. vulnerable patients.
The Effect of Cannabis in Pancreatic Cancer

Cannabinoids are known to increase appetite, but THC components have psychogenic properties too. CBD is the main component in the plant, and have only minimal psychogenic effects. The aim was to test the appetite stimulating effects of CBD in patients with pancreatic cancer in palliative treatment.

Randomization of consecutive patients who wanted to participate to a daily dose of CBD or not as a supplement to the standard treatment.

Eligibility Criteria:
Inclusion Criteria:

* Adult, palliative pancreatic cancer diagnosis, weight loss \> 5%, understand and read Danish.

Exclusion Criteria:

* Regular use of cannabis, psychiatric disorders, alcohol abuse, life expectancy \< 6 months
Diaphragm Injury and Dysfunction During Mechanical Ventilation

This study is designed to evaluate the relationship between diaphragm activity during mechanical ventilation and the development of ventilator-induced diaphragm dysfunction (VIDD). Diaphragm structure, activity, and function are monitored longitudinally over the first 7 days of mechanical ventilation.

Multiple factors are responsible for injury to the diaphragm during mechanical ventilation and critical illness. Suppression of respiratory drive and respiratory muscle activity can contribute to diaphragm dysfunction and increase the risk of prolonged mechanical ventilation.

The objective of this study is to determine whether diaphragm inactivity or injurious loading of hte diaphragm during mechanical ventilation leads to the development of diaphragm weakness. To address this question, we are monitoring the diaphragm longitudinally over the first week of mechanical ventilation.

Diaphragm activity is monitored by measurements of transdiaphragmatic pressure and diaphragm electrical activity. Diaphragm function is assessed by maximal transdiaphragmatic pressure generation and by measurements of diaphragm neuromuscular coupling. Diaphragm structure is assessed by daily ultrasound imaging.

Study measurments commence at enrolment (within 36 hours of intubation) and continue for the first 7 days of the study (or until extubation or death, if earlier).

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (\>18) with acute respiratory failure receiving invasive mechanical ventilation for less than 36 hours diagnosed with any of the following conditions: acute severe brain injury; moderate or severe ARDS; septic shock; pneumonia

Exclusion Criteria:

* Predicted probability of remaining alive and on the ventilator on ICU day 7 is less than 50%
* Liberation from mechanical ventilation is expected/planned within 24 hours
* High cervical spine injury (C5 or higher)
* Receiving mechanical ventilation for neuromuscular disease
* Acute exacerbation of an obstructive lung disease
* Known esophageal varices or any other condition for which the attending physician deems an orogastric catheter to be unsafe
* Esophageal, gastric or duodenal surgical procedures within the last 6 months
* Received mechanical ventilation for \> 48 hours in the preceding 6 months
The Use of Nomegestrol Acetate/Estradiol in Random Start Rapid Endometrial Preparation

The presence of a thin endometrium plays an important role in enabling the best conditions for hysteroscopic surgery. Recently, for this purpose, many studies have evaluated the effect of preoperative administration of a variety of drugs. We explored the efficacy of random started 14-day administration of Nomegestrol Acetate/Estradiol, in rapid preparation of endometrium for hysteroscopic polypectomy.


Eligibility Criteria:
Inclusion Criteria:

* Patients with endometrial polyps.

Exclusion Criteria:

* Patients with other endometrial pathologies.
COLON-MD: Colon Cancer Longitudinal Study

The goal of this proposal is to identify how the composition of the gut microbiome and diet interact to impact chemotherapy-induced diarrhea incidence and severity.

In this longitudinal observational study patients will supply samples of their gut microbiome prior to scheduled colonoscopy or surgery along with dietary intake and blood samples; the relative abundance of microbes from those samples along with dietary data will be used to predict the presence or absence and severity of chemotherapy-induced diarrhea. Microbiome and diet based predictions from blinded samples will be combined to map the diet-microbiome changes during treatment to the changes in immune markers and risk of chemotherapy-induced diarrhea.

Eligibility Criteria:
Inclusion Criteria:

* Colon cancer diagnosis
* Age \>18 and \< or equal to 79.
* Ability to perform informed consent
* FOLFOX treatment expected

Exclusion Criteria:

* Not Pregnant
* Does not have Lynch syndrome or FAP diagnosis.
* Inability to perform inform consent
* inability to comply with follow up program
* history of prior colon cancer diagnosis
* previous treatment with antibiotics in the last month.
* previous bowel resection.
Effectiveness, Safety, and Tolerability Study of Oxymorphone Immediate Release (IR) Oral Liquid in Opioid Tolerant Pediatric Subjects

The purpose of this study is to evaluate the effectiveness, tolerability, and safety of oxymorphone immediate release (IR) oral liquid as an analgesic in pediatric subjects having severe to moderate chronic pain.


Eligibility Criteria:
Inclusion Criteria:

1. Males or females 2 to ≤6 years of age, inclusive
2. Chronic cancer or non-cancer pain, currently requiring treatment of pain with a strong opioid for at least 5 days (3 of 5 days at a dose \>1 mg/kg qd oral morphine equivalent)
3. Expected to continue to require a strong opioid for pain relief for at least 4 months
4. Able to swallow the oxymorphone HCl immediate-release oral liquid
5. Have been informed of the nature of the study and informed consent and assent by minor (if IRB required) has been obtained from the legally responsible parent/legal guardian in accordance with IRB requirements

Exclusion Criteria:

1. Known allergy to, or a significant reaction to, oxymorphone or another opioid
2. Life expectancy \<4 months
3. Any clinical condition in the investigator's opinion that would preclude participation
4. Plan to undergo a surgical procedure within 1 month of study entry or anytime during study
5. Currently prescribed a long-acting opioid (eg., Kadian® morphine sulfate extended release) as part of their analgesic regimen
6. Received any investigational medication within 30 days prior to the first dose of study medication, or are scheduled to receive an investigational drug other than oxymorphone during the course of the study
7. An ileostomy
8. Received a monoamine oxidase inhibitor (MAOI) within 14 days prior to the start of study medication
9. Investigator anticipates that the subject would be unable to comply with the protocol
10. Parent/legal guardian is unable to complete the subject's daily study medication diary
11. Parent/legal guardian is unable to effectively communicate the subject's status to the investigator
Buprenorphine Detox With Two Types of Treatment. BBD I - 10

The purpose of this study is to compare overall treatment outcome between behavioral versus standard treatment types.


Eligibility Criteria:
Please contact site for information.
Gene Polymorphism of Taste Receptors and Circulating Endocannabinoids in Normal Weight and Obese Subjects

The study aims at evaluating in normal weight and obese subjects those factors such as taste sensitivity and circulating endocannabinoids in influencing dietary choice and thereby lipid and energy metabolism in order to design personalized nutritional strategies.


Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index (BMI), range for normal weight subjects 17.5-24.95, for obese subjects 29.6-52.20
* No intake of nutritional supplements for at least six months before the trial

Exclusion Criteria:

* major diseases (diabetes, kidney disease, etc.),
* pregnancy or lactation;
* food allergies;
* the use of medications that interfere with taste or smell (e.g., steroids, antihistamines, certain antidepressants).
Immune Responses to Antigens in Non-infectious Eye Inflammatory Diseases

This study will collect blood samples from patients with non-infectious eye inflammatory diseases a spectrum of eye disorders that can produce sight-threatening vision loss. The blood will be analyzed for substances that may provide a better understanding of the nature of these disorders, possibly leading to improved treatments. Treatment is not offered under this protocol.

Patients 6 years of age and older with an eye inflammatory disease, including non-infectious uveitis, ocular cicatricial pemphigoid, non-infectious scleritis, episcleritis, Stevens Johnson syndrome, Moorens ulcer, peripheral ulcerative keratitis and keratoconjunctivitis sicca, may be eligible for this study. Patients may or may not currently be participating in a treatment trial.

Participants will have blood drawn through a needle in an arm vein. More samples may be collected if patients enrolled in another study are scheduled for additional visits. No more than 4 teaspoonfuls of blood will be collected at any one time.

Ocular inflammatory diseases can lead to visual loss in adults as well as in children. These conditions are usually characterized by repeated exacerbations and remissions. The underlying cause of majority of these conditions is not clear even though an autoimmune mechanism has been implicated. Various studies have reported an altered immunological profile in these patients. An underlying immune mechanism has been thought to be playing a role in at least some of the ocular inflammatory diseases. In addition, evidence from literature also suggests inflammatory disease may be an important mechanism leading to Age related macular degeneration and Diabetic retinopathy, two leading causes for vision loss. However, very little is known about the involvement of immune components in these patients.

This protocol proposes to test for proliferative cell mediated and humoral responses against self-antigens from patients with ocular inflammatory diseases, AMD and diabetic retinopathy. Patients will be recruited from other ongoing protocols. An attempt would be made to find any correlation between the clinical disease and the immunological findings. These findings will not be used for diagnostic nor therapeutic purposes.

Eligibility Criteria:
* INCLUSION CRITERIA:

  1. Participant is 6 years or older.
  2. Adult participant is able to understand and sign the informed consent. If the participant is younger than 18 years of age at enrollment, has a parent or legal guardian who is able to understand and sign the consent on their behalf. Children must provide assent.
  3. Patients must have a diagnosis of an ocular inflammatory disease, AMD or diabetic retinopathy.

EXCLUSION CRITERIA:

1. The presence of non-ocular inflammatory disease.
2. Unwilling or unable to provide a blood sample.
A Prospective Cohort for ex Vivo Cure Studies With Chronic HIV Infected Patients in the Netherlands

A prospective non-interventional cohort study at Erasmus MC of adult chronic HIV infected patients of ≥18 years of age who initiate antiretroviral therapy in routine care.

HIV cannot be cured with the current treatment armamentarium. A reservoir of latently HIV infected long lived CD4+T-cells is present in patients with HIV that are not affected by antiretroviral therapy. The evolution of this reservoir after therapy initiation is ill understood, as are the potential strategies to eradicate this reservoir. This study aims to anticipate on future HIV cure strategies by building a cohort to study ex vivo the reservoirs of HIV patients, the obstacles to cure HIV, and new therapeutic compounds and strategies.

Main study parameters/endpoints:

1. Change in viral reservoir size after antiretroviral treatment initiation.
2. Evolution of phenotypical and functional aspects of the anti-HIV host immune responses.
3. Ex vivo activity of established and novel HIV latency reversing agents.
4. Variance in HIV reservoir and host immunity between HIV subtypes and clinical variables.

A project from the Erasmus MC HIV Eradication Group (EHEG).

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years.
* Confirmed HIV-1 or HIV-2 infection
* Judged willing to initiate and adhere to cART by the HIV physician.

Exclusion Criteria:

* Inability to place venous catheters to draw blood.
* Major comorbidities:

  1. Severe symptomatic anemia or recent symptomatic cardiovascular event (un-stable angina pectoris, decompensated heart failure, myocardial infarction).
  2. The inability to participate due to any other relevant social, environmental,psychological, factors or according to the HIV treating physician's judgement.