cyrilzakka/clinical-trials huggingface dataset:
Cognitive Functional Therapy for Treating Individuals With Chronic Shoulder Pain

Shoulder pain is a debilitating musculoskeletal condition with functional, physical, and psychological impacts. Interventions for chronic shoulder pain should address the biopsychosocial model, with Cognitive Functional Therapy emerging as a promising physiotherapy approach. Cognitive Functional Therapy approaches the multidimensional nature of pain, integrating physical and cognitive aspects.

The aim of this randomized controlled trial is to compare the effects of Cognitive Functional Therapy with therapeutic exercise on biological aspects of pain (pain intensity, disability, function, perception of improvement/deterioration, and central pain processing), and psychosocial aspects of pain (sleep quality, self-efficacy, and biopsychosocial factors). The hypothesis of this study is that CFT will lead to greater improvements in these outcomes compared to therapeutic exercise.

This will be a randomized controlled trial, single-blinded with two parallel groups. Seventy-two individuals with chronic shoulder pain will be randomly assigned to one of two groups: CFT or Therapeutic exercises. The interventions will last eight weeks, with the CFT group receiving therapy once a week and the therapeutic exercise group receiving sessions twice weekly. The primary outcomes will be pain intensity and disability, while the secondary outcomes will include function, self-efficacy, sleep quality, biopsychosocial factors, perception of improvement/deterioration, and central pain processing.

Eligibility Criteria:
Inclusion Criteria:

* Men or women;
* Age between 18 and 60 years;
* Presence of shoulder pain for more than 3 months;
* Pain intensity of 4 points or more on the 11-point Numeric Pain Rating Scale.
* High level of disability or moderate level of irritability.

Exclusion Criteria:

* History of fracture or surgery of the clavicle, scapula, and/or humerus, surgical stabilization or rotator cuff repair;
* History of dislocation, instability (positive sulcus sign or apprehension test), and/or rotator cuff tear (positive drop arm test);
* Adhesive capsulitis verified by the presence of gradual onset pain associated with stiffness and reduced passive and active mobility;
* Ongoing pregnancy;
* Reproduction of shoulder pain radiating to the entire upper limb during cervical or thoracic spine tests (positive Spurling test);
* Neurological or systemic diseases that may alter muscle strength and sensitivity such as rheumatoid arthritis, fibromyalgia, lupus, gout, and diabetes;
* Corticosteroid injection in the shoulder region in the last 3 months;
* Physiotherapy treatment in the last 6 months.
* Active treatment for cancer
Single Ascending Dose Study of PRX003 in Healthy Subjects

This single ascending dose study is to determine safety, tolerability, pharmacokinetics and immunogenicity of PRX003 in approximately 40 healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects
* Body mass index (BMI) between 18-32 kg/m2 with a minimum weight of 45 kg
* Female subjects must be surgically sterile or post-menopausal or if of child-bearing potential must use contraception
* Male subjects and their partners of childbearing potential must use contraception

Exclusion Criteria:

* Positive test for drug of abuse
* Past or current history of alcohol abuse
* Positive for TB, hepatitis B, hepatitis C or HIV infection
Study to Investigate the Efficacy and Safety of Dupilumab Administered With Topical Corticosteroids (TCS) in Participants ≥6 to <12 Years With Severe Atopic Dermatitis (AD)

The main objective of the trial is to demonstrate the efficacy of dupilumab administered concomitantly with topical corticosteroids (TCS) in participants ≥6 years to \<12 years of age with severe atopic dermatitis (AD).

The secondary objective is to assess the safety of dupilumab administered concomitantly with TCS in patients ≥6 years to \<12 years of age with severe AD.


Eligibility Criteria:
Key Inclusion Criteria:

1. Diagnosis of AD according to the American Academy of Dermatology consensus criteria (Eichenfield 2003) at screening visit
2. Chronic AD diagnosed at least 1 year prior to the screening visit
3. IGA = 4 at screening and baseline visits
4. EASI ≥21 at the screening and baseline visits
5. BSA ≥15% at screening and baseline visits
6. Documented recent history (within 6 months before the baseline visit) of inadequate response to topical AD medication(s)
7. At least 11 (of a total of 14) applications of a stable dose of topical emollient (moisturizer) twice daily during the 7 consecutive days immediately before the baseline visit

Key Exclusion Criteria:

1. Participation in a prior dupilumab clinical study
2. Treatment with a systemic investigational drug before the baseline visit
3. Treatment with a topical investigational drug within 2 weeks prior to the baseline visit
4. Treatment with crisabarole within 2 weeks prior to the baseline visit
5. History of important side effects of medium potency topical corticosteroids (e.g, intolerance to treatment, hypersensitivity reactions, significant skin atrophy, systemic effects), as assessed by the investigator or patient's treating physician
6. Treatment with a topical calcineurin inhibitor (TCI) within 2 weeks prior to the baseline visit
7. Having used any of the following treatments within 4 weeks before the baseline visit, or any condition that, in the opinion of the investigator, is likely to require such treatment(s) during the first 4 weeks of study treatment:

   1. Immunosuppressive/immunomodulating drugs (e.g, systemic corticosteroids, cyclosporine, mycophenolate-mofetil, interferon gamma, Janus kinase inhibitors, azathioprine, methotrexate, etc.)
   2. Phototherapy for AD
8. Treatment with biologics, as follows:

   1. Any cell-depleting agents including but not limited to rituximab:

      within 6 months before the baseline visit, or until lymphocyte and CD 19+ lymphocyte count returns to normal, whichever is longer
   2. Other biologics: within 5 half-lives (if known) or 16 weeks before the baseline visit, whichever is longer
9. Treatment with a live (attenuated) vaccine within 4 weeks before the baseline visit
10. Body weight \<15 kg at baseline

Note: Other Inclusion/ Exclusion criteria apply
RCT Comparing Avatar Intervention to Supportive Intervention to Reduce Cannabis Use in Patients With Psychotic Disorders

The goal of this clinical trial is to conduct a single-blind randomized controlled trial to verify whether the Avatar Intervention has greater efficacy over supportive intervention to reduce cannabis use in patients with psychotic disorders.

Psychotic disorders (PD) are characterized by a loss of contact with reality. Cannabis use is one of the key factors leading to psychiatric re-hospitalization in PD. In these populations, cannabis use is also associated with depressive symptoms, medication non-compliance, hostility as well as reduced quality of life. Unfortunately, there is no evidence-based intervention available for the treatment of cannabis use disorder (CUD) in this population. Novel interventions for CUD are thus critically needed. Virtual reality-based therapies are a promising avenue that allow patients to try novel strategies in real time instead of having to learn abstract rules. To fill a clinical need, the investigators have created a distinctive intervention for CUD in patients with PD. The Avatar Intervention displays strong experiential and relational components that are crucially missing in conventional interventions.

Hence, the primary outcomes are reductions in cannabis use, cannabis use disorder severity, and increased quality of life. The investigators will also explore whether the greater improvements attributable to the Avatar Intervention persist in time, and perform analyses on sex/gender, motivation to change cannabis habits, psychotic relapses, and THC metabolite levels.

Noteworthily, cannabis-related hospitalizations have been identified as one of the core indicators to measure the success of cannabis legalization. As a result, there is a pressing need to design innovative interventions that could have a significant impact on this costly and prime outcome. As there is no evidence-based therapeutic options for CUD in patients with PD, the current trial will contribute to the validation of a novel approach and create new therapeutic possibilities.

Eligibility Criteria:
Inclusion Criteria:

* Males or females over 18 years of age who meet the DSM-5 criteria for CUD (≥4 criteria) ;
* Patients will meet the DSM-5 criteria for schizophrenia, schizoaffective disorder, or bipolar disorder with psychotic symptoms. Diagnoses will be established with the Structured Interview for DSM-5 (SCID-5).

Exclusion Criteria:

* Current SUD for a substance other than cannabis ;
* Ongoing pharmacological or psychological treatment for CUD ;
* Ongoing detoxification for cannabis withdrawal ;
* Presence of neurological disorders ;
* Presence of a severe and unstable physical illness ;
* Inability to provide consent.
Serial Epstein-Barr Virus DNA Surveillance in Nasopharyngeal Carcinoma Patients

Endemic nasopharyngeal carcinoma (NPC) is invariably associated with Epstein-barr virus (EBV) infection. Plasma EBV DAN detected by polymerase chain reaction (PCR)-based assays can provide important informations of disease screening, disease relapse, and risks classification. In this study, the investigators will explore the impact of serial plasma EBV DNA during chemotherapy and radiotherapy on initial tumor response and long-term survival in patients with non-metastatic nasopharyngeal carcinoma


Eligibility Criteria:
Inclusion Criteria:

1. Patients with newly histologically confirmed non-keratinizing carcinoma (according to WHO histological type)
2. No evidence of distant metastasis (M0)
3. Receive standard radical treatment
4. Not exhibiting overt psychopathology, and willing to participate and written informed consent was obtained

Exclusion Criteria:

1. WHO type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma.
2. Treatment with palliative intent
3. Previous chemotherapy or radiotherapy (except non-melanomatous skin cancers outside the intended RT treatment volume)
4. Severe intercurrent disease
A Randomized Phase II Study of Oral Sapacitabine in Patients With Advanced Cutaneous T-cell Lymphoma

This is an open label, randomized phase II study designed to evaluate the tolerability and response rate of high-dose and low-dose regimens in patients with advanced cutaneous T-cell lymphoma (CTCL).

This is an open label, randomized phase II study designed to evaluate the tolerability and response rate of high-dose and low-dose regimens in patients with advanced cutaneous T-cell lymphoma (CTCL) who have had progressive, recurrent, or persistent disease on or following 2 systemic therapies.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients with advanced CTCL
* Have had at least 2 systemic therapies
* Must have evaluable disease
* Eastern Cooperative Oncology Group performance status 0-2
* Adequate bone marrow, hepatic and renal function
* At least 3 weeks from prior therapies
* Not receiving topical steroids or have been on a stable dose of topical steroids for at least 2 weeks
* Able to swallow capsules
* At least 3 weeks from major surgery
* Agree to practice effective contraception
* Able to understand and willing to sign the informed consent form

Exclusion Criteria:

* Receiving systemic steroids
* Receiving topical or systemic retinoids or vitamin A
* Receiving radiotherapy, biological therapy,or any other investigational agents
* Uncontrolled intercurrent illness
* Pregnant or lactating women
* Known to be HIV-positive
* Active hepatitis B and/or hepatitis C infection
Double Blind Randomized Trial of Saline vs Pentaspan for Resuscitation After Cardiac Surgery

This is a randomized double blind trial of the use of the use of colloids vs crystalloid solutions for resuscitation of patients after cardiac surgery. Patients are managed with an algorithm driven protocol that is based on the flow response to fluid challenges. The hypothesis is that the use of a colloid solution will result in less use of catecholamines at 8:00 the morning following surgery. Secondary end-points include total use of catecholamines, time in the ICU, return to the ICU, and safety issues including bleeding and renal function.


Eligibility Criteria:
Inclusion Criteria:

* status post cardiac surgery
* pulmonary artery occlusion catheter in place
* informed consent
* morning case (must be out of OR by 2:00 PM

Exclusion Criteria:

* excessive bleeding (\> 200 cc/hr)
* intraaortic balloon pump
* refusal by treating team
* emergency cases
* patients with known adverse reactions to starch solutions
Cost-effectiveness of Adalimumab and Surgery vs Adalimumab in HS

The primary objective of this randomized controlled clinical trial in a real life setting is to evaluate the cost-utility of limumab monotherapy compared with the combination of adalimumab and a maximum of three surgeries after two years of treatment in adult patients with moderate to severe HS.

The primary objective of this randomized controlled clinical trial in a real life setting is to evaluate the cost-utility of limumab monotherapy (Group A) with the combination of adalimumab and a maximum of three surgeries (Group B) years of treatment in adult patients with moderate to severe HS.

Patients in group A will be treated with adalimumab monotherapy according to normal clinical practice and will be given the possibility to crossover into Group B when they do not achieve the HiSCR after 6 months of treatment. Additionally patients will be offered treatment with infliximab, according to clinical practice, until the last surgery. Patients in group B will receive adalimumab combined with a maximum of three adjuvant excisions of active lesions, both according to routine clinical practice.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years.
* Moderate to (very) severe HS defined as a score of ≥3 points on the PGA (range 1-5) and with a DLQI of at least 11 (range 0-30).
* Indication for adalimumab: i.e. uncontrolled disease (HS) under conventional therapy and/or minor surgery.
* A diagnosis of HS for more than six months prior to baseline.
* Clearance of HS can reasonably be achieved with three surgical interventions as based on consensus between two dermatosurgeons.
* Willing and able to undergo general anaesthesia or procedural sedation and analgesia.
* Able and willing to give written informed consent and to comply with the study requirements.

Exclusion Criteria:

* Contraindication for treatment with adalimumab (sepsis or risk of sepsis, active or latent tuberculosis, serious active local and/or chronic infections, heart failure NYHA class III/IV, severe liver disease, pre-existing HIV, active viral hepatitis, demyelinating disease, or allergy to adalimumab or any other ingredients of HUMIRA®).
* Previous or current use of adalimumab or other anti-TNF-α therapy.
* Current or recurrent clinically significant skin condition in the HS treatment area other than HS.
* Presence of other uncontrolled clinically significant major disease.
* Pregnant and lactating women.
* Malignancy (except basal cell carcinoma), lymphoproliferative disease or a history of malignancy.
* Current use of oral antibiotics (a washout period of 14 days is required).
* Current use of oral corticosteroids (a washout period of 30 days is required).
Heating Precondition of Epidural Catheter Decrease the Incidence of Injury to Blood Vessel During Epidural Catheter Placement

To explore the effect of heating precondition of epidural catheter on the incidence of injury to blood vessel during epidural catheter placement.


Eligibility Criteria:
Inclusion Criteria:

* Elective cesarean delivery
* Epidural anesthesia.

Exclusion Criteria:

* blood coagulation disorders
The Dietary Intervention in e-Shopping Trial

The supermarket industry now services many customers through online food shopping over the Internet. The Internet shopping process offers a novel opportunity for the modification of dietary patterns. The aim of this study was to evaluate the effects on consumers' purchases of saturated fat of a fully automated computerised system that provided real-time, personally tailored advice recommending foods lower in saturated fat.

Objective The supermarket industry now services many customers through online food shopping over the Internet. The Internet shopping process offers a novel opportunity for the modification of dietary patterns. The aim of this study was to evaluate the effects on consumers' purchases of saturated fat of a fully automated computerised system that provided real-time, personally tailored advice recommending foods lower in saturated fat.

Design Blinded, randomized controlled trial.

Setting \& Participants Consumers using a commercial on-line Internet shopping site between February and June 2004.

Intervention Individuals assigned to intervention received fully automated individually tailored advice that recommended specific switches from selected products higher in saturated fat to alternate similar products lower in saturated fat. Participants assigned to control received general non-specific advice about how to eat a diet lower in saturated fat.

Outcome measure The percent of food purchased that was saturated fat. Results There were 497 randomised participants, mean age 40 each shopping for an average of about 3 people. The amount of saturated fat in the foods purchased by the intervention group was 0.66% lower (95% confidence interval 0.48-0.84, p\<0.0001) than in the control group. The effects of the intervention were sustained over time and there was no difference in the average cost of the food bought by each group.

Conclusions Fully automated, personally tailored dietary advice offered to customers doing Internet shopping can bring about changes in food purchasing habits that are likely to have significant public health implications. Because implementation is simple to initiate and maintain this strategy would likely be highly cost-effective.

Eligibility Criteria:
Inclusion Criteria:

- Consumers using a commercial on-line Internet shopping site between February and June 2004.

Exclusion Criteria:

Children, non-internet shoppers

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The Headache Inducing Effects of Cilostazol on Migraine Patients

We will use Cilostazol as a tool to investigate its headache inducing effects in migraine patients.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with migraine without aura according to the IHS criteria from 2004.
* Healthy besides migraine

Exclusion Criteria:

* Tension-type headache more than 3 days per month
* Other types of primary headaches
* Pregnancy
* History of vascular diseases or psychiatric diseases.
Peptide Vaccination With PD-L1 and PD-L2 Peptides in Untreated Chronic Lymphatic Leukemia.

This study is investigating the efficacy of PD-L1 and PD-L2 peptides in untreated CLL patients with unmutated IGHV gene status.

Chronic lymphocytic leukemia (CLL) is an incurable disease with the unmutated immunoglobulin heavy chain variable region (IGHV) gene status being an unfavorable prognostic marker. These patients have shorter time to first treatment which consist of toxic chemotherapy.

Programmed death ligand 1 (PD-L1) and programmed death ligand 2 (PD-L2) are immune checkpoints hampering immune responses in many tumors including CLL. These proteins are expressed by suppressive bystander cells as well as CLL cells. Vaccinating subcutaneously with PD-L1 and PD-L2 peptides mobilises cytoxic T-cells specific towards PD-L1 and PD-L2 expressing cells. In this study we investigate if the PD-L1 and PD-L2 specific responses can overcome leukemic cells in CLL.

Eligibility Criteria:
Inclusion Criteria:

* CLL according to national guidelines (Lymphoma.dk).
* Unmutated IGHV gene according to ERIC recommendations.(25)
* No prior CLL directed treatment
* Age ≥ 18
* Eastern cooperative oncology group (ECOG) performance status of 0 or 1
* No life-threatening conditions
* Adequate bone marrow function: Neutrophils \> 1,0 x 109/l; Platelets \> 100 x 109/l
* Adequate renal function: Glomeruli filtration rate (eGFR)/1,73 m2 \> 50 mL/min
* Adequate liver function: Aspartate Aminotransferase \< 100 U/L
* For fertile women: agreement to use contraceptive methods with a failure rate of \< 1% per year during the treatment period and for at least 120 days after the last treatment.
* For men: agreement to use contraceptive measures and agreement to refrain from donating sperm.

Exclusion Criteria:

* Other active malignant diseases requiring treatment.
* Significant medical condition per investigators judgement e.g. severe Asthma or chronic obstructive lung disease (COLD), poorly regulated heart condition, insulin dependent diabetes mellitus.
* Acute or chronic viral/bacterial infection e.g. human immunodeficiency virus (HIV), Cytomegalo virus (CMV), Epstein-barr virus (EBV), hepatitis or tuberculosis
* Serious known allergies or earlier anaphylactic reactions.
* Known sensibility towards Montanide ISA51
* Any active autoimmune diseases e.g. autoimmune neutropenia, thrombocytopenia or hemolytic anemia, systemic lupus erythematosus, scleroderma, myasthenia gravis, autoimmune glomerulonephritis, autoimmune adrenal deficiency, autoimmune thyroiditis etc.
* Pregnant and breastfeeding women.
* Fertile women not using secure contraception with a failure rate less than \< 1%
* Psychiatric disorders that according to the investigator could influence compliance.
* Treatment with other experimental drugs
Predicting Responsiveness in Oncology Patients Based on Host Response Evaluation During Anti Cancer Treatments

This study will develop an algorithm of identifying patients with stage IV NSCLC and Melanoma who could benefit from cancer treatment they receive.

The goal of this research study is to develop an algorithm that predicts the patient's treatment outcome.This algorithm will serve as a tool for physicians when making treatment decisions, specifically for stage IV NSCLC and malignant melanoma patients receiving anti-cancer treatments. The investigators also aim to identify the metabolic pathways that could lead to better therapeutic options. The patients will be given their treatment according to the institute's standard of care. The patients will provide two blood samples and clinical data will be collected from their medical records.

In the first part of the trial, the data obtained from the blood samples and the medical records of the patients will be used to develop the prediction algorithm, and in the second part of the trial, the algorithm will be validated by comparing the objective response rate of the patients to the theoretical response prediction of the algorithm.

Eligibility Criteria:
Inclusion Criteria:

* Cancer patients with stage IV NSCLC or stage IV malignant melanoma
* Patient must have at least one measurable lesion and the relevant images in order to enable assessment of response
* ECOG PS - 0/1-2
* Normal hematologic, renal and liver function:

  1. Absolute neutrophil count higher than 1500/mm3
  2. Platelets count higher than 100,000/mm3
  3. haemoglobin higher than 9 g/dL
  4. Creatinine concentration ≤1.4 mg/dL, or creatinine clearance higher than 40 mL/min
  5. Total bilirubin lower than 1.5 mg/dL, ALT and AST levels ≤ 3 times above the upper normal limit.

Exclusion Criteria:

* Concurrent and/or other active malignancy that has required systemic treatment within 2 years of first dose of study drug
* Generalized impairment or mental incompetence that would render the patient unable to understand his/her participation in the study.