cyrilzakka/clinical-trials huggingface dataset:
Study to Assess In-home Use of Evolocumab (AMG 145) Using a Prefilled Syringe or a Prefilled Autoinjector/Pen

The primary objective of this study was to assess users' ability to administer a full dose of evolocumab in home-use using either a pre-filled syringe or autoinjector/pen.


Eligibility Criteria:
Inclusion Criteria:

* Fasting LDL-C at screening \> 85 mg/dL
* Fasting triglycerides less than or equal to 400 mg/dL (4.5 mmol/L) Exclusion Criteria:
* New York Heart Association (NYHA) III or IV heart failure
* Uncontrolled cardiac arrhythmia
* Uncontrolled hypertension
* Type 1 diabetes or poorly controlled type 2 diabetes
* Uncontrolled hypothyroidism or hyperthyroidism
Navigator Guided e-Psychoeducational Intervention

The purpose of this study is to evaluate the impact of providing newly diagnosed prostate cancer patients and their caregivers with an interactive mobile tablet technology-based application delivered by a community navigator versus providing National Cancer Institute (NCI) information booklets delivered by a Community Navigator (CN) on patient outcomes (decisional satisfaction, quality of life, knowledge, decisional conflict) and shared decision making practices (decision making involvement).


Eligibility Criteria:
Inclusion Criteria:

* Men newly diagnosed (within 6 months) with biopsy confirmed case of prostate cancer
* 40 - 80 years of age
* Able to speak and read English
* Live within 120 miles of a healthcare treatment facility
* Have no documented or observable visual, auditory, psychiatric, or neurological disorders that would interfere with study participation
* Be able to complete telephone interviews
* Have not completed the first course of treatment
* Have a family member/caregiver willing to participate
* Capable of providing written consent for study participation. Men diagnosed with early stage, locally advanced or metastatic disease or men who are on active surveillance will be eligible to participate in this study.
* Caregiver must be aged 18 or older
* Caregiver must be identified by patient as their caregiver (i.e., provider of emotional and/or physical care)
* Caregiver must have not been diagnosed with cancer in the previous year or be receiving cancer treatment
Experience of the Father Following the Announcement of a First Pregnancy

Experience of the father following the announcement of a first pregnancy Its context, immediate reactions and actions. Possible impact of this moment of life a few months or years later?


Eligibility Criteria:
Inclusion Criteria:

- Male having been the father of at least one pregnancy whatever the outcome (pregnancy pursued, or abortion)

Exclusion Criteria:

* Patients with severe or neurological psychiatric disorders inducing significant cognitive impairment
* Patients who do not master the French language
* Patients who cannot give free and informed consent (guardianship, curatorship, safeguard of justice ...)
Device Study to Evaluate the Detection and Characterization of Middle Ear Fluid in Children

The study has three objectives:

1. To determine if the device can detect if middle ear fluid is present in children who are scheduled for tube placement (myringotomy)
2. If fluid is present to characterize the fluid as thick or thin
3. Evaluate the safety of the device


Eligibility Criteria:
Inclusion Criteria:

* 6 months to 17 years
* scheduled to undergo myringotomy procedure

Exclusion Criteria:

* mastoiditis
* tympanostomy tubes
* chronic middle ear disease
* otitis externa
* perforations of the middle ear
* use of antibiotic ear drops within 2 days of surgery
* systemic antibiotic use
Tiotropium Induced Bronchodilation in Lung CT Scored Emphysema

To evaluate if tiotropium (Spiriva)induced bronchodilation of inspiratory capacity in patients with moderate to severe copd subjected to metronome paced hyperventilation induced dynamic hyperinflation is dependent upon the extent of underlying emphysema as determined by high resolution-thin section CT lung.

We will analyze post hoc, data that was previously published: Gelb AF et al.Chest 2006;131:690-695. We have shown that tiotropium increases resting inspiratory capacity thereby providing lung volume protection against metronome paced hyperventilation induced dynamic hyperinflation. End point will be to correlate increase in tiotropium induced FEV 1(L) and inspiratory capacity with extent of underlying emphysema as scored by lung CT ( Gelb AF et al:Chest 1996; 109: 353-359)in 29 patients with COPD. We will also correlate the decrease in inspiratory capacity following metronome paced hyperventilation induced dynamic hyperinflation with extent of lung CT scored emphysema.

Eligibility Criteria:
Inclusion Criteria

* moderate to severe copd

Exclusion Criteria

* unable to tolerate tiotropium
* unable to perform metronome paced hyperventilation induced dynamic hyperinflation
Meaning-Centered Pain Coping Skills Training for Cancer Pain

This study is a randomized controlled trial of a psychosocial pain management intervention called, Meaning-Centered Pain Coping Skills Training (MCPC). Patients with advanced solid tumor cancer and pain interference (N=210) will be randomized to MCPC or a standard care control condition. Patient-reported outcomes will be assessed at baseline and 8- and 12-week follow-ups. The risk and safety issues in this trial are low and limited to those common to a psychosocial intervention (e.g., loss of confidentiality).

Many patients with advanced cancer describe pain as a debilitating symptom that greatly interferes with activities they care about. Psychosocial interventions show promise for improving cancer-related pain; however, there is a lack of interventions that address existential and spiritual concerns (e.g., a loss of meaning, purpose, and peace) that are common among those facing high levels of pain interference from advanced cancer.

To address this need, an intervention called Meaning-Centered Pain Coping Skills Training (MCPC) was developed. In this trial, the investigators will randomize 210 patients to MCPC or enhanced usual care control. Patient-reported outcomes will be assessed at baseline and 8- and 12-weeks after baseline. As in the investigators' extensive pilot work, MCPC's four 45-to-60 minute individual weekly sessions will be delivered by trained study therapists via an accessible videoconference format. Intervention sessions focus on training participants in evidence-based cognitive-behavioral skills, such as guided imagery and activity pacing. Emphasis is placed on using skills to reduce the degree to which pain interferes with participants' sense of meaning, purpose, and peace.

The first aim of this trial is to determine the efficacy of MCPC for reducing the primary outcome of pain interference at 8-weeks. The second aim is to determine the efficacy of MCPC for improving secondary outcomes at 8-weeks. The third aim is to test the maintenance of MCPC's effects on primary and secondary outcomes at 12-weeks. The fourth aim is to estimate the cost-effectiveness of implementing MCPC.

Eligibility Criteria:
Inclusion Criteria:

* Stage IV solid tumor cancer diagnosis
* Eastern Cooperative Oncology Group (ECOG) performance status of 2 or lower
* At least one clinical pain severity rating \> 0 out of 10 in past month
* At least moderate pain interference (8-item Patient-Reported Outcomes Measurement Information System \[PROMIS\] Pain Interference T-score \>/= 55) in the past week at telephone screening
* Ability to speak and read in English
* Age \>/= 18 years.

Exclusion Criteria:

* Significant cognitive impairment as indicated in medical chart or during telephone screening
* Serious untreated mental illness
* Primary brain cancer diagnosis
* Previous engagement in Pain Coping Skills Training or Meaning-Centered Psychotherapy
* Enrollment in hospice at screening
Celebrex - Cervix: Celecoxib in the Treatment of Patients With Locally Advanced Carcinoma of the Cervix

This is a phase I/II study to evaluate the safety and toxicity of celecoxib in combination with standard concurrent cisplatin and radiotherapy in women with locally advanced cervix cancer. In addition, we aim to determine the effect of celecoxib (Celebrex) on tumour oxygenation, interstitial fluid pressure, COX-2 levels, prostaglandin E2 levels, angiogenesis and apoptosis.


Eligibility Criteria:
Inclusion Criteria:

* Biopsy-proven carcinoma of the cervix, with visible/palpable tumours; FIGO stage T1B-3B, NO/1, MO, to be treated with definitive radiotherapy and chemotherapy
* ECOG performance status of 0, 1, or 2
* Adequate hematologic function; Granulocyte count greater than 1.5 x 109/L, Platelet count greater than 100 x 109/L
* Adequate organ function; Serum creatinine £ 1.25 x ULN, or a calculated creatinine clearance ³ 50 mL/min, Serum bilirubin £ 1.25 x ULN and AST/ALT £ 3xULN
* No prior treatment for cervix cancer
* Informed consent

Exclusion Criteria:

* Use of an NSAID in the 2 weeks prior to study enrollment
* Patients with an active malignancy at another site
* Patients with significant cardiac, renal, or pulmonary disease or any other medical conditions that may preclude radical therapy
* Patients who have significant history of ischaemic heart disease or stroke who would be deemed not suitable for cessation of their daily prophylactic aspirin
* Patients with history of peptic ulcer disease or previous NSAID related gastrointestinal bleeding
* Patients with hypersensitivity to NSAIDS or celecoxib, or sulfonamides
* Patients who unwilling or unable to give informed consent
The Effect of a Curriculum-based Physical Activity Intervention on Physical Activity in Schoolchildren

A non-randomised mixed methods controlled before-and-after study. The study evaluated the effects of a classroom-based physical activity intervention in primary school children on physical activity. Two schools were allocated to deliver the classroom-based intervention for eight weeks, and three schools continued with their usual school routine.

The primary aim of this study was to test the feasibility and potential effect of a classroom-based, curriculum-embedded intervention - ExCiTE; Exercise Classes in the Teaching Environment- on total physical activity and moderate to vigorous physical activity. The secondary aim was to measure and describe health-related quality of life and physical fitness components, and to gain understanding of the experiences, views and attitudes towards the ExCiTE intervention among participating children and schoolteachers.

Eligibility Criteria:
Inclusion Criteria:

* Parental Consent
* Child Assent

Exclusion Criteria:

* Respiratory infections; or.

  * Condition of injury affecting child's ability to undertake exercise
  * Allergic to sticky tape
Cervical/Thoracic Neuromodulation and Nociceptive Processing

Several studies have demonstrated that direct currents delivered through the skin at the level of the low-thoracic spinal cord can influence spinal cord function. In human volunteers, anodal low-thoracic transcutaneous spinal direct current stimulation (tsDCS) alters spinal processing of nociceptive inputs. Whether cervical tsDCS is able to do the same is less well known. In this double-blinded, sham-controlled and cross-over trial, the investigators will compare the effects on the nociceptive processing of healthy volunteers of cervical and low-thoracic tsDCS.

The investigators will compare the effects on the nociceptive processing of healthy volunteers of cervical and low-thoracic tsDCS. This study will be a double-blinded, sham-controlled, cross-over trial. Each participant will undergo three experimental sessions (anodal cervical tsDCS and sham thoracic tsDCS vs. sham cervical tsDCS and anodal thoracic tsDCS vs. sham cervical tsDCS and sham thoracic tsDCS), separated by at least one week.

Eligibility Criteria:
Inclusion Criteria:

Healthy young adults

Exclusion Criteria:

* Known medical conditions (e.g., diabetes, neuropathy, psychiatric disorders, seizure, migraine, pacemaker or other implanted medical devices...)
* Use of any medication (except contraception)
Molecular Characterization for Understanding Biliary Atresia

Although considered a rare disease, Biliary Atresia (BA) is the leading cause of neonatal cholestasis and liver transplantation in children. Little is known about the molecular mechanisms that drive BA. The purpose of this study is to collect the fluid samples, explanted liver tissue samples and dermal biopsy samples to enable investigators to perform the genetic and molecular analyses that might point to the gene(s) and cellular pathway involved in etiology of BA disease.

Biliary atresia (BA) is a disease characterized by intra- and extra-hepatic bile duct obstruction diagnosed in the neonatal period. If left untreated, this obstruction leads to biliary cirrhosis and early death. Although considered a rare disease (between 1/15,000 and 1/20000 births), it is the leading cause of neonatal cholestasis and liver transplantation in children. The reasons for this obstruction are still poorly known and might involve several factors (immune, infectious and possible toxin effect). The accumulating evidence point to genetic factors involved, yet they are not of the classic monogenic or Mendelian types. The purpose of this study is to collect the fluid samples, explanted liver tissue samples and dermal biopsy samples to enable investigators to perform the genetic and molecular analyses that might point to the gene(s) and cellular pathway involved in etiology of BA disease.

Eligibility Criteria:
Inclusion Criteria:

* confirmed diagnosis of biliary atresia in patients
* parents of BA patients

Exclusion Criteria:

* no
Pre-operative Epirubicin, Cisplatin, and Capecitabine in Patients With Newly Diagnosed Localised Oesophageal Adenocarcinoma

To investigate the efficacy and safety of epirubicin, cisplatin and capecitabine as neoadjuvant therapy prior to radical resection in patients with newly diagnosed operable oesophageal adenocarcinoma.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years.
* Histologically verified adenocarcinoma of the thoracic oesophagus or type 1, 2 and 3 tumours of the oesophagogastric junction (type 1 refers to lower oesophageal, type 2 refers to cardial and type 3 refers to subcardinal cancers).
* AJCC Stage II-III (T2-3 N0-1 M0) (28), as assessed by spiral or multi-slice CT and endoscopic ultrasound, where primary surgery would be considered with curative intent.
* No previous chemotherapy, radiotherapy or other investigational drug treatment for this indication.
* WHO performance status 0,1 or 2.
* Adequate bone marrow function with platelets \> 100 x 109/l; WBC \> 3 x 109/l; neutrophils \> 1.5 x 109/l at the time of study entry.
* Serum bilirubin \< 35 mol/l.
* Serum creatinine \< 180 mol/l and measured creatinine clearance over 60ml/min.
* No concurrent uncontrolled medical condition.
* No previous malignant disease other than non-melanotic skin cancer or carcinoma in situ of the uterine cervix in the last 10 years.
* Life expectancy \> 3 months.
* Adequate contraceptive precautions if relevant.
* Informed written consent.

Exclusion Criteria:

* The presence of locally advanced or metastatic disease precluding curative surgical resection (T4 or Stage IV or M1a-b)
* Total dysphagia (O'Rourke's swallowing function scoring system 5) precluding swallowing of capecitabine even when crushed
* Medical or psychiatric conditions that compromise the patient's ability to give informed consent.
* Patients with disease in any of the following areas on the basis of CT scan and/or endoscopic ultrasound:

  * Evidence of liver, lung or other distant metastases
  * Para-aortic/coeliac lymphadenopathy \> 1cm diameter on CT, \> 6mm diameter on EUS
  * Invasion of airways, aorta, pericardium, or lung
* New York Heart Association classification Grade III or IV.
* Uncontrolled angina pectoris.
* Pregnancy or breast feeding.
* Impaired renal function with measured creatinine clearance less than 60 ml/min.
* Known malabsorption syndromes.
* Patients with a known hypersensitivity to 5-FU or with a dihydropyrimidine dehydrogenase (DPD) deficiency.
Cladribine Plus Pegylated Interpheron Alfa-2a in Systemic Mastocytosis

The aim of this study is to evaluate the efficacy in terms of clinical and biological response rates of Cladribine plus Pegylated Interpheron alpha-2a therapy in patients with advanced systemic mastocytosis carrying D816V or other exon 17 KIT mutations.


Eligibility Criteria:
Inclusion Criteria:

* Age older than 18 years.
* Diagnosis of advanced systemic mastocytosis (aggressive systemic mastocytosis or proggressing systemic mastocytosis) with D816V or other exon 17 KIT mutations.
* ECOG ≤ 3.
* Signed informed consent.

Exclusion Criteria:

* Impaired liver function (total bilirubin ≥ 2.0 mg/dl, AST or ALT \> 3 x upper limit of normal)not related to mastocytosis.
* Impaired renal function (≥ 2.0 mg/dL)not related to mastocytosis.
* Grade III-IV cytopenias not related to mastocytosis. Severe cardiopathy (grade III/IV of NYHA, or left ventricular ejection fraction \< 50%).
* Pregnancy or breastfeeding.
* Female patients who do not use contraceptive methods.
Improving Short Course Treatment for Common Pediatric Infections

Randomized quality improvement trial to improve the proportion of cases of community-acquired pneumonia (CAP) treated with no more than 5 days of antibiotics the proportion of cases of skin and soft tissue infections (SSTI) treated with no more than 7 days of antibiotics by primary care clinicians (PCC) within the Pediatric Physicians' Organization at Children's (PPOC), a state-wide pediatric primary care network. Interventions include education and feedback; clinical decision support (CDS) delivered at the point of care; and the combination of the two.


Eligibility Criteria:
INCLUSION CRITERIA

* Primary care clinician practicing within a PPOC primary care pediatric practice
* Treated at least one case of pneumonia or skin and soft tissue infection in calendar year 2022

EXCLUSION CRITERIA

-None
Laparoscopic Versus Open Devascularization for Portal Hypertension, a Randomized Controlled Trial

Many patients with portal hypertension require surgical treatment each year,and Hassab's operation, or esophagogastric devascularization and splenectomy, is an elective procedure. In recent years,laparoscopic esophagogastric devascularization and splenectomy has been used to treat portal hypertension. However, the potential benefits remain to be demonstrated in the context of a randomized trial. In this study, 120 patients will randomize equally receiving laparoscopic or open esophagogastric devascularization and splenectomy. Inclusion criteria included: platelet count \< 50×109/ml, esophageal and gastric varices revealed, agreeing the informed consent. PerioperativeOutcomes are: technical success, blood loose and infusion during the operation, recurrent varicose veins on gastroscopy examination, patterns of reflux on duplex ultrasound examination, complications, platelet and liver function variation, length of hospital stay. Follow-up will last 5 years, and gastroscopy and ultrasonic will perform at 3 months, 1 year, 3 years, and 5 years. Further more, this study was proved by the ethical committee of second hospital of Xi'an jiaotong university.


Eligibility Criteria:
Inclusion Criteria:

* The cause of portal hypertension was cirrhosis
* Platelet count \< 50×109/ml
* Esophageal and gastric varices revealed
* Agreeing the informed consent.

Exclusion Criteria:

* Thrombosis present in portal vein preoperatively
* Accompany with liver cancer
* Operation procedure is laparoscopy converse to open
* Patients disagree with the study.
A Study to Assess Immunization Responses in Adult and Adolescent Participants With Moderate-to-Severe Atopic Dermatitis Treated With Nemolizumab

The purpose of this study is to assess the effect of nemolizumab (CD14152) on humoral immune responses to tetanus and meningococcal vaccination in adult and adolescent participants with moderate-to-severe atopic dermatitis (AD).

This is a randomized, double-blind, placebo-controlled, multi-center, parallel-group study in adult and adolescent subjects (≥ 12 to 54 years) with moderate-to-severe AD. Eligible subjects must have a documented history of inadequate response to topical AD medication(s). Approximately 200 subjects will be randomized 1:1 to receive either 30 mg nemolizumab (with a 60 mg loading dose) or placebo, stratified by baseline disease severity (IGA = 3, moderate; IGA = 4, severe). The study consists of a 2- to 4-week screening period, a 16-week treatment period, and an 8-week follow-up period (12 weeks after the last study drug injection).

Eligibility Criteria:
Inclusion Criteria:

* Chronic AD for at least 2 years
* EASI score \>= 16
* IGA score \>= 3
* AD involvement \>= 10% of BSA
* Peak (maximum) pruritus NRS score of at least 4.0

Exclusion Criteria:

* Body weight \< 30 kilogram (kg)
* History of hypersensitivity (including anaphylaxis) to an immunoglobulin product (plasma-derived or recombinant, eg, monoclonal antibody) or to any of the study drug excipients
* History of severe allergic reaction to either vaccine or to vaccine components including alum, thimerosal, phenol
* Participants for whom administration of the meningococcal vaccine provided in this study is contraindicated or medically inadvisable
* Participants for whom administration of the tetanus, diphtheria, and pertussis vaccine provided in this study is contraindicated or medically inadvisable
* Receipt of any vaccine (except inactivated influenza vaccine) within 12 weeks prior to screening, any meningococcal vaccine within 1 year prior to screening, or any tetanus-, diphtheria-, or pertussis-containing vaccine within 5 years prior to screening
Regulatory Post Marketing Surveillance Study on Nexavar®

This surveillance are to identify problems/questions regarding adverse events, factors that are considered to affect on safety and efficacy in the clinical practice of using Nexavar

The objectives of this surveillance are to identify problems/questions regarding the followings in the clinical practice of using Nexavar®.

1. Unknown adverse events (in particular, serious adverse events)
2. Identification of adverse events occurred in the real practice.
3. Factors that are considered to affect on safety.
4. Factors that are considered to affect on effectiveness

Eligibility Criteria:
Inclusion Criteria:

* Patients with diagnosis of advanced RCC or HCC and decision taken by the physician to prescribe Nexavar.

Exclusion Criteria:

* Exclusion criteria must be read in conjunction with the local product information but patients who are participating in other interventional studies currently will be excluded.