cyrilzakka/clinical-trials huggingface dataset:
Feasibility Randomised-Controlled Trial of Online Stroke Interventions

Many people have difficulties organising their behaviour and problem-solving (also known as executive function difficulties) after stroke. This can have serious, wide-ranging consequences for wellbeing and ability to regain independence. Currently, access to psychological interventions after stroke varies and there is not enough evidence to recommend a specific intervention for executive function difficulties after stroke. A short intervention was designed to help with executive function difficulties by making it easier to set goals and achieve them after stroke. The intervention is designed for online delivery to make it accessible to as many stroke survivors as possible. The present trial aims to investigate the acceptability and feasibility of a single blinded randomized controlled trial of this online executive function intervention (active intervention) compared to an online stroke psychoeducation intervention (control intervention).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of stroke
* ≥ 18 years of age
* Capacitous consent to participate
* Access to a computer / tablet, the internet, and an email address

Exclusion Criteria:

* Another significant mental or physical health condition
* Current involvement in another research trial
* Severe depression (over 20 on PHQ-9)
* Not able to read or understand English
* Visual, auditory or motor difficulties of a severity that limit the ability to attend to the content of the interventions, read the Participant Information Sheet or complete the consent form and outcome measures
* Not registered with a GP or unwilling to provide GP information (for reporting suicidal ideation concerns
Target Engagement for Oxytocin: Dose Ranging Study

This study will evaluate the effect of 8 doses of intranasal oxytocin or placebo on two proposed measures of target engagement in brain. The targets are (1) the suppression of a particular wave form (mu) on the electroencephalogram (EEG) while subjects observe a socially relevant form of motion and (2) pupil dilation will subjects identify faces showing different emotions.

Subjects with schizophrenia spectrum disorders will be randomly assigned to one of 8 doses of oxytocin. After screening and informed consent subjects will receive either their assigned dose or a placebo. Thirty minutes following the drug administration patients will be evaluated on the EEG and pupillometry tasks followed by two tests that evaluate social salience. One week later subjects will have a second challenge in the alternative (drug or placebo) condition.

Eligibility Criteria:
Inclusion Criteria:

* Schizophrenia, Schizoaffective Disorder, Delusional Disorder
* Able to cooperate with study procedures

Exclusion Criteria:

* Serious medical condition or substance use
* Pregnancy
K301 for the Treatment of Seborrhoeic Eczema (SE) of the Scalp

Seborrhoeic eczema (SE) is a chronic, inflammatory skin disorder confined to areas of the head and trunk where sebaceous glands are most prominent. The severity varies from mild dandruff to exfoliative erythroderma that ranges from mild, patchy scaling to widespread, and thick, adherent crusts. The worldwide prevalence of SE is 3-5%, although dandruff, the mildest form of the disorder affects up to 15-20% of the population.

In this multicentre, randomised, double-blind, placebo-controlled phase III study, adult SE patients are treated once daily for 4 weeks. The population for this study is patients with mild to moderate SE.

The primary endpoint for this study is the efficacy of K301 compared to placebo which was based on the sum score for erythema and desquamation after 4 weeks of daily application. Secondary endpoints are to evaluate safety and tolerability as well as efficacy.


Eligibility Criteria:
Inclusion Criteria:

* Male or female (including fertile women)
* 18-70 years of age
* Seborrhoeic eczema of the scalp for at least 2 months
* Presenting erythema and desquamation of mild to moderate intensity
* Signed written informed consent

Exclusion Criteria:

* Seborrhoeic eczema or any other cutaneous disease of the face or scalp requiring a specific topical treatment (corticosteroids, antifungals, selenium sulphide, antibiotics, retinoids, benzoyl peroxide or a-hydroxyacids) during the previous 15 days
* Oral treatment with cyclines, lithium, antifungals or inhaled corticosteroids during the previous month
* Use of systemic corticosteroids and retinoids during the previous 2 months
* Seborrhoeic eczema associated with Parkinson's disease or HIV infection
* Current or any history of ear, nose, and throat carcinoma
* Current or any history of severe concomitant disease according to Investigator's judgement
* Allergy to any of the tested treatment components
* Subject who has been previously enrolled in the phase II study K40-3 investigating Kaprolac® K40
A Proof-of-Concept Study to Assess the Efficacy, Safety and Tolerability of Itepekimab (Anti-IL-33 mAb) in Participants With Non-cystic Fibrosis Bronchiectasis

ACT18018 is a multinational, randomized, double-blind, placebo-controlled, parallel-group, Phase 2 study with 3 treatment groups. The purpose of this study is to evaluate efficacy, safety and tolerability with 2 dosing regimens of itepekimab compared with placebo in male and/or female participants with NCFB aged 18 years of age up to 85 years of age (inclusive).

Study details include:

* The study duration (screening, 24-52-week treatment, 20-week safety follow-up) will be up to 47-77 weeks.
* The treatment duration will be up to 24-52 weeks.
* The follow-up duration will be 20 weeks.
* Site/phone visits are at a monthly interval.


Eligibility Criteria:
Inclusion Criteria:

* Participant must be 18 to 85 years of age inclusive.
* Clinical history consistent with NCFB (cough, chronic sputum production and/or recurrent respiratory infections).
* Participants with a FEV1 % predicted ≥30%.
* Participants with at least 2 moderate or 1 severe Pulmonary exacerbations (PEs) in the past 12 months.

Exclusion Criteria:

Participants are excluded from the study if any of the following criteria apply:

* Have bronchiectasis due to CF, hypogammaglobulinemia, common variable immunodeficiency, known active nontuberculous mycobacteria (NTM) lung infection, or pulmonary fibrosis.
* Known or suspected immunodeficiency disorder.
* Pulmonary exacerbation which has not resolved clinically during screening period.
* Have significant haemoptysis.
* Have any clinically significant abnormal laboratory values at Screening or diseases or disorders.
* History of lung transplantation.
* History of malignancy within 5 years before Screening, or during the screening period
* Currently being treated with antimicrobial therapy for tuberculosis (TB).
* Currently on active treatment for allergic bronchopulmonary aspergillosis (ABPA).
* Participants with active autoimmune disease or participants using immunosuppressive therapy for autoimmune disease
* Known allergy to itepekimab or to excipients
* Live-attenuated vaccine(s) within 4 weeks prior to Screening or plans to receive such vaccines during the study
* Unstable ischemic heart disease
* Cardiomyopathy or other relevant cardiovascular disorder
* Clinically significant new abnormal electrocardiogram (ECG) within 6 months prior to, or at Screening
* History of human immunodeficiency virus (HIV) infection or positive HIV 1/2 serology at Screening.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
PATH Study: People With Injecting Related Infections: Assessing Treatment Outcomes for Those Who Are Hospitalised.

We seek to characterise the burden and outcomes of and understand the current experience of people who inject drugs admitted to hospital with invasive injecting-related infections, in order to implement and evaluate strategies to improve completion of therapy and reduce patient-directed discharges, with ultimate benefit to the patient and health service.

This study will be conducted as a prospective, observational cohort study of adults admitted with invasive bacterial and fungal infectious diseases. This study will be conducted at multiple hospitals in Australia.

Participants will be invited for Screening whilst they are inpatients of the hospital. Participants will be screened for history of injection drug use in the last 6 months and presence of an invasive bacterial or fungal infection.

Eligible participants will be treated through standard of care with the applicable treatment. All participants will commence antimicrobial treatment whilst they are inpatients. For participants who are discharged before planned treatment completion, a hospital discharge visit (Early Discharge Electronic Case Report Form \[eCRF\]) will be conducted. Following the end of treatment, participants will be reviewed at 6, 12 and 48-weeks post-enrolment. At follow-up visits, behavioural surveys, health-related quality of life, and experiences with hospital care will be assessed.

Individual patient involvement will include four visits over a 12-month period.

The duration of the study is anticipated to be 5 years.

Eligibility Criteria:
Inclusion Criteria:

1. Have voluntarily signed the informed consent form,
2. 18 years of age or older,
3. Injected drugs within the last 6 months,
4. Admitted to hospital with invasive bacterial or fungal infection, a. Examples of invasive infection include: bloodstream infection, bone and joint infection (osteomyelitis, septic arthritis, discitis), central nervous system infection (epidural abscess, meningitis), deep abscess (i.e., brain, liver, muscle, spleen), endovascular infection (infective endocarditis, septic thrombophlebitis, mycotic aneurysm, septic embolism), skin or soft tissue infection (necrotising fasciitis, myositis),

Exclusion Criteria:

1) Is unable or unwilling to provide informed consent or abide by the requirements of the study.
Testing How Well Magnesium Citrate Capsules Work as Preparation for a Colonoscopy

This study compares a colonoscopy preparation composed of magnesium citrate capsules to a preparation of polyethylene glycol solution. The hypothesis is that the magnesium citrate capsules work as well and are better liked by patients due to the lack of taste.


Eligibility Criteria:
Inclusion Criteria:

* • Scheduled for colonoscopy at Sinai Hospital or Woodholme GI Associates

Exclusion Criteria:

* • Calculated creatinine clearance under 30ml/min

  * On PPI and unable to stop for five days before colonoscopy
  * On H2 blockers and unable to stop for two days before colonoscopy
  * achlorhydria
  * Previous colon surgery
  * Cardiovascular disease, including uncontrolled congestive heart failure, unstable angina pectoris, or recent (3 months) percutaneous transluminal coronary angioplasty, myocardial infarction, or coronary artery bypass graft surgery
  * Colon disease, including chronic constipation (\<2 bowel movements per week for \>1 year), ileus and/or acute obstruction, ileostomy, right or transverse colostomy, subtotal colectomy (≥50% of colon removed) with ileosigmoidostomy, hypomotility syndrome, megacolon, or idiopathic pseudo-obstruction
  * Pregnant women
The TISA Trial - Senegal

This study evaluates the addition of a simple, scalable "WASH kit", including household water treatment products, a safe water storage container, and hygiene promotion, to the standard national protocol for outpatient treatment of uncomplicated severe acute malnutrition among children aged 6-59 months of age in northern Senegal.

Severe acute malnutrition (SAM) is defined as a weight-for-height z-score (WHZ) below -3 of the World Health Organisation growth standards. It is a short-term acute condition with a high case-fatality rate that increases both the susceptibility of children to infection and the risk of mortality. The global prevalence of SAM in children is estimated to be over 17 million with most of those affected living in sub-Saharan Africa and Asia.

Community-Based Management of Acute Malnutrition (CMAM) has significantly changed standard practice for the treatment of SAM. Uncomplicated SAM cases are now predominantly managed on an outpatient basis and Action Contre la Faim (ACF) supports outpatient treatment programs (OTP) across the globe, particularly in Africa and Asia. This innovation has increased coverage, and reduced the cost of treatment for both the health system and individuals. However, under CMAM, the treatment context has moved from a more controlled health facility setting to the generally less controlled household setting where the risk of infection due to environmental hazards, such as contaminated water, may be higher.

The TISA trial described here will evaluate the effectiveness of combining a simple, scalable "WASH kit" with OTP on the recovery rate among uncomplicated SAM cases aged 6-59 compared to the national standard OTP. The WASH kit includes a plastic container, a supply of Aquatabs® (effervescent chlorine tablets), and training in their use and associated hygiene practices. The study is a cluster randomized controlled trial (cRCT), with health centres constituting the clusters. Clusters are randomly allocated to either a control group receiving the standard OTP or an intervention group receiving OTP plus the WASH kit. The primary outcome of the trial is the recovery rate and the secondary outcomes are weight gain, referral rate, longitudinal prevalence of diarrhoea, prevalence of enteric pathogen detection and all-cause mortality.

Eligibility Criteria:
Inclusion Criteria:

* Weight-for-height z-score \<-3; or
* Brachial perimeter (mid-upper arm circumference) \<115; or
* Bilateral oedema

Exclusion Criteria:

* Not able and/or willing to participate for up to 8-weeks
* Clinical complications requiring referral and/or inpatient treatment
Effects of a Western-type Diet on Colorectal Inflammation

This study will look at the inflammatory (changes usually associated with infection/injury to the body) and bowel permeability (bowel's ability to allow contents to enter the body) effects of a Western-style diet (high fat and low in calcium) and a prudent-style diet (low fat and high in calcium) on the colon (large bowel). This study may provide information to prevent colorectal cancer in a high-risk population

Hypothesis: Compared to a prudent-style diet, does a western-style diet increase colorectal inflammation thereby increasing gut permeability and causing increased endotoxins and markers of systemic inflammation.

This is a single blind crossover study. Subjects will be randomized to begin on either a WD or a PD for 30 + 3 days. Once that dietary intervention is complete, subjects will have a four (4) week wash-out period and then will be placed on the other dietary intervention for 30 + 3 days. The following study measures are performed during both the dietary intervention study periods. All the baseline tests will be repeated at the end of each dietary intervention period.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male or post-menopausal ( 2 years after menopause or stopping HRT)healthy female subjects
* Age between 50 and 72 years
* At increased risk for colorectal cancer (this includes those have had a colorectal adenoma excised, or have a first or second degree relative with colorectal neoplasia).

Exclusion Criteria:

* Personal history of cancer other than non-melanoma skin cancer within the past 10 years
* History of hereditary non-polyposis colon cancer
* Intestinal malabsorption, inflammatory bowel disease
* Prior gastrointestinal surgery other than appendectomy or surgery of the esophagus
* Any excess bleeding or coagulation disorders
* Subjects taking anti-coagulants, sterol-binding resins, NSAIDs other than aspirin, \< 600mg per day, other study medications, or other multiple medications that might, in the view of the study physicians, alter colonic function or inflammation
* Total cholesterol greater than 240mg/dl, triglycerides \> 600mg, LDL-C \> 175
* Subjects with a history of coronary artery disease
* HIV positive subjects
* Subjects taking antibiotics, anti-diabetes, hormone replacement therapy, oral, transplanted or injected contraceptives (thyroid hormone therapy is permitted as long as the subject is euthyroid)
* Currently participating in other clinical studies or completed participation in other clinical studies within the last 30 days
Evaluation of the Safety and Performance of Glycobone in Sinus Lift

Multicentre, interventional, longitudinal, open-label study conducted in France, evaluating the clinical performance and safety of Glycobone® as a bone filling material in the context of a lateral approach sinus lift on 40 patients with dental implant placement. Implant placement took place 6 months after bone filling.

A multicentre, interventional, longitudinal, open-label, prospective, pilot exploratory study of first-in-man administration in France, evaluating the clinical performance, safety and bone filling properties of Glycobone® during a lateral sinus lift procedure with deferred implant placement.

The study will follow a panel of 40 patients for 9 months in three consecutive stages:

Stage 1: Inclusion of a group of up to 5 patients Stage 2: If safety validation in stage 1 is confirmed: Inclusion of a group of 15 additional patients (maximum) Step 3: If safety validation in step 2 is confirmed: Inclusion of a group of 20 additional patients.

Eligibility Criteria:
Inclusion Criteria:

* 1. Adult patient, male or female, aged 18-84 years at the time of signing the consent form

  2. Patient who has been informed and has signed consent prior to any procedure related to the investigation 3. Patient requiring a dental implant procedure:
* Implant project associated with at least one lateral approach sinus lift due to sub-sinus bone height \< 5 mm, without full bridge
* Associated with a bone filling
* With implant placement deferred to approximately 6 months within the limit of a maximum of 3 implants in the framework of the investigation 4. Availability of a cone beam with radiological guide less than 3 months old 5. Patient covered by a health insurance plan.

Exclusion Criteria:

1. 3 months or less old tooth extraction (≤ 3 months)
2. Sinus lift project requiring placement of all contralateral implants at the same time (i.e. 2 sinus lift projects associated with a full bridge)
3. Contralateral sinus lift of the site to be included performed within 3 months prior to inclusion
4. 4. Patient's general condition does not allow the investigator to perform the investigative procedures
5. Pregnant or breastfeeding patient at the time of the sinus lift and filling procedure (D0)
6. Patient with a concomitant ENT infection that may interfere with the investigative procedures
7. Patient with an uncontrolled chronic condition that may interfere with investigative procedures
8. Patient on VKA with INR \>4, biphosphonates, denosumab or having been treated with radiotherapy in the study area
9. Patient unable to receive any type of analgesic during the investigation
10. Patient allergic to any of the components of Glycobone®.
11. Patient participating or having participated in another drug or medical device clinical trial within 30 days prior to inclusion in this study
12. Patient considered by the investigator to be non-compliant with study procedures
13. Patient deprived of liberty by court or administrative order or under legal protection (e.g. guardianship)
Safety and Effectiveness of Abatacept in Psoriatic Arthritis Participants

The purpose of this study is a long-term, observational study of Abatacept in patients with Psoriatic Arthritis, a chronic inflammatory disorder.


Eligibility Criteria:
Inclusion Criteria:

* Participants 18 years or older
* Participants who signed an informed consent
* Participants diagnosed with PsA as per the criteria of the Classification of Psoriatic Arthritis (CASPAR) Study Group18
* Participants naïve of abatacept and who at their physician's discretion initiate abatacept
* Participants meeting criteria for abatacept treatment for PsA as specified in the German label

Exclusion Criteria:

* Participants who are currently included in any interventional clinical trial in PsA/Rheumatoid Arthritis (RA)
A Study of SHR-1210 in Combination With Capecitabine + Oxaliplatin or Apatinib in Treatment of Advanced Gastric Cancer

The purpose of this trial is to estimate overall response rate (ORR) of SHR-1210 combined with capecitabine and oxaliplatin or with apatinib as first-line treatment in subjects with locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.

Approximately 110 participants will be assigned to SHR-1210 + capecitabine + oxaliplatin combination therapy (Cohort 1), or SHR-1210 + apatinib combination therapy (Cohort 2).

Eligibility Criteria:
Inclusion Criteria:

* Has histologically- or cytologically-confirmed diagnosis of locally advanced unresectable or metastatic adenocarcinoma of stomach or the esophagogastric junction (GEJ).
* Age ≥ 18 years old, male or female.
* NO previous therapy for advanced/metastatic disease of GC/GEJ (including HER2 inhibitor). Subjects with previous adjuvant/neo-adjuvant therapy completed more than 6 months can be enrolled.
* Has measurable disease per RECIST 1.1.
* Life expectancy ≥ 12 weeks.
* Eastern Cooperative Group (ECOG) performance status of 0 to 1.
* Has adequate organ function.
* Females of childbearing potential (FOCBP), who are not surgically sterile or postmenopausal, must conduct pregnancy test (serum or urine) within 7 days before enrollment, and must not be pregnant or breast-feeding women. If the result is negative, she must agree to use adequate contraception during the experiment and 3 months after the last administration of the test drugs. And non-sterilized males who are sexually active must agree to use adequate contraception during the experiment and 3 months after the last administration of the test drugs.

Exclusion Criteria:

* Has known HER2-positive status.
* Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibody, or a VEGFR inhibitor.
* Has known active central nervous system metastases.
* Has received a live vaccine within 4 weeks prior to the first dose of study treatment.
* With any active autoimmune disease or history of autoimmune disease, including but not limited to the following: hepatitis, pneumonitis, uveitis, colitis (inflammatory bowel disease), hypophysitis, vasculitis, nephritis, hyperthyroidism, and hypothyroidism, except for subjects with vitiligo or resolved childhood asthma/atopy. Asthma that requires intermittent use of bronchodilators or other medical intervention should also be excluded.
* Clinically significant cardiovascular and cerebrovascular diseases, including but not limited to severe acute myocardial infarction within 6 months before enrollment, unstable or severe angina, Congestive heart failure (New York heart association (NYHA) class \> 2), or ventricular arrhythmia which need medical intervention.
* Hypertension and unable to be controlled within normal level following treatment of anti-hypertension agents(within 3 months): systolic blood pressure \> 140 mmHg, diastolic blood pressure \> 90 mmHg.
* Coagulation abnormalities (INR \> 1.5 or APTT \> 1.5×ULN), with bleeding tendency or are receiving thrombolytic or anticoagulant therapy.