cyrilzakka/clinical-trials huggingface dataset:
Allergen Challenge Chamber Study With Single Dose Oral GSK835726 Compared With Placebo

A randomised, double-blind, placebo-controlled, 4-period incomplete block crossover study of single oral dose GSK835726 (100mg, 50mg, 10mg), Cetirizine (10mg) and placebo to evaluate the efficacy and safety using an Environmental challenge chamber in male subjects with seasonal allergic rhinitis


Eligibility Criteria:
Inclusion Criteria:

* Subject is healthy apart from seasonal allergic rhinitis, as determined by a physician. Can have mild asthma.
* Male
* Aged 18 - 60
* Weight 50kg+, BMI 19-32 kg/m2
* Exhibit response to Challenge Chamber and skin prick test.
* Non-smoker
* Capable of giving informed consent

Exclusion Criteria:

* No nasal structural abnornmality/polyposis, surgery, infection.
* any respiratory disease, other than mild asthma or seasonal allergic rhinitis
* participated in another clinical study within 30 days.
* Subject has donated a unit of blood within 1 month
* Use of prescription or non-prescription drugs, including vitamins and st john's wort within 7 days of trial.
* History of sensitivty to drug
* History of alcohol/drug abuse within 12 months.
* Positive Hepatitis B antibody test
* Positive HIV antibody test
* Risk of non-compliance with study protocol
* Perenial allergic rhinitis
* Administration of oral, injectable or dermal corticosteriods within 8 weeks, intranasal or inhaled within 3 weeks.
* Past or present disease that may affect outcome, as judge by investigator
* Specific Immunotherapy within 2 years
Study of Different Suturing Techniques for Perineal Repair After Delivery

We wish to determine wich of two standardized suturing techniques is the best for perineal repair if a perineal laceration or an episiotomy is present after vaginal birth.

The participants are healthy primi para and deliver at term.

A randomised controlled trial with 400 participants was initiated in August 2004. The two suture techniques compared were both 2-layered and either continuous sutures or interrupted, inverted stitches to perineal muscles and the subcuticular layer. A polyglactin 910 multifilament thread on an atraumatic needle was used and the perineal skin was left unsutured. Healthy primiparas \>36+0 weeks gestation could participate if they had a either a 2nd degree perineal laceration or an episiotomy.

The trial was a double-blind and analysis was done on an intention-to-treat basis. Main outcomes were pain, wound healing and patient satisfaction.

Eligibility Criteria:
Inclusion Criteria:

Primipara, 2nd degree perineal laceration or episiotomy. Vaginal birth of one child in occipital position terminating a pregnancy at 36 weeks or later. A soft cup used to deliver the baby was accepted. Participants must be able to understand and speak Danish.

Exclusion Criteria:

Perineal 3rd or 4th degree injuries, post partum haemorrhage extending 1000 ml. or manual removal of placenta, former perineal wounds, foetus mortuus or delivery of a child immediately transferred to the neonatal ward, Diabetes Mellitus, instrumental delivery, Caesarean Section or gemelli.
Feedback Using BehaviOral EconOmic Theories on STEP CountS in Cardiovascular Disease Patients

This is a prospective, randomized controlled trial. The aim of the study is to verify the effectiveness of interventions using gamification with social incentives and social support to increase physical activity in patients with CVD through randomized controlled trials.

The three aims of this randomized controlled trials;

1. To demonstrate the effectiveness of loss framing in gamification for achieving increased physical activity in patients with CVD.
2. To demonstrate the effectiveness of social support in gamification for achieving increased physical activity in patients with CVD.
3. To evaluate the impact of the intervention using social incentives and social support through gamification on changes in participants; subjective assessment of physical activity levels, body mass index (BMI), and lipid panel in blood tests.

Secondary Objective:

1. To assess whether the differences between study groups in achieving the goal of increased physical activity during the 6-week intervention period persist during the 6-week follow-up period.
2. To investigate how the increase in physical activity through gamification in patients with CVD is influenced by patients; behavioral characteristics and environmental factors.

This trial will be a five-group, randomized controlled trial (RCT) with an intervention period of 6 weeks and a follow-up period of additional 6 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* History of old myocardial infarction or chronic heart failure
* Ability to read and provide informed consent to participate in this trial
* Owning a smartphone capable of installing this application

Exclusion Criteria:

* Having difficulty using smartphones (due to vision problems or IT literacy issues)
* Exercise therapy is contraindicated (in accordance with the 2021 revised guidelines on rehabilitation in cardiovascular diseases)
* Ability to read and provide informed consent to participate in this trial
* Owning a smartphone capable of installing this application
* Participating in other studies related to physical activity
* Being pregnant
* Any other medical conditions or reasons they are unable to participate in a physical activity study for 12 weeks
Using Augmentative & Alternative Communication to Promote Language Recovery for People With Post-Stroke Aphasia

The currently available interventions only partially restore language abilities in patients with post-stroke aphasia; preventing successful reintegration into society. This study will increase our knowledge of how we can use assistive technology interventions to help people with aphasia restore language function. Further, this project will help us identify regions of the brain responsible for these changes.

In aphasia rehabilitation, usual care is focused on helping people recuperate as much of their pre-stroke language capacity as possible.Typically, usual care is a non-standardized therapy that is tailored to the specific needs of the person with aphasia.Once a person reaches a plateau in language recovery, AAC is implemented with a focus on circumventing, or compensating for the communication challenges associated with aphasia.

The ability of people with aphasia to (1) recover language function well-into the chronic phase of stroke recovery and (2) self-cue to promote word retrieval during anomic events offer the solution for how AAC could be employed as a dual-purpose tool to augment language recovery and compensate for deficits. This approach, however, this requires a shift in how AAC is implemented. With the goal of language recovery, treatment needs to focus on instructing people with aphasia how to use AAC as a mechanism for self-cueing, rather than as a tool to replace speaking. Based on our pilot data, we hypothesize that this novel method to AAC implementation will promote language recovery by coupling the canonical language and visual processing neural networks.

This work will also contribute to our ability to identify, a priori, who will respond to this particular AAC intervention and who will not, by combining neuroimaging with behavioral and clinical data. This has the potential to reduce the cost of healthcare for stroke recovery by implementing the most effective treatment possible. Importantly, when we identify non-responders, this will allow us to construct a profile and identify features of the AAC treatment that require adjustment to meet their unique needs.

Eligibility Criteria:
Inclusion Criteria:

* at least 18 years old
* native speaker of american English
* compatible for 3 Tesla MRI
* Ischemic, left middle cerebral artery stroke
* at least 12 months post stroke
* pass hearing screening
* pass vision screening
* diagnosis of aphasia on the Western Aphasia Bedside Screen
* ability to produce 5-10 intelligible words
* no more than a moderate apraxia of speech or dysarthria
* minimal or no AAC/iPad experience
* written consent by self or guardian

Exclusion Criteria:

* fails to meet the above
* Underlying degenerative or metabolic disorder or supervening medical illness
* Severe depression or other psychiatric disorder
* Report of pregnancy by women of childbearing age
Diagnostic Value of Optical Enhancement Technology in Early Esophageal Squamous Neoplasia

The aims of the present study：

1. To investigate the diagnosing value of optical enhancement technology for early esophageal squamous neoplasia.
2. To assess the detection rate of early esophageal squamous neoplasia by virtual chromoendoscopy with optical enhancement technology .

Detection and differentiation of esophageal squamous neoplasia (ESN) are of value in improving patient outcomes.Optical enhancement technology can serves in the diagnosis of GI neoplasia. However, its performance in ESN has not yet been reported.The aims of the present study is:

1. To investigate the diagnosing value of optical enhancement technology for early esophageal squamous neoplasia.
2. To assess the detection rate of early esophageal squamous neoplasia by virtual chromoendoscopy with optical enhancement technology .

Eligibility Criteria:
Inclusion Criteria:

1. Patients with high-risk factors for esophageal squamous cell carcinoma who meet any of follows：

   * Long term living in the high incidence area of esophageal squamous cell carcinoma ；
   * First degree relatives have a history of esophageal squamous cell carcinoma ；
   * Previous history of esophageal lesions （ esophageal squamous neoplasia ）；
   * The patients having a history of cancer；
   * A long history of smoking ；
   * A long history of drinking ；
   * Having bad eating habits such as eating fast, hot diet, high salt diet, eating pickles.
2. Patients aged between 40 to 74 years old.

Exclusion Criteria:

1. Having advanced esophageal carcinoma;
2. After esophageal surgery or endoscopic treatment ;
3. Known esophageal radiotherapy or chemotherapy ;
4. Esophageal stenosis;
5. Acute bleeding;
6. A known allergy to iodine;
7. Coagulopathy (prothrombin time \<50% of control, partial thromboplastin time \>50 seconds);
8. Having food retention;
9. Severe hepatic ,renal, cardiovascular or metabolic dysfunction ;
10. Being pregnant or lactating;
Association of the Risk for Thrombotic Thrombocytopenia Syndrome and Exposure To COVID-19 Vaccines

Background/Rationale: A very rare syndrome of thrombosis associated with low platelets has been reported in a few cases of recent exposure to COVID-19 vaccine. This thrombotic thrombocytopenia syndrome seems to be affecting patients of all ages and both genders; at present there is no clear signal of risk factors.

Objectives: To evaluate an association between COVID-19 vaccine exposure and thromboembolic events occurring with thrombocytopenia (thrombotic thrombocytopenia syndrome; TTS).

Study design: Two primary study designs will be considered, a case control study and a self-controlled case series (SCCS). A cohort analysis will be considered, in addition or as an alternative to either of the primary study designs, pending feasibility assessment of the follow-up time.

Data Source(s): Data for the study will be accessed through the NHS Digital Trusted Research Environment (TRE), providing national data coverage. Primary care data will be linked with vaccination, hospitalization, COVID-19 test results, mortality data. Initial exploratory analyses will be conducted using the Oxford-Royal College of General Practitioners sentinel network; ORCHID network database (N\>15million).

Subjects of interest are patients who have received a COVID-19 vaccine. However, investigators will require access to data from all subjects in the databases.

Statistical Analysis: The study period will start on December 02, 2020, when the COVID-19 vaccine was first approved in the UK and will end at the end of data availability.

For the case-control design, all cases of TTS will be matched with control using risk-set matching. A case or matched control will be considered exposed if a COVID-19 vaccination will be within risk interval prior to the diagnosis date of the matched case.

For the SCCS, estimates of relative incidence (RI), in all risk intervals will be reported.

For the retrospective cohort design, the incidence of TTS after receiving COVID-19 vaccine will be estimated and investigators will compare this incidence with that occurring in an unvaccinated comparator group about levels of infection across the whole population.

Variables: Demographic, socioeconomic descriptors, clinical diagnosis, vaccines, potential confounders, thrombotic phenomena, COVID-19 infection, and other characteristics as applicable.


Eligibility Criteria:
Inclusion Criteria:

* A minimum of 12 months medical history prior to the start of the study period

Exclusion Criteria:

* Less than 12 moths medical history prior to the start of the study period
Association Between Genetic Variant Scores and Warfarin Effect

Study objective is to determine whether there is an association between genetic variant risk scores and clinical outcomes (percent time in therapeutic range, time to reach therapeutic international normalized ratio (INR), INR ≥ 4, bleeding event, ischemic stroke, death) in participants taking warfarin for atrial fibrillation, deep vein thrombosis (DVT), pulmonary embolism (PE), and/or intracardiac thrombosis.

It is anticipated that next generation genomic sequencing will identify rare genetic variants in ethnically diverse populations, which otherwise would not have been detected using commercially available warfarin tests. Furthermore, retrospective review of clinical outcomes (percent time in therapeutic range, time to reach therapeutic international normalized ratio (INR), INR ≥ 4, major bleeding event, ischemic stroke) of study participants will determine the clinical utility of genetic variant risk scores. Study outcomes will provide guidance on future directions for optimizing dosing algorithms for warfarin that combine pharmacogenetic principles with clinical dosing.

Eligibility Criteria:
Inclusion Criteria:

1. Non-valvular atrial fibrillation
2. Deep venous thrombosis (DVT) and/or pulmonary embolism (PE) with no hypercoagulable condition
3. Non-valvular atrial fibrillation and DVT/PE (with no hypercoagulable condition)
4. Intracardiac thrombosis (i.e. apical thrombosis, atrial thrombosis, auricular thrombosis, mural thrombosis, and/or ventricular thrombosis)
5. Age 18-99 years
6. Signed informed consent

Exclusion Criteria:

1. Presence of a mechanical heart valve
2. Failure to provide signed informed consent
3. Known diseases that affects coagulation test results such as vitamin K deficiency, disseminated intravascular coagulopathy, Von Willebrand disease, hemophilia, liver failure, etc.
GSK BHR Study (Sont - Second Study)

The purpose of this study was to determine whether asthma control and reduced bronchial responsiveness could be achieved and maintained at a lower dose of inhaled corticosteroids with ADVAIR DISKUS BID or FP BID in adult and adolescent patients with persistent asthma


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of asthma
* Controller asthma medication or medium dose ICS
* Current or historical reversibility

Exclusion Criteria:

* Life-threatening asthma
* Asthma instability
* Concurrent respiratory disease
* Drug allergies
* Respiratory tract infection
* Systemic corticosteroid use
* Immunosuppressive medication use
* Postive pregnancy test
* Tobacco use
* Investigation medication use
* Site affiliation
Liquid Biopsy in Advanced Oligometastatic NSCLC Receiving Surgery

A prospective, observational study that assesses the clinical feasibility of ctDNA-based liquid biopsy in patients with oligometastatic NSCLC receiving surgery.

60 eligible patients will be enrolled. Dynamic blood samples before and after surgery and tissue samples will be obtained for exploratory analysis.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent must be obtained from patients and ability for patients to comply with the requirements of the study；
* Patients must be a man or woman of more than 18 years;
* ECOG PS ≦1；
* The function of the organs was evaluated by the surgeon to tolerate local surgical treatment；
* The classification was evaluated as simultaneous oligometastases at initial treatment or oligoresidual/oligoprogression/oligorecurrence after induction therapy; \[Define: Initial treatment of simultaneous oligometastases: without systemic treatment, at the time of diagnosis, up to 5 metastases and up to 3 organs were involved, excluding pleural metastases or myeloid metastases.

Oligoresidual after induction therapy: after systemic therapy, distant metastases were stable or reduced, primary lesions were stable or reduced, PET/CT metabolism was reduced, and no more than 5 residual lesions and no more than 3 organs were involved.

Oligoprogression after induction therapy: After systemic therapy, some lesions were stable or reduced, while some original lesions were larger than before.

Oligorelapses after induction therapy: after systemic therapy, systemic lesions were stable or reduced, and new local lesions appeared.\]

* Lesion evaluation can be surgically removed. \[Definition of operable resection: the lesion is limited and can be completely removed through surgery as assessed by the surgeon, with no significant impact on postoperative quality of life. Pulmonary surgical procedures include lobectomy, segmental resection and wedge resection. Pneumonectomy is not included.\]

Exclusion Criteria:

* Patients with a confirmed or suspected autoimmune disease;
* Patients with a history of human immunodeficiency virus (HIV) positive or acquired immunodeficiency syndrome (AIDS);
* Patients with a history of any arterial thrombosis within 6 months and history of deep vein thrombosis, pulmonary embolism, or any other severe thromboembolism within 3 months;
* Patients with any unstable systemic disease (eg, active infection, high-risk hypertension, unstable angina, congestive heart failure, etc.);
* Patients with a history of other malignancies in the past 5 years;
* Patients identified by the investigators patients with contraindications to local treatment;
* Patients with serious mental illness;
* Patients who cannot sign informed consent;
* Patients who cannot be followed up as scheduled;
Colon Cancer Prevention Study

The goal of this research study is to design messages which can help people learn more about how to prevent colon cancer. Eligible participants will be asked to review a series of short cancer prevention messages and share their opinions on them. Participants also need to fill out a short survey with questions on their background and attitudes and knowledge about physical activity and colon cancer. The whole study can be completed online and will take less than 1 hour. After completing the entire study, participants will receive $25.

If you are interested in participating in this study, please visit the following website:

https://surveys.chaicore.com/preventcancer/

The goal of this research is to develop and test potential intervention messages which can be used to help increase colon cancer prevention behaviors. Two sets of intervention messages will be developed: generic and behavioral. Using a randomized control design the investigators will evaluate the behavioral messages among women. This message testing protocol will help them determine if the messages are relevant, acceptable, comprehensible, memorable, and motivating for the target audience. The investigators' hypothesis is that the behavioral messages will receive more positive ratings than the generic messages. If so, they will be used to promote cancer screening and physical activity in future intervention studies.

Eligibility Criteria:
Inclusion Criteria:

* Female
* Ages 50-80 years old
A Phase 2 Study of AMG 193 in Participants With MTAP-deleted Advanced NSCLC

The main objective of the study is to characterize safety and efficacy of 2 dose levels of AMG 193 by investigator, and to evaluate AMG 193 monotherapy efficacy by Blinded Independent Central Review (BICR).


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed metastatic or unresectable locally advanced MTAP-deleted (Homozygous deletion of MTAP in the tumor tissue) non-small cell lung cancer
* Participants will have received and progressed or experienced disease recurrence on or after receiving at least 1 prior systemic therapy for locally advanced and unresectable or metastatic disease.
* Either an archival tissue sample or an archival block must be available.
* Life expectancy of greater than 3 months, in the opinion of the investigator.
* Participants who have had brain metastases and have been appropriately treated with radiation therapy or surgery ending at least 14 days before study day 1 are eligible.
* Participants with untreated asymptomatic brain metastases smaller or equal to 2 cm in size (per lesion if more than one) and not requiring corticosteroid treatment are eligible.

Exclusion Criteria:

Disease Related

• Tumors harboring the following mutations amenable to targeted therapies: epidermal growth factor receptor (EGFR), ALK receptor tyrosine kinase (ALK), ROS proto-oncogene 1 (ROS1), neurotrophic tyrosine receptor kinase (NTRK), MET proto-oncogene (MET), B-Raf proto-oncogene (BRAF), RET proto-oncogene (RET), Human epidermal growth factor receptor 2 (HER2), KRAS proto-oncogene (KRAS).

Other Medical Conditions

* Major surgery within 28 days of study day 1.
* Untreated symptomatic central nervous system (CNS) metastatic disease regardless of size or asymptomatic brain metastases greater than 2 cm per lesion.