cyrilzakka/clinical-trials huggingface dataset:
Implementing the Wuqinxi on Patients With Pulmonary Arterial Hypertension

Aims and objective: The primary objective of this study was to assess the effects of a traditional Chinese Qigong practice known as Wuqinxi on activity tolerance，negative emotions and quality of life in pulmonary arterial hypertension patients.

Methods: In the current prospective, randomized-controlled clinical trial, 60 patients with pulmonary arterial hypertension were randomly assigned to one of two groups: intervention or control. Participants in the intervention group received targeted pharmacological therapy and five sessions of qigong exercise per week. In contrast, individuals in the control group underwent targeted drug therapy and routine care. Observe the change in exercise tolerance as measured by the 6-minute walking distance (6MWD). Serological indicators (n-terminal brain natriuretic peptide precursor, NT-pro BNP) ,negative emotions(PHQ-9/GAD-7)and the MOS Item Short Form Health Survey (SF-36) or emPHasis-10 were used to assess patients condition and quality of life.

In the previous study, we examined the effects of comprehensive respiratory function exercise on exercise tolerance in patients with PAH. The results indicated that limb exercise combined with breath regulating guidance affects patients' physical health.Given these TCM principles, the current study investigated the clinical utility of Wuqinxi for improving patients' exercise tolerance and quality of life by comparing the intervention and control groups' NT-pro BNP scores, 6MWD data, negative emotionsand quality of life indices.

Eligibility Criteria:
Inclusion Criteria:

* (1) patients with PAH related to IPAH(idiopathic pulmonary arterial), CTD(connective tissue disease), DPAH(drug-induced pulmonary hypertension), CHD(congenital heart disease) and associated with secondary disease, aged 18-75 years; (2)patients with PAH as defined by the American College of Cardiology Foundation/American Heart Association (right heart catheterization: mPAP≥20mmHg and PAWP≤15mmHg); (3) patients with WHO pulmonary arterial hypertension functional class II-III; (4) patients on drug-based treatment for ≥1 month and in the recovery period; (5) could read, write, and comprehend Chinese; (6) volunteered for this trial and provided written informed consent.

Exclusion Criteria:

* (1) patients unable or unwilling to complete the 6MWD; (2) The physician confirms that the disease requires bed rest or with severely impaired cardiopulmonary function, tumors, and limb dysfunction; (3) patients who were unable to complete the questionnaire independently; (4) a history of mental problems and cognitive impairment; or have had psychotherapy or taken any psychiatric medication in the past or present.(5) patients who were hospitalized with severe disease.
The Use of Biomarkers to Guide Management of Patients Treated With Radiofrequency Ablation for Early Oesophageal Neoplasia

This prospective cohort study aims to assess the utility of a panel of molecular biomarkers for predicting the risk of relapse of Barrett's Oesophagus after endoscopic treatment of early oesophageal neoplasia with RadioFrequency Ablation (RFA). Patients who received endoscopic treatment of early oesophageal neoplasia with RFA and achieved endoscopic remission will be recruited. During the surveillance visits patients will receive a Cytosponge test followed by an endoscopy with Narrow Band Imaging (NBI) magnification and biopsies. Patients will receive an endoscopy every 6 months and Cytosponge every 12 months for at least 2 years. Molecular biomarkers including a methylation panel on DNA and immunohistochemical markers on formalin fixed paraffin embedded samples. After 2 years of intensive endoscopic follow up, patients will be prospectively tracked for up to 3 years.

The investigators will also evaluate:

* The risk of progression to dysplasia or oesophageal intestinal metaplasia (IM) in patients with IM at the GOJ post RFA in the absence of retreatment
* the diagnostic accuracy of NBI for IM/dysplasia at the GOJ .

The panel of predetermined molecular biomarkers includes:

1. IM-SCORE - a score quantifying the extent of intestinal metaplasia at GOJ, which uses a 4-tier system based on the number of glands and the number of biopsies with features of IM. The score has been developed in a pilot study (manuscript under submission) and will be validated in this study
2. Methylation markers- assessed by a PCR-based method (Methylight) on Cytosponge samples.
3. P53 status.
4. TFF3 protein expression.

Eligibility Criteria:
Inclusion Criteria

1. Previous RFA for dysplastic BE or following EMR for BE-related neoplasia
2. No definite endoscopic evidence of BE defined as at least 1cm tongue of columnar oesophagus or oesophageal BE islands larger than 5mm.
3. No histological evidence of oesophageal IM including buried BE at first post RFA follow up. GOJ IM is allowed
4. No evidence of suspicious lesions with dysplasia at the GOJ.

Exclusion criteria

1. Evidence of BE requiring additional RFA
2. Anticoagulant or antiplatelet therapy for high risk conditions, whereby discontinuation of the treatment is not recommended.
3. Individuals with a diagnosis of an oro-pharynx, oesophageal or gastro-oesophageal tumour (T2 staging and above), or symptoms of dysphagia,
4. Oesophageal varices, stricture or requiring dilatation of the oesophagus
5. Individuals who have had a myocardial infarction or any cardiac event less than six months ago
6. Patients whose primary previous ablative treatment was different from RFA, such as Photodynamic therapy (PDT), APC or Cryotherapy
7. Participants who are unable to provide informed consent.
8. Participants under age 18.
9. Endoscopy is generally avoided in pregnant women and therefore it is unlikely that any pregnant women will be included although pregnancy would not be an absolute contraindication. Pregnancy/ pregnancy test will not be recorded as part of the trial.
Short and Long Outcomes Between Laparoscopic and Open Hepatectomy

LLR was applied for tumors located at the lower edge and lateral segments of the liver that could be resected more easily than posterosuperior segments. With the development of technology and the growing experience of hepatobiliary surgeons, LLR has been expanded to major liver resections, anatomical resections, and donor hepatectomies by skilled surgeons. However, due to the concerns over the risk of operative bleeding, tumor seeding and positive resection margin, the true benefit of LLR remains unclear across surgical community.

The 2nd International Consensus Conference on Laparoscopic Liver Resection (ICCLLR) was held in Morioka, Japan, in 2014. The new recommendations of the ICCLLR state that the outcomes of LLR are not inferior than OLR regarding to operative mortality rate and margin negativity, and are superior in decreasing postoperative complications, blood loss, and the length of the postoperative hospital stay. However, it is not clear that whether LLR is able to alleviate the impairment of liver function after hepatic resection, and there is no RCTs to compare the short and long outcomes between LLR and OLR.

Eligibility Criteria:
Inclusion Criteria:

1. Patient who underwent hepatectomy for benign or malignant neoplasm of the liver, and is suitable for both open and laparoscopic liver resection;
2. Child-Pugh A without portal hypertension
3. No portosystemic shunt
4. No previous abdominal operation history.
5. American society of anesthesiology class(ASA): I or II
6. Age 18 to 80

Exclusion Criteria:

1. Additional intervention to the liver (Radio Frequent Ablation, Percutaneous Ethanol. Injection Therapy or others)
2. Combined hepatectomy
3. Intrahepatic duct stone disease
4. Liver disease caused splenomegaly
5. Previous hepatectomy
6. Combined operation for extrahepatic disease
7. Vulnerable population (mental retardation, pregnancy)
Real-life Pan-HER-blockade With Neratinib

So far, there is no data available on treatment of patients with early-stage hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2)-overexpressed/amplified breast cancer, who completed adjuvant trastuzumab-based therapy less than one year ago, in the clinical routine setting.

ELEANOR - designed as a prospective, longitudinal, non-interventional study (NIS) - will investigate real-world use of neratinib and its treatment management in patients with HR-positive, HER2-overexpressing/amplified breast cancer stage I-III having completed adjuvant trastuzumab-based therapy less than one year ago. Data from this study will contribute to a deeper understanding and characterization of the everyday use of neratinib in a broader patient population in the German and Austrian routine setting.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent of the patient with regard to the pseudonymized documentation;
* Legally capable female patient ≥ 18 years of age (no upper limit);
* Decision was taken to treat the patient with neratinib in accordance with the current SmPC and by prescription; this decision was taken prior to and independent from the inclusion into the study;
* Treatment with neratinib is planned to be started;
* Hormone receptor (HR) positive, Human epidermal growth factor receptor 2 (HER2) overexpressing/amplified breast cancer stage I-III;
* Completion of prior trastuzumab-based therapy less than 1 year ago;
* No signs of relapse before initiation of neratinib treatment.

Exclusion Criteria:

* Presence of any contraindication with regard to the neratinib treatment as specified in the corresponding Summary of Product Characteristics (SmPC);
* Current or upcoming participation in an interventional clinical trial;
* Prisoners or persons who are compulsorily detained (involuntarily incarcerated)
Moderate Rheumatoid Arthritis (RA) With Etanercept (Enbrel)

This study is designed to evaluate the effectiveness of adding etanercept to disease modifying anti-rheumatic drug (DMARD) therapy in patients with moderately active Rheumatoid Arthritis (RA).


Eligibility Criteria:
Inclusion Criteria:

* Male or female ≥18 and ≤80 years of age at time of screening
* Diagnosed with rheumatoid arthritis as determined by meeting 1987 American College of Rheumatology (ACR) classification criteria and has had rheumatoid arthritis for at least 6 months
* Moderate rheumatoid arthritis during screening, as defined by a disease activity score (28 joint) calculated using the C-reactive protein formula (DAS28-CRP) \> 3.2 and ≤ 5.1
* Active rheumatoid arthritis defined as ≥ 3 swollen joints (out of 28 joints examined) and ≥ 3 tender/painful joints (out of 28 joints examined) at screening and baseline. (A full 66/68 count joint count will be performed at baseline, but only joints in the 28-count joint count will be considered for eligibility. The 28-joint count consists of the finger joints excluding the distal interphalangeal joints, the wrists, elbows, shoulders, and knees)
* Must be currently taking a DMARD such as methotrexate, sulfasalazine, leflunomide, minocycline, and/or hydroxychloroquine

Exclusion Criteria:

* Prosthetic joint infection within 5 years of screening or native joint infection within 1 year of screening
* Class IV rheumatoid arthritis according to ACR revised response criteria
* Any active infection (including chronic or localized infections) for which anti-infectives were indicated within 28 days prior to first investigational product dose
* Previously used more than one experimental biologic DMARD. Patient with prior use of no more than one experimental biologic is permitted if the subject received no more than 8 weeks of treatment. The use of the experimental biologic must not have occurred within 2 months of the first dose of investigational product
* Previously used more than one commercially available biologic DMARD. Subject with prior use of no more than one commercially available biologic is permitted if the patient received no more than 8 weeks of treatment and did not discontinue because of lack of effect. The use of the biologic must not have occurred within 2 months of the first dose of investigational product. Acceptable prior use of biologics include the following examples:
* No more than 4 injections of adalimumab
* No more than 8 (50 mg) injections of etanercept
* No more than 2 infusions of infliximab
* No more than 2 infusions of abatacept
* Additional inclusion (exclusion) criteria may apply
A Study of Semagacestat for Alzheimer's Patients

The primary objective of the original study was to assess the safety of semagacestat in Alzheimer's disease (AD) patients during 24 months of open-label treatment. Baseline for the efficacy measures is defined as the baseline for feeder studies LFAN (NCT00594568) and LFBC (NCT00762411). For all safety analyses (adverse events), baseline for patients will be week 0 of this study (LFBF).

Preliminary results from LFAN and LFBC showed semagacestat did not slow disease progression and was associated with worsening of clinical measures of cognition and the ability to perform activities of daily living. Study drug was stopped in all studies. Studies LFAN, LFBC and LFBF have been amended to continue collecting safety data, including cognitive scores, for at least seven months. The CT-Registry will reflect results of analyses from the original protocol in addition to those from the amended protocol. Very few participants from LFBC rolled over into LFBF (N = 9). Due to insufficient sample size, the data for LFBC participants who rolled into LFBF were not analyzed.


Eligibility Criteria:
Inclusion Criteria:

* Meets National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) criteria for probable Alzheimer's Disease
* Completed semagacestat study LFAN or study LFBC through 88 weeks
* Must continue to have a reliable caregiver
* Capable of swallowing whole oral medication
* Agrees not to participate in other investigational compounds for the duration of study

Exclusion Criteria:

* Meets LFAN or LFBC study discontinuation criteria at the last visit of the LFAN or LFBC study
Investigate the Influence of Severe Hepatic Impairment on the Pharmacokinetics of Acalabrutinib and Its Metabolite

This study is investigate the influence of severe hepatic impairment on the pharmacokinetics of acalabrutinib and its metabolite.


Eligibility Criteria:
Inclusion Criteria

* Women must be of non childbearing status
* Understands the study procedures in the ICF and be willing and able to comply with the protocol.
* Willingness and ability to swallow study drug capsule.
* Adult men or women, 18 to 75 years of age

Hepatic-Impaired Subjects Only:

* Subject has a diagnosis of chronic, stable HI.
* Subject's score on the Child-Pugh scale must range from 10 to 15 at screening.

Exclusion Criteria

* History or presence of clinically significant or unstable medical or psychiatric condition or disease in the opinion of the PI.
* Dosed in another clinical trial within 28 days before dosing of study drug and throughout the current study.
* History or presence of drug abuse within 2 years before screening.
Trial With Bronchipret and Sinupret to Evaluate Acceleration of Mucociliary Clearance (MCC)

Proof of concept: Superiority of Bronchipret or Sinupret to placebo in respect to mucociliary clearance


Eligibility Criteria:
Inclusion Criteria:

1. Volunteers who have given their signed declaration of consent and have signed the data protection declaration
2. Male or female volunteers 25 - 40 years
3. Current smokers (5-20 cigarettes per day since 5 years at least)
4. Ability to taste sweetness of saccharin
5. Perception of sweetness within 30 minutes after placement of saccharin behind nasal valve

Exclusion Criteria:

1. Ciliary dyskinesia
2. Cystic fibrosis
3. COPD/emphysema
4. Asthma
5. Chronic rhinosinusitis
6. Acute respiratory tract infection within the last 6 weeks prior to enrolment
7. Septal or sinus surgery
8. Symptomatic allergic rhinitis
9. Known allergic rhinitis
10. Treatment with not-permitted previous or concomitant therapy
11. History of snuff consumption for longer than 1 month or intranasal consumption of recreational drugs such as cocaine or heroin for longer than 1 month
12. Any disease or condition that might affect the safety of the subject during the trial, according to the investigator's judgement
Diffuse Diabetic Maculopathy With Intravitreal Triamcinolone or Laser

This study compares the use of intravitreous triamcinolone and laser therapy to treat maculopahty in patients with type 2 diabetes mellitus in a short-tem period of 6 months

The purpose of this double blind randomized clinical trial was to compare the treatment of diffuse diabetic macular oedema with intravitreal triamcinolone and laser in patients with type 2 diabetes mellitus (DM), using a morphofunctional assessment. Patients with clinically significant diffuse macular oedema, previously untreated and with a macular thickness \>250 μm at optical coherence tomography (OCT) were randomized for treatment with Laser or intravitreal injection of Triamcinolone acetate. Optical coherence tomography (OCT), biomicroscopy, fundoscopy, fluorescein angiography, tonometry, scotometry, visual acuity and contrast acuities were performed at 0, 1, 3 and 6 months.

Eligibility Criteria:
Inclusion Criteria:

* patients with type 2 DM, diffuse macular oedema secondary to diabetic retinopathy, seen at the Centre of Reference for Diabetic Retinopathy at Hospital de Clinicas de Porto Alegre (HCPA) and at the Ophthalmology Outpatient Clinic at HCPA,

Exclusion Criteria:

* patients with type 2 DM and previous treatment of diffuse macular oedema secondary to diabetic retinopathy
Prediction and Management of Acute Kidney Injury With Explainable Artificial Intelligence

The goal of this clinical trial is to compare the occurrence of acute kidney injury (AKI) in inpatients when information from the 'PRIME solution' (AKI prediction program utilizing artificial intelligence) is provided. The main questions it aims to answer are: •\[When Artificial intelligence (AI) provides information regarding AKI occurrence prediction within 48 hours, what would change in the physician's behavior?\] •\[If provided with AI information, what would be the incidence of AKI, severe AKI (stage 2 or 3), kidney replacement therapy, and changes in mortality during hospitalization?\] In the case of the intervention group that receives AI information, autonomous treatment is conducted by referring to AI prediction information. Researchers will compare it with a usual-care group that does not receive AI prediction results.

The investigators designed a prospective, investigator-initiated, single-center, single-blinded, randomized controlled study with two experimental groups. A total of 1438 participants with hospitalized patients will be enrolled and randomized into two groups; intervention or usual-care groups. The investigators will apply an AKI prediction model based on the patient's demographic. The investigators will collect data on vital signs, laboratory test results, medication history, and surgical records. The investigators provide information on whether AKI develops within 48 hours and the top 10 explanatory factors for predicting AKI to the physician. The intervention group receives the prediction results daily until the patient is discharged or up to 7 days after admission. The usual-care group does not receive analysis results.

Eligibility Criteria:
Inclusion Criteria:

* Inpatients aged \> 18 years
* Admitted to the Department of Nephrology, Geriatrics, Urology, Surgery, and Orthopedics
* written consent

Exclusion Criteria:

* Patients with a scheduled hospital stay of 2 days or less
* Patients who have been hospitalized for more than 8 days since the date of hospitalization
* Patients scheduled to be discharged the next day
* Patients with last measured serum creatinine greater than 4.0 mg/dL or less than Estimated Glomerular Filtration Fate Chronic Kidney Disease Epidemiology Collaboration (eGFR-CKD-EPI) 15 ml/min/1.73 m2
* Patients undergoing dialysis (Hemodialysis, peritoneal dialysis) due to end-stage renal disease
* Declined to participate
Diagnostic Accuracy of Teledermatology in Patch Test Interpretation

The goal of this clinical trial is to learn about accuracy of teledermatology in patch test interpretation in patch test\&amp;#39;s patients population. The main question\[s\] it aims to answer are:

* Accuracy of teledermatology in patch test interpretation by dermatologist
* Accuracy of teledermatology in patch test interpretation by Residency
* Accuracy of teledermatology in patch test interpretation by Scitentist
* The factors influencing the interpretation of remote dermatologic patch test results from photographs of patients.

Participants will

* do patch test in Siriraj hospital and come to follow up at 48 hr and 72 hr for interpretation of patch test
* take a photo at home and sent the photo to contact clinic via online application or email on the day of 48 hr, 72 hr and 7 days following the interpretation of patch test

Researchers will compare in-clinic group and telephoto group to see if the accuracy of patch test interpretation is more or less.


Eligibility Criteria:
Inclusion Criteria:

* Participants in the study must be 18 years of age or older.
* Participants in the study must have undergone patch testing for contact allergies.
* Participants in the study should be able to take photos of test results on their back and/or arms using a mobile phone or personal camera, and send them to the researcher through the Line application and/or email within 48 hours, 96 hours, and on the 7th day.
* Participants in the study should be able to read and comprehend the questionnaire in Thai and respond to the questionnaire independently.
* Participants in the study must have at least one positive result in the patch testing.
* Participants in the study must provide consent to participate in the study by signing the informed consent document.

Exclusion Criteria:

* Participants in the study who are unable to attend follow-up appointments for result assessments.
Do Antibiotics Prevent Anal Fistulae Formation?

Purpose: This randomized study assesses the effects of antibiotics on the formation of fistulae after drainage of anorectal abscesses.

Methods: Patients who underwent abscess drainage in 3 major colorectal units between September 2005 and January 2008 were included. Previous anorectal surgery history, immunecompromised states, pregnancy, inflammatory bowel disease, antibiotic usage prior to surgery and the presence of an anal fistulae at the time of surgery were the exclusion criteria. Patients were randomized and given either placebo or amoxicillin-clavulanic acid combination treatment for 10 days. Patients were followed one year for perianal fistulae formation.


Eligibility Criteria:
Inclusion Criteria:

* Presence of anorectal abscess

Exclusion Criteria:

* Allergy to penicillin derivatives
* Treatment with any antimicrobial agent in the week before enrolment
* Recognized other infection at the time of surgery
* Previous anorectal surgery
* Presence of inflammatory bowel disease
* Suspicion of Fournier's gangrene
* Secondary and recurrent anorectal abscesses
* Presence of an internal opening
* Any additional surgical procedure performed in the same session or during follow-up
* Antibiotic prophylaxis indicated for another reason
* Immunosuppressive and/or anticoagulant drug treatment being taken at the time of surgery
* Diabetes mellitus
* Known chronic disabling disease
* Pregnancy
* Lactation.
Study Of Adults And Adolescents With Vasomotor Rhinitis

The primary objective of this study is to compare the efficacy and safety of GW685698X 100mcg once daily (QD) aqueous nasal spray with vehicle placebo nasal spray in adult and adolescent subjects (12 years of age and older) with vasomotor rhinitis (VMR).


Eligibility Criteria:
Inclusion criteria:

* Must be outpatients.
* Diagnosis of VMR.
* Literate in English or native language.

Exclusion criteria:

* Significant concomitant medical condition.
* Use corticosteroids or other allergy medications during the study.
* Used tobacco products within the past year.