cyrilzakka/clinical-trials huggingface dataset:
A Study of Participants With Initially Unresectable Hepatocellular Carcinoma That is Treated With Atezolizumab and Bevacizumab Plus Transarterial Chemoembolization

This is a multicenter, retrospective, observational cohort study to describe the effectiveness and safety of Atezo+Bev plus Transarterial Chemoembolization (TACE) among adult patients with unresectable hepatocellular carcinoma (HCC) in real-world clinical practice in China. Eligible patients diagnosed with unresectable HCC initiating the Atezo+Bev and TACE between 28 October 2020 and 31 December 2023 will be included in this study.


Eligibility Criteria:
Inclusion criteria:

1. Initiating both Atezo+Bev and TACE between 28 October 2020 and 31 December 2023 regardless of sequencing, number of doses/cycles, and type of TACE
2. At least one dose of Atezo+Bev and one cycle of TACE spaced no longer than 4 weeks
3. Diagnosed with HCC and considered as unresectable by any of the below criteria:

   * Predicted insufficient future liver remnant volume (FLRV) after liver resection, OR
   * Predicted unattainable safe negative tumor margin resection, i.e., R0 resection, OR
   * "Unresectable" directly documented in the medical records

Exclusion Criteria:

1. No visit record after initiating both Atezo+Bev and TACE
2. Treated with other systemic therapy or resection against HCC
3. Diagnosed with concomitant cancer except for basal cell carcinoma
4. Advanced portal vein tumor thrombosis (PVTT) as defined by: Grade Vp 4, Cheng's Classification Type III or IV, or presence of a tumor thrombus in the main trunk of the portal vein, a portal vein branch contralateral to the primarily involved lobe, or superior mesenteric vein
5. China Liver Cancer (CNLC) Stage IIIb, or history of extrahepatic metastasis
6. Terminal-stage HCC
Exploring Breathing Patterns

Study Title Exploring patterns of speech and breathing to indicate the presence of obstructive respiratory disease.

Study Design Prospective Case Control Study Study Participants Participants will be patients attending the respiratory physiology clinic at the Cardiopulmonary Unit, Prince Charles Hospital for an assessment of their lung function. In addition a cohort of control participants without obstructive respiratory disease will be recruited with the assistance of the British Lung Foundation charity.

Planned Size of Sample (if applicable) We have received funding for 52 ½ day sessions and we plan to recruit on average 2 participants per session. As such we aim to recruit a minimum of 100 participants. In addition we are working with the British Lung Foundation to recruit a smaller Cohort of control participants and aim to recruit a minimum of 25 control participants.

Planned Study Period Jan 2019 - Aug 2019 Research Aim(s) This primary objective of this novel study it to create an anonymised database of speech patterns of patients with chronic respiratory disease and healthy aged matched controls for comparison with lung function and medical history.

The primary aims are to:

* Collect breathing patterns from individuals under a range of talking modalities
* Understand how easy it is to gather short speech recordings
* Explore the preferences of patients to be recorded talking


Eligibility Criteria:
6.1.2 Inclusion criteria Patient Participants

1. Adult patient \>18 years old referred for spirometry in the Respiratory Physiology Clinic at Prince Charles Hospital;
2. Clinically defined obstructive or restrictive respiratory disease (indicated by spirometry)
3. Clinically stable (indicated by being able to undergo spirometry)
4. No significant unstable disease co-morbidities (indicated by being able to undergo spirometry)
5. Capable of providing informed consent.
6. Willing to take part in all study measurements.
7. The speaking exercise will be conducted in English on this study.
8. Participants are not taking part in any other research. 6.1.3 Inclusion criteria Control Participants

1. No obstructive or restrictive respiratory disease (indicated by spirometry) 2. Clinically stable (indicated by being able to undergo spirometry) 3. No significant unstable disease co-morbidity's (indicated by being able to undergo spirometry) 4. Capable of providing informed consent. 5. Willing to take part in all study measurements. 6. The speaking exercise will be conducted in English on this study. 7. Participants are not taking part in any other research.

6.1.4 Exclusion criteria for both Patient and Control Participants

1. Any form of challenge testing in the Respiratory Physiology Department involving salbutamol.
2. Severe Sensory and/or Cognitive Impairment
3. Inability to complete study measurements
The Effect of AI-based Microbiome Diet on IBS-M Symptoms

This study was designed as a pilot, open-labelled study. We enrolled consecutive IBS-M patients (n=25, 19 females, 46.06 ± 13.11 years) according to Rome IV criteria. Fecal samples were obtained from all patients twice (pre- and post-intervention) and high-throughput 16S rRNA sequencing was performed. Patients were divided into two groups based on age, gender and microbiome matched.

Six weeks of AI-based microbiome diet (n=14) for group 1 and standard IBS diet (Control group, n=11) for group 2 were followed. AI-based diet was designed based on optimizing a personalized nutritional strategy by an algorithm regarding individual gut microbiome features. An algorithm assessing an IBS index score using microbiome composition attempted to design the optimized diets based on modulating microbiome towards the healthy scores. Baseline and post-intervention IBS-SSS (symptom severity scale) scores and fecal microbiome analyses were compared.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with IBS by a medical doctor.
* BMI between 18.5-39.9 kg/m2
* No hospitalization in the last 12 months.
* No antibiotics use in the last 6 months.
* No cancer diagnosis by a medical doctor.
* No chronic complex diseases including diabetes and hypertension.

Exclusion Criteria:

* Not being diagnosed with IBS.
* Having a diagnosed chronic disease.
* Having a diagnosed mental or psychiatric disorder .
* Having endocrinal disorders.
* Being pregnant.
* Antibiotics use in the last 6 months.
* Hospitalization history in the last 12 months.
* Drug use.
* Being morbid obese.
Early Functional Outcomes After Closed Reduction With Pinning Versus Open Reduction Internal Fixation of Wrist Fractures

The purpose of this study is to compare early return to function in patients treated with closed reduction percutaneous pinning and open reduction internal fixation in displaced fractures of the distal radius.

Hypothesis: Wrist range of motion, grip strength and outcome at 2-3 months after injury are better in patients treated with open reduction, internal fixation (ORIF) than in patients treated with closed reduction percutaneous pinning techniques (CRPP). In addition patients treated with ORIF return to work at faster rates.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or greater
* Patient functions independently
* Dorsally displaced, extra-articular fracture (Colles' fracture); or simple intra-articular fracture with a single split between the scaphoid and lunate facets.
* Isolated injury (no other injuries).
* One of the following criteria:

Substantial initial displacement

* Greater than 20 degrees dorsal angulation of the articular surface on the lateral view.
* Greater than 100% loss of apposition.
* Greater than 5 millimeters of shortening by ulnar variance on the posteroanterior radiograph.
* Greater than 2 millimeters articular incongruity (step or gap).
* Both dorsal and volar comminution. Inadequate initial manipulative reduction
* Greater than 5 degrees of dorsal angulation of the articular surface on the lateral radiograph.
* Greater than 3 millimeters of radial shortening by ulnar variance on the posteroanterior radiograph.
* Greater than 2 millimeters articular incongruity.
* Bayonett apposition of the volar cortex.
* Less than 15 degrees of ulnarward inclination of the articular surface in the posteroanterior radiograph. Loss of reduction within 3 weeks of injury.
* Any of the following changes in alignment from the initial post- reduction radiographs qualify:

  * 5 degrees or greater loss of palmar tilt of the articular surface on the lateral radiograph.
  * 2 millimeters or greater loss of radial height by ulnar variance on the posteroanterior radiograph.
  * 5 degrees or greater loss of ulnarward inclination of the articular surface of the distal radius on the posteroanteriorradiograph.
  * 2 millimeters or greater articular incongruity.

Exclusion Criteria:

* More complex articular fractures (i.e. anything more than a simple sagittal split between the scaphoid and lunate facets).
* Volarly displaced fractures.
* Infirm patients.
* Patients that rely on others for basic functional activities.
* Open fractures
* Fractures associated with neurovascular injury.
* Fractures associated with major head, neurological, or visceral injuries that will inhibit the ability to participate in a structured exercise program.
* Associated musculoskeletal injuries to the same arm.
Paulista Cardiovascular Surgery Registry I

Cardiovascular diseases represent the greatest burden of morbidity and mortality for the health system and cardiac surgery has an important impact on their resolutivity. The association and correlation of patients' demographic and clinical relevant information with the resources required for each stratum represent the possibility to adapt, improve and innovate into the healthcare programs. This project aims to remodel the "InsCor" risk score for the formulation of the SP- SCORE (Sao Paulo System for Cardiac Operative Risk Evaluation) in order to better reflects the complexity of cardiac surgical care, The participating hospitals include the Health Technology Assessment Centers in of the Health Secretarlat'HTA Network of São Paulo State (HTA-NATSs / SES-SP). The SP-SCORE will use 10 variables of the InsCor model and others 8 variables with presumed influence in Brazil. The primary endpoints are morbidity and mortality. This project will contribute for the SUS- SP regionalized health-care (RRAS) sustainability and financing of the CABG and/or heart valve surgery programs promoting equitable allocation, increasing access and effectiveness, as well as characterizing the magnitude of available resources and its impact. (AU)


Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent isolated coronary artery bypass grafting (CABG) surgery, mitral valve surgery, aortic valve surgery, combined mitral + aortic valve surgery, and CABG + heart valve surgery

Exclusion Criteria:

* Patients operated on in an emergency or rescue situation and who underwent percutaneous or transcatheter procedures were excluded from this analysis.
A Study of TQB3473 Tablets in Subjects With Relapsed or Refractory Hematological Malignancies

This is a study to evaluate the maximum tolerated dose (MTD), occurrence of all adverse events (AE) and serious adverse events (SAE) , pharmacokinetic parameters and antitumor effect of TQB3473 tablets in Chinese adult patients with Relapsed or refractory hematological malignancies.


Eligibility Criteria:
Inclusion Criteria:

-1.Understood and signed an informed consent form. 2. Relapsed or refractory malignant hematological tumors. 3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1; Life expectancy ≥12 weeks.

4. Has at least one measurable lesion. 5. Adequate organ system function. 6. Patients need to adopt effective methods of contraception.

Exclusion Criteria:

* 1. Severe hypersensitivity to the drug or ingredients. 2. Has received chemotherapy, radiotherapy, immunotherapy or any other anti-tumor therapy within 14 days before the first dose.

  3. Has received spleen tyrosine kinase (SYK) inhibitors. 4. Has to use ≥ 10 mg/day glucocorticoid prednisone. 5. Has received BTK inhibitors and PI3K inhibitors before the first dose. 6. Has received allogeneic hematopoietic stem cell transplantation. 7. Has received autologous hematopoietic stem cell transplantation within 12 weeks before the first dose.

  8. Has any acute or chronic gastrointestinal diseases. 9. Has primary central nervous system lymphoma, or brain metastases with clinical symptoms, spinal cord compression, cancerous meningitis.

  10. Intermediate-risk or high-risk myelodysplastic syndrome. 11. Pregnancy and lactation women. 12. Has any serious and/or uncontrollable disease. 13. Has active autoimmune disease and received immunosuppressive therapy. 14. Has a history of neurological or mental disorders. 15. Has uncontrollable systemic bacterial, fungal or viral active infections 16. The toxicity of previous antitumor treatment is not recovered to ≤ grade 1. 17. Has other malignancies. 18. Has received surgery within 4 weeks before the first administration. 19. Has participated in any other clinical trials. 20. According to the judgement of the investigators, there are other factors that may lead to the termination of the study.
Alzheimer's Disease - Input of Vitamin D With mEmantine Assay

The purpose of this study is to compare the effect after 24 weeks of the oral intake of vitamin D3 (cholecalciferol) with the effect of a placebo on the change of cognitive performance in patients suffering from moderate Alzheimer's disease or related disorders (ADRD) and receiving memantine.

Current treatments for Alzheimer's disease and related disorders (ADRD) are symptomatic and can only temporarily slow down ADRD. Future possibilities of care could rely on multi-target drugs therapies that address simultaneously several pathophysiological processes leading to neurodegeneration. We hypothesized that the combination of memantine with vitamin D could be neuroprotective in ADRD, thereby limiting neuronal loss and cognitive decline.

The primary objective of this trial is to compare the effect after 24 weeks of the oral intake of vitamin D3 with the effect of a placebo on the evolution of cognitive performance in patients suffering from moderate ADRD and receiving memantine.

The secondary objectives of the study are as follows:

* To compare the effect after 12 weeks of the oral intake of vitamin D3 with the effect of a placebo on the evolution of cognitive performance in patients suffering from moderate ADRD and receiving memantine.
* To compare the effect after 12 and 24 weeks of the oral intake of vitamin D3 with the effect of a placebo on the evolution of functional abilities in patients suffering from moderate ADRD and receiving memantine.
* To compare the effect after 12 and 24 weeks of the oral intake of vitamin D3 with the effect of a placebo on the evolution of postural and gait performance in patients suffering from moderate ADRD and receiving memantine.
* To determine the compliance to treatment and tolerance of the oral intake of vitamin D3 in patients suffering from moderate ADRD and receiving memantine.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 60 years
* Diagnosis of moderate Alzheimer's disease or related disorders (DSM-IV/NINCDSADRDA) with a score of Mini-Mental State Examination (MMSE) between 10 and 20 inclusively
* To have hypovitaminosis D (i.e., serum 25-hydroxyvitamin D \[25OHD\]concentration \< 30 ng/mL)
* To have no hypercalcemia (defined as serum calcium concentration ≥ 2,65 mmol/L)
* To have given and signed an informed consent form to participate in the trial (or informed consent form obtained from the trusted person or legal representative, as appropriate)
* To be affiliated to French Social Security

Exclusion Criteria:

* The use of standard antidementia drugs (i.e., anticholinesterasics, memantine, or vasodilatators) in the past 60 days
* Severe hepatic or renal failure
* Severe, unstable or poorly controlled medical conditions at the time of the inclusion
* Other cognitive disorders (untreated dysthyroid, deficiency in vitamin B9 or B12, chronic ongoing ethylism, history of syphilis, stroke, delirium revealed with the Confusion Assessment Method (CAM), severe depressive symptomatology (Geriatric Depression score ≥ 10/15))
* Contra-indications to memantine or vitamin D
* Enrollment in another simultaneous clinical trial
Study of the Relation Between Lipid Myocardial Overload Evaluated by Cardiac Magnetic Resonance Imaging (MRI), Alteration of Longitudinal Myocardial Deformations by Echocardiography, and Clinical Achievements (Functional, Biological and Electrical) in Fabry Disease, and Its Outcomes.

Anderson-Fabry disease is a genetic lysosomal storage disease, linked to chromosome X (gene GLA), responsible of enzyme synthesis deficit in α-galactosidase A with intracellular sphingolipids accumulation and multiorganic achievement.

If renal complication is principally responsible of the pejorative evolution of the disease, it may also exist a cardiac achievement, symptomatic or not (heart failure symptoms including dyspnea, conduction abnormalities, supra-ventricular and ventricular arrhythmias), with or without left ventricular hypertrophy (LVH).

Administration of agalsidase-α or ß, a genetic engineering synthetic equivalent of the deficient enzyme, should significantly slow disease evolution indeed reduce LVH.

Some patients with Fabry disease without LVH should present, compared to healthy subjects, indirect early markers of intramyocyte lipid overload:

* in echocardiography, longitudinal myocardial deformation (strain) should be altered while ejection fraction is preserved, and
* in cardiac MRI, T1 mapping should be reduced1. This was also previously demonstrated in Fabry patients with LVH2. However, are these abnormalities of longitudinal deformation in echocardiography and of T1 mapping in MRI correlated to the presence of pejorative cardiac markers (such as clinical and functional tolerances, Brain Natriuretic Peptide (BNP) level and electrical complications)?


Eligibility Criteria:
Inclusion Criteria:

Patients group :

* Adults (age ≥18 years), male and female.
* Patients diagnosed genetically having Fabry disease, with or without clinical cardiac symptoms and with different evolution stades of the disease.
* For female in age of procreation, efficient contraception will be required and a negative pregnancy test.
* Oral agreement of the patient after having read information note.
* Patient affiliated to social national Security registry.

Healthy volunteers group:

* Adults (age ≥18 years), male and female.
* Unscathed of cardiovascular pathologies and cardiovascular risk factors.
* For female in age of procreation, efficient contraception will be required and a negative pregnancy test.
* Oral agreement of the patient after having read information note.
* Patient affiliated to social national Security registry.

Exclusion Criteria:

For the 2 groups :

* Extracardiac pathology limiting life expectancy \<1 year (cancer).
* Pregnant or breastfeeding female.
* Claustrophobia.
* Mechanical prosthetic valve.
* Severe obesity \> 140 kg
* Patients with intracardiac device (implantable cardiac defibrillator, pace maker, resynchronisation), surgical clips not MRI compatible, neurosensorial stimulators, cochlear implants, ferromagnetic foreign bodies (ocular, cerebral), neurosurgical derivation valves)
* Impossibility to provide consent or refusal to sign the consent form.

For the patients:

- Previous history of hypersensitivity to gadolinium.
Evaluation of the Efficacy of 0.08% Tacrolimus Nanoencapsulated Aqueous Solution Spray Vs. 0.1% Free Tacrolimus Commercial Ointment in the Treatment of Oral Lichen Planus

The goal of this clinical trial is to assess the efficacy of different formulations of the drug tacrolimus in treating patients with oral lichen planus. The main questions it aims to answer are:

* Does the nanoencapsulation of tacrolimus in an aqueous solution, used as a spray, improve the effectiveness of treating oral lichen planus lesions compared to the commercially available tacrolimus ointment?
* Which tacrolimus formulation can keep participants free of lesions for longer periods?

Researchers will compare a spray of 0.08% tacrolimus nanoencapsulated aqueous solution against a 0.1% free tacrolimus commercial ointment to determine which formulation is more effective.

Participants will:

* Apply one of the proposed tacrolimus formulations twice a day for 1 month.
* Visit the clinic once every 2 weeks for checkups and tests, with follow-ups extending up to 3 months.


Eligibility Criteria:
Inclusion Criteria:

* individuals with a clinical and histopathological diagnosis of erosive/ulcerative/atrophic and symptomatic oral lichen planus, according to the criteria established by the American Academy of Oral and Maxillofacial Pathology

Exclusion Criteria:

* History of oral cancer;
* history of allergic reactions to tacrolimus or any other component of the formulas;
* history of organ transplant or have a systemic condition that induces significant immunosuppression;
* be pregnant or lactating.
Antenatal and Postnatal Care Research Collective - Household Survey (ARCH)

The overarching goal of the ARCH Survey is to establish a prospective longitudinal pregnancy surveillance study in Lusaka, Zambia, to precisely characterize the pregnancy rate and outcomes of women of reproductive age prior to, during, and following pregnancy and to investigate the structural, sociodemographic, and clinical covariates that contribute to adverse outcomes in each reproductive epoch.

The overall purpose of this study is to better understand the health and well-being of women before and after they become pregnant and of their infants. This information will contribute to the understanding of the health needs of women and their children, which may help doctors provide mothers and children with better care in the future.

Participants in this study will be visited four times a year (every 3 months) for up to three years in total. At each visit a review of their medical records, a brief physical exam and urine pregnancy test will be conducted. Participants will also answer survey questions and self-collect vaginal swabs for future testing. We will enroll up to 5,500 women and include any infants that are born to them during their study participation.

Eligibility Criteria:
We will initially obtain verbal consent from the head of household (HoH), defined as an available adult (\> 18 years old) who is able to provide information about household composition for pre-screening purposes. We will then identify potentially eligible women of reproductive age within each household and invite them to complete study screening procedures.

Women of reproductive age eligibility criteria

Inclusion criteria:

* Verbal consent obtained from head-of-household
* 15-49 years of age and a member of household in the catchment area
* Willing and able to provide written informed consent or assent with next-of-kin consent
* Willing to undergo study procedures

Exclusion criteria:

Any other condition (social or medical) that, in the opinion of the study staff, would make participation unsafe or complicate data interpretation. Study staff may note physical, psychological, or social conditions not explicitly stated in the eligibility criteria that could make some women poor candidates for study participation.