cyrilzakka/clinical-trials huggingface dataset:
Serplulimab Combined With Anti-VEGF Antibody in Advanced Lung Adenocarcinoma

In order to further evaluate the efficacy of immunotherapy combined with antivascular therapy in the real world, we used Serpluimab combined with Bevacizumab and platinum-based chemotherapy in previously untreated EGFR/ALK-negative advanced non-squamous NSCLC patients, to evaluate the efficacy and safety of this regimen.


Eligibility Criteria:
Inclusion Criteria:

* Fully understood this study and voluntarily signed the informed consent form (ICF);

  -≥ 18 years and ≤ 75 years old;
* ECOG score 0-1;
* Non-squamous NSCLC;
* stage IV;
* EGFR and ALK negative;
* Treatment-naive;
* According to RECIST1.1 criteria, there are measurable or evaluable lesions.

Exclusion Criteria:

* Tumor histology or cytology confirmed that it was associated with squamous cell carcinoma or small cell lung cancer;
* Patients with severe organ dysfunction were indicated by examination, Exclude subjects with any active, known or suspected autoimmune diseases;
* The estimated survival time is less than 3 months.
The Effect of Laughter Yoga on Psychological Wellness

The aim of the thesis is to determine the effect of laughter yoga on psychological well-being in women diagnosed with Gynecological Cancer.The population of the study consists of the patients registered in the oncology service of Tepecik Training and Research Hospital in Izmir. The study was carried out with 70 patients, 35 of which were interventions and 35 controls, who were treated in the oncology service of Izmir Tepecik Training and Research Hospital.

The aim of the thesis is to determine the effect of laughter yoga on psychological well-being in women diagnosed with Gynecological Cancer.The population of the study consists of the patients registered in the oncology service of Tepecik Training and Research Hospital in Izmir. The study was carried out with 70 patients, 35 of which were interventions and 35 controls, who were treated in the oncology service of Izmir Tepecik Training and Research Hospital between October 1, 2021 and April 1, 2022. In order to measure the effect of laughter yoga on psychological well-being, the Psychological Well-Being Scale was applied to both the experimental group and the control group patients.

Eligibility Criteria:
Inclusion Criteria:

* • Volunteering to participate in the study

  * Having the ability to read, write, speak and understand Turkish
  * Being diagnosed with gynecological cancer
  * Being in Stage II or Stage III of the gynecological cancer staging processes
  * The patient's internet access

Exclusion Criteria:

* The patient is Stage 4
* Lack of internet access
Impact of Socioeconomic Status and Oral Hygiene Practice on Periodontal Health of Egyptian Adults

evaluation the relationship between the socioeconomic status and periodontal health of Egyptian adults.

It is a cross-sectional study for evaluation and assessment of periodontal health, socioeconomic status and oral hygiene measurements among Egyptian adults recruiting from the outpatient clinic and the payed treatment clinics at faculty of Dentistry, Cairo University.

The faculty of Dentistry, Cairo University is an open public facility, a tertiary healthcare and a referral center.

Eligibility Criteria:
Inclusion Criteria:

* -Patients whose age is 18-70 years old recruiting from the outpatient clinic and the payed clinic
* Provide informed consent.

Exclusion Criteria:

* Patients having problem in opening their mouth or undergoing intermaxillary fixation where oral examination will not be possible.
* Patients diagnosed with psychiatric problems or intoxicated with alcohol or drugs.
* pregnant patients.
* patients undergoing orthodontic treatment.
* patients who had undergone periodontal treatment over the past six months.
A Study of Early Immunologic Response in Asian Patients With Chronic Hepatitis B, Treated With Pegasys (Peginterferon Alfa-2a (40KD)), Nucleoside Analogues, or Both

This open-label, randomized, parallel-arm study will assess the early immunologic response in treatment-naïve Asian male patients with chronic hepatitis B after initiation of treatment with Pegasys or tenofovir or Pegasys plus tenofovir. Patients will be randomized to one of 4 cohorts to receive either Pegasys (360mcg subcutaneously weekly) or tenofovir (300mg orally daily) or both or no treatment for 2 weeks. After 2 weeks on study treatment, patients may opt to receive standard of care treatment with Pegasys. Target sample size is \<50.


Eligibility Criteria:
Inclusion Criteria:

* male adults of Southeast and/or East Asian origin, 18-55 years of age
* HBeAg-positive chronic hepatitis B
* detectable HBV DNA

Exclusion Criteria:

* prior antiviral therapy for chronic hepatitis B
* evidence of bridging fibrosis, cirrhosis or decompensated liver disease
* positive test at screening for HAV (IgM), HCV, HDV or HIV
* history or evidence of medical condition associated with chronic liver disease
* antineoplastic or immunomodulatory treatment \</=6 months prior to first dose of study drug
Validation of a Screening Tool for Swallowing Disorders for the Elderly

Swallowing disorder, or dysphagia, is a lack of protection of the airways during the passage of the food bolus towards the esophagus. Swallowing disorder is characterized by a feeling of discomfort when swallowing, difficult swallowing in elderly people or a blockage felt during the progression of food between the mouth and the stomach, sometimes with falsities. These disorders can be the cause of a loss of appetite and a reduction in food consumption in older people.

In the most serious cases, they can lead to aspiration, weakening the pulmonary passages and possibly leading to suffocation.

Swallowing disorders constitute an important public health problem due to their prevalence among the elderly. Many early readmissions could be avoided thanks to better quality of care in these patients.

In the elderly, the number of comorbidities and the multiplicity of medications and drug intake increase the incidence of swallowing disorders in this population. They constitute a common pathology, probably underestimated and underdiagnosed in the geriatric population.

Given the aging of the Martinique population, it is appropriate to offer an easy-to-use, quickly achievable tool for diagnostic purposes, making it possible to quickly identify potential swallowing disorders, and therefore to anticipate meal intake, and on the adaptation of the prescription to a medicinal alternative (before any food or medication taken during hospitalization).

In the Geriatric Short-Stay Unit of the Martinique University Hospital, a tool called "Deglut'G", was developed, and has been used since 2015, in order to allow caregivers a rapid, reliable and relevant assessment of swallowing disorders in the elderly, in order to guide care and medication alternatives.It now appears important to validate this tool, by comparing it with the results of examinations of swallowing disorders obtained from a speech-language pathologists (SLPs) and an ENT doctor.


Eligibility Criteria:
Inclusion Criteria:

* Person aged 75 or over hospitalized in the Geriatric Short-Stay Unit,
* Person having been informed of the research,
* Person having given free written and informed consent,
* Person affiliated to a social security scheme.

Exclusion Criteria:

* Person unable to take the tests,
* Person with an oral condition that hinders normal swallowing (stomatitis, gingivitis, etc.),
* Elderly person under legal protection, under guardianship or curatorship,
* Person who refused to participate in the study.
Recovery Profiles in Patients With SARS-CoV-2 Outcomes Undergoing Rehabilitation

COVID19 patients survivors, after discharge from hospital show reduced lung function and reduced ability to exercise. Furthermore, mental health problems including stress, anxiety and depression and a low quality of life were observed. The prospective observational study involves COVID19 patients who have needed rehabilitation at the University Hospital of Ferrara. Patients receive comprehensive rehabilitation based on their specific needs in both acute and subacute rehabilitation. At the end of hospital rehabilitation, patients are offered a program to be carried out at home for both physical and psychological problems. A range of demographic and clinical data will be collected. Patients will also undergo a battery of functional, cognitive and psychological tests at 12, 26 and 52 weeks from the infection onset. Moreover, a specific assessement (both clinical and instrumental) on the pain symptom experienced, where present, will be done.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of covid19 (WHO criteria);
* indication for respiratory and / or neuromotor rehabilitation treatment

Exclusion Criteria:

* cognitive or communication impairment precluding informed consent
* severe medical conditions
* pregnancy
Outcome Prediction in Head&Neck Cancer Patients After Radiotherapy

The primary and general objective of the clinical introduction of the Standard Follow-up Program (SFP) as the current standard of care is to improve the quality of radiotherapy for head and neck cancer patients by reducing radiation-induced side effects without hampering treatment efficacy in terms of locoregional tumour control and overall survival and to systematically evaluate the beneficial effect of newly introduced radiation technology for this particular group of patients. The clinical introduction of the SFP will allow for a systematic and broad scale quality improvement cycle for head and neck cancer patients treated with radiotherapy. In fact, this methodology can be considered a kind of quality circle for the clinical introduction of new radiation techniques, aiming at continuous efforts for further improvement.

For head and neck squamous cell carcinoma (HNSCC), radiation therapy is one of the mainstays of therapy either as definitive therapy alone or in combination with systemic therapy or following surgical resection as postoperative treatment. Nowadays there's great attention for personalized medicine which aims at offering a patient the treatment that best suits the individual patient and its tumor characteristics. To apply personalized therapy, we need accurate outcome prediction models for disease control, treatment related toxicity and quality of life.

The main factors used for predictive/prognostic nomograms are clinical factors, like patient-, tumor- and treatment related factors (1). Standard examples of these include age, gender, co-morbidity, smoking history, hemoglobin levels, tumor site, TNM stage, tumor volume, HPV-status, and others. For larynx cancer the nomogram was made publicly available on www.predictcancer.org.

However, we anticipate that other factors will contribute to the (improvement of) prediction models. These factors may include genomic analysis of tumor specimens, quantitative image analysis (radiomics), blood biomarkers, and/or tumor-tissue markers (2).

In addition, treatment-related parameters also need to be considered and these not only include factors like overall treatment time, use of systemic therapy, prescribed radiation dose and fraction dose. With new techniques using EPID dosimetry, it is now possible to measure the delivered radiation dose and compare this to the prescribed dose (3,4). This offers the potential to apply Dose Guide RadioTherapy (DGRT), which especially in HNSCC may have a large impact, because anatomical changes during fractionated therapy are known to occur and lead to dose changes to targets and organs at risk (5,6).

The final objective of this study is to integrate all potential prognostic factors and develop reliable nomograms both for tumor control as well as complications.

Eligibility Criteria:
Inclusion Criteria:

All patients planned for curatively intended primary or postoperative radiotherapy

Exclusion Criteria:

All patients planned for palliative radiotherapy
TMS Augmented Exposure Therapy

This study investigates the beneficial effects of prefrontal brain stimulation (with a facilitating TMS protocol) before exposure therapy in acrophobic patients. The two exposure sessions were realized in virtual reality. Before and after therapy, the phobic symptoms were measured on a subjective, behavioral and physiological level. The placebo-controlled single blinded study includes 50 phobic patients, which were randomized into verum or sham TMS.


Eligibility Criteria:
Inclusion Criteria:

Criteria for a simple phobia: specific heights

Exclusion Criteria:

Objective tinnitus Involvement in psychiatric treatments Clinically relevant psychiatric comorbidity Clinically relevant unstable internal or neurological comorbidity History of or evidence of significant brain malformation or neoplasm, head injury Cerebral vascular events Neurodegenerative disorder affecting the brain or prior brain surgery Metal objects in and around body that can not be removed Pregnancy Alcohol or drug abuse history of seizures
Treatment of Metastatic Tumors of the Urogenital Area With Cytokine-induced Killer Cells

Treatment of metastatic tumors of the urogenital area with cytokine-induced killer cells

Treatment of metastatic tumors of the urogenital area using autologous cytokine-induced killer cells

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed diagnosis of pTa metastatic tumors of the urogenital area;
* Patient who require repetitive transurethral resection;
* Expression of muc-1/wt-1 by the tumor;
* EGOC 0-3;

Exclusion Criteria:

* any medical condition which can be associated with the high risk for the patient;
* pregnancy/lactation;
* chronic infections, including hepatitis B/C, tuberculosis, HIV
Pharmacokinetics of Lu AF35700 in Subjects With Renal Impairment

This study will evaluate the pharmacokinetics of Lu AF35700 after a single dose tablet to subjects with renal impairment (kidney insufficiency) and compare that with healthy subjects

If the initial data shows a substantial effect in subjects with severe renal impairment, the study will be expanded to include subjects with intermediate level (mild and moderate) of renal impairment.

Eligibility Criteria:
Inclusion Criteria:

-Healthy subjects: The subject has a Glomerular Filtration Rate as based on creatinine clearance (CLCr) ≥90 mL/min (estimated by the Cockcroft-Gault method)

-Subjects with renal impairment: The subject has any form of renal dysfunction which includes polycystic kidney disease

The subject is classified as having renal impairment at Screening according to Cockroft-Gault method for estimating creatinine clearance:

Severe: CLCr ≤ 29 mL/min Moderate: 30 mL/min ≤ CLCr ≤ 59 mL/min Mild: 60 mL/min ≤ CLCr ≤ 89 mL/min

Exclusion Criteria:

-The subject has previously been dosed with Lu AF35700
Embryo Culture At a Constant Temperature of 36.6°C or 37.1°C

On the day of oocyte retrieval, participants will be randomized to stable culture at 37.1°C or 36.6°C with the ultimate aim of finding a difference in clincial pregnancies.

A previous study in our centre analysed stable embryo culture at 36.6°C and 37.1°C, on sibling oocytes. The primary aim was to analyse possible differneces in embryo development (utilization rate) up to day 5/6. In this study, the investigators found a high difference in clinical pregnancy rate between both groups (46.4% versus 77.4%). Since this study was not powered to find differences in clincial pregnancy rates between both groups, this RCT was especially powered as a superiority trial to find differences in clincial pregnancy rates between both groups. On the day of oocyte retrieval, patients will be allocated to culture at one of both temperatures.

Eligibility Criteria:
Inclusion Criteria:

* Day 5 transfer
* Single embryo transfer
* Only ejaculated sperm (fresh or frozen, autologous or heterologous)
* BMI \<35
* Age \<40 years
* Cycle rank \<3 for the current child
* Last ultrasound: 8 follicles of at least 12 mm
* At least 6 mature oocytes

Exclusion Criteria:

* IVF
* IVF versus ICSI
* Failed fertilization in previous cycle
* no previous cycle without embryo transfer
* No use of Ca ionophores for embryo quality or fertilization problems
Study on the Effects of Sacubitril/Valsartan on Physical Activity and Sleep in Heart Failure With Reduced Ejection Fraction Patients.

The purpose of this study was to investigate the effects of initiation of sacubitril/valsartan vs enalapril treatment on objective measures of both waking activity and sleep in subjects with heart failure with reduced ejection fraction.


Eligibility Criteria:
Key Inclusion Criteria:

* Written informed consent must be obtained before any assessment is performed.
* Men and women between 18 and 80 years of age
* Subjects diagnosed with NYHA class II or III heart failure and with reduced ejection (HFrEF).

(Reduced ejection is defined as left ventricular EF ≤ 40%. LVEF ≤40% may be determined via any local measurement within the past 6 months prior to signing consent, using echocardiography, multi gated acquisition scan (MUGA), CT scanning, MRI or ventricular angiography provided no subsequent study documenting an EF of \>40%. If the EF measurement is expressed as a value range, the average of the range endpoint values should be used as the EF).

* Subjects must be a candidate for treatment with sacubitril/valsartan as per USPI.
* Subjects must be living in a traditional residence, apartment, or non-communal adult home where they can move about freely and frequently and are primarily responsible for scheduling their sleep and daily activities.

Key Exclusion Criteria:

* Subjects with a history of hypersensitivity to any of the study drugs, including history of hypersensitivity to drugs of similar chemical classes, or allergy to ACEIs, ARBs, or NEP inhibitors as well as known or suspected contraindications to the study drugs.
* Subjects with a history of angioedema drug related or otherwise
* Subjects with symptomatic hypotension or systolic blood pressure \<100 mmHg at screening or \<95 mmHg at randomization
* Subjects with any conditions in skin or upper extremities which would limit the ability to tolerate a wrist-worn actigraphy device on the non-dominant arm for 24 hours/day for the duration of the study.
* Subjects who are non-ambulatory or use mobility assistive devices such as motorized devices, wheelchairs, or walkers. The use of canes for stability while ambulating is acceptable.
* Subjects with physical activity impairment primarily due to conditions other than heart failure such as:
* Exertional angina inflammatory or degenerative joint disease -gout
* peripheral vascular disease
* neurologic disease affecting activity or mobility
Pilot Testing A Pregnancy Decision Making Tool for Women With Spinal Cord Injury (SCI)

The purpose of this project is to pilot test a decision-making tool that is tailored for women with SCI to support them in the decision-making process. Pilot testing focuses on feasibility and preliminary efficacy.

The purpose of this project is to pilot test a decision-making tool that is tailored for women with SCI to support them in the decision-making process. Pilot testing focuses on feasibility and preliminary efficacy.

Eligibility Criteria:
Inclusion Criteria:

* Spinal cord injury (traumatic or non-traumatic)
* Need for assistance with daily life activities and/or personal care; women with mild, moderate or severe severity will be eligible
* actively planning or in the process of making a decision about whether or not to get pregnant in the near future

Exclusion Criteria:

- No plans for getting pregnant
Adherence to Electrical Glossal In Situ Stimulation for Sleep Apnea (AEGIS Study)

The purpose of this research is to assess how well people with mild obstructive sleep apnea (OSA) adhere to the eXciteOSA device and specifically examine whether adherence of the device is different with low versus high electrical stimulation. In addition, this research study will assess how well the device affects mild sleep apnea and if it improves sleepiness and quality of life.


Eligibility Criteria:
Inclusion Criteria:

1. Age greater than 18 years
2. Ability to consent
3. Home sleep apnea test demonstrating mild obstructive sleep apnea.
4. Smartphone or tablet

Exclusion Criteria:

1. Current pacemaker, defibrillator, or neuro-stimulation device
2. No prior oropharyngeal surgery for sleep apnea
3. No implants, metal prostheses, dental braces, or soft tissue/bony ulcerations in the oral cavity
4. No prior use of mandibular advancement device (MAD) or continuous positive airway pressure (CPAP)
5. Heart failure (New York Heart Association Class 3 or 4; or ejection fraction \< 45%)
6. Active coronary disease defined as an intervention (e.g., angioplasty, coronary artery bypass surgery) in the prior 6 months
7. Uncontrolled hypertension (BP \> 160/100)
8. Clinician diagnosis of any chronic lung disease except asthma
9. Chronic fatigue syndrome or fibromyalgia
10. Self-reported current illicit drug use in the past 30 days
11. Self-reported use of marijuana or opiates in the past 30 days
12. Use of supplemental oxygen
13. Self-reported use of prescribed or over the counter sleeping medications in the past 30 days
14. Current pregnancy or intention of becoming pregnant
15. Oropharyngeal abnormalities (class 2 or class 3 malocclusion)
16. Periodic breathing (Cheyne Stoke respiration)
17. Central sleep apnea (central apnea index (CAI) \> 5/h)
18. Investigator discretion
19. Prisoners
Precision Ablation for Pulmonary Vein Isolation: Targeting Pulmonary Vein Myocardial Sleeves (PVMS) with Omnipolar Mapping Technology

The purpose of this study is to compare procedural times and Radiofrequency (RF)applications required for Pulmonary vein myocardial sleeves targeted pulmonary vein ablation (PVS-PVI) , to compare the efficacy of PVS-PVI , to compare the safety of PVS-PVI and to assess other clinical outcomes of PVS-PVI in individuals with symptomatic paroxysmal Atrial fibrillation (AF) using Omnipolar Technology with conventional Wide area circumferential ablation (WACA).


Eligibility Criteria:
Inclusion Criteria:

* Symptomatic paroxysmal AF refractory to at least one Class I or Class III antiarrhythmic medication, intolerance to antiarrhythmic medications, or a preference to not trial antiarrhythmic medications
* A minimum of one documented AF episode via 12-lead ECG, Holter monitor, or loop recorder
* Capability to provide informed consent

Exclusion Criteria:

* Persistent or permanent AF
* Prior history of catheter or surgical ablation for AF or left atrial ablation for atypical flutter
* Reversible causes of AF
* Congenital heart disease
* Significant valve disease (moderate or severe mitral/aortic stenosis or regurgitation)
* Pregnancy
* Known presence of intracardiac thrombus
* Systemic oral anticoagulation therapy contraindicated, including a history of heparin-induced thrombocytopenia
* Broad vortex-like connections and no clear PVMS to be targeted