cyrilzakka/clinical-trials huggingface dataset:
Intraoperative Air-Test

Although imaging techniques are the reference standard to diagnose alveolar collapse, in the postoperative period and using the peripheral hemoglobin oxygen saturation (SpO2), a non-invasive simple and accurate test (Air-Test) was recently validated to diagnose alveolar collapse.

The aim of this study is to non-invasively describe the incidence of intraoperative atelectasis with the Air-Test in an unselected surgical population. In addition, we attempt to describe the association between positive Air-Test and the patient´s preoperative or intraoperative variables.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologist (ASA) I-IV
* General Anesthesia
* Mechanical ventilation

Exclusion Criteria:

* age \< 18 years old
* pregnancy
* patients undergoing cardiothoracic surgery
* ASA physical status V
Clinical Study for the Evaluation of the Safety and Initial Performance of the ClearRing System for the Treatment of Benign Prostatic Hyperplasia

The ProArc Medical ClearRing™ system is a prostatic reshaping device that is designed to treat Lower Urinary Tract Symptoms (LUTS) due to BPH.

During the procedure an implant is delivered into the prostate tissue obstructing the urethra and restricting urine flow. The delivery system uses an electro-cutting blade to perform a circular and superficial incision, in which the implant is placed. Such an implant, with the shape of an open ring, expands the obstructed area, reducing the fluid obstruction through the prostatic urethra.

The proposed study will be conducted on BPH patients, candidates for TURP and will aim to evaluate the ability of the ClearRing™ to improve BPH symptoms while conforming to safety of the procedure.

In the proposed study the implants will be inserted by a dedicated delivery system with the aid of resectoscope. Electrical current will be administered by off-the-shelf CE Mark diathermy that passes through the system to cut and pave the ring course.

The proper positioning of the implants will be evaluated by cystoscopy or TRUS and following implant positioning the device will be withdrawn.

The delivery tool, the implants, resectoscope and the diathermy equipment will be supplied by ProArc Ltd.

Eligibility Criteria:
Inclusion Criteria:

1. Male 50 years of age and up to 85 years old.
2. Diagnosed with symptomatic benign prostatic hyperplasia (BPH)
3. International Prostate Symptom Score (IPSS) \>13
4. Peak flow rate ≤ 12 ml/sec (with voided volume ≥ 125ml)
5. Subject is in good general health.
6. Subject understands and has signed the study informed consent form.
7. PSA according to the American Urological Association) AUA) guideline.

Exclusion Criteria:

1. Subjects who are known to be infected with Hepatitis B, Hepatitis C, or HIV viruses.
2. Subject allergic to nickel or titanium
3. Concomitant participation in another study
4. Diagnosed with Cancer except of BCC or SCC of the skin
5. Any medical condition at the investigator discretion that may interfere with the procedure.
6. Patient with coagulopathy due to medications or congenital
7. Patient is taking steroids
8. Previous prostate surgery
9. Compromised renal function due to obstructive uropathy
10. Urinary Tract Infection (UTI)
11. Intravesical lobe (based on ultrasound and/or cystoscopy and/or medical history)
12. Prostate volume (based on Trans Rectal Ultrasound) \> 80g
13. American Society of Anesthesiologists score (ASA)≥3
14. Known neurogenic bladder
15. Implanted electronic device such as pacemaker/CRT/ICD/DBS.
16. Recent myocardial infarction (less than three months)
PrefeRences And ChemoTherapy In Breast Cancer patiEnts

The aim of the present study is to ask women treated with adjuvant or neoadjuvant chemotherapy for breast cancer what survival benefit would justify the treatment.

The benefit should be evaluated in terms of Survival rate trade off and Survival time trade off value. The analyses will be conducted into three different groups of patients to value the survival benefit expected:

1. before to start the chemotherapy
2. during chemotherapy
3. after the end of chemotherapy

The chemotherapy is generally proposed a large number of early breast cancer patients to reduce the risk of recurrence and death. However chemotherapy is associated with side effects that impact the quality of life of the patients.

Patients are more likely to accept treatment on the basis of presented relative rather than absolute risks and so the question arises as to whether unrealistic improvements in outcome are expected by patients. The interviews with patients in the proposed trial will elicit the expected gains both in terms of survival and life years and will be able to assess the proportion of patients who considered an improvement of realistic size was sufficient to justify the treatment.

Eligibility Criteria:
Inclusion Criteria:

* Patients with early or locally advanced breast cancer
* Patients candidate to adjuvant/neoadjuvant chemotherapy or patients who are receiving adjuvant/neoadjuvant chemotherapy or patients who received adjuvant/neoadjuvant chemotherapy
* Sufficient literacy in Italian to complete the questionnaires
* Patients must provide signed, written or advanced electronic signature (AES or AdES), informed consent

Exclusion Criteria:

* None
Per-Oral Endoscopic Myotomy (P.O.E.M.) for Treatment of Primary Esophageal Motility Disorders

Spastic esophageal motility disorders induced significant symptoms including dysphagia, retrosternal pain and regurgitation. Per oral endoscopic myotomy (P.O.E.M.) is a novel approach to perform myotomy through the esophagus with long submucosal tunnel. This study aimed to investigate the feasibility and safety of P.O.E.M. and translate the techniques from animal study to clinical practice in human.


Eligibility Criteria:
Inclusion Criteria:

* All patients with age ranged 18 to 80 who had primary esophageal motility disorders will be recruited. The primary motility disorders included: Achalasia, hypertensive LES, Nutcracker esophagus and Diffuse esophageal spasm.

Exclusion Criteria:

* Patients will be excluded from this study with the followings -

  1. Pregnancy
  2. Informed consent not available
  3. Previous history of esophagectomy or mediastinal surgery
  4. Previous history of endoscopic resection for early esophageal cancers, including endoscopic mucosal resection and endoscopic submucosal dissection
  5. End-stage Achalasia with dilated esophagus more than 6cm on Barium swallow Investigations before and after POEM
Optimizing Surgical and Prosthetic Workflow for Implant-supported Ear and Nose Prostheses With Early Loading and Distant Prosthesis Fabrication: A Prospective Cohort Study

Facial defects created by trauma, oncological procedures or congenital conditions can be repaired with ear, nose and/or eye prostheses. These are fixed on intraosseous implants placed in the temporal, nasal and orbital bone. To date, an osseointegration period of 3-6 months is maintained after which the implants are loaded.

This study aims to achieve two goals:

1. To load the implants with a nose or ear prosthesis within one month (preferably \<3 weeks). Patients with an orbital prosthesis will not be recruited. In other words, an optimization of an existing protocol will be investigated. The quality of life of the patients as well as possible complications of the implants will be investigated.
2. Because of the short time between the surgery and the placement of the prosthesis, the prosthesis will be fabricated remotely. This means that the patient will not have to travel to the prosthetist. The feasibility and aesthetics will be analyzed through questionnaires for the patient.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients with a facial defect in the nasal and/or temporal area that will not be repaired with autologous tissue;
* Adult patients receiving oncological resection or trauma resulting in a facial defect in the nose and/or ear that will not be repaired with autologous tissue;
* Patients who can come to the hospital every week for 6 weeks.

Exclusion Criteria:

* Patients with insufficient bone mass for implant placement
* Patients who cannot come to the hospital for weekly follow-ups
* Patients that wish an autologous reconstruction
* Patient is unable to tolerate general anesthesia
Prognostic Biomarkers in Patients With Endometrial Cancer

This research study is studying prognostic biomarkers in tissue samples from patients with endometrial cancer. Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PRIMARY OBJECTIVES:

I. To validate the clinicopathologic associations and prognostic significance of ATR mutation in endometrioid endometrial cancer cases with defective DNA mismatch repair.

OUTLINE: This is a multicenter study.

DNA extracted from previously collected tumor samples is analyzed to validate the clinicopathologic associations and prognostic significance of ATR mutation.

Eligibility Criteria:
Inclusion Criteria:

* Women who were eligible and evaluable for the GOG-0210 molecular staging protocol in women with endometrial cancer

  * Women who were registered during the unrestricted enrollment period (through 9/23/07) will automatically qualify
  * Women who were registered during the restricted enrollment period (after 9/23/07) will only be considered if needed
* Women who had histologically confirmed endometrioid endometrial adenocarcinoma regardless of stage or grade
* Women who have defective DNA mismatch repair and are microsatellite instability positive (MSI+ and MSI-low)
* Women who consented to allow their specimens and clinical data to be used for future cancer research
* Women who have sufficient high-quality genomic DNA from tumor available for mutation analysis of ATR
The Efficacy and Safety of Oral Oxcarbazepine 300-1200 mg/Day as Adjuvant Therapy in the Treatment of Adolescents With Impulsivity and Aggressive Behavior in Conduct Disorder This Study is Not Being Conducted in the United States.

Conduct disorder is a group of psychiatric symptoms that can include clinical characteristics of impulsivity and aggressive behavior. This study will investigate the efficacy a safety of oxcarbazepine in the treatment of adolescents with conduct disorder.


Eligibility Criteria:
Inclusion Criteria:

* History of conduct disorder, oppositional defiant disorder, and disruptive behavior disorder not otherwise specified
* Score \>8 on the Impulsivity Rating Scale

Exclusion Criteria:

* Other serious medical or psychiatric conditions excluding conduct disorder, oppositional defiant disorder, and disruptive behavior disorder not otherwise specified
* Treatment with antiepileptic medications

Other protocol-defined inclusion/exclusion criteria may apply.
An Efficacy and Safety Comparison Study of Two Marketed Drugs in Patients With Relapsing-remitting MS

The purpose of this study is to determine the difference in preventing a relapse between Betaseron and Avonex. Patients with RRMS currently treated with Avonex will be randomized into 2 equal-size arms; one arm will continue on the standard dose of Avonex; one arm will be converted to Betaseron standard dose.

This study has previously been posted by Berlex, Inc. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc.Bayer HealthCare Pharmaceuticals, Inc.is the sponsor of the trial.

Eligibility Criteria:
Inclusion Criteria:

* RRMS patients that are receiving treatment with Avonex 30 µg once weekly

Exclusion Criteria:

* Primary Progressive or Secondary Progressive MS
Enterotomy Closure and Minimally Invasive Gastrectomy

All consecutive patients from January 2009 to december 2019 who underwent minimally invasive partial gastrectomy for gastric cancer at thirteen high volume institutions will be retrospective analysed to assess the better way to fashion a handsewn intracorporeal enterotomy closure after a stapled anastomosis.

Different ways to fashion intracorporeal anstomoses will be investigated: robotic vs laparoscopic approach; laparoscopic HD vs 3D vs 4K technologies; single layer vs double layer enterotomy closure. Additionally double layer enterotomies will be analysed layer by layer, comparing running vs interrupted suture, presence vs absence of deep corner suture and type of suture thread (barbed, braided, non braided suture)

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* laparoscopic or robotic partial gastrectomy for gastric cancer
* Roux en Y or Billroth II reconstruction

Exclusion Criteria:

* Age \< 18 years
* open gastrectomy
* total gastrectomy
* Billroth I reconstruction
Effects of Two Strength Exercise Programs on Upper Limb Functionality in Breast Cancer

The goal of this experimental study is to evaluate the effect of a therapeutic exercise program based on upper limb plyometric exercises in breast cancer patients and breast cancer survivors to determine changes in upper limb functionality.

The main question it aims to answer is: Does upper limb plyometric strength exercise improve upper limb dysfunctions in breast cancer patients and survivors? The researchers will compare the effects of plyometric exercise with the effects of strength training exercise to determine whether plyometric exercise improves shoulder dysfunctions in breast cancer patients and survivors.

Participants from the Pontevedra group will undergo the intervention using plyometric exercise (Experimental Group), while those from the Vigo group will perform strength training exercise (Control Group). They will complete two sessions per week for six weeks. Outcome variables related to upper limb functionality will be assessed at baseline and after the intervention.


Eligibility Criteria:
Inclusion Criteria:

* Pathological diagnosis of breast cancer.
* Patients who have undergone a mastectomy, including unilateral, total breast, or breast-conserving surgery.
* Postoperative chemotherapy or radiotherapy as required.
* No other malignant tumors in the last 5 years.
* Absence of contraindications related to physiotherapy or physical exercise.
* Willingness to participate in the study and sign the informed consent form.

Exclusion Criteria:

* Metastasis to other organs and tissues (liver, kidney, lung, brain, etc.) that prevent participation in the exercise program.
* Underlying heart disease, cerebrovascular disease, or mental illness that impairs proper execution of the exercise program.
* Pre-existing shoulder pathology before surgery.
* Inability to understand the plyometric exercise program.
An Awareness, Courage, and Love Intervention to Help Chinese Older Adults in the Post-pandemic Era

The purpose of this study is to explore the potential effectiveness of a one-session online Awareness, Courage, and Love intervention for reducing loneliness, depression and anxiety symptoms, and enhancing social connectedness and subjective well-being among older adults. the study also aims to estimate the effect sizes of the Awareness, Courage, and Love intervention.

The recruitment process will commence with referrals from local community organizations. Eligible individuals will be provided with detailed information about the study, and informed consent will be obtained from those willing to participate. After the confirmation of participant recruitment, a randomization process will be implemented to ensure the equitable distribution of participants between the intervention and waitlist control groups. An independent researcher will generate computer-generated random codes for group assignment, and these codes will be securely sealed in opaque envelopes. The envelopes will be sequentially numbered, and the randomization process will remain blinded throughout to prevent bias. Participants will be notified via email or text for the details of the condition they are assigned, and their willingness to engage in both the intervention and data collection will be confirmed.

Eligibility Criteria:
Inclusion Criteria:

1. aged 60 years or older and dwelling in the community;
2. able to communicate in Cantonese;
3. have access to the internet and videoconferencing devices such as a mobile phone;
4. able to give informed consent to participate.

Exclusion Criteria:

1. severe emotional distress based on PHQ-4 screening assessment or presenting an imminent suicidal risk;
2. known history of autism, intellectual disability, schizophrenia-spectrum disorder, bipolar disorder, Parkinson's disease, or dementia/significant cognitive impairment;
3. illiterate;
4. difficulty in communication.
Study of the Blood Levels and Effects of ATL-962 on Fat Excretion in Obese Subjects

The purpose of this study is to investigate the amount of metabolites of ATL-962 in the blood and to investigate the effect of ATL-962 on the amount of fat that is excreted in the faeces in subjects who are obese

Obesity is a significant and increasing clinical problem. There is a need for effective therapeutic agents to help people reduce weight. ATL-962 is a lipase inhibitor which could reduce the amount of fat absorbed from a person's diet, leading to weight reduction.

Eligibility Criteria:
Inclusion Criteria:

* Obese, otherwise-healthy subjects
* Body mass index 30-45kg/m2

Exclusion Criteria:

* Women who are pregnant or breast feeding
* Any drug treatment within 2 weeks of commencement of dosing in this study
Virtual Reality Distraction During Dental Local Anesthesia Among Children

To evaluate the effect of virtual reality (VR) distraction on anxiety and pain during buccal infiltration anesthesia (BIA) in pediatric patients.

Design and Participants: This randomized clinical trial was conducted including healthy, and cooperative 6-12-year-old children, with no known allergy and/or sensitivity to local anesthesia who are currently in need of nonemergency dental treatment under local anesthetic infiltration by one of the postgraduate or interns at the pediatric dentistry students, were eligible for the study. Patients with history of epilepsy and anxiety disorder were excluded from the study

Methods and Material: In the test group, subjects received BIA while being distracted using VR goggles; in the control group, subjects watched a cartoon video on a regular screen. Subjects' heart rate (HR) was measured at baseline and at four different timepoints during BIA administration to assess anxiety. The face, legs, activity, cry, consolability (FLACC) Behavioral Pain Assessment Scale was scored by two calibrated investigators to assess pain. After BIA, subjects rated their pain using the Arabic version of Wong-Baker FACES Pain Rating Scale.

Eligibility Criteria:
Inclusion Criteria:

* Healthy
* 6-12-year-old children
* Cooperative during dental treatments
* In need of nonemergency dental treatment under local anesthetic infiltration

Exclusion Criteria:

* Allergy and/or sensitivity to local anesthesia
* Epilepsy
* Anxiety Disorder
Randomized Controlled Trial of Early Palliative Care for Patients With Advanced Cancer

Patients with advanced cancer often have numerous physical and psychological symptoms, which can negatively affect their quality of life. A palliative care team of different health care professionals (including doctors, nurses, social workers and therapists) specializes in treating these symptoms and offers support for patients and their families. However, palliative care teams are currently involved only in the last two months of a patient's life or not at all.

The main purpose of this study is to determine whether, compared to conventional cancer care, early involvement by a specialized symptom control and palliative care team in patients with advanced cancer will be associated with: better quality of life, greater patient and caregiver satisfaction with care, better symptom control, improved communication with healthcare providers and improved caregiver quality of life.

Twenty-four cancer outpatient clinics at Princess Margaret Hospital, Toronto have been randomly assigned so that patients attending them will receive either early palliative care (referral to the palliative care team) or routine cancer care.

Patients are recruited from Gastrointestinal, Lung, Genitourinary, Gynecology and Breast clinics and are eligible to participate if they have advanced cancer, and have a life expectancy of six months to two years.

Patients and their caregivers who agree to participate are asked to complete questionnaires at baseline and every month for 4 months. These questionnaires ask about their quality of life, and satisfaction with their medical care. After they have completed the 4-month questionnaires, some patients and their caregivers will be interviewed, so that they can describe in their own words their quality of life, satisfaction with care, and views about palliative care. These interviews will be audiotaped and analyzed to provide additional information that cannot be obtained by questionnaires alone.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Dx of stage IV cancer (metastatic); refractory to hormonal therapy for breast or prostate cancer; stage III or IV for lung cancer.
* ECOG performance status ≤ 2 (estimated by primary oncologist)
* Prognosis of \>6 months to 2 years (estimated by primary oncologist)

Exclusion Criteria:

* Insufficient English literacy to complete questionnaires
* Inability of pass the cognitive screening test (SOMC - Short Orientation Memory Concentration test score \<20 or \>10 errors)
Identification of Factors Associated With the Occurrence of Severe Forms of COVID-19 Infection in Patients With Inflammatory Rheumatism or Autoimmune Diseases

Factors associated with severe forms of COVID-19 infection in patients with inflammatory rheumatic diseases (IRD) or Autoimmune Diseases (AID) are unknown. This unprecedented situation leads to empirical and potentially erroneous advice and recommendations for care. Identifying factors associated with severity, in the context of this pandemic, which is expected to last many months, and possibly years, is crucial for future patients. The objective of this work is to identify the factors associated with the occurrence of severe forms of COVID-19 infection in patients with IRD or AID, by combining analysis of 2 large databases.


Eligibility Criteria:
Inclusion Criteria:

* Patients with known chronic inflammatory rheumatism, auto-immune or auto-inflammatory diseases (Rheumatoid arthritis, Spondyloarthritis, Psoriatic arthritis Lupus, Sjögren's syndrome, Inflammatory Myositis, Systemic Vasculitis, Sarcoidosis, Scleroderma, PPR/Horton's, other ...)
* At least 18 years old
* SARS-Cov-2 infection (COVID-19) by biological data (serological or positive Cov-2 PCR) or CT scan images or clinical observations consistent with covid-19 between January 2020 and September 2020
* data available in the APHP health data center (EDS) or in the french RMD Covid19 cohort

Exclusion Criteria:

* patients opposed to the use of their data
Evaluation of the Three-Seeds Mixture Treatment in Chronic Obstructive Pulmonary Disease Patients

The purpose of this study is to test whether the three-seeds mixture tea reduces sputum and/or cough in COPD patients, and if so, to evaluate whether the three-seeds mixture changes the lung microbiome.


Eligibility Criteria:
Inclusion Criteria:

1. Males or females ages 50-80 at the time of entry
2. Non-smoker for at least 1 year
3. Chronic bronchitis with Fev1 \<80% and Fev1/ Fvc \<0.7 and daily sputum production
4. Documentation of COPD. We define COPD as the presence of irreversible airflow obstruction, presence of emphysema on CT scan or both. This determination will be by the pulmonary physicians leading this study.
5. Ability and willingness to provide informed consent.

Exclusion Criteria:

1. Current Smoker 2. Asthma or other respiratory diseases 3. Frail patients (unintended weight loss, long term fatigue). 4. Patients with acute COPD exacerbation

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