cyrilzakka/clinical-trials huggingface dataset:
Group Compassionate Mind Training for Adults Experiencing the Menopause Transition

Menopause transition occurs naturally for women aged 45-55. In addition to the hormone changes, there are often changes in other areas of life including low mood, anxiety, 'brain fog' and embarrassment. Some people may not be eligible for or want to receive hormone replacement therapy, therefore psychological treatments for menopause have been investigated. There is growing evidence for the use of Compassionate Mind Training (CMT). CMT aims to reduce feelings of self-criticism and shame which are commonly reported by adults experiencing the menopause, by helping individuals to take better care of themselves, known as self-compassion. Findings show menopausal individuals who are more self-critical may be more vulnerable to difficulties during menopause. Therefore, CMT could help manage this. CMT improves self-compassion and reduces depressive symptoms, with group formats found to be more effective than individual or self-help. A previous study of online self-help CMT for the menopause received positive feedback for the therapy and people improved in several areas including self-compassion. Clearly, there could be benefits to offering CMT as a treatment for menopause. Given that group CMT is effective in other populations and groups are more economical and practical for the NHS, this study is interested in looking at the impact of group CMT on menopause.

This study aims to find out how practical and suitable group CMT is for improving the wellbeing of adults experiencing the menopause, and what their views are on the therapy and taking part in the study. To measure the aims, we will look at the ease of recruiting people to the study, whether they are happy to be randomly allocated to receive the therapy or not, whether they stay in the study, the number of completed questionnaires and feedback from participants. It will also look at whether there have been any changes in different domains e.g. anxiety and self-compassion. This will be done through a variety of quantitative and qualitative outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Adults (aged 40-60) who are biologically female
* Women who are experiencing symptoms of the menopause or peri-menopause; which is naturally occurring. This is identified through the STRAW criteria. Individuals have to answer Yes on at least one of the STRAW screening questions to ensure women are in the perimenopause or menopausal period.
* Substantial English verbal communication and comprehension skills
* Capacity to consent
* Confident in using video conferencing applications (MsTeams)
* Willingness to take part in a post-intervention interview about their experience.
* PHQ-9 score 5-19 (mild to moderate clinical cut offs)
* GAD-7 score 5-15 (mild to moderate clinical cut offs)

Exclusion Criteria:

* People under the age of 40
* People currently receiving any form of psychology intervention.
* Transgender females who are biologically male
* More than 5 years post menopause.
* PHQ-9 score greater or equal to 20 (severe clinical cut off)
* GAD-7 score greater or equal to 15 (severe clinical cut off)
Early Warning Value of Consumer Wearable Devices in AECOPD

This is a prospective, multi-center cohort study. 150 subjects with COPD and in stable stage will be included. Wearable device's physiological parameters will be continually collected, the investigators aim to explore whether consumer wearable devices are useful for early warning deterioration of COPD.

This is a prospective cohort study. 150 subjects aged 35～80y with stable COPD will be recruited. After enrollment, subjects wear consumer wearable devices and install APP on their mobile phones. The first 7 days of wearing are to evaluate the stability of data collection and the subject compliance, and to correct the wrong wearing. The subjects are required to fill in the COPD symptom diary every day, and conducted online or offline follow-up at the 4th, 8th, 12th, 16th, 20th, and 24th weeks after enrollment. The physiological parameters of wearable devices, including pulse rate, blood oxygen saturation, physical activity, electrocardiogram, and sleep, will be continuously collected during the study. The Department of Respiratory and Critical Care of Peking University First Hospital is responsible for this research. Primary outcome is the moderate or more severe COPD acute exacerbation events. The purpose of this study is to use consumer wearable devices to monitor the changes of COPD, and to establish a physiological parameters model of wearable device that can predict the acute exacerbation of COPD.

The study protocol has been approved by the Peking University First Hospital Institutional Review Board (IRB) (2021-397). Any protocol modifications will be submitted for the IRB review and approval.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with stable COPD (refer to 2021 GOLD guidelines);
* Age between 35 and 80 years (both 35 and 80), either gender;
* A post-bronchodilator forced expiratory volume in 1 second percentage (FEV1%) predicted between 25%\~80%;
* Having mobile phone which can install APP of wearable device;
* Able to engage in daily activities;

Exclusion Criteria:

* History of asthma, lung cancer, active pulmonary tuberculosis, bronchiectasis, diffuse lung disease (interstitial pneumonia, pulmonary sarcoidosis, occupational lung disease, sarcoidosis et al) and pleural disease;
* History of lobectomy and/or lung transplantation;
* Predicted life expectancy less than 3 years;
* History of serious underlying diseases (including severe psychiatric illnesses, mental disorders, neurological disorders, malignant tumors, chronic liver disease, heart failure, autoimmune diseases, chronic kidney disease);
* Alcoholism, drug or toxic solvents abuse;
* Moderate to severe anemia;
* Smoking or quitting smoking for less than 6 weeks;
* Skin pigmentation, deformity, arterial stenosis or occlusion of both upper limbs;
* Skin allergy to metal/plastic;
* Those who are participating in other clinical trials, cannot be followed up for a long time or have poor compliance.
Pulmonary Surgery and Protective Mechanical Ventilation

The purpose of this trial is to evaluate the efficacy and the safety of lung protective ventilation during anesthesia in patients undergoing pneumonectomy or lobectomy for lung cancer.

Extended description of the protocol could be provided by the URC-EST, SAINT ANTOINE HOSPITAL, University of Paris-VI and by principal investigator.

Pneumonectomy or lobectomy is associated with a high risk for postoperative complication. The benefit of lung protective ventilation with low tidal volume has been demonstrated in patients with acute respiratory distress syndrome (ARDS) and acute lung injury (ALI). Recent clinical studies have suggested that mechanical ventilation with low tidal volume may also profit in others setting. Lung protective ventilation during anaesthesia has been found to limit the inflammatory response in the lung and to decrease postoperative systemic inflammatory response. However, others trials did not found benefit of protective ventilation strategy during anaesthesia.

This study will be a randomized, controlled, doubled blind trial comparing two management ventilator strategies during anaesthesia for thoracotomy. Only patients undergoing pneumonectomy or lobectomy for lung primitive cancer will be included in this trial. During anesthesia, one group will receive mechanical ventilation with low tidal volume (5 ml/kg of ideal body weight) plus PEEP and the other will receive tidal volume of 10 ml/kg of ideal body weight without PEEP. After surgery, data concerning oxygen delivery, blood analysis, complications, cancer recurrence and death will be collected.

Eligibility Criteria:
Inclusion Criteria:

* Primary lung cancer.
* Elective Pneumonectomy or lobectomy or bilobectomy
* Written informed consent

Exclusion Criteria:

* Patients undergoing surgical procedure other than pneumonectomy or lobectomy or bilobectomy
* Mesothelioma
* Liver cirrhosis
* Chronic renal failure
* Need for mechanical ventilation or non invasive ventilation (CPAP for obstructive sleep apnea syndrome for example) before surgery
* Emergency surgery
A Phase III, Randomized, Multi-center Study to Determine the Efficacy of the Intercalating Combination Treatment of Chemotherapy and Gefitinib or Chemotherapy as Adjuvant Treatment in NSCLC With Common EGFR Mutations.

This study aims to compare the efficacy of intercalating chemotherapy (gefitinib and pemetrexed/cisplatin) and chemotherapy (navelbine/cisplatin) in completely resected NSCLC with common EGFR mutations.


Eligibility Criteria:
Inclusion Criteria:

1. Completely resected non-squamous cell NSCLC with stage IIa to IIIb (excluding N3) according to Version 8 of the IASLC Staging Manual in Thoracic Oncology
2. Tumors with common EGFR mutations (19del or L858R)
3. Adequate oran function

Exclusion Criteria:

1. Patients who were exposed to the chemotherapy or EGFR TKIs for NSCLC.
2. Patients with interstitial lung disease
Ceftobiprole in the Treatment of Patients With Community-Acquired Pneumonia

The purpose of this study is to compare the clinical cure rate (ratio of clinically cured patients to the total number of patients) of ceftobiprole medocaril versus a comparator in the treatment of patients with community-acquired pneumonia.

Ceftobiprole medocaril is a cephalosporin antibiotic with anti-MRSA (Methicillin-Resistant Staphylococcus Aureus) activity. Ceftobiprole medocaril is not yet approved for the treatment of community-acquired pneumonia. This is a randomized, double-blind, multicenter study of ceftobiprole medocaril plus placebo versus a comparator to assess the effectiveness and safety of ceftobiprole medocaril in patients with community-acquired pneumonia. The patients will be randomized to ceftobiprole medocaril plus placebo or a comparator. Patients who meet specified criteria may be switched to an alternative oral treatment. The primary endpoint is that the clinical cure rate among patients treated with ceftobiprole at the test of cure visit. The patients will receive either ceftobiprole medocaril plus placebo or a comparator.

Eligibility Criteria:
Inclusion Criteria:

* Patients suffering from community-acquired pneumonia severe enough to require hospitalization
* Female patients must be postmenopausal for at least 1 year, surgically sterile, or practicing an effective method of birth control before entry and throughout the study

Exclusion Criteria:

* Patients with known or suspected hypersensitivity to any related antibiotic medications
* Treatment with any experimental drug within 30 days before enrollment
* Prior enrollment in this study or any study with ceftobiprole medocaril
A Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics and Pharmacodynamics of M281 Administered to Adults With Generalized Myasthenia Gravis

The purpose of this study is to evaluate the safety, tolerability, and efficacy of M281 administered to participants with generalized myasthenia gravis (gMG) who have an insufficient clinical response to ongoing standard of care therapy.


Eligibility Criteria:
Participants must be ≥18 years of age with a documented history of Generalized Myasthenia Gravis (gMG) and clinical signs/symptoms of gMG, not pregnant or breastfeeding, and no history of any neurologic disorder other than MG that might interfere with the accuracy of study assessments.

Additional, more specific criteria are defined in the protocol.
Study Evaluating Desvenlafaxine Succinate Sustained-Release Tablets (DVS SR) In The Treatment Of Child and Adolescent Outpatients With Major Depressive Disorder

The primary purpose of this study is to evaluate the long-term safety and tolerability of Desvenlafaxine Succinate Sustained-Release (DVS SR) in child and adolescent outpatients with major depressive disorder. A secondary aim is to evaluate the efficacy of DVS SR in the treatment of child and adolescent outpatients with major depressive disorder in an exploratory manner.


Eligibility Criteria:
Inclusion Criteria:

* Outpatients who have completed 8-weeks of treatment in the preceding study, 3151A6-2000, and who, in the opinion of the investigator, would benefit from long-term treatment.
* Study participants who are not surgically sterile or postmenopausal must agree and commit to the use of a reliable method of birth control for the duration of the study and for 15 days after the last dose of test article. Sexually active study participants must agree and commit to the use of condoms in addition to other contraceptive methods.

Exclusion Criteria:

* Clinically important abnormalities on baseline physical examination or any clinically significant abnormality on electrocardiogram (ECG), laboratory test results, or vital signs recorded before the final study day (day 56 visit) of the preceding study 3151A6-2000.
* Unresolved clinically significant adverse events or serious adverse events in the preceding study 3151A6-2000.
* Poor compliance with the preceding study 3151A6-2000, as assessed by the investigator and the medical monitor.
* Other exclusion criteria apply.
Effect of Targeted Health Education Program on Nurses' Awareness About Postpartum Depression

To assess nurses' knowledge of PPD at Ain Shams University Maternity Hospital and measure their knowledge level after an educational program on postpartum depression.

Postpartum depression (PPD) is a serious mental illness that involves the brain and affects behavior and physical health of women after childbirth . Multiple factors may influence PPD, such as lack of support, interpersonal events, withdrawal of hormones after delivery, psychosocial stressors, psychological stressors, personality, environment, and ineffective adaptation.

Symptoms of PPD may include feeling restless or moody, feeling sad, crying a lot, having thoughts about hurting the baby or yourself, not feeling connected to the baby, having no energy or motivation, eating, or sleeping too little or too much, feeling worthless and guilty, losing interest or pleasure in activities, and withdrawing from friends and family .

PPD is one of the most important health problems due to its prevalence; 10-15% . and serious negative mother-baby outcomes. PPD affects the health of mothers and their newborns and is associated with long-term psychological and socioeconomic implications .

As the knowledge affects attitudes and practices of people, nurses' knowledge can affect profoundly women after birth specially regarding PPD .

In an American web-based study , nurses' self-efficacy about PPD was associated to their knowledge . In another American electronic survey of 372 nurses, 95% reported an association between post-partum education and mortality and 72% reported that it is their responsibility to provide education to mothers .

In a Ghanaian study, nurses had good knowledge about PPD but poor knowledge about screening and management . In a Kazakh study, 90% of nurses didn't attend training courses on PPD ).

Furthermore, in a Malaysian study, 44.4 % of participants were below than median total knowledge score and only 25.9% practiced screening. In a Saudi study, the confidence of nurses and midwives to educate women about PPD was associated with their knowledge. In a Turkish study, 84.4 % of nurses had little knowledge and 75.5% reported that psychological service for evaluating mothers wasn't offered.

PPD can have devastating effects on women, their infants, and families associated with lower levels of bonding and reduced breastfeeding initiation and duration. Consequently, women experiencing PPD may cause harm to their baby, themselves, or others.

As, nurses in Maternity Hospitals are poised to play a pivotal role in the early identification and prompt treatment of PPD, assessing their knowledge is very important. To date, according to our knowledge, there is no previous study in Egypt assessing the nurses' knowledge about PPD, therefore the present study will be conducted to compare their knowledge regarding PPD before and after the health education program.

Eligibility Criteria:
Inclusion Criteria:

* Nurses at Ain Shams University Maternity Hospital

Exclusion Criteria:

none

-
MMP-9 Expression in Permanent Mature Teeth With Symptomatic Pulpitis

Matrix metallopeptidase-9 (MMP-9) expression was compared in healthy and inflamed pulp and the outcome of coronal pulpotomy in teeth with symptomatic pulpitis was assessed. After procedure blood samples were examined using Elisa kit.

Introduction: Widely used diagnostic tests do not provide information to distinguish the pulp inflammation stage while improvement of materials, techniques and vital pulp therapy have received a wider acceptance in symptomatic pulpitis treatment. The aim of this clinical study was to compare MMP-9 expression in healthy and inflamed pulp and to assess the short-term outcome of coronal pulpotomy in mature permanent teeth with symptomatic pulpitis.

Methods: Patients diagnosed with symptomatic pulpitis were included in this clinical study. Coronal pulpotomy was performed using calcium-silicate based material and blood samples were taken. Initial and postoperative pain was recorded by Heft-Parker visual analog scale at 24 hours and 72 hours after the procedure. In control group teeth with healthy pulp were used. During follow-up visits after three and six-months, patients were examined clinically and radiographically. The ELISA kit was used to determine the levels of MMP-9 in inflamed and healthy coronal pulp tissue.

Eligibility Criteria:
Inclusion Criteria:

* Teeth diagnosed with symptomatic pulpitis
* Patients who did not use any NSAIDs before the treatment
* Positive cold test of investigated teeth
* Clinically dental caries in contact with pulp chamber
* Permanent teeth with radiographically closed root apex

Exclusion Criteria:

* Patients who refuse to participate in the study
* Medically compromised patients (with immunosuppressive/systemic diseases, patients on medications)
* Teeth with periapical radiolucency or clinical signs of apical periodontitis
* Periodontological compromised teeth (probing depth ≥4mm)
* Internal/external root resorption in periapical radiograph
* Pulp chamber and/or root canal calcification in periapical radiograph
* Teeth with unrestorable crown
* Teeth with a negative response to cold test
Clinical Applications of Domperidone in Patients With Delayed Gastric Emptying

The purpose of the study is to treat patients with on-going slow stomach emptying(gastroesophageal reflux disease), who have failed to respond to standard therapy

This is a study on the effectiveness of domperidone, which increases movement through the digestive system for relief of symptoms, in patients who have delayed gastric solid-phase emptying

Eligibility Criteria:
Inclusion Criteria:

* Persistent esophagitis
* Heartburn
* Nausea
* Vomiting
* Severe dyspepsia
* Severe chronic constipation

Exclusion Criteria:

* History of, or current arrhythmias including ventricular tachycardia, - Ventricular fibrillation and Torsade des Pointes.
Study Evaluating the Benefit of Two Immunosuppressive Strategies on Renal Function

Prospective, multicenter, randomized and open label study evaluating the benefit on renal function at 12 months post-transplantation, with an immunosuppression without calcineurin inhibitor at 3 months and combining mycophenolate sodium-Everolimus versus an immunosuppression combining Everolimus-Tacrolimus, in de novo renal transplant patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients receiving a first kidney transplant from a cadaveric or living donor

Exclusion Criteria:

* Double transplant
* Patient who has been treated with an immunosuppressive drug or study drug during the four weeks before administration of the first dose of Everolimus
Impact of Weight Loss Interventions for Overweight Breast Cancer Survivors

Obesity is an epidemic and the majority of breast cancer survivors are overweight or obese. The American Cancer Society has called for weight loss treatment to be standard of care for overweight women with breast cancer. During therapy women with breast cancer often gain weight and lose lean muscle mass. Overweight breast cancer survivors are more likely to have their cancer come back. The reason why overweight breast cancer survivors are more likely to re-occur has not been well studied, but changes in how insulin works may contribute. Overweight survivors are also at risk for the other chronic diseases associated with obesity. Fortunately, weight losses of as little as 5-7% of baseline body weight can improve risk of chronic disease. An effective behaviorally-based, lifestyle intervention delivered via the internet has been developed at the University of Vermont. This successful intervention has not been tested among breast cancer survivors. Given that women tend to lose muscle mass during cancer therapy the addition of a resistance training component to the weight loss intervention may be important. Therefore the overall goal of this project is to pilot test a proven distantly- delivered behavioral weight loss intervention among overweight breast cancer survivors and to evaluate whether a resistance program results in improvements in lean body mass, while studying how both interventions change insulin sensitivity.

Specifically, this project is a randomized, controlled clinical trial designed to test the effectiveness and acceptability of a 6-month behavioral weight loss intervention with and without resistance training. Participants will be randomized to one of two groups: 1) behavioral weight control treatment via the Internet; or 2) behavioral weight control treatment via the Internet plus a resistance training program. Women eligible to participate include overweight breast cancer survivors who are age 50 or older and 6-36 months past receiving chemotherapy. Assessments will be conducted at baseline and six months and will include measures of body weight, muscle mass, adherence to treatment, and insulin sensitivity.


Eligibility Criteria:
Inclusion Criteria:

* Post-menopausal (last period 12 mos prior to study enrollment or oophorectomy)
* Age 40-65
* DCIS, Stage I, II, III Breast Cancer
* BMI between 27-50
* Completed chemotherapy to treat early stage breast cancer (Stage I-III) no less then 6 months and no more than 48 months from start of study or for specific aim 3 Diagnosis of DCIS or Stage I breast cancer who did not receive chemotherapy.

Exclusion Criteria:

* Participant can not have a psychotic or central nervous system impairment that would limit compliance with study requirements
* Evidence of metastatic disease
* Chemotherapy for cancer other than breast cancer
* Diabetes mellitus, uncontrolled hypo or hyper thyroidism, liver failure
* Celiac sprue, inflammatory bowel disease
* Inability to walk for exercise
* Lymphedema as indicated by a 2 cm circumference difference at the elbow
* weight loss in the previous 6 months of 10 lbs or greater