cyrilzakka/clinical-trials huggingface dataset:
Effect of Roflumilast on Pulmonary Function and Respiratory Symptoms in Patients With Chronic Obstructive Pulmonary Disease (COPD) (BY217/M2-110)

The aim of the study is to compare the effect of roflumilast and placebo on the lung function in patients with COPD.


Eligibility Criteria:
Main Inclusion Criteria:

* Clinical diagnosis of COPD (Chronic Obstructive Pulmonary Disease)
* Currently stable COPD with no change in COPD treatment in the prior 4 weeks

Main Exclusion Criteria:

* Clinical diagnosis of asthma
* Poorly controlled COPD
* Regular need for daily oxygen therapy
Music Therapy as a Tool for Anxiety Reduction in Localized Breast Cancer

Breast cancer is the number one cancer in women worldwide, with 58,500 new cases in metropolitan France in 2018. The announcement of the cancer, the treatment methods and their side effects can generate unpleasant emotions, such as fear, for example, and the resources for coping with them differ according to the patient. Coming to the hospital as an outpatient for chemotherapy is in itself a source of anxiety.

The use of music in the treatment process is a therapy that can help patients to reduce the intensity of their unpleasant emotions. Active music therapy involves the patient playing an instrument, including voice and body movement in rhythm, without requiring any musical skills. The presence of a qualified music therapy professional is essential, particularly in the reception of the emotions that may be generated during the sessions. These sessions can be collective or individual. In breast cancer, music therapy has been shown to be effective in reducing pain, anxiety, depressive symptoms and length of hospitalisation in patients undergoing mastectomy.


Eligibility Criteria:
Inclusion Criteria:

* Patient with localized breast cancer
* Indication for adjuvant or neoadjuvant chemotherapy
* Patient \> 18 years of age
* Patient with signed consent
* Patient affiliated to a social security scheme

Exclusion Criteria:

* Metastatic patient
* Triple negative patient
* Patient not eligible for curative surgery
* Patient who has already received chemotherapy
* Unaided deaf patient
* Women who are pregnant, likely to be pregnant or breastfeeding
* A patient presenting a depressive episode or a psychotic pathology at the time of the initial consultation
* Patient who does not understand French
* Cognitive disorder or inability to understand,
* Patient protected by law, under court protection, guardianship or curatorship
Effect of Resistance Exercise on Physical and Psychological Factors

Physical inactivity is a key risk factor for cardiovascular and metabolic disorders, negatively affecting emotional well-being by increasing psychological distress and reducing mental health. This study aimed to evaluate the impact of a resistance-based physical activity program on physical and psychological outcomes in physically inactive adults.

Background/Objectives: Sedentary behavior is a prevalent risk factor contributing to the development and progression of cardiovascular and metabolic diseases. Additionally, physical inactivity has been linked to diminished emotional well-being, characterized by elevated levels of psychological distress and compromised mental health. The present study was designed to investigate the effects of a resistance-focused physical activity intervention on both physical and psychological health outcomes in adults with chronically low levels of physical activity. A randomized controlled trial design was employed. The participant comprised 32 adults (mean age = 46.61 ± 7.33 years) included in the study. These individuals were randomly allocated to either a resistance exercise group (EG, n = 15) or a control group (CG, n = 17). Comprehensive assessments were conducted at baseline and following the 12-week intervention. These assessments included evaluations of muscle strength (knee flexors, knee extensors, ankle dorsiflexors, plantar flexors, and core isometric strength), static and dynamic balance, proprioception, and functional movement capacity (as measured by the Functional Movement Screen (FMS)). Participants' psychological states were quantified using the Depression, Anxiety, and Stress Scale-21 (DASS-21). The EG participated in a supervised resistance training program 3 days per week for 12 weeks, with each session lasting approximately 55-60 minutes. Conversely, the CG did not engage in any structured exercise program and were advised to maintain their customary lifestyle habits throughout the study duration.

Eligibility Criteria:
Inclusion Criteria:

* Aged between 40-60 years
* Physically independent
* Not having cardiac, orthopedic, or musculoskeletal dysfunctions
* Not participating in regular physical activity more than once a week for the last 5 months before the beginning of the study

Exclusion Criteria:

* Chronic ankle instability
* Lower extremity musculoskeletal injury in the previous 6 months
* Undergoing hormonal replacement therapy
* Having uncontrolled diabetes
* Having uncontrolled hypertension
* Histroy of cardiovascular disease
The Effect of DPP4 Inhibitor on Vasclular Healing

This study evaluate the effect of dipeptidyl-peptidase 4 inhibitor on vascular healing after biodegradable polymer based sirolimus eluting stent implantation in diabetic pateints.


Eligibility Criteria:
Inclusion Criteria:

* Non-ST segement elevation acute coronary syndrome

Exclusion Criteria:

* Left main disease
* Known hypersensitivity or contraindication to any of the following medications: Heparin, aspirin, clopidogrel, sirolimus, siptagliptin and statin
* Congestive heart failure (patients with LVEF \<30% or cardiogenic shock)
* Uncontrolled myocardial ischemia (repeated chest pain or dyspnea after revascularization)
* Uncontrolled ventricular arrhythmia
* History of malignancy with chemotherapy
* Serious hematologic disease (e.g. CML, MDS)
* Current infectious disease needs antibiotics therapy
* Creatinine level \>1.5 mg/dL or dependence on dialysis
* Other severe concurrent illness (e.g. active infection, malignancy).
* Life expectancy of less than one year
* Pregnancy or women with potential childbearing
* Type I DM
* Treatment with insulin
* History of pancreatitis
* Who cannot read the informed consent form (e.g. illiteracy, foreigner)
Impact of Multi-Component Interventions on High Risk COPD Population

Study Participants: High-risk COPD population, defined as individuals whose score of COPD-SQ is 16 and above and whose age is 35 and above. COPD-SQ questionnaire will be assigned to a representative sample of local residents in Xishui County, and they will finish the questionnaire online through mobile phone.

Intervention: Within the intervention arm, we have constructed a population-based pay-for-performance mechanism to encourage medical practitioners to care for population health. For study participants in the intervention arm, we will ask them to finish an online COPD-SQ questionnaire with notification of his or her COPD high risk status. Those whose score exceeds 16 will be invited to do a face-to-face survey, simple physical examination, pulmonary function tests, and provide a multi-component intervention at baseline. For High-risk COPD population in the intervention arm, we provide community-based spirometry pulmonary function test (PFT) and education; If individuals whose post-bronchodilator FEV1/FVC\<0.7, they will be spirometry-defined COPD patients and will be encouraged to seek treatment and medication to the superior hospitals. Additionally, we provide (1) two digital health intervention programs to smokers and individuals with mental health issues; (2) CBT-based health education for study participants with abnormal BMI; (3) active recruitment into National Essential Public Health Program in China for those with abnormal blood pressure and blood glucose. Intensive follow-ups will be conducted at month 3 (telephone interview), month 6 (face-to-face with full steps of physical examination), and month 12.

Comparison: Those who are assigned in the control arm, we will ask them to finish the same COPD-SQ online questionnaire with notification of his or her COPD high risk status and a face-to-face survey. No physical examinations, community-based pulmonary function tests will be given.

Outcomes: The primary outcomes are COPD knowledge, COPD screening, and FEV1 measurement at month 12.


Eligibility Criteria:
Inclusion Criteria:

* Aged 35 and above;
* COPD-SQ score is 16 and above;
* Residents who have lived in one township over the past 3 months and plan to reside in the same township in the upcoming year;
* Finished the informed consent.

Exclusion Criteria:

* Pregnancy and other conditions that are not allowed to finish pulmonary function tests;
* Severe cognitive disorder or total loss of capability of daily living
Chlamydia Trachomatis Immunology and Vaccinology Study

The primary objective is to prospectively follow 200 women with or at risk of cervicitis to determine the chlamydia-specific cellular responses that correlate with protection against incident infection. The hypothesis is that a positive IFN-y response by peripheral CD4+ T cells responding to stimulation with HSP60 will be significantly associated with protection from incident C. trachomatis infection.

A total of 200 women with or at high risk of having cervicitis will be prospectively followed for correlations between chlamydia-specific cellular responses and protection against incident infection.

At enrollment participants will undergo a history and physical examination; blood draw; and pelvic examination including collection of vaginal and cervical samples, STD testing and endometrial biopsy.

Participants will have follow up visits conducted at 1, 4, 8 and 12 months following enrollment. At the follow-up visits, participants will undergo a repeat history and physical, blood draw and pelvic examination including collection of vaginal and cervical samples and STD testing.

The study design will allow comprehensive identification of the antigen-specific cell mediated immune responses most strongly associated with protection against C. trachomatis infection.

The primary objective is to prospectively follow 200 women with or at risk for cervicitis to determine the chlamydia-specific cellular responses that correlate with protection against incident infection.

Eligibility Criteria:
Inclusion Criteria

1. Women 15-35 years of age. Note: Minors must have written informed consent from her parent/legal guardian to participate.
2. At least one of the following:

   1. Current , untreated endocervical C. trachomatis infection.
   2. Mucopurulent cervicitis: defined by the presence of yellow or green endocervical mucopurulent discharge and/ or easily induced endocervical bleeding (bleeding when the first swab is placed in the endocervix).
   3. Sexual contact with a male partner (regardless of condom use) recently diagnosed (within the past 3 months) with C. trachomatis and/or non-gonococcal urethritis.

Exclusion Criteria:

1. Pregnant or nursing a baby. Note: a urine pregnancy test will be done at enrollment. Result must be negative to participate in the study.
2. Gynecologic surgery or surgical abortion in preceding 2 months of enrollment.
3. Allergy to any of the study medications and/or derivatives (cephalosporins, azithromycin, erythromycin, any macrolide or ketolide antibiotic) or Type 1 hypersensitivity allergic reaction to penicillin.
4. Systemic or vaginal antibiotic therapy in preceding 7 days of enrollment.
5. Prior hysterectomy.
6. Menopause.
7. Any condition, in the opinion of the investigator that would interfere with the participant's safety or with study outcomes.
8. Participation in any study involving an investigational product in the past 30 days or anticipation of participation in any study using an investigational product in the next 30 days.
9. Previous participation in this study.
Solving Insomnia Electronically: Sleep Treatment for Asthma

Insomnia is commonly reported by adults with asthma. Insomnia can worsen asthma patients' quality of life and increase the risk for asthma attacks.This clinical trial will compare sleep and asthma control in adults with asthma and insomnia who receive either an internet-based intervention for insomnia or an educational video about insomnia.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18-75 years
2. Telephone, email address, reliable Internet access
3. Have a current primary care physician or a physician who is managing patient's asthma
4. Diagnosis of asthma supported by at least one of the following:

   1. Patient self-report of physician diagnosis of asthma
   2. Asthma diagnosis in the electronic medical record
5. Self-report of current use of medications for asthma
6. FEV1 of ≥ 45% of the predicted normal value for the patient, after withholding bronchodilators at or personal best peak expiratory flow of \> 100 L/min
7. Not well-controlled asthma: Score 12-19 on Asthma Control Test for those on an inhaled corticosteroid; Score 16-19 on Asthma Control Test for those not on an inhaled corticosteroid.
8. Impaired asthma-specific quality of life: Score ≤ 5 on Asthma Quality of Life Questionnaire
9. If subjects are on a controller medication (i.e., inhaled corticosteroid, inhaled corticosteroid and long acting beta-agonists, Singulair, etc.), they must be on stable doses and schedules (i.e., unchanged) of therapy for 2 months prior to enrollment.
10. Meets criteria for DSM-5 Insomnia Disorder
11. At least moderate insomnia severity: Score \> 7 on Insomnia Severity Index
12. Stable self-reported medical, psychiatric conditions

Exclusion Criteria:

1. Non-English speaking, illiterate, or sensory deficits
2. Plans to move or leave present source of care during the following 8 months
3. Receiving antibiotics for upper respiratory infection or pulmonary condition in previous 2 weeks
4. Heavy smoking: Age \< 30 years and smoking history \> 10 pack years OR age ≥ 30 and smoking history \> 15 pack years OR smoking within previous 12 months
5. Substance abuse disorder within previous 3 months
6. Self-reported cystic fibrosis, COPD or interstitial lung disease
7. Self-report of \> 3 asthma attacks/exacerbations requiring systemic corticosteroids, emergency room visit, or hospitalization within the previous year
8. Oral corticosteroid dosage of \> 10 mg/daily
9. Poorly controlled gastroesophageal reflux disease (GERD)
10. Untreated severe obstructive sleep apnea based on apnea-hypopnea index of ≥ 55
11. Self-reported untreated restless legs syndrome
12. History of bipolar disorder or psychosis
13. Current major depression or active suicidal ideation.
14. Asthma attacks/exacerbations requiring systemic corticosteroids, emergency room visit, or hospitalization within the previous 4 weeks
15. Self-report of current pregnancy or trying to become pregnant. Participants who become pregnant during course of the study will be withdrawn from the study.
16. Shift work that includes working the night shift (between the hours of 12:00 a.m. - 6:00 a.m.)
17. Enrolled in prior R03 study (HL135213)
Safety Evaluation of Lactobacillus Salivarius AP-32 and Bifidobacterium Animalis Subsp. Lactis CP-9 in Healthy Infants.

This is a three-arm, double-blind, placebo-controlled study to investigate the safety of Lactobacillus salivarius AP-32 and Bifidobacterium animalis subsp. lactis CP-9 used individually in healthy infants.

Infants will be given the content of one capsule (mixed in infant formula or breast milk) twice daily (morning and evening) for 15 weeks.

This is a three-arm, double-blind, placebo-controlled study to investigate the safety of Lactobacillus salivarius AP-32 and Bifidobacterium animalis subsp. lactis CP-9 used individually in healthy infants.

Infants will be given the content of one capsule (mixed in infant formula or breast milk) twice daily (morning and evening) for 15 weeks. Follow-up visits will take place at study days 14±3, 42±3, 70±4 and 105±4.

Caregivers will keep a diary of the volume of formula intake/minutes of breastfeeding, stool frequency and consistency (hard, formed, soft/paste or loose/watery), symptoms of digestive tolerance (regurgitation and flatulence), sleeping time, crying/fussing time and episodes for 3 days before each visit. At each visit, the research team will review the diary and conduct physical examination, including anthropometric measurements (weight, recumbent length, and head circumference).

Fecal samples will be collected prior to the first administration of the assigned study product and at the end of study for microbiota analysis.

Adverse events (AEs) will be assessed based on inquires to the caregivers. AEs will be classified as related or unrelated based on a relationship to study product intake according to the investigator.

Eligibility Criteria:
Inclusion Criteria:

* Having informed consent of the parent or legal guardian.
* Healthy male and female infants between 7 days and 2 months (60 ± 2 days) of age at the time of study initiation.
* Full term ( ≧ 36 weeks gestation at birth).
* Birth weight ≧ 2500 g.
* Able and willing to comply with all study requirements.

Exclusion Criteria:

* Failure to thrive (weight gain \< 100 grams/week average from birth to the last recorded weight).
* Major acute or chronic illness (e.g. significant cardiac, respiratory, hematological, gastrointestinal or other systemic diseases, major developmental or genetic abnormality).
* Use of substances that alter gut microbiota (antibiotics, prebiotics, probiotics or gastric acid inhibitors) within 2 weeks prior to the study initiation.
* For breastfed infants, use of antibiotics, prebiotics and probiotics by the mothers.
* Cow's milk protein allergy.
* Feeding difficulties.
* History of any allergies to maltodextrin.
* Participation in another clinical trial.
* Any other clinically significant medical, psychiatric and/or social reason as determined by the investigator.
Use of Endobronchial Valves in Non-Upper Lobe Heterogeneous Emphysema

Hypothesis: Patients with advanced emphysema with predominance of the disease in areas other than the upper lobes, as determined by high resolution computed tomography (HRCT), could have a positive response to valve treatment.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-80 years
* Ex-smoker with smoking cessation confirmed by exhaled carbon monoxide (CO) levels
* Moderate to severe airflow obstruction FEV1 \<50% Predicted
* Severe dyspnoea - mMRC ≥2
* Hyperinflation - total lung capacity (TLC) ≥100% predicted, RV ≥150% predicted
* SWT ≥75m
* Optimum COPD treatment for at least 6 weeks
* No COPD exacerbation for at least 6 weeks
* Less than 4 admissions for exacerbation in the preceding 12 months

Exclusion Criteria:

* Patient unable to provide informed consent
* Patient without clear targets for airflow re-distribution
* Total lung CO uptake (TLCO) \<15% predicted and FEV1 \<15% predicted
* pO2 on air \<6.0kPa
* pCO2 on air \>8.0kPa
* Neurological, rheumatological or other cause of exercise limitation
* Other major medical illness, e.g. lung cancer that will limit participation
* Production of purulent sputum more often than not (more than 50% of days)
* Clinically significant bronchiectasis
* Large bulla - more than 1/3 of hemithorax volume (i.e. where bullectomy would be more suitable) on CT scan
* Arrhythmia or cardiovascular disease that poses a risk during procedure or exercise
* Prednisolone dose greater than 15mg a day
* Significant pulmonary hypertension - RVSP ≥45mmHg
* Left ventricular failure - left ventricular ejection fraction \<45% or left ventricular fraction shortening \<23%
* Prior LVRS or lobectomy
* Lung nodule requiring surgery
* Subject completed or is participating in a standard pulmonary rehabilitation program within 3 months of enrolment
* Female of childbearing age with positive pregnancy test
* Subject participated in a research study of investigational drug or device in prior 30 days
* Subject taking clopidogrel, warfarin, or other anticoagulants and unable to abstain for 5 days pre-procedure
Uniformity of Oral Contrast Material in the Bowel

Although positive oral contrast agents are used for the majority of abdominopelvic CT scans in the United States, the quality of bowel opacification has not been compared between the three major classes of positive oral contrast material (barium sulfate, ionic iodinated contrast material, and non-ionic iodinate contrast material). This is a retrospective single institution study of clinical records to show whether the uniformity of bowel opacification is different between the three main types of positive CT oral contrast material used in the United States (Barium sulfate, Diatrizoate, and Iohexol). The investigators will retrospectively identify 250 patients each who received oral barium sulfate, diatrizoate, and iohexol for CT scanning of the abdomen and pelvis (total 750 patients) and assess the quality of bowel lumen opacification by the positive oral contrast agents.

Although positive oral contrast agents are used for the majority of abdominopelvic CT scans in the United States, the quality of bowel opacification has not been compared between the three major classes of positive oral contrast material (barium sulfate, ionic iodinated contrast material, and non-ionic iodinate contrast material). The investigators will retrospectively identify 250 patients each who received oral barium sulfate, diatrizoate, and iohexol for CT scanning of the abdomen and pelvis (total 750 patients) and assess the quality of bowel lumen opacification by the positive oral contrast agents.

Primary objective:

* To show the uniformity of bowel opacification is different between the three main types of CT oral contrast material used in the United States (Barium sulfate, Diatrizoate, and Iohexol).

Secondary objectives:

* To show whether or not one of the oral contrast agents provides more uniform opacification than the others in the proximal or distal bowel
* To assess the relative opacification of the distal small bowel (ileum) by the three contrast agents.

Eligibility Criteria:
Inclusion Criteria:

* CT scans in which oral contrast material was given

Exclusion Criteria:

* CT scans in which an obvious paucity of oral contrast material is seen,
* CT scans of patients who had studies within 1 week prior where enteric contrast may have been given, including fluoroscopic, endoscopic, or interventional studies
Remission Rate of Newly Diagnosed Type 2 Diabetes Outpatients Treated With Short-term Intensive Insulin Therapy

To evaluate the long-term remission rate of short-term intensive insulin (STII) therapy in newly diagnosed type 2 diabetes outpatients and investigate the predictors contributing to the remission rate.


Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed, insulin-naive type 2 diabetes outpatients
* Diabetes duration less than 1 year

Exclusion Criteria:

* Various acute complications
* Hepatic transaminase \>2.5x normal reference value (glutamic-pyruvic transminase\>100U/L, glutamic-oxalacetic transaminase \> 100U/L)
* Abnormal renal functions (serum cretinine\>the normal reference value)
* Cardiac insufficiency (America NYHA caediac function \>3)
* Type 1 diabetes mellitus
* Ongoing hormone therapy
* Women in gestation and lactation
* Patients with other endocrine disorders