cyrilzakka/clinical-trials huggingface dataset:
Safety and Tolerability of Multiple Inhaled NVA237 Doses in Chronic Obstructive Pulmonary Disease (COPD) Patients

This study will evaluate the pharmacokinetics, pharmacodynamics and safety of multiple doses of the NVA237 in mild and moderate COPD patients .


Eligibility Criteria:
Inclusion Criteria:

* Male and/or female patients aged from 40-75 years of age with mild to moderate COPD.
* Diagnosis of mild/moderate COPD, according to the GOLD guidelines.
* Bronchodilatory response to ipratropium at screening
* Current or ex-smokers with a smoking history of \>10 pack-years. Ten pack-years is defined as 20 cigarettes a day for 10 years, or 10 cigarettes a day for 20 years etc.
* Female patients must have been surgically sterilized at least 6 months prior to screening or: Postmenopausal women must have no regular menstrual bleeding for at least 1 year prior to inclusion.
* Lab and post-bronchodilator values within a certain range.
* Body mass index (BMI) must be within the range of 18 to 32 kg/m2.

Exclusion Criteria:

* Any significant medical condition that in the opinion of the Investigator may compromise patient safety, patient compliance, interfere with evaluations, or preclude completion of the trial.
* Any medical condition that may make spirometry unsafe
* History of glaucoma, symptomatic prostatism or urinary retention.
* Participation in any clinical investigation within 4 weeks prior to dosing or longer if required by local regulations and for any other limitation of participation based on local regulations. Previous participation in a study with either the investigational or comparator drugs does not exclude a patient from participation in this study.
* Donation or loss of 400 ml or more of blood within 8 weeks prior to first dosing, or longer if required by local regulation.
* Significant illness (other than respiratory illness) within the two weeks prior to dosing.
* Clinically significant ECG abnormalities indicative of an unstable underlying cardiac problem, e.g. recent myocardial infarction, 2nd/3rd degree heart block, or a family history grandparents, parents and siblings of a prolonged QT-interval syndrome.
* History of clinically significant drug allergy or history of atopic allergy (asthma, urticaria, eczematous dermatitis). A known hypersensitivity to the study drug or drugs similar to the study drug.
* History of immunocompromise, including a positive HIV (ELISA and Western blot) test result.
* A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result.
* History of drug or alcohol abuse within the 12 months prior to dosing or evidence of such abuse as indicated by the laboratory assays conducted during the screening or baseline evaluations.
* Patients who are unable to demonstrate appropriate use of the Concept 1 device at screening

Other protocol-defined inclusion/exclusion criteria may apply
Controlling Asthma at School

To implement and evaluate a coordinated set of activities for asthma identification, education, management, and prevention in the predominantly minority inner city schools in the Detroit metropolitan area.

BACKGROUND:

The study was part of an initiative "Interventions to Improve Asthma Management and Prevention at School". The Broad Agency Announcement was released in June, 1994.

DESIGN NARRATIVE:

The intervention was a combination of: targeted education for children with asthma, other children in the school, families, physicians and school personnel; concerted effort to change school policies working against effective self-management of asthma; community action/education to create awareness and support for the schools' efforts to control the disease. Open Airways for School, a proven educational program, was adapted for students in the Detroit metropolitan area as part of the intervention. This program was based on social cognitive theory while modeling effective asthma management behavior, involving students in activities where they mastered skills relevant to asthma management, and developing the students' sense of confidence to carry out asthma management tasks. For education of all students, a learning module called "Environmental Detective" was developed to complement the Michigan Model of comprehensive health education offered in classrooms in Michigan. The Environmental Detective game sensitized children without asthma to the problems of children with asthma. The intervention was evaluated through a controlled research design to determine if it had an impact on asthma morbidity, the number of days of limited activity of the child with asthma, and his or her academic performance.

The project was a collaboration of the University of Michigan School of Public Health and School of Medicine, the Henry Ford Hospital Center of Detroit, the Washtenaw County Health and Human Services Department, the American Lung Association of Michigan, and the State of Michigan Department of Education.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
A Study Comparing the Efficacy and Safety of Nivolumab in Combination With Bacillus Calmette-Guerin (BCG) Versus BCG Alone in Participants With High-Risk Non-Muscle Invasive Bladder Cancer (HR NMIBC)

A study comparing nivolumab and bacterial drugs given to help the body's immune system in the bladder versus bacterial drugs alone in high risk bladder cancer participants.


Eligibility Criteria:
Inclusion Criteria:

* Persistent or recurrent disease ≤ 24 months of last BCG dose, but not classified as BCG unresponsive
* Histologically confirmed persistent or recurrent high-risk non-muscle-invasive urothelial carcinoma (UC)
* Treated with at least 1 adequate course of induction BCG therapy (at least 5 out of 6 doses)
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2

Exclusion Criteria:

* Previous or concurrent muscle invasive, locally advanced, or disseminated/metastatic UC
* UC in the upper genitourinary tract (kidneys, renal collecting systems, ureters) within 24 months of enrollment
* UC and/or CIS in the prostatic urethra within 12 months of enrollment

Other protocol-defined inclusion/exclusion criteria apply
The Efficacy and Safety of Prophylactic Central Lymph Node Dissection in Papillary Thyroid Carcinoma

The aim of this study is to investigate the efficacy and safety of prophylactic central lymph node dissection in papillary thyroid carcinoma.

The aim of this study is to investigate the efficacy and safety of prophylactic central lymph node dissection in papillary thyroid carcinoma. Primary outcome is the surgical completeness, recurrence rate, and successful ablation rate. Secondary outcomes are the incidence of postoperative complications and PTC stage. The enrolled patients were randomly assigned to control group and intervention group (1:1 allocation).

Eligibility Criteria:
Inclusion criteria were as follows:

1. patients aged 20 to 70 years old
2. patients diagnosed with PTC or suspicious for PTC on fine needle aspiration or core needle biopsy
3. patients with no evidence of LNM before and during surgery(cN0)
4. patients with no evidence of distant metastasis(cM0).

Exclusion criteria were as follows:

1. patients suspected of advanced PTC(clinically T3 or T4) such as invasion of peripheral organs on preoperative examination
2. patients who have previous history of cervical radiation therapy or surgery.
3. pregnant women
4. uncontrolled diabetes, hypertension, or chronic renal failure
5. aspirin or anticoagulant medication within 7 days
6. other clinical trial participation within 30 days
7. radiation exposure to the head and neck
8. previous operation to the neck
9. advanced thyroid cancer including adjacent organ invasion
Buccal Graft + Collagen Matrix Versus Free Gingival Graft for Keratinized Mucosa Augmentation at Implant Sites

The study aims at comparing two different approaches for soft tissue augmentation at implants lacking keratinized and adherent mucosa width: the free gingival graft (FGG) vs the Buccal Strip Graft in combination with a xenogeneic collagen matrix (BSG + CM)

Conventional free gingival graft (FGG), serving as control group, will be compared to buccal strip gingival graft (BSG) in combination with a collagen matrix (CM), serving as test group, in terms of clinical, volumetric, ultrasonographic, and patient-reported outcomes related to soft tissue augmentation at implant sites lacking keratinized and adherent mucosa.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years,
* Periodontally and systemically healthy,
* Full-mouth plaque score and full-mouth bleeding ≤ 20% (measured at four sites per tooth),
* Presence of at least one dental implant with \< 2 mm of KM and lack of firm/adherent mucosa,
* Presence of at least 4 mm of keratinized gingiva in two or more teeth nonadjacent to the implant to be treated,
* Implants diagnosed as healthy (Berglundh et al. 2018),
* The patient must be able to perform good oral hygiene.

Exclusion criteria:

* Contraindications for surgery,
* Systemic condition (e.g. diabetes mellitus, HIV, cancer, etc) that could compromise wound healing,
* Patients pregnant or attempting to get pregnant (self-reported),
* Untreated periodontitis,
* Untreated peri-implant mucositis or peri-implantitis (Berglundh et al. 2018),
* Smoking,
* Allergy to collagen-based medical products or iodine,
* Previous free gingival graft procedure at the target site.
Continuous Endostar Infusion Combined With Radiotherapy in Patients With Brain Metastases

The aim of this study is to evaluate the clinical efficacy and safety of continuous Endostar infusion combined with radiotherapy for treatment of brain metastases.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed malignancy with presence of intraparenchymal brain metastases
* Karnofsky performance status ≥ 40
* Measurable disease according to RECIST criteria
* Hematologic function: WBC ≥ 4.0×109/L, PLT ≥ 80×109/L, Hb ≥ 90g/L
* Renal function: Cr ≤ 2.0×ULN
* Hepatic function: BIL ≤ 2.0×ULN, ALT/AST ≤ 5.0×ULN
* Adequate cardiac function
* Life expectancy ≥ 3 months

Exclusion Criteria:

* Evidence of bleeding diathesis or serious infection
* Serious cardiovascular disease (congestive heart failure, uncontrollable arrhythmia, unstable angina, myocardial infarction, serious heart valve disease, resistant hypertension)
* Uncontrollable mental and nervous disorders
* Pregnant or lactating women
Influence of Conditional Workout Postpartum on Arterial Stiffness Among Women With Status After Preeclampsia, Superimposed Preeclampsia or HELLP-syndrome

Evaluation of practicability in survey and test procedures and of successful implementation of complex interventions - feasibility analysis based on a pilot study: Influence of conditional workout postpartum on arterial stiffness among women with status after preeclampsia, superimposed preeclampsia or HELLP-syndrome

Cardiovascular disease is the main cause of death among women in Europe and in the USA. Its costs amount annually more than 196 billions Euro in Europe. The federal state of Saxony-Anhalt occupies leading position in mortality in myocardial infarction and coronary heart disease in Germany. Up to 8 percent of all pregnant women develop a severe pregnancy-associated hypertension, like preeclampsia, superimposed preeclampsia or HELLP-syndrome. These women have an increased lifetime risk for cardio- and cerebrovascular diseases.

The consecutive increasing arterial stiffness because of endothelial dysfunction is a determining factor in etiology of pregnancy-associated hypertension and results in increased cardiovascular risk. Aortal pulse wave velocity is used as Goldstandard for measuring arterial stiffness.

Pregnant women suffering from a severe pregnancy-associated hypertension present higher levels in arterial stiffness measured by pulse wave velocity than healthy pregnant women. Pathological changes of the vascular systems persistent from 6 month until 10 years after delivery and give an explanatory approach for an increased cardiovascular longterm risk at these patients. Numerous medical associations like American Heart Association aim at reducing especially cardiovascular longterm risk in women with status after preeclampsia, superimposed preeclampsia or HELLP syndrome.

Pregnancy-independent studies in patients with coronary heart disease and analysis in women with metabolic syndrome show a reduction of arterial stiffness by regular conditional workout.

Scientific problem of this pilot study: If a reduction in arterial stiffness in women from a risk group - during a 6-month-ongoing intensive regular conditional workout within a midwife-supported teamwork and under inclusion of dietary interventions - achieved?

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of preeclampsia, superimposed gestosis or HELLP syndrome
* capacity for content

Exclusion Criteria:

* eclamptic stroke
* New York Heart Association \> Stadium II
* severe neurological or orthopedic disabilities
* peripheral arterial occlusive disease
* severe disease of the newborn which leads to an intensive familial care
Study to Evaluate the Efficacy, Safety, Tolerability and Immunogenicity of 100µg NIC002 Vaccine in Cigarette Smokers Who Are Motivated to Quit Smoking.

This study is designed to determine the efficacy of high nicotine-specific antibody titers in smoking cessation.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female smoking subjects age 18 to 65 years of age
* Subjects must be smoking 10 or more cigarettes per day during the past 12 months
* The exhaled breath carbon monoxide (CO) concentration must be 10 ppm or more at screening. Urine cotinine at screening must be positive.
* The Fagerström Test for Nicotine Dependence (FTND) score of 5 or above at screening.

Exclusion Criteria:

* Attempted to quit smoking in the three (3) months.
* Prior use of smoking cessation aid.

Other protocol-defined inclusion/exclusion criteria may apply
Memory for Flu Facts and Myths and Effects on Vaccine Intentions

Objectives: To determine whether people systematically misremember the "myths" (false information) as true, and to assess effects on perceptions of risk and behavioral intentions.

Public information campaigns often warn people about false and unreliable medical claims by juxtaposing "myths" and "facts." The effectiveness of such communications has rarely been assessed. We assessed whether people systematically misremember the "myths" (false information) as true, and to assess effects on perceptions of risk and behavioral intentions.

In an experimental study, participants read either a published CDC flyer on "Facts and Myths" about the flu vaccine, or a "Facts Only" version; a separate control group read no flyer. Participants completed the outcome measures either immediately or after 30 minutes.

Primary measures were memory for information about the flu presented in the flyer, ratings of perceived risks associated with the flu, and personal intentions to get vaccinated in the upcoming season.

After a delay of 30 minutes, participants who read the "Facts and Myths" flyer systematically misremembered myths as facts. Both versions of the flyer had the immediate effect of increasing intentions to get a flu vaccine, compared to the control group. After 30 minutes, however, participants who read the "Facts and Myths" flyer reported lower intentions to get vaccinated, compared to those who read the same flyer with no delay, and compared to all participants who read the "Facts Only" flyer.

In sum, people show a bias to think that incompletely remembered information is true, turning "myths" into "facts." Hence public information campaigns should emphasize information that is true. Repeating false information, even as a warning, can create the unintended consequence of belief in the information.

Eligibility Criteria:
Inclusion Criteria:

* Must be able to read and write fluent English

Exclusion Criteria:

-
Effect of Proton Pump Inhibitor of Daily Use for One Month on Kidney Function Test

The aim of this study to:

evaluate the association between prolonged use of PPI and adverse renal outcomes on patients with normal renal function and others with abnormal renal function

Proton pump inhibitors (PPIs) are one of the most widely used classes of drugs and are prescribed primarily for gastric acid-related diseases, eradication of Helicobacter pylori, and prevention of nonsteroidal anti-inflammatory drug (NSAID)-induced gastropathy,and gastroesophagial reflux diseases , Although PPIs have an excellent overall safety profile, some severe adverse effects, which include bone fracture, dementia, myocardial infarction, infections, micronutrient deficiencies, and kidney diseases, PPIs may trigger acute interstitial nephritis,a potentially sever adverse event commonly associated with acute kidney injury. The increase in prescription and inadequate use of this class of medication calls for studies on the effects of prolonged PPI therapy on renal function.

Eligibility Criteria:
Inclusion Criteria:

* patients with peptic ulcer disease or gastroesophagial reflux with normal l renal function
* patients with peptic ulcer disease or gastroeosophagial reflux with abnormal renal function

Exclusion Criteria:

* 1- cigarette smoker: Cigarette smoking status was defined categorically as current,former, or never smoker at baseline.

  2-biabetic patients: diabetes mellitus is defined by a fasting blood glucose concentration \>_ 126 mg/dl ,random glucose level of \>200 mg 3-patients take corticosteroid 4-patients with hypersensitivity to these drugs
M1231 in Participants With Solid Tumors

This study is to establish a safe and tolerable dose and to investigate pharmacokinetics and the first clinical efficacy signals of M1231 as a single agent in participants with solid tumors (Part 1) and with metastatic Non-small Cell Lung Cancer (NSCLC) and esophageal squamous cell carcinoma (Part 2). Dose escalation will be followed by the dose expansion once the maximum tolerated dose (MTD) or recommended dose for Expansion (RDE) has been defined.


Eligibility Criteria:
Inclusion Criteria:

For Part 1 and 2:

* The Investigator reviews the medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a female with an early undetected pregnancy

For Part 1:

* Locally advanced or metastatic disease that is intolerant or refractory to standard therapy or for which no standard therapy is judged appropriate by the investigator
* Participants with solid tumors expressing or likely to expressing EGFR and MUC1, including but not limited to lung cancer, squamous esophageal cancer, head and neck squamous cell carcinoma, breast cancer and ovarian cancer, should be prioritized for enrollment

For Part 2:

* Cohort A: Participants must have progressed on at least 2 prior lines of therapy
* Cohort B: Participants must have progressed on at least 1 prior line of platinum therapy and for microsatellite instability-high (MSI-H) at least 1 prior line with pembrolizumab
* Eastern Cooperative Oncology Group (ECOG) Performance Status less than 1
* Tumor accessible for biopsies and agreement to conduct fresh tumor biopsies at Screening and before first dosing

Exclusion Criteria:

* Participants not recovered from adverse events (AE) (less than or equal to Grade 1) related to previous therapies (excluding Grade 1 neuropathy and alopecia)
* Participant has a history of a second malignancy within 3 years before the date of enrollment
* Known brain metastasis
* Unstable angina, myocardial infarction, congestive heart failure or a coronary revascularization procedure within 180 days of study entry
* Cerebrovascular accident/stroke
* Diagnosis of fever within 1 week prior to study intervention administration
* Life expectancy of less than 4 months
* Steroid therapy for anti-neoplastic intent taken less than 7 days prior to the first dose of study intervention
* Major surgery within 4 weeks prior to start of study intervention
* Received growth factors (including erythropoietin (EPO), darbepoetin, granulocyte-colony stimulating factor (G-CSF), granulocyte macrophage-colony stimulating factor (GM-CSF), and platelet stimulators or transfusions within 2 weeks prior to the first day of study intervention
A Study of IBI362 Evaluating Weight Loss in Obese and Overweight Chinese Subjects

This is a study of IBI362 in participants with overweight and obesity. The main purpose is to learn more about how IBI362 affects body weight. The study period including 4-8 weeks dose titration and 40-44 weeks maintain treatment and 12 weeks follow up.


Eligibility Criteria:
Inclusion Criteria:

1. Body mass Index (BMI) ≥28 kilograms per square meter (kg/m²), or ≥24 kg/m² and previous diagnosis with at least one of the following comorbidities: hypertension, dyslipidemia, obstructive sleep apnea
2. History of at least one unsuccessful dietary effort to lose body weight

Exclusion Criteria:

1. Diabetes mellitus
2. Weight change \> 5.0% after diet and exercise control for at least 12 weeks before screening
3. Have used or are currently using weight loss drugs within 3 months before screening
4. History of pancreatitis
5. Family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)
6. History of moderate to severe depression，or have a history of serious mental illness
7. Any lifetime history of a suicide attempt
Feasibility of a Technology-Based Treatment Support System

This study aims to evaluate a technology-based treatment support system for patients undergoing the treatment of depression. The investigators will explore the usefulness of the technology-based treatment support system as an adjunct to psychotherapy for depression.

This study aims to evaluate a technology-based treatment support system "mConnect" for patients undergoing the treatment of depression. This system will be evaluated by conducting a randomized controlled trial where patients will either receive the mConnect mobile app or treatment as usual.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* English-speaking
* Currently enrolled in outpatient treatment
* Current diagnosis of major depressive disorder
* Ownership of a smartphone device compatible with the mobile app

Exclusion Criteria

* visual, hearing, voice, or motor impairment that would prevent completion of the study procedures or use of mobile phone
* diagnosis of a psychotic disorder, bipolar disorder, dissociative disorder, substance use disorder, or other diagnosis for which participation in this trial is inappropriate, severe suicidality (has ideation, plan, and intent).
* having completed more than 3 sessions of psychotherapy with current therapist