cyrilzakka/clinical-trials huggingface dataset:
Impact of Multi-component Interventions on Populations with Mental Health Symptoms and High-risk COPD

Study Participants: High-risk COPD population with mental health symptoms, defined as individuals whose score of COPD-SQ ≥ 16, whose age is 35 and above, and whose Warwick-Edinburgh Mental Well-being Scale \<45 .

Intervention: We have constructed a pay-for-population mechanism for medical practitioners within the intervention townships to encourage them caring 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. For those with high-risk COPD population, we will provide face-to-face survey, simple physical examination, pulmonary function tests, and provide a multi-component intervention at baseline. For high-risk COPD population with mental health issues 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. A CBT-based digital health intervention program, EmoEase, will be provided to our study participants with an intelligent mobile phone. Also health education in terms of mental health issues will be given. Additionally, we provide (1) a digital health intervention programs to smokers; (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 PHQ-9 scores for depression symptoms, GAD-7 symptoms for anxiety symptoms, and WEM-WBS score at month 12.


Eligibility Criteria:
Inclusion Criteria:

* Aged 35 and above;
* High-risk COPD population, defined by score of COPD-SQ ≥ 16;
* Mental health issues, defined by WEM-WBS scale \< 45;
* Local residents who stay within a township in the previous 3 months and plan to stay within the same township for the next 12 months.

Exclusion Criteria:

* Those who suffer from severe cognitive disorder or total loss of ability of daily living.
Metabolic Effects of Enfuvirtide in Healthy Volunteers

The metabolic effects of T-20 are not completely known, since the drug is used in combination with other antiretroviral agents. A short-term study in healthy volunteers, with a double-blind crossover design vs. placebo will illustrate if there may be some direct metabolic effects without the influence of HIV infection and the concurrent use of other drugs.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adult males
* BMI between 19-24.9 kg/m2
* No active concomitant clinical conditions
* Negative HIV, HBV and HCV serologies
* Negative abuse drug urine test

Exclusion Criteria:

* Prior psychiatric illness
* Prior dyslipemia
* Alcohol consumption \> 30g/day
* Caffeine consumption \> 5 units/day
* Current smoker
* Known drug allergies
* Participation in other drug trials in the previous 3 months
* No medications in the previous 30 days
Conservative Treatment of Esotropia in Children up to 3 Years Old

The objective of this prospective study is the treatment of esotropia by prescribing the full precise optical correction of refractive errors in children up to 3 years old.

This investigation includes children with esotropia associated with hyperopia, hypermetropic astigmatism, myopia, myopic astigmatism and minor ametropias. All children are prescribed full optical correction of refractive errors with special attention to astigmatism up to 0.5 Dpt to achieve maximal clear image on the retina of both eyes.If necessary, direct occlusion or penalization were administered to the children. The investigators suggest that this approach will give good results in the treatment of esotropia.

Eligibility Criteria:
Inclusion Criteria:

* Within the age of 3 months to 3 years (inclusive infantile esotropia)
* Patients with constant or periodic esotropia and with revealed angle of deviation 5 degrees or over by Hirschberg test
* Patients with refractive errors (inclusive minor ametropias from 0.5 Dptr)

Exclusion Criteria:

* Age above 3 years
* Patients with neurological diseases and paralytic strabismus
Long-term of 10 Years Results of a Prospective Longitudinal Study

Previous cross-sectional studies have demonstrated that blood pressure (BP) measurements at home (HBP) in the morning offer stronger predictive power for micro- and macrovascular complications in patients with type 1 and 2 diabetes than casual/clinic blood pressure measurements (CBP) (Kamoi K et al, 2002-2003). Further, a prospective, longitudinal study for 6 years in patients with type 2 diabetes also demonstrated that control of wakening-up HBP provides the stronger predictive power for the outcomes than that of CBP did (Kamoi et al, 2010).

However, it is not clear to show which of BP measurement provides the stronger predictive power for outcomes by comparing cumulative events over a longer time than 6 years. Therefore, the investigators examined which of HBP or CBP provides the stronger predictive power for outcomes in addition of renal anemia reported previously over 10 years in the patients with type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* After a detailed baseline examination, 400 Japanese subjects with type 2 diabetes reported previously are followed up for all-cause mortality and morbidity.

Exclusion Criteria:

* Other than the above, patients judged inappropriate as the subjects of this study by the investigator
Comparison Between Internal and External Preoperative Biliary Drainage in Periampullary Cancers

Preoperative biliary drainage methods include percutaneous transhepatic biliary drainage (PTBD), endoscopic nasobiliary drainage (ENBD), and endoscopic retrograde biliary drainage (ERBD). Endoscopic biliary drainages often induce peritumoral inflammation and it increase difficulties in determining a proper resection margin. The purpose of this study is to compare the clinicopathological outcomes according to the methods of preoperative biliary drainage in periampullary cancers causing obstructive jaundice, and to find out a proper biliary drainage method.


Eligibility Criteria:
Inclusion Criteria:

* patient who have periampullary tumors causing obstructive jaundice
* patient age: ≥20 and ≤85
* resectable state of disease
* no history of previous chemotherapy or radiotherapy
* patients without uncontrollable severe cardiovascular, respiratory disease
* Karnofsky performance scale ≥70
* informed consent

Exclusion Criteria:

* patients with distant metastasis or locally advanced disease with major vascular invasion
* duodenal cancer
* biliary drainage before randomization
* previous chemotherapy or radiotherapy
* uncontrollable active infection except cholangitis
* severe comorbid disease (cardiac, pulmonary, cerebrovascular)
Sarcopenia in Head and Neck Cancer Patients Treated with Curative Hadrontherapy

The study focuses on the impact of sarcopenia on acute and late toxicities in head and neck tumor affected patients treated with particle therapy.

To evaluate in HNC patients treated with particle therapy the impact of SP (measured by low skeletal muscle mass at the C3 vertebral body) on toxicity profile assessed according to NCI's Common Terminology Criteria for Adverse Events CTCAE (version 5.0), defined as:

* Acute toxicity: within 3 months from the beginning of particle RT
* Late toxicity: more than 6 months after the end of particle RT. To investigate possible association between SP and nutritional

Eligibility Criteria:
Inclusion Criteria:

* All HNC histologies and stages
* Histological and/or radiological diagnosis of head and neck tumors
* The patient is able to give consent
* Definitive/postoperative treatment with curative intent
* Age \>18 years
* KPS\> 80

Exclusion Criteria:

* Plurimetastiatic disease
* Palliative intent and re-irradiation treatments
* Known cases of any psychiatric and neurological diseases leading to disability (eg, manic disorder, schizophrenia etc..), which could impair compilation of questionnaires
NEPA to Prevent Chemotherapy Induced Nausea and Vomiting in Patients With Breast Cancer

This study evaluates if the activity of one-day of NEPA plus dexamethasone, to prevent chemotherapy-induced nausea and vomiting in breast cancer patients receiving adjuvant AC-based chemotherapy, is maintained during all the chemotherapy cycle treatment (maximum 4 cycles).

Patients included in the study should be treated with the following antiemetic prophylaxis, during all the AC-based chemotherapy cycles, up to a maximum of 4 cycles:

* NEPA will be administered orally at the dose of 300 mg netupitant/0.5 palonosetron 1 hour before the start of any chemotherapy cycle.
* Dexamethasone 12 mg will be added on day 1 only of each cycle.

Eligibility Criteria:
Inclusion Criteria:

1. Women ≥ 18 years old
2. Histologically or cytologically confirmed diagnosis of breast cancer
3. Naïve patients
4. Be scheduled to receive adjuvant chemotherapy with anthracycline (doxorubicin or epirubicin) + cyclophosphamide (AC-based regimen)
5. ECOG (Eastern Cooperative Oncology Group) performance status 0-2
6. Body Mass index (BMI) ≥ 18.5
7. Written informed consent
8. If women of childbearing potential age: reliable contraceptive measures must be used during the study treatment period and up to 30 days after last NEPA administration
9. Acceptable hepatic function (\<= 2 times the upper limit of normal for liver transaminases) and renal function (creatinine \< 1.5 times the upper limit of normal);
10. Ability and willingness of the patient to complete the diary.

Exclusion Criteria:

1. Advanced/metastatic breast cancer
2. Patients already submitted to non-AC-based chemotherapy
3. Treatment with investigational medications in 30 days before NEPA
4. Myocardial infarction within the last 6 months
5. Documented or known hypersensitivity to 5HT3RA (5-Hydroxytryptamine Receptor 3 Antagonists) or NK1RA (Neurokinin-1 Receptor Antagonists) and excipients
6. Uncontrolled diabetes mellitus
7. Nausea and vomiting at baseline
8. Chronic use of other antiemetic agent(s)
9. Patient's inability to take oral medication
10. Gastrointestinal obstruction or active peptic ulcer
11. Pregnancy or breastfeeding
12. Prior malignancies at other sites except surgically treated non-melanoma skin cancer, superficial cervical cancer, or other cancer from which the patient had been disease-free for ≥ 5 years
13. Psychiatric or CNS (Central Nervous System) disorders interfering with ability to comply with study protocol
Tiotropium Respimat Pharmacokinetic Study in COPD

The purpose of this study is compare the effect of different doses of tiotropium delivered by the HandiHaler and Respimat device on lung function. Additionally, the study will investigate the pharmacokinetic profile of these different doses. Studying the pharmacokinetic profile shows what happens to the medication in the body over a period of hours and provides information on potential effects of the medication.


Eligibility Criteria:
Inclusion criteria:

1. All patient must sign an informed consent consistent with IInternational Conference on Harmonisation- Good Clinical Practice (ICH-GCP) guidelines and local legislation prior to any study-related procedures, including medication washout and restrictions.
2. Relatively stable, moderate to very severe Chronic Obstructive Pulmonary Disease (COPD)
3. Current or ex-smokers (smoking history of at least 10 pack years)
4. Able to perform lung function tests
5. Able to use study inhalers

Exclusion criteria:

1. Significant diseases other than COPD
2. Recent myocardial infarction, unstable or life-threatening cardiac arrhythmia, hospitalisation for cardiac failure.
3. Malignancy requiring resection, radiation therapy or chemotherapy within the last 5 years
4. History of asthma, life-threatening pulmonary obstruction, cystic fibrosis or clinically evident bronchiectasis 5 Active tuberculosis

6. History of alcohol or drug abuse 7. Pulmonary resection 8. Recent completion of a pulmonary rehabilitation program or current participation which will not be continued 9. Daytime oxygen therapy for more than 1 hour per day. 10. Use of other investigational drugs, restrictions on the use of some respiratory medications during the study period.

11. Current participation in another clinical trial 12. Pregnant or nursing women 13. Women of childbearing potential not using a highly effective method of contraception (e.g: implants, injectable, oral contraceptives)
Bioequivalence of IMP 08P1902F0 Relative to Contramal® (100 mg/mL Oral Solution)

This study aims to demonstrate the bioequivalence between the formulation of 5 mg/mL Tramadol Hydrochloride Oral Solution (08P1902F0) Relative to the reference product Contramal® (100 mg/mL Oral Solution).


Eligibility Criteria:
Inclusion Criteria:

* Male and non-pregnant female human subjects, age 18-50 years
* Body mass index between 18.5-30 Kg/m²
* Subject with normal findings
* Willingness to follow the protocol requirements

Exclusion Criteria:

* History of hypersensitivity to tramadol hydrochloride
* Significant history of asthma, thyrotoxicosis, tumours, peptic or gastric ulcer, gastrointestinal malabsorption or haemorrhage in the gastro-intestinal tract, sinusitis, pharyngitis, renal disorder (impaired renal function), hepatic disorder (impaired hepatic function), cardiovascular disorder (ex. severe heart failure), neurological disease such as epilepsy, haematological disorders or diabetes, psychiatric, dermatologic or immunological disorders
* Presence of any clinically significant results from laboratory tests,
* lactating female or woman of childbearing potential unwilling to use an effective contraception
Efficacy, Safety, and Pharmacokinetics of Intravenous Ibuprofen in Adult Febrile Patients

The primary objective of this study is to evaluate the efficacy of intravenous ibuprofen on reducing fever at 4 hours.

The primary objective of this study is to evaluate the efficacy of a single 400 mg dose of intravenous ibuprofen on reducing fever greater than or equal to 101.0ºF (38.3ºC), as compared with the efficacy of parallel placebo treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Be hospitalized
2. Have new (not chronic, within last 7 days) onset of fever, documented by temperature greater than or equal to 101.0ºF (38.3ºC)
3. Have adequate intravenous access
4. Have the ability to understand the requirements of the study, be willing to provide written informed consent (as evidenced by signature on an informed consent document approved by an Institutional Review Board), and agree to abide by the study restrictions and to return for the required assessments

Exclusion Criteria:

1. Be less than 18 years of age
2. Have received antipyretic drug therapy (e.g., aspirin, other NSAIDs, or acetaminophen) within 4 hours before dosing
3. Have any history of allergy or hypersensitivity to any component of IVIb, NSAIDs (including aspirin), or COX-2 inhibitors
4. Be pregnant or nursing
5. Have a history of severe head trauma that required current hospitalization, intracranial surgery, or stroke within the previous 30 days, or any history of intracerebral arteriovenous malformation, cerebral aneurysm, or central nervous system mass lesions
6. Weigh less than 40 kg
7. Have a history of congenital bleeding diatheses (e.g., hemophilia) or any active clinically significant bleeding, or have underlying platelet dysfunction, including (but not limited to) idiopathic thrombocytopenic purpura, disseminated intravascular coagulation, or congenital platelet dysfunction
8. Have gastrointestinal bleeding that has required medical intervention within the previous 6 weeks (unless definitive surgery has been performed)
9. Have a platelet count less than 30,000/mm3
10. Be receiving full dose anticoagulation therapy
11. Have fever secondary to blood or drug reaction
12. Have an expected life span of less than 14 days because of imminent withdrawal of life support or severity of illness
13. Be receiving treatment with corticosteroids (Patients who are expected to receive corticosteroids during the Treatment Period or through Hour 120 of the Post-treatment Period are not eligible.)
14. Have neurogenic fever
15. Be on dialysis, have oliguria or creatinine greater than 3.0 mg/dL, or be receiving nephrotoxic drugs
16. Have had major surgery within the past 12 hours, unless adequate hemostasis has been achieved
17. Have received another investigational drug within the past 30 days
18. Become afebrile (temperature below 101.0ºF \[38.3ºC\]) before dosing and not redevelop fever entry criteria during this hospitalization
19. Be otherwise unsuitable for the study, in the opinion of the Investigator
Real-world Effects of Using Intermittently Scanned Continuous Glucose Monitoring and Pharmacist-led Coaching on the Management of Type 2 Diabetes Among Adults Not Using Insulin (REAL IsCGM T2D)

The goal of this prospective study is to evaluate diabetes outcomes after initiating second generation intermittently scanned continuous glucose monitoring (isCGM) plus one pharmacist consultation session compared with capillary blood glucose (CBG) monitoring among insulin-naïve adults with type 2 diabetes (T2D) in a specialist endocrinology clinical setting in Canada.

Primary Outcome - To evaluate change in HbA1c at 3-6 months follow-up after initiating isCGM plus one pharmacist consultation (isCGM cohort) compared with CBG monitoring (CBG cohort) among insulin-naïve adults with T2D.

Secondary Outcomes - To determine the change in metabolic outcomes and patient reported outcomes (PROs) and number of non-insulin antihyperglycemic agents (AHAs) prescribed from baseline to 3-6 months (± 6 weeks) in the isCGM cohort compared to the CBG cohort. Another secondary outcome is to assess isCGM metrics and number of isCGM discontinuations in the isCGM cohort at 3-6 months (± 6 weeks) compared to baseline. Additionally the study will describe and/or evaluate glycemic and metabolic outcomes, and PROs in participants who initiate an isCGM device and opt to enroll in a diabetes coaching program (isCGM+coaching cohort) at baseline compared to follow-up at 3-6 months (± 6 weeks).

Exploratory Outcomes - To compare change in HbA1c between the matched isCGM cohort and CBG cohort by subgroups: age (\< 65 years old vs ≥ 65 years old) and baseline HbA1c (\< 8.5% vs ≥ 8.5%).


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Clinical diagnosis of T2D ≥ one year
* Using at least one AHA
* Status as a Sun Life group benefits member, initiates isCGM device through Lumino Health™ Pharmacy, and completes one initial pharmacist consultation (isCGM cohort) or completes 2 or more diabetes coaching program consultations (isCGM+coaching cohort); or has private health insurance and uses CBG monitoring (CBG cohort)
* Baseline HbA1c ≥ 7.0%
* ≥ 1 HbA1c value up to 6 months prior to index date
* Exclusive use of isCGM for ≥ 3 months
* Informed consent

Exclusion Criteria:

* Have a history of insulin use
* Are pregnant or breastfeeding at the time of study enrollment or become pregnant during the study
* Have an estimated glomerular filtration rate (eGFR) \< 30 ml/min/1.73m2
* Previously used rtCGM or isCGM for \> 3 months
* Recent or expectant change to antihyperglycemic medications or doses within 30 days of index date
Comparison of Different Physical Therapy Modalities in Lateral Epicondylitis

Comparison of the effects of kinesiotaping and high intensity laser therapy in patients with lateral epicondylitis: a randomized controlled study

In this study, it was aimed to compare the effects of exercise therapy, kinesiology taping and high-intensity laser therapy on pain, muscle strength and functional status in patients with LE. Patients who applied to the outpatient clinic of the Sadi Konuk Training and Research Hospital Physical Medicine and Rehabilitation clinic due to elbow pain and were diagnosed with unilateral LE will be included. The study was planned as randomized, prospective and controlled. Patients will be randomized using a random (randomized) numbers table and distributed equally to the groups. Only exercise will be applied to the first group, high-intensity laser therapy and exercise to the second group, and kinesiology taping and exercise treatments to the third group. Sixty people will be included in the study. Patients will be evaluated before treatment, immediately after treatment, and at 4 weeks post-treatment. In the evaluation of the patients, the severity of pain during rest and activity measured with the Visual Analogue Scale (VAS), Quick Disability of the Arm, Shoulder and Hand (QuickDASH), Patient Based Lateral Epicondylitis Evaluation Test - Patient Rated Tennis Elbow Evaluation (PRTEE), Jamar' Hand grip strength will be evaluated with the hand dynamometer.

Eligibility Criteria:
Inclusion Criteria:

- Volunteer patients diagnosed with unilateral lateral epicondylitis

Exclusion Criteria:

* Those who have previously received treatment for lateral epicondylitis
* Current extremity fracture or surgical history
* Presence of congenital deformity in the upper extremity
* Cervical radiculopathy, myelopathy, plexopathy, entrapment neuropathies
* Presence of neurological disease such as stroke, Parkinson's, multiple sclerosis, epilepsy and muscle disease
* Presence of skin lesion, infection and open wound on the affected extremity
* Presence of metal implant in the affected extremity
* Rheumatological disease
* Pregnancy
* Pacemaker presence
* Malignancy
* Cognitive dysfunction
* Presence of psychiatric illness