cyrilzakka/clinical-trials huggingface dataset:
Observational Study to Evaluate Health Status of Chronic Obstructive Pulmonary Disease (COPD) Patients in Response to Real-life Treatments in Thailand

The purpose of this study is to evaluate health status of uncontrolled Chronic Obstructive Pulmonary Disease (COPD) patients in response to treatments in clinical practice.

MC MD

Eligibility Criteria:
Inclusion Criteria:

1. Provision of informed consent prior to any study specific procedures
2. Male or non-pregnant female aged \>40 years
3. A clinical diagnosis of COPD with FEV1/ FVC \<0.70 and require combination or modified therapy
4. Smoke \> 10 Pack Year

Exclusion Criteria:

1. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site)
2. Participation in a clinical study (precluding non-interventional study or registry) during the last 3 months
A Randomised Controlled Trial of N-acetylcysteine for the Management of Alcohol Use Disorder

To explore the effectiveness of n-acetylcysteine in improving treatment outcomes for alcohol use disorder in a double-blind randomised placebo-controlled trial.

Australia urgently requires new treatment strategies for the treatment of alcohol dependence. Although alcohol use disorders are a leading cause of preventable death in Australia, their treatment is generally not evidence based. The medications currently approved for use in Australia for the management of alcohol dependence have limited efficacy, and existing research does not address the heterogeneity of treatment response. Targeted personalised medicine addresses this heterogeneity with better medicine selection for patients based on their genotype and clinical comorbidities.

Following on from a recent pilot study conducted by CI Morley (NCT03879759), this project will evaluate the clinical efficacy and tolerability of NAC, relative to a placebo, in heavy drinkers. We hypothesise that NAC-treated participants will be better able to achieve a reduction in heavy drinking. We will utilise a double-blind, randomised, controlled design. A sample of 280 individuals will receive 12 weeks of treatment with NAC (2400 mg/day) or placebo.

Eligibility Criteria:
Inclusion Criteria:

* Alcohol Use Disorder according to the DSM-V criteria
* A desire to reduce or stop drinking
* Consumed at least 21 standard drinks per week or 2 heavy drinking days per week (HDD: ≥ 5 standard drinks/day for men; ≥4 for women) in the month prior to screening
* Adequate cognition and English language skills to give valid consent and complete research interviews
* Stable housing
* Willingness to give written informed consent

Exclusion Criteria:

* Pregnancy or lactation (women will be advised to use reliable contraception during the trial and a pregnancy test will be performed were necessary)
* Concurrent use of any psychotropic medication other than antidepressants (provided these are taken at stable doses for at least two months)
* Any substance dependence other than nicotine
* Clinically unstable systemic medical (e.g. cancer, end stage liver disease: e.g. MELD score ≥ 10) or psychiatric disorder (e.g. active psychosis, borderline personality disorder, active suicide risk: e.g. MADRAS item 10 score of 6) that precludes trial participation
* Concurrent use of selenium, vitamin D or other anti-oxidants
* Any alcohol pharmacotherapy within the past month
Back to the Traditional: Anti-COX Drugs Can Improve the Outcome of COVID-19 Patients Admitted to ICU

Retrospective multicenter study to evaluate the data of COVID-19 patients who were admitted to university hospitals in relation to their recent administration or maintenance on non-steroidal anti-inflammatory drugs (NSAID) prior to have COVID-19 disease and to analyze it in relation to outcome of these patients.

The data contained in hospital registry were collected, categorized into demographic, previous medical history, the use of NSAID as maintenance therapy or its recent administration before diagnosis of COVID-19 disease, presenting manifestations, laboratory and CT findings, applied therapies or interventions. Outcomes will be categorized as survival and non-survival outcome. Survivors will be subdivided as complete recovery or recovery with getting new morbidities. Mortality was subdivided as total hospital and ICU mortality. Data will be statistically analyzed in relation to outcomes

Eligibility Criteria:
Inclusion Criteria:

* assured diagnosis of COVID-19 by RT-PCR

Exclusion Criteria:

* No
Muscle Function in Elderly Postoperative Patients

During the last decades there has been an increase in the relative proportion and life expectancy of elderly people in the industrialised countries. Consequently the amount of elderly with diseases and disabilities related to aging has increased. It therefore appears paramount to gain a better understanding of how disuse and immobilisation affects neuromuscular properties in the elderly, as well as to identify training regimes that ensures an effective rehabilitation.The population of interest in the present study was elderly individuals with long term hip-osteoarthritis undergoing a hip-replacement operation. The study was divided in two parts, a cross-sectional study and an intervention study.

The cross-sectional study investigated muscle size, maximal muscle strength, specific force, neural drive and explosive muscle force characteristics in elderly individuals who were affected by unilateral prolonged disuse due to hip-osteoarthritis. The data clearly indicated that the side with hip-osteoarthritis was affected by a marked decrease in muscle mass, maximal muscle strength, neural drive and explosive muscle force characteristics compared to the unaffected side.

The intervention study investigated if elderly patients that undergo hip-replacement surgery could benefit from additional training in the early postoperative phase. The data clearly demonstrated that resistance training was an effective and safe way to increase muscle mass, maximal muscle strength, neuromuscular activity, functional performance and decrease the hospitalisation period compared to regimes of conventional rehabilitation regimen or electrical muscle stimulation. Additionally the intervention study demonstrated that resistance training effectively induced marked increases in explosive muscle force characteristics in elderly subjects compared to rehabilitation regimes using electrical muscle stimulation or conventional rehabilitation. Furthermore, the gains in maximal muscle strength and explosive muscle force characteristics were accompanied by significant increases in EMG amplitudes. Furthermore, the demonstration that explosive muscle force capacity of the neuromuscular system remains trainable in elderly recovering from prolonged limb disuse and major surgery may have important implications for future rehabilitation programs, especially when considering the importance of rapid muscle force capacity on postural balance, maximal walking speed and other tasks of daily life actions.


Eligibility Criteria:
Inclusion Criteria:

* Age over 60 years
* Unilateral primary hip replacement due to hip osteoarthritis in patients

Exclusion Criteria:

* Cardiopulmonary, neurological or cognitive problems
Cognitive Remediation for Cocaine Dependence

The purpose of this study is to evaluate treatments designed to improve cocaine treatment success by combining medications that target cocaine-related cognitive impairments.


Eligibility Criteria:
Inclusion Criteria:

* meet criteria for cocaine dependence
* seeking treatment for cocaine dependence
* be in acceptable health based on medical history and physical exam

Exclusion Criteria:

* dependent on drugs other than cocaine, nicotine, marijuana
* have a medical condition contraindicating treatment with study medications
* having conditions of probation or parole requiring reports of drug use to officers of the court
Access to a Sit-stand Computer Workstation and Back Pain

The purpose of the study is to evaluate the changes in back pain from access to a sit-stand workstation. Other muscle and joint pain and/or discomfort will also be evaluated. We hypothesize that access to a sit-stand workstation will allow one to experience postural variation and reduce back pain.


Eligibility Criteria:
Inclusion Criteria:

* Back pain lasting ≥3 months and reported at a minimum of 4 out of 10 on the pain scale.
* Sits \>6 hours out of an 8-hour work day for work purposes
* Able and willing to fill out a daily survey for the first week prior to randomization
* Participants must be \>18 years of age. There are no gender/race-ethnic restrictions.
* Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

* Unable to stand for at least 10 minutes.
* Currently using a sit-stand desk
PKPD Study of Ticagrelor and Prasugrel in Healthy Korean Males

This study is to characterize the pharmacokinetic and pharmacodynamics of ticagrelor and prasugrel in healthy Korean male subjects.

The study is open label, one sequence, crossover design. In period 1, a single oral dose of 180 mg ticagrelor will be administrated. After at least 7 days washout period, in period 2, a single oral dose of 60 mg prasugrel will be administrated.

After dosing each period, blood sampling for PK and PD assessment will be conducted.

1. Blood Sampling Times

   1. PK :predose,10 min,15 min,25 min, 0.5,1,1.5,2,2.5,4,6,8,12 and 24h post-dose
   2. PD :predose,15 min,0.5,1,2,4,6,8,12 and 24h post-dose
2. Bioanalysis

   1. plasma Ticagrelor
   2. plasma AR-C124910XX (active metabolite of ticagrelor)
   3. plasma R-95913 (inactive metabolite of prasugrel)
   4. plasma R-13727 (active metabolite of prasugrel)
3. Platelet Aggregation Test using turbidometric Method Maximal Platelet Aggregation(MPA)
4. PK-PD Modeling analysis


Eligibility Criteria:
Inclusion Criteria:

1. male aged 19 - 45 years at screening visit
2. body weight at least 60 kg at screening visit
3. body mass index 18 - 30 kg/m2
4. SBP 90 - 149 mmHg and DBP 60 - 99 mmHg and pulse rate(beat per minute) 45 - 100 at screening visit

Exclusion Criteria:

1. any history of or having any clinically significant abnormalities
2. any gastrointestinal disorder having impact on absorption of study drug
3. any history of hypersensitivity of ticagrelor or prasugrel or compounds related study drugs
4. any history of taking original medicines within 30 days before dosing or history of taking prescribed drug within 14 days before dosing or history of taking OTC drug within 7 days before dosing
5. any history of taking other study drug within 60 days before dosing
6. any history of whole blood transfusion within 60 days before dosing or history of blood elements transfusion or history of heaving been transfused within 30 days before 30 days
7. any history of taking metabolic inducer or inhibitor
8. overuse (caffeine: \> 5 units/day , alcohol: \> 21 units /week, smoking: \> 10 cigarettes/day)
9. positive serology testy(Hbs antigen, HIV, Hepatitis C virus, Syphilis)
10. any abnormality in clinical laboratory tests result or any ECG finding considered to be inadequate by investigator
Primary and Secondary Ventral Hernia Repair Using Long-term Resorbable Versus Non-resorbable Large Pore Synthetic Mesh.

Since abdominal wall hernia repair is currently performed with the use of a mesh, side effects associated with the mesh are frequently reported during long term follow-up. These side effects are related to shrinkage of the mesh, adhesions to the bowl, pain, and inflammation of the skin and bowl. To reduce or prevent these effects, a fully resorbing mesh has been developed, which provides sufficient support and strength to allow efficient recovery of the abdominal wall, but also disappear from your body in three years time, so that you no longer have any synthetic material in your body. Previous resorbing meshes also disappeared but over a much shorter period of time, so that the hernia was insufficiently healed, with recurrence as a result.

The TIGR™ mesh (the resorbable mesh used in the study) is in principle a synthetic mesh, made of two commonly used polymers, however it will retain 50% of its initial strength after six months. This in theory is enough to provide support of the collagen healing process during the initial wound-healing phase, but also to support the transition of initial collagen to functional collagen.

The aim of this study is to compare TIGR™ with large pore mesh used in the repair of the anterior abdominal wall repair (incisional hernia, umbilical hernia, etc..Inguinal hernias are not part of the study).

Therefore the patients will be divided into two groups, one group will be treated with a resorbing mesh, the other group will be treated with a permanent mesh. Otherwise there will be no difference in the medication or the surgical techniques used.


Eligibility Criteria:
Inclusion Criteria:

* Primary and secondary ventral hernia

  * less than 20 cm in length
  * less than 6 cm in width

Exclusion Criteria:
The Stanford Plant-based Educational Study: Providers Learning About Nutrition Together (PLANT)

More than 70% of chronic illnesses can be prevented or reversed with a whole-food, plant-based diet (WFPBD). This dietary pattern is also more sustainable for our planetary health. The majority of physicians receive fewer than 20 hours of nutrition education during the entire course of their medical training. Although many physicians are aware of the importance of diet on their well-being, they face significant barriers in following a healthy diet. Because physicians' own habits strongly influence patient health habits, the investigators theorize that physicians who eat a WFPBD themselves will be much more likely to successfully counsel their patients on nutrition and recommend a WFPBD.

The most effective methods that can be successfully used to encourage busy physicians to adopt a WFPBD have not yet been identified. Given the increasing rates of diet-related chronic illnesses, if proven effective, this study may offer a new scalable approach to encourage physicians, and ultimately their patients, to adopt a WFPBD.

The aims of this study are to:

1. Assess the impact of a multimodal 6-week educational program on WFPBD on a) change in physicians' diet type and quality, b) change in mindset about WFPBD, and c) stage of change based on the transtheoretical model of behavior change (Figure 1), compared to the delayed-intervention (control group) from baseline to week 6.
2. Assess the impact of the 6-week educational program on the development of skills and knowledge required to a) adopt a WFPBD and b) counsel patients on the same.

Study overview:

This is a randomized, delayed intervention trial testing a flexible, multimodal WFPBD educational program for 6 weeks for providers at Stanford in any department.

Research Activities:

1. Screening: Interested participants will participate in a Qualtrics survey, which will determine eligibility.
2. Enrollment: If the provider expresses interest in participating, the research team will send an email that explains details about the study. A waiver of consent will be utilized given minimal risk.
3. Intervention: a 6-week multimodal educational intervention program. We will utilize a pre- and post-study survey which will include information on current dietary habits and use of Diet ID (assessment of diet type and quality). We will also assess their mindset for adopting a WFPBD. Finally, we will assess measures of motivation and confidence to adopt a WFPBD and to prescribe a WFPBD to patients. The educational program will include interactive didactic sessions, cooking classes, and weekly emails with suggested resources and activities including movies, recipes, and websites.

Eligibility Criteria:
Inclusion Criteria:

* Clinical personnel at Stanford who agree to participate in this nutritional intervention study

Exclusion Criteria:

* None
Comparison of Efficacy and Safety of Insulin Detemir and Insulin Glargine in Patients With Type 1 Diabetes

The trial is conducted in Europe and Africa. The aim of the trial is to compare the use of insulin detemir twice daily combined with mealtime insulin aspart against that of insulin glargine once daily combined with mealtime insulin aspart. The trial involves patients with Type 1 Diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes for at least 12 months
* Current daily insulin dose of more than 1.4 IU/kg
* BMI lesser than or equal to 35 kg/m2
* HbA1c greater than 7.5% and less than or equal to 12.0%
* In Austria, age more than 19 years

Exclusion Criteria:

* Proliferate retinopathy or maculopathy
* Recurrent major hypoglycaemia
* Any condition or disease such as uncontrolled hypertension or AIDS/HIV that rule out trial participation according to the judgement of the investigator
Development of a Methamphetamine Early Intervention

Methamphetamine abuse has a strong and consistent epidemiologic association with high-risk sexual behavior and both prevalent and incident HIV in men who have sex with men (MSM), and some authorities have advocated methamphetamine treatment as an HIV prevention strategy. However, methamphetamine interventions have not been evaluated in controlled trials, nor have they been implemented and assessed outside of substance abuse treatment programs. This application proposes preliminary investigations to adapt a methamphetamine treatment intervention previously associated with decreased sexual-risk taking among MSM for use as an early intervention among MSM in Seattle, Washington. Sixty methamphetamine-using MSM will be enrolled in a randomized controlled trial of contingency management (CM) versus no intervention. CM participants will have their urine tested for methamphetamine 3 times weekly for 12 weeks, and will receive vouchers of escalating value when their urines test negative; vouchers will be withheld when participants' urines test positive for methamphetamine or participants miss urine testing visits. All participants will undergo urine methamphetamine testing and audio-computer assisted self-interviews on sexual behavior and substance use at baseline and at 6 week intervals for 6 months. Participants will be tested for HIV, syphilis, rectal gonorrhea and chlamydial infection, and pharyngeal gonorrhea at baseline and at 3 and 6 month follow-up. The study will determine how often MSM will initiate and complete the early intervention, and will longitudinally measure unsafe sexual behaviors among intervention and control participants. Study results will determine the feasibility of instituting and studying CM as an early intervention; define whether the intervention is sufficiently promising to justify a larger, definitive randomized controlled trial; and will provide estimates for defining the number of participants such a trial would require.


Eligibility Criteria:
Inclusion Criteria:

* Anal sex with another man in the month prior to enrollment
* Use of methamphetamine on at least 2 days in the month prior to enrollment

Exclusion Criteria:

* Plans to move from the study catchment area within 6 months of enrollment
* A mutually monogamous relationships with a man of the same HIV status lasting 2 or more years
Univation® X Follow-Up Study

The study is designed as a monocentric, prospective, observational, comparative follow-up study based on two previously treated patient groups. The first group consists of patients treated with the patient-specific unicondylar knee implant iUni®. For that group, 30 patients will be included in the study and analyzed. The final follow-up after 24 months has already been documented by the study center. Compared to that, a consecutive series of 50 Univation® X patients will be invited for a 24 months follow-up in 2018. In total, it is planned to include 80 retrospective patients for that historical control study design.

The products under investigation were used in routine clinical practice and according to the authorized Instructions for Use (IfU). Those data that are obtained in routine clinical use will be documented in the Case Report Form (CRF).


Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent UKA in 2015/2016 (using one of the products under investigation)
* Signed informed consent

Exclusion Criteria:

* pregnancy
* patients \< 18 years
The Fast Track Rehabilitation in Thoracic Surgery

This prospective, randomized study is designed to evaluate the effectiveness of postoperative care pathway using the Fast Track Rehabilitation protocol (FTR) in comparison with the traditional postoperative care.

In order to conduct this study, patients having a thoracic surgery will be randomly attributed to FTR protocol group or control group.

Traditionally, patients who underwent thoracic surgery have been treated with a classical protocol which include; bed rest, ambulation prohibited for 24-48 hours and starvation for several postoperative days till the recovery of bowel. Some studies reported the efficacy of early rehabilitation protocols or FTR protocols in thoracic surgery to reduce postoperative complications and to minimize hospital stay. But these studies are few and retrospective. Prospective randomized trials focuses based on the "fast track regimen" or medical fast track that interest only on the medical component .

This prospective, randomized study is designed to evaluate the effectiveness of postoperative care pathway using FTR protocol in comparison with the traditional postoperative care.

In order to conduct this study, patients having a thoracic surgery will be randomly attributed to FTR protocol group or control group.

Eligibility Criteria:
Inclusion Criteria:

* All patients who have lung surgery during the study period after their consents are included.

Exclusion Criteria:

* Patients who have bad general state are unable to move or require a wake in the resuscitation.
* The Patients with thoracic soft tissue surgery.
* patients having mediastinoscopy, surgery of the chest wall or mediastinum.
Effects of Cardiac Telerehabilitation During COVID-19 on Cardiorespiratory Capacities in Coronary Artery Disease Patients.

After an acute coronary syndrome, an adapted cardiac rehabilitation program is necessary to restore or increase physical capacities and decrease cardiovascular risk. This multidisciplinary care combines physical training sessions and therapeutic education workshops.

The COVID-19 pandemic imposed restrictions such as the closure of rehabilitation centres. To remedy this problem, one solution was to adapt the existing program to a remote cardiac telerehabilitation, i.e., medical and paramedical supervision of rehabilitation sessions and therapeutic patient education meetings via digital tools. Recent studies have shown that it was a safe (no reported adverse effects), effective (similar gains in peak oxygen consumption compared to traditional cardiac rehabilitation and patient-adherence alternative.

The hypothesis of this study is that telerehabilitation was more effective on cardiorespiratory functions.

Eligibility Criteria:
Inclusion Criteria:

Both groups:

* Acute Coronary Syndrome treated in the last 6 months
* Medical revascularization (angioplasty ± stenting) or surgical (coronary artery bypass)

For Telerehabilitation group:

* Internet connexion (computer or digital tablet)
* Equipped with an exercise bike

Exclusion Criteria:

Both groups:

* Pulmonary hypertension
* Aortic pathway anomaly
* Uncontrolled ventricular rhythm disorders

For Telerehabilitation group:

* Important muscular deconditioning
* Patient requiring medical supervision in institute