louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05069493: Long-term Follow-up After Hiatal Hernia Repair by Tension-free Mesh Closure or Simple Suturing
Official title: Hiatal Hernia Repair by Tension-free Mesh Closure or Simple Suturing of the Diaphragmatic Hiatus. Long-term (>10 Years) Follow-up of a Randomized, Double-blind Clinical Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: GERD
Hiatal Hernia
Dysphagia, Esophageal
Quality of Life
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
Collaborators: name: Ersta Hospital, Sweden
First posted: 2021-10-06
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who were included in the previous study (hiatal hernia repair by tension-free mesh closure or simple suturing) and are available for inclusion at the long-term follow-up.

Brief summary: 10 years of follow-up after surgery for hiatal hernia by tension-free mesh closure or simple suturing.

Detailed description: One-hundred and fifty-nine patients undergoing Nissen fundoplication for symptomatic gastro-oesophageal reflux disease (GORD), who had a concomitant hiatal hernia of \> 2 cm axial length, were previously randomized to closure of the diaphragmatic hiatus with either crural sutures alone or tension-free closure with a non-absorbable mesh. Primary outcome variable was the incidence of radiologically verified recurrent hiatal hernia 3 years after the surgery and secondary outcomes were dysphagia score, reflux control and quality of life. The study showed no differences between the groups regarding hiatal hernia recurrence but higher dysphagia scores for solid food at 3 years in mesh group.

This study is a long-term follow-up (\>10 years) after surgery for hiatal hernia by tension-free mesh closure or simple suturing.

Eligibility criteria: Inclusion Criteria:

-Patients available at the time of follow-up

Exclusion Criteria:

* Deceased
* Declined participation

Primary outcomes:
measure: Recurrent hiatal hernia
timeFrame: 10 years
Secondary outcomes:
measure: Dysphagia
timeFrame: 10 years
measure: Gastrointestinal symptom rating scale (GSRS)
timeFrame: 10 years
measure: Quality of Life, physical and mental score: SF-36
timeFrame: 10 years
measure: Proton pump inhibitor (PPI)
timeFrame: 10 years
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Ersta Hospital
Study officials:
References:
Clinical trial NCT04611893: Monitoring of NOAC Therapy: Standardizing Reference Intervals
Official title: Monitoring of NOAC Therapy: Standardizing Reference Intervals
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ischemic Stroke
Stroke, Acute
Stroke Syndrome
Ischemic
Keywords: stroke
ischemic stroke
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2020-11-02
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are on dabigatran, apixaban and rivaroxaban based on the above inclusion and exclusion criteria will be recruited from the Prince of Wales Hospital, either in-patient or out-patient clinic.

Brief summary: This study is aimed to establish reference intervals of NOAC (dabigatran, apixaban and rivaroxaban) in ethnic Chinese patients.

Detailed description: 360 patients who are on dabigatran, apixaban and rivaroxaban based on the above inclusion and exclusion criteria will be recruited. After the informed consent, the patient will be needed for blood taking before and 2 hours after the medication (NOAC). The patient's demographic data and medical history will also be retreived from Central Medical Syetem too.

Eligibility criteria: Inclusion Criteria:

1. Ethnic Chinese ONLY
2. 18 years old or above
3. Non-valvular atrial fibrillation
4. Duration of NOAC use at least 3 months
5. No changes in NOAC dosage or type within 3 months
6. Creatinine Clearance (by Cockcroft-Gault formula) \>/=30mL/min

Exclusion Criteria:

1. Valvular atrial fibrillation or no atrial fibrillation
2. Recent haemorrhage or ischemia within 1 year
3. Active liver disease
4. Abnormal baseline clotting profile
5. Abnormal baseline thrombocytopenia or thrombocytosis
6. Thromboembolic tendency other than atrial fibrillation (e.g. antiphospholipid syndrome, protein C, S, anti-thrombin III deficiency)
7. Non-compliant patients, defined as missing any doses of NOAC in recent 1 month
8. Anticoagulation for disorders other than AF
9. Pregnancy

Primary outcomes:
measure: NOAC level in blood
timeFrame: One week after the recruitment
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Chinese University of Hong Kong
Study officials:
affiliation: Chinese University of Hong Kong
name: Yiu Ming Bonaventure IP, MRCP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05277493: A Registry of Chinese AL Amyloidosis Patients Treated With Subcutaneous or Intravenous Daratumumab
Official title: A Registry of Chinese AL Amyloidosis Patients Treated With Subcutaneous or Intravenous Daratumumab
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: AL Amyloidosis
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2022-03-14
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Patients will be enrolled in this registry pending on expressing an informed consent of the use of their data for research purposes

Brief summary: The purpose of this protocol is to generate a registry of Chinese patients with AL amyloidosis treated with subcutaneous/intravenous daratumumab alone or subcutaneous/intravenous daratumumab combined with chemotherapy.


Eligibility criteria: Inclusion Criteria:

* 18 years and older
* newly diagnosed or refractory/relapsed AL amyloidosis
* treated with subcutaneous/intravenous daratumumab alone or subcutaneous/intravenous daratumumab combined with chemotherapy

Exclusion Criteria:

* co-diagnosis of multiple myeloma or Waldenström's macroglobulinemia

Primary outcomes:
measure: Hematologic complete response at 3 months
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
Study officials:
References:
Clinical trial NCT01151293: Personality of Diabetic Patients Will Influence Their Medical compliance-a 5 Years Cohort Follow up With Type D Personality
Official title: Personality of Diabetic Patients Will Influence Their Medical compliance-a 5 Years Cohort Follow up With Type D Personality
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes Mellitus
Keywords: Type D personality
diabetes
medical compliance
HbA1c
complication
mortality
T2DM
Lead sponsor: Far Eastern Memorial Hospital
Sponsor class: OTHER
First posted: 2010-06-28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: T2DM patients for OPD Age 18-80 y/o Inform consent

Brief summary: Diabetes is one of the most common causes of death in Taiwan. With the raising prevalence of diabetes, it became the fourth most common cause of death since 2002. Up to one-tenth of the national health insurance expenditure was used directly in diabetic care. Besides, more expenditure was used in the management of the complications of diabetes, like vascular diseases, renal disease, blindness and neuropathy. Diabetes is a chronic disease, the target treatment is to control HbA1c below 7%, by intensive life style modification, diet control, exercise and medications. Diabetic patient should have a good medical compliance, in order to prevent the tragedy of the complication. A good medical compliance is depended on the individual personality. Personality is the major cause of chronic stress, which is one of the most important cause of psychological stress and the risk factors of the vascular disease and hypertension. Recently, Type D personality had shown the close relationship with patients' prognosis, morbidity, mortality and life quality in different vascular diseases. These vascular diseases are the result of the atherosclerotic process, and diabetes is one of the most important risk factors of the atherosclerotic changes. The investigators believed that type D personality may also affect the medical compliance, the severity (in terms of HbA1c), and the prognosis of diabetic patients. The first part of this study is a cross sectional study, the investigators will try to figure out the relationship of the type D personality toward diabetic medical compliance, and their comorbidity. The second part of this study is a cohort study, base on the population in first part of the study, the investigators will like to construct the correlation of type D personality and diabetic patients' 5-years complication and mortality. The investigators want to establish a more complete vascular care system, improve the medical compliance, lower the complication rates, and improved the quality of life.


Eligibility criteria: Inclusion Criteria:

* T2DM patients for OPD
* Age 18-80 y/o
* Inform consent

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Far Eastern Memorial Hospital
name: Lung Chan, M.D., M. Sc.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03852693: Distant Metastases and Long-Term Survival After Complete Resection of Neuroendocrine Tumors of the Appendix
Official title: Distant Metastases and Long-Term Survival After Complete Resection of Neuroendocrine Tumors of the Appendix: An International Multicenter Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neuroendocrine Tumors of the Appendix
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2019-02-25
Enrollment: 278
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The investigators will include all patients with aNET measuring 1 - 2 cm and complete resection between 01.01.2005 and 31.12.2010 of the primary tumor.

Brief summary: The aim of the present project is to evaluate the frequency of distant metastases and clinically relevant relapse and mortality, respectively, of aNEN (Neuroendocrine Neoplasms of the Appendix) measuring 1 - 2 cm.

The investigators hypothesize that the mortality rate of aNET (Neuroendocrine Tumors of the Appendix) measuring 1 - 2cm is less than 1%. Furthermore, the investigators hypothesize that regional lymph node metastases of aNET measuring 1 - 2 cm are clinically not relevant and are not associated with reduced survival. The investigators therefore hypothesize that oncological right-sided hemicolectomy has no impact on long-term survival after complete resection of aNET measuring 1 - 2 cm and that the malignant potential quo ad vitam of these tumors is lower than the risk of oncological hemicolectomy.


Eligibility criteria: Inclusion Criteria:

* The investigators will include all patients with aNET measuring 1 - 2 cm and complete resection between 01.01.2005 and 31.12.2010 of the primary tumor.

Exclusion Criteria:

-

Primary outcomes:
measure: Clinically relevant relapse of aNET measuring 1 - 2 cm in a population based manner
timeFrame: 10 years
measure: Clinically relevant mortality of aNET measuring 1 - 2 cm in a population based manner
timeFrame: 10 years
measure: Frequency of distant metastases in aNET measuring 1-2 cm
timeFrame: 10 years
Secondary outcomes:
measure: Association of histological risk factors in aNET measuring 1 - 2 cm and qualifying for oncological right-sided hemicolectomy according to ENETS guidelines with the occurrence of regional lymph node and distant metastases
timeFrame: 10 years
measure: Relationship between regional lymph node metastasis and survival in patients with aNET measuring 1 - 2 cm
timeFrame: 10 years
measure: Long-term survival after complete resection of aNET measuring 1 - 2 cm with or without oncological right-sided hemicolectomy
timeFrame: 10 years
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: UHIBerne
Study officials:
affiliation: Insel Gruppe AG, University Hospital Bern
name: Reto Kaderli, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04089293: The Postero-superior Contact and Rotator Cuff Lesion
Official title: Does the Contact Between the Deep Surface of the Supraspinatus Muscle Tendon and the Posterior Superior Labrum Physiological ?
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: GLENOID CAVITY
Keywords: GLENOID CAVITY
HUMERAL HEAD
SHOULDER JOINT
SUPRASPINATUS MUSCLE
LABRUM
ABER POSITION
SCAPULOHUMERAL
INTERNAL IMPINGEMENT
ABDUCTED POSITION
SCAPULOHUMERAL JOINT
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2019-09-13
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients operated at the Hopitaux Universitaires de Strasbourg between 01/01/2012 and 31/12/2013 under arthroscopy of anterior instability, uninjured tendinopathy of the rotator cuff, or extra-articular pathology.

Brief summary: The possibility of physiological contact between the deep surface of the tendon of the supraspinatus muscle and the labrum and/or posterior superior glenoidal rim during an armed movement of the arm (abduction and external rotation or ABER position) has been described for many years. The physiological hypotheses put forward to explain this contact are first of all that the intrinsic mobility of the scapulohumeral joint is limited by these 2 structures, that an anterior instability or micro-instability induces an abnormal anterior translation when performing an abduction and lateral rotation movement, or finally that there is a decrease in humeral retroversion. When this contact becomes symptomatic, it is called a posterior superior conflict. This pathology is mainly found in throwing athletes or athletes repeating maximum external rotation in the abducted position of the arm. This conflict is also described among some manual workers, and is then observed in an older age group.


Eligibility criteria: Inclusion criteria:

* Major subject ((≥18 years old)
* Operated subject (at the HUS between 01/01/2012 and 31/12/2013) under arthroscopy of anterior instability, of an unruptured tendinopathy of the rotator cuff, or of an extra-articular pathology.
* Subject not expressing opposition to the use of his data for research purposes

Exclusion criteria:

* Subject having expressed his opposition to participating in the study
* Patient under safeguard of justice
* Subject under guardianship or curatorship

Primary outcomes:
measure: Study of posterior-superior contact in a patient with no rotator cuff lesion.
timeFrame: The period from January 1st, 2012 to December 31st, 2013 will be examined
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de chirurgie du membre supérieur Hautepierre 2
Study officials:
affiliation: University Hospital, Strasbourg, France
name: Philippe CLAVERT, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02953093: Study of Acarbose in Longevity
Official title: Study of Changes in Muscle and Fat Gene Transcription With Acarbose Treatment: a Crossover Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Aging
Keywords: acarbose
aging
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
First posted: 2016-11-02
Enrollment: 10
Sex: MALE
Minimum age (years): 60
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The investigators are studying the effects of acarbose on muscle and adipose gene transcription in older adults.

Detailed description: Acarbose, an FDA approved drug for the treatment of type 2 diabetes, has known effects on glucose metabolism. Evidence from mice indicates that acarbose may prolong lifespan. In humans, acarbose improves inflammatory markers and reduces cardiovascular events. Consequently, acarbose is of interest in clinical translational aging research since it may influence fundamental processes that contribute to age-related diseases. The study described herein is an exploratory study to examine the effect of acarbose treatment on the biology of aging in humans. Specifically, the investigators plan to study whether treatment with a 10 week course of acarbose will alter the gene expression profile in adipose tissue and muscle in older adults in pathways that are known to be affected by human aging, in a placebo-controlled crossover study.

Eligibility criteria: Inclusion Criteria:

* Male
* age \>60 years
* impaired fasting glucose (IFG) or impaired glucose tolerance (IGT)

Exclusion Criteria:

* cancer
* heart failure
* COPD
* inflammatory conditions
* eGFR\<45
* active liver disease
* poorly controlled hypertension
* epilepsy
* recent cardiovascular disease event (last 6 months)
* inflammatory bowel disease
* history of bariatric or other gastric surgery
* cigarette smoking
* serious substance abuse.
* Treatment with drugs known to influence glucose metabolism
* Hypersensitivity to acarbose or any component of the formulation.
* Treatment with anti-coagulant medications or anti-platelet drugs

Primary outcomes:
measure: Tissue gene expression after placebo vs after acarbose.
timeFrame: 10 weeks
Secondary outcomes:
measure: Serum microRNA
timeFrame: 10 weeks
measure: Fecal microbiome
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
Study officials:
affiliation: Albert Einstein College of Medicine Montefiore Medical Center
name: Nir F Barzilai, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06292793: Cyclical Sighing for Pain
Official title: Cyclical Sighing for Pain in an Orthopedic Clinic Waiting Room
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Lead sponsor: Florida State University
Sponsor class: OTHER
First posted: 2024-03-05
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This is a single-site, two-arm, parallel-group randomized clinical trial (RCT). The clinical effects of a 4-minute audio-recorded cyclical sighing intervention for orthopedic patients will be investigated relative to a 4-minute audio-recoding about pain psychoeducation.


Eligibility criteria: Inclusion Criteria:

* Age ≥18
* Seeking treatment at the Tallahassee Orthopedic Clinic

Exclusion Criteria:

* Cognitive impairment preventing completion of study procedures.
* Other unstable illness judged by medical staff to interfere with study involvement.

Primary outcomes:
measure: Change in Pain Unpleasantness Numeric Rating Scale
timeFrame: immediately after the 4-minute audio recording
Secondary outcomes:
measure: Change in Pain Intensity Numeric Rating Scale
timeFrame: Immediately after the 4-minute audio recording
measure: Change in Anxiety Numeric Rating Scale
timeFrame: Immediately after the 4-minute audio recording
measure: Change in Depression Numeric Rating Scale
timeFrame: Immediately after the 4-minute audio recording
Other outcomes:
Locations:
city: Tallahassee
country: United States
facility: Tallahassee Orthopedic Clinic (TOC)
state: Florida
Study officials:
References:
Clinical trial NCT01417793: Effects of a Smoking Cessation Program for Prison Inmates
Official title: Effects of a Smoking Cessation Program for Prison Inmates-A Case Study of a Prison in Central Taiwan
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Smoking Cessation
Keywords: Smoking cessation rate
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
First posted: 2011-08-16
Enrollment: 500
Sex: MALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: According to WHO database, an average of 540 million people worldwide dies from smoking related diseases every year. The use of tobacco products may reduce the average life expectancy of about 15 years. The data of 2009 from Department of Health Bureau of Health showed 38.57% male adults and 4.75% female adults smoked in Taiwan. Studies about smoking rate within prison inmates were between 64-91.8%, which was over 3 times than the general population. Smoking cessation can lower the risks of smoking related health problems. Two thirds of smokers in Taiwan once tried smoking cessation but the success rate was about 5% every year.

In view of high smoking rate within prison inmates in Taiwan, Agency of Correction, Ministry of Justice announced a smoking cessation program for inmates in April 2010. The purpose of this study was to investigate the effects of this program and the difference of cessation success rate between various interventional methods, using questionnaires for smokers and smoking cessation clinics database.


Eligibility criteria: Inclusion Criteria:

* Prison inmates with age equal or more than 20 years old and have smoked for equal or more than one year

Primary outcomes:
measure: Smoking Cessation Rate
timeFrame: 6 months after each subject's enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Taichung Prison,Agency of Corrections, Ministry of Justice
Study officials:
affiliation: China Medical University Hospital
name: Yulung Chen, M.D
role: PRINCIPAL_INVESTIGATOR
References: