louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03928054: Immediate Effects Of Alliance Therapy In Modulation Of Pain And Disability In Subjects With Knee Osteoarthritis
Official title: Immediate Effects Of Alliance Therapy In Modulation Of Pain And Disability In Subjects With Knee Osteoarthritis: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arthritis
Knee Osteoarthritis
Lead sponsor: Faculdade de Ciências Médicas da Santa Casa de São Paulo
Sponsor class: OTHER
First posted: 2019-04-25
Enrollment: 40
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: INTRODUCTION: The Osteoarthritis (OA) is the most common type of joint disease, its features include joint space narrowing, osteophytes formation of the joint margins, motor deficit, reduced strength, and persistent pain. As a treatment option physiotherapy has several resources for the patient approach. However, the effect of treatment is not only the application of therapeutic techniques and resources but also to existing contextual factors such as the therapeutic alliance. OBJECTIVE: To assess the effects of an intervention with the focus on positive therapeutic alliance in subjects OA knee on pain and disability. METHODS: This is a randomized study of two arms with a blind evaluator. 40 subjects were randomized into 2 groups: group 1 "Kinesio Taping® KT" group 2 " Kinesio Taping® with therapeutic alliance KT+AT". Both groups received the application of Kinesio Taping® method as the concepts of the original method. The group "KT+AT" session was conducted in order to increase the relationship between the therapist and the patient.


Eligibility criteria: Inclusion Criteria:

* Patients with both sexes from 40 to 80 years old
* who underwent imaging examination evidencing grade II or III knee osteoarthritis according to the Kellgren and Lawrence classification
* who were referred to the physiotherapy service by a physician.

Exclusion Criteria:

* Patients who are unable to walk
* with a history of cancer
* associated neurological diseases
* morbid obesity

Primary outcomes:
measure: Pain intensity: VAS
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Claudio Cazarini Júnior
state: São Paulo
Study officials:
References:
citation: Lawrence RC, Felson DT, Helmick CG, Arnold LM, Choi H, Deyo RA, Gabriel S, Hirsch R, Hochberg MC, Hunder GG, Jordan JM, Katz JN, Kremers HM, Wolfe F; National Arthritis Data Workgroup. Estimates of the prevalence of arthritis and other rheumatic conditions in the United States. Part II. Arthritis Rheum. 2008 Jan;58(1):26-35. doi: 10.1002/art.23176.
Clinical trial NCT01317654: Study Of The Long Term Outcome Of Tuberculous Meningitis In Vietnamese Adults Treated With Adjunctive Dexamethasone
Official title: Study Of The Long Term Outcome Of Tuberculous Meningitis In Vietnamese Adults Treated With Adjunctive Dexamethasone
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tuberculosis Meningitis
Keywords: Tuberculosis meningitis
Lead sponsor: Oxford University Clinical Research Unit, Vietnam
Sponsor class: OTHER
Collaborators: name: Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam
name: Pham Ngoc Thach Hospital, Ho Chi Minh City, Vietnam
First posted: 2011-03-17
Enrollment: 340
Sex: ALL
Minimum age (years): 1
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Survivors of TBM trial 2001-2005

Brief summary: All patients who were alive at the end of the dexamethasone treatment trial conducted by Oxford University CLinical Research Unit from 2001-2005 (n=340) will be eligible to participate in this long-term follow-up study.

All eligible and consenting patients will undergo an assesment consisting of a simple questionnaire, a clinical examination and a blood test. Data collected will focus on survival, neurological disability and tuberculosis relapse. Data will be collected in individual case record forms and entered into a computer database.


Eligibility criteria: Inclusion Criteria:Patients were alive at the end of the dexamethasone study (n=340) will be eligible to participate in this long-term follow-up study Informed consent

Exclusion Criteria:

Patients without informed consent

Primary outcomes:
measure: Survival
timeFrame: 5 years
Secondary outcomes:
measure: Neurological disability
timeFrame: 5 years
measure: Tuberculosis relapse rate
timeFrame: 5 years
Other outcomes:
Locations:
Study officials:
affiliation: Oxford University Clinical Research Unit - Viet Nam
name: Estee Torok, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Torok ME, Nguyen DB, Tran TH, Nguyen TB, Thwaites GE, Hoang TQ, Nguyen HD, Tran TH, Nguyen TC, Hoang HT, Wolbers M, Farrar JJ. Dexamethasone and long-term outcome of tuberculous meningitis in Vietnamese adults and adolescents. PLoS One. 2011;6(12):e27821. doi: 10.1371/journal.pone.0027821. Epub 2011 Dec 8.
Clinical trial NCT00216554: The Safety and Efficacy of Risperidone as Adjunctive Therapy to Mood Stabilizers in the Long-term Treatment of Bipolar Mania
Official title: A Multicenter, Open-Label Study to Evaluate Safety and Efficacy of Risperidone as Adjunctive Therapy to Mood Stabilizers in the Long-term Treatment of Bipolar Mania
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Bipolar Disorder
Keywords: Bipolar
risperidone
Adjunctive therapy
Lead sponsor: Janssen Korea, Ltd., Korea
Sponsor class: INDUSTRY
First posted: 2005-09-22
Enrollment: 118
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate effect of risperidone as a long-term combination therapy to mood stabilizers in the treatment of bipolar mania

Detailed description: The use of mood stabilizers such as lithium and carbamazepine is known to be effective for preventing and treating bipolar disorder. But the use of antipsychotic drugs is more effective in patients suffering severe episodes of mania as it elicits behavioral changes and spurs the effects of mood stabilizers. Antipsychotic drugs are used for patients who failed to respond to mood stabilizers or for the acute management of manic episodes associated with bipolar disorders.

This study aims to evaluate the safety and efficacy of risperidone as an adjunctive therapy to mood stabilizers in the long-term treatment (6months) of bipolar disorder using various assessment instruments, including the Young Mania Rating Scale. The Simpson-Angus Rating Scale will be also employed to assess the presence of extrapyramidal side effects and other adverse events. The patients will receive orally 0.5, 1, 2 mg risperidone tablet once daily for 6 months

Eligibility criteria: Inclusion Criteria:

* In- or out-patient
* Diagnosis of bipolar I disorder
* most recent episode manic with or without psychotic features
* YMRS \> 20 (manic)
* Need antipsychotic combination on the basis of clinicians' experience

Exclusion Criteria:

* Rapid cycling
* Risk of suicide or violence
* History of Substance dependence within 3 months
* Comorbidities
* Unstable medical illness
* Previous sensitivity history to risperidone
* Pregnant woman or those without proper contraception
* History of clozapine and one cycle of depot use prior to entry
* History of treatment resistance: at least two mood stabilizers
* Prior history of active treatment with risperidone
* As for patients having wash-out period, patients that show 25% or more decrease in YMRS at baseline as compared to that at enrollment time, should be excluded.

Primary outcomes:
measure: The change in YMRS score from baseline at 6 months
Secondary outcomes:
measure: The change from baseline in Clinical Global Impression-Severity (CGI-S) score at 6 months; The change from baseline in HAMD score at 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Janssen Korea, Ltd.
name: Janssen Korea, Ltd. Clinical Trial
role: STUDY_DIRECTOR
References:
Clinical trial NCT05384054: Association Between Erythroferron and Perioperative Hemoglobin Levels in Patient Undergoing Heart Valve Surgery
Official title: Association Between Erythroferron and Perioperative Hemoglobin Levels in Patient Undergoing Heart Valve Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Postoperative Anemia
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2022-05-20
Enrollment: 150
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patient older than 20 years and undergong elective valvular heart surgery.

Brief summary: In patients undergoing cardiac surgery, perioperative anemia is an important factor in surgical recovery. In addition to the low preoperative hemoglobin level, the delayed recovery of the postoperative hemoglobin level is an important problem affecting the incidence of postoperative anemia. Erythroferron is the early response to of the red blood cell production in stressful situations such as anemia, bleeding, and hypoxia. Therefore, it is thought that acute blood loss and systemic inflammatory reaction that inevitably occurs after cardiac surgery will synthesize erythroferron, which helps to restore hemoglobin level at postoperative period by promoting hematopoiesis by simultaneously inhibiting hepcidin and activating hematopoiesis.

In this study, the investigators will investigate the association between Erythroferron and perioperative hemoglobin levels in patient undergoing heart valve surgery.


Eligibility criteria: Inclusion Criteria:

* Patients older than 20 years
* undergoing elective valvular heart surgery

Exclusion Criteria:

* Emergency operation
* Co-operation with other surgeries
* Patients with cardiogenic shock or ventricular-assist device (eg. ECMO, IABP)
* Patients requiring mechanical ventilator care in preoperative period
* Patient with severe chronic kidney disease (GFR(CKD-EPI) \<30ml/min/1.73m2)
* Patients with preoperative infection status (Eg. Sepsis)
* Patients with acute bleeding status
* Hemoglobin concentration below 10g/dL
* Disease directly affecting hematopoiesis (eg. Leukemia, myeloma, aplastic anemia)
* Uncompensated liver cirrhosis, acute hepatitis, alcoholics
* Patients who participated in other clinical studies that could affect prognosis
* Patients who cannot understand the informed consent (eg. Foreigner)

Primary outcomes:
measure: Change of hemoglobin concentration level after surgery in patients undergoing heart valve surgery
timeFrame: at immediate after surgery, 1 day after surgery, 2 days after surgery(POD2), 7 days after surgery (POD7), first outpatient visit (up to 1 month after surgery) after discharge
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei University Health System, Severance Hospital
Study officials:
References:
Clinical trial NCT00745654: Chronic Pain After Lung Transplantation, an Incidence Study
Official title: Chronic Pain After Lung Transplantation, an Incidence Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Transplantation
Keywords: Lung Transplantation
Chronic pain
Thoracotomy
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2008-09-03
Enrollment: 111
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Post lung transplantation patients in Denmark

Brief summary: This is an investigation on the frequency of chronic pain amongst recipients after lung transplantation. Factors relating to the development of chronic pain are investigated.


Eligibility criteria: Inclusion Criteria:

* Able to understand and give consent
* Can read
* Residing in Denmark

Exclusion Criteria:

* Unable to understand the written information in Danish
* Abuse (Medicine, Drugs, Alcohol)
* Severe psychiatric Illness
* Conflicting neurological disease

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Section for Surgical Pathophysiology 4074
Study officials:
affiliation: Section for Surgical Pathophysiology 4074
name: Kim Wildgaard, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Section for Surgical Pathophysiology 4074
name: Henrik Kehlet, MD,Phd,Proff
role: STUDY_CHAIR
References:
Clinical trial NCT04485754: Telemedicine Follow-up for Post-ACS Patients
Official title: Telemedicine Follow-up for Post-Acute Coronary Syndrome Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ACS - Acute Coronary Syndrome
Keywords: Telemedicine follow-up visit
Post-ACS rehabilitation
Lead sponsor: Tomsk National Research Medical Center of the Russian Academy of Sciences
Sponsor class: OTHER
First posted: 2020-07-24
Enrollment: 88
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim is to compare the safety of using telemedicine and office visit follow-up in post-acute coronary syndrome patients

Detailed description: Rehabilitation after acute coronary syndrome includes visits to the cardiologist's office at 1, 2, 6 and 12 months after discharge. Due to the Covid-19 pandemic, visiting a cardiologist's office maybe impossible. In such cases telemedicine follow-up visit would be reasonable choice. Taking into account the absence of studies in this area, providing investigation evaluating parameters of safety for both methodics is relevant.

Eligibility criteria: Inclusion Criteria:

1. Signed informed consent
2. Age ≥ 40 years
3. PCI with coronary artery stenting for ACS
4. Angiographic success PCI

Exclusion Criteria:

1. Patients with cancer
2. Severe CHF (EF LV \<35% or functional class of heart failure III-IV NYHA)
3. Severe valvular heart disease or Prosthetic heart valves.
4. Severe forms of CKD (GFR\<30mL/min)
5. Planned staged revascularization during the next 12 months
6. Planned surgery within the next 12 months

Primary outcomes:
measure: MACCE
timeFrame: 1 year
Secondary outcomes:
measure: High level of MT optimization
timeFrame: 1 year
measure: PB < 140/90 mm/Hg (<135/85 mm/Hg for Diabetes)
timeFrame: 1 year
measure: LDL < 1.4 mmol/L
timeFrame: 1 year
measure: Not smoking
timeFrame: 1 year
measure: Decrease in overweight
timeFrame: 1 year
measure: Aspirin or other antiplatelet or anticoagulant
timeFrame: 1 year
measure: Adherence to prescribed medication
timeFrame: 1 year
measure: Hospitalization
timeFrame: 1 year
Other outcomes:
Locations:
city: Tyumen
country: Russian Federation
facility: Tyumen Cardiology Research Center, Tomsk National Research Medical Center, Russian Academy of Science
Study officials:
affiliation: Tyumen Cardiology Research Center
name: Ivan S Bessonov, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02239354: A Safety, Tolerability, and Efficacy Study of VC-01™ Combination Product in Subjects With Type I Diabetes Mellitus
Official title: A Prospective, Multicenter, Open-Label, First-in-Human Phase 1/2 Study With Two Cohorts to Evaluate the Safety, Tolerability, and Efficacy of Various Doses of VC-01™ Combination Product in Subjects With Type 1 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Type 1 Diabetes Mellitus
Lead sponsor: ViaCyte
Sponsor class: INDUSTRY
Collaborators: name: California Institute for Regenerative Medicine (CIRM)
First posted: 2014-09-12
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: OTHER

Brief summary: The purpose of this trial is to test if VC-01™ combination product can be implanted subcutaneously in subjects with Type 1 Diabetes and maintained safely for two years. It will also test if VC-01 is an effective treatment for subjects with Type 1 Diabetes.


Eligibility criteria: Inclusion Criteria:

* Men and women (non-pregnant and non-childbearing potential)
* Diagnosis of type 1 diabetes mellitus for at least 3 years
* Stable diabetic treatment
* Willingness to use a continuous glucose meter
* Acceptable candidate for implantation

Exclusion Criteria:

* Advanced complications associated with diabetes
* Immunosuppressive therapy

Primary outcomes:
measure: Number of Adverse Events Reported During the Study.
timeFrame: Thru the Month 24 Visit
measure: Change in C-peptide
timeFrame: Baseline to the Month 6 Visit
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: University of California at San Diego
state: California
city: Edmonton
country: Canada
facility: University of Alberta Hospital
state: Alberta
Study officials:
References:
citation: Satin LS, Soleimanpour SA, Walker EM. New Aspects of Diabetes Research and Therapeutic Development. Pharmacol Rev. 2021 Jul;73(3):1001-1015. doi: 10.1124/pharmrev.120.000160.
citation: Saber N, Bruin JE, O'Dwyer S, Schuster H, Rezania A, Kieffer TJ. Sex Differences in Maturation of Human Embryonic Stem Cell-Derived beta Cells in Mice. Endocrinology. 2018 Apr 1;159(4):1827-1841. doi: 10.1210/en.2018-00048.
citation: Pase C, Mathias AD, Garcia CD, Garcia Rodrigues C. Using Social Media for the Promotion of Education and Consultation in Adolescents Who Have Undergone Kidney Transplant: Protocol for a Randomized Control Trial. JMIR Res Protoc. 2018 Jan 9;7(1):e3. doi: 10.2196/resprot.8065.
Clinical trial NCT01630954: A Comparison of Single Versus Double Evacuation for Treatment of Hydatidiform Mole
Official title: A Comparison of Single Versus Double Evacuation for Treatment of Hydatidiform
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hydatidiform Mole
Keywords: Hydatidiform mole
Molar pregnancy
H Mole
GTN
GTD
Lead sponsor: Nilratan Sircar Medical College
Sponsor class: OTHER_GOV
First posted: 2012-06-28
Enrollment: 120
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Hydatidiform mole is a common complication of pregnancy with an incidence of 1in 400 pregnancies in India. Although this is a benign condition , it is having the malignant potential too. A repeat curettage after evacuation of hydatidiform mole was generally advocated till 1990s. A thorough curettage at the time of initial evacuation was not performed because of larger size of uterus and risk of perforation. Subsequently a number of studies assessed the usefulness of repeat curettage and found it was unnecessary and not cost effective . However all these studies are retrospective in design and conducted in developed countries where hydatidiform mole is diagnosed earlier because of wider use of ultrasonography. Thus there is a need to perform a well designed prospective study to compare the effectiveness of single evacuation with double evacuation in treatment of hydatidiform mole for prevention of Gestational Trophoblastic Neoplasia.This study compares the effectiveness of single evacuation versus double evacuation for treatment of hydatidiform mole for prevention of gestational trophoblastic neoplasia .


Eligibility criteria: Inclusion Criteria:

* Ultrasound confirmed complete mole

Exclusion Criteria:

* Partial mole
* History of treatment for molar pregnancy like prior evacuation or chemotherapy
* Women requiring hysterectomy for treatment of H Mole

Primary outcomes:
measure: Proportion of patents diagnosed as GTN following treatment in each group
timeFrame: Six months following evacuation
Secondary outcomes:
measure: Maternal complications,
timeFrame: Six months
measure: Time interval of normalization of HCG
timeFrame: Six months following evacuation
measure: Duration of hospital stay
timeFrame: Two weeks following admission
Other outcomes:
Locations:
city: Kolkata
country: India
facility: Dr Snehamay Chaudhuri
state: West Bengal
Study officials:
affiliation: Associate Professor, Obstetrics and Gynecology, NRS Medical College , Kolkata,India
name: Snehamay Chaudhuri, MD, DNB
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06281054: Acute Myocardial Infarction in Cancer Patients
Official title: Risk and Clinical Outcomes of Acute Myocardial Infarction in Patients With Cancer: A Nationwide Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Acute Myocardial Infarction
Cancer
Keywords: Acute myocardial infarction
Cancer
Incidence
Prognosis
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
Collaborators: name: Chonnam National University
First posted: 2024-02-28
Enrollment: 4500000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who were diagnosed with cancer from 2002 to 2021 will be considered in the study. Among these patients, those diagnosed with acute myocardial infarction after the diagnosis with cancer will be included in the study.

Brief summary: Using national health insurance service database, current study aim to evaluate the risk and prognosis of acute myocardial infarction in cancer patients and to find the optimal treatment strategy for acute myocardial infarction that can improve long-term prognosis.

Detailed description: This study will be conducted using Korean National Health Insurance Service database. Patients who were diagnosed with cancer from 2002 to 2021 will be included in the study. Using the selected patients, current study will analyze the incidence and prognosis of acute myocardial infarction in cancer patients and the prognosis according to the treatment method for acute myocardial infarction will be compared. Primary outcome will be all-cause death. Secondary outcomes will be myocardial infarction, revascularization, hospitalization for heart failure, stroke, and clinically relevant bleeding.

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with cancer between 2002 and 2021
* Patients who were diagnosed with acute myocardial infarction after cancer diagnosis

Exclusion Criteria:

* Patients who died during period of cancer diagnosis

Primary outcomes:
measure: All-cause death
timeFrame: 2-years after diagnosis of acute myocardial infarction
Secondary outcomes:
measure: Myocardial infarction
timeFrame: 2-years after diagnosis of acute myocardial infarction
measure: Revascularization
timeFrame: 2-years after diagnosis of acute myocardial infarction
measure: Hospitalization for heart failure
timeFrame: 2-years after diagnosis of acute myocardial infarction
measure: Stroke
timeFrame: 2-years after diagnosis of acute myocardial infarction
measure: Clinically relevant bleeding
timeFrame: 2-years after diagnosis of acute myocardial infarction
Other outcomes:
Locations:
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital, Chonnam National University Medical School
Study officials:
affiliation: Samsung Medical Center
name: Joo Myung Lee, MD, MPH, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Chonnam National University Hospital
name: Seung Hun Lee, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: