louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00764842: Efficacy of the CLP® Hip - Retrospective
Official title: Post-Market Study: The Efficacy of the CLP® Hip
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Osteoarthritis
Avascular Necrosis
Rheumatoid Arthritis
Lead sponsor: Encore Medical, L.P.
Sponsor class: INDUSTRY
First posted: 2008-10-02
Enrollment: 61
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: Individuals who meet the indications for use of the CLP Hip Stem AND who meet the inclusion/exclusion criteria

Brief summary: The purpose of this study is to evaluate the survivorship and efficacy of the Encore CLP® Hip stem in a group of no more than 200 patients from whom data has already been collected.


Eligibility criteria: Inclusion Criteria:

1. Patients must be 18 years of age or older.
2. Noninflammatory degenerative joint disease including

   * Osteoarthritis of the natural femoral head
   * Avascular necrosis of the natural femoral head
   * Rheumatoid arthritis
3. Correction of functional deformities
4. Femoral fracture
5. Patients must be able and willing to complete all study-related visits.

Exclusion Criteria:

1. Anyone who is under 18 years of age
2. Infection or sepsis
3. Insufficient bone quality which may affect the stability of the implant
4. Muscular, neurological or vascular deficiencies, which compromise the affected extremity
5. Skeletally immature patients and cases where there is a loss of abductor musculature, poor bone stock, poor skin coverage around hip joint which would make the procedure unjustifiable
6. Osteomyelitis
7. Rapid joint destruction or bone absorption apparent on roentgenogram
8. Pathological conditions of the acetabulum which would prevent achieving proper range of motion, appropriate head stability, and/or a well-seated and supported smooth articulation of the head within the acetabulum
9. Alcoholism or other addictions
10. Materials sensitivity
11. Loss of ligamentous structures
12. High levels of physical activity (e.g., competitive sports, heavy physical labor)
13. Pregnancy

Primary outcomes:
measure: The survivorship and efficacy of the Encore CLP® Hip stem
timeFrame: 2 year
Secondary outcomes:
Other outcomes:
Locations:
city: Fresno
country: United States
facility: Center for Excellence
state: California
Study officials:
affiliation: Center for Excellence
name: D. Kevin Lester, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03247842: The Analgesic Efficacy Supra-scapular Nerve RF After Breast Surgery
Official title: The Analgesic and Rehabilitative Value of Supra-scapular Nerve Radiofrequency in Patients With Chronic Shoulder Pain After Breast Surgery.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain Syndrome
Keywords: post mastectomy pain
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2017-08-14
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Eighty patients with chronic shoulder pain after breast surgery were allocated randomly into 2 groups; forty patients received fluoroscopically guided supra-scapular nerve pulsed radiofrequency (PRF) followed by injection of 0.25% bupivacaine solution containing 40 mg of methylprednisolone (group1) and forty patients received fluoroscopically guided supra-scapular nerve injection of of 0.25% bupivacaine solution containing 40 mg of methylprednisolone (group 2) without active pulsed radiofrequency only demo mode was applied.

Detailed description: Eighty patients with chronic shoulder pain after breast surgery were allocated randomly into 2 groups ; forty patients received fluoroscopically guided supra-scapular nerve pulsed radiofrequency (PRF) followed by injection through the radiofrequency needle of 0.25% bupivacaine solution containing 40 mg of methylprednisolone (group1) and forty patients received fluoroscopically guided supra-scapular nerve injection of 0.25% bupivacaine solution containing 40 mg of methylprednisolone (group 2) without active pulsed radiofrequency only demo mode was applied.

Eligibility criteria: Inclusion Criteria:

* patients with post-mastectomy pain

Exclusion Criteria:

* Exclusion criteria are patients with any medical contraindications to neurolysis, patients with other bone metastases.

Primary outcomes:
measure: postoperative pain
timeFrame: immedite postopertive
Secondary outcomes:
measure: shoulder movement
timeFrame: 6 months after surgery
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Tanta university hospital
Study officials:
References:
Clinical trial NCT03333642: Surgery Treatment of Type 2 Diabetes Mellitus Patients With Grade 1 Obesity and Overweight
Official title: Ileal Interposition With Sleeve Gastrectomy for Type 2 Diabetes Mellitus Treatment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes Mellitus
Obesity
Overweight
Keywords: diabetes
metabolic surgery
ileal interposition
Lead sponsor: Hospital Federal de Bonsucesso
Sponsor class: OTHER
First posted: 2017-11-07
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study evaluate the Duodenal Ileal Interposition with Sleeve Gastrectomy for Type 2 Diabetes Mellitus in grade 1 obesity and overweight patients.

Detailed description: A clinical trial, 1-arm treatment (Duodenal Ileal Interposition with Sleeve Gastrectomy for Type 2 Diabetes Mellitus), including 50 research subjects with type 2 diabetes mellitus and obesity class I or overweight. The main objective is to analyse the effect on glycemic control after 2 years of follow-up.

Eligibility criteria: Inclusion Criteria:

* Documented diagnosis of type 2 diabetes mellitus;
* Patients of both sexes treated with oral antidiabetic agents and / or insulins,
* Stable antidiabetic medication in the last 8 weeks prior to selection, if the therapy includes insulin, the mean daily dose should not have been changed by more than 10% in the last 8 weeks;
* HbA1c\> 7.0%;
* Age\> 20 years and \<65 years;
* Body mass index (BMI) of 25 to 35 kg / m²;
* Agree to sign the consent form;

Exclusion Criteria:

* Diabetes mellitus type 1 (anti-glutamic acid decarboxylase(GAD) positive) or anti-GAD negative body with low β-cell function (peptide C after stimulation \<0.5 ng / ml);
* Recent vascular event (myocardial infarction, coronary angioplasty or encephalic vascular accident in the last 6 months);
* Malignant neoplasm;
* Portal hypertension;
* Difficulty to cooperate with segment;
* Low ability to understand surgery;
* Unrealistic expectations of results;
* Cognitive deficit;
* Current pregnancy;
* Moderate or severe mood disorder; severe anxiety; eating disorders (based on Substance-Related Disorders DSM-V criteria);
* Chemical dependence or alcoholism (based on Substance-Related Disorders DSM-V criteria).

Primary outcomes:
measure: Remission of type 2 Diabetes at 24 months
timeFrame: 2 years
Secondary outcomes:
measure: Control of type 2 diabetes
timeFrame: 2 years
Other outcomes:
measure: Quality of life assessment
timeFrame: Before and 1, 3, 6, 12, 18 and 24 months after surgery
measure: Measurement of surgical adverse events
timeFrame: 2 years
Locations:
city: Rio de Janeiro
country: Brazil
facility: Hospital Federal de Bonsucesso
Study officials:
affiliation: Hospital Federal de Bonsucesso
name: Leonardo R Ferraz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04800042: Study of the Prevalence of Iron Deficiency in Patients With Scheduled Major Surgery (CARENFER PBM)
Official title: Study of the Prevalence of Iron Deficiency in Patients With Scheduled Major Surgery (CARENFER PBM)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diagnostic
Lead sponsor: VIFORFRANCE
Sponsor class: INDUSTRY
First posted: 2021-03-16
Enrollment: 1700
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Many patients who are candidates for scheduled major surgery have a pre-operative iron deficiency which is poorly diagnosed. The management of per-operative iron deficiency is a part of the concept of the "Patient Blood Management", which is a concept recommended by health regulatory agencies in many countries. The objective of this study is to obtain updated data on the prevalence of iron deficiency in France in patients undergoing a scheduled major surgery, applying the French recommendations (determination of ferritinemia and Transferrin Saturation Factor).


Eligibility criteria: Inclusion Criteria:

* Patient, male or female, over 18 years of age
* Patient with scheduled major surgery
* Patient with signed consent

Exclusion Criteria:

* Protected patient : major under guardianship, tutorship or other legal protection, deprived of liberty by judicial or administrative decision
* Pregnant or breastfeeding woman

Primary outcomes:
measure: Blood iron status
timeFrame: Preoperative
measure: Complete blood iron status
timeFrame: Preoperative
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03268642: Clinical Assessment of New Treatment Regimen for Adult Fulminant Myocarditis
Official title: Assesment of Clinical Therapeutic Efficacy of "Life-support Based Comprehensive Treatment Regimen" for Adult Fulminant Myocarditis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Fulminant Myocarditis
Keywords: Fulminant Myocarditis
Retrospective cohort study
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2017-08-31
Enrollment: 150
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 150 hospitalized patients with fulminant myocarditis will be enrolled in this study.

Brief summary: This is a retrospective cohort study to assess the clinical outcome of patients with fulminant myocarditis using "Life-support Based Comprehensive Treatment Regimen" and conventional therapy. In the present study, participants receive various treatment as part of routine medical care without any assignment of specific interventions to them. The process of treatment during hospitalization were recorded in medical chart and was reviewed by independent research personnel.


Eligibility criteria: Inclusion Criteria:

* 16 years of age or older;
* Diagnosed as fulminant myocarditis:

  * Evidence of myocarditis on biopsy or increased biomarkers of myocardial injury (TNI and CK-MB and BNP or NT-pro-BNP);
  * Acute onset of symptoms of cardiac dysfunction: dyspnea, palpation, chest pain, and/or syncope;
  * Image for cardiac injury: marked diffused reduction in left ventricle wall movement, with dramatically decreased left ventricle ejection fraction (LVEF) \< 45%;
  * Cardiogenic shock, e.g., systolic blood pressure ≤90 mmHg or mean arterial pressure \< 70mm Hg or a systolic blood pressure decrease \> 40 mm Hg, which is associated with the signs of hypofusion: cyanosis, cold extremities, oliguria, and/or changes in mental status.

Exclusion Criteria:

* Also considering acute coronary syndrome but unable to perform coronary angiography to distinguish acute coronary syndrome from fulminant myocarditis;
* Myocardial injury caused by sepsis, chemotherapeutical agents, or poisons;
* Unstable hemodynamics or shock caused by hypovolemia.

Primary outcomes:
measure: death or cardiac transplantation
timeFrame: through hospital discharge, an average of 10 days
Secondary outcomes:
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji Hospital
state: Hubei
Study officials:
affiliation: Tongji Hospital
name: Dao Wen Wang, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wang J, He M, Li H, Chen Y, Nie X, Cai Y, Xie R, Li L, Chen P, Sun Y, Li C, Yu T, Zuo H, Cui G, Miao K, Zhao C, Jiang J, Heidecker B, Barnett O, Maisel A, Chen C, Wang DW. Soluble ST2 Is a Sensitive and Specific Biomarker for Fulminant Myocarditis. J Am Heart Assoc. 2022 Apr 5;11(7):e024417. doi: 10.1161/JAHA.121.024417. Epub 2022 Apr 4.
Clinical trial NCT06204042: Multinational Glanzmann Study
Official title: Glanzmann Thrombasthenia Natural History Study+
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Glanzmann Thrombasthenia
Lead sponsor: UMC Utrecht
Sponsor class: OTHER
First posted: 2024-01-12
Enrollment: 200
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with biochemically or genetically diagnosed Glanzmann thrombasthenia.

Brief summary: Glanzmann thrombasthenia is a rare autosomal recessive platelet disorder characterized by a lack of functional integrins alfaIIb or beta3 (glycoproteins IIb/IIIa). The prevalence is variously reported to be between 1:200,000 to 1:1,000,000, with substantial geographic variation. The clinical phenotype is dominated by an increased mucocutaneous bleeding tendency. In absence of a primary bleeding prophylaxis, the current treatment of Glanzmann thrombasthenia is mainly focused on prevention or management of bleeding. However, as potential new therapies emerge, clinicians require unbiased, long-term safety and efficacy data for both current treatment and new therapies.

We have designed this study to investigate genetic phenotype (ITGA2B and ITGB3 genes) and the prevalence of antibodies against human leucocyte antigen (HLA) and human platelet antigen (HPA), the latter two being a potential consequence of the current golden standard treatment: platelet transfusion. The results of this study will be merged with a longitudinal registry with retrospective and prospective data collection of clinical phenotype, haemorrhagic burden and bleeding management. Analysis of the data from the Glanzmann-NHS+ study and the registry will help us to get a better understanding of the clinical variation among participants with Glanzmann thrombasthenia. The ultimate goal is to accelerate improvement in the care of patients with Glanzmann thrombasthenia.


Eligibility criteria: Inclusion Criteria:

* Adult patients (≥16 years);
* Biochemically or genetically diagnosed Glanzmann thrombasthenia.
* Willing and able to give written informed consent.

Exclusion Criteria:

* Patients with acquired thrombasthenic states caused by auto-immune disorders or drugs.

Primary outcomes:
measure: Genetic analysis for Glanzmann thrombasthenia
timeFrame: Single measurement at Baseline
Secondary outcomes:
measure: Incidence of anti-Human Leucocyte Antigen (HLA) antibodies
timeFrame: Single measurement at Baseline
measure: Incidence of anti-Human Platelet Antigen (HPA) antibodies
timeFrame: Single measurement at Baseline
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04177342: Post Operative Pain Control of POEM Procedure
Official title: Influence of Intraoperative Opioids (Oxycodone/Fentanyl) Usage on the Post-operative Pain Management of Peroral Endoscopic Myotomy (POEM)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Achalasia
Keywords: achalasia
Peroral endoscopic myotomy
post-operative pain
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2019-11-26
Enrollment: 196
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: patients will be devided randomly into two groups. One group will be given oxycodone and the other will be given fentanyl during the POEM procedure. Post procedure pain condition will be recorded.
Primary purpose: TREATMENT

Brief summary: Peroral endoscopic myotomy (POEM) is a minimally invasive treatment for esophageal achalasia with a natural orifice transluminal endoscopic procedure and far less invasive than the standard surgical or laparoscopic Heller myotomy (LHM). Less is known about the postoperative pain after POEM and the minor surgery trauma, short length of stay may lead to underestimation of postoperative pain control. We tend to observe the pain status after the POEM surgery under the empirical treatment in our center, and find a proper intra-operative way of pain control to solve the post-operative pain and seek the possible influence factors of postoperative pain.


Eligibility criteria: Inclusion Criteria:

* Achalasia patients undergoing elective POEM surgery
* age 18-80
* BMI 18-30 kg/m2

Exclusion Criteria:

* Patient refusal
* ASA≥ 3
* abnormality of liver and kidney function in patients
* patients with mental disorder, language disorder, and other patients who can not cooperate with and complete the follow-up and questionnaire pre- and post- operatively
* patients (including propanotamo, propofol, lidocaine, and other drugs) against drug taboos in the anesthetic scheme
* patients with chronic pain before operation with analgesic drugs

Primary outcomes:
measure: post-operative pain condition
timeFrame: 36 hours after the POEM surgery
measure: post-operative PCA usage volumn
timeFrame: 36 hours after the POEM surgery
measure: post-operative sleep quality
timeFrame: 48 hoursafter the surgery
Secondary outcomes:
measure: chronic pain condition
timeFrame: 28 days after discharge
Other outcomes:
Locations:
Study officials:
affiliation: Shanhai Zhongshan
name: Wannan Chen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03527342: Sahlgrenska Cardiomyopathy Project
Official title: Sahlgrenska University Hospital Cardiomyopathy Project: Mapping and Diagnosis of Cardiomyopathies to Enable Early and Specific Treatment
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Dilated Cardiomyopathies
Hypertrophic Cardiomyopathy
Restrictive Cardiomyopathy
Arrhythmogenic Right Ventricular Cardiomyopathy
Myocarditis
Sarcoidosis With Myocarditis
Giant Cell Myocarditis
Amyloidosis; Heart (Manifestation)
Lead sponsor: Göteborg University
Sponsor class: OTHER
Collaborators: name: Sahlgrenska University Hospital
First posted: 2018-05-17
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Eligible patients are all patients referred to Sahlgrenska University Hospital, Gothenburg, Sweden with a cardiomyopathy diagnose.

Brief summary: This is a joint project by Sahlgrenska University Hospital: Sahlgrenska, Östra and Mölndal.

Our objective is to diagnose and map patients with well phenotyped cardiomyopathies (CMP) including in depth clinical and molecular phenotyping to enable earlier and specific treatment. The project will serve as:

1. resource for diagnostic and therapeutic trials
2. common biomaterial bank
3. resource for detailed molecular analyses on patients' biomaterials and patient specific symptoms and examination results


Eligibility criteria: Inclusion Criteria:

* Patients with primary cardiomyopathies including hereditary and inflammatory dilated cardiomyopathy, hypertrophic cardiomyopathy, restrictive cardiomyopathy, left ventricular non-compaction cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, myocarditis, giant cell myocarditis, sarcoidosis and amyloidosis engaging the heart

Exclusion Criteria:

* Patient with other preexisting cardiac diseases such as significant valvular, ischemic or pericardial disease before they receive a cardiomyopathy diagnose
* patients \< 18 years

Primary outcomes:
measure: Time to disease progression
timeFrame: 2018-2028
Secondary outcomes:
Other outcomes:
measure: Progression in biomarker NT-proBNP
timeFrame: 2018-2028
measure: Changes over time in presence of autoantibodies
timeFrame: 2018-2028
measure: Disease activity evaluated by positron-emissions-tomography computed tomography (PET-CT)
timeFrame: 2018-2028
measure: Disease activity evaluated by magnetic resonance imaging (MRI)
timeFrame: 2018-2028
Locations:
city: Göteborg
country: Sweden
facility: Göteborg University, Sahlgrenska Universitetssjukhuset
Study officials:
References:
Clinical trial NCT06308042: Remote Evaluation in Patients With Multiple Sclerosis
Official title: Remote Reliability Of 30 Seconds Sit And Stand Test In Patients With Multiple Sclerosis
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Multiple Sclerosis
Keywords: 30 SECONDS SIT AND STAND TEST
REMOTE RELIABILITY
Lead sponsor: Inonu University
Sponsor class: OTHER
First posted: 2024-03-13
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: multiple sclerosis patients

Brief summary: This study aimed to demonstrate the remote reliability of the 30-second sit-to-stand test in patients with multiple sclerosis.

Detailed description: The population of the research will be participants with multiple sclerosis. The 30-second sit-to-stand test will be performed in the participant's home environment. . Patients will be instructed to cross their arms over their chest and complete as many standing cycles as possible in 30 seconds, standing until fully upright and then sitting until the hips touch the chair without the assistance of the hands. Inter-rater reliability will be assessed by two different raters in the same video interview. In contrast, intra-rater reliability will be evaluated by analyzing the number of repetitions recorded by the same rater in two different video interviews conducted 24-28 hours apart.

Eligibility criteria: Inclusion Criteria:

* Having been diagnosed with MS according to the McDonald criteria by a neurologist
* having and being able to use a device with Internet access (e.g. smartphone, computer or tablet)
* having EDSS between 1.5 and 6.5,
* being between the ages of 18-65.

Exclusion Criteria:

* Patients who have had a recurrence of the disease in the last 30 days,
* have an additional health problem (orthopedic, neurological, internal or cardiorespiratory) that prevents standing/walking,
* do not agree to participate in the study.

Primary outcomes:
measure: 30 second sit and stand test
timeFrame: 24-48 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Inonu University
name: Burcu talu
role: STUDY_DIRECTOR
References: