louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01830296: Intravenous Remifentanil Plus Morphine or Morphine Alone for Postthoracotomy Pain
Official title: COADMINISTRATION OF INTRAVENOUS REMIFENTANIL AND MORPHINE FOR POSTTHORACOTOMY PAIN; COMPARISON WITH IV MORPHINE ALONE
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain
Keywords: Postthoracotomy pain,
patient controlled analgesia,
remifentanil and
morphine.
Lead sponsor: Cukurova University
Sponsor class: OTHER
First posted: 2013-04-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Background; Post-thoracotomy pain remains a major problem. This double-blind, randomized study tested the effects of coadministration of patient controlled remifentanil+morphine combination on postthoracotomy pain, analgesic consumption and side effects compared with morphine PCA alone

Detailed description: Methods; Sixty patients were allocated randomly to receive an intravenous patient-controlled analgesia with morphine alone (M), or morphine plus remifentanil (MR), in a double-blind manner. Postoperatively patients were allowed to use bolus doses of morphine (0.2 mg kg-1) or morphine (0.2 mg kg-1) plus remifentanil (0.2 µg kg-1) mixture every 10 min without a background infusion. Pain, discomfort, sedation scores, total and bolus patient-controlled morphine consumption, rescue analgesic requirement and side-effects were recorded for up to 24 h after the start of patient-controlled analgesia.

Eligibility criteria: Inclusion Criteria:

* 60 ASA physical status I-III patients, between the ages of 18 and 59 years, scheduled for elective thoracotomy surgery with general anaesthesia were included in this study

Exclusion Criteria:

* severe hepatorenal disease history, sensitivity or contraindication to morphine and remifentanil, chronic pain (defined as regular use of opioid analgesics for \> 3 months), drug or alcohol abuse and contraindication to administration of PCA

Primary outcomes:
measure: COADMINISTRATION OF INTRAVENOUS REMIFENTANIL AND MORPHINE FOR POSTTHORACOTOMY PAIN; COMPARISON WITH IV MORPHINE ALONE
timeFrame: Two years
Secondary outcomes:
Other outcomes:
Locations:
city: Adana
country: Turkey
facility: Hakkı Unlugenc
Study officials:
affiliation: Cukurova University, Department of Anaesthesiology
name: Mediha Turktan, Assist Prof
role: STUDY_DIRECTOR
References:
Clinical trial NCT03968796: Efficacy of Transcutaneous Electrical Nerve Stimulation (TENS) and Kinesio Taping in Patients With Lateral Epicondylitis
Official title: TENS and Kinesio Tape for Treatment Lateral Epicondylitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain in Arm, Unspecified
Tenosynovitis Elbow
Lateral Epicondylitis (Tennis Elbow) Bilateral
Keywords: Kinesio Taping
Lateral epicondylitis
Tennis elbow
TENS
Lead sponsor: European University of Lefke
Sponsor class: OTHER
First posted: 2019-05-30
Enrollment: 78
Sex: ALL
Minimum age (years): 19
Maximum age (years): 72
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Lateral epicondylitis is the most common condition affecting the elbow and characterized by pain over the lateral epicondyle. The aim of this study was to determine and compare the efficacy of TENS and Kinesio Taping in lateral epicondylitis.

Detailed description: In this prospective-randomized, assessor blinded controlled trial, seventy-eight patients (63 women, 15 men, mean age 47,5 ±7,94 years) with lateral epicondylitis were enrolled. Patients were allocated into 4 treatment groups: Group 1 received TENS and Kinesio Taping, group 2 received TENS+sham Kinesio Taping, group 3 received sham TENS+ Kinesio Taping and group 4 received sham TENS+sham Kinesio Taping. TENS was applied for 10 sessions and Kinesio Taping for 4 times in 10 days. All patients were given a progressive exercise program and were informed about the disease. All patients were told to take paracetamol 500 mg if their pain is severe and to note the number of the paracetamol taken.

Outcome measures were pain-free grip strength, pressure pain threshold and pain severity at rest, night and forced wrist extension test. Patient-rated tennis elbow evaluation (PRTEE) was used to determine functional status. Patients were assessed for outcome measures at screening, after treatment (day 10) and 12th week after the treatment.

Eligibility criteria: Inclusion Criteria:

* Aged 19 to 72
* Enough cognitive ability to fill clinical assessment forms
* Agreed to participate in the study

Exclusion Criteria:

* Severe or progressive neurological deficits
* Severe psychiatric disease history, substance and/or alcohol dependence,
* Uncontrolled diabetes mellitus, malignancy, osteoporosis
* A history of inflammatory or infectious disease
* A skin allergy story
* Previously undergone physical therapy due to lateral epicondylitis

Primary outcomes:
measure: Pain-free grip strength
timeFrame: 12 week
measure: Pain severity at rest, night and forced wrist extension test
timeFrame: 12 week
measure: Pressure pain threshold
timeFrame: 12 week
measure: Patient-rated tennis elbow evaluation (PRTEE)
timeFrame: 12 week
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: European University of Lefke
name: Hilal Telli, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02298296: Trajectory of Positive Psychological States in Patients With ACS
Official title: Trajectory of Positive Psychological States in Patients With Acute Coronary Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Coronary Syndrome
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2014-11-21
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects were recruited from inpatient cardiac units in a large, urban hospital.

Brief summary: The purpose of the study is to to determine the natural history of positive psychological states, health status, and functioning, over an 8 week period following admission for an acute coronary syndrome (ACS). We aim to compare the changes in these factors from baseline to 8-week follow-up with corresponding changes in the completed proof-of-concept intervention trial (NCT02004158).


Eligibility criteria: Inclusion Criteria:

* Suboptimal adherence to health behaviors. This will be defined as mean item score of \<15 (suboptimal) on three Medical Outcomes Study-Specific Adherence Scale (MOS SAS) items.
* Submaximal self-reported optimism. This will be defined as a total score of \<30 on the Life Orientation Test-Revised (LOT-R) .
* Submaximal self-reported positive affect. This will be defined as a total score of \<50 on the Positive and Negative Affect Schedule (PANAS) .

Exclusion Criteria:

* Cognitive deficits, assessed via a 6-item cognitive screen used to assess appropriate participation of medically-ill patients in research studies.
* Medical conditions precluding interviews or likely to lead to death within 6 months, determined in consultation with the primary treatment team and cardiology co-investigator Dr. Januzzi.
* Inability to communicate in English.
* Inability to participate in physical activity.

Primary outcomes:
measure: Change in positive affect measured by self-report questionnaires
timeFrame: Baseline, 8 weeks
Secondary outcomes:
measure: Change in behavior adherence measured by a self-report questionnaire
timeFrame: Baseline, 8 weeks
measure: Change in function measured by self-report questionnaires
timeFrame: Baseline, 8 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Massachusetts General Hospital
name: Jeff C Huffman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03728296: A Study of Autologous Induced Islet Body With Type 1 Diabetes
Official title: Clinical Study on the Safety and Efficacy of Autologous Induced Islet Body With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Type 1 Diabetes
Lead sponsor: Allife Medical Science and Technology Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2018-11-02
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This is a single centre、single arm、open-label study，to investigate the safety and efficacy of Autologous induced islet body With Type 1 diabetes


Eligibility criteria: Inclusion Criteria:

1. Male or female, 18 to 70 years old (including 18 and 70 years old)
2. Diagnosed as type I diabetes, the diagnostic criteria refer to the 1990 WHO diabetes diagnostic criteria:

（1）Diabetes symptoms (hyperglycemia caused by polydipsia, polyphagia, weight loss, itchy skin, blurred vision and other acute metabolic disorders) + random blood glucose ≥ 11.1nmol / L; （2）Fasting blood glucose ≥7.0mmol/L or 75g glucose meets 2-hour blood glucose ≥11.1mmol/L.

3、Voluntary informed consent is given, agree to follow the trial treatment and visit plan.

Note: 2 is the venous plasma glucose level, if there is no diabetes symptoms, it is necessary to repeat the test on the next day.

Exclusion Criteria:

1. Patients with acute complications of diabetes: including diabetic ketosis, diabetic ketoacidosis, diabetes, hyperglycemia, hypertonic state, etc.
2. Patients with Severe bacterial and viral infections
3. patients are participating in other clinical trials and treating with other immune cellular products (DC, CIK, T, NK, and Car T products with CD19 or other targets)
4. Patients with severe cardiovascular and cerebrovascular disease (NYHA class 3-4) cannot cooperate with the study
5. Patients with severe liver dysfunction(liver function AST and ALT exceeded 2.5 times the normal upper limit).
6. Patients with kidney disease or moderate to severe renal insufficiency (renal function eGFR \<60 ml/min/1.73 m2)
7. Women in pregnancy (urine/blood pregnancy test positive) or lactation; men or women with pregnancy plans in the last year; patients are not guaranteed to take effective contraceptive measures during the trial;
8. patients were diagnosed as tumor or tumor chemotherapy, radiotherapy and acute uric acid nephropathy within 5 years.
9. Other circumstances that researchers do not consider suitable for research.
10. Withdrawal from trial, loss of follow-up or death due to other reasons
11. Incomplete data, affecting effectiveness and safety judges
12. Researchers believe that the need for termination of the trial is needed.

Primary outcomes:
measure: Occurrence of treatment related adverse events as assessed by CTCAE v4.0
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05527496: Effect of Hp Infection on the Quality of Gastric Mucosa Preparation
Official title: Effect of Hp Infection on the Quality of Gastric Mucosa Preparation and Study on Different Gastric Mucosa Preparation Schemes in Patients With Hp Infection
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Helicobacter Pylori Infection
Lead sponsor: Second Affiliated Hospital of Xi'an Jiaotong University
Sponsor class: OTHER
First posted: 2022-09-02
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All outpatients or inpatients requiring general gastroscopy

Brief summary: The purpose of this study was to evaluate the effect of Helicobacter pylori infection on the quality of gastric mucosa preparation.

Detailed description: The purpose of this study was to evaluate the effect of Helicobacter pylori infection on the quality of gastric mucosa preparation by comparing the cleanliness of gastric mucosa between patients with Helicobacter pylori infection and those without Helicobacter pylori infection.

Eligibility criteria: Inclusion Criteria:

* Adults who volunteered to participate in this study and signed an informed consent form
* Have been tested for Helicobacter pylori and have definite test results

Exclusion Criteria:

* Contraindications for gastroscopy (such as severe cardiopulmonary diseases, liver and kidney dysfunction, shock, etc.)
* History of upper gastrointestinal surgery
* Therapeutic endoscopy and emergency surgery are required
* Recent history of upper gastrointestinal bleeding
* Corrosive substance ingestion
* The pregnancy
* Abnormal mental state cannot cooperate with the examination
* Patients with contraindications to the drugs used in the study.

Primary outcomes:
measure: Cleanliness of gastric mucosa
timeFrame: The time the patient underwent gastroscopy procedure
Secondary outcomes:
measure: Time to complete gastroscopy
timeFrame: The day of gastroscopy
measure: Patient comfort score
timeFrame: Records were made on the 1 day of the gastroscopy
measure: adverse reaction
timeFrame: Within 24 hours after endoscopy
measure: Endoscopic findings
timeFrame: About 15 days after endoscopy
Other outcomes:
Locations:
city: Xi'an
country: China
facility: The Second Affiliated Hospital of Xi 'an Jiaotong University
state: Shaanxi
Study officials:
References:
Clinical trial NCT04791696: Risk Factors for Human Corneal Graft Failure : a Monocentric Retrospective Observational Cohort
Official title: Risk Factors for Human Corneal Graft Failure : a Monocentric Retrospective Observational Cohort, Montpellier, South of France
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Corneal Transplant Rejection
Keywords: Cornea / surgery
Corneal Transplantation* / adverse effects
Corneal Transplantation* / methods
Graft Rejection / prevention & control
Humans
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2021-03-10
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All consecutives keratoplasty performed in the ophthalmology department of the CHRU (Centre Hospitalier Régional Universitaire) of Montpellier between 15/06/2005 and 18/09/2018, a period of just over 13 years.

Brief summary: Keratoplasty is one of the most common grafts and penetrating keratoplasty is still the technique most used in the world, ahead of lamellar grafts, and is estimated to represent 70% of the total.

Graft rejection is still the main cause of failure of this type of surgery, to the extent that nearly a third of all patients will in some way be affected by rejection in due course.

Numerous risk factors for rejection have been identified, whether related to the donor, the recipient, or the surgical procedure itself.

In addition, many of the studies performed have used univariate analysis only, and yet there is a strong case for multivariate analysis, given the wide range of factors that need to be examined.

This study seeks to analyze the rejection rates and the survival of penetrating keratoplasty for a group of patients from Montpellier Hospital (France).


Eligibility criteria: Inclusion criteria:

-keratoplasty performed in the ophthalmology department of the CHRU of Montpellier between 15/06/2005 and 18/09/2018

Exclusion criteria:

* a non-optical graft (tectonic and analgesic graft)
* lamellar graft (DALK (Deep Anterior Lamellar Keratoplasty) and DSAEK (Descemet Stripping Automated Endothelial Keratoplasty))
* Silica gel re-dried cornea, duplicates (we included each patient only once per eye)
* medical record missing from the archives.

Primary outcomes:
measure: graft rejection
timeFrame: 1 day
Secondary outcomes:
measure: irreversible graft rejection
timeFrame: 1 day
Other outcomes:
Locations:
city: Montpellier
country: France
facility: UH Montpellier
Study officials:
affiliation: University Hospitals of Montpellier
name: Vincent DAIEN, MD, PhD, HDR
role: PRINCIPAL_INVESTIGATOR
References:
citation: Debourdeau E, Builles N, Couderc G, Boulhic J, Chamard C, Villain M, Babeau F, Daien V. Risk factors of rejection after penetrating keratoplasty: a retrospective monocentric study. Graefes Arch Clin Exp Ophthalmol. 2022 Nov;260(11):3627-3638. doi: 10.1007/s00417-022-05691-w. Epub 2022 May 12.
Clinical trial NCT01419496: Study of Proteins in Promoting Chemotherapy Resistance in Samples From Patients With Acute Myeloid Leukemia
Official title: Identifying Stat3-Dependent Chemotherapy Resistance Pathways in Relapsed AML
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Leukemia
Keywords: recurrent adult acute myeloid leukemia
recurrent childhood acute myeloid leukemia
adult acute myeloid leukemia with 11q23 (MLL) abnormalities
adult acute myeloid leukemia with inv(16)(p13;q22)
adult acute myeloid leukemia with t(15;17)(q22;q12)
adult acute myeloid leukemia with t(16;16)(p13;q22)
adult acute myeloid leukemia with t(8;21)(q22;q22)
adult acute myeloid leukemia with del(5q)
Lead sponsor: Children's Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2011-08-18
Enrollment: 40
Sex: ALL
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with acute myeloid leukemia

Brief summary: RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about cancer and development of drug resistance in patients.

PURPOSE: This research trial is studying proteins that may promote chemotherapy resistance in samples from patients with acute myeloid leukemia.

Detailed description: OBJECTIVES:

* Investigate whether changes in prosurvival signaling occur by comparing activation of the signal transducer and activator of transcription-3 (Stat3) and Stat5 pathways in paired diagnostic and relapse samples.
* Investigate changes in leukemia cell responses to extrinsic cues from the environment change, using a bone marrow stromal-cell co-culture model of chemotherapy resistance.

OUTLINE: Cryopreserved samples are analyzed for Stat3 and Stat5 expression by flow cytometry and in vitro chemotherapy sensitivity.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Paired diagnostic and relapsed cryopreserved samples from patients with acute myeloid leukemia

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified

Primary outcomes:
measure: Changes in Stat3 and Stat5 in paired diagnostic and relapsed AML samples
measure: Reduction in chemotherapy sensitivity by relapsed samples compared to diagnostic samples
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Texas Children's Cancer Center
name: Michele S. Redell, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04449796: Predictive Value of Bio-impedance Vector Analysis on Long-term Outcome in ICU Patients
Official title: Predictive Value of Bio-impedance Vector Analysis on Long-term Outcome in ICU Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Long-term Outcome
Survival
Lead sponsor: Frisius Medisch Centrum
Sponsor class: OTHER
First posted: 2020-06-29
Enrollment: 1025
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: all patiens admitted to the ICU

Brief summary: Phase angle, derived from bioimpedance analysis (BIA), reflects tissue quality and quantity in which cell mass, membrane integrity and hydration state are represented. Phase angle, as a measure of body composition, changes with the physical condition of patients and is associated with survival in several disease states and during ICU admission. Aim of the study is to explore the predictive value of the phase angle for long term ICU outcome.

Detailed description: Phase angle, derived from bioimpedance analysis (BIA), reflects tissue quality and quantity in which cell mass, membrane integrity and hydration state are represented. Phase angle, as a measure of body composition, changes with the physical condition of patients and is associated with survival in several disease states and during ICU admission. Aim of the study is to explore the predictive value of the phase angle for long term ICU survival.

A single-centre prospective observational cohort will be performed with consecutive patients, elective and non elective, admitted to the ICU between 1st June 2018 and 1st June 2019. Demographic data, APACHE III, comorbidity and phase angle are collected and the ICU- , hospital- and 6 months survival will be registered.

Eligibility criteria: Inclusion Criteria:

* all patients admitted to the ICU, elective and acute.

Exclusion Criteria:

* age below 18
* Length of stay at ICU \< 6 hours
* All invalid bio-impedence analysis (BIA) measurements

Primary outcomes:
measure: 3 months survival
timeFrame: 3 months
measure: 6 months survival
timeFrame: 6 months
measure: 12 months survival
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Leeuwarden
country: Netherlands
facility: Medical Centre Leeuwarden - Intensive Care Unit
Study officials:
affiliation: Frisius Medisch Centrum
name: E.C. Boerma, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stellingwerf F, Beumeler LFE, Rijnhart-de Jong H, Boerma EC, Buter H. The predictive value of phase angle on long-term outcome after ICU admission. Clin Nutr. 2022 Jun;41(6):1256-1259. doi: 10.1016/j.clnu.2022.03.029. Epub 2022 Apr 6.