louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04419246: The Effect of Intravenous Tranexamic Acid and Interscalene Block Applied on Shoulder Arthroscopy
Official title: The Effect of Intravenous Tranexamic Acid and Interscalene Block Applied on Shoulder Arthroscopy on Total Blood Loss; a Prospective, Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Nerve Block
Tranexamic Acid
Lead sponsor: Bursa Yüksek İhtisas Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2020-06-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Nerve blocks are used for pain and surgery after many operations today. It has been demonstrated by studies that the amount of postoperative bleeding decreases. On the other hand, surgical teams can use additional medications, such as Tranexamic acid, which have been proven by different studies that have reduced bleeding during and after arthroscopic surgery.

Detailed description: The investigators aimed to investigate the effect of interscalene block application and tranexamic acid on bleeding in shoulder arthroscopy operation.

Eligibility criteria: Inclusion Criteria:

* Patients who were in the American Society of Anesthesiologists (ASA) I-III class
* underwent elective shoulder arthroscopy
* Patients with consent to participate in the study

Exclusion Criteria:

* history of arterial or venous thromboembolic disease
* Bleeding diathesis disorder
* Allergy to local anesthetics
* cardiac stent placement

Primary outcomes:
measure: serum hemoglobin exchange
timeFrame: preoperative, postoperative 1st and 2nd day
Secondary outcomes:
measure: postoperative bleeding amount
timeFrame: postoperative 24 hours
measure: Visual Analog Scale
timeFrame: Postoperative 24 hours
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06031246: Selective Lymph Node Dissection for cT1N0M0 Invasive NSCLC With CTR>0.5 Located in the Apical Segment (ECTOP-1018)
Official title: Selective Lymph Node Dissection for cT1N0M0 Invasive Non-small Cell Lung Cancer With CTR>0.5 Located in the Apical Segment: a Single-arm, Multi-center, Phase III Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Lung Adenocarcinoma
Lymph Node Metastasis
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2023-09-11
Enrollment: 634
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a clinical trial from Eastern Cooperative Thoracic Oncology Project (ECTOP), numbered as ECTOP-1018. The goal of this clinical trial is to confirm the theraputic effect of selective lymph node dissection for cT1N0M0 invasive non-small cell lung cancer with CTR\>0.5 located in the apical segment. The main questions it aims to answer are:

The 5-year overall survival of patients having cT1N0M0 invasive non-small cell lung cancer with CTR\>0.5 located in the apical segment; The post-operative lymph node metastasis and recurrence-free survival. Participants will receive selective lymph node dissection as the surgical procedure.


Eligibility criteria: Inclusion Criteria:

1. Patients who sign the informed consent form and are willing to complete the study according to the plan;
2. Aged from 18 to 80 years old;
3. ECOG equals 0 or 1;
4. Not receiving lung cancer surgery before;
5. Resectable peripheral cT1N0M0 tumors with CTR\>0.5 located in the apical segment;
6. Non-lepidic predominant invasive NSCLC dignosed by frozen section;
7. Not receiving chemotherapy or radiotherapy before.

Exclusion Criteria:

1. Not cT1N0M0;
2. Nodules not located in the apical segment or CTR≤0.5;
3. Pre-invasive lung adenocarcinoma, lepidic predominant adenocarcinoma, or not lung adenocarcinoma diagnosed cytologically or pathologically;
4. Receiving lung cancer surgery before;
5. Receiving radiotherapy or chemotherapy.

Primary outcomes:
measure: 5-year overall survival
timeFrame: 5 years
Secondary outcomes:
measure: Lymph node metastasis
timeFrame: 5 years
measure: 5-year recurrence-free survival
timeFrame: 5 years
measure: The accuracy of frozen section
timeFrame: 5 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Chaoqiang Deng
state: Please Select
Study officials:
affiliation: Fudan University
name: Haiquan Chen, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01231646: Does Valproate Increase Levels of Folate Receptor Autoantibodies in Women?
Official title: Does Valproate Increase Levels of Folate Receptor Autoantibodies in Women?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Epilepsy
Psychiatric or Mood Diseases or Conditions
Keywords: Folate Receptor Autoantibodies
Epilepsy
Psychiatric conditions
Lead sponsor: Northwell Health
Sponsor class: OTHER
Collaborators: name: Epilepsy Foundation
First posted: 2010-11-01
Enrollment: 38
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients in epilepsy and/or psychiatric clinics

Brief summary: Women who take folate (folic acid) before getting pregnant can lower the risk of giving birth to infant with certain birth defects. However, some medications may affect the action of folate. The purpose of this study is to compare the effect of two anti-epileptic drugs on how folate works in our body.


Eligibility criteria: Inclusion Criteria:

* Women ages 18-50 years inclusive who are taking valproate or lamotrigine for neurologic or psychiatric conditions
* Valproate of lamotrigine must be used as monotherapy at stable doses for 6 weeks prior to the study for the neurologic or psychiatric illness; medications taken for other reasons are not excluded.

Exclusion Criteria:

* Women with prior exposure to valproate or lamotrigine if they are taking lamotrigine or valproate respectively.

Primary outcomes:
measure: Levels of Folate Receptor Autoantibodies
timeFrame: On the same day after informed consent was obtained
Secondary outcomes:
Other outcomes:
Locations:
city: Great Neck
country: United States
facility: North Shore Long Island Jewish Health System
state: New York
Study officials:
affiliation: North Shore-Long Island Jewish Medical Center
name: Cynthia Harden, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01495546: Total Hip Arthroplasty (THA): Early Load Versus Load Late
Official title: Randomized Comparison of Quality of Life and Functional Patients Undergoing Total Hip Replacement Uncemented. Load Early X Load Late
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Primary Total Hip Arthroplasty
Keywords: total hip arthroplasty
THA
prosthesis type Lepine
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2011-12-20
Enrollment: 45
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: In Brazil, several hip surgeries performed, especially total knee arthroplasty, which represents 1.5 million procedures (Penedo, New, 2007). The rehabilitation of these individuals is slow with respect to the march because it requires an aid and not to use the operated leg as support for three weeks, according to conventional methods. After the third week, the support becomes part and after that period (sixth week), the support becomes total. Therefore, and in order to provide better quality of life, the goal of this work is to compare the march in 40 patients divided into two groups of 20 subjects each. In the control group, the treatment approach is the traditional, i.e., without immediate loading, while the other charge will be applied immediately in the operated limb. In order to verify the possible gain in the quality of life of these patients, the SF-36 will be applied. The march will be assessed with the Time Up and Go test and the force platform and the Harris Hip score analyze the function of the hip. Individuals will receive such care at the Institute of Orthopedics and Traumatology, Hospital das Clinicas, Faculty of Medicine, University of São Paulo (IOT - HC - USP). The results of comparisons between the two groups and the clinical findings obtained will be subjected to appropriate statistical tests, guided by the principles of evidence-based clinical practice, seeking to facilitate and improve the lives of these individuals so they can move freely.


Eligibility criteria: Inclusion Criteria:

* Patients served by the institution with THA without cement;
* BMI less than 40, ie, present in most class II obesity;
* Patients with diseases such as osteoarthritis and osteonecrosis of the femoral head;
* Absence of systemic involvement;
* Patients with prosthetic type Lépine.

Exclusion Criteria:

* Bilateral arthroplasty;
* Partial arthroplasty;
* Arthroplasties for review;
* Cemented arthroplasties;
* Surgical complications.

Primary outcomes:
measure: Recovery time after THA
timeFrame: Until 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Institute of Orthopedics and Traumatology, Hospital das Clinicas, Faculty of Medicine, University of Sao Paulo
Study officials:
References:
Clinical trial NCT02851446: Prevalence and Risk Factors of Reventilation Syndrome in a Population of Patients Under Ventilation for Whatever Reason
Official title: Prevalence and Risk Factors of Dreentilation Syndrome in a Population of Patients Under Ventilation for Whatever Reason
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Prevalence of and Factors Associated With Reventilation Syndrome (DS)
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2016-08-01
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: population of patients with ventilation whatever the reason, in a stable state, and followed by the medical devices department of Dijon CHU

Brief summary: Non-invasive nocturnal ventilation is an effective treatment for chronic respiratory failure, whether due to obstructive (COPD), restrictive or neuromuscular causes, notably for patients in the last two categories for whom it significantly prolongs life expectancy. Overall, the treatment is well tolerated, its principal adverse effects being discomfort related to the mask.

In certain patients, morning dyspnoea when the mask is removed has been described. This is disabling as it limits everyday activities for at least 30 minutes, and defines deventilation syndrome. The pathophysiology of this syndrome is uncertain, notably the roles of hyperinflation, patient/ventilator asynchrony, or the sudden increase in diaphragmatic work after a night of rest.

The aim of this study is to investigate the prevalence of and factors associated with reventilation syndrome (DS) in a population of patients with ventilation whatever the reason, in a stable state, and followed by the medical devices department of Dijon CHU, so as to better understand the mechanisms. Patients with DS will subsequently be invited to participate in a therapeutic trial.


Eligibility criteria: Inclusion Criteria:

* patients over 18 years old
* ventilation for whatever reason
* in the ST mode
* not in life support
* at more than 1 month after the last episode of respiratory decompensation

Exclusion Criteria:

* guardianship
* inability to understand instructions and provide consent
* uncontrolled psychiatric disease

Primary outcomes:
measure: presence of diagnostic criteria for reventilation Syndrome (dyspnoea > Borg 7)
timeFrame: at withdrawal of the machine, disabling for everyday activities for at least 30 minutes after stopping the ventilation
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: CHU Dijon Bourgogne
Study officials:
References:
Clinical trial NCT03332446: Influence of Cooling on the Effect of Strength Training
Official title: Influence of Cooling on the Effect of Strength Training
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Strength Training Effects
Keywords: cold water immersion, strength training, training effect
Lead sponsor: Universität des Saarlandes
Sponsor class: OTHER
First posted: 2017-11-06
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The aim of this study is to investigate if regular cold water immersion after strength training has a negative influence on the desired training-induced performance enhancement.

Detailed description: Recovery strategies represent a not sufficiently investigated chance in elite training control to optimize the complete training process. Coaches and athletes are confronted with numerous potentially effective recovery methods, e.g. cooling, warming, active recovery, compression, massage or power naps. However, the effectivity of these methods has rarely been investigated under controlled scientific conditions. Based on the state of the art,so far hardly any definite practical conclusions regarding effective recovery methods can be drawn, especially regarding sport-specific strategies and settings. Currently, cold water immersion is a particularly popular recovery strategy. However, there are hints that repeated cooling interventions after training can impair the training effect. This could potentially be caused by a faster reconstitution of homeostasis due to cooling. For fast recovery of performance, this effect would be desirable, but at the same time these homeostatic disturbances are the basis of signal processes leading to training adaptations.

The aim of this study is to investigate if regular cold water immersion after strength training has a negative influence on the desired training-induced performance enhancement.

Eligibility criteria: Inclusion Criteria:

* healthy, 18-40 years, strength training experience, 8 weeks no leg strength training

Exclusion Criteria:

-

Primary outcomes:
measure: 1 Repetition Maximum
timeFrame: 8 weeks
Secondary outcomes:
measure: Counter Movement Jump
timeFrame: 8 weeks
measure: blood parameters
timeFrame: 8 weeks
measure: muscle biopsy
timeFrame: 8 weeks
measure: muscle thickness
timeFrame: 8 weeks
measure: subjective restfulness of sleep
timeFrame: 2 weeks
measure: time in bed
timeFrame: 2 weeks
measure: sleeping time
timeFrame: 2 weeks
measure: questionnaire on recovery and stress
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Saarbrücken
country: Germany
facility: Saarland University
state: Saarland
Study officials:
affiliation: Universität des Saarlandes
name: Tim Meyer, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02659046: Prehospital Severe Traumatic Brain Injury
Official title: The Effect of Different Emergency Medical Systems on the Prognosis of Traumatic Brain Injury
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Traumatic Brain Injury
Keywords: Traumatic Brain Injury
Lead sponsor: Tampere University Hospital
Sponsor class: OTHER
First posted: 2016-01-20
Enrollment: 266
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: primary care clinic

Brief summary: The aim of the study is to measure the effect of Finnish physician-staffed EMS unit treatment methods on traumatic brain injury (TBI) patient prognosis.

In the second part of the study the gathered data will be combined with the data from an earlier study (NCT01454648) for regression analysis. The aim of the second study is to identify prehospital factors influencing the prognosis of prehospital TBI patients.

Detailed description: A secondary aim is to identify out-of-hospital treatment factors that can be influenced by education and protocols.

Eligibility criteria: Inclusion Criteria:

* TBI with GCS ≤ 8 or unconsciousness verified by an on-call neurosurgeon during admission to the hospital

Exclusion Criteria:

* Multiple trauma

Primary outcomes:
measure: Mortality
timeFrame: 1 year
Secondary outcomes:
measure: Glasgow outcome score
timeFrame: 1 year
Other outcomes:
Locations:
city: Tampere
country: Finland
facility: Tampere University Hospital
Study officials:
affiliation: Tampere University Hospital
name: Arvi Yli-Hankala, Professor
role: STUDY_DIRECTOR
References:
citation: Pakkanen T, Kamarainen A, Huhtala H, Silfvast T, Nurmi J, Virkkunen I, Yli-Hankala A. Physician-staffed helicopter emergency medical service has a beneficial impact on the incidence of prehospital hypoxia and secured airways on patients with severe traumatic brain injury. Scand J Trauma Resusc Emerg Med. 2017 Sep 15;25(1):94. doi: 10.1186/s13049-017-0438-1.
Clinical trial NCT04196946: Use of Intrathecal Analgesia in Appendectomy
Official title: Comparison of Bupivacaine-Fentanyl and Bupivacaine-Alfentanil Used Intrathecally in Laparoscopic Appendectomy Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia
Analgesia
Keywords: intrathecally fentanyl
alfentanil
visual pain scale
analgesia
Lead sponsor: Nigde Omer Halisdemir University
Sponsor class: OTHER
First posted: 2019-12-12
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Acute appendicitis which is the most common cause of acute abdominal pain, is an acute inflammation of appendix vermiformis. Appendectomy operations can be performed as laparoscopic and open surgery. Addition of opioids to intrathecal local anesthetics to improve the quality of preoperative analgesia is an increasingly used method in recent years. The aim of this study is to compare bupivacaine-fentanyl and bupivacaine-alfentanil which are used intrathecally to create motor and sensory block. 50 volunteer patients who were diagnosed as appendicitis by laboratory tests and clinical diagnostic methods in general surgery clinic and classified as American Society of Anesthesiologists Classification I-II (ASA Class I-II) aged between 20-60 years scheduled for laparoscopic appendectomy operation, were included in this study. The patients were randomly assigned into two groups, Group I and Group II. Patients received spinal anesthesia with either 10 mg heavy bupivacaine (2 cc)+25 mcg fentanyl (0.5 cc) intrathecally (Group I, n=25) or 10 mg heavy bupivacaine (2 cc)+250 mcg alfentanil (0.5 cc) intrathecally (Group II, n=25).


Eligibility criteria: Inclusion Criteria:

* Individuals who will undergo laparoscopic appendectomy operation and volunteer to participate in the study were included.

Exclusion Criteria:

* Individuals who meet the criteria but are not volunteers
* Previously underwent appendectomy

Primary outcomes:
measure: Patients diagnosis with appendicitis
timeFrame: With the completion of laparoscopic appendectomy operation, average 30 minutes to 1 hour
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Nigde Omer Halisdemir University
name: Mehtap Balcı, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02635646: Interdisciplinary and Family Intervention to Prevent Type 2 Diabetes
Official title: Efficacy of a Family and Interdisciplinary Intervention to Prevent Diabetes, and Effect on Family Profiles of Insulin Secretion and Insulin Resistance in Patients With Prediabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prediabetes
Lead sponsor: Universidad de Guanajuato
Sponsor class: OTHER
Collaborators: name: University of Texas
name: National Council of Science and Technology, Mexico
First posted: 2015-12-21
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of the study is to evaluate the effect of a family and interdisciplinary approach on individual and family insulin resistance and insulin secretion in patients with prediabetes.

Detailed description: This a randomized clinical trial designed to evaluate the efficacy of the following treatments:

1. Family and interdisciplinary approach that includes nutritional, physical activity and psychological counseling + metformin 850mg twice at day for 12 months
2. Individual approach that includes nutritional and physical activity counseling + metformin 850mg twice at day for 12 months

To improve individual and family insulin resistance and insulin secretion in patients with prediabetes.

Patients will have a follow-up visit every month in the Metabolic Research Laboratory at the University of Guanajuato, Mexico, and will have a fasting measurement of lipids, glucose and insulin every 3 months, as well as 2h oral glucose tolerance test (OGTT) at basal, 6 and 12 months.

Eligibility criteria: Inclusion Criteria:

* Patients with prediabetes (Fasting glucose 100-125mg/dl and/or 2h post OGTT glucose 140-199mg/dl)
* Family of patients with prediabetes (in case of the patients that are randomized to FAMILY APPROACH)
* Signing of the inform consent

Exclusion Criteria:

* Type 2 diabetes
* Pregnancy
* Liver disease
* Renal disease

Primary outcomes:
measure: Individual Insulin Resistance and Insulin Secretion
timeFrame: 6 months
measure: Individual Insulin Resistance and Insulin Secretion
timeFrame: 12 months
Secondary outcomes:
measure: Family Insulin Resistance and Insulin Secretion (Matsuda Index Measured in the Relatives of the Patients)
timeFrame: 12 months
measure: Weight
timeFrame: 12 months
measure: 2h OGTT Glucose
timeFrame: 6 and 12 months
Other outcomes:
Locations:
city: León
country: Mexico
facility: Universidad de Guanajuato
state: Guanajuato
Study officials:
affiliation: Universidad de Guanajuato
name: Rodolfo Guardado, Dr
role: PRINCIPAL_INVESTIGATOR
References: