louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00213616: Bilateral Laryngeal Paralysis Reinnervation
Official title: Bilateral Laryngeal Paralysis Reinnervation. Speech and Ventilatory Results Analysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vocal Cord Paralysis
Keywords: bilateral vocal cord paralysis
reinnervation
phrenic nerve
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2005-09-21
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Bilateral laryngeal reinnervation induces a rise in laryngeal resistance and speech alteration. The aim of this study is to propose laryngeal reinnervation by a phrenic nerve root to patients with bilateral laryngeal paralysis.


Eligibility criteria: Inclusion Criteria:

* Bilateral laryngeal paralysis without any amelioration for six months

Exclusion Criteria:

* Laryngeal paralysis more than 3 years
* Arycricoideus ankylostosis
* Pacemaker
* Pregnancy

Primary outcomes:
measure: LARYNGEAL REINNERVATION
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rouen
country: France
facility: Rouen University Hospital
Study officials:
affiliation: University Hospital, Rouen
name: Jean Paul Marie, MD, PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00484016: Drug Delivery and Toxicities of Adjuvant Chemotherapy in Resected NCSLC
Official title: Drug Delivery and Toxicities of Adjuvant Chemotherapy in Resected Non Small Cell Lung Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Adjuvant
Chemotherapy
Lung
Cancers
Keywords: adjuvant
chemotherapy
observation
resected
cancers
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2007-06-08
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 88
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE

Brief summary: There are limited numbers of retrospective studies showing the effectiveness of adjuvant chemotherapy over observation in resected lung cancers.

Detailed description: We propose to retrospectively examine the Washington University School of Medicine experience on all patients receiving adjuvant chemotherapy between 2003 and 2005. We will retrospectively analyze the survival and outcomes in the lung cancer patients receiving adjuvant chemotherapy following surgical resection.

Eligibility criteria: Inclusion Criteria:

* Patients that received adjuvant chemotherapy
* 18-88 years

Exclusion Criteria:

* Any patients that have not received adjuvant chemotherapy
* Patients under 18 or over 88

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Washington University School of Medicine
name: Ramaswamy Govindan, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Arriagada R, Bergman B, Dunant A, Le Chevalier T, Pignon JP, Vansteenkiste J; International Adjuvant Lung Cancer Trial Collaborative Group. Cisplatin-based adjuvant chemotherapy in patients with completely resected non-small-cell lung cancer. N Engl J Med. 2004 Jan 22;350(4):351-60. doi: 10.1056/NEJMoa031644.
Clinical trial NCT01555216: Continuous Tibial Nerve Block Versus Single Shot Tibial Nerve Block
Official title: A Randomized Comparison of a Continuous Posterior Tibial Nerve Block and Single Injection Posterior Tibial Nerve Block in Patients Undergoing Forefoot Surgery
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Hallux Valgus
Keywords: Forefoot surgery
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2012-03-15
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Foot surgery often causes severe and prolonged pain postoperatively. Prior methods of postoperative pain control included oral narcotics, single injection regional techniques and more recently continuous nerve catheters. Recent studies have demonstrated a benefit with continuous popliteal catheters when compared to single injection techniques in regards to postoperative pain control and patient satisfaction for foot surgeries.

Nerve blocks in the popliteal fossa involve both the common peroneal nerve and the tibial nerve. The innervation to the plantar surface of the forefoot involves the tibial nerve and does not involve the peroneal nerve. The purpose of this study is to compare the continuous posterior tibial nerve catheter with a single injection posterior tibial nerve block when used as part of a surgical ankle block for forefoot surgery.


Eligibility criteria: Inclusion Criteria:

* Adult patients (18 to 65 years old) undergoing elective scheduled forefoot surgery (hallux valgus repair and metatarsal osteotomy).

Exclusion Criteria:

* Patient refusal to be included
* Presence of language barrier that prohibits proper communication with patient
* Under age of 18,
* Pregnancy
* History of allergy to local anesthetics or opioids
* Presence of a progressive neurological deficit
* Chronic opioid or drug abuse
* Diabetes
* Active infection in leg
* Unstable cardiovascular, renal or hepatic disease,
* Unwillingness to comply with follow up.

Primary outcomes:
measure: Quality of recovery
timeFrame: Up to five days
Secondary outcomes:
measure: Pain control (pain score)
timeFrame: Up to 1 week
measure: Opioid consumption
timeFrame: Up to 1 week
measure: patient satisfaction
timeFrame: Up to 1 week
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
Study officials:
affiliation: Northwestern Memorial Hospital
name: Antoun Nader, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04879316: Energy for Lymphocytes
Official title: Analysis of Nutritional Biomarkers to Predict the Efficacy of Immunotherapy by Anti-PD/PDL1 Checkpoints Inhibitors in Metastatic Non-small Cell Lung Cancer Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-small Cell Lung Cancer
Progression, Disease
Keywords: cachexia
immunotherapy
carcinoma
Non-small cell lung cancer
Basal metabolism
Energy expenditure
inflammation
6-month Progression free survival
Lead sponsor: Hôpital Cochin
Sponsor class: OTHER
Collaborators: name: Assistance Publique - Hôpitaux de Paris
First posted: 2021-05-10
Enrollment: 144
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: Adult patients with NSCLC initiating nivolumab or pembrolizumab in real-life conditions

Brief summary: CERTIM is a cohort created in July 2015 to set up a multidisciplinary follow-up of cancer patients treated with immune checkpoint inhibitors.

From the CERTIM cohort, we conducted a longitudinal, prospective, observational study (ELY) in two tertiary university centers (Cochin hospital and European Georges Pompidou Hospital), which included patients between August 2016 and October 2019 and ended follow-up in April 2020.

Patients were treated with nivolumab, at a dose of 3 mg/kg every 2 weeks, or pembrolizumab, at a dose of 2mg/kg every 3 weeks. The investigators report findings from an evaluation of rest energy expenditure (REE) assessed using indirect calorimetry in the outpatient setting before treatment with checkpoints inhibitors.


Eligibility criteria: Inclusion Criteria:

* 18 years or older
* Stage IV histologically proven Non Small Cell Lung Cancer (NSCLC)
* Monotherapy with nivolumab or pembrolizumab.
* Patients were required to have measurable disease per the Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1.

Exclusion Criteria:

* Active malignancy other than NSCLC,
* ALK or EGFR mutated NSCLC
* Anticancer therapy or surgery within the past 2 weeks or inability to breathe under the calorimetry.

Primary outcomes:
measure: 6-month Progression-free survival
timeFrame: 6 months after start of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Cochin Hospital
Study officials:
References:
Clinical trial NCT03215316: Screening Expiratory Flow Limitation by Flow-time Curve
Official title: Screening Expiratory Flow Limitation by Flow-time Curve
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: ARDS, Human
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
First posted: 2017-07-12
Enrollment: 45
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: PROBABILITY_SAMPLE
Study population: Intubated patients in the intensive care unit (ICU) receiving mechanical ventilation.

Brief summary: Expiratory flow limitation (EFL) is defined as a dynamic condition that expiratory flow cannot be further increased with higher expiratory driving pressure. Under mechanical ventilation, it can cause intrinsic positive end-expiratory pressure (PEEP) and dynamic hyperinflation, and be associated with worse clinical outcome. The detection of EFL however needs special maneuvers and offline analysis of flow-volume curves, which are infeasible in routine practice and cannot be used during real-time monitoring. The investigators propose a new and simple approach using flow derived parameters to detect EFL in real time without needing any intervention.


Eligibility criteria: Inclusion Criteria:

1. Age ≥18 years, intubated or tracheostomized
2. Receiving invasive mechanical ventilation in assist/control mode with PEEP ≥ 5 cmH2O
3. Receiving continuous intravenous sedation
4. Displaying a monotonous regular breathing pattern with no obvious asynchrony

Exclusion Criteria:

1. Severe hypoxemia in baseline clinical ventilator settings (SpO2 \< 90%)
2. Hemodynamic instability (mABP \<60 mmHg, systolic arterial pressure \>180 mmHg, heart rate \<40/min or \>150/min)

Primary outcomes:
measure: Outcome (Presence / absence of EFL) will be determined by off-line analysis of recorded flow-volume loops during PEEP reduction.
timeFrame: 2 years
Secondary outcomes:
measure: Percentage of intrinsic PEEP caused by the EFL.
timeFrame: 2 years
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
Study officials:
References:
Clinical trial NCT01171716: The Body's Response to Changes in Dietary Protein and Meal-Frequency In Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Protein Dietary Intake
High Protein Dietary Intake
Keywords: overweight, protein intake, satiety, eating, meal patterns
Lead sponsor: Purdue University
Sponsor class: OTHER
First posted: 2010-07-28
Enrollment: 13
Sex: MALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: the purpose of this study is to identify how the body responds to increased dietary protein (that includes pork and eggs) and meal-frequency in adult men. During this study, the changes in blood glucose, hormones, appetite, and energy expenditure will be examined.


Eligibility criteria: Inclusion Criteria:

* 21 and older, BMI between 25.0-34.6, Weight Stable for at least 6 mths, body \>25%, non smoking, clinically normal blood profiles, non-diabetic.

Exclusion Criteria:

* intermittently been involved in a diet and/or exercise program within the last 3 months, Have no allergies to eggs.

Primary outcomes:
measure: The Body's Response to Changes in Dietary Protein and Meal-Frequency In Men
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: West Lafayette
country: United States
facility: Purdue University, Dept of Foods and Nutrition
state: Indiana
Study officials:
References:
Clinical trial NCT04437316: Effect of Low Level Laser Therapy After Wisdom Tooth Removal
Official title: Effect of Low Level Laser Therapy After Wisdom Tooth Removal on Swelling, Pain and Mouth Opening in a Randomized, Double-blind Split-mouth Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tooth, Impacted
Wound Heal
Quality of Life
Keywords: Wisdom tooth
Low Level Laser
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2020-06-18
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: split-mouth design
Primary purpose: TREATMENT

Brief summary: The aim is to test the effect of low level laser therapy on the relief of symptoms after wisdom tooth removal.

Detailed description: Each Patient will get all four wisdom teeth removed, left and right side separately. After the operation, low level laser therapy is applied intra- and extraorally. Two different lasers are used, one for each side. The two lasers look identical. Only one of the lasers has therapeutic light, the other one shows just non-therapeutic red light. The effect of the low level laser is measured by several parameters and they are compared with the other side. These parameters are pain, swelling and mouth opening. The selection of the lasers to the sides is double-blind and randomized.

Eligibility criteria: Inclusion Criteria:

* Indication for prophylactical wisdom tooth removal
* 4 wisdom teeth

Exclusion Criteria:

* pregnancy
* taking blood thinners
* known infectious diseases
* untreated diabetes mellitus
* taking immunosuppressants
* Previous infections in the area of the wisdom teeth
* smoking

Primary outcomes:
measure: Postoperative Pain
timeFrame: 3 days after wisdom tooth removal
Secondary outcomes:
measure: Postoperative Pain
timeFrame: 7 days after wisdom tooth removal
measure: Postoperative Swelling
timeFrame: 3 and 7 days after wisdom tooth removal
measure: Postoperative Mouth opening
timeFrame: 3 and 7 days after wisdom tooth removal
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: Center of dental medicine
Study officials:
affiliation: Clinic for maxillofacial and oral surgery
name: Martin Ruecker, Prof.
role: STUDY_DIRECTOR
References:
Clinical trial NCT02125916: Evaluating the Effect of Oxygentherapy on Concentration at Chronic Lung Patients
Official title: Evaluating the Effect of Oxygentherapy on Concentration at Chronic Lung Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Diseases, Interstitial
Pulmonary Disease, Chronic Obstructive
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2014-04-29
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The objective is to study the cognitive functions in patients with chronic obstructive lung disease (COLD) and patients with interstitial lung disease (ILD) compared to healthy controls. The cognitive functions are tested with and without oxygen therapy to clarify the effect of oxygen therapy. Driving simulations is used to test the cognitive functions.

The hypothesis is that patients with chronic lung disease have decreased cognitive functions and that oxygen therapy will increase their cognitive functions.


Eligibility criteria: Inclusion Criteria:

* COLD with forced expiratory volume at one second (FEV1) \<50%, without long term oxygen therapy
* COLD with FEV1 \<50%, with long term oxygen therapy
* ILD with diffusion capacity of lung for carbon monoxide (DLCO) \< 50%, without long term oxygen therapy

Exclusion Criteria:

* comorbidity which decreases cognitive function
* comorbidity which decreases concentration
* physical comorbidity which makes it impossible to complete the test

Primary outcomes:
measure: Standard deviation from the centre of the road
timeFrame: During the 45 min. of driving in the simulator
measure: Number of nil responses
timeFrame: During the 45 min. of driving in the simulator
measure: Response time
timeFrame: During the 45 min. of driving in the simulator
measure: Number of off-road events per hour
timeFrame: During the 45 min. of driving in the simulator
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Department of pulmonology and allergology, Aarhus University Hospital, NBG
Study officials:
affiliation: Department of pulmonology and allergology, Aarhus University Hospital, NBG
name: Thomas Skovhus Prior, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of pulmonology and allergology, Aarhus University Hospital, NBG
name: Ole Hilberg, Dr.med, MD
role: STUDY_CHAIR
References:
citation: Skovhus Prior T, Troelsen T, Hilberg O. Driving performance in patients with chronic obstructive lung disease, interstitial lung disease and healthy controls: a crossover intervention study. BMJ Open Respir Res. 2015 Dec 17;2(1):e000092. doi: 10.1136/bmjresp-2015-000092. eCollection 2015.
Clinical trial NCT01318616: The Effect of Strength Training on the Hip Adduction Strength Measured With Hand-held Dynamometry
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hip Adduction Strength
Keywords: hip adduction strength training
Improvement in adductor strength
Lead sponsor: Amager Hospital
Sponsor class: OTHER
First posted: 2011-03-18
Enrollment: 34
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to investigate the effect of strength training with elastic bands on hip strength in soccer players, the effect measured with hand-held dynamometry. The primary outcomes are isometric and eccentric hip adduction strength. The hypothesis is that strength training with elastic bands will result in a clinical relevant increase in hip adduction strength.


Eligibility criteria: Inclusion Criteria:

* Sub-elite danish soccer players

Exclusion Criteria:

* Injury in the lower back or legs with a duration of more than 6 weeks within the last year before the study was initiated.
* Systematic strength training of the hip adductors more than once a week within the last 6 months before the study was initiated.
* Groin pain during soccer play with a duration of more than 1 week and witch resulted in loss of soccer training/game within the last 3 months before the study was initiated.
* Groin injuries within the last month before the study was initiated.

Primary outcomes:
measure: Isometric hip adduction strength
timeFrame: 8 weeks
measure: Eccentric hip adduction strength
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Amager Hospital
Study officials:
References:
Clinical trial NCT04979416: Video Messages and Vaccination Intention
Official title: The Impact of Video Messaging on Vaccination Intention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19 Vaccination
Lead sponsor: University of Southern California
Sponsor class: OTHER
First posted: 2021-07-28
Enrollment: 1001
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study uses an online panel survey to test the impact of video messages on stated likelihood of COVID-19 vaccination. Participants, who have self-identified as unvaccinated against COVID-19, are randomly assigned to either no video message or 1 of 3 video messages to encourage vaccine take-up. The key endpoint is a question about the likelihood of getting vaccinated in the next 30 days.

Detailed description: This study uses an online panel survey to test the impact of video messages on stated likelihood of COVID-19 vaccination. Participants are recruited from the Prolific.co platform. Those who have indicated to Prolific that they have not been vaccinated will be randomly assigned to either no video message or 1 of 3 video messages created by the Vaccinate LA/USC collaborative. The key endpoint is a question about the likelihood of getting vaccinated in the next 30 days.

Eligibility criteria: Inclusion Criteria:

* adults in the Prolific.co panel
* unvaccinated against COVID-19

Exclusion Criteria:

* indicated to Prolific.co that they have received a COVID-19 vaccination

Primary outcomes:
measure: Vaccination intention
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: USC
state: California
Study officials:
References:
Clinical trial NCT00770016: Insulin Sensitivity and Metabolism Before and After Treatment in Patients With Hypothyroidism
Official title: Insulin Sensitivity and Metabolism Before and After Treatment in Patients With Hypothyroidism
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Hypothyroidism
Keywords: insulin sensitivity
Substrate metabolism
Fatty liver
intramyocellular lipid
intracellular signaling
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: MR Research Center, Skejby Sygehus, Brendstrupgaardsvej 100, 8200 Aarhus N
First posted: 2008-10-09
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of this study is to further characterize the treatment related changes in insulin sensitivity, substrate metabolism and intra hepatic- and intramyocellular lipid content in patients with hypothyroidism


Eligibility criteria: Inclusion Criteria:

* written informed consent
* must be of legal age and competent
* Age \> 18 years
* presently diagnosed with hypothyroidism

Exclusion Criteria:

* alcohol consumption \>21 units per week
* Malignant disease
* pregnancy
* magnetic implants or material in the body
* BMI \> 30
* Heart disease (NYHA \>2)
* Uncontrolled hypertension
* Manifest diabetes mellitus
* Changes in medication, with any influence on glucose metabolism, 2 months prior to and until the end of the trial.

Primary outcomes:
measure: intracellular lipid content in liver and muscle
timeFrame: before and after 3 months treatment with growth hormone
measure: intraabdominal lipid content
timeFrame: before and after treatment
measure: insulin sensitivity
timeFrame: before and after treatment
measure: substrate metabolism
timeFrame: before and after treatment
measure: intracellular signaling in the basal state and during insulin stimulation
timeFrame: before and after treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Medical department M (Endocrinology and Diabetes), Aarhus University Hospital, Aarhus Sygehus,
Study officials:
References: