louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02502955: Virtual Autopsy in Cardiology, Cardio- and Vascular-Surgery
Official title: Virtual Autopsy in Cardiology, Cardio- and Vascular-Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Death
Keywords: Quality Control
Cardiosurgery
Cardiology
Vascular Surgery
ICU
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
Collaborators: name: University Hospital, Basel, Switzerland
name: Insel Gruppe AG, University Hospital Bern
First posted: 2015-07-20
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients dying after a cardiological intervention or a cardio-/vascular surgery.

Brief summary: Today complex vascular and cardiological interventions are performed in severely ill patients.

Autopsy is the reference standard for quality control for almost two centuries, but autopsy rates for patients dying in hospitals are decreasing rapidly.

Virtual autopsy has shown to be a good alternative for classic autopsy.

Detailed description: Patients dying within 96h after a cardiological intervention of a cardio-/vascular-surgery are eligible to be included in the study.

If the next of kin give oral informed consent a virtual autopsy based on a CT angiography followed by a classic medical autopsy will be performed.

Ante mortem findings will be compared to findings from both autopsy methods and presented to the clinicians.

Primary outcome will be the inter-method agreement. Secondary outcome will be the satisfaction of the clinicians evaluated by a standardized questionnaire.

Eligibility criteria: Inclusion Criteria:

* 18 years or older AND
* dying after a cardiological intervention or a cardio-/vascular surgery AND
* oral informed consent from next of kind

Exclusion Criteria:

* not fulfilling all inclusion criteria

Primary outcomes:
measure: Agreement of virtual autopsy and medical autopsy (inter-method agreement)
timeFrame: 1 week
Secondary outcomes:
measure: Quality evaluation (satisfaction of the clinicians evaluated by a standardized questionnaire)
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: Department of Intensive Care Medicine, University Medical Center Hamburg-Eppendorf (UKE)
Study officials:
affiliation: Department of Intensive Care Medicine, University Medical Center Hamburg
name: Dominic Wichmann, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03163355: Comparison of Pureed Rice Using a Gelling Agent and Standard Pureed Rice
Official title: Comparison of Pureed Rice Using a Gelling Agent and Standard Pureed Rice in Swallowing in Elderly Patients With Dysphagia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Swallowing Disorder
Keywords: pureed diet
dysphasia
Lead sponsor: Showa Inan General Hospital
Sponsor class: OTHER
First posted: 2017-05-23
Enrollment: 50
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: The texture of the pureed diet is likely to be most useful factor predictive of the prevention of aspiration pneumonia. However, it has not been previously reported what kinds of texture of the pureed diet can prevent aspiration pneumonia. Using endoscopic swallowing evaluation, we attempt to compare two kinds of the pureed diets to choose the better texture of pureed diets in elderly patients with severe dysphagia.

Detailed description: The degree of dysphagia is evaluated using Hyodo.Komagane score (0-12). Subsequently, a randomized, crossover trial using pureed rice containing a gelling agent (Softia U, Nutri Co., Ltd., Yokkaichi, Japan), or standard pureed rice is performed in patients with dysphagia.

The extent of pharyngeal clearance after swallowing of each pureed rice and test jelly (Isotonic green jelly®, Nutri Co., Ltd., Yokkaichi, Japan) is scored as follows:

1. No remains
2. Pharyngeal clearance is obtained after swallowing of test jelly once
3. Pharyngeal clearance is obtained after swallowing of test jelly twice
4. Pharyngeal clearance is obtained after swallowing of test jelly three times and more
5. In spite of swallowing of test jelly, pharyngeal residues remain and/or penetrate into larynx.

Evaluation Primary outcome: The pharyngeal clearance score (1-5) Secondary outcome: Patient feeling regarding pharyngeal clearance after the swallowing of pureed rice and/or test jelly (0 remains -100% complete clearance)

Eligibility criteria: Inclusion Criteria:

* hospitalized patients who underwent endoscopic swallowing evaluation at Showa Inan General Hospital

Exclusion Criteria:

* an age less than 65 years old or the presence of an acute infection.

Primary outcomes:
measure: The pharyngeal clearance score (1-5)
timeFrame: 24 months
Secondary outcomes:
measure: Patient feeling regarding pharyngeal clearance
timeFrame: 24 months
Other outcomes:
Locations:
city: Komagane
country: Japan
facility: Showa Inan General hospital
state: Nagano
Study officials:
affiliation: Showa Inan General Hospital
name: Akira Horiuchi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02408055: ADME Study in Healthy Male Subjects With TA-8995
Official title: A Phase I Study to Assess the Mass Balance Recovery, Pharmacokinetics, Metabolism and Excretion of 14C-TA-8995 in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Dyslipidemia
Lead sponsor: Xention Ltd
Sponsor class: INDUSTRY
First posted: 2015-04-03
Enrollment: 6
Sex: MALE
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A study to measure the absorption, metabolism and excretion of a single dose of radiolabelled TA-8995 (10mg) in healthy male subjects.


Eligibility criteria: Inclusion Criteria:

* Healthy male subjects

Exclusion Criteria:

* Clinically significant abnormalities

Primary outcomes:
measure: AUC of TA-8995
timeFrame: 35 days
measure: Mass balance recovery of total radioactivity from excreta for radiolabelled TA-8995
timeFrame: 35 days
measure: Measure the amount of radiolabelled TA-8995 recovered from urine and faeces.
timeFrame: 35 days
measure: Measure the levels of major metabolites of TA-8995 in plasma, urine and faeces after oral administration of radiolabelled TA-8995
timeFrame: 35 days
measure: Elimination of half-life of radiolabelled TA-8995
timeFrame: 35 days
Secondary outcomes:
measure: Number of adverse events
timeFrame: 35 days
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: Covance Clinical Research Unit Ltd
Study officials:
affiliation: Covance
name: Ashley Brooks
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01904955: Should Colorectal Cancer Patients be Followed After Five Years? Study of Recurrence in a Population Cohort
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2013-07-22
Enrollment: 598
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with adenocarcinoma of the colon or rectum

Brief summary: The results of this study will make it possible, thanks to better understanding of the natural history of colorectal cancer, to define new treatment and surveillance strategies for colorectal cancers resected with curative intent, so as to improve management and thus improve patient survival.

These data will also make it possible to calculate the prevalence of patients who require treatment or surveillance because of their disease.


Eligibility criteria: Inclusion Criteria:

* with adenocarcinoma of the colon or rectum (ICD-O: C18, C19 and C20)
* residing in the département of Côte-d'Or (501,000 inhabitants according to the 1999 census) or Calvados (511, 012 inhabitants) at the moment of diagnosis
* recorded by either Registry between January 1985 and December 2000
* treated by resection with a curative intent.

Exclusion Criteria:

Will be excluded other morphologic tumours and initially metastatic colorectal cancers, anal cancers.

Primary outcomes:
measure: data concerning evolving relapse
timeFrame: during the 10 years following resection for colorectal cancer with curative intent
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: CHU de Dijon
Study officials:
affiliation: CHU Dijon Gastroentérologie
name: FAIVRE Jean
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05247255: Quadratus Lumborum Block for Total Hip Arthroplasty
Official title: Quadratus Lumborum (QL) Nerve Block for Patients Undergoing Primary Total Hip Arthroplasty (THA)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Pain, Postoperative
Keywords: quadratus lumborum nerve block, analgesia, total hip arthroplasty, postoperative outcomes
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2022-02-18
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The quadratus lumborum (QL) block is a fascial plane block that has been described to provide analgesia from T7-L3 dermatomes. The investigators aim to evaluate the efficacy of QL blocks in patients undergoing primary total hip arthroplasty (THA).

Detailed description: Investigators will enroll subjects planned for primary THA and allocate them into receiving a QL block with either saline or ropivacaine. Primary outcome will be pain scores over the first 48 hours after surgery.

Eligibility criteria: Inclusion Criteria:

* Adult subjects undergoing elective primary total hip arthroplasty

Exclusion Criteria:

* patients age \< 18,
* documented allergy to local anesthetic
* presence of peripheral neuropathy
* patients with current long term opioid use defined as receiving an opioid on most days in a 90 day period
* patients with a contraindication to spinal and regional anesthesia such as coagulopathy or infection at the site of the regional technique.

Primary outcomes:
measure: Pain score
timeFrame: Up to 48 hrs post op
Secondary outcomes:
measure: Opioid usage
timeFrame: Up to 48 hrs post op
measure: Time to first stand
timeFrame: Up to 1 week post surgery
measure: Time to first ambulation
timeFrame: Up to 1 week post surgery
measure: Ambulation distance
timeFrame: Up to 1 week post surgery
measure: Length of hospital stay
timeFrame: Until discharge from hospital, up to 1 week post surgery
measure: Patient satisfaction
timeFrame: Until day of discharge from the hospital, up to 1 week post surgery
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: UCLA Medical Center, Santa Monica
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Pamela Chia, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04573855: TREATMENT WITH ANTI-SARS-COV-2 IMMUNOGLOBULIN IN PATIENTS WITH COVID-19
Official title: TREATMENT WITH ANTI-SARS-COV-2 IMMUNOGLOBULIN IN PATIENTS WITH COVID-19: A PHASE I / II STUDY
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Covid19
Lead sponsor: D'Or Institute for Research and Education
Sponsor class: OTHER
First posted: 2020-10-05
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A Phase I/II clinical trial for safety and efficacy evaluation of treatment with anti-SARS-CoV-2 equine immunoglobulin (F(ab')2) in hospitalized patients with COVID-19 not requiring of invasive ventilation support.


Eligibility criteria: Inclusion Criteria:

* Inpatients diagnosed with COVID-19 by RT-PCR;
* Time between symptom onset and inclusion ≤ 10 days;
* Age ≥ 18 years and \<75 years
* No indication of invasive ventilatory support at the time of randomization;
* Signature of the Informed Consent Form.

Exclusion Criteria:

* Pregnant or lactating women
* Severe comorbidity: Severe heart disease, severe COPD or O2-dependent COPD, terminal cancer.
* Any confirmed or suspected immunosuppressive or immunodeficiency state, including HIV (regardless of treatment, CD4 count or viral load status); asplenia; severe recurrent infections and chronic use (more than 14 days) of immunosuppressive medication in the last 6 months, except for topical steroids or short-term oral steroids (cycle lasting ≤14 days);
* History of anaphylaxis or severe allergic reaction;
* Previous use of any heterologous serum;
* Participation in trials of prophylactic drugs or vaccines for COVID-19;
* Administration of immunoglobulins and / or any blood products in the previous three months.

Primary outcomes:
measure: Rate of adverse events related to the infusion of anti-SARS-CoV-2 immunoglobulin through CTCAE v4.0.
timeFrame: 28 days
measure: Clearence of viral RNA evaluated by RT-PCR
timeFrame: 72 h
Secondary outcomes:
measure: Reduction of viral load evaluated by area under the curve of RT-PCR values
timeFrame: Day 0, Day 3, Day 7 and Day 14
measure: Length of hospital stay
timeFrame: For as long as the duration of the hospital stay
measure: Orotracheal Intubation Rate
timeFrame: 28 days
measure: Infusional reaction rate
timeFrame: 28 days
measure: Mortality rate
timeFrame: 28 days
measure: Assessment of adverse events
timeFrame: 28 days
measure: Evaluation of clinical status
timeFrame: Day 0, Day 14, Day 21 and Day 28
measure: Modulation of serum and cellular inflammatory marker
timeFrame: Day 0, Day 3 and Day 7.
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02158455: Vein vs Arterial Grafts for Coronary Artery Bypass Grafting Surgery
Official title: No-touch Saphenous Vein Grafts vs Radial Artery Grafts; A Randomized Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Angina Pectoris
Keywords: CABG
Saphenous vein
Radial artery
Lead sponsor: Region Örebro County
Sponsor class: OTHER
First posted: 2014-06-06
Enrollment: 108
Sex: ALL
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators have developed a novel technique for saphenous vein graft harvesting for coronary artery bypass grafting (CABG) where the graft is harvested with a pedicle of surrounding tissue. A randomized trial has shown a significantly higher patency rate for vein grafts harvested with this new methode compared to conventional harvesting technique 8.5 years after surgery (90 vs 76 %). In 2004 the investigators started a prospective randomized trial comparing patency between vein grafts harvested with surrounding tissue and radial artery grafts. The result showed that vein grafts harvested with surrounding tissue had a significantly higher patency rate compared to radial artery grafts 3 years after surgery (98 vs 84 %). The present study is a long-term follow-up (8 years) of the patients included in the second randomized trial. The hypothesis is that vein grafts harvested with surrounding tissue have a significantly higher patency rate compared to radial artery grafts 8 years after surgery.


Eligibility criteria: Inclusion Criteria:

* Three vessel coronary artery disease

Exclusion Criteria:

* 65 years or older
* Elevated creatinine
* Raynauds disease
* Vein stripping

Primary outcomes:
measure: Graft patency
timeFrame: 5 months
Secondary outcomes:
Other outcomes:
Locations:
city: Orebro
country: Sweden
facility: University hospital
Study officials:
References:
Clinical trial NCT05811455: Comparative Effects of Aerobic Exercises and Progressive Muscle Relaxation Exercises on Pain and Quality of Life
Official title: Comparative Effects of Aerobic Exercises and Progressive Muscle Relaxation Exercises on Pain,Anxiety and Quality of Life
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain Syndrome
Anxiety
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2023-04-13
Enrollment: 42
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Premenstrual syndrome is the clinical condition in which reproductive age females suffer from emotional and physical symptoms not related to any disease, starting usually 5 days before the menstrual cycle for 3 consecutive cycles.

Detailed description: Premenstrual syndrome is the clinical condition in which reproductive age females suffer from emotional and physical symptoms not related to any disease, starting usually five days before the menstrual cycle for three consecutive cycles. As menstrual cycle starts in females these symptoms vanish on 4th day of menstruation. Around 10% to 53% of female adults suffer from this condition. This condition limits activities of daily life and adversely effects the quality of life therefore, the administration of proper medical intervention is very important. Aerobic exercises and progressive muscle relaxation exercises have been effective in the treatment of premenstrual syndrome previously in a few studies. However, these two interventions have never been compared to test their effects on pain, and functional performance.

Eligibility criteria: Inclusion Criteria:

* Age between 18 to 40 years
* Females in their last week of the luteal phase (1 week before menstruation)
* Females with regular menstrual with equal intervals between 21 and 35 days
* Females with a score of 133 and above after being screened with Premenstrual syndrome scale
* Females suffering from PMS for at least the past six months

Exclusion Criteria:

* Females with the irregular menstrual cycle
* Pregnant females
* Menstruating females or females in the follicular or ovulatory phase
* History of physical exercise in the past three months before the beginning of the study
* Females suffering from other gynecological issues such as endometriosis, PCOS, uterine or cervical cancer

Primary outcomes:
measure: 1. For Anxiety, Depression: • DASS-21 The Depression, Anxiety and Stress Scale - 21 Items (DASS-21)
timeFrame: 6 weeks
measure: Numerical rating scales (NRSs)
timeFrame: 6 weeks
measure: • SF-36 The 36-Item Short Form Health Survey questionnaire (SF-36)
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Johar Institute of Professional Studies
state: Punjab
Study officials:
affiliation: Riphah International University
name: Fatima Tariq, Mphill
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04603755: Electrical Impedance Tomography: Collapse in Dependent Areas as a Predictor of Response to Prone Position Ventilation in COVID-19 Acute Respiratory Distress Syndrome
Official title: Electrical Impedance Tomography: Collapse in Dependent Areas as a Predictor of Response to Prone Position Ventilation in COVID-19 Acute Respiratory Distress Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: SARS-CoV Infection
Acute Respiratory Distress Syndrome
Lead sponsor: Direction Centrale du Service de Santé des Armées
Sponsor class: OTHER
First posted: 2020-10-27
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population is composed of patients who have been admitted to the intensive care unit for SARS-CoV-2 ARDS.

Brief summary: There are several clinical presentations of SARS-CoV-2 infection. Among the severe forms, pulmonary involvement with respiratory failure is common. Although severe lung involvement with SARS-CoV-2 meets the Berlin criteria for Acute Respiratory Distress Syndrome (ARDS), it differs from classic ARDS in that compliance (reflecting distensibility of the lung parenchyma) is frequently preserved.

If the interest of Electrical Impedance Tomography has been demonstrated in classical ARDS, this is not the case in ARDS with COVID-19.

However, the use of this technique in this particular patient population would make it possible to distinguish patients with severe hypoxemia linked to derecruitment from those without derecruitment, in whom hypoxemia is more likely to be linked to the loss of hypoxic vasoconstriction.


Eligibility criteria: Inclusion Criteria:

* Patients admitted to the intensive care unit for SARS-CoV-2 ARDS
* Under controlled invasive ventilation for less than 7 days

Exclusion Criteria:

* Pneumothorax
* Deformation of the rib cage
* Contraindication to Electrical Impedance Tomography
* Pregnant or breastfeeding woman

Primary outcomes:
measure: Coefficient of correlation between the percentage of derecruitment of dependent areas (measured with Electrical Impedance Tomography) and the response to prone position
timeFrame: Up to 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: Hôpital de la Timone
city: Toulon
country: France
facility: Hôpital d'Instruction des Armées Sainte-Anne
Study officials:
References:
citation: Cardinale M, Boussen S, Cungi PJ, Esnault P, Mathais Q, Bordes J, Meaudre E, Goutorbe P. Lung-Dependent Areas Collapse, Monitored by Electrical Impedance Tomography, May Predict the Oxygenation Response to Prone Ventilation in COVID-19 Acute Respiratory Distress Syndrome. Crit Care Med. 2022 Jul 1;50(7):1093-1102. doi: 10.1097/CCM.0000000000005487. Epub 2022 Feb 11.