louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02424370: Geriatric Evaluation to Predict Mortality and Functional Recovery After Trans Aortic Valve Implantation
Official title: Geriatric Evaluation to Predict Mortality and Functional Recovery After Trans Aortic Valve Implantation. Multicenter Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Symptomatic Aortic Stenosis
Keywords: Aortic stenosis
TAVR
Frailty
Elderly
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Medtronic
First posted: 2015-04-23
Enrollment: 515
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: person aged over 75 years with indication for implantation of TAVI

Brief summary: Transcutaneous trans-aortic valve replacement (TAVR) is now a common procedure to treat symptomatic aortic stenosis. Although as effective and safe as surgical aortic valve replacement, it is still restricted to high surgical risk patient who are frail. The aim of the TAVI-EVA is to identify geriatric biomarkers that may help to predict survival and functional recovery after TAVR

Detailed description: Primary objective: identify geriatric biomarkers associated with vital/functional status after TAVR.

Primary outcome measure is altered functional status at six month follow-up defined as an absolute decrease of 15 points of the Barthel Index.

Secondary outcome measures are: Barthel index and survival at 6, 9 and 12 months follow-up. QOL during follow-up

Eligibility criteria: Inclusion Criteria:

* Age ≥75
* Symptomatic aortic stenosis
* Prior geriatric evaluation
* Patient who agreed to answer the telephone follow-up to 6, 9 and 12 months
* Patient given his non-opposition to using his data
* Patient affiliated to the French social security.

Exclusion criteria:

Primary outcomes:
measure: Maintaining or improving the level of functional independence, defined as a score of Barthel index at 6 months
timeFrame: at 6 months
Secondary outcomes:
measure: Score of Barthel
timeFrame: at 6, 9 and 12 months
measure: Maintain or improve the quality of life score at 6 months, defined as a score of SF-12 scale at 6 months
timeFrame: at 6 months
measure: Survival rate at 6 months, 9 months, 12 months
timeFrame: at 6, 9 and 12 months
measure: Survival time after TAVI during the study
timeFrame: up to 30 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Institut de Cardiologie-GH Pitié Salpétirère
state: Ile De France
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Joël BELMIN, MD,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Assistance Publique - Hôpitaux de Paris
name: Jean Philippe COLLET, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05717270: Two-layer Suturing of Achilles Tendon Ruptures
Official title: Two-layer Suturing of Achilles Tendon Ruptures - an Ambidirectional Cohort Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Achilles Tendon Rupture
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
First posted: 2023-02-08
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with diagnosed acute Achilles tendon rupture

Brief summary: The purpose of the present study is to measure whether a new technique of double row suturing of a ruptured Achilles tendon will result in a normalization of the length of the Soleus part (primary outcome) and of the superficial Gastrocnemius part of the tendon (secondary outcome) one-week post-operative. Results will be compared to that of a participants group that underwent the same operation but with a standard operative technique and the same rehabilitation regime recently completed (NCT04263493).

The investigators hypothesize that the new suturing technique will result in an elongation of the Soleus part of the Achilles tendon (primary outcome) by 8.9 mm or less relative to the uninjured contralateral side one week (primary endpoint) after surgery compared to retrospective data from a recently completed randomized controlled trial

Detailed description: This study is an ambidirectional cohort study with a retrospective part based on a recently completed trial (NCT04263493) and this prospective registered trial.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with a traumatic, complete mid-substance Achilles tendon rupture
* Manages transportation to/from the hospital on their own
* Presented within 14 days from injury
* Adult (18 to 60 years)
* Understands Danish

Exclusion Criteria:

* Other injuries affecting their lower limb functions
* Prior Achilles contralateral tendon rupture
* Contraindications for MRI
* Re-rupture
* Smoking
* Systemic diseases influencing tendon healing
* Anticoagulation treatment
* Inability to follow rehabilitation or complete follow-ups
* Immunosuppressive treatment including systemic corticosteroid treatment.

Primary outcomes:
measure: Tendon length
timeFrame: One week after surgery.
Secondary outcomes:
measure: Tendon length Soleus
timeFrame: One week after surgery.
measure: Tendon length Triceps Surae
timeFrame: 6 months.
measure: Plantar flexion function
timeFrame: 6 and 12 months.
measure: Patient perception
timeFrame: 12 months
measure: Vascularisation
timeFrame: 6 months.
measure: Muscle architecture fascicle length
timeFrame: 6 months.
measure: Muscle architecture pennation angle
timeFrame: 6 months.
measure: Muscle cross sectional area
timeFrame: 6 months.
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Institute of Sports Medicine Copenhagen
state: NV
Study officials:
References:
Clinical trial NCT04883970: CLDN18.2 Targeting PET Imaging in Patients With Gastrointestinal Tumors
Official title: CLDN18.2 Targeting 124I-18B10(10L) PET Imaging in Patients With Gastrointestinal Tumors
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Gastrointestinal Cancer
Lead sponsor: Peking University Cancer Hospital & Institute
Sponsor class: OTHER
First posted: 2021-05-12
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: The objective of the study is to constrcut a noninvasive approach 124I-18B10(10L) PET/CT to detect the CLDN18.2 expression of tumor lesions in patients with gastrointestinal tumors and to identify patients benefiting from CLDN18.2 targeting treatment.


Eligibility criteria: Inclusion Criteria:

* 1. Aged \>18 years old; ECOG 0 or 1;
* 2. Patients with Gastrointestinal tumors;
* 3. Has at least one measurable target lesion according to Response Evaluation Criteria in Solid Tumors (RECIST V1.1);
* 4. life expectancy \>=12 weeks.

Exclusion Criteria:

* 1. Significant hepatic or renal dysfunction;
* 2. Is pregnant or ready to pregnant;
* 3. Cannot keep their states for half an hour;
* 4. Refusal to join the clinical study;
* 5. Suffering from claustrophobia or other mental diseases;
* 6. Any other situation that researchers think it is not suitable to participate in the experiment.

Primary outcomes:
measure: Standardized uptake value（SUV）
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: HUA ZHU
Study officials:
affiliation: Peking University Cancer Hospital & Institute
name: Hua Zhu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04838470: Prognosis Predictors for Heart Failure
Official title: Looking for Prognostic Factors That Affect the Survival of Patients With Heart Failure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Rehabilitation
Morality
Hospitalization
Life Quality
Keywords: cardiac rehabilitation
multidisciplinary program
heart failure
mortality
renin-angiotensin-aldosterone system
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2021-04-09
Enrollment: 792
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A total of 792 patients were recruited between May 2014 and July 2019 and follow-up conducted at the Kaohsiung HF center until August 2020. All patients were introduced to a multidisciplinary HF disease management program (HFDMP).

Brief summary: This study is looking for the predictors of the survival or rehospitalization of patients with heart failure with reduced ejection fraction. Participants who are discharged from an acute heart failure hospitalization are enrolled.

Detailed description: This study is looking for the predictors of the survival or rehospitalization of patients with heart failure with reduced ejection fraction. Participants who are discharged from an acute heart failure hospitalization are enrolled. The prognostic factors provide information about the treatment of this disease in the future. This study is a retrospective observational study. Investigators will collect data from May 2014 to July 2019 in the heart failure center of Kaohsiung Chang Gung Memorial Hospital. A follow-up is conducted at the Kaohsiung HF center until August 2020. Investigators want to know whether the risk factors such as atrial fibrillation, diabetes, nephropathy, and some biochemical indexes can be an index that predicts future survival or rehospitalization of these patients. Besides, investigators will also explore the cardiac rehabilitation can also effectively improve the survival rate of such patients.

Eligibility criteria: Inclusion Criteria:

* inpatient, age \>= 20 years old, male or female
* patient with heart failure with a reduced ejection fraction and discharged alive from the hospital
* received heart failure disease management program

Exclusion Criteria:

* Estimated survival time \< 6 months
* Long-term bedridden for more than 3 months
* Cannot tolerance exercise test due to muscular-skeletal disorder
* Cannot co-operate all functional studies
* Ventilator dependent
* Terminal heart status
* The family reject to participate in this project

Primary outcomes:
measure: all-cause mortality
timeFrame: May, 2014 ~ August 2020
Secondary outcomes:
measure: first heart failure rehospitalization
timeFrame: May, 2014 ~ August 2020
measure: Change From Baseline to Month 6 and Month 12 for the Kansas City Cardiomyopathy Questionnaire 12 (KCCQ 12) Clinical Summary Score
timeFrame: May , 2014 ~ August 2020
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03002870: Characteristics of Patient Population With Endometriosis
Official title: Characteristics of Patient Population With Endometriosis - A Prospective Database and BioBank
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endometriosis
Lead sponsor: St. Louis University
Sponsor class: OTHER
First posted: 2016-12-26
Enrollment: 1100
Sex: FEMALE
Minimum age (years): 13
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to collect and analyze data on the characteristics of women who are seeking treatment for endometriosis, suspected endometriosis, pain and/or infertility as part of their standard medical care. Data collected will contribute to the development of guidelines for the surgical management of endometriosis. In addition, specimens will be collected for future testing regarding diagnosing, and/or staging of endometriosis, or suspected endometriosis, pain and infertility.

Detailed description: Patients seen at Saint Louis University Center for Endometriosis (which has offices locations at St. Mary's, St. Luke's and the SLU-UMG clinic - all of which are in the SLU Epic system), and operated on for endometriosis, suspected endometriosis, pain and/or infertility at St. Mary's hospital (only).

A preoperative questionnaire will be provided to the subject. Questions from the survey include information on baseline demographics, severity and type of pain, and previous medical and surgical history. Operative data will also be collected and analyzed.

A post-operative questionnaire will be administered to the participants at 6 months, and then at regular yearly intervals after the surgery by a secure on-line process using the RedCap software. Improvement in quality of life and pain scores will be analyzed.

Specimens will also be collected and stored for future testing regarding diagnosing, and/or staging of endometriosis, suspected endometriosis, pain and infertility.

Eligibility criteria: Inclusion Criteria:

* Female patients
* 13-55 years of age
* Anyone seen at the Center for Endometriosis

Exclusion Criteria:

* Prior bilateral salpingo-oophorectomy
* post natural menopause
* Significant mental or chronic systemic illness that might confound pain assessment or the inability to complete the study.

Primary outcomes:
measure: Quality of life, pain and fertility
timeFrame: every 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Saint Louis University
state: Missouri
Study officials:
affiliation: St. Louis University
name: Patrick Yeung, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02798770: Reasons for Prehospital Delay in Patients With Acute Ischemic Stroke
Official title: Reasons for Prehospital Delay in Patients With Acute Ischemic Stroke: a Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Ischemic Stroke
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2016-06-14
Enrollment: 337
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with an acute ischemic stroke hospitalized in the Stroke Center of the University Hospital Basel.

Brief summary: Ischemic stroke is the leading cause of acquired disability among adults, and one of the main causes of death. In Switzerland, the approved time window for stroke treatment with intravenous thrombolysis after symptom onset is 4.5 h. Even within the 4.5 h time-window, however, the benefit of treatment strongly decreases as time passes.

Moreover, only around 10% patients receive thrombolytic treatment, since patients with stroke arrive too late to the hospital (prehospital delay). Despite efforts to educate the community on the symptom of stroke, prehospital delay did not decrease over time, and the reasons remain incompletely understood. Prehospital delay reduces the proportion of patients with ischemic stroke treated with thrombolysis, and reduces the odds of favorable outcome among the minority treated with thrombolysis.

This prospective cohort study aims at understanding the causes of prehospital delay among patients with acute ischemic stroke. Trained study-nurses will interview, at the bedside, patients and proxies along a standardized questionnaire on prehospital delay. Avoiding modificables causes of prehospital delay may increase the thrombolysis rate and improve outcomes after stroke.


Eligibility criteria: Inclusion Criteria:

* Patients with an acute ischemic stroke hospitalized in the Stroke Center of the University Hospital Basel.

Exclusion Criteria:

* Patient not able to answer the in-person, bedside questionnaire asked by a trained study Nurse.
* Patient not willing to participate to the study

Primary outcomes:
measure: Prehospital Delay between between Stroke Onset and Admission to the Hospital as assessed by In-Person Interview
timeFrame: an average of 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Stroke Center University Hospital Basel
Study officials:
References:
citation: Fladt J, Meier N, Thilemann S, Polymeris A, Traenka C, Seiffge DJ, Sutter R, Peters N, Gensicke H, Fluckiger B, de Hoogh K, Kunzli N, Bringolf-Isler B, Bonati LH, Engelter ST, Lyrer PA, De Marchis GM. Reasons for Prehospital Delay in Acute Ischemic Stroke. J Am Heart Assoc. 2019 Oct 15;8(20):e013101. doi: 10.1161/JAHA.119.013101. Epub 2019 Oct 2.
Clinical trial NCT03395470: Safety, Tolerability and PK of PXL770 in Healthy Male Subjects
Official title: A Double-blind, Randomised, Placebo-controlled Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Doses of PXL770, Including an Open-label, One-sequence Part to Assess the Drug-drug Interaction With Rosuvastatin in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Metabolic Disease
Lead sponsor: Poxel SA
Sponsor class: INDUSTRY
First posted: 2018-01-10
Enrollment: 60
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: PXL770 is a direct activator of 5' adenosine monophosphate-activated protein kinase (AMPK) being developed by Poxel S.A. for the treatment of type 2 diabetes mellitus (T2DM). In Part A of this study, we'll test the safety, tolerability and pharmacokinetics (PK) of repeated doses. In Part B, we'll co-administer PXL770 and rosuvastatin (a HMG-CoA reductase inhibitor) to assess any drug-drug interaction.


Eligibility criteria: Inclusion Criteria:

* Male subjects deemed healthy on the basis of a clinical history, physical examination, ECG, vital signs, and laboratory tests of blood and urine
* body mass index in the range 18.5-29.9 kg/m²
* body weight at least 60 kg
* willing to use reliable contraception
* able to give fully informed written consent.

Exclusion Criteria:

* Pregnant or lactating woman, or sexually active woman of child-bearing potential not using reliable contraception
* Clinically relevant abnormal findings at the screening assessment
* Clinically significant vital signs outside the acceptable range at screening
* Clinically relevant abnormal medical history, surgery or concurrent medical condition
* Acute or chronic illness
* Estimated glomerular filtration rate less than 80 mL/min/1.73 m2
* Severe adverse reaction to any drug or sensitivity to the trial medication or its components
* Significant food allergy; vegetarian or vegan
* Participation in other clinical trials of unlicensed or prescription medicines, or loss of more than 400 mL blood, within the 3 months before first dose of trial medication
* Drug or alcohol abuse
* Smoking of more than 5 cigarettes daily
* Possibility that subject will not cooperate
* Positive test for hepatitis B \& C, HIV
* Objection by a General Practitioner

Primary outcomes:
measure: Part A: PK parameters of PXL770 after repeated doses Part B: PK parameters of rosuvastatin before and after repeated doses of PXl770
timeFrame: From baseline to day 14
measure: Part A: PK parameters of PXL770 after repeated doses
timeFrame: From baseline to day 14
measure: Part A: PK parameters of PXL770 after repeated doses
timeFrame: From baseline to day 14
Secondary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
timeFrame: From baseline to day 14
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Hammersmith Medicines Research (HMR)
Study officials:
References:
Clinical trial NCT00902070: Protocol for Eslax Intravenous Drug Use Investigation (Study P06082)
Official title: Protocol for Eslax Intravenous Drug Use Investigation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anesthesia
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2009-05-14
Enrollment: 3969
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Japanese 3000 patients

Brief summary: The main purpose of this investigation is to collect safety and efficacy information of Eslax Intravenous 25mg/2.5mL and 50mg/5.0mL (hereinafter referred to as "Eslax") in daily clinical settings.

Detailed description: Post-marketing surveys are not considered applicable clinical trials and thus the results of this survey will not be posted at its conclusion. The results will be submitted to public health officials as required by applicable national and international laws.

Eligibility criteria: Inclusion Criteria:

* Patients to whom Eslax has been administered to relax muscles at the time of anesthesia or tracheal intubation.

Exclusion Criteria:

* Patients with a history of hypersensitivity to Eslax or bromide.
* Patients with myasthenia gravis or myasthenic syndrome.

Primary outcomes:
measure: incidence of adverse events
timeFrame: The standard observation period for a patient is duration of hospital stay (from one week before Eslax administration to one week after administration at a maximum).
Secondary outcomes:
measure: intubation score
timeFrame: From administration of Eslax to completion of intubation
measure: intubation completion time
timeFrame: From administration of Eslax to completion of intubation
Other outcomes:
Locations:
Study officials:
References: