louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05718219: Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of Escalating Doses of SIM0348 as a Single Agent in Advanced Solid Tumors
Official title: A Phase I, First-in-Human, Open-Label, Dose Escalation Study to Investigate the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of SIM0348 in Subjects With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Advanced Solid Tumors
Lead sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-02-08
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This is a multicenter, open label, phase I trial to evaluate the safety and tolerability, pharmacokinetic/ pharmacodynamic characteristics and to assess the preliminary efficacy of SIM0348 as monotherapy in adult subjects with advanced and metastatic solid tumors. The trial starts with a dose escalation and dose expansion part (Part 1) followed by a cohort expansion part (Part 2).


Eligibility criteria: Inclusion Criteria:

* Adults 18 years of age or older
* Must have failed at least one established standard anti-cancer therapies
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Life expectancy at least 12 weeks
* Adequate hematologic and end organ function
* Histologic documentation of locally advanced, recurrent, or metastatic incurable malignancy that has progressed after at least one available standard therapy; or for which standard therapy has proven ineffective, intolerable, or considered inappropriate; or for which a clinical trial of an investigational agent is a recognized standard of care
* Confirmed availability of representative tumor specimens
* Measurable disease according to RECIST Version 1.1

Exclusion Criteria:

* Malignancies other than disease under study within 2 years prior to Day 1 of Cycle 1
* Primary central nervous system (CNS) malignancy, or untreated/active CNS metastases
* History of interstitial lung disease, evidence of active pneumonitis (history of radiation pneumonitis in the radiation field \[fibrosis\] is permitted), and active pneumonia that are considered inappropriate by the investigator
* History of severe hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
* History of autoimmune disease
* Positive human immunodeficiency virus (HIV) test
* Severe infection within 2 weeks prior to the first dose of study treatment
* Significant cardiovascular disease
* History of allogeneic tissue/solid organ transplant or graft-versus-host disease
* Known clinically significant liver disease

Primary outcomes:
measure: Dose-limiting toxicity (DLT)
timeFrame: DLT evaluation window was from Baseline to the end of Cycle 1 (up to 28 days)
measure: Objective response rate (ORR) assessed by Investigator per RECIST v.1.1
timeFrame: up to approximately 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01649219: Intensity of Exercise and Glucose Metabolism
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Prediabetes
Keywords: Prediabetes, objectively measured exercise, glucose and lipid metabolism, dose response, muscle metabolism.
Lead sponsor: University of Oulu
Sponsor class: OTHER
Collaborators: name: Finnish Diabetes Association
name: Oulu University Hospital
First posted: 2012-07-25
Enrollment: 80
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Our aim is to investigate the effects of a 12-week structured aerobic exercise on fasting and 2 h glucose, insulin and lipid concentrations in sedentary overweight subjects in whom impaired fasting glucose and/or impaired glucose tolerance was observed for the first time.

Detailed description: Study type: Interventional

Study design: Randomized

Endpoint classification: Changes in fasting and 2 h glucose, insulin and lipid concentrations

Intervention model: Parallel assignment

Masking: Open label

Primary purpose: Prevention and dose response assessment of exercise on glucose and lipid metabolism

Condition: Prediabetes

Intervention: Supervised exercise - The training sessions of the intervention group are carried out indoors 3 times a week for 3 months and supervised by an exercise instructor and physician. Each session last for 60 min and include a 5-min warm-up and stretching, a 20-min walking at speeds 2-4 km/h depending of the participant's physical condition, a 5-min stretching and balance training, a 20-min walking, and a 10-min stretching and balance training. After 1.5 months the 5-min stretching and balance training between the two 20-min walkings is excluded, and the walking time become 45 min.

No intervention: control group; couseling at baseline. Participants of the control group are advised to continue their usual physical and dietary habits.

Experimental: 1 -supervised exercise intervention. No intervention: 2 - standard counseling at baseline.

Eligibility criteria: Inclusion Criteria:

* prediabetes determined by 2 hr oGTT

Exclusion Criteria:

* any functional limitation or chronic disease that might have limited the physical exercise and testing
* vigorous physical activity/exercise as revealed by questionnaire and physician exam

Primary outcomes:
measure: Glucose and lipid metabolism
timeFrame: 3-month intervention
Secondary outcomes:
measure: Changes in muscle metabolism
timeFrame: 3-months intervention
Other outcomes:
Locations:
city: Oulu
country: Finland
facility: University of Oulu
Study officials:
affiliation: University of Oulu
name: Karl-Heinz Herzig, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03323619: Impact of Anesthesia Technique on Post-operative Delirium After Transcatheter Aortic Valve Implantation
Official title: Impact of Anesthesia Technique on Post-operative Delirium After Transcatheter Aortic Valve Implantation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Delirium
Post-Op Complication
Anesthesia
Aortic Valve Disease
Keywords: Transcatheter aortic valve replacement
Anesthesia technique
Delirium
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2017-10-27
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patient admitted for TAVI intervention

Brief summary: Aortic stenosis is a frequent valvulopathy in Europe and North America. It occurs mainly over 65 years (2-7% of the population over 65 years). Treatment of symptomatic stenosis is an indication of aortic valve replacement. For patients with high surgical risk (EuroSCORE II\> 6), TAVI (Transcatheter Aortic Valve Implantation) is recommended. This type of procedure concerns elderly patients (75-80 years on average in the literature) therefore the anesthesia technique must be optimal. The postoperative complications are, on the one hand, well-described surgical complications (Cardiogenic shock, bleeding, rhythm disorders, renal insufficiency) and, on the other hand, those related to anesthesia which are less well characterized. There is no consensus on best anesthesia technique for TAVI procedure managment. Between teams practices are different. It may consist of general anesthesia (GA) or local anesthesia with sedation (LASed). Elderly anesthesia has specific complications, including acute cerebral disturbances (delirium) usually occurring within 24 to 48 hours postoperatively and up to 7 days. It is recommended to screen delirium for patients admitted in intensive care using the CAM-ICU scale. The aim of the study is to observe the impact of the anesthesia technique (GA versus LASed) on delirium in post-operative aortic valve replacement with TAVI procedure


Eligibility criteria: Inclusion Criteria:

* Hospital admission for TAVI femoral way
* Age \> 18 years
* Psychiatric disease

Exclusion Criteria:

* Opposition of the operator (Interventional Cardiologist or Surgeon) to one of the two anesthesia technique
* Contraindication to local anesthesia with sedation: agitation, delirium, allergy to local anesthetics, risk of inhalation
* Opposition of the patient to use his data for research

Primary outcomes:
measure: Delirium
timeFrame: 7 days
Secondary outcomes:
measure: ICU stay
timeFrame: 30 days
Other outcomes:
Locations:
city: Nancy
country: France
facility: CHRU - Hopital de Brabois
state: Lorraine
Study officials:
affiliation: Central Hospital, Nancy, France
name: MATTEI Mathieu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05572619: Evaluation of Clinical Decision Support System for Large Vessel Occlusion Using Brain CT Images
Official title: An Open Label, Single-center, Retrospective, Pivotal Study to Evaluate the Efficacy of Clinical Decision Support System for Large Vessel Occlusion Using Brain CT Images
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ischemic Stroke
Lead sponsor: Heuron Inc.
Sponsor class: INDUSTRY
First posted: 2022-10-07
Enrollment: 479
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: (1) Adults over 19 years old (2) Brain non-contrast CT, CT perfusion and CT angiography acquired (3) who confirmed with large vessel occlusion(positive group) or not large vessel occlusion or normal(negative group)

Brief summary: cELVO is a software that has been pre-learned based on a large vessel occlusion diagnosis model using brain CT images, and clinical decision support system for diagnosing large vessel occlusion by automatically analyzing brain CT images by assisting the medical team.

The specific aims of this study are to evaluate efficacy of cELVO compared to the sensitivity and specificity levels of medical team to diagnosis with and without cELVO used.


Eligibility criteria: Inclusion Criteria:

* Adults over 19 years old
* Brain non-contrast CT, CT perfusion and CT angiography acquired
* Positive group: A patient diagnosed with large vessel occlusion after a non-contrast CT, CT perfusion and CT angiography
* Negative group: A normal person or a patient not diagnosed with large vessel occlusion after a non-contrast CT, CT perfusion and CT angiography

Exclusion Criteria:

* Poor or incomplete brain non-contrast CT, CT perfusion and CT angiography quality

Primary outcomes:
measure: Sensitivity and specificity of medical team compared with/without cELVO
timeFrame: Within 2 weeks after completion of reading
Secondary outcomes:
measure: Accuracy of medical team compared with/without cELVO
timeFrame: Within 2 weeks after completion of reading
measure: ROC Curve for medical team compared with/without cELVO
timeFrame: Within 2 weeks after completion of reading
measure: AUC values for medical team compared with/without cELVO
timeFrame: Within 2 weeks after completion of reading
measure: Sensitivity and specificity of each reader compared with/without cELVO
timeFrame: Within 2 weeks after completion of reading
measure: Sensitivity and specificity of cELVO
timeFrame: Within 2 weeks after completion of reading
Other outcomes:
Locations:
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
state: Namdong-gu
Study officials:
affiliation: Gachon University Gil Medical Center
name: Myeong Jin Kim, M.D.pH.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02040519: Time of Effect Onset in Treating Overactive Bladder or Non Obstructive Urinary Retention by Sacral Neuromodulation
Official title: Time of Onset and Time of Offset of Sacral Neuromodulation Effect - "Wash in - Wash Out"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overactive Bladder
Non Obstructive Urinary Retention
Keywords: Overactive bladder
Non obstructive urinary retention
Sacral neuromodulation
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2014-01-20
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Sacral neuromodulation (SNM) is a minimally invasive secondary treatment for overactive bladder syndrome (OAB) or for non-obstructive urinary retention (NOR), when refractory to conservative treatment. Success rates range from 70 to 80%, and good long-term results are reported. The working mechanism of SNM is not completely understood, and the only prognostic factor for good response to this treatment is a successful test stimulation period. There is no consensus on the duration of this test stimulation period. The experience in our clinic during test stimulation period is that for responders it takes up to one week to achieve maximal effect, after the system is turned 'on'. On the other hand the investigators notice that after turning the neuromodulation system 'off', it will take a few hours for symptoms to return to the baseline situation. The fact is: no information concerning the so called "time of onset" and "time of offset" (or popular called: wash-in / wash-out) of sacral neuromodulation is available in current literature.


Eligibility criteria: Inclusion Criteria:

* In order to be eligible to participate in this study, a subject must meet all of the following criteria: Patients should have been diagnosed with overactive bladder syndrome and should be put on the waiting list for scheduling treatment with sacral neuromodulation.

Exclusion Criteria:

A potential subject who meets any of the following criteria will be excluded from participation in this study:

* patients receiving neurological or psychiatric medication without being diagnosed with a neurological or psychiatric disease
* patients who have been treated by means of bladder wall botulin toxin injections in the previous year
* patients with evident subsequent complaints of bladder pain syndrome or other pelvic pain

Primary outcomes:
measure: Time of onset of effect of treatment with sacral neuromodulation
timeFrame: 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Centre
state: Limburg
Study officials:
affiliation: Maastricht University Medical Centre
name: G. A. van Koeveringe, urologist
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04475419: Restoration Quality in Molars Affected by Molar Incisor Hypo Mineralization
Official title: Restoration Quality in Molars Affected by Molar-incisor-hypomineralization Using Composite Restorations or Preformed Metal Crowns: Two-arm Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Molar Incisor Hypomineralization
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-07-17
Enrollment: 30
Sex: ALL
Minimum age (years): 7
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: parallel groups
Primary purpose: TREATMENT

Brief summary: Restoration quality of molars affected by MIH using two different types of restorations direct composite and preformed crowns

Detailed description: MIH or molar incisor hypomineralization is one of the difficult clinical situations to be managed by dentists the aim of this study is to specify which is the better treatment among composite restorations and preformed crowns in terms of gingival health patient satisfaction pain hypersensetivity acceptability by the patienat hypersensetivity and the need for future retreatment

Eligibility criteria: Inclusion Criteria:

.Children with molar incisor hypo mineralization in one fully erupted molar or more.

* Age ranging from 7-12 years.
* Cooperative children
* Good general health

Exclusion Criteria:

* Patients participating in other experiments .Patients with parents planning to move away within the following year.
* Patients with only mildly affected MIH molars that do not require extensive restorative treatment.
* MIH-affected molars that have a very poor prognosis and require extraction.
* First permanent molars that are affected with other developmental defects, such as hypoplasia, dental fluorosis or amelogenesis imperfecta.

Primary outcomes:
measure: pain after the restoration .Binary (yes or No)
timeFrame: 12 MONTHS
Secondary outcomes:
measure: Acceptability of the treatment Binary (yes or No)
timeFrame: 12 months
measure: restoration quality Score index
timeFrame: 12 months
measure: health-related quality of life changes by the therapies
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
affiliation: CU
name: manalf M elshiekh, MASTER
role: STUDY_CHAIR
References:
Clinical trial NCT06480019: IPT-based Group Intervention by Non-specialist for Improvement of Depressive Symptoms in Community Young Adults in Brazil
Official title: IPT-based Group Intervention by Non-specialist for Improvement of Depressive Symptoms in Community Young Adults in Brazil: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Depression
Interpersonal Relations
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
First posted: 2024-06-28
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Major depressive disorder is a highly prevalent, recurrent, and debilitating disease, the third cause of years of lost life in the world, and it may be the most common disease in 2030, according to the World Health Organization (WHO). Furthermore, it's also related to decreased quality of life and high mortality. Interpersonal psychotherapy (IPT) is a first-line treatment and can also be used for the prevention of depression.

This randomized controlled clinical trial is planned to have 50 participants randomized between an interventional and a control group (waiting list). Our study covers young adults (18 to 24 years old) with depression. Participants will be invited by social media to undergo treatment in an IPT group. The intervention group will be separated into groups with up to 10 participants, with a weekly meeting for eight weeks. The intervention will focus on interpersonal relationships within the model of IPT and will be held by a university student and a doctor trained in IPT.


Eligibility criteria: Inclusion Criteria:

* Young adults (between 18 and 24 years old)
* Young adults who work, live or study in Porto Alegre
* PHQ ≥ 5 - without suicide ideation

Exclusion Criteria:

* Maniac or hypomanic episode
* Psychotic Syndrome
* Substance Abuse
* Suicide Risk or Ideation

Primary outcomes:
measure: Patient Health Questionnaire-9
timeFrame: Pre-treatment, Week 1 to 8
measure: Quality of Life (WHOQOL-BREF)
timeFrame: Pre-treatment, Week 1 to 8
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: Pre-treatment, Week 1 to 8
measure: Self-Reporting Questionnaire (SRQ-20)
timeFrame: Pre-treatment, Week 1 to 8
measure: Social support scale (MOS-SSS)
timeFrame: Pre-treatment, Week 1 to 8
measure: Attachment (RSQ)
timeFrame: Week 1 and 8
Secondary outcomes:
measure: General Health Questionnaire (GHQ-12)
timeFrame: Pre-treatment, Week 1 to 8
measure: Resilience (CD-RISC-10)
timeFrame: Pre-treatment, Week 1 to 8
measure: Clinical Global Impression (CGI)
timeFrame: Pre-treatment, Week 1 to 8
measure: Psychotherapy side effects (UE-ATR checklist)
timeFrame: Week 1 to 8
measure: Childhood Trauma Questionnaire (CTQ)
timeFrame: Week 1
measure: Life Stressful Events Questionnaire
timeFrame: Week 1 to 8
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Clinical Hospital for Porto Alegre
state: RS
Study officials:
References:
Clinical trial NCT01044719: Duration of Antibiotics in Infective Exacerbations of Cystic Fibrosis
Official title: What Duration of Intravenous Antibiotic Therapy Should be Used in the Treatment of Infective Exacerbations of Cystic Fibrosis Chronically Colonised With Pseudomonas Aeruginosa
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Cystic Fibrosis
Lead sponsor: Imperial College London
Sponsor class: OTHER
First posted: 2010-01-08
Enrollment: 240
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Cystic Fibrosis patients attending with infective exacerbations will be enrolled into the study. The trial is a double blinded, randomised trial with patients randomised to 10,14 or 21 days of antibiotic therapy, comprising of tobramycin and either ceftazidime or meropenem.


Eligibility criteria: Inclusion Criteria:

* 16 years or older
* Diagnosis of Cystic Fibrosis
* Presenting with Infective exacerbation

Exclusion Criteria:

* Unable to give consent
* Allergy to study medications
* Intolerance of aminoglycoside antibiotics
* Pseudomonas resistant to study antibiotics
* On the active transplant list or FEV1\<20% predicted
* Pregnancy/breast-feeding
* Co-existent ABPA requiring a change in treatment
* Co-existent mycobacterial infection
* A previous participant in the study

Primary outcomes:
measure: Treatment failure at completion of antibiotic course
timeFrame: 21 days
measure: Time to next exacerbation
timeFrame: 6 months
Secondary outcomes:
measure: Change in Spirometry
timeFrame: up to 21 days
measure: Change in inflammatory markers
timeFrame: up to 21 days
measure: Change in sputum bacteriology
timeFrame: up to 21 days
measure: Adverse effects of study antibiotics
timeFrame: Up to 21 days
measure: Quality of life scores
timeFrame: Up to 21 days
measure: Change in nutritional status
timeFrame: up to 21 days
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Department of Cystic Fibrosis, Royal Brompton Hospital
Study officials:
affiliation: Imperial College London
name: Margaret Hodson, MD FRCP DA
role: PRINCIPAL_INVESTIGATOR
References: