louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01164020: Creatine Supplementation and Cognition
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognition
Aging
Keywords: cognition
supplementation creatine
resistance training
aging
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2010-07-16
Enrollment: 56
Sex: FEMALE
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Resistance training as well as creatine supplementation may be beneficial for cognitive function, such as memory and attention. Therefore, the investigators speculate that resistance training combined with creatine supplementation would promote additive benefits on cognitive function in elderly women.


Eligibility criteria: Inclusion Criteria:

* women older than 60 years old

Exclusion Criteria:

* cardiovascular diseases or muscular disturbances precluding exercise training
* drugs affecting the cognition

Primary outcomes:
measure: cognitive function
timeFrame: six months
Secondary outcomes:
measure: physical capacity
timeFrame: six months
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: School of Medicine - Division of Rheumatology
Study officials:
affiliation: University of Sao Paulo
name: Bruno Gualano, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Sao Paulo
name: Antonio H Lancha Junior, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Alves CR, Merege Filho CA, Benatti FB, Brucki S, Pereira RM, de Sa Pinto AL, Lima FR, Roschel H, Gualano B. Creatine supplementation associated or not with strength training upon emotional and cognitive measures in older women: a randomized double-blind study. PLoS One. 2013 Oct 3;8(10):e76301. doi: 10.1371/journal.pone.0076301. eCollection 2013.
Clinical trial NCT00260520: LMWH to Prevent Preeclampsia and Fetal Growth Restriction
Official title: Low Molecular Weight Heparin Vs No Treatment in Pregnant Women With Previous Preeclampsia or Fetal Growth Restriction Who Were Heterozygote for Factor V Leiden or Prothrombin Gene G20210A Mutation
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Preeclampsia
Keywords: Low molecular weight heparin
Preeclampsia
Fetal Growth Restriction
Thrombophilia
Factor V Leiden
G20210A prothrombin gene mutation
Lead sponsor: University of Florence
Sponsor class: OTHER
First posted: 2005-12-01
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes

Brief summary: The objective of this trial will be to determine whether prophylactic low-molecular weight heparin therapy in pregnant women with the heterozygous Factor V Leiden and G20210A prothrombin gene mutations thrombophilia and a history of severe preeclampsia and/or severe fetal growth restriction reduces the risk of the composite outcome of preeclampsia, fetal growth restriction, or both.

Detailed description: The objective of this trial will be to determine whether prophylactic low-molecular weight heparin therapy in pregnant women with the heterozygous Factor V Leiden and G20210A prothrombin gene mutations thrombophilia and a history of severe preeclampsia and/or severe fetal growth restriction reduces the risk of the composite outcome of preeclampsia, fetal growth restriction, or both. We also will assess the effect of treatment on other indicators of maternal and neonatal complications, and the growth of fetal body composition in terms of fat and lean body mass.

Eligibility criteria: Inclusion Criteria:

* Previous severe preeclampsia
* Previous severe fetal growth restriction
* Heterozygous Factor V Leiden
* Heterozygous G20210A prothrombin gene mutations

Exclusion Criteria:

* renal disease
* chronic hypertension
* preexisting diabetes mellitus
* homozygosity for Factor V Leiden
* homozygosity for prothrombin G20210A mutation
* hyperhomocysteinemia
* protein C deficency
* protein S deficency
* antithrombin deficiency
* positive anticardiolipin antibodies
* positive lupus anticoagulant

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Department of Gynecology, Perinatology and Human Reproduction, University of Florence, Italy
name: Giorgio Mello, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03558620: Effect of an Endoscopic Bite Block on Mask Ventilation
Official title: Effect of an Endoscopic Bite Block on Mask Ventilation in Anesthetized and Paralyzed Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ventilator Lung
Keywords: manual ventilation
Lead sponsor: SMG-SNU Boramae Medical Center
Sponsor class: OTHER
First posted: 2018-06-15
Enrollment: 59
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: Evaluation of effects of an endoscopic bite block on mask ventilation. In the present study, expiratory tidal volume and minute ventilation are measured under same pressure controlled mode in ventilator with three kinds of holding a mask. ( by one hand, one hand with an endoscopic bite block and two hand hold.)

Detailed description: Evaluation of effects of an endoscopic bite block on mask ventilation. In the present study, expiratory tidal volume and minute ventilation are measured under the same pressure controlled mode in ventilator (Pressure 15cmH2O, Respiratory rate 15/min, I:E=1:1) with three kinds of holding a mask. ( by one hand, one hand with an endoscopic bite block and two hand hold.)

Eligibility criteria: Inclusion Criteria:

* patients scheduled for elective surgery under general anesthesia and agree with the purpose of the study

Exclusion Criteria:

* patients with diseases or structural abnormalities in the upper airway, wobbly teeth, and limited mouth opening of less than 3.5 cm or those who were at risk of aspiration

Primary outcomes:
measure: Expiratory tidal volume
timeFrame: during mask ventilation after anesthesia induction
Secondary outcomes:
measure: Minute ventilation
timeFrame: during mask ventilation after anesthesia induction
measure: Incidence of inadequate ventilation or dead space ventilation
timeFrame: during mask ventilation after anesthesia induction
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul Metropolitan Government Seoul National University Boramae Medical Center
Study officials:
affiliation: Seoul Metropolitan Government Seoup National University Boramae Medical Center
name: Jin-Young Hwang, M.D., phD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hart D, Reardon R, Ward C, Miner J. Face mask ventilation: a comparison of three techniques. J Emerg Med. 2013 May;44(5):1028-33. doi: 10.1016/j.jemermed.2012.11.005. Epub 2013 Mar 7.
citation: Joffe AM, Hetzel S, Liew EC. A two-handed jaw-thrust technique is superior to the one-handed "EC-clamp" technique for mask ventilation in the apneic unconscious person. Anesthesiology. 2010 Oct;113(4):873-9. doi: 10.1097/ALN.0b013e3181ec6414.
citation: Walsh JH, Maddison KJ, Platt PR, Hillman DR, Eastwood PR. Influence of head extension, flexion, and rotation on collapsibility of the passive upper airway. Sleep. 2008 Oct;31(10):1440-7.
Clinical trial NCT06573320: Effect of Exercise on Clinical Symptoms, Cognitive Performance, and Quality of Life in Schizophrenia Patients Treated With Clozapine
Official title: Investigating the Effect of Exercise on Clinical Symptoms, Cognitive Performance, and Quality of Life in Schizophrenia Patients Treated With Clozapine
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Schizophrenia
Clozapine
Exercise
Lead sponsor: Dr. Lutfi Kirdar Kartal Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2024-08-27
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This prospective study aims to investigate the effects of exercise on clinical symptoms, cognitive performance, and quality of life in schizophrenia patients treated with Clozapine.

Detailed description: The first developed atypical antipsychotic is clozapine. Its efficacy has been demonstrated in individuals with schizophrenia who have insufficient response to other antipsychotic therapies; nonetheless, its adverse effect profile is extensive. Among the antipsychotic medications now available, clozapine is not utilized as a first-line therapy because of major side effects such agranulocytosis. Increased salivation, sleepiness, weight gain, changes in blood pressure (sometimes an increase, sometimes a drop), elevated heart rate, dizziness, exhaustion, constipation, fever, and nocturnal enuresis are common adverse effects of clozapine usage.

Eligibility criteria: Inclusion Criteria:

* Patients treated who were diagnosed with schizophrenia according to DSM-V criteria by psychiatrist at the Turkish Ministry of Health Kartal Dr. Lütfi Kırdar City Hospital
* using a therapeutic dose of 300-500 mg/day of clozapine,

Exclusion Criteria:

* pregnancy

Primary outcomes:
measure: Montreal Cognitive Assessment (MOCA)
timeFrame: 12 weeks
measure: Positive and Negative Syndrome Scale (PANSS)
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Kartal Dr Lütfi Kırdar Şehir Hastanesi
Study officials:
References:
Clinical trial NCT06803420: AI-powered Portable MRI Abnormality Detection
Official title: AI-powered Portable MRI Abnormality Detection
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Head Injury
Lead sponsor: King's College Hospital NHS Trust
Sponsor class: OTHER
Collaborators: name: King's College London
First posted: 2025-01-31
Enrollment: 400
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: This study aims to test a new AI-powered portable MRI scanner that can quickly identify whether a brain scan is normal or abnormal. Currently, standard MRI scans are expensive and have long waiting times. Our goal is to see if a smaller, cheaper, and more accessible MRI scanner-combined with artificial intelligence (AI)-can help doctors identify abnormalities faster and improve patient care.

We will invite patients from King's College Hospital (KCH) who are already having a standard MRI scan. They will be asked to have an extra scan using the portable MRI, which takes about 60 minutes. The AI tool will then analyse these scans and compare its results to those of expert radiologists.

By the end of the study, we hope to prove whether portable MRI with AI can be used in hospitals and GP clinics, making brain scans more accessible, reducing wait times, and helping doctors prioritise urgent cases.

This study is funded by the Medical Research Council (MRC) and has been approved by UK research ethics committees.


Eligibility criteria: Inclusion Criteria:

Adults ≥18 years old. Undergoing standard brain MRI including T2-weighted sequences.

Exclusion Criteria:

Contraindications to MRI (e.g. pacemaker, pregnancy). Poor quality MRI scans without a neuroradiology report.

Primary outcomes:
measure: Accuracy of AI toll for triaging scans as "normal or "abnormal"
timeFrame: 36 months
Secondary outcomes:
measure: Generalisability of AI tool (evaluated on external dataset).
timeFrame: 36 months
measure: Patient acceptability of portable MRI (survey/interviews)
timeFrame: 36 months
measure: Feasibility of integrating portable MRI in clinical pathways.
timeFrame: 36 months
Other outcomes:
Locations:
Study officials:
affiliation: King's College London & King's College Hospital
name: Thomas Booth, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05912920: Laparoscopic Natural Gastric Banding for Morbid Obesity
Official title: Laparoscopic Natural Gastric Banding for Management of Morbid Obesity
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity, Morbid
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2023-06-22
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 18
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: to do gastric banding using round ligament or omental flap instead of synesthetic band

Detailed description: the round ligament or omental flap is used for gastric band instead of synesthetic band which had many complications that led to its abandon

Eligibility criteria: Inclusion Criteria:

* obese patients with BMI more than 40 with or without co-morbidity or more than 35 with co-morbidity
* patients fit for laparoscopic surgery
* give approval to share in the study
* previous restrictive bariatric procedure

Exclusion Criteria:

* patients unfit for surgery
* patients aged less than 18 and older than 60
* patient with previous upper abdominal surgery either for obesity or other diseases

Primary outcomes:
measure: %EWL
timeFrame: 12 months
Secondary outcomes:
measure: complications rate
timeFrame: 12 months
Other outcomes:
Locations:
city: Minya
country: Egypt
facility: Faculty of medicine
city: Minya
country: Egypt
facility: Minia university hospital
Study officials:
References:
Clinical trial NCT04148820: One Versus Twice Daily Administration of Multiple Cardiovascular Agents in Patients With Ischemic Heart Disease
Official title: One Versus Twice Daily Administration of Multiple Cardiovascular Agents in Patients With Ischemic Heart Disease: An Open Label, Randomized, Multicenter Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Ischemic Heart Disease
Keywords: coronary artery disease
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2019-11-04
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be randomized into two parallel groups
Primary purpose: TREATMENT

Brief summary: Patients with ischemic heart disease are often treated with multiple cardiovascular agents, including aspirin, statins, ezetimibe, Angiotensin Converting Enzyme (ACE) inhibitors or beta-blockers.

Uncertainty about the optimal timing and clinical implications of administration of cardiovascular drugs still persists.

The investigators will perform a pilot randomized trial to evaluate the efficacy and safety of a one daily administration of multiple drugs vs. twice daily administration.

Detailed description: Patients with ischemic heart disease are often treated with multiple cardiovascular agents, including aspirin, statins, ezetimibe, Angiotensin Converting Enzyme (ACE) inhibitors or beta blockers.

These drugs are usually given at different timetables. Recent investigations, however, have demonstrated that adherence to medical treatment is significantly greater if a one daily strategy is adopted.

Uncertainty about the optimal timing and clinical implications of administration of cardiovascular drugs still persists.

The investigators will perform a pilot randomized trial to evaluate the efficacy and safety of a one daily administration of multiple drugs vs. twice daily administration.

Eligibility criteria: Inclusion Criteria:

Ischemic heart disease, willing to participate, compliance to medical therapy

Exclusion Criteria:

Patients with acute coronary syndrome; pregnancy

Primary outcomes:
measure: Major Adverse Outcome Event (MACE)
timeFrame: Up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Rome
country: Italy
facility: San Raffaele Pisana
city: Rome
country: Italy
facility: Sapienza University
Study officials:
affiliation: San Raffaele Pisana
name: Giuseppe Marazzi
role: STUDY_DIRECTOR
References:
Clinical trial NCT00774020: Efficacy and Safety of Single Dose of 5 mg Zoledronic Acid in Chinese Patients With Paget's Disease of Bone (PDB)
Official title: A 6 Months, Open-Label Phase IV Study to Confirm the Safety and Efficacy of Single Intravenous Dose of 5 mg Zoledronic Acid for the Patients of Paget's Disease of Bone (PDB) in China
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Paget's Disease of Bone
Keywords: Paget's Disease of Bone
Serum Alkaline Phosphatase
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2008-10-16
Enrollment: 9
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to document the efficacy and safety profiles of single intravenous dose of 5 mg zoledronic acid for the Chinese patients of Paget's Disease of Bone (PDB).


Eligibility criteria: Inclusion Criteria:

* Confirmed diagnosis of PDB by radiological reports
* Serum Alkaline Phosphatase level (SAP) at least two times the upper limit of the normal (ULN)

Exclusion Criteria:

* History of hypersensitivity to the active substance or to any of the excipients or to any bisphosphonates;
* History of malignancy of any organ system
* Severe liver or bladder disease;
* Calculated creatinine clearance \< 35 mL/min at baseline;
* Hypocalcaemia;
* Patients with pre-existing dental diseases or who predict to have dental surgeries during the study;
* Evidence of vitamin D deficiency.

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: The proportion of patients who achieve therapeutic response (a reduction of at least 75% from baseline in total Serum Alkaline Phosphatase (SAP) excess or normalization of SAP.
timeFrame: at the end of 3 months and 6 months
Secondary outcomes:
measure: The percent change from baseline in total Serum Alkaline Phosphatase (SAP).
timeFrame: at the end of 3 months and 6 months
measure: The percent change from baseline in serum cross-linked C-telopeptide of type I collagen (CTX).
timeFrame: at the end of 3 months and 6 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Novartis Investigative Site
city: Guangzhou
country: China
facility: Novartis Investigative site
city: Nanjing
country: China
facility: Novartis Investigative site
city: Shanghai
country: China
facility: Novartis Investigative site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05071820: Microlearning Application for Diabetes Prevention
Official title: Validation of a Microlearning Approach to a Diabetes Prevention Program
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: PreDiabetes
Elevated Blood Sugar
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2021-10-08
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
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 test the effectiveness of a mobile application diabetes prevention program delivered with microlearning and microcoaching.

Detailed description: Patients with prediabetes who are interested in joining a diabetes prevention program will be randomized to either the mobile application diabetes prevention program or the traditional diabetes prevention program, which is delivered as a mixed program of in-person and virtual sessions.

Study participants in the mobile application version will download the Health U app from the Apple application store. The user will complete the daily microlearning modules and the health coach interactions within the Health U application. The 12-month diabetes prevention program will follow the widely clinically-validated CDC Get Active to Prevent T2 curriculum.

For participants participating in the in-person version, they will complete the diabetes prevention program, which meets in-person and virtually approximately once every two weeks.

Eligibility criteria: Inclusion Criteria:

* 18 to 85 years old
* high risk for type 2 diabetes (history of gestational diabetes, A1c 5.7-6.4)

Exclusion Criteria:

* pregnant
* non-English speaker
* not comfortable using a mobile application

Primary outcomes:
measure: Percent weight lost at 12 months from baseline weight
timeFrame: 12 months
Secondary outcomes:
measure: change in hemoglobin A1c
timeFrame: 12 months
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford Health Care
state: California
Study officials:
affiliation: Stanford University
name: Sandra A Tsai, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04649320: Perception of the COVID-19 Pandemic in Patients With Haematological or Solid Neoplasias
Official title: Investigation of the Perception of the COVID-19 Pandemic in Patients With Haematological or Solid Neoplasias Using Patient-reported Outcome Measures (PROMs)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Covid19
Keywords: SARS-CoV-2
COVID19 pandemic
cancer patients
distress
HRQOL
Lead sponsor: Medical University Innsbruck
Sponsor class: OTHER
First posted: 2020-12-02
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: adult cancer patients, with solid or hematologic malignancies, neither tested positive nor having COVID19 symptoms, with an age over 18 years

Brief summary: Cancer patients are among the most vulnerable individuals, whose health-related quality of life (HRQOL) may be substantially impacted by the COVID19 pandemic. We want to study how the COVID-19 pandemic influences the life of cancer patients and how these patients cope with the additional distress with the aim to facilitate the development of improved future interventional strategies to maintain resilience and HRQOL

Detailed description: In December 2019, the novel human pathogenic virus "SARS-CoV2" from the coronavirus family was identified, causing a respiratory disease known as "COVID19" (coronavirus disease 2019). COVID19 manifests itself primarily with influenza-like symptoms, but in special cases it can lead to severe conditions such as ARDS (acute respiratory distress syndrome). Compared to other pulmotropic viruses such as the influenza virus, SARS-CoV-2 is associated with a higher contagiousness and mortality.

Haematological and oncological patients are particularly vulnerable due to their advanced age, immunological restrictions in the context of the underlying disease and the treatment modalities (chemotherapy, radiation therapy, ...).

To evaluate the effects of the COVID19 pandemic on the perception of patients with malignant diseases, we aim to record so-called "patient-reported outcomes" (PROs) from patients at the University Hospital of Innsbruck at the Department of Internal Medicine V (Hematology and Oncology) and at the Department for Radiotherapy and Radiation Oncology. We use the validated EORT QLQ-C30 and a specially developed questionnaire for COVID19.

Eligibility criteria: Inclusion Criteria:

* Age \> 18 years
* validated hematological or oncological disease
* informed consent

Exclusion Criteria:

* Age \< 18 years
* Insufficient discernment

Primary outcomes:
measure: Influence of the COVID-19 pandemic on cancer patient's daily life
timeFrame: single time
Secondary outcomes:
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: Medical University of Innsbruck
state: Tyrol
Study officials:
affiliation: Medical University of Innsbruck, Anichstraße 35, A-6020 Innsbruck, Austria
name: Reinhard Stauder, M.D.
role: PRINCIPAL_INVESTIGATOR
References: