louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06419764: Combining Chinese Medicine and Nutrition to Enhance Weight Loss After Bariatric Surgery
Official title: Combining Chinese Medicine and Nutrition to Enhance Weight Loss After Bariatric Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Traditional Chinese Medicine Treatment
Weight Change
Lead sponsor: China-Japan Friendship Hospital
Sponsor class: OTHER
First posted: 2024-05-17
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to investigate the effects of Chinese herbal granule preparations on improving gastrointestinal symptoms in patients after bariatric surgery. It seeks to establish a novel treatment model that combines bariatric surgery with traditional Chinese medicine, providing clinical practice with additional evidence-based medical support.


Eligibility criteria: Inclusion Criteria:

1. BMI ≥ 27.5 kg/m²;
2. Undergoing metabolic bariatric surgery;
3. Traditional Chinese Medicine syndrome differentiation classified as Spleen Deficiency and Excess Dampness syndrome.

Exclusion Criteria:

1. Contraindications for metabolic bariatric surgery;
2. Type 1 diabetes;
3. Complicated by other significant systemic diseases, such as severe liver and kidney diseases, malignant tumors, psychiatric disorders, etc;
4. Concurrent use of other medications or treatments that may affect body weight, such as metformin, semaglutide, endoscopic interventions, etc;
5. Pregnant or lactating women.

Primary outcomes:
measure: Percentage change in body weight
timeFrame: Before bariatric surgery, 1 month after surgery, and 3 months after surgery.
Secondary outcomes:
measure: Traditional Chinese Medicine syndrome score
timeFrame: Before bariatric surgery, 1 month after surgery, and 3 months after surgery.
measure: blood glucose indicators
timeFrame: Before bariatric surgery, 1 month after surgery, and 3 months after surgery.
measure: blood lipid profile
timeFrame: Before bariatric surgery, 1 month after surgery, and 3 months after surgery.
Other outcomes:
Locations:
city: Beijing
country: China
facility: China-Japan Friendship Hospital
Study officials:
References:
Clinical trial NCT01781364: Neuroplasticity-oriented Cognitive Intervention in Early Onset and First Admission Schizophrenia
Official title: Neuroplasticity-oriented Cognitive Intervention in Early Onset and First Admission Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psychosis
Keywords: Brain Oscillations
Cognitive Performance
Lead sponsor: University of Konstanz
Sponsor class: OTHER
First posted: 2013-02-01
Enrollment: 20
Sex: ALL
Minimum age (years): 17
Maximum age (years): 37
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to reveal the specific effects of computer-aided cognitive training on course and rehabilitation in early onset schizophrenia

Detailed description: Impairment in cognitive functions is one of the main symptoms in schizophrenia and is currently one of the challenges in the treatment of the disease. We examine the beneficial effect of computer-aided training program on course and rehabilitation of young psychotic patients with early onset psychosis. In addition we develop predictors for the course of disorder from neuroimaging data.

Eligibility criteria: Inclusion Criteria:

* Early Onset Psychosis

Exclusion Criteria:

* Chronicity
* Insufficient German skills

Primary outcomes:
measure: change from baseline at post-training and at 3-months and at 7-months follow-up in each of the following outcome measures: neuropsychological test performance (MCCCB), GAF, PANSS, MEG event-related potentials (M50), alpha activity
timeFrame: baseline, post-training (training duration 4 weeks), 3-month follow-up, 7-month follow-up
Secondary outcomes:
measure: change from baseline in GAF score at 3-months and 7-moths follow-up
timeFrame: baseline, 3-months follow-up, 7-months follow-up
Other outcomes:
Locations:
city: Konstanz
country: Germany
facility: University Konstanz
state: Baden Wuerttemberg
Study officials:
affiliation: University of Konstanz
name: Brigitte S Rockstroh, Prof. Dr.
role: STUDY_DIRECTOR
References:
Clinical trial NCT05587764: Tempus Pro Monitor Registry
Official title: A Post Market Clinical Follow-up Study to Evaluate the Safety and Clinical Performance of the Tempus Pro, a Multi-parameter Vital Signs Monitoring Device With Specific Reference to ECG Recordings and Data Transmission Using Telemedicine
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sudden Cardiac Arrest
Emergency Care
Keywords: Tempus Pro
IntelliSpace Corsium
Lead sponsor: Philips Clinical & Medical Affairs Global
Sponsor class: INDUSTRY
Collaborators: name: North American Science Associates, LLC
First posted: 2022-10-20
Enrollment: 103
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pre- and inter-hospital transfer: emergency patients (adults and pediatrics).

Brief summary: A multicenter, prospective and retrospective, observational, post market study.

Detailed description: This observational study is to collect real-world data on the safety and performance of the Tempus Pro device, its accessories and the IntelliSpace Corsium telemedicine software device when used according to its intended purpose and the instructions for use, when used for patient monitoring.

Eligibility criteria: Inclusion Criteria:

Patients monitored by using Tempus Pro during pre-hospital care (ambulance transportation)

One or more 12-lead ECG recorded

Use of 3 or more of the following sensors to measure vital signs

* NIBP (Non-Invasive Blood Pressure)
* HR (Heart Rate)
* SpO2 (Oxygen Saturation)
* PVI (Pleth Variability Index)
* SpCO (Carboxyhemoglobin)
* SpOC (Oxygen Content)
* SpHb (Total Hemoglobin)
* SpMet (Methemoglobin Saturation)
* EtCO2 (End-tidal Carbon Dioxide)

Exclusion Criteria:

* None defined

Primary outcomes:
measure: Clinician assessment of 12-lead ECG reports
timeFrame: through study completion, an average of 1 year
measure: Diagnostic quality of 12-lead
timeFrame: through study completion, an average of 1 year
measure: Consistency of transmitted vital signs by Tempus Pro via IntelliSpace Corsium
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Number of all activated alarms
timeFrame: through study completion, an average of 1 year
measure: IntelliSpace Corsium transmission
timeFrame: through study completion, an average of 1 year
Other outcomes:
measure: Adverse Device Effects
timeFrame: through study completion, an average of 1 year
measure: Device Deficiencies
timeFrame: through study completion, an average of 1 year
Locations:
city: Pittsburgh
country: United States
facility: Philips
state: Pennsylvania
Study officials:
affiliation: CONSULTANT IN EMERGENCY MEDICINE, NHS LOTHIAN
name: Richard Lyon, MB CHB (HONS) MD MRCP FRCEM
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01774864: Efficacy and Safety Study of Udenafil to Treat Erectile Dysfunction
Official title: Phase 3 Study to Evaluate the Efficacy and Safety of Once-a-day Dosing of Udenafil in the Treatment of Erectile Dysfunction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Erectile Dysfunction
Lead sponsor: Dong-A ST Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2013-01-24
Enrollment: 349
Sex: MALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Study Design : multi-center, double-blind, placebo-controlled, randomized,

parallel group, fixed dose design

Phase : Phase III


Eligibility criteria: Inclusion Criteria:

* Male patients aged 20 years or more diagnosed with ED

Exclusion Criteria:

* Had uncontrolled blood pressure
* Had hepatic or renal dysfunction
* Was currently under anticancer chemotherapy
* Had a treatments for ED using other PDE-5 inhibitors

Primary outcomes:
measure: IIEF EF domain score
timeFrame: 24 weeks
Secondary outcomes:
measure: IIEF, IPSS
timeFrame: 24 weeks
Other outcomes:
Locations:
Study officials:
affiliation: the Catholic University of Korea St. Mary's Hospital
name: S W Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Korea University Guro Hospital
name: D G Moon, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Korea University Anam Hospital
name: J J Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Pusan National University Hospital
name: N C Park, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Samsung Medical Center
name: S W Lee, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Seoul National University Hospital
name: J S Paick, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Asan Medical Center
name: T Y Ahn, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Yeungnam University Hospital
name: K H Moon, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ewha Womans University
name: W S Chung, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Inje University
name: K S Min, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Chonbuk National University Hospital
name: J K Park, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kangdong Sacred Heart Hospital
name: D Y Yang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00148564: Energy Homeostasis Under Treatment With Atypical Antipsychotics
Official title: Energy Homeostasis and Metabolism in Patients With Schizophrenic Disorders Under Treatment With Atypical Antipsychotics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Schizophrenia
Keywords: weight gain
schizophrenia
atypical antipsychotics
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2005-09-08
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effects of different atypical antipsychotics on weight changes, energy homeostasis, metabolism, energy intake as well as activity.

Patients with schizophrenia or schizoaffective disorders will be randomly assigned to be treated with ziprasidone or olanzapine for 24 weeks.

Primary outcome parameter are the weight changes after 24 weeks.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of schizophrenia or related disorders(DSM-IV)
* Indication for long-term treatment with antipsychotics
* BMI between 20 to 30
* Weight changes less than 3kg in the last 3 months before inclusion
* Informed consent

Exclusion Criteria:

* Psychiatric comorbidity
* Depot antipsychotic in the last 2 months
* Antipsychotics in the last 2 weeks
* Treatment with olanzapine, clozapine or ziprasidone in teh last 3 months
* Treatment with drugs, that may lead to weight changes
* Significant endocrine, neurological, cardiovascular, hepatic, renal, metabolic, or other medical diseases or any clinically relevant abnormalities in laboratory tests
* Female subjects during pregnancy and breastfeeding
* Female subjects within childbearing years who were not using adequate birth control
* Patients who are judged by the investigator to be at serious suicide risk

Primary outcomes:
measure: Primary outcome parameter are the weight changes after 24 weeks between olanzapine and ziprasidone treatment
timeFrame: during treatment
Secondary outcomes:
measure: Changes in energy homeostasis, food intake, metabolism
timeFrame: during and after treatment
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité Universitaetsmedizin Berlin; Campus Charité Mitte; Dept. for Psychiatry and Psychotherapy
Study officials:
affiliation: Charite Campus Mitte; Dept. of Psychiatry and Psychotherapy and Department of Psychiatry, Kliniken Essen-Mitte
name: Martin Schaefer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02836964: Early Loading of Dental Implants: A Prospective Study in the Mandibular First Molar Area
Official title: Early Loading of Dental Implants: A Prospective Study in the Mandibular First
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Dental Implants
Lead sponsor: Loma Linda University
Sponsor class: OTHER
First posted: 2016-07-19
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Dental patients who are seen at the LLU Department of Implant Dentistry

Brief summary: This study will compare tissue healing outcome between early dental implant loading at 4 weeks and conventional dental implant loading at 3 months.

Detailed description: Both loading times are standard of care procedures. The rationale behind early loading is to reduce waiting time so dental implants can be utilized sooner.

Eligibility criteria: Inclusion Criteria:

1. Patients aged 18 years or older.
2. Willingness to comply with all study requirements.
3. Partially edentulous in the in mandibular first molar with presence of the mandibular second molar
4. Patients of ASA I and ASA II group. No relevant medical conditions such as uncontrolled diabetes mellitus, osteoporosis, malignancies, irradiation and blood dyscrasias.
5. Free from soft tissue mucosal lesions, caries, and active periodontitis at the time of implant insertion.
6. Sufficient alveolar bone volume at the implant recipient site at the time of the insertion.
7. Adequate oral hygiene. Full-mouth plaque score (FMPS) (O'Leary et al. 1972) full-mouth bleeding score (FMBS) (Ainamo \& Bay 1975) record as the percentage of surfaces, four per each tooth, patients need to have controlled their periodontal conditions (FMPS 20%, FMBS 20%).

Exclusion Criteria:

1. Pregnant or lactating females.
2. Systemic disease likely to compromise implant surgery; uncontrolled diabetes mellitus.
3. History of irradiation in the head and neck area.
4. Smoking.
5. Untreated periodontitis.
6. Alcohol or drug abuse.
7. History of Intravenous Bisphosphonate.
8. Previously augmented or tooth extraction at the intended implant recipient site within the last 6 months.
9. The use of regenerative procedures in conjunction with implant placement.
10. Presence of residual roots at the implant recipient site.
11. Stomatological diseases.
12. Clinical signs of bruxism.
13. Initial stability at least 30Ncm

Primary outcomes:
measure: Assessment of marginal bone level changes
timeFrame: Change between Implant Placement Visit and Final evaluation Visit at 6 months post dental implant
Secondary outcomes:
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University, Center for Implant Dentistry
state: California
Study officials:
affiliation: associate professor
name: Aladdin Alardah, DDS, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01508364: Nexavar as First Targeted Therapy in Patients With Advanced Renal Cell Carcinoma
Official title: NEXTAR - NEXavar® as First TARgeted Treatment for Patients With Advanced Renal Cell Carcinoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carcinoma, Renal Cell
Keywords: renal cell carcinoma, first targeted therapy, observational study
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2012-01-12
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will consist of patients with metastatic/advanced RCC (all histologies), who failed prior cytokine therapy or are not suitable for cytokine therapy and for whom Nexavar constitutes first targeted therapy.

Brief summary: This is an observational study which will investigate the use of Nexavar as first targeted therapy in patients with advanced renal cell carcinoma.


Eligibility criteria: Inclusion Criteria:

* Patients with a diagnosis of advanced Renal cell carcinoma (RCC) for whom the decision has been taken by the investigator to prescribe Nexavar.
* Patients who failed cytokine therapy or who are not suitable for cytokines for whom Nexavar is the first targeted drug treatment.

Exclusion Criteria:

* Prior targeted therapy for RCC
* Contraindications of Nexavar described in the Summary of Product Characteristics (SPC).

Primary outcomes:
measure: Duration of Nexavar treatment
timeFrame: up to 3 years
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: 1 - 1.5 years after LPLV
measure: Health related quality of life (HRQoL)
timeFrame: up to 3 years
measure: Progression-free survival (PFS)
timeFrame: up to 3 years
measure: Tumor status, of patients will be evaluated according to the categories "Complete Response", "Partial Response", "Stable Disease", "Clinical Progression", "Radiological Progression".
timeFrame: up to 3 years
measure: Incidence of Treatment-emergent Adverse Events (TEAE)
timeFrame: up to 3 years
Other outcomes:
Locations:
city: Many Locations
country: Germany
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT06171464: Prognostic Value of Pre-therapy 18F-FDG PET/CT for the Outcome of 18 FDG PET-guided SIB-IMRT in Patients With Head and Neck Cancer
Official title: Prognostic Value of Pre-therapy 18F-FDG PET/CT for the Outcome of 18 FDG PET-guided SIB-IMRT in Patients With Head and Neck Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Head and Neck Cancer
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2023-12-14
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients suffering from head and neck cancer who performed a PET-CT investigation with 18F-FDG for treatment planning with Intensity modulated Radiotherapy with integrated simultaneous boost (IMRT-SIB).

Brief summary: Head and neck cancer is the fifth most common cancer and represents 5% in the world.

Selecting patients for the most appropriate treatment remains difficult. Approximately 60-65% of patients undergo surgery followed or not by radiotherapy. Patients with early stage disease (I-II) are treated with one treatment modality (surgery or radiotherapy), while patients with more advanced stage disease (III-IV) receive multimodal treatment (surgery together with associated radiotherapy or less to chemotherapy). PET/CT plays a fundamental role in the management of head and neck cancer patients. This investigation is indicated for staging, especially in patients with disease in advanced stages, for evaluating the response to therapy and for looking for recurrences as it is more accurate in distinguishing scar tissue from neoplasm. The objective of this retrospective study is to evaluate the prognostic value of PET/CT in predicting the outcome of patients undergoing SlB-IMRT/intensity modulated radiotherapy). The study proposed here involves the retrospective recruitment of patients who have performed a PET/CT investigation with 18F-FDG (fluorodeoxyglucose) at the U.O. of HSR Nuclear Medicine in the staging and treatment planning phase, between 2005 and 2011. The inclusion condition of the patients was their PET/CT evaluation (planning and treatment) using the "DSTE" PET/CT system installed at the U.O. of Nuclear Medicine HSR on which, in the presence of homogeneous lesions. a particular correction technique is applicable, developed and validated previously by the research group, which allows possible metabolic markers to be extracted from the lesions in a quantitatively accurate way.


Eligibility criteria: Inclusion Criteria:

* patients suffering from head and neck cancer;
* patients who underwent PET-CT with 18F-FDG.

Exclusion Criteria:

* patients \<18 years

Primary outcomes:
measure: PET-CT investigation with 18F-FDG for staging patients with head and neck cancer.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03681964: Diagnostic Suspicion of Primitive Syndrome Sjögren's : Brest Cohort
Official title: Diagnostic Suspicion of Primitive Syndrome Sjögren's : Brest Cohort
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Primary Sjögren's Syndrome (pSS)
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2018-09-24
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with suspected pSS underwent a standardised evaluation

Brief summary: This study aims to evaluate the diagnosis performance of several item used for the classification, the diagnosis and the prognostic of pSS (primary Sjogren syndrome)


Eligibility criteria: Inclusion Criteria:

* Patients with suspected pSS underwent a standardised evaluation

Exclusion Criteria:

* Opposition of patient

Primary outcomes:
measure: classification criteria
timeFrame: Inclusion (Day 0)
Secondary outcomes:
Other outcomes:
Locations:
city: Brest
country: France
facility: CHRU de Brest
Study officials:
affiliation: CHRU de Brest
name: Valerie Devauchelle
role: STUDY_DIRECTOR
References:
Clinical trial NCT00000264: Subjective/Psychomotor/ Effects of Combined Alcohol & Nitrous Oxide - 16
Official title: Subjective/Psychomotor/ Effects of Combined Alcohol & Nitrous Oxide
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid-Related Disorders
Substance-Related Disorders
Keywords: nitrous oxide
inhalant
ethanol
subjective effects
psychomotor effects
healthy volunteer
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 1999-09-21
Enrollment: 8
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Intervention model: CROSSOVER

Brief summary: The purpose of this study is to examine the subjective, psychomotor, and reinforcing effects of combined alcohol and nitrous oxide intake in healthy volunteers.


Eligibility criteria: Please contact site for information.

Primary outcomes:
measure: Mood
timeFrame: Baseline and post inhalation
measure: Psychomotor performance
timeFrame: Baseline and post inhalation
measure: Cognitive performance
timeFrame: Baseline and post inhalation
measure: Choice of nitrous oxide vs placebo
timeFrame: after each ethanol session
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago, Anesthesia & Critical Care
state: Illinois
Study officials:
affiliation: University of Chicago
name: James Zacny, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: