louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04558190: Mitochondrial Dysfunction and Insulin Resistance in Skeletal Muscle
Official title: Mitochondrial Dysfunction and Insulin Resistance in Skeletal Muscle
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insulin Resistance
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
First posted: 2020-09-22
Enrollment: 10
Sex: MALE
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate the link between insulin resistance and alterations in skeletal muscle mitochondrial redox homeostasis


Eligibility criteria: Inclusion Criteria:

* Body mass index (BMI) ≥25 and \<40 kg/m2
* Fasting plasma glucose ≥ 5.6 mmol/L or HbA1c ≥ 5.7%
* HOMA2-IR \> 1.4
* VO2max \<45 ml/kg/min

Exclusion Criteria:

* Treatment with \>2 antidiabetic medications
* Insulin usage
* Chronic disease deemed by the study responsible medical doctor to interfere with any part of the study
* Chronic use of prescription medicine deemed by the study responsible medical doctor to interfere with any part of the study
* Smoking

Primary outcomes:
measure: Whole body Insulin sensitivity
timeFrame: 5 hours after lipid infusion
measure: Skeletal muscle insulin sensitivity
timeFrame: 5 hours after lipid infusion
Secondary outcomes:
measure: Mitochondrial respiration
timeFrame: Baseline
measure: Mitochondrial reactive oxygen species
timeFrame: Baseline
measure: Mitochondrial oxidative stress
timeFrame: Before (baseline) as well as 3 and 5 hours after lipid infusion
measure: Muscle redox status
timeFrame: Before (baseline) as well as 3 and 5 hours after lipid infusion
measure: Insulin signalling
timeFrame: Before (baseline) as well as 3 and 5 hours after lipid infusion
Other outcomes:
measure: Cardiorespiratory fitness
timeFrame: Baseline
measure: Body composition
timeFrame: Baseline
Locations:
city: Copenhagen
country: Denmark
facility: August Krogh Building
Study officials:
References:
Clinical trial NCT03882190: The Clinical Significance of Ovarian Function Detection and Protection in Fertility Preservation Surgery for Ovarian Malignancy
Official title: The Clinical Significance of Ovarian Function Detection and Protection in Fertility Preservation Surgery for Ovarian Malignancy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fertility Preservation Surgery
Ovarian Malignancy
Lead sponsor: Second Affiliated Hospital of Wenzhou Medical University
Sponsor class: OTHER
First posted: 2019-03-20
Enrollment: 20
Sex: FEMALE
Minimum age (years): 1
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The design of this prospective interventional study is to investigate the clinical significance of applying GnRHa preoperatively and postoperatively and detecting physical and endocrinic change in fertility preservation surgery

Detailed description: 20 patients with ovarian maligancies are anticipated to be enrolled in this study within 2 years. With their permission, they will be randomized into the control group and the experimental group when the latter is supposed to receive GNRHa preoperatively and postoperatively. And their physical and endocrinic indexes will be monitored. The effect of extra use of GnRHa will be observed by comparing these two groups' outcomes.

Eligibility criteria: Inclusion Criteria:

1. Volunteer to participate in the study with informed consent;
2. Females aged 10-90 who are confirmed with ovarian malignancy and are willing to receive GnRHa experimentally to preserve their fertility function.

Exclusion Criteria:

1. Pregnancy, lactation and postmenopause;
2. Suspected or identified as other tumors of genital tract;
3. History of hyperparathyroidism, infectious diseases (tuberculosis, AIDS), autoimmune diseases, or digestive system diseases (malabsorption, crohn disease and dysentery);
4. Other diseases or heavy injuries that will interfere with the results;
5. Simultaneous participation in another clinical study with investigational medicinal product(s) or researcher thinks the subjects are not suitable for this trial.

Primary outcomes:
measure: the content of FSH(mIU/mL), LH(mIU/mL), E2(pmol/L), P(nmol/L), T(nmol/L) and PRL(nmol/L)
timeFrame: 1 year during the perioperative period
measure: the volume of ovary(cm*cm*cm)
timeFrame: 1 year during the perioperative period
measure: the ovulating period
timeFrame: 1 year during the perioperative period
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02724150: Comparison of Low Against High Regimen of Proton Pump Inhibitors for Treatment of Acute Peptic Ulcer Bleeding
Official title: Low Dose Against High Dose of Proton Pump Inhibitors in Treatment Acute Peptic Ulcer Bleeding
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Gastroduodenal Ulcer
Marginal Ulcer
Peptic Ulcer Hemorrhage
Keywords: Gastroduodenal Ulcer
Marginal Ulcer
Peptic Ulcer Hemorrhage
Peptic Ulcer
Lead sponsor: Damascus Hospital
Sponsor class: OTHER
First posted: 2016-03-31
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evaluate the efficacy of Two different regimens of proton pump inhibitors High against Low in the management of acute peptic ulcer bleeding

Detailed description: Evaluate the efficacy of Two different regimens of proton pump inhibitors in the management of acute peptic ulcer bleeding First: loading dose 80 mg then 8mg/h iv continuous infusion for 3 days Second Loading dose 80 mg the 40 mg every 12 h for 3 days

Eligibility criteria: Inclusion Criteria:

* High risk ulcers defined according to the Forrest classification With respect to high-risk stigmata,
* active bleeding was defined as a continuous blood spurting (Forrest IA)
* oozing (Forrest IB) from the ulcer base.
* A non-bleeding visible vessel at endoscopy was defined as a discrete protuberance at the ulcer base(Forrest IIA).
* An adherent clot was one that was resistant to forceful irrigation or suction (Forrest IIB).

Exclusion Criteria:

* ulcer was malignant
* non ulcerative bleeding such as angiodysplasia , a Mallory-Weiss tear....

Primary outcomes:
measure: Mortality
timeFrame: 1 month
Secondary outcomes:
measure: Rebleeding
timeFrame: one month
measure: Surgery
timeFrame: one month
measure: Length of hospital stay
timeFrame: one month
measure: Blood transfusions
timeFrame: one month
Other outcomes:
Locations:
city: Damascus
country: Syrian Arab Republic
facility: Damascus Hospital
Study officials:
affiliation: Damascus Hospital
name: Marouf Alhalabi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06517550: Pulmonary Complications in Elderly Patients
Official title: Effect of Protective Lung Ventilation Measures on Pulmonary Complications in Elderly Patients After Upper Abdominal Laparoscopy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Postoperative Complications
Lead sponsor: China-Japan Friendship Hospital
Sponsor class: OTHER
First posted: 2024-07-24
Enrollment: 136
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The incidence of postoperative pulmonary complications in elderly patients undergoing upper abdominal laparoscopic surgery remains high, and the lung protective mechanical ventilation strategy aims to reduce the incidence of lung injury caused by ventilators. PEEP, as an important protective ventilation strategy, maintains end expiratory alveolar volume to improve intraoperative oxygenation and pulmonary respiratory mechanics, and plays a protective role in the lungs; Personalized PEEP is the most beneficial, especially for elderly patients. However, there is currently no ideal way to achieve precise and personalized regulation of PEEP. This project aims to target and control intraoperative mechanical ventilation to drive pressure, personalize PEEP titration, and conduct a randomized controlled study on perioperative changes in pulmonary oxygenation function and pulmonary complications in elderly patients undergoing upper abdominal laparoscopy.


Eligibility criteria: Inclusion Criteria:

* ASA\<III、 general anesthesia, 60-80 years, BMI\<30kg/m2, pneumoperitoneum time\>0.5h, laparoscopic surgery on the upper abdomen (stomach, liver, gallbladder)

Exclusion Criteria:

* Severe anemia (Hb\<60g/L), OSA, severe COPD (FEV1\<30% pre), asthma, bronchiectasis, preoperative pulmonary infection, respiratory failure, thoracic deformity, postoperative return to ICU, heart function grade III-IV, severe liver and kidney dysfunction (Child B or C, dialysis), intraoperative bleeding greater than 30% of blood volume.

Primary outcomes:
measure: the changes of oxygenation index
timeFrame: pre-surgery, leave-PACU, one-day after surgery and 7-day after surgery
Secondary outcomes:
measure: Incidence of pulmonary complications
timeFrame: 30 and 90 days after surgery
Other outcomes:
Locations:
city: Beijing
country: China
facility: China-Japan Friendship Hospital
state: Beijing
Study officials:
affiliation: China-Janpan Friendship Hospital
name: Feng X Ren, doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01755650: Phase 0 of 18F FPM Using PET/CT in Patients With a Variety of Malignancies
Official title: A Phase 0 Exploratory Microdosing Study of S-(3-18Ffluoropropyl)Homocysteine Hydrochloride; 18FFPM Using PET/CT in Patients With a Variety of Malignancies.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: EARLY_PHASE1
Conditions: Squamous Cell Carcinoma
Keywords: 18F FPM
PET/CT
microdosing
Lead sponsor: Peter MacCallum Cancer Centre, Australia
Sponsor class: OTHER
First posted: 2012-12-24
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to investigate the safety and potential effectiveness of the imaging compound 18F FPM for finding sites of malignancies.


Eligibility criteria: Inclusion Criteria:

* Written informed consent obtained prior to any protocol-specific procedures
* Male and female patients with histologically confirmed squamous cell carcinoma
* At least one site of active malignancy, as demonstrated on the pre-study 18F FDG PET/CT scan performed as part of routine clinical care
* Age \>/= 18 years
* Life expectancy \>/= 3 months
* ECOG Performance score of 0-2

Exclusion Criteria:

* Pregnant or breastfeeding females
* Systemic anti-neoplastic therapy within the 2 weeks prior to the pre-study 18F FDG PET/CT scan until after the 18F FPM PET/CT scan
* Any serious medical condition which the investigator feels may interfere with the procedures or evaluations of the study
* Patients unwilling or unable to comply with protocol or with a history of non-compliance or inability to grant informed consent

Primary outcomes:
measure: Safety of D-18F FPM and L-18F FPM administration as measured by occurrence of adverse clinical, biochemical or haematological events following 18F FPM administration
timeFrame: Up to 28 days following 18F FPM administration (+/- 7 days)
Secondary outcomes:
measure: Percentage of injected D-18F FPM and L-18F FPM dose in organs of interest.
timeFrame: 10, 30, 60 and 120 minutes post 18F FPM administration
measure: Percentage of unmetabolized D-18F FPM and L-18F FPM in plasma and urine after radiotracer administration.
timeFrame: 30 (plasma only) and 90 (plasma and urine) minutes post 18F FPM administration
measure: Absorbed organ doses expressed as micro Sv/MBq of administered D-18F FPM and L-18F FPM, and whole body dose expressed as milliSv/200MBq of administered dose
timeFrame: 10, 30, 60 and 120 minutes post 18F FPM administration
Other outcomes:
Locations:
city: East Melbourne
country: Australia
facility: Peter MacCallum Cancer Centre
state: Victoria
Study officials:
affiliation: Peter MacCallum Cancer Centre, Australia
name: Ben Solomon
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01610050: A Phase I Study of LFA102 in Japanese Patients
Official title: A Phase I, Multicenter, Open-label Study of LFA102 Administered Intravenously in Japanese Patients With Castration-resistant Prostate Cancer or Advanced Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Castration-resistant Prostate Cancer, Advanced Breast Cancer
Keywords: castration-resistant prostate cancer, advanced breast cancer
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2012-06-01
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will evaluate safety and tolerability to determine the MTD/RD.

Detailed description: This is a phase I open-label, multi-center, dose escalation study in Japanese patients with CRPC or advanced BC. LFA102 will be administered intravenously once every 4 weeks during the study. All patients will remain on treatment until they meet the criteria for study discontinuation (e.g. disease progression, unacceptable toxicity, patient withdrawal) or study closure.

This study is to evaluate the safety, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of LFA102. Each cohort will enroll a minimum of 3 patients. A two-parameter Bayesian logistic regression model employing the escalation with overdose control principle will be used during the escalation phase for dose level selection and for determination of the MTD or RD.

Eligibility criteria: Inclusion Criteria:

* Histologically confirmed diagnosis of prostate cancer
* Histologically or cytologically confirmed locally advanced or metastatic breast cancer

Exclusion Criteria:

* Patients with untreated and/or symptomatic metastatic CNS disease
* Prior anaphylactic or other severe infusion reaction
* Treatment with agent which affect prolactin levels
* Active autoimmune disease

Other protcol-defined Inclusion/Exclusion criteria may apply.

Primary outcomes:
measure: Dose Limiting Toxicities (DLT)
timeFrame: 1st treatment cycle (28 days)
Secondary outcomes:
measure: Frequency, duration and severity of Adverse Events (AEs)
timeFrame: at informed consent, until 28 days after treatment discontinuation
measure: Serum Concentration
timeFrame: cycle 1 day 1 until disease progression
measure: Objective Response Rate
timeFrame: every 8 week or 12 weeks, until disase progression
measure: Antibodies against LFA102
timeFrame: day 1 of each treatment cycle until disease progression
measure: Progression Free Survival
timeFrame: every 8 or 12 weeks until disease progression
measure: PK parameters
timeFrame: cycle 1 day 1 until disease progression
Other outcomes:
Locations:
city: Nagoya-city
country: Japan
facility: Novartis Investigative Site
state: Aichi
city: Kobe-city
country: Japan
facility: Novartis Investigative Site
state: Hyogo
city: Chuo-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT05898750: Antidiabetic Potiential of Moringa and Dom Extract
Official title: Antidiabetic Potential of Hyphanea Thebaica Fruits and Moringa Olifera Leaves
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Diabetes
Lead sponsor: Deraya University
Sponsor class: OTHER
First posted: 2023-06-12
Enrollment: 25
Sex: ALL
Minimum age (years): 30
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The Antidiabetic potential of Hyphaene thebaica fruits and Moringa oleifera leaves will be investigated in diabetic patients (type 2). The patients will be maintained on tea of both drugs for 6 weeks. The fasting blood glucose levels of patients will be checked on a daily basis. Other blood biomarkers will be also reported such as insulin concentration, Lipid profile, liver enzymes, c-peptide and glycated hemoglobin


Eligibility criteria: Inclusion Criteria:

* diabetic patients type 2

Exclusion Criteria:

* liver failure
* heart failure
* renal failure

Primary outcomes:
measure: Blood glucose level
timeFrame: 3 months
Secondary outcomes:
measure: blood level of lipid profile
timeFrame: two weeks
measure: Liver enzymes
timeFrame: two weeks
measure: C-peptide level
timeFrame: two weeks
measure: Insulin level
timeFrame: two weeks
Other outcomes:
Locations:
city: Minya
country: Egypt
facility: Soad A. Mohamad
Study officials:
References:
Clinical trial NCT00614250: Evaluation of the Effect of AVE0657 on Obstructive Sleep Apnea
Official title: A Double-blind, Randomized, Placebo-controlled, Study of the Safety and Activity of Four Escalating Single Doses of AVE0657 in Patients Suffering From Obstructive Sleep Apnea Hypopnea Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Sleep Apnea, Obstructive
Keywords: Obstructive sleep apnea
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2008-02-13
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to assess the activity of 4 escalating doses of AVE0657 in comparison to placebo in patients with Obstructive Sleep Apnea Hypopnea Syndrome.


Eligibility criteria: Inclusion Criteria:

* Subjects diagnosed with Obstructive Sleep Apnea Hypopnea Syndrome based on International Classification of Sleep Disorders

Exclusion Criteria:

* Subjects having been treated by Continuous Positive Airway Pressure, oral appliance during 4-weeks prior to randomization
* Chronic respiratory disease or inadequate respiratory parameters
* Body Mass Index (BMI) of ≤20 kg/m² or ≥35 kg/m²
* Surgical procedure to correct apnea within the last three months.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: Change in Apnea Hypopnea Index (AHI)
timeFrame: 2 days
Secondary outcomes:
measure: Safety and tolerability
timeFrame: 5 days
Other outcomes:
Locations:
city: Paris
country: France
facility: Sanofi- Aventis Administrative Office
city: Berlin
country: Germany
facility: Sanofi-Aventis Administrative Office
city: Barcelona
country: Spain
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: Hôpital Michallon - Grenoble - France
name: Patrick LEVY, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01091350: Influence of Equilibration Rate Constant (ke0) of Propofol on the Effect Site Concentration for Loss of Consciousness
Official title: Influence of Equilibration Rate Constant (ke0) of Propofol on the Effect-site Concentration for Loss of Consciousness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: General Anesthesia
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2010-03-24
Enrollment: 60
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The aim of this study is to validate that an effect compartment concentration for loss of consciousness (LOC) was varied according to different Keo value.


Eligibility criteria: Inclusion Criteria:

* Adult patients undergoing general anesthesia

Exclusion Criteria:

* Hepatic or renal disease
* Drug addiction

Primary outcomes:
measure: Estimated effect-site propofol concentration at loss of consciousness
timeFrame: after propofol infusion
Secondary outcomes:
measure: Time to loss of consciousness
timeFrame: after propofol infusion
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04866550: Health in Smart Rurality: Impact on Coordination of Care of Telemonitoring and Data Centralization of Frailty Patients
Official title: Health in Smart Rurality: Impact on Coordination of Care of Telemonitoring and Data Centralization of Frailty Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Obstructive Pulmonary Disease
Heart Failure
Keywords: Chronic diseases
Aging people
Cross-border care
New communication technology
Lead sponsor: Université de Reims Champagne-Ardenne
Sponsor class: OTHER
First posted: 2021-04-29
Enrollment: 50
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients aged over 60, living at home, with heart failure and / or chronic obstructive pulmonary disease, potentially requiring care cross-border (France and Belgium).

Brief summary: Chronic diseases are frequent (around 10% of the total population and 30% after 60 years) and accelerate age-related functional decline. Concerning cross-border patients, use of health services can be delayed given the distances, the lack of rapid road access and the limited availability of public transport and the complex organization of coordinated care.

One of the ways to reduce acute exacerbations and preserve the quality of life of patients is to detect warning signs early. One of the ways to do this is to use new communication technologies.

Detailed description: The aim of the study is to assess feasibility of using a connected tablet to assess clinical parameters with an alert system in frailty patients aged over 60, living at home, with heart failure and / or chronic obstructive pulmonary disease, potentially requiring care cross-border (France and Belgium).

Eligibility criteria: Inclusion Criteria:

* Patients aged over 60
* Patients living at home
* Patients with heart failure and / or chronic obstructive pulmonary disease,
* Patients potentially requiring care cross-border (France and Belgium).
* Patients agreeing to participate to the study

Exclusion Criteria:

* Patients who do not speak French
* Patients with severe cognitive impairment

Primary outcomes:
measure: Alert according to the connected tablet
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Reims
country: France
facility: Université de Reims Champagne-Ardenne
Study officials:
affiliation: Université de Reims Champagne-Ardenne - CHU de Reims
name: Jean-Luc NOVELLA
role: PRINCIPAL_INVESTIGATOR
References: