louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01487421: An Observational Study of Insulin Aspart and, if Necessary, Insulin Levemir (FlexPen®) in the Evening or at Bedtime
Official title: The Physiological Therapy of Type 2 Diabetes - NovoRapid® FlexPen® Before Meals, Additionally Levemir® FlexPen® in the Evening or at Bedtime if Needed
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2011-12-07
Enrollment: 2134
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: Patients with insufficiently controlled type 2 diabetes mellitus treated with diet, OAD (oral anti-diabetes drug), long acting insulin, premixed insulin or a combination

Brief summary: This study is conducted in Europe. The aim of this study is investigate the potential of a supplementary insulin therapy regimen (SIT) as intensification for insufficiently controlled patients with type 2 diabetes in a normal diabetes care setting.


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes
* OAD monotherapy
* OAD combination therapy
* Therapy with OAD and basal insulin
* Conventional insulin therapy with premixed insulin

Primary outcomes:
measure: HbA1c (glycosylated haemoglobin)
Secondary outcomes:
measure: Fasting blood glucose (FBG)
measure: 2-hours postprandial blood glucose
measure: Hypoglycemia
measure: Weight development
measure: Adverse Drug Reactions (ADRs) including Serious Adverse Drug Reactions (SADRs)
Other outcomes:
Locations:
city: Mainz
country: Germany
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT02504021: Family Meeting Study for End Stage Renal Disease
Official title: Family Consultation for High-Risk Inpatients With End Stage Renal Disease: A Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: End-stage Renal Disease
Lead sponsor: Wayne State University
Sponsor class: OTHER
Collaborators: name: Henry Ford Health System
First posted: 2015-07-21
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A randomized clinical trial for patients with end stage renal disease in which a family consultation condition is compared against a treatment as usual control condition on the hospital readmissions after 1 month as the primary outcome variable.

Detailed description: Patients hospitalized at Henry For Hospital who have end stage renal disease will complete baseline questionnaires and be randomized into the experimental or control condition. Patients randomized into the experimental condition will have a single family consultation session before the patient is discharged. A trained, master's level therapist will conduct the family consultation, which will use education, motivational interviewing, and other techniques to help the family engage and support the patient's health needs. Patients in both the experimental and control conditions will complete follow up questionnaires 1 month after discharge. Investigators will conduct chart reviews of outcome data, including readmissions, at 1, 3, and 6 months post-discharge.

Eligibility criteria: Inclusion Criteria:

* Hospitalized in inpatient Nephrology Unit at Henry Ford Hospital
* Has end-stage renal disease
* Willing and able to contact support person / family member about participating in the study

Exclusion Criteria:

* Persistent Delirium
* Non-English speaking

Primary outcomes:
measure: Early Hospital Readmissions - 1 Month
timeFrame: 1 Month
Secondary outcomes:
measure: Change in Instrumental Social Support
timeFrame: Baseline and 1-month follow-up
measure: Change in Medication Adherence
timeFrame: Baseline and 1-month follow-up
measure: Change in Depression
timeFrame: Baseline and 1-month follow-up
measure: Change in Anxiety
timeFrame: Baseline and 1-month follow-up
measure: Change in Biological Measures of Health
timeFrame: Baseline, 1, and 3 months
measure: Hospital Readmissions - 3 Months
timeFrame: 3 Months
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
Study officials:
affiliation: Henry Ford Health Systems
name: Mark W Ketterer, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01032421: Gonadal Steroid Manipulation and Personality Characteristics: Association With Mood Fluctuations and in Vitro Fertilization (IVF) Outcomes
Official title: Gonadal Steroid Manipulation and Personality Characteristics: Association With Mood Fluctuations & IVF Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mood Disorders
Keywords: women admitted to the In Vitro Fertilization unit
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2009-12-15
Enrollment: 100
Sex: FEMALE
Maximum age (years): 42
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women admitted for their first or second IVF cycle, under the age of 42. Please see the detailed inclusion and exclusion criteria.

Brief summary: The current study's primary aim is to investigate the association between neuroendocrine fluctuations and mood disorders by monitoring mood states over distinct hormonal phases during in-vitro-fertilization (IVF) treatment. The secondary goal of this study is to explore psychological profiles and coping mechanisms of women undergoing IVF, and to identify the ones that are associated with successful psychological adaptation to the process and a successful biological outcome.


Eligibility criteria: Inclusion Criteria:

1. Admitted for their first or second IVF cycle;
2. Demonstrated sufficient communication skills and level of understanding in the Hebrew language;
3. signed an informed consent;
4. Were under the age of 42;
5. Were not suffering from endometriosis or male factor in patients who underwent testicular sperm extraction (TESE);
6. Were not under psychotherapeutic or psychopharmacological treatment. The accepted indications for the IVF included a female factor, male factor or unexplained infertility.

Exclusion Criteria:

1. All others.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Zaig I, Azem F, Schreiber S, Amit A, Litvin YG, Bloch M. Psychological response and cortisol reactivity to in vitro fertilization treatment in women with a lifetime anxiety or unipolar mood disorder diagnosis. J Clin Psychiatry. 2013 Apr;74(4):386-92. doi: 10.4088/JCP.12m07805.
citation: Bloch M, Azem F, Aharonov I, Ben Avi I, Yagil Y, Schreiber S, Amit A, Weizman A. GnRH-agonist induced depressive and anxiety symptoms during in vitro fertilization-embryo transfer cycles. Fertil Steril. 2011 Jan;95(1):307-9. doi: 10.1016/j.fertnstert.2010.07.1073.
Clinical trial NCT05643521: The Acute Effects of Eucaloric and Hypocaloric Carbohydrate Restriction on Liver Fat Content and Metabolism in Obese Individuals
Official title: The Acute Effects of Eucaloric and Hypocaloric Carbohydrate Restriction on Liver Fat Content and Metabolism in Obese Individuals
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: NAFLD
Overweight and Obesity
Metabolic Syndrome
Diabetes
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
Collaborators: name: University of Copenhagen Danish Research Centre for Magnetic Resonance
name: Nutrition Exercise and sports Copenhagen University
First posted: 2022-12-08
Enrollment: 14
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Crossover Assignment Randomized diet intervention study in a cross over design
Primary purpose: BASIC_SCIENCE

Brief summary: The primary aim of this study is to investigate the acute changes in liver fat content in response to a fixed carbohydrate restriction (i.e. intake of 60g/day or 70g/day for women and men, respectively) in individuals with obesity. This will be performed both as 2 days of very low calorie diet (500 and 600 kcal/day for women and men, respectively) and 2 days of eucaloric low carbohydrate diet.


Eligibility criteria: Inclusion Criteria:

* Men (30-75 years) and postmenopausal women 45-75 years old
* Hba1c \<48 mmol/mol without antidiabetic treatment
* Obese (BMI 27-40 kg/m2)
* Non smokers

Exclusion Criteria:

* Anemia (hemoglobin \<8 mmol/L for men and \<7 mmol/L for women)
* TSH outside reference range
* Medication known to influence glucose metabolism or appetite regulation
* Contraindications for MR-scan: abdominal height exceed limitations of the MR-scanner, pacemaker or other electronic device implanted, implanted metal devices, severe claustrophobia
* Food allergies (including lactose and gluten intolerance), vegetarian/vegan diet or following specific dietary plans
* Alcohol consumptions \>84/168 g/week (women/men)
* Strenuous activity level \> 120 minutes per week
* \>5 kg weight loss within the last three months or previous bariatric surgery
* High risk of fibrosis of the liver (estimated by FIB4 score \> 3,25)

Primary outcomes:
measure: The primary outcome is the 1H-Magnetic Resonance Spectroscopy (MRS) determined liver TG content.
timeFrame: After 2 days completion of dietary intervention
Secondary outcomes:
measure: Secondary outcomes are fasting and postprandial plasma glucose, insulin, and plasma TG concentrations after 2 days VLCD or LC compared with 2 days of eucaloric conventional diet.
timeFrame: After 2 days completion of dietary intervention
Other outcomes:
measure: Explorative outcomes
timeFrame: After 2 days completion of dietary intervention
Locations:
Study officials:
References:
Clinical trial NCT02825121: Evaluation of Monitoring Neuromuscular Blockade the Flexor Hallucis Compared to the Adductor Pollicis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Observation of Neuromuscular Block
Flexor Hallucis
Adductor Pollicis
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2016-07-07
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Current guidelines recommend monitoring of neuromuscular blockade at the adductor pollicis by stimulation of the ulnar nerve at the wrist.

However, in certain situations (laparoscopic surgery, cranial surgery or surgical comfort, arterial catheterization), it is impossible to access the patient's wrists, delaying monitoring, antagonizing the neuromuscular block, the emergence from anesthesia and patient extubation , leading in some cases to single injections lack of control of the reversal of the patient.

To overcome these technical difficulties, a group nerve / muscle looks interesting and often easily accessible to the anesthesiologist.

The stimulation of the posterior tibial nerve can observe a response to the flexor hallucis brevis muscle and allows quick access to monitoring the reversal before the end of the intervention.

The primary outcome was to compare the speed of recovery from neuromuscular block flexor hallux versus that of the adductor pollicis.

The secondary objective was to compare the speed of installation of deep neuromuscular block flexor hallucis versus that of the adductor pollicis.

This is a prospective, exploratory, uncontrolled, single-center for routine care.

Are included all aged patients over 18 years, ASA I or II, without guardianship, having no known allergy to Atracurium, without neuromyopathy known, emergency surgery or full stomach, predictable difficult intubation .


Eligibility criteria: Inclusion Criteria:

* over 18 years
* Any elective surgery with single or multiple injection Atracurium for which hand and foot are accessible at the same time.
* ASA I or II patients
* free subject, without guardianship or subordination
* No opposition given by the patient after information

Exclusion Criteria:

* under 18 years
* known neuromyopathy
* Diabetics
* Emergency surgery and a full stomach
* predictable difficult intubation
* Pregnant or breastfeeding women, women of childbearing age who do not have effective contraception

Primary outcomes:
measure: Time of occurrence of a T4 / T1 ratio> 0.90 in the train of four flexor hallucis
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Poitiers
country: France
facility: Poitiers Universitary Hospital
Study officials:
References:
citation: Le Merrer M, Frasca D, Dupuis M, Debaene B, Boisson M. A comparison between the flexor hallucis brevis and adductor pollicis muscles in atracurium-induced neuromuscular blockade using acceleromyography: A prospective observational study. Eur J Anaesthesiol. 2020 Jan;37(1):38-43. doi: 10.1097/EJA.0000000000001090.
Clinical trial NCT05954221: Red Cell Lysis Buffer Application Versus Conventional Sample Processing in EUS-FNB
Official title: Red Cell Lysis Buffer Application Versus Conventional Sample Processing in Endoscopic Ultrasonography (EUS)-Guided Biopsy for Solid Pancreatic Lesions
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pancreatic Diseases
Keywords: EUS-FNB
sample processing
solid pancreatic lesion
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
First posted: 2023-07-20
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The goal of this clinical trial is to evaluate the application of red cell lysis buffer (RCLB) versus conventional sample processing in endoscopic ultrasonography (EUS)-guided biopsy for solid pancreatic lesions. The main questions it aims to answer are:

whether the application of red cell lysis buffer improves histological tissue quality by decreasing blood contamination.

Participants with solid pancreatic lesions who needs histological diagnosis will receive EUS-guided biopsy. The obtained specimens will be processed by RCLB and conventional formalin solution.

Researchers will compare the blood contamination score of specimens in RCLB group with the conventional group see if the blood contamination can be improved.


Eligibility criteria: Inclusion Criteria:

18 to 80 years old; Solid pancreatic lesions confirmed by clinical and CT/MRI/ PET imaging. Signed written informed consent

Exclusion Criteria:

Contraindication of EUS-guide procedure or technical infeasibility (e.g.,coagulation disorder, anatomical changes, large vessels along the puncture path) Pregnant Patient is enrolled in any other clinical protocol or investigational trial

Primary outcomes:
measure: Microscopic blood contamination assessments
timeFrame: 2 months
Secondary outcomes:
measure: Tissue integrity assessments
timeFrame: 2 months
measure: Macroscopic blood contamination assessments
timeFrame: 2 months
measure: Length of white core tissue
timeFrame: 2 months
measure: Diagnostic sensitivity
timeFrame: 2 months
measure: Diagnostic accuracy
timeFrame: 2 months
measure: Diagnostic specificity
timeFrame: 2 months
measure: Immunohistochemical assessment
timeFrame: 2 months
measure: RNA and DNA adequancy
timeFrame: 2 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Changhai Hospital
state: Shanghai
Study officials:
affiliation: Department of Gastroenterology, Changhai Hospital, Naval Medical University (Second Military Medical University), Shanghai, China.
name: Zhao Shen Li, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05448521: Postoperative Lactate and Atrial Fibrillation After CABG
Official title: Association of Postoperative Lactate Levels With Postoperative Atrial Fibrillation in Patients Undergoing Isolated Coronary Artery Bypass Graft Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Artery Disease
Atrial Fibrillation
Lead sponsor: Başakşehir Çam & Sakura City Hospital
Sponsor class: OTHER_GOV
First posted: 2022-07-07
Enrollment: 250
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 consecutive adult patients undergoing isolated CABG during the study period in the Department of Cardiovascular Surgery at Basaksehir Cam Sakura City Hospital will be evaluated for possible enrollment.

Brief summary: Postoperative atrial fibrillation (POAF) is associated with increased mortality and morbidity in patients undergoing isolated coronary artery bypass grafting (CABG). It has been estimated that 5-40% of CABG patients experience POAF. Advanced age, P wave abnormalities, left atrial dilation, emergency surgery, low left ventricle ejection fraction, low glomerular filtration rate and chronic obstructive pulmonary disease have been reported in the etiology. Predicting which patients would experience POAF following CABG is important since it would allow physicians to apply more focused prophylactic measures. Lactate is the final product of anaerobic glycolysis. Serum lactate level are increased in case of inadequate oxygen delivery to tissues. The investigators aim to assess whether serum lactate levels measured early in the postoperative period could be used as a predictive marker of POAF in adults undergoing isolated CABG.


Eligibility criteria: Inclusion Criteria:

* Undergoing isolated CABG
* Age \>18 years

Exclusion Criteria:

* Age \<18 years
* Pregnancy
* History of paroxysmal atrial fibrillation prior to surgery
* Undergoing concomitant procedures (e.g., CABG + valve surgery)
* Any preoperative cardiac rhythm other than normal sinus rhythm
* More than mild cardiac valve stenosis or insufficiency

Primary outcomes:
measure: Postoperative atrial fibrillation
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Basaksehir Cam Sakura City Hospital
Study officials:
affiliation: Başakşehir Çam & Sakura City Hospital
name: Ahmet Can Topcu, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Greenberg JW, Lancaster TS, Schuessler RB, Melby SJ. Postoperative atrial fibrillation following cardiac surgery: a persistent complication. Eur J Cardiothorac Surg. 2017 Oct 1;52(4):665-672. doi: 10.1093/ejcts/ezx039.
citation: O'Connor E, Fraser JF. The interpretation of perioperative lactate abnormalities in patients undergoing cardiac surgery. Anaesth Intensive Care. 2012 Jul;40(4):598-603. doi: 10.1177/0310057X1204000404.
citation: Dobrev D, Aguilar M, Heijman J, Guichard JB, Nattel S. Postoperative atrial fibrillation: mechanisms, manifestations and management. Nat Rev Cardiol. 2019 Jul;16(7):417-436. doi: 10.1038/s41569-019-0166-5.
Clinical trial NCT00385021: ChronoFOLFOX Plus Avastin for Patients With Metastatic Colorectal Cancer
Official title: ChronoFOLFOX Plus Avastin for Patients With Metastatic Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Colorectal Neoplasms
Keywords: Advanced
metastatic
colorectal
cancer
Avastin
Lead sponsor: Southwestern Regional Medical Center
Sponsor class: OTHER
First posted: 2006-10-06
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 86
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To determine efficacy in the delivery of chronomodulated chemotherapy.

Detailed description: The purpose of this study is to determine if treatment with 5-Fluorouracil, leucovorin, oxaliplatin, and Avastin will cause colorectal tumor cells to shrink or disappear. The study will also determine the safety of these drugs when given together and the quality of life of the patients who are enrolled in the study.

It is thought that these drugs will be better tolerated if they are chronomodulated, i.e., if they are given at certain times of day rather than as a continuous infusion.

Eligibility criteria: Inclusion Criteria:

* Histological proof of adenocarcinoma in primary colon or rectum tumor.
* Evidence of metastatic colorectal cancer or loco-regional recurrence or unresectable disease.
* Ages 18 to 86 years.
* Presence of at least one bi-dimensionally measurable disease with at least one diameter \> or = 2 cm.
* WHO/ECOG performance status \< 3 (0, 1, or 2)
* Prior treatment with oxaliplatin, 5-FU, or leucovorin permitted.
* Signed informed consent

Exclusion Criteria:

* Peripheral sensory neuropathy \> or = grade 3.
* Serum bilirubin (total) \> 3 X ULN.
* Symptomatic or uncontrolled brain metastasis.
* Metastases limited to bone, pleural effusion, or ascites.
* Uncontrolled overt cardiac disease.
* Uncontrolled hypercalcemia.
* Uncontrolled infections.
* Uncontrolled hypertension (\>180/110)
* History of GI perforation.
* History of arterial thromboembolic events.
* History of congestive heart failure.
* Patients taking warfarin (Coumadin).
* Patients who are pregnant.

Primary outcomes:
measure: The primary objective is to determine if the rate of adverse events among patients receiving chronoFOLFOX plus Avastin is acceptable compared to that in previous studies using the FOLFOX4 regimen.
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Tulsa
country: United States
facility: Cancer Treatment Centers of America at Southwestern Regional Medical Center, Inc.
state: Oklahoma
Study officials:
affiliation: Cancer Treatment Centers of America at Southwestern Regional Medical Center, Inc.
name: Petra Ketterl, MD
role: PRINCIPAL_INVESTIGATOR
References: