louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00989534: Extended Work Schedules, Sleep Loss and Health
Official title: Extended Work Schedules and Health: Role of Sleep Loss
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep
Keywords: shift work
diabetes
Affects of shift work and sleep loss on health
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2009-10-05
Enrollment: 49
Sex: ALL
Minimum age (years): 21
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: This study aims to determine whether abnormal bodily rhythms contribute to elevate the risk of diabetes, independently of the amount of sleep loss.


Eligibility criteria: Inclusion Criteria:

* normal healthy men and women between the ages of 21 years and 39 years (inclusive) with normal weight (i.e., body mass index under 28 kg/m2 in men, 27 kg/m2 in women)
* normal findings on clinical examination, normal results on routine laboratory tests, normal EKG, normal glucose tolerance test, negative pregnancy test for women
* no personal history of psychiatric or endocrine illness
* no personal history of sleep disorder, usual total sleep time of at least 7 hours
* only female volunteers with normal ovulatory cycles will be included

Exclusion Criteria:

* subjects with irregular life habits (shiftworkers and subjects having traveled across time zones less than one month prior to the beginning of the baseline study)
* subjects taking any medication (including hormonal contraceptive therapy), and smokers are excluded
* subjects with significant sleep apnea (apnea index above 10) or significant arousal-associated periodic leg movements are excluded

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: The University of Chicago
state: Illinois
Study officials:
References:
citation: Leproult R, Holmback U, Van Cauter E. Circadian misalignment augments markers of insulin resistance and inflammation, independently of sleep loss. Diabetes. 2014 Jun;63(6):1860-9. doi: 10.2337/db13-1546. Epub 2014 Jan 23.
citation: Grimaldi D, Carter JR, Van Cauter E, Leproult R. Adverse Impact of Sleep Restriction and Circadian Misalignment on Autonomic Function in Healthy Young Adults. Hypertension. 2016 Jul;68(1):243-50. doi: 10.1161/HYPERTENSIONAHA.115.06847. Epub 2016 Jun 6.
Clinical trial NCT01512134: Deep Brain Stimulation for the Treatment of Obesity
Official title: Deep Brain Stimulation For Morbid, Treatment-Refractory, Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Obesity
DBS
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2012-01-19
Enrollment: 3
Sex: ALL
Minimum age (years): 22
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The purpose of this clinical study is to investigate the safety and efficacy of deep brain stimulation (DBS) as a treatment option for obesity.

Detailed description: The purpose of this clinical study is to investigate the safety and efficacy of deep brain stimulation (DBS) as a treatment option in the management of severe, treatment refractory, morbid obesity.

Eligibility criteria: Inclusion Criteria:

* At least 24 months post Roux-en-Y gastric bypass surgery without evidence of a sustained improvement in BMI after gastric bypass surgery for at least 6 months.
* Participant is willing to comply with all follow-up evaluations at the specified times
* Participant is able to provide informed consent
* Fluent in English

Exclusion Criteria:

* Medical contraindications for general anesthesia, craniotomy, or DBS surgery
* Evidence of neurological disorders, e.g., multiple sclerosis, Parkinson's disease and ischemic stroke, or severe brain atrophy or the presence of subdural hygromas or subdural hematomas.
* Severe cardiovascular, pulmonary, renal, liver, hematological disease, severe coagulopathy, acute infectious process

Primary outcomes:
measure: Percentage of excess weight loss
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University Medical Center
state: Ohio
Study officials:
affiliation: Ohio State University
name: Ali Rezai, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Weichart ER, Sederberg PB, Sammartino F, Krishna V, Corrigan JD, Rezai AR. Cognitive Task Performance During Titration Predicts Deep Brain Stimulation Treatment Efficacy: Evidence From a Case Study. Front Psychiatry. 2020 Feb 19;11:30. doi: 10.3389/fpsyt.2020.00030. eCollection 2020.
Clinical trial NCT06392334: Mast Cells and Its Proteases in COPD
Official title: The Role of Mast Cells and Its Proteases in Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: COPD Exacerbation
Keywords: mast cell
tryptase
chymase
COPD
Lead sponsor: Voronezh N.N. Burdenko State Medical Academy
Sponsor class: OTHER
First posted: 2024-04-30
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Mast cells proteases such as chymase and tryptase will be studied in the tissue of small and large airways in COPD patients


Eligibility criteria: Inclusion Criteria:

- COPD patients

Exclusion Criteria:

Other lung diseases, tumors, pregnancy

-

Primary outcomes:
measure: Number of mast cells in COPD lung tissue
timeFrame: up to 10 -12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Voronezh
country: Russian Federation
facility: Voronezh State Medical University
Study officials:
References:
Clinical trial NCT00518934: Study for Safety and Efficiency of Therapeutic Angiogenesis for Patients With Limb Ischemia by Transplantation of Human Cord Blood Mononuclear Cell
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Ischemia
Keywords: Safety and efficiency of angiogenesis for patients with limb
ischemia by transplantation of human cord blood mononuclear
cells
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2007-08-21
Sex: ALL
Maximum age (years): 60
Standard ages: CHILD
ADULT
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to analyze the safety and efficiency of therapeutic angiogenesis for patients with limb ischemia by transplantation of human cord blood mononuclear cells.


Eligibility criteria: Inclusion Criteria:Patients with ischemic symptoms such as claudication, rest pain or nonhealing ischemic wound

* Without evidence of improvement in response to conventional medical therapy
* Not candidates for surgical intervention or radiologic intervention

Exclusion Criteria:

* Malignant disease
* More than 60 years old
* Other significant medical conditions, including diabetes mellitus, hypertension, hyperlipidemia, etc.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center, Sungkyunkwan University School of Medicine
Study officials:
affiliation: Professor of division of vascular surgery, Samsung Medical Center, Sungkyunkwan University of School of Medicine
name: Dong-Ik Kim, Professor
role: STUDY_DIRECTOR
References:
citation: Kim DI, Kim MJ, Joh JH, Shin SW, Do YS, Moon JY, Kim NR, Lim JE, Kim AK, Eo HS, Kim BS, Cho SW, Yang SH, Park CJ, Shim JS. Angiogenesis facilitated by autologous whole bone marrow stem cell transplantation for Buerger's disease. Stem Cells. 2006 May;24(5):1194-200. doi: 10.1634/stemcells.2005-0349. Epub 2006 Jan 26.
Clinical trial NCT03293134: Clinical and Molecular Characterization of Cerebral Proliferative Vasculopathy
Official title: Clinical and Molecular Characterization of Cerebral Proliferative Vasculopathy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Proliferative Vasculopathy
Keywords: Fowler syndrome
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2017-09-26
Enrollment: 25
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Intrauterine fetal death and those from termination of pregnancy for fetal abnormality.

Brief summary: As principal objective, the study aims to:

1. Describe the spectrum and evaluate the frequency of angiodysplasia of the nevrax;
2. Establish the physiopathological basis of Fowler's syndrome;
3. Identify FLVCR2 partners and the signaling pathways involved;
4. Test new candidate genes: GPR124 and possible partners of FLVCR2.

As second objective, the study aims to:

* perform phenotype / genotype correlation if necessary;
* and propose a prenatal diagnosis in families with identified mutations.


Eligibility criteria: Inclusion Criteria:

* Angiodysplasia restricted to central nervous system with or without glomerular vasculopathy.
* Informed consent signed.

Exclusion Criteria:

* Vascular malformations not confined to the nevrax.
* No signature of consent.

Primary outcomes:
measure: Morphological analysis
timeFrame: throughout the study: 36 months
Secondary outcomes:
measure: Identification of novel disease
timeFrame: throughout the study: 36 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Necker Enfants Malades, APHP
Study officials:
affiliation: Hôpital Necker Enfants Malades, APHP
name: Tania Attié-Bitach, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Thomas S, Encha-Razavi F, Devisme L, Etchevers H, Bessieres-Grattagliano B, Goudefroye G, Elkhartoufi N, Pateau E, Ichkou A, Bonniere M, Marcorelle P, Parent P, Manouvrier S, Holder M, Laquerriere A, Loeuillet L, Roume J, Martinovic J, Mougou-Zerelli S, Gonzales M, Meyer V, Wessner M, Feysot CB, Nitschke P, Leticee N, Munnich A, Lyonnet S, Wookey P, Gyapay G, Foliguet B, Vekemans M, Attie-Bitach T. High-throughput sequencing of a 4.1 Mb linkage interval reveals FLVCR2 deletions and mutations in lethal cerebral vasculopathy. Hum Mutat. 2010 Oct;31(10):1134-41. doi: 10.1002/humu.21329.
Clinical trial NCT05785234: The Effects of Sufentanil vs. Remifentanil in Total Intravenous Anesthesia With Remimazolam on Postoperative Pain
Official title: The Effects of Sufentanil-remimazolam vs. Remifentanil-remimazolam Total Intravenous Anesthesia on Postoperative Pain in Laparoscopic-assisted Gastrectomy - A Randomized, Controlled Study-
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stomach Neoplasms
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2023-03-27
Enrollment: 66
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: In this study, the investigators evaluate the effect of total intravenous anesthesia using sufentanil-remimazolam and remifentanil-remimazolam on postoperative pain in patients undergoing laparoscopic gastrectomy.


Eligibility criteria: Inclusion Criteria:

1. 20years or older
2. Scheduled for laparoscopic-assisted gastrectomy
3. American Society of Anesthesiologists(ASA) physical status I and III

Exclusion Criteria:

1. Emergency operation
2. Patients with a history of severe hypersensitivity reaction to dextran 40
3. Patients who cannot use patient controlled analgesia(PCA)
4. Patients with morbid obesity \[body mass index (BMI) \>35 kg/m2\]
5. Patients with history of uncontrolled hypertension (diastolic BP \>110mmHg) or DM
6. Patients with history of heart failure (unstable angina, congestive heart failure)
7. Patients with history of liver failure, renal failure, allergic to medicine
8. Patients with history of cerebrovascular disease (cerebral hemorrhage, cerebral ischemia)
9. Patients with history of uncontrolled psychiatric disease (PTSD, anxiety, depression)
10. Patients with obstructive sleep apnea
11. Patients who cannot read the consent form (examples: Illiterate, foreigner)
12. Patients who withdraw the consent

Primary outcomes:
measure: Total consumption of fentanyl in 24 hours after surgery
timeFrame: after 24 hours postoperative period
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine
Study officials:
affiliation: Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine
name: Sun Joon Bai, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04327934: Mechanisms of Hypertension in Women With Polycystic Ovary Syndrome
Official title: Mechanisms of Hypertension in Women With Polycystic Ovary Syndrome
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: EARLY_PHASE1
Conditions: Polycystic Ovary Syndrome
Hypertension
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2020-03-31
Enrollment: 28
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Women with androgen excess polycystic ovary syndrome (AE-PCOS) leads to hypertension.

Detailed description: Our scientific premise is that in AE-PCOS women, the androgen-dominant hormonal milieu causes BP increases via sympathetic activation, vasoconstriction and renal sympathetic nervous system activation. Moreover, this androgen-dominant milieu increases BP via activation of the renin-angiotensin system.

Eligibility criteria: Inclusion Criteria:

* Clinical Diagnosis of Polycystic Ovary Syndrome
* Able to inject study drug
* Able to swallow pills

Controls:

-Diagnosis of Insulin resistance

Exclusion Criteria:

* Any woman that does not fit the inclusion criteria
* Males

Primary outcomes:
measure: Baroreflex Response to LBNP
timeFrame: Baseline, assessed at 7 days of GnRH, assessed at 16 days GnRH+ 5 days of Testosterone
measure: Free Plasma Testosterone Levels
timeFrame: Baseline, assessed at 7 days of GnRH, assessed at 16 days GnRH+ 5 days of Testosterone
measure: Renal Response to LBNP
timeFrame: Baseline, assessed at 7 days of GnRH, assessed at 16 days GnRH+ 5 days of Testosterone
measure: Renal Responses to LBNP
timeFrame: Baseline, assessed at 7 days of GnRH, assessed at 16 days GnRH+ 5 days of Testosterone
measure: Resting Systolic Blood Pressure
timeFrame: Baseline, assessed at 7 days of GnRH, assessed at 16 days GnRH+ 5 days of Testosterone
measure: Final Systolic Blood Pressure
timeFrame: Baseline, assessed at 7 days of GnRH, assessed at 16 days GnRH+ 5 days of Testosterone
measure: Resting Sympathetic Activity
timeFrame: Baseline, assessed at 7 days of GnRH, assessed at 16 days GnRH+ 5 days of Testosterone
measure: Sympathetic Baroreflex
timeFrame: Baseline, assessed at 7 days of GnRH, assessed at 16 days GnRH+ 5 days of Testosterone
Secondary outcomes:
measure: Aldosterone
timeFrame: Baseline, assessed at 7 days of GnRH, assessed at 16 days GnRH+ 5 days of Testosterone
measure: Renal Responses
timeFrame: Baseline, assessed at 7 days of GnRH, assessed at 16 days GnRH+ 5 days of Testosterone
Other outcomes:
Locations:
city: New Haven
country: United States
facility: The John B Pierce Laboratory
state: Connecticut
Study officials:
affiliation: Yale University
name: Nina Stachenfeld, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06825234: Prognostic Value of a Multidimensional Assessment for Survival in Elderly Patients With CKD 4B/5
Official title: Prognostic Value of a Multidimensional Assessment for Survival in Elderly Patients With CKD 4B/5
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Chronic Kidney Disease Stage 5
Chronic Kidney Disease Stage 4B
Keywords: Frailty
Patient-Related Outcomes
Personalised care
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2025-02-13
Enrollment: 390
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The population consisted of patients aged 75 years and older with stage 4B/5 chronic kidney disease (GFR\<20ml/min/1.73m²), who spoke French and were under the usual care of the nephrology units involved in the study.

Brief summary: The aim of this study is to determine a multidimensional signature (integrating frailty and patient-reported outcomes measures (PROMs) at entry into stage 4B/5 CKD) to improve prediction of renal death (dialysis, transplantation, conservative management, death).

Detailed description: In 2019, 4,263 patients starting dialysis in France were aged 75 years or older. This elderly population, often with comorbidities, poses a number of challenges for nephrologists, both in terms of initiation and modalities of dialysis and access to transplantation. Dialysis may offer little benefit in terms of survival, often at the cost of a significant impact on quality of life and number of hospitalisations. There is a current trend to offer conservative treatment as an alternative to dialysis. However, there are no objective criteria to guide this decision and the uremic syndrome may distort certain clinical perceptions. The aim of this study is to determine whether an assessment that incorporates multiple dimensions, including those of frailty, can help the clinician determine the best course of treatment for the patient.

Eligibility criteria: Inclusion Criteria:

* Patients with CKD stage 4B or 5 (first consultation with GFR \< 20 mL/min /1.73 m2 in CKD-EPI 2009).
* Fluency in French
* Membership of a French social security scheme
* Non-opposition from the subject to participate in the study

Exclusion Criteria:

* Subjects with limited legal capacity.
* Subjects still in the exclusion period of another study, or according to the national registry of clinical trial participants.
* Subjects with no social security coverage.
* Subjects judged by the investigator to be unlikely to comply with study procedures
* Subjects unable to understand the reasons for the study; psychiatric disorders judged by the investigator to be incompatible with inclusion in the study.

Primary outcomes:
measure: Overall survival
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Besançon
country: France
facility: Besançon University Hospital
city: Tours
country: France
facility: Tours University Hospital
Study officials:
References:
Clinical trial NCT05543434: Application of Hyaluronic Acid in Diabetes
Official title: Evaluation of The Clinical & Radiographic Parameters in Controlled Type 2 Diabetic Patients Treated With Non-Surgical Periodontal Therapy With & Without Using Hyaluronic Acid Gel
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Periodontal Diseases
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-09-16
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: sub gingival application of hyaluronic acid create great clinical improvement of periodontal pocket treatment.

Detailed description: To clinically and radiographically evaluate the adjunctive effect of the local application of a 0.8% hyaluronan gel in addition to scaling and root planing in treatment of controlled diabetic patients with stage II periodontitis.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years.
* Patient with controlled diabetic type 2 (HgA1C \<7) (Mori et al., 2021).
* Periodontitis stage II.
* Periodontitis grade B.
* Pocket depth \> 4 mm.
* Smoking ≤ 10 cigarettes/day.
* Cooperative patients able and accept to come for follow up appointments

Exclusion Criteria:

* • The use of antibiotics or anti-inflammatory drugs 1 month prior to the procedure and till the end of 6 months of follow-up.

  * Having surgical therapy or undergoing orthodontic treatment.
  * Ongoing drug therapy that might have an impact on the clinical signs and symptoms of periodontitis.
  * Pregnant and lactation females.
  * Smoking ˃ 10 cigarettes/day.
  * Patients with poor oral hygiene.
  * Any known allergies

Primary outcomes:
measure: Clinical attachment level gain
timeFrame: 3 months
Secondary outcomes:
measure: Pocket depth reduction
timeFrame: 3 moths
measure: Bleeding on probing
timeFrame: 3 months
measure: Gingival Recession
timeFrame: 3 months
measure: Radiographic Evaluation
timeFrame: 3 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: faculty of dentistry Cairo university
Study officials:
affiliation: master student
name: Reem M Alabbadi, BDS
role: PRINCIPAL_INVESTIGATOR
affiliation: Lecturer of Oral Medicine and Periodontology- faculty of dentistry/Cairo University
name: Nesma M Shemais, PHD
role: STUDY_DIRECTOR
affiliation: Associate Professor of Oral Medicine and Periodontology, Faculty of Dentistry, Cairo University
name: Karim F Elsayed, professor
role: STUDY_CHAIR
References: