louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05183529: Monitoring Vital Signs With a Wireless Ingestible Device in Subjects Undergoing Polysomnography
Official title: Monitoring Vital Signs With a Wireless Ingestible Device in Subjects Undergoing Polysomnography
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep
Lead sponsor: Celero Systems, Inc.
Sponsor class: INDUSTRY
First posted: 2022-01-10
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: This Minimal Risk study is designed to evaluate the ability of the Celero ingestible Vitals Monitoring Pill (i.e., VM Pill) to measure respiration from within the gastrointestinal tract, in addition to performing an exploratory comparative analysis of data collected by the VM Pill and data collected from clinical monitoring sensors as part of polysomnography.


Eligibility criteria: Inclusion Criteria:

* Healthy individuals ages 18 - 65 inclusive who are indicated for a polysomnography study.

Exclusion Criteria:

* Patients with a history of abdominal surgery and/or any condition that may impact the GI tract, including but not limited to:

  * Constipation
  * Esophageal stricture
  * Esophagitis
  * Gastritis
  * Gastric ulcers
  * Peptic ulcer
  * Gallstones
  * Celiac Disease
  * Crohn's Disease
  * Ulcerative Colitis
  * Irritable Bowel Syndrome
  * Diverticulitis
  * Colorectal cancer

Primary outcomes:
measure: Evaluate the ability of the VM Pill to monitor respiration from within the GI tract
timeFrame: During polysomnography
Secondary outcomes:
Other outcomes:
Locations:
city: Morgantown
country: United States
facility: West Virginia University
state: West Virginia
Study officials:
affiliation: West Virginia University
name: Justin Kupec, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06239129: The Stockholm CREAtinine Measurements Project
Official title: The Stockholm CREAtinine Measurements (SCREAM) Project
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Kidney Diseases
Acute Kidney Injury
Diabetes Mellitus
Cardiovascular Diseases
Hypertension
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Region Stockholm
First posted: 2024-02-02
Enrollment: 3200000
Sex: ALL
Minimum age (years): 0
Maximum age (years): 110
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Stockholm residents with/without ever testing for creatinine or albumuninuria

Brief summary: The Stockholm CREAtinine Measurements (SCREAM) project is a healthcare utilization cohort including, at present, all adult residents in Stockholm between 2006 and 2021. The region of Stockholm had a population of 2.3 million citizens in 2021and provides universal healthcare with a single unified health-system. Administrative databases with complete information on socidemographic data, healthcare use, diagnoses and therapeutic/surgical procedures, and vital status were enriched with performed laboratory tests, dispensed prescriptions at Swedish pharmacies and validated kidney replacement therapy endpoints. Registries were linked and de-identified by the Swedish National Board of Welfare and are considered to have no or minimal loss to follow-up. Because the study utilized de-identified data, it was deemed not to require informed consent and was approved by the regional ethical review boards and the Swedish National Board of Welfare.

For detailed description of available data and linked registers please consult:

https://pubmed.ncbi.nlm.nih.gov/35028991/

Detailed description: Please consult cohort description in:

https://pubmed.ncbi.nlm.nih.gov/35028991/ https://pubmed.ncbi.nlm.nih.gov/26798472/

Eligibility criteria: Inclusion Criteria:

For both cohorts:

Be a resident of Stockholm during 2006-2021, of all ages

For the primary cohort:

To have undertaken at least one test of serum creatinine or albuminuria during 2006-2021. If this condition is met, we will then extract a broad range of laboratory tests

For the secondary cohort:

Anyone not undertaking a test of serum creatinine or albuminuria will conform the secondary cohort. In this cohort we will not extract any other laboratory test, but will obtain the rest of healthcare information

Exclusion criteria:

None

Primary outcomes:
measure: Adverse health events by levels of kidney function
timeFrame: 2006-2021
measure: Safety and efficacy of medications by levels of kidney function
timeFrame: 2006-2021
measure: Effect of medications or conditions on kidney function decline
timeFrame: 2006-2021
Secondary outcomes:
measure: Adverse health events associated to laboratory abnormalities
timeFrame: 2006-2021
Other outcomes:
Locations:
Study officials:
affiliation: Karolinska Institutet
name: Juan J Carrero, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03984929: Conexion: A Localized Information Resource on Diabetes and Depression for a Low-income Hispanic Community
Official title: Conexion: A Localized Information Resource on Diabetes and Depression for a Low-income Hispanic Community
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Depression
Keywords: Conexion
Diabetes
Depression
Low-income
Hispanic
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: National Library of Medicine (NLM)
First posted: 2019-06-13
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The proposed Conexion resource combines best publicly available evidence-based information and local community resources in one place. The information is curated and contextualized to meet local needs of consumers and providers. Content is tailored culturally and geographically to fit the community. This approach is consistent with evidence showing that individuals' interactions with health information and technology are "community embedded".

Detailed description: Nationwide, Hispanics have many barriers to accessing health information, and are subject to significant health disparities, including disproportionate burden of diabetes and untreated mental illness. The research team's preliminary research has identified diabetes and depression as the highest priority needs in the study community of Washington Heights-Inwood (WAHI), which is an urban, low-income neighborhood in New York City with 71% Hispanic residents, predominantly immigrants from the Dominican Republic. Many high-quality health information resources already exist on the internet but they are not reaching many segments of the population, including parts of the WAHI community. The novel concept the investigators propose here is an information resource localized to a community.

Eligibility criteria: Inclusion Criteria:

* Age 18 or older
* Washington Heights/Inwood resident (zip codes 10032, 10033, 10034, 10040)
* interest in information on diabetes or depression
* speak English or Spanish

Exclusion Criteria:

-

Primary outcomes:
measure: Patient Activation
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Isabella Geriatric Center
state: New York
city: New York
country: United States
facility: YM-YWHA of Washington Heights
state: New York
Study officials:
affiliation: Columbia University
name: Rita Kukafka, DrPH, FACMI
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00528229: Multi-Slice CT of the Chest( MSCT Findings After Lung Transplantation)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: CT of the Lung After Lungetransplantation
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2007-09-12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Time perspective: OTHER

Brief summary: The purpose of the study is to compare Multi-Slice Computer Tomography findings with histological and physiological changes observed in transplanted lungs with Progressive Graft Disfunction.


Eligibility criteria: Inclusion Criteria:

* All patients that have had a lung transplantation

Exclusion Criteria:

* Under 18,
* Reduced kidney function,
* Known contrast allergy; and
* Language problems that make cooperation difficult.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Department of Radiology, Rigshospitalet, Blegdamsvej 9
Study officials:
affiliation: Department of Radiology, Rigshospitalet. Denmark
name: Esther Belmaati, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01113229: Combined Use of Oxytocin and Misoprostol in the Prevention of Post Partum Haemorrhage
Official title: Combined Use of Oxytocin and Misoprostol in the Prevention of Post Partum Haemorrhage
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Hemorrhage; Complicating Delivery
Keywords: Post Partum Haemorrhage,
oxytocin,
misoprostol,
prevention,
delivery.
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2010-04-29
Enrollment: 1721
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To demonstrate that the combined used of oxytocin and misoprostol prevent from post partum haemorrhage better than oxytocin alone, following vaginal birth at 36 to 42 weeks.

Detailed description: Objective :

To demonstrate that the combined used of oxytocin and misoprostol prevent from post partum haemorrhage better than oxytocin alone, following vaginal birth at 36 to 42 weeks'.

Method :

Double blinded Randomized controlled trial in two centers over 30 months.

Treatment :

Patients will be randomly allocated into one of the two following group :

Group A : 10 UI of oxytocin IV during delivery of the anterior shoulder of the newborn and two misoprostol tablets taken orally (400µg) following cord clamp.

Group B: 10 UI of oxytocin IV during delivery of the anterior shoulder of the newborn and two placebo tablets taken orally following cord clamp.

Number of patients:

1550 patients per group (one third reduction of occurrence with alpha and beta set at 0.05 and 0.20 respectively). Patients were included in the study during 48 hours.

Eligibility criteria: Inclusion Criteria:

* Women\>18 years,
* during first stage of normal labor,
* at 36 to 42 weeks,
* with epidural analgesia and informed signed consent

Exclusion Criteria:

* Cesarean section delivery,
* clotting disorders,
* prostaglandin allergy,
* absent consent.

Primary outcomes:
measure: Occurrence of post partum hemorrhage > 500mL in 1 hour
timeFrame: 1 HOUR
Secondary outcomes:
measure: Occurrence of post partum hemorrhage > 1000mL in 1 hour
timeFrame: 1 HOUR
Other outcomes:
Locations:
city: Poissy
country: France
facility: Chi Poissy St Germain
Study officials:
affiliation: CHI POISSY ST GERMAIN
name: Patrick Rozenberg, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Quibel T, Ghout I, Goffinet F, Salomon LJ, Fort J, Javoise S, Bussieres L, Aegerter P, Rozenberg P; Groupe de Recherche en Obstetrique et Gynecologie (GROG). Active Management of the Third Stage of Labor With a Combination of Oxytocin and Misoprostol to Prevent Postpartum Hemorrhage: A Randomized Controlled Trial. Obstet Gynecol. 2016 Oct;128(4):805-11. doi: 10.1097/AOG.0000000000001626.
Clinical trial NCT00894829: Efficacy and Safety of Sodium Heparin (Eurofarma)
Official title: Randomized Clinical Trial of Sodium Heparin Effectiveness and Security in Patients Submitted to Heart Surgery Using Bypass
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cardiac Surgery
Keywords: heparin cardiac surgery
Lead sponsor: Azidus Brasil
Sponsor class: INDUSTRY
First posted: 2009-05-07
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The objective of this study is to verify, through a randomized, single-blind, multicentre, parallel and comparative study, the effectiveness of heparin sodium of porcine origin in patients undergoing heart surgery at that require the aid of cardiopulmonary bypass, through the control of hemostasis during and after surgery, based on the strengths of markers of coagulation TCA, TTPA, Anti-Xa, heparin bioavailable and loss of excessive blood (bleeding) at the end of the surgery.


Eligibility criteria: Inclusion Criteria:

* Patients who agree with all aspects of the study and sign the FICT;
* Patients of both sexes;
* Patients aged above 18 years;
* Patients with cardiac surgery and requiring movement; AND
* Extracorporeal.

Exclusion Criteria:

* Patients with hematological disorders that compromise the surgical changes (eg myeloproliferative syndromes, anemia Hb \<11.0 g / dL,
* Platelets \< 150,000 mm3);
* Patients with disorders of hemostasis (INR\> 1.40) (rTTPA\> 1.40);
* Patients with renal dysfunction (creatinine\> 1.50);
* Patients with deep hyperthermia;
* Liver disease (AST and ALT\> 2 times that of the reference value);
* Patients with a history of allergy to heparin or protamine;
* Patients with history of heparin-induced thrombocytopenia;
* Tables infection (eg endocarditis, infection of immune human (HIV), hepatitis B and C, septicemia and pneumonia);
* Reoperations;
* Use of antiplatelet (clopidogrel and ticlopidine) for less than 7 days;
* Use of acetylsalicylic acid is less than 5 days;
* Use of low molecular weight heparin for less than 24 hours; OR
* Use of non-fractioned heparin for less than 12 hours.

Primary outcomes:
measure: Comparison of TTPA, Anti-Xa and ACT
timeFrame: Pre - Operative (T0) Pre Heparinization (T1) Top of Extracorporeal (T2) Period Intraoperative (T3) Termination Extracorporeal (T4) Postoperative
measure: Comparison of bleeding
timeFrame: Pre - Operative (T0) Pre Heparinization (T1) Top of Extracorporeal (T2) Period Intraoperative (T3) Termination Extracorporeal (T4) Postoperative
Secondary outcomes:
measure: Adverse reactions
timeFrame: Pre - Operative (T0) Pre Heparinization (T1) Top of Extracorporeal (T2) Period Intraoperative (T3) Termination Extracorporeal (T4) Postoperative
Other outcomes:
Locations:
city: Valinhos
country: Brazil
facility: LAL Clinica Pesquisa e Desenvolvimento Ltda
state: Sao Paulo
Study officials:
References:
Clinical trial NCT03566329: Magnesium Sulphate Versus Lidocaine for Control of Emergence Hypertension
Official title: Control of Emergence Hypertension After Craniotomy: Comparison Between the Efficacy of Magnesium Sulphate and Lidocaine Infusion (Randomized Controlled Study)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Craniotomy
Hypertension
Keywords: craniotomy- Emergence- hypertension
Lead sponsor: Kasr El Aini Hospital
Sponsor class: OTHER
First posted: 2018-06-25
Enrollment: 90
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: Post-craniotomy emergence hypertension is a common phenomenon that may predispose to development of intracranial hematoma and cerebral edema.The aim of this study is to compare the safety and efficacy of Mgso4 versus lidocaine infusion for control of emergence hypertension after craniotomy.


Eligibility criteria: Inclusion Criteria:

* ASA physical status Ι or Π.
* scheduled patients for brain tumor excision.

Exclusion Criteria:

* Hepatic, renal, cardiac, pulmonary, or endocrine impairment.
* Signs of increased intracranial pressure or allergy to any of the used drugs.

Primary outcomes:
measure: postcraniotomy emergence hypertension response to the study drugs
timeFrame: 4hours
Secondary outcomes:
measure: Recovery time
timeFrame: 2 hours
measure: Incidence of side effects of the used drugs
timeFrame: 4 hours
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ahmed ELbadawy
Study officials:
affiliation: Faculty of medicine- Cairo University- Egypt
name: Ahmed ELbadawy, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01591629: The Effects of ∆-9-THC and Naloxone in Humans
Official title: Assessment of Cannabinoid-opiate Interactions in Humans With a Cannabis Use Disorder and Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Healthy
Keywords: Cannabis
Marijuana
Naloxone
THC
Psychotic Disorders
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2012-05-04
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this project is to examine the effects of mu-opiate antagonism on the rewarding and reinforcing effects of delta-9-tetrahydrocannabinol (THC), the main psychoactive ingredient of cannabis.


Eligibility criteria: Inclusion Criteria:

* At least one exposure to Cannabis

Exclusion Criteria:

* Cannabis Naive

Primary outcomes:
measure: Behavioral Measures
timeFrame: 4 test days
Secondary outcomes:
measure: Visual analog scales
timeFrame: 4 test days
measure: Clinician Administered Dissociative States Scales (CADSS)
timeFrame: 4 test days
measure: Psychotomimetic States Inventory (PSI)
timeFrame: 4 test days
measure: Marijuana Withdrawal Scale
timeFrame: 4 test days
measure: Clinical Opiate Withdrawal Scale
timeFrame: 4 test days
measure: Marijuana Craving Scale
timeFrame: 4 test days
measure: Neuro cognitive battery
timeFrame: 4 test days
Other outcomes:
Locations:
city: West Haven
country: United States
facility: VA Connecticut Healthcare System
state: Connecticut
Study officials:
References:
Clinical trial NCT06050629: The Characteristics of Backscattering With Depth in the Progression of Keratoconus
Official title: The Characteristics of Backscattering With Depth in the Progression of Keratoconus and Its Role in Forme Fruste Keratoconus Detection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Elasticum, Incomplete Pseudoxanthoma
Lead sponsor: Tianjin Eye Hospital
Sponsor class: OTHER
First posted: 2023-09-22
Enrollment: 223
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study was performed on patients with keratoconus and healthy participants admitted to Tianjin Eye Hospital from January 2020 to December 2022.

Brief summary: To investigate the variation in backscattering with depth between forme fruste keratoconus (FFKC), keratoconus, and normal eyes; to determine the backscattering changes in the characteristics of keratoconus progression; and to explore the diagnostic value of backscattering in FFKC.

Detailed description: To investigate the variation in backscattering with depth between forme fruste keratoconus (FFKC), keratoconus, and normal eyes; to determine the backscattering changes in the characteristics of keratoconus progression; and to explore the diagnostic value of backscattering in FFKC. A Scheimpflug corneal tomography image and caliper tool were used to obtain backscatter at every 2% depth at the thinnest point of the cornea, with the measured values expressed in grayscale units (GSU).

Eligibility criteria: Inclusion Criteria:

1. BCVA \<20/20 and a history of myopia or astigmatism;
2. presence of any of the following positive signs on slit lamp examination: corneal stromal thinning, cone-shaped anterior protrusions, Fleischer's ring, Vogt's striae, epithelial or subepithelial scarring;
3. abnormal corneal topography (maximum keratometry (K) value of \>47.2 diopters (D), bow-tie pattern with skewed radial axes, or inferior-superior asymmetry(3-mm I-S keratometric difference \>1.4 D).

Exclusion Criteria:

1. Patients with severe corneal scarring that affected light scattering and density maps showing "black holes" 2.Participatients with other corneal diseases 3. Eyes that have undergone surgery or trauma 4. Eyes with corneal dystrophy

-

Primary outcomes:
measure: backscattering
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Eye Hospital
state: Tianjin
Study officials:
References:
Clinical trial NCT03328429: Comparison of Intraoperative and Postoperative Outcomes of Bartholin Gland Marsupialisation Versus Cystectomy
Official title: Comparison of Intraoperative and Postoperative Outcomes of Bartholin Gland Marsupialisation Versus Cystectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bartholin Abscess
Keywords: bartholin
marsupialisation
abscess
Lead sponsor: Kanuni Sultan Suleyman Training and Research Hospital
Sponsor class: OTHER
First posted: 2017-11-01
Enrollment: 154
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare intraoperative and postoperative outcomes of Bartholin marsupialisation versus excision

Detailed description: Bartholin cysts and abscess are commonly seen. Different surgical procedures are done for therapy. Our aim is to compare intraoperative results and postoperative healing of patients undergoing marsupialisation versus excision.

Eligibility criteria: Inclusion Criteria:

* Age 18-40, Bartholin cyst/abscess

Exclusion Criteria:

* patients with systemical diseases, patients with recurrent Bartholin abscess

Primary outcomes:
measure: postoperative
timeFrame: 3 months
Secondary outcomes:
measure: operation time
timeFrame: during procedure
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Kanuni SSTRH
Study officials:
affiliation: KSSTRH
name: Berna Aslan Çein
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ozdegirmenci O, Kayikcioglu F, Haberal A. Prospective Randomized Study of Marsupialization versus Silver Nitrate Application in the Management of Bartholin Gland Cysts and Abscesses. J Minim Invasive Gynecol. 2009 Mar-Apr;16(2):149-52. doi: 10.1016/j.jmig.2008.10.006.