louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03761147: Gastrointestinal Activation Post-elective CS (Cesarean Section) :A Comparison of Paula Method to Standard Care
Official title: Women's First Gastrointestinal Activation Post-elective Cesarean Birth During Post-partum Hospitalization:A Comparison of Paula Method (the Circular Exercises Method) to Standard Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bowel Dysfunction
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2018-12-03
Enrollment: 64
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Women generally report discomfort and a delay in GI motility after CS. The Paula method, circular exercises of ring muscles has been shown to increase GI motility. This method had not been studied in women post CS. The current study is comparing the resumption of bowel sounds after CS in women utilizing the Paula exercises to standard care (no exercises).


Eligibility criteria: Inclusion Criteria:

* Elective, singleton, term CS, with spinal or epidural anesthesia

Exclusion Criteria:

* GI/ absorption disorders (Chron's, IBS)
* general anesthesia
* urgent CS

Primary outcomes:
measure: Time to the Resumption of Bowel Functioning as Assessed by Flatus Passage
timeFrame: 72 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization, Jerusalem, Israel
Study officials:
References:
citation: Liebergall-Wischnitzer M, Shaphir A, Solnica A, Hochner-Celnikier D. Are Paula method exercises effective for gastrointestinal reactivation post-elective cesarean delivery? Randomized controlled trial. J Adv Nurs. 2021 Apr;77(4):2026-2032. doi: 10.1111/jan.14681. Epub 2020 Nov 29.
Clinical trial NCT05137847: A Study of Remitoro in Participants With Recurrent or Refractory Peripheral T Cell Lymphoma and Cutaneous T Cell Lymphoma (All Case Study)
Official title: Post-marketing Observational Study of Remitoro® Intravenous Injection 300 μg - Safety of Remitoro in Patients With Recurrent or Refractory Peripheral T Cell Lymphoma and Cutaneous T Cell Lymphoma (All Case Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lymphoma, T-cell, Peripheral
Lymphoma, T-cell, Cutaneous
Keywords: Peripheral T cell lymphoma
Cutaneous T cell lymphoma
Remitoro
E7777
Adverse drug reactions
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2021-11-30
Enrollment: 118
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants with recurrent or refractory PTCL or CTCL administered Remitoro will be included in this study.

Brief summary: The primary purpose of the study is to investigate the incidence of adverse drug reactions (ADRs) (ADR of special interest: capillary leak syndrome, infusion reaction, rhabdomyolysis, myelosuppression, infection, hepatic dysfunction, visual impairment/color blindness, ischemic heart disease/arrhythmia/cardiac failure, and severe skin disorders).


Eligibility criteria: Inclusion Criteria:

1. Participants with PTCL or CTCL.

Primary outcomes:
measure: Percentage of Participants with ADR
timeFrame: Up to Week 24
Secondary outcomes:
measure: Percentage of Participants With Best Overall Response (BOR)
timeFrame: Up to Week 24
Other outcomes:
Locations:
city: Nagoya
country: Japan
facility: Eisai Trial Site 3
city: Osaka
country: Japan
facility: Eisai Trial Site 1
city: Tokyo
country: Japan
facility: Eisai Trial Site 2
Study officials:
References:
Clinical trial NCT05925647: The Effects of Mesenchymal Stem Cell Secretome in Rheumatoid Arthritis Patients
Official title: The Effects of Mesenchymal Stem Cell Secretome in Rheumatoid Arthritis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis, Messenchymal stem cell secretome
Lead sponsor: Universitas Sebelas Maret
Sponsor class: OTHER
First posted: 2023-06-29
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study was divided into two groups, namely, control and treatment. Both received intervention in the form of a 1.5 cc injection on the scheduled day
Primary purpose: TREATMENT

Brief summary: This research is a clinical trial of administering mesenchymal stem cell secretome to rheumatoid arthritis patients.

Detailed description: This research is experimental. The research subjects were 30 rheumatoid arthritis patients. The control group received a placebo, and the treatment group received mesenchymal stem cell secretome on the 1st, 2nd, 3rd, 4th, 5th, 6th, 7th, 14th, 21st, and 28th. The data collected were erythroblastic acidity, hsCRP, interlukin 6, DAS-28, and assessment of drug side effects before and after therapy. Statistical test with paired difference test with p\<0.05

Eligibility criteria: Inclusion Criteria:

* Rheumatoid Arthritis Patients

Exclusion Criteria:

* Pregnancy

Primary outcomes:
measure: Rheumatoid Arthritis Disease Activity
timeFrame: The change of Disease activity score patients at 1 months
Secondary outcomes:
Other outcomes:
Locations:
city: Surakarta
country: Indonesia
facility: Moewardi General Hospital
state: Middle Java
Study officials:
affiliation: Universitas Sebelas Maret
name: Nurhasan Agung Prabowo, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pratama YS, Pradiptakirana R, Rachmah A, Prabowo NA. Autoimmune Thrombocytopenia in SLE and COVID-19. Eur J Case Rep Intern Med. 2021 Nov 3;8(11):002863. doi: 10.12890/2021_002863. eCollection 2021.
citation: Sholihah MM, Kusuma TRH, Hanif MI, Prabowo NA. Letter to the Editor on Type 1 diabetes onset triggered by COVID-19. Acta Diabetol. 2021 Sep;58(9):1283-1284. doi: 10.1007/s00592-021-01761-3. Epub 2021 Jun 28. No abstract available.
Clinical trial NCT02307747: Disruption of Circadian Rhythm and Healthcare-related Infection in Patients With Severe Trauma
Official title: Disruption of Circadian Rhythm and Healthcare-related Infection in Patients With Severe Trauma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infection
Keywords: infection in ICU
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2014-12-04
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Circadian rhythms, which play crucial roles in physiology, are emerging as important regulators of specific immune functions. Hospitalization in intensive care unit leads to a deep impairment of circadian rhythm. Infection is a frequent event during ICU hospitalization.

The investigators hypothesis is that in trauma patients the lack of circadian rhythm variations is associated with the occurrence of infection. The primary aim of the study is to assess the circadian variations of plasma Bmal1 in the occurrence of healthcare related infection during the 30 days after inclusion. The secondary aims are to assess the plasma expression of circadian genes (Clock, Cry1, Per3, and Rev-erba), the production of cytokines in plasma, and the concentration of cortisol, according to the occurrence of an infection.


Eligibility criteria: Inclusion Criteria:

* Trauma patients with an injury severity score \> 15, requiring mechanical ventilation for at least 24 h during the first 48 h and an arterial catheter.

Exclusion Criteria:

* Pregnant and lactating women

Primary outcomes:
measure: area under the curve representing the maximal expression of Bmal1 gene during the first 24 h following inclusion
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique Hôpitaux de Marseille
Study officials:
affiliation: Assistance Publique Hôpitaux de Marseille
name: Urielle Desalbres
role: STUDY_DIRECTOR
References:
citation: Coiffard B, Diallo AB, Culver A, Antonini F, Hammad E, Leone M, Mege JL. Exacerbation of circadian rhythms of core body temperature and sepsis in trauma patients. J Crit Care. 2020 Dec;60:23-26. doi: 10.1016/j.jcrc.2020.07.010. Epub 2020 Jul 16.
Clinical trial NCT05465447: The Long-term Outcome After Toric Intraocular Lens Implantation
Official title: The Long-term Outcome After Cataract Surgery With Toric Intraocular Lens Implantation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Corneal Astigmatism
Cataract
Lead sponsor: Wenzhou Medical University
Sponsor class: OTHER
First posted: 2022-07-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: From December 2012 to present, cataract patients underwent phacoemulsification combined with Toric IOL(SN6ATX) implantation by an experienced ophthalmologist (Dr. Zhao Yune) in Wenzhou Medical University Affiliated Eye Hospital(hangzhou branch).

Brief summary: Corneal astigmatism is refractive error that impairs uncorrected visual acuity. When patients undergo cataract surgery, implantation of toric IOL is deemed the most effective choice for correcting corneal astigmatism and reducing postoperative spectacle dependence. Previous studies report that the visual effects and rotational stability of toric IOLs are well maintained over 1- or 2-year follow-up periods. However, the long-term changes in the effects of toric IOLs remain unclear.

Detailed description: Corneal astigmatism is refractive error that impairs uncorrected visual acuity. When patients undergo cataract surgery, implantation of toric IOL is deemed the most effective choice for correcting corneal astigmatism and reducing postoperative spectacle dependence. Previous studies report that the visual effects and rotational stability of toric IOLs are well maintained over 1- or 2-year follow-up periods. However, there is a long-term against-the-rule (ATR) change of corneal astigmatism with aging，which influences the long-term outcomes of refractive surgery. The long-term changes in the effects of toric IOLs remain unclear. This study aim to observe the clinical effect of Toric IOL implantation in the correction of corneal astigmatism.

Eligibility criteria: Inclusion Criteria:

* ≥18years old
* Regular astigmatism
* Corneal astigmatism ≥ 0.75D

Exclusion Criteria:

* Macular degeneration and retinal disease, history of glaucoma, corneal disease
* Previous corneal or intraocular surgery, and history of ocular inflammation.
* Pupils can not be dilated (\< 7mm)

Primary outcomes:
measure: changes of magnitude of corneal astigmatism from pre-surgery to 3-5 years after surgery
timeFrame: before surgery and 3-5 years after surgery
measure: changes of axis of corneal astigmatism from pre-surgery to 3-5 years after surgery
timeFrame: before surgery and 3-5 years after surgery
measure: changes of manifest refractive astigmatism from1 -3 months after surgery to 3-5 years after surgery
timeFrame: 1-3 months after surgery and 3-5 years after surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03456947: Pregabalin Stabilize Cardiovascular Response to Intubation
Official title: Research of Pregabalin Stabilize Cardiovascular Response to Laryngoscopy and Tracheal Intubation of Patients Under General Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Effect of Laryngoscopy and Tracheal Intubation
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2018-03-07
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: The purpose of the study is to evaluate whether Pregabalin is safe and effective in stabilizing cardiovascular response to laryngoscopy and tracheal intubation of patients under general anesthesia.


Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists(ASA) grade I and II scheduled for elective surgery

Exclusion Criteria:

* patient refusal.
* patients with serious chronic kidney, liver, lungs, or cardiovascular diseases.
* allergy to any of the study medications.
* patients taking sedation or antihypertensive medications.
* suspected difficult intubation or intubation time more than 22s.
* pregnant or breastfeeding women.
* BMI\>30.

Primary outcomes:
measure: heart rate
timeFrame: heart rate 3 minutes after intubation
Secondary outcomes:
measure: Mean arterial blood pressure
timeFrame: baseline mean arterial blood pressure before drug administration, heart rate before intubation, heart rate after 0 minute, 1minute, 3minutes, 5 minutes, 7minutes, 10minutes after intubation and before skin incision
measure: systolic blood pressure
timeFrame: baseline systolic blood pressure before drug administration, heart rate before intubation, heart rate after 0 minute, 1minute, 3minutes, 5 minutes, 7minutes, 10minutes after intubation and before skin incision
measure: diastolic blood pressure
timeFrame: baseline diastolic blood pressure before drug administration, heart rate before intubation, heart rate after 0 minute, 1minute, 3minutes, 5 minutes, 7minutes, 10minutes after intubation and before skin incision
measure: Ramsay score
timeFrame: baseline Ramsay score before drug administration and Ramsay score before intubation
measure: Incidence of all clinical adverse events
timeFrame: 1hour after surgery
Other outcomes:
Locations:
Study officials:
affiliation: Zhongshan Hospital Qinpu Branch, Fudan University, Shanghai
name: Wei Chen
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chen W, Huang H, Yang C, Hu X, Bao F, Jiang H. Preoperative Low-dose and High-dose Pregabalin and Cardiovascular Response to Endotracheal Intubation: A Prospective, Randomized, Single-blind, Controlled Study in China. Clin Ther. 2019 Jan;41(1):68-77. doi: 10.1016/j.clinthera.2018.11.006. Epub 2018 Dec 13.
Clinical trial NCT06183047: Predictive Value of Early Changes of Chromogranin A Levels in Patients With Neuroendocrine Tumours Treated With PRRT
Official title: Predictive Value of Early Changes of Chromogranin A Levels in Patients With Neuroendocrine Tumours Treated With PRRT
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Early Release of Chromogranin A (CgA)
Lead sponsor: Military Institute od Medicine National Research Institute
Sponsor class: OTHER
First posted: 2023-12-27
Enrollment: 38
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: Patients with neuroendocrine tumours (NET) treated with peptide receptor radionuclide therapy (PRRT).

Brief summary: The results of the study suggest that an early change in CgA levels might serve as a prognostic factor in NET patients treated with PRRT.


Eligibility criteria: Inclusion Criteria:

* confirmed NET
* peptide receptor radionuclide therapy (PRRT)

Exclusion Criteria:

* lack of patient consent to a clinical trial

Primary outcomes:
measure: The CgA level change
timeFrame: 2016-2023
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Military Institute of Medicine
name: Andrzej Mazurek, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00726947: Ultrasound Elasticity Imaging of Venous Thrombi
Official title: Aging Venous Thrombi With Ultrasound Elasticity Imaging
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Thrombosis
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2008-08-01
Enrollment: 254
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to see if the investigators can use ultrasound imaging to determine the type of clots in patients to help better manage their care.

Detailed description: Deep vein thrombosis (DVT) is a blood clot and is a common illness that can result in pain and death if not recognized and treated well. Death can occur when the venous clots break off and form pulmonary emboli (PE), which can block the arteries of the lungs. DVT and PE most often complicate the course of sick patients but may also affect healthy persons. DVT can also be a chronic disease. In those instances in which DVT and PE develop, in addition to the death risk, hospitalization is drawn out and healthcare costs are increased. Therefore, the purpose of this study is to see if we can use ultrasound imaging to determine the type of clots in patients to help better manage their care.

Eligibility criteria: Inclusion Criteria:

* Male or female subjects who have a diagnosis of chronic DVT that is at least 2 weeks old and are free from an acute DVT on top of your chronic DVT.
* Male and female patients who have been diagnosed with an acute blood clot by the Diagnostic Vascular Lab and w/symptoms occurring within the previous 2 weeks.
* Patients under the age of 18 who give assent (permission) and whose parents give consent.
* Adult patients who give consent.

Exclusion Criteria:

* None

Primary outcomes:
measure: To determine if ultrasound imaging will aid in the diagnosis and classification of venous blood clots
timeFrame: approximately one year
Secondary outcomes:
measure: Follow-up with subjects who have been diagnosed with Acute DVT to see if they develop post-thrombotic syndrome (PTS)
timeFrame: first year following diagnosis of acute DVT
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Health System
state: Michigan
Study officials:
affiliation: University of Michigan
name: Jonathan Rubin, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03560947: Individual Responder Analysis of the Effectiveness of Manual Therapy and Exercise Versus Usual Care in Patients With Chronic Nonspecific Neck Pain
Official title: Modelo Preditivo Para os Resultados de Sucesso Com um Programa Combinado de Terapia Manual e exercício em indivíduos Com Dor Cervical crónica de Origem não-especifica
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Nonspecific Neck Pain
Keywords: chronic nonspecific neck pain
exercise
manual therapy
Lead sponsor: Universidade Nova de Lisboa
Sponsor class: OTHER
First posted: 2018-06-18
Enrollment: 46
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: The aim of this study is to compare the effectiveness of a combined intervention of manual therapy and exercise versus usual care, on pain intensity, disability, and global perceived recovery, in patients with chronic nonspecific neck pain.


Eligibility criteria: Inclusion Criteria:

* Chronic nonspecific neck pain at least 3 months, defined as pain in the cervical region without a specific anatomopathological diagnosis;
* Adults between 18 and 65 years of age and literate in Portuguese;

Exclusion Criteria:

* History of cervical trauma and/or history of surgery in the prior 6 months;
* Clinical signs of infection, tumor, neurological, inflammatory or systemic diseases;
* Pregnancy

Primary outcomes:
measure: Neck Pain Intensity
timeFrame: Baseline
measure: Neck Pain Intensity
timeFrame: 3 weeks
measure: Neck Pain Intensity
timeFrame: 6 weeks
measure: Neck Pain Intensity
timeFrame: Follow-up 3 months
measure: Neck Disability
timeFrame: Baseline
measure: Neck Disability
timeFrame: 3 weeks
measure: Neck Disability
timeFrame: 6 weeks
measure: Neck Disability
timeFrame: Follow-up 3 months
Secondary outcomes:
measure: Neck Global Perceived Recovery
timeFrame: Change from baseline of the global perceived recovery at 3 weeks; 6 weeks; Follow-up 3 months
Other outcomes:
Locations:
Study officials:
affiliation: NOVA Medical School | Faculdade de Ciências Médicas, Universidade Nova de Lisboa
name: Lúcia Domingues, M.Sc.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03731247: Optical Coherence Microscopy in Dermato-oncology
Official title: In Vivo Imaging Innovation : Optical Coherence Microscopy in Dermato-oncology
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Cancer
Keywords: Optical biopsy
Skin cancer
Diagnostic performance
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
Collaborators: name: DAMAE Médical
First posted: 2018-11-06
Enrollment: 273
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: One group of skin cancer patients One group without skin cancer patients
Primary purpose: DIAGNOSTIC

Brief summary: OCTAV is a medical device class I, CE marked, based on a new technique for high-resolution imager (cell) internal microstructures of all types of biological tissues in vivo or ex vivo, to a depth of penetration 800 .mu.m. It allows to explore the epidermis, the dermo-epidermal junction and middle dermis in a totally non-invasive (direct contact with the tissue without sampling).

Detailed description: At the coming of the patient in Dermatology for resection / biopsy of the tumor (usual practice), for the study, an image of the tumor will be performed with the OCTAV device (about 5 minutes) for the study. Then, according to usual practice, resection / biopsy will be performed.

This study aims to validate the clinical relevance of this device to characterize the 3 main skin cancers and to obtain the necessary data for the implementation of future clinical trials.

Eligibility criteria: FOR PATIENT

Inclusion Criteria:

* Patient with a cutaneous lesion suspicious for melanoma, basal cell carcinoma, squamous cell carcinoma, requiring a surgical excision
* Consent form signed
* Major patient

Exclusion Criteria:

* Allergy or intolerance to immersion oil (used for microscopy)
* If female, pregnant or breast-feeding
* Patient unable to stand still for 60 seconds
* Skin lesions located near patient eyes (\<3 cm)

FOR CONTROL GROUP

Inclusion Criteria:

* Aged between 18 to 40 years
* Consent form signed
* Patient of the dermatology department with non-pathological forearm skin

Exclusion Criteria:

* Allergy or intolerance to immersion oil (used for microscopy)
* If female, pregnant or breast-feeding
* Patient unable to stand still for 60 seconds

Primary outcomes:
measure: Sensitivity
timeFrame: Day 1
measure: Specificity
timeFrame: Day 1
Secondary outcomes:
measure: Measure of the thickness of the different skin layers (mm)
timeFrame: Day 1
Other outcomes:
Locations:
city: Saint Etienne
country: France
facility: Chu de Saint Etienne
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Jean-Luc PERROT, MD
role: PRINCIPAL_INVESTIGATOR
References: