louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06350370: Short-term and Long-term Outcomes of Colorectal Cancer Treated With Natural Orifice Specimen Extraction Surgery : a National Registry-based Study
Official title: Short-term and Long-term Outcomes of Colorectal Cancer Treated With Natural Orifice Specimen Extraction Surgery : a National Registry-based Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Colorectal Cancer
Keywords: Colorectal cancer
Natural orifice specimen extraction surgery
Minimally invasive surgery
Lead sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Sponsor class: OTHER
First posted: 2024-04-05
Enrollment: 8000
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: TREATMENT

Brief summary: Natural orifice specimen extraction surgery (NOSES) has gained widespread recognition among scholars and has gradually been promoted and popularized around the world. However, the development of NOSES is still in the exploratory stage and there is a lack of strong evidence from evidence-based medicine to support its feasibility and safety, which has greatly affected its clinical application and development. Based on this, at the call of Professor Xishan Wang, the Chinese NOSES Alliance conducted a large retrospective clinical study involving multiple centers. By summarizing the NOSES cases of nearly 100 centers in China, the study aims to clarify the current status of NOSES surgery in China. Additionally, a comprehensive analysis and summary was conducted by combining the basic information of NOSES patients, perioperative data, postoperative pathological data, and follow-up information to further demonstrate the safety and feasibility of NOSES in the treatment of colorectal cancer. This study also provides more real and objective evidence-based medicine support for the promotion and development of NOSES surgery.


Eligibility criteria: Inclusion Criteria:

1. Pathological diagnosis of primary malignant tumor in the colon or rectum;
2. The surgery meets the definition in the "Consensus of NOSES Experts in Colorectal Cancer";

Exclusion Criteria:

1. Postoperative pathological diagnosis does not belong to primary malignant tumors in the colon or rectum;
2. The surgery does not meet the definition in the "Consensus of NOSES Experts in Colorectal Cancer".

Primary outcomes:
measure: Rate of short-term complication
timeFrame: 30 days after surgery
Secondary outcomes:
measure: Operative duration
timeFrame: 7 days
measure: Intraoperative blood loss
timeFrame: 7 days
measure: Time to first flatus after surgery
timeFrame: 7 days
measure: Time to first stool after surgery
timeFrame: 7 days
measure: Length of stay after surgery
timeFrame: 7 days
measure: 3-year disease free survival
timeFrame: 3 year
measure: 3-year overall survival
timeFrame: 3 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Hospital Chinese Academy of Medical Sciences
state: Beijing
Study officials:
References:
Clinical trial NCT02129270: Hematoma Block for Reduction of Distal Radius Fractures
Official title: Phase 4 Study of Hematoma Block for Reduction of Distal Radius Fractures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Fractures of the Distal Radius
Keywords: Fractures of the distal radius
Hematoma block
Lidocaine
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
First posted: 2014-05-02
Enrollment: 24
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to Prove that injection of 15 to 20 mL of lidocaine 1% into the fracture site (Hematoma block) is more effective in terms of pain relieving then injection of 10 mL of lidocaine 2%, and equally safe in terms of complications, for closed reduction of distal radius fractures.


Eligibility criteria: Inclusion Criteria:

* Patients with Fractures of the distal radius, with or without ulna fracture

Exclusion Criteria:

* Children,
* pregnant women,
* patients with infection or suspected infection on the site for injection.
* Patients whose condition requires general anesthesia (patients with more fractures other than the distal radius and ulna, patients with many damage...)

Primary outcomes:
measure: This study will be measured effective in terms of pain relieving with Visual Analog Scale.
timeFrame: 1 year
Secondary outcomes:
measure: This study will be measured safe in terms of complications to injection.
timeFrame: 1 year
Other outcomes:
Locations:
city: Afula
country: Israel
facility: HaEmek medical center
Study officials:
affiliation: HaEemek Medical Center
name: Nimrod Rozen, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00409370: Trial of Safety Nets In Hospitalized Patients
Official title: A Randomized Clinical Trial to Compare The Use Of Safety Net Enclosures With Standard Restraints in Agitated Hospitalized Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Delirium
Agitated Behavior
Alcohol Withdrawl
Acute Confusional State
Acute Psychosis
Lead sponsor: Griffin Hospital
Sponsor class: OTHER
First posted: 2006-12-08
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study compared standard hospital restraints to a newer safety net restraint system to compare them for acceptability, tolerance, duration of restrain, length of stay in the hospital, and satisfaction of MD, nurse, and relatives of patients.


Eligibility criteria: Inclusion Criteria:

1. age more than 18
2. hospitalized
3. acute confusion or agitation

Exclusion Criteria:

1. Patients who require acute respiratory or cardiac support such as patients requiring ventilator support or patients in cardiac or septic shock
2. Patients who have a documented history of claustrophobia
3. Patients or family members who refuse to consent for safety net treatment under any circumstances. Failure to obtain consent due to absence of or inability to reach a family member or to give consent to participate in the study
4. Failure to obtain consent due to absence of or inability to reach a family member within reasonable time or to give consent to participate in the study.
5. Acutely ill patients requiring intravenous vasopressors, intubation or ventilatory support
6. Other conditions deemed terminal within 24 hours as determined by the patient's attending physician
7. Patients who stay less than 24 hours in the hospital
8. If patient is already on restrains for more than 48 hours preceding enrollment.
9. If two or more limbs are already on restraint to protect IV lines.
10. Extreme degree of agitation requiring continuous IV sedation or anesthesia. Such patients may pose a danger to staff or themselves if their restraints were to be discontinued in order to put them on study restraints.
11. When the intent of single wrist restraint is only to hold the IV line and patient is not agitated or in delirium.

Primary outcomes:
measure: Perception of the Nurse
measure: perception of physician
measure: perception of family member
measure: agitated behavior scale
measure: alcohol withdrawal assessment scale
Secondary outcomes:
measure: total duration of restraint use
measure: length of hospital stay
measure: total sedative medication dose used
Other outcomes:
Locations:
city: Derby
country: United States
facility: Griffin Hospital
state: Connecticut
Study officials:
affiliation: Griffin Hospital
name: haq nawaz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03065270: Efficacy of Unstable Shoes for Instability and Lumbopelvic Pain
Official title: Efficacy of Masai Barefoot Technology (MBT) for Decreasing Pain and Improvement of Lumbopelvic Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lumbopelvic Postpartum Pain
Lead sponsor: Universidad Europea de Madrid
Sponsor class: OTHER
First posted: 2017-02-27
Enrollment: 24
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: During pregnancy, pregnant women adopt an atypical pattern position with the intention to maintain stability and balance.These postural changes can cause instability at the level of the sacroiliac joint with painful condition during pregnancy and postpartum.

40 % of women have postpartum lumbopelvic instability. In 17 % of cases the lumbopelvic pain is perpetuated.

Another alteration influenced by the gestational status and progress of labor is urinary incontinence (UI).

The mechanism developed by Masai Barefoot Technology (MBT) provides an unstable base. Some studies reviewed, indicate that this shoe increases muscle activity, contributes to the decrease of joint overload and thereby, decreases pain.

Objective To compare the efficacy of shoes with unstable sole MBT®, over the use of conventional sports shoes, in primiparous women with lumbopelvic postpartum pain.

Material and Methods Randomized clinical trial. 24 postpartum women from the Gynecology Service of the Hospital Universitario Madrid Chiron were included in the study.

The subjects were randomly divided into experimental and control group.


Eligibility criteria: Inclusion Criteria:

Primparous women.

* Postpartum, between 8-12 weeks after the date of delivery.
* With lumbopelvic pain and positive diagnostic tests of sacroiliac pain
* Women with ambulation ability.

Exclusion Criteria:

* Presence of vaginal prolapses.
* Be receiving another treatment for the alteration that concerns us, pharmacological or any other type of therapy.
* Neuromuscular alterations.

Primary outcomes:
measure: Pain
timeFrame: 9th week
Secondary outcomes:
measure: Pelvic Stability
timeFrame: 9th week
Other outcomes:
Locations:
Study officials:
affiliation: Universidad Europea
name: Raquel Diaz-Meco Conde, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05554770: Prevalence of Positional Nystagmus in a Population of Healthy Adults
Official title: Prevalence of Positional Nystagmus in a Population of Healthy Adults
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Positional Nystagmus
Healthy Volunteers
Lead sponsor: Aalborg University Hospital
Sponsor class: OTHER
First posted: 2022-09-26
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A population of healthy adults who meets the in- and exclusion criteria.

Brief summary: To investigate the prevalence of positional nystagmus in a population of healthy Danish adults.

Detailed description: Open-label, cross-sectional prospective study examining the prevalence of positional nystagmus in healthy adults (adult with no previous or current inner ear disease) using a mechanical repositioning chair (TRV-chair, Interacoustics, Middelfart, Denmark). Patients will undergo traditional testing related to positional nystagmus by means of both the Dix-Hallpike test and Supine Roll Test (SRT) bilaterally. Latency, duration, and slow phase velocities will be registered and examiner as well as order of the positional tests performed with the TRV chair will be block randomized.

Eligibility criteria: Inclusion Criteria:

* + 18 years

Exclusion Criteria:

* Previous or current BPPV, inner ear disease, other ear conditions or neurological conditions
* Reduced eye mobility
* Alcohol consumption within 48 hours
* Weight \> 150 kg.
* Known cerebral aneurysm
* Cerebral haemorrhage within 1 month
* Trouble cooperating during examinations
* DHI-score \> 14

Primary outcomes:
measure: Prevalence of positional nystagmus
timeFrame: 2 years
Secondary outcomes:
measure: Characteristics of positional nystagmus
timeFrame: 2 years
Other outcomes:
measure: Specify current diagnostic criteria for Benign Paroxysmal Positional Vertigo
timeFrame: 2 years
Locations:
city: Aalborg
country: Denmark
facility: Department of Otolaryngology, Head- and Neck Surgery and Audiology
state: North Denmark Region
Study officials:
affiliation: Aalborg University Hospital
name: Dan D Hougaard, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02705170: IMR Assessment in Patients With New Diagnosis of Left Ventricle Dilatation
Official title: Index of Microcirculatory Resistance (IMR) Assessment in Patients With New Diagnosis of Left Ventricular Dilatation Without Significant Coronary Artery Lesions: IMPAIRED Pilot Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiomyopathies
Microcirculation
Microvessels
Keywords: index of microvascular resistance
Lead sponsor: University Hospital of Ferrara
Sponsor class: OTHER
First posted: 2016-03-10
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing coronary artery angiography for new diagnosis of left ventricular dilatation (dilatative cardiomyopathy)

Brief summary: To establish if, in patients with new diagnosis of left ventricular dilatation without documentation at the coronary artery angiography of significant coronary artery lesions, there is a damage of the coronary microcirculation at the IMR (index of microcirculatory resistance) assessment

Detailed description: The Authors will enroll at the moment of coronary artery angiography patients without history of ischemic heart disease and new diagnosis (at transthoracic echocardiography) of left ventricular dilation.

All patients will undergo coronary artery angiography. To be enrolled, it is necessary to have the absence of significant coronary artery stenosis (angiographic evaluation of the lesion \>40%) in all the vessels (main and side branch).

The Authors will proceed to perform the evaluation of the index of microvascular resistance (IMR). The target vessel will be the left anterior descending artery.

An intracoronary pressure/temperature sensor-tipped guidewire will be used. Thermodilution curves will be obtained during maximal hyperemia. The IMR will be calculated from the ratio of the mean distal coronary pressure at maximal hyperemia to the inverse of mean hyperemic transit time.

Eligibility criteria: Inclusion Criteria:

* new diagnosis of left ventricular dilation (dilatative cardiopathy)
* absence of significant (\>40%) coronary artery disease at coronary artery angiography

Exclusion Criteria:

* history of ischemic heart disease
* history of significant valvular disease
* contraindication to hyperemic agent

Primary outcomes:
measure: Index of microcirculatory resistance
timeFrame: during coronary artery angiography
Secondary outcomes:
measure: cardiac death
timeFrame: 1-year
Other outcomes:
measure: all-cause death
timeFrame: 1-year
measure: heart failure
timeFrame: 1-year
Locations:
city: Cona
country: Italy
facility: University Hospital of Ferrara
state: Ferrara
Study officials:
affiliation: Azienda Ospedaliera Universitaria di Ferrara
name: Gianluca Campo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06083870: An Early Stage Study to Evaluate Oba01 for Injection in Patients With DR5 Positive LA/mNSCLC
Official title: A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of Oba01 for Injection in Patients With DR5 Positive LA/mNSCLC
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Non-small Cell Lung Cancer Metastatic
Lead sponsor: Shanghai Chest Hospital
Sponsor class: OTHER
First posted: 2023-10-16
Enrollment: 35
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: TREATMENT

Brief summary: This study will evaluate the safety, tolerability, pharmacokinetics and efficacy of Oba01 for injection in patients with DR5 positive LA/mNSCLC.


Eligibility criteria: Inclusion Criteria:

* Voluntary agreement to provide written informed consent.
* Man or woman ≥ 18 years and ≤75 years of age at the time of enrollment.
* Histologically and/or cytologically-confirmed locally advanced or metastatic NSCLC.
* Measurable lesion according to RECIST 1.1.
* Progression after systemic treatment for advanced NSCLC.
* Available archived paraffin-embedded or fresh tumor tissue from the primary tumor or metastasis for submission to the central laboratory.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Measurable and/or non-measurable disease as per RECIST 1.1 criteria.
* Adequate organ function as assessed by laboratory tests.
* Male or female subjects of child-producing potential must agree to use avoidance of pregnancy measures during the study and for 6 months after the last day of treatment.

Exclusion Criteria:

* Patient has received previous treatment with DR5 targeted regimen or antibody-MMAE conjugate.
* Brain metastases unless asymptomatic, stable and not requiring steroids for at least 7 days prior to start of study treatment.
* Subject with positive HCV-Ab, Anti-HIV or positive HBS-Ag with copies of HBV DNA \> ULN.
* Pregnancy, lactation, or breastfeeding.

Primary outcomes:
measure: maximal tolerance dose (MTD) of Oba01
timeFrame: DLT will be evaluated on 21 days of observation period
Secondary outcomes:
measure: Overall response rate(ORR)
timeFrame: Up to approximately 2 years
measure: Disease control rate (DCR)
timeFrame: Up to approximately 2 years
measure: Duration of response (DOR)
timeFrame: Up to approximately 2 years
measure: Progression-free survival (PFS)
timeFrame: Up to approximately 2 years
measure: Overall survival (OS)
timeFrame: Up to approximately 2 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Department of Oncology, Shanghai Lung Cancer Center, Shanghai Chest Hospital, Shanghai Jiao Tong University
Study officials:
References:
Clinical trial NCT03234270: Changes in Aviators' Body Core Temperature Measurements at F-35
Official title: Changes in Aviators' Body Core Temperature Measurements at F-35
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Aviation
Heat Stress
Keywords: Heat stress, pilots
Lead sponsor: Israeli Air Force Aeromedical Center
Sponsor class: OTHER_GOV
First posted: 2017-07-31
Enrollment: 10
Sex: MALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: The many complaints that have been expressed by the US aircrew of the F-35 regarding the heat stress in the cockpit raised an obvious concern that, as a result of such heat levels, the aviators' core body temperature may increase significantly, and subsequently cause severe cognitive impairment- risking both the pilot and the mission.

In order to validate this hypothesis, we will measure the aviators' core body temperatures while inside the cockpit of the F-35, to see whether their core body temperatures are rising to a level that can cause heat stress or not. The temperatures will be measured on another fourth generation aircraft as well for comparing purposes.

The temperatures will be measured using a Telemetric pill which will be ingested by each aviator. Once ingested, the pill will transmit the data to an external monitor. The collected data will be examined and analyzed in order to determine the likelihood of heat stress occurrence.


Eligibility criteria: Inclusion Criteria:

* F35 pilots
* Signing on informed consent

Exclusion Criteria:

* Sickness two weeks prior the experiment

Primary outcomes:
measure: Mean core temp. of F35 pilots in hot weather conditions
timeFrame: 40 minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02714270: Paperless Partograph for Management of Low Risk Labor
Official title: A Randomized Clinical Trial of Paperless Versus Modified World Health Organization Partograph in Management of First Stage of Labour
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Normal Labor
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2016-03-21
Enrollment: 370
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Paperless partograph is a technique used for monitoring the progress of labor before delivery, and arriving at the accurate time to intervene for ensuring a safe delivery.

The study will be carried out to find out the effectiveness of paperless partograph in management of labor and its effect on maternal and neonatal outcomes


Eligibility criteria: Inclusion criteria:

1. Age: 18 to 40 years
2. Gestational age 38-42 weeks
3. Singleton pregnancy
4. Vertex presentation
5. Women who will accept to participate in the study

Exclusion criteria:

1. Malpresentation
2. Induced labour
3. Multiple pregnancy
4. Medical diseases with pregnancy

Primary outcomes:
measure: Duration of active phase of labor
timeFrame: 12 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Ahmed Abbas
state: Cairo
Study officials:
References: