louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02167841: Comparison of Efficiency Between Practicing of Knee Chest Position and External Cephalic Version in Cases of Breech Presentation.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breech Presentation
Keywords: Breech presentation,
External cephalic version,
Maternal posture,
Pregnancy,
Caesarean section.
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2014-06-19
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Background: The incidence of breech presentation in pregnant women is 4%. The situation can be treated by two methods. The first is a version of the fetus from breech presentation to head presentation, which can be performed in several ways, such as, an action called EXTERNAL CEPHALIC VERSION as well as the Knee-Chest position by the pregnant mother and the second is a cesarean section. In this study we wish to investigate if the Knee-Chest position is as effective as the ECV action and as a result to decrease the need for ECV.

Hypotheses: According to our assumption, the Knee-Chest position can reduce the need for the ECV action.

Objectives: Investigate whether daily Knee-Chest position is as effective as ECV.

Methods: The investigators will conduct a "randomized clinical trial" study. Every pregnant woman in a breech presentation with a singleton between weeks 28-32 will be randomly assigned into one of two groups. In the first group the women will perform daily the Knee-Chest position between weeks 32-37. In week 37 the investigators will check via ultra sound if there was a successful version (if not, the woman would go to ECV) in the second group we will perform ECV without doing maternal Knee-Chest position before. Every woman will fill a questionnaire which includes gynecological history and details regarding the degree of persistence and performance of the activity. At the end of this process the investigators will analyze the results and will come to the conclusions.

Significance: With ECV there are number of risks and complications such as fetal distress, placental abruption, rupture of membrane, amniotic fluid embolism or damage to the uterus. The frequency of these complications is 1%-2%. If it is discovered that the Knee-Chest position is effective as the ECV action, the investigators will recommend every patient to persist with this position and avoid the ECV action and the risks it entails.


Eligibility criteria: Inclusion Criteria:

Pregnant woman in a breech presentation with a singleton between weeks 28-32.

Exclusion Criteria:

* Antepartum Hemorrhage.
* Premature rupture of membranes.
* Placenta Previa.
* Oligohydramnios.
* Twin Pregnancy.
* Uterine malformation.

Primary outcomes:
measure: number of participants
timeFrame: up to 5 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Kfar Saba
country: Israel
facility: Meir Hospital
Study officials:
References:
Clinical trial NCT06508541: The Prognosis of Colorectal Cancer Patients After Indocyanine Green Fluorescence-guided Radical Surgery
Official title: The Prognosis of Colorectal Cancer Patients After Indocyanine Green Fluorescence-guided Radical Surgery: a Retrospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Keywords: Indocyanine green
Colorectal cancer
prognosis
Lead sponsor: Shanghai Tong Ren Hospital
Sponsor class: OTHER
First posted: 2024-07-18
Enrollment: 235
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all patients with newly diagnosed CRC who underwent CRC surgery between December 2016 and August 2021 in Shanghai Tongren hospital

Brief summary: Previous studies of Indocyanine green (ICG) in colorectal surgery have focused on lymphatic mapping, lymph node detection, and the number of harvested lymph nodes. However, relatively few studies have evaluated the outcomes of this imaging technology, especially the prognosis following of colorectal cancer resection. The present study assessed the prognosis of colorectal cancer patients following ICG fluorescence-guided surgery as compared to conventional surgery without the use of ICG Fluorescence imaging


Eligibility criteria: Inclusion Criteria:

* age \&amp;gt; 18 years,
* confirmed diagnosis of primary CRC,
* preoperative tumor stage of cT1 to cT4, N-/+, M0 as determined by contrast-enhanced computed tomography (CT),
* no distant metastasis, -American Society of Anesthesiologists(ASA)Physical Status Classification score of 1, 2, or 3-

Exclusion Criteria:

* history of previous colorectal surgery, emergent surgery, or palliative resection;
* pregnancy or breastfeeding;
* allergy or history of an adverse reaction to ICG; and
* severe mental disorder.

Primary outcomes:
measure: disease-free survival(DFS)
timeFrame: 1 month
Secondary outcomes:
measure: the number of harvested lymph nodes
timeFrame: 1month
Other outcomes:
Locations:
city: Changning
country: China
facility: Shanghai Tongren Hospital
state: Shanghai
Study officials:
References:
Clinical trial NCT01750541: Haloperidol vs. Valproate in Agitation
Official title: Haloperidol vs. Valproate in the Management of Agitated Patients Presenting to the Emergency Department: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Psychomotor Agitation
Lead sponsor: Shahid Beheshti University of Medical Sciences
Sponsor class: OTHER
First posted: 2012-12-17
Enrollment: 56
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 aim of this study is to compare the efficacy of haloperidol and valproate in management of people with agitation in emergency department


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of psychomotor agitation
* aged 18 to 65 years

Exclusion Criteria:

* Pregnant patients
* Severe liver disease
* History of drug (haloperidol/valproate) allergy
* Readily amendable causes for the agitation (hypoxemia or hypoglycemia)
* Hypotension (systolic blood pressure (SBP) ≤ 90 mm Hg)
* Known history of liver disease or uncontrolled diabetes
* Noticeable or suspected head trauma
* Previous history of neuroleptic malignant syndrome
* Receiving psychotropic medication, neuroleptic agents or cholinesterase inhibitors at the time of enrollment

Primary outcomes:
measure: Reduction in Agitated Behavior Scale (ABS) score
timeFrame: within the first 30 minutes of treatment onset
Secondary outcomes:
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Department of Emergency Medicine, Imam Hossein Hospital
Study officials:
affiliation: Department of Emergency Medicine, Imam Hossein Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
name: Kamran Heydari, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02646241: Biopsy Protocol of Upper Gastrointestinal Subepithelial Tumors:Diagnostic Accuracy of EUS-FNB Versus Unroofing Biopsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Upper Gastrointestinal Subepithelial Tumors
Keywords: stomach neoplasm
biopsy
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2016-01-05
Enrollment: 47
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: To increase the diagnostic accuracy of subepithelial tumors, larger tissue samples are required. It is difficult to obtain adequate tissue samples. There were several biopsy methods to obtain tissue samples. Pathological examination would include mitosis counts, particularly in hypoechoic subepithelial tumors located in the 4th layer of the gastric wall, where differentiation between leiomyoma of benign nature and gastrointestinal stromal tumor (GIST) of malignant potential is essential.

So We hypothesize that unroofing biopsy is an more appropriate method than EUS-FNB(endoscopic ultrasonography guided fine needle biopsy). We will compare diagnostic accuracy and complications between EUS-FNB \& unroofing biopsy.


Eligibility criteria: Inclusion Criteria:

* Older than 19 years old and younger than 80 years old
* Suspected upper gastrointestinal subepithelial tumors(≥15mm, ≤35mm) that were originated from muscularis propria layer on endoscopic ultrasonography(EUS)

Exclusion Criteria:

* Patient who had bleeding tendency
* Any previous surgery on esophagus, stomach or duodenum
* Patients who can not be underwent sedated endoscopy
* Gastrointestinal subepithelial tumor that was not origianted from muscularis propria layer on EUS
* Constrast related allergic disease

Primary outcomes:
measure: diagnostic accuracy
timeFrame: within 7 days
Secondary outcomes:
measure: number of complications of procedure
timeFrame: within 7 days
measure: accuracy of malignant potential on contrast enhanced EUS
timeFrame: within 7 days
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Sevrance hospital
Study officials:
References:
citation: Park J, Park JC, Jo JH, Kim EH, Shin SK, Lee SK, Lee YC. Prospective comparative study of endoscopic ultrasonography-guided fine-needle biopsy and unroofing biopsy. Dig Liver Dis. 2019 Jun;51(6):831-836. doi: 10.1016/j.dld.2019.01.028. Epub 2019 Feb 19.
Clinical trial NCT04136041: Study Protocol for a Smartphone Application-based Intervention for Subthreshold Depression
Official title: Study Protocol for a Pilot Randomized Controlled Trial on a Smartphone Application-based Intervention for Subthreshold Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Subthreshold Depression
Lead sponsor: Kibi International University
Sponsor class: OTHER
First posted: 2019-10-23
Enrollment: 32
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: The investigators plan to conduct a randomized controlled trial to examine whether a Smartphone-based Intervention improves subthreshold depression symptoms compared to no intervention.

The purpose of this pilot randomized controlled trial is to investigate the feasibility of the final randomized controlled trial.


Eligibility criteria: Inclusion Criteria:

* 18 Years and older
* Males and females
* Center for Epidemiologic Studies Depression Scale score ≥16
* Written informed consent prior to participation
* Owns a smartphone with the iOS® operating system

Exclusion Criteria:

* Lifetime history of psychiatric disorders
* Currently receiving treatment for a mental health problem from a mental health professional
* Experience of a major depressive episode in the 2 weeks prior to the study, as ascertained using the Mini-International Neuropsychiatric Interview
* Vision or hearing deficits that negatively impact everyday life

Primary outcomes:
measure: Depression severity as measured by the Center for Epidemiologic Studies Depression Scale (CES-D) score.
timeFrame: Change from Baseline CES-D at 5 weeks
Secondary outcomes:
measure: Psychological distress as measured by the Kessler Screening Scale for Psychological Distress (K6) score.
timeFrame: Change from Baseline K6 at 5 weeks
measure: Anxiety as measured by the 7-item Generalized Anxiety Disorder Scale (GAD-7).
timeFrame: Change from Baseline GAD-7 at 5 weeks
Other outcomes:
Locations:
city: Takahashi
country: Japan
facility: Kibi International University
state: Okayama
Study officials:
References:
citation: Kato Y, Kageyama K, Mesaki T, Uchida H, Sejima Y, Marume R, Takahashi K, Hirao K. Study protocol for a pilot randomized controlled trial on a smartphone application-based intervention for subthreshold depression: Study protocol clinical trial (SPIRIT Compliant). Medicine (Baltimore). 2020 Jan;99(4):e18934. doi: 10.1097/MD.0000000000018934.
Clinical trial NCT03630341: Adding L-Carnitine to Clomiphene Citrate for Induction of Ovulation in Women With Polycystic Ovary Syndrome
Official title: Adding L-Carnitine to Clomiphene Citrate for Induction of Ovulation in Women With Polycystic Ovary Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Polycystic Ovary Syndrome
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-08-14
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Polycystic ovary syndrome is one of the most common endocrine disorders, affecting about 6-10% of women in their reproductive age. Anovulation and hyperandrogenism are often present together with hyperinsulinaemia and insulin resistance


Eligibility criteria: Inclusion Criteria:

* Primary or secondary infertility.
* Normal Hysterosalpingo-graphy
* Normal Semen analysis of the husband.

Exclusion Criteria:

* Patient's refusal.
* Male factors of infertility and/or abnormal Hysterosalpingo-graphy
* Hyperprolactinemia (prolactin ≥ 22 ng/dl).
* FSH on day 3 \> 15 mIU/mL.
* Gross ovarian pathology diagnosed by ultrasound.

Primary outcomes:
measure: clinical pregnancy rate
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01486641: Anterolateral Versus Posterolateral Approach to the Fractured Hip Arthroplasty
Official title: Anterolateral Versus Posterolateral Approach to the Fractured Hip Arthroplasty - a Change in Approach at Sundsvall Hospital.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Femoral Neck Fracture
Keywords: femoral neck fracture
arthroplasty
surgical approach
anterolateral
posterolateral
Lead sponsor: Sundsvall Hospital
Sponsor class: OTHER
First posted: 2011-12-06
Enrollment: 160
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether the anterolateral in comparison to posterolateral approach to the hip arthroplasty gives an equal or better clinical results.

Detailed description: The purpose of this study is to compare the anterolateral- to posterolateral approaches in patients suffering a displaced femoral neck fracture operated with an hip arthroplasty. Our hypothesis is that the anterolateral approach gives equal or better clinical function, health related quality of life and less complication and reoperations.

Eligibility criteria: Inclusion Criteria:

* Age \> 65 years
* Displaced femoral neck fracture

Exclusion Criteria:

* Pathologic fracture
* Not Swedish speaker
* Not living in Västernorrlands county

Primary outcomes:
measure: Womac
timeFrame: 1 year postoperatively
Secondary outcomes:
measure: EQ5D
timeFrame: 1 year postoperatively
measure: Harris Hip Score
timeFrame: 1 year postoperatively
Other outcomes:
Locations:
city: Sundsvall
country: Sweden
facility: Sundsvall Hospital
state: Västernorrlands län
city: Sundsvall
country: Sweden
facility: Department of orthopedic surgery Sundsvall Hospital
Study officials:
affiliation: Umeå University
name: Arkan S Sayed-Noor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ritter MA, Harty LD, Keating ME, Faris PM, Meding JB. A clinical comparison of the anterolateral and posterolateral approaches to the hip. Clin Orthop Relat Res. 2001 Apr;(385):95-9. doi: 10.1097/00003086-200104000-00016.
citation: Gore DR, Murray MP, Sepic SB, Gardner GM. Anterolateral compared to posterior approach in total hip arthroplasty: differences in component positioning, hip strength, and hip motion. Clin Orthop Relat Res. 1982 May;(165):180-7.
citation: Skoldenberg O, Ekman A, Salemyr M, Boden H. Reduced dislocation rate after hip arthroplasty for femoral neck fractures when changing from posterolateral to anterolateral approach. Acta Orthop. 2010 Oct;81(5):583-7. doi: 10.3109/17453674.2010.519170.
Clinical trial NCT00788541: A Dose-Volume Study of a Treatment for Elevated IOP Due to Open-Angle Glaucoma or Ocular Hypertension
Official title: A Dose-Volume Study of the Safety and IOP-Lowering Efficacy of Anecortave Acetate in Patients With Open-Angle Glaucoma or Ocular Hypertension
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Open-Angle Glaucoma
Ocular Hypertension
Keywords: Open-Angle Glaucoma
Intraocular Pressure
Anecortave Acetate
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2008-11-11
Enrollment: 197
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 purpose of this study was to assess the effects of total volume and total dose on the safety and intraocular pressure-lowering efficacy of Anecortave Acetate Suspension (3 mg and 48 mg) in 0.5 mL and 0.8 mL volumes when administered by anterior juxtascleral depot (AJD) for the treatment of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of Open-Angle Glaucoma or Ocular Hypertension for at least 6 months;
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Prior angle surgery in the study eye, severe visual field loss in either eye;
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Mean Intraocular Pressure
timeFrame: 6 months
Secondary outcomes:
measure: Percent of patients who remain rescue-medication free
timeFrame: 6 Months
Other outcomes:
Locations:
city: Fort Worth
country: United States
facility: Contact Alcon Call Center For Trial Locations
state: Texas
Study officials:
References:
Clinical trial NCT01616641: Orofacial Evaluation in Women With Rheumatoid Arthritis
Official title: Orofacial Evaluation in Women With Rheumatoid Arthritis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Keywords: rheumatoid arthritis
bite force
grip strenght
oral health
quality of life
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
name: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
First posted: 2012-06-12
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: 150 individuals, half of them, 75 were rheumatoid arthritis and the others 75 consisted the group control

Brief summary: Rheumatoid arthritis (RA) can affect any synovial joint. Unlike the hand, ever so valued in the physical examination of patients with RA, the joints in the area of the jaw and neck may also be affected in this disease and have their involvement usually underdiagnosed. There are few studies evaluating the incidence of orofacial alteration in the examination as well as the correlation between bite force (BF) and clinical and functional parameters in these patients. The aim of our study was to chacacterize the orofacial alterations in RA patients, correlate the results of the orofacial evaluation with clinical and disease activity parameters, and correlate the bite force with the hand strenght.


Eligibility criteria: Inclusion Criteria:

RA group:

* rheumatoid arthritis (American College of Rheumatology)

Control group:

* healthy

Exclusion Criteria:

* edentate be total, have been subjected to surgical procedure in the last six months in the region of the hands or oral maxillo facial

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00524641: Asthma Control-A "Patient Follow up Programme" Maintenance and Reliever Therapy in a Single Inhaler
Official title: A Patient Follow-up Program to Assess Asthma Control in Patients Using Symbicort® as Maintenance and Relief Therapy in a Single Inhaler (Symbicort® SMART: Budesonide/Formoterol 160/4.5 Mcg, 1 or 2 Inhalations x 2 Times Plus Additional Inhalations as Needed)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Keywords: Asthma
Symbicort
NIS
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2007-09-03
Enrollment: 1254
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Hospital out-patient departments and private clinics in all areas of Vietnam

Brief summary: To investigate the change in patient's asthma symptom control using ACQ scores after 4 to 6 weeks of Symbicort Turbuhaler (budesonide/ formoterol) in SMART approach.


Eligibility criteria: Inclusion Criteria:

* Asthma patients from both sexes, age 18 or older
* Have already been on Symbicort SMART treatment
* Willing to give written informed consents to participate in the program.

Exclusion Criteria:

* Patients who are not willing to give written informed consent
* Patients in emergency care for asthma at ICUs or COPD patients are excluded from the program.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Hanoi
country: Vietnam
facility: Research Site
city: Ho Chi Minh City
country: Vietnam
facility: Research Site
Study officials:
affiliation: TB and Lung Disease Hospital, Hanoi
name: Dinh Ngoc SY, MD
role: STUDY_CHAIR
affiliation: Cho Ray Hospital
name: Tran Van Ngoc, MD, PhD
role: STUDY_CHAIR
affiliation: Pharm Ngoc Thach Hospital
name: Nguyen Hong Duc
role: STUDY_CHAIR
affiliation: Ho Chi Minh City Univ of Medicine and Pharmacist
name: Do Van Dung, MD, PhD
role: STUDY_CHAIR
References: