louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03983889: Sedation Strategies for Diagnostic Bronchoscopy 2
Official title: The Effect and Safety of Different Sedation Strategies for Diagnostic Bronchoscopy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bronchoscopy
Sedation
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
Collaborators: name: Shanghai Zhongshan Hospital
name: Ruijin Hospital
name: Shanghai Pulmonary Hospital, Shanghai, China
First posted: 2019-06-12
Enrollment: 200
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: Diagnostic bronchoscopy is an invasive procedure performed to diagnose respiratory diseases. But pain has been complained by most of the patients receiving such procedures. Sedation or anesthesia was required by both of the patients and bronchoscopists. Unfortunately, no consensus has been made upon the sedation strategies. Multiple sedation approaches have been applied, such as midazolam and fentanyl, remifentanil and propofol, dexmedetomidine and propofol. The present study was designed to compare these protocols in sedation for diagnostic bronchoscopy.


Eligibility criteria: Inclusion Criteria:

* Scheduled for flexible diagnostic bronchoscopy
* Adult patients aged 18 to 65 years
* American Society of Anesthesiologists (ASA) Physical Status Classification I-II
* BMI 18.5-25kg/m2
* Subjects provide informed consent

Exclusion Criteria:

* Severe airway obstruction
* Coagulation disorder
* Repeat bronchoscopy (more than 3 times)
* Severe liver and renal dysfunction
* Cardiovascular and cerebrovascular diseases
* Pregnancy
* Chronic opioid user
* Drug abusers or addicts

Primary outcomes:
measure: Cough score
timeFrame: From the completion of local anesthesia with lidocaine to the completion of bronchoscopy procedure, assessed up to 2 hours
Secondary outcomes:
measure: Body movement
timeFrame: From the completion of local anesthesia with lidocaine to the completion of bronchoscopy procedure, assessed up to 2 hours
measure: Satisfaction score of the patients and bronchoscopists
timeFrame: Across the procedure, assessed up to 2 hours
measure: Amount of the rescue use of propofol
timeFrame: After sedation induction, assessed up to 2 hours
measure: Recovery time
timeFrame: After termination of the sedation medication, assessed up to 2 hours
measure: Prevalence of the side effects of respiratory and circulatory system
timeFrame: Across the sedation duration, assessed up to 2 hours
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Faculty of Anesthesiology, Changhai Hospital
state: Shanghai
Study officials:
References:
Clinical trial NCT04340089: Squatting on the Toilet and Capsule Endoscopy
Official title: The Effect of Squatting on the Toilet on Gastric Transit Time and Complete Examination Rate of Capsule Endoscopy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Intestinal Diseases
Keywords: squatting on the toilet
capsule endoscopy
Lead sponsor: The Second Affiliated Hospital of Chongqing Medical University
Sponsor class: OTHER
First posted: 2020-04-09
Enrollment: 300
Sex: ALL
Minimum age (years): 8
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: the patients needed to the examination of capsule endoscopy.

Brief summary: This study evaluates the effect of squatting on the toilet on gastric transit time and complete examination rate of capsule endoscopy.In the observation group, the patients could go to squatting on the toilet at any time as they want to after taking the capsule.

Detailed description: The subjects were divided into a control group and an observation group according to whether the patient squatted in the toilet, In the control group, the patients took discontinuous right lateral position, walked on a flat road and climbed the stairs alternately. In the observation group, in addition to the above ways, the patients could go to squatting on the toilet at any time in the first hour after taking the capsule. The operator observed the position of capsule every one hour. The examination was over when capsule endoscopy entered the colon. If the capsule remained in the small intestine, the examination continued until the capsule ran out of power.

Eligibility criteria: Inclusion Criteria:

* unexplained gastrointestinal bleeding, unexplained chronic abdominal pain and diarrhea, suspected Crohn's disease, suspected small intestinal tumor, and patients needing to exclude small intestinal diseases.

Exclusion Criteria:

* suspected intestinal obstruction and intestinal stenosis, esophageal stenosis or dysphagia, history of abdominal operation, or diabetes mellitus.

Primary outcomes:
measure: CER
timeFrame: 72 hours
Secondary outcomes:
measure: GTT
timeFrame: 72 hours
Other outcomes:
Locations:
city: Chongqing
country: China
facility: The second affiliated hospital of Chongqing Medical University
state: Chongqing
Study officials:
affiliation: Director of department
name: Song He, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04978389: Inter-observer Reproductibility of Visual Estimation of Left Ventricular Ejection Fraction in Critical Care
Official title: Inter-observer Reproductibility of Visual Estimation of Left Ventricular Ejection Fraction in Critical Care
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ventricular Failure
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2021-07-27
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: practitioners working in intensive care.

Brief summary: Inter-observer reproductibility of visual estimation of left ventricular ejection fraction is known to be good in cardiology but has not been studied in ICU. The goal of the study is to determine if this reproductibility is good enough.


Eligibility criteria: Inclusion criteria:

* practitioners working in intensive care.
* age \> 18 years

Exclusion criteria:

- Age under 18

Primary outcomes:
measure: reproductibility of LVEF in percentage
timeFrame: day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: UH Montpellier
name: Kada KLOUCHE, MD PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05989789: Radioactive Seed-guided Resection of Cholangiocellular Carcinoma in Cirrhotic Patients
Official title: Radioactive Seed-guided Resection of Cholangiocellular Carcinoma in Cirrhotic Patients - Report of Two Cases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Liver Cancer
Liver Cirrhosis
Lead sponsor: Clarunis - Universitäres Bauchzentrum Basel
Sponsor class: OTHER
First posted: 2023-08-14
Enrollment: 2
Sex: MALE
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Detection of cholangiocellular and hepatocellular carcinomas can be challenging in both radiologic imaging and during surgical resection. Therefore, radioactive seed-guided resection of these tumors, analogously to breast cancer, could be an interesting approach. The investigators present two cases of cirrhotic patients where this method of tumor labelling was used.

Detailed description: The investigators selected two cases of patients with liver cirrhosis where seed-guided liver resection was used. Seed-guided resection is procedure that is usually commonly used in breast cancer surgery but so far not in liver surgery.

This report emphasizes the difficulties, which surgeons and radiologists may face in tumor entities that are difficult to identify both macroscopically, by palpation and intraoperative imaging techniques.

The first case was a patient suffering from suspected hepatocellular carcinoma with the background of alcoholic liver cirrhosis. This patient already underwent liver surgery to remove the suspected tumour but the lesion could not be removed correctly as identification was not possible neither with palpation nor with the help of intraoperative ultrasound. For this reason, the patient was selected for seed-guided resection.

The second patient, who presented nine months after the first one, presented with the suspicion of cirrhosis, two lesion small in size and in a surgically difficult localization. Therefore, the patient was selected for seed-guided resection.

Eligibility criteria: Inclusion Criteria:

* suspect cancerous liver lesion
* fit for surgery

Exclusion Criteria:

* emergency surgery
* age under 18

Primary outcomes:
measure: R0-Resection according to the tumour classification system
timeFrame: 1 week after operation
measure: Procedure-Safety (No residual source of radiation)
timeFrame: 1 Day
Secondary outcomes:
measure: Number of patients without side effects
timeFrame: 6 months
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University hospital
Study officials:
affiliation: Clarunis Basel
name: Savas D Soysal, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01223989: Bread in Overweight/Obesity Treatment
Official title: Evaluation of the Utility of an Hypocaloric Diet With or Without Bread in Overweight/Obesity Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Overweight
Obesity
Keywords: overweight
obesity
bread
hypocaloric diet
Lead sponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz
Sponsor class: OTHER
First posted: 2010-10-19
Enrollment: 122
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the utility of an hypocaloric diet with or without bread in patients with overweight and obesity


Eligibility criteria: Inclusion Criteria:

* age \> 18 years
* sex female
* signed informed consent
* patient with overweight and obesity (IMC: \> 25 \< 39.9)

Exclusion Criteria:

* Family and social environment that prevents compliance with treatment diet.
* Having to perform any kind of diet special sickness associated: Celiac disease, chronic renal failure, etc.
* patients with Diabetes Mellitus.
* patients with Eating disorders.
* patients with Dementia, Mental illness or impaired function cognitive.
* consuming drugs or substances for losing weight (except in those cases in which suspension thereof 15 days of beginning the study).
* Present disease which may interfere with weight loss: serious psychiatric disease, hypothyroidism not controlled.
* Be pregnant or period of lactation.
* Inability to comply with the physical activity plan agreed.
* Want to quit smoking during the time that lasts for the study.

Primary outcomes:
measure: changes in anthropometric parameters
timeFrame: after 16 weeks of start the diet
Secondary outcomes:
measure: changes in biochemical parameters
timeFrame: after 16 weeks of start the diet
measure: Adherence
timeFrame: after 16 weeks of start the diet
measure: change in satiety and hunger Test
timeFrame: after 16 weeks of start the diet
Other outcomes:
Locations:
Study officials:
affiliation: Jefe Unidad Nutrición Clínica y Dietética Hospital Universitario La Paz
name: Carmen Gómez Candela, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Loria-Kohen V, Gomez-Candela C, Fernandez-Fernandez C, Perez-Torres A, Garcia-Puig J, Bermejo LM. Evaluation of the usefulness of a low-calorie diet with or without bread in the treatment of overweight/obesity. Clin Nutr. 2012 Aug;31(4):455-61. doi: 10.1016/j.clnu.2011.12.002. Epub 2011 Dec 30.
Clinical trial NCT00732589: SSNB in Hemiplegic Shoulder Pain
Official title: Suprascapular Nerve Block in Hemiplegic Shoulder Pain.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Shoulder Pain
Stroke
Keywords: suprascapular nerve block
shoulder pain
hemiplegia
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
First posted: 2008-08-12
Enrollment: 0
Sex: FEMALE
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 compare suprascapular nerve block with therapeutic ultrasound in stroke patients who have shoulder pain in weak side.

Detailed description: Shoulder pain is a common complication after a cerebrovascular accident.Hemiplegic shoulder pain has been shown to affect stroke outcome in a negative way.It interferes with recovery after stroke:it can cause distress and reduced activities and can markedly hinder rehabilitation.Suprascapular nerve block has been shown to be effective as an analgesic for different indications such as shoulder capsulitis.The purpose of this study was to evaluate the effectiveness of this technique conjunction with a rehabilitation program to reduce shoulder pain in hemiplegic patients.

Eligibility criteria: Inclusion Criteria:

* Stroke patients who develope shoulder pain at weak limb.
* Good conscious and able to access pain score.
* No history of drug reaction with xylocaine
* No history of fracture,tumor or blood tendency.
* Willing to enrolled to study and signs inform consent.

Exclusion Criteria:

* Patients who do not meet the inclusion criteria.

Primary outcomes:
measure: VAS score of pain
timeFrame: 4 weeks after intervention
Secondary outcomes:
measure: Range of motion of the shoulder joint
timeFrame: 4 weeks after intervention
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Department of physical medicine and rehabilitation, Faculty of medicien, Chulalongkorn University
Study officials:
affiliation: Unaffiliation
name: Jariya Boonhong, physiatist
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05191589: Haptic Devices Impact on Laparoscopic Simulators
Official title: Haptic Devices vs Non Haptic Devices - Results of a Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Medical Education
Lead sponsor: Copenhagen Academy for Medical Education and Simulation
Sponsor class: OTHER
First posted: 2022-01-13
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Trainees/participants are randomized to either control or interventional group. After reaching proficiency participants must come back after 3-6 weeks to perform a retention test.
Primary purpose: OTHER

Brief summary: The study investigates the impact haptic devices have on reaching proficiency on a laparoscopic simulator as well as investigation if there is a difference in retention of the acquired skills.


Eligibility criteria: Inclusion Criteria:

* Must be a junior doctor working in a surgical department

Exclusion Criteria:

* Having performed any laparoscopic surgeries as primary surgeon
* Lack of Basic Danish on a conversational basis

Primary outcomes:
measure: Time (minutes) to reach the predefined proficiency level for the basic skills and salpingectomy procedure
timeFrame: From randomization till participants have passed all modules on the simulator (approx 3-4 weeks)
Secondary outcomes:
measure: Time (minutes) to reach the predefined proficiency level for the basic skills and salpingectomy procedure after 3-6 weeks without laparoscopic training on the non-haptic devices (retention test).
timeFrame: From randomization till participants passes all modules on the virtual reality simulator in the trial (approx. 3-4 weeks)
Other outcomes:
measure: Exploratory outcome: To observe and register mechanical/technical malfunctions during the intervention and retention.
timeFrame: During trial, up to 1 year
Locations:
city: Copenhagen
country: Denmark
facility: CAMES
state: Region Hovedstaden
city: Copenhagen
country: Denmark
facility: CAMES
Study officials:
References:
Clinical trial NCT04598789: A Multicentre, Retrospective Study to Evaluate the Outcome of HSCT Mismatch Unrelated Donors
Official title: Study to Evaluate the Outcome of HSCT Mismatch Unrelated Donors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Leukemia, Myeloid
Lead sponsor: Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'Anna
Sponsor class: OTHER
First posted: 2020-10-22
Enrollment: 61
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients (children and adults) having HSCT from a one-antigen mismatch unrelated donors and treated at the Centro Trapianti Metropolitano di Torino between 2012 to 2017

Brief summary: The primary endpoint of the study was the acute GvHD incidence, the secondary endpoints were chronic GvHD incidence, overall survival (OS), transplant related mortality (TRM) incidence, relapse incidence (RI) and neutrophil and platelets engraftment after GvHD prophylaxis with ATG-CSA-MTX or PTCy-MMF-FK506


Eligibility criteria: Inclusion Criteria:

* children and adults)
* HSCT from a one-antigen mismatch unrelated donors
* Treated at the Centro Trapianti Metropolitano di Torino between 2012 to 2017

Exclusion Criteria: none

Primary outcomes:
measure: acute GvHD incidence
timeFrame: 2012-2017
Secondary outcomes:
Other outcomes:
Locations:
city: Turin
country: Italy
facility: AOU Città della Salute e della Scienza di Torino - Presidio Infantile Regina Margherita
Study officials:
References:
citation: Berger M, Barone M, Spadea M, Saglio F, Pessolano R, Fagioli F. HSCT with mismatched unrelated donors: Bone marrow versus peripheral blood stem cells sources in pediatric patients. Pediatr Transplant. 2022 Jun;26(4):e14233. doi: 10.1111/petr.14233. Epub 2022 Jan 28.
Clinical trial NCT04962789: Endometrial Compaction in Assissted Reproduction
Official title: The Impact of Endometrial Compaction on Ongoing Pregnancy Rate in Assisted Reproductive Technology Cycles : Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Infertility, Female
Keywords: infertility
IVF , ICSI
endometrium
compaction
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-07-15
Enrollment: 145
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: women undergoing IVF/ICSI.

Brief summary: To record the dynamic change of endometrial thickness (Day of embryo transfer Versus. Day of ovulation trigger administration in case of fresh cycles or end of estrogen phase in frozen cycles), and to investigate the impact of endometrial thickness change on pregnancy outcomes

Detailed description: Clinical pregnancy rate in IVF cycles depends on embryo quality and endometrial receptivity . It is challenging to assess endometrial receptivity. Measuring endometrial thickness by ultrasonography is a simple , noninvasive and accurate method to do so. Many studies have implicated endometrial thickness and pattern as prognostic parameters for successful outcomes in IVF-ET.

Some studies have suggested a minimal thickness for a successful pregnancy to occur, while others have reported adverse effects of increased endometrial thickness above which pregnancy is unlikely to occur.

Now there is a novel hypothesis that not only the initial endometrial thickness can affect implantation rate and clinical pregnancy rate ,but also the decrease in endometrial thickness in the time interval between the ovulation triggering and the embryo transfer or what is called endometrial compaction increases the implantation and clinical pregnancy rate

Eligibility criteria: Inclusion Criteria:

* • Infertile women aged 18 years to 40 years undergoing IVF/ ICSI for any indication.

Exclusion Criteria:

* • History of recurrent pregnancy loss (≥ 2 spontaneous abortions) and/or history of recurrent (≥ 2) ICSI failure after embryo transfer.

  * Uterine malformations.
  * Uncorrected hydrosalpinx.
  * Intrauterine conditions affecting pregnancy outcomes such as ( intrauterine adhesions, fibroids, polyps).
  * Any previous hysteroscopic surgery eg. Metroplasty or hysteroscopic myomectomy or uterine surgeries involving the endometrium eg. myomectomy during which uterine cavity was opened.
  * History suggesting endometritis.
  * Use of hCG for endometrial preparation or luteal phase support.
  * Poor quality embryos( according to Istanbul consensus workshop on embryo assessment )

Primary outcomes:
measure: Ongoing pregnancy rate
timeFrame: 12 weeks after embryo transfer if hCG tested positive
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Women Health Hospital
Study officials:
References:
Clinical trial NCT01634789: A Pilot Bioavailability Study of 3 Test Tablet Formulations of Bazedoxifene Compared With A Reference Tablet Formulation of Bazedoxifene/Conjugated Estrogens in Healthy Postmenopausal Women
Official title: A Phase 1, Open-label, Single-dose, Randomized, 4-treatment, 4- Period, Crossover, Pilot Bioavailability Study of 3 Test Tablet Formulations of Bazedoxifene (Bza) Compared With A Reference Tablet Formulation of Bza/Conjugated Estrogens (ce) in Healthy Postmenopausal Women
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Healthy
Keywords: bioavailability
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2012-07-06
Enrollment: 2
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to evaluate 3 test formulations relative to a reference formulation.


Eligibility criteria: Inclusion Criteria:

* Generally healthy postmenopausal women
* Body mass index (BMI) in the range of 18.0 to 35.0 kg/m2 and body weight \>= 50 kg

Exclusion Criteria:

* Pregnant or nursing females; females of childbearing potential

Primary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: 0, 0.5, 0.75, 1, 1.5, 2, 3, 4.5, 6, 9, 16, 24, 48 hours post-dose
measure: Area Under the Concentration-Time Curve from Time 0 to Last Observable Concentration (AUCT)
timeFrame: 0, 0.5, 0.75, 1, 1.5, 2, 3, 4.5, 6, 9, 16, 24, 48 hours post-dose
Secondary outcomes:
measure: Area Under the Concentration-Time Curve from Time 0 to Infinity (AUCinf)
timeFrame: 0, 0.5, 0.75, 1, 1.5, 2, 3, 4.5, 6, 9, 16, 24, 48 hours post-dose
measure: Time of Maximum Plasma Concentration (Tmax)
timeFrame: 0, 0.5, 0.75, 1, 1.5, 2, 3, 4.5, 6, 9, 16, 24, 48 hours post-dose
measure: Elimination-phase Half-life (t1/2)
timeFrame: 0, 0.5, 0.75, 1, 1.5, 2, 3, 4.5, 6, 9, 16, 24, 48 hours post-dose
measure: Relative Bioavailability (F)
timeFrame: 0, 0.5, 0.75, 1, 1.5, 2, 3, 4.5, 6, 9, 16, 24, 48 hours post-dose
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Pfizer Investigational Site
state: Connecticut
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: