louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04043702: Combination of Topiramate and Empagliflozin is Considered a Good Option for the Treatment of Obesity
Official title: Combination of Topiramate(Conviban) and Empagliflozin(Jardiance) is Considered a Good Option for the Treatment of Obesity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Keywords: obesity
drug combination
empagliflozin(jardiance)
topiramate(conviban)
Lead sponsor: Ministry of Health and Population, Egypt
Sponsor class: OTHER_GOV
First posted: 2019-08-02
Enrollment: 200
Sex: ALL
Minimum age (years): 30
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: obese peoples , age from 35 to 55 years

Brief summary: The aim was to show if a combination of topiramate and empagliflozin have the greatest weight decreasing effect in comparison to each drug alone and to group with no treatment( control group).

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Detailed description: The aim was to show if a combination of topiramate and empagliflozin have the greatest weight decreasing effect in comparison to each drug alone and to group with no treatment( control group).

Materials and methods 200 obese patients 4 groups. had been monitored in a private clinic, each group 50 patients number, with 35 females and 15 males who were already on treatment.

Eligibility criteria: Inclusion Criteria:

1. stable weight in the previous 6 months.
2. a sedentary lifestyle.
3. no history of diabetes mellitus.
4. taking medication that affects appetite, or weight within the past 6 months

Exclusion Criteria:

1. severe anemia
2. hypothyroidism and hyperthyroidism
3. Diabetes mellitus
4. moderate to severe liver or kidney disease
5. body mass index less than 30

Primary outcomes:
measure: change in weight
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Mahmoud Younis
Study officials:
affiliation: egyptian ministry of health
name: mahmoud younis, M.S
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04203602: Hospital Discharge Following Bariatric Surgery by Telepresence Robot
Official title: Assessment of Feasibility and Efficacy of Hospital Discharge Following Bariatric Surgery Using a Telepresence Robot: a Non-inferiority Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Severe Obesity
Keywords: obesity
bariatric surgery
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
First posted: 2019-12-18
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: non-inferiority randomized controlled trial
Primary purpose: TREATMENT

Brief summary: This is a non-inferiority randomized controlled trial aimed to compare the effectiveness and feasibility of performing the ward round using a telepresence robot vs. a face-to-face ward round to discharge patients after bariatric surgery.

Detailed description: This study is aimed to analyze the effectiveness and feasibility of performing the ward round using a telepresence robot (PadBot U, Inbot Technology Ltd, China), compared to the face-to-face ward round, for hospital discharge after bariatric surgery. Patients who underwent either laparoscopic Roux-en-Y gastric bypass or laparoscopic sleeve gastrectomy will be randomized to one of two groups: intervention group - who will be evaluated and discharged, on postoperative day (POD) 2, during ward rounds with the assistant team present, but the telepresent surgeon via robot; and control group - who will be evaluated and discharged, on POD 2, during ward rounds with the whole team physically present.

The study main hypothesis is that the ward rounds with the surgeon telepresent by a robot are not inferior to the face to face ward rounds, to evaluate and discharge patients after bariatric surgery.

Eligibility criteria: Inclusion Criteria:

* Patients that underwent bariatric surgery (either laparoscopic Roux-en-Y gastric bypass or laparoscopic sleeve gastrectomy

Exclusion Criteria:

* complications during surgery; unable to sign informed consent; admitted to ICU; previous foregut surgery.

Primary outcomes:
measure: Hospital discharges by robotic or face-to-face rounds
timeFrame: 2 days
Secondary outcomes:
measure: contact with team
timeFrame: 2 weeks
measure: complications, reoperations, readmissions
timeFrame: up to 30 days after surgery
measure: Patients' and team's impressions
timeFrame: 2 days
Other outcomes:
Locations:
city: Montenegro
country: Brazil
facility: Unimed Vale do Caí
state: RS
Study officials:
affiliation: Hospital de Clinicas de Porto Alegre
name: Guilherme S Mazzini, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Unimed Vale do Caí
name: Cacio Wietzycoski, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05348902: Locked-in Syndrome Caused by Pulmonary Arteriovenous Malformation: A Case Report
Official title: Locked-in Syndrome Caused by Pulmonary Arteriovenous Malformation: A Case Report
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Locked-In Syndrome；Pulmonary Arteriovenous Malformation
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2022-04-27
Enrollment: 1
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A patient with locked-in syndrome

Brief summary: In this case, we report a case of atresia syndrome (LIS), a serious neurological disease caused by pulmonary arteriovenous fistula (PAVM). We present a previously healthy middle-aged woman who developed atresia syndrome after severe pontine infarction due to basilar artery occlusion due to undiagnosed arteriovenous malformation. This report reviewed the medical history, post-admission examination and related literature, and concluded that PAVM should be considered as the cause of implicit stroke, especially in young patients with right-to-left shunt, and should be actively treated.


Eligibility criteria: Inclusion Criteria:

* A case of Locked-in syndrome due to pulmonary arteriovenous malformation

Exclusion Criteria:

* Patients or family members objected to the study

Primary outcomes:
measure: Locked-in syndrome caused by pulmonary arteriovenous malformation . Check list report
timeFrame: 1month
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Study officials:
References:
Clinical trial NCT04799002: Topotecan and Melphalan for Retinoblastoma
Official title: Choice of Topotecan or Melphalan in Retinoblastoma Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Retinoblastoma
Chemotherapy Effect
Keywords: Retinoblastoma
topotecan
Melphalan
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2021-03-16
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate topotecan and melphalan for retinoblastoma patients.

Detailed description: To evaluate the effectiveness and complications of topotecan and melphalan for intraocular injection in retinoblastoma patients.

Eligibility criteria: Inclusion Criteria:

* diagnosed as retinoblastoma
* receiving eyeball-sparing treatment

Exclusion Criteria:

* disease progression during follow-up

Primary outcomes:
measure: Eyeball-sparing rate
timeFrame: 5 years after chemotherapy
Secondary outcomes:
measure: Side effects
timeFrame: 5 years after chemotherapy
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Huashen Yang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01450202: Safety and Efficacy of Carbon Dioxide Insufflation During Colonoscopy With Consecutive Esophagogastroduodenoscopy in Reduction of Abdominal Pain in Sedated Outpatients
Official title: Carbon Dioxide Insufflation During Colonoscopy With Consecutive EGD is Safe and Decreases Abdominal Pain in Sedated Outpatients: a Randomized, Double-blind, Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain
Keywords: Carbon dioxide insufflation
Colonoscopy
Esophagogastroduodenoscopy
Bowel insufflation
Postprocedure pain
Pain Due to Certain Specified Procedures
Lead sponsor: Inje University
Sponsor class: OTHER
First posted: 2011-10-12
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Compared with performing each procedure individually, performing two combined procedures such as colonoscopy consecutive Esophagogastroduodenoscopy (EGD) cause more bowel gases, abdominal distension and post-procedure pain because of longer procedure time related to more bowel insufflated gas than one procedure. To the best of the investigators knowledge, there has been no randomized controlled trial of CO2 versus air for insufflations during combined two procedures, colonoscopy with consecutive EGD. And there are a few well randomized trials concerned CO2 insufflation in patients receiving sedation during colonoscopy.

The aim of the present study was to evaluate the efficacy of CO2 in reducing post-procedural abdominal pain and distension during colonoscopy consecutive EGD and to confirm the safety of CO2 insufflation when it is used during procedure in sedated outpatients.


Eligibility criteria: Inclusion Criteria:

* outpatients between the ages of 18 and 70 years who are scheduled for colonoscopy with consecutive EGD

Exclusion Criteria:

* age \< 18 or \> 70 years
* pregnancy
* breast feeding
* chronic obstructive lung disease (COPD)
* known CO2 retention and refusal to participate in the study

Primary outcomes:
measure: post-procedural pain
timeFrame: 3 months
Secondary outcomes:
measure: abdominal distention
timeFrame: 3 months
measure: ETCO2
timeFrame: 3 months
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Haeundae Paik Hospital
Study officials:
References:
Clinical trial NCT06265402: Retrolaminar Block Versus Tab Block in Abdomioasty
Official title: Comparison Between US Guided Retrolaminar Block and Transversus Abdominis Plane Block for Post Operative Analgesia in Patient Undergoing Abdominal Plastic Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Block
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2024-02-20
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of the study is to compare the analgesic efficacy of Us guided retrolaminar block versus transversus abdominis plane block in patient under going abdominal plastic surgery

Detailed description: Pain from intra abdominal surgery is a combination of somatic and visceral pain visceral pain transmitted by autonomic nervous system via sympathetic fibers from plexuses in close proximity to the viscera them selves Regional anesthetic are commonly used to prevent or minimize these side effect the use of ultra sound nerve block are commonly use as apart of multimodal post operative analgesia The tab block is used to decrease the need of post operative analgesia in patient undergoing abdominal plastic surgery It was found an alternative approach to para vertebral block the retro laminar block is performed with us guided imaging to reduce pain post operative and need analgesia

Eligibility criteria: Inclusion Criteria:

- 90patients aged 18/65years of both sexes and asa physical status one two and three undergoing abdominal plastic surgery

Exclusion Criteria:

* patient refusal Patient taking analgesia of chronic illness or have history of substance abuse Patient who are unable to describe their post operative pain Patient with history of coagulabathy Un cooperative patient Patient with known allergy to study drug Patient with infection at site needle puncture Patient with decompensated hepatic renal respiratory or cardiac disorder

Primary outcomes:
measure: Total dose of morphine consumption in the first postoperative 24hours
timeFrame: First 24hours
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: TantaU U
Study officials:
affiliation: Tanta University
name: Hadeel Elsagheer
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03439202: Low Intensity Exercise in Different Normobaric/Hypobaric Normoxic/Hypoxic Conditions.
Official title: The Effects of Low Intensity Exercise in Hypobaric vs. Normobaric Normoxic and Hypoxic Conditions on Baroreflex Sensitivity, Physiological Responses and Cerebral Functions in Pilots.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Baro-reflex Sensitivity
Heart Rate Variability
EEG, Microstates
Cerebral Blood Flow Regulation
Cerebral Oxygenation
Oxygen Saturation
Concentration Performance
Keywords: Hypoxia
Baro-reflex sensitivity
Low-intensity exercise
Hear rate variability
EEG
Concentration performance
Lead sponsor: Fliegerärztliches Institut
Sponsor class: OTHER
Collaborators: name: University of Lausanne
First posted: 2018-02-20
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Crossover randomized study
Primary purpose: OTHER

Brief summary: The main goal of this project is to investigate how low intensity cycling exercise (1.5W/kg, for 6 minutes) influences cerebral functions, such as: Cerebral blood flow, oxygenation, and other physiological variables in different normobaric and hypobaric hypoxic conditions.

Detailed description: Subjects will bike at 1W/kg for 6 minutes at different simulated altitude level in the hypobaric chamber at the FAI in Dübendorf. Concentration performance also will be measured to better understand how hypobaric and hypoxia conditions may affect physiological responses, cerebral and cognitive functions.

Eligibility criteria: Inclusion Criteria:

* Study Indication
* Male and Female subjects from 18 years to 40 years of age
* Healthy volunteer
* Signed Informed Consent after being informed

Exclusion Criteria:

* Contraindications to the study intervention.
* Define drugs, treatments or interventions not allowed during the study or for specific periods of time prior to the intervention,
* Women who are pregnant or breast feeding,
* Intention to become pregnant during the course of the study,
* Known or suspected non-compliance, drug or alcohol abuse,
* Previous problem with hypoxia or altitude exposure,
* Known pathologies/diseases
* Relevant medical disorders
* Anemia or poor health
* History of flight sickness

Primary outcomes:
measure: Baro-reflex sensitivity
timeFrame: 6 minutes per record.
Secondary outcomes:
measure: Concentration performance
timeFrame: 4 minutes per test
measure: EEG microstates
timeFrame: 6 minutes per record
measure: Heart rate variability (HRV)
timeFrame: 6 minutes per record
measure: Cerebral blood flow
timeFrame: 6 minutes per record.
Other outcomes:
Locations:
city: Dübendorf
country: Switzerland
facility: Aeromedical Center / Fliegerärztliches Institut
state: ZH
Study officials:
affiliation: Aeromedical Center
name: Denis Bron, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03136302: Correlation of Tractography and Motor Evoked Potentials in Deep Brain Stimulation
Official title: Correlation of Tractography and Motor Evoked Potentials in Deep Brain Stimulation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Improving Accuracy of Implanting Stimulation Electrodes
Lead sponsor: Nova Scotia Health Authority
Sponsor class: OTHER
First posted: 2017-05-02
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who qualify for deep brain stimulation on the basis of a movement disorder and chronic pain

Brief summary: The goal is to establish another anatomical referencing system in order to achieve an even higher accuracy when implanting stimulation electrodes.

Detailed description: The main goal is to find out what are the optimal distances to these reference fiber tracts when stimulating and to find the optimal target. This has to be evaluated for each target, such as globus pallidus (Gpi), subthalamic nucleus (STN) and ventral intermediate nucleus of the thalamus (VIM) separately. This is of special importance as the investigators can demonstrate the internal capsule, which is often a generator of stimulation-induced side effects: tetanic muscle contractions, dysarthria and gaze deviations.

Eligibility criteria: Inclusion Criteria:

* Patient qualifying for deep brain stimulation on the basis of a movement disorder (Parkinson's Disease, tremor, dystonia) or chronic pain disease.
* Informed consent

Exclusion Criteria:

* Lack of consent
* Electrical or other devices that preclude the performance of an MRI

Primary outcomes:
measure: distance between stimulation electrode and motor fibers in mm
timeFrame: Intraoperative
Secondary outcomes:
measure: Intraoperative intensity of stimulation in milliampere (mA)
timeFrame: Intraoperative
measure: Stimulation thresholds in milliampere (mA)
timeFrame: Intraoperative
measure: Change in disease score units on the UPDRS rating scale
timeFrame: twelve months
measure: Change in disease score units on the FTRS rating scale
timeFrame: twelve months
measure: Change in disease score units on the BFMDRS rating scale
timeFrame: twelve months
measure: Change in disease score units on the TWSTR rating scale
timeFrame: twelve months
measure: Change in disease score units on the PDQ-39 rating scale
timeFrame: twelve months
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: Queen Elizabeth Health Science Centre
state: Nova Scotia
Study officials:
affiliation: Dalhousie University
name: Lutz Weise, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00575302: Study of Optimal Posology of Gonadotrophins in Patients With Insufficient Ovarian Response Due to Age
Official title: Study of Optimal Posology of Gonadotrophins in Patients With Insufficient Ovarian Response Due to Age
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Infertility
Keywords: IVF
poor responder
recFSH
Fertilization in Vitro
Poor responders
Lead sponsor: Centre Hospitalier Chretien
Sponsor class: OTHER
Collaborators: name: EMD Serono
First posted: 2007-12-18
Enrollment: 400
Sex: FEMALE
Minimum age (years): 38
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In In vitro fertilization (IVF) treatment, poor responder patients of more than 38 years old are randomized prospectively into two dosages of gonadotrophins. The outcome of treatment will be analyzed.

Detailed description: Women \> 38 years, who had an insufficient response to stimulation with regular (for age) posology of 225 IU of gonadotrophins (urinary or recombinant), in an agonist protocol will be randomized prospectively into 2 groups:

300 IU versus 450 IU of Gonal-f® administered in a short agonist protocol. Insufficient response is defined as: development of ≤ 4 mature follicles (of ≥ 16 mm) at time of hCG administration.

Patient can be eligible for several cycles in same protocol.

Eligibility criteria: Inclusion Criteria:

* Women \> 38 years with insufficient response to stimulation with 225 IU of gonadotrophins (urinary or recombinant), in an agonist protocol.
* Insufficient response is defined as: development of ≤ 4 mature follicles (of ≥ 16 mm) at time of hCG administration.
* Patient can be eligible for several cycles in same protocol.

Exclusion Criteria:

* Patients who already received doses \> 225 IU
* Patients older than 42 years
* Patients with basal FSH concentrations ≥ 15 mU/ml at day 3

Primary outcomes:
measure: number of mature oocytes
timeFrame: 1 month
Secondary outcomes:
measure: follicular development
timeFrame: 1 month
measure: fertilization rate
timeFrame: 1 month
measure: implantation rate
timeFrame: 1 month
measure: embryo quality
timeFrame: 1 month
measure: pregnancy rate
timeFrame: 1 month
Other outcomes:
Locations:
city: Rocourt
country: Belgium
facility: CHC Saint-Vincent
state: Liège
city: Brussels
country: Belgium
facility: CHU Saint-Pierre
city: Brussels
country: Belgium
facility: IMEC
city: Gent
country: Belgium
facility: UZ Gent
Study officials:
affiliation: CHC Saint-Vincent
name: Annick Delvigne, PhD
role: PRINCIPAL_INVESTIGATOR
References: