louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01540019: Paullinia Cupana for Anorexia in Oncologic Patients
Official title: Guarana (Paullinia Cupana) for Anorexia Related to Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Cancer-related Problem/Condition
Anorexia
Loss of Weight
Keywords: anorexia
Paullinia cupana
loss of weight
Lead sponsor: Faculdade de Medicina do ABC
Sponsor class: OTHER
First posted: 2012-02-28
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Denutrition, lost of weight and anorexia are present in many oncologic patients at any time of the disease. Anorexia is the spontaneous loss of appetite and many changes in the metabolism are made in this case, leading to this syndrome called anorexia-cachexia, that includes changes in the tumoral response and inflammatory pathways. The guaraná (Paullinia cupana) is originally from Brazil and Venezuela and has been used culturally for headaches, muscle pains, depression and others. As it has shown a good response and tolerability for fatigue, the investigators decide to try guaraná for anorexia. Patients will receive guaraná as capsules of 50 mg twice daily, for 4 weeks, and will be weighted and respond questionaries about quality of life.

Detailed description: Patients 18 years and older, diagnosed with any cancer, that is losing weight and have anorexia will be selected. They must have normal levels of creatinine, thyroid evaluation and hepatic function. If they are taking corticosteroid, they must keep losing weight and refer anorexia, as well as if they are on treatment with chemotherapy.

Patients will receive 50mg of the guaraná twice daily for 4 weeks. Every week will be an evaluation of the weight, level of appetite and answer 2 questionaries of quality of life and level of symptoms (FACT-G and MDASI).

This is a fase II study, open-label, no randomized, with two steps following ¨two stages of Simon¨ model. First step 18 patients will be included and if there are 3 good responses second step will follow, including 17 more patients. Response will be considered if there is at least 5% of gain in the weight.

Eligibility criteria: Inclusion Criteria:

* adults (18 years old and older)
* palliative care or oncologic treatment
* loss of weight
* anorexia

Exclusion Criteria:

* gastrointestinal obstruction
* blood pressure not controlled
* diabetes not treated

Primary outcomes:
measure: weight
timeFrame: eight weeks
Secondary outcomes:
measure: quality of life
timeFrame: eight weeks
Other outcomes:
Locations:
city: Santo André
country: Brazil
facility: Faculdade de Medicina do ABC
state: São Paulo
Study officials:
affiliation: Faculdade de Medicina do ABC
name: Claudia Latorre
role: STUDY_CHAIR
References:
Clinical trial NCT04351919: Assessment of Efficacy and Safety of HCQ and Antibiotics Administrated to Patients COVID19(+)
Official title: Assessment of Efficacy and Safety of HCQ and Antibiotics Administrated to Patients COVID19(+), inTunisia
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Patients With COVID19
Lead sponsor: Abderrahmane Mami Hospital
Sponsor class: OTHER
Collaborators: name: Eshmoun Clinical Research Center
name: Dacima Consulting
First posted: 2020-04-17
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: open, interventional, multicentric study
Primary purpose: TREATMENT

Brief summary: The study will assess the number of patients who become asymptomatic from clinical signs of COVID19 and will assess the efficacy of Hydroxychloroquine (HCQ) and Azithromycine effects on paucisymptomatic patients with ou without co-morbidities


Eligibility criteria: Inclusion Criteria:

* confirmed COVID19 (+)
* Qt\<500ms
* no severity criteria
* pauci-symptomatique patients
* signed consent form

Exclusion Criteria:

* no confirmed patient COVID19
* severity criteria
* known allegies to macrolides and HCQ
* Treated with HCQ within 1 month prior to inclusion
* hepatitis insufficiency
* Renal insufficiency
* treatment no indicated with azithro and HCQ
* hypovolemia
* complete brach block
* retinopathia
* psoriasis
* pregnancy or breastfeeding

Primary outcomes:
measure: improvment or healing of clinical signs
timeFrame: at the end of the study treatment - 1 month after inclusion
measure: Evolution of clinical signs
timeFrame: at the end of the study treatment - 1 month after inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Tunis
country: Tunisia
facility: Eshmoun Clinical Research Centre/ Hôpital Abderrahmen Mami-Ariana
Study officials:
References:
Clinical trial NCT06833619: Efficacy of Endoscopic Ultrasound Guided Liver Biopsy Using Dynamic Wet Technique
Official title: Efficacy of Endoscopic Ultrasound Guided Liver Biopsy Using Dynamic Wet Technique
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Efficacy of Endoscopic Ultrasound Guided Liver Biopsy Using Dynamic Wet Technique
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2025-02-19
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Endoscopic ultrasound-guided liver biopsy (EUS-LB) can overcome many shortcomings of percutaneous liver biopsy and TJLB. Targeted and non-targeted liver biopsies can be done through this biopsy. It can be done in patients with international normalized ratio (INR) up to 2. It has less tissue fragmentation compared with TJLB.

Needle entering the liver can be viewed in real-time (intrahepatic vessels and bile duct can be spared from injury) (Sharma et al., 2023). Both lobes of the liver can be accessed. It provides minimal patient discomfort. EUS-LB can access liver lesions that may not be safely accessible by routine US or computed tomography (tenBerge et al., 2002). It provides better results in obese individuals compared with percutaneous liver biopsy. It is safe in pregnant females requiring liver biopsy (Khare et al., 2024). Despite these advantages, EUS-LB is largely limited to tertiary care centers and its use is not yet widespread. This may be because, since its inception, numerous variations in needle shape, needle size, and, most notably, sampling techniques have been adopted.

However, no consensus protocol for acquisition has been recognized, leading to poor procedural standardization and wide ranges of reported outcomes in sample quality and diagnostic yield. As such, there is a substantial need for a uniform technique that will safely maximize diagnostic performance with minimal needle passes (Khare et al., 2024).


Eligibility criteria: Inclusion Criteria:

* The participants of the study were adults in need of liver biopsy for the evaluation of Altered liver function test

Exclusion Criteria:

* Using anti-platelets or anticoagulants within the last 5days
* Inability to provide informed consent
* Moderate-to-gross ascites
* Child C cirrhosis
* INR more than 2.01
* Platelet count less than 50,000/µL3

Primary outcomes:
measure: Efficacy of Endoscopic Ultrasound Guided Liver Biopsy Using Dynamic Wet Technique
timeFrame: -Study period: Duration of the study will be 12 months after acceptance of The Ethical Committee Of The Medical Research. All patients will sign an informed written consent before starting the data collection with respect to patient's confidentiality.
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag University
Study officials:
affiliation: Sohag
name: Sara Elbadry Eirabie, master
role: STUDY_DIRECTOR
References:
Clinical trial NCT06093919: Study of Prevalence of Eating Disorder in Liver Transplant Patients
Official title: Study of Prevalence of Eating Disorder in Liver Transplant Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Eating Disorders
Eating Disorder Binge
Liver Transplant; Complications
Alcohol Use Disorder
Cirrhosis Alcoholic
Lead sponsor: Centre Hospitalier Henri Laborit
Sponsor class: OTHER
First posted: 2023-10-23
Enrollment: 118
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will consist of all liver transplant patients at the University Hospital of Poitiers followed between 01/01/2023 and 06/30/2024

Brief summary: The main goal of this observational study is to measure the prevalence of binge eating disorder in liver transplant patients by evaluating the responses to the Bulimia Test.

Secondary objectives of the study are to:

* Determine the prevalence of binge eating disorders in liver transplant patients following alcoholic cirrhosis, evaluated by the Bulimia Test;
* Study the association between the presence of eating disorder behaviours and liver damage : hepatic steatosis and fibrosis determined by Fibroscan (Transient elastography and controlled attenuation parameter)
* Study the association between presence of eating disorder behaviours and alcohol use disorder, measured by Alcohol Use Disorders Identification Test-Consumption


Eligibility criteria: Inclusion Criteria:

* over 18 years old
* had a liver transplant and followed at University Hospital of Poitiers
* responded to the Bulimia Test-Revised and to the Alcohol Use Disorders Identification Test-Consumption
* had a Fibroscan within the year

Exclusion Criteria:

* Patient without Fibroscan and not responded to both scale : Bulimia Test-Revised and Alcohol Use Disorders Identification Test-Consumption

Primary outcomes:
measure: Prevalence of binge eating disorder in liver transplant patients
timeFrame: 1 year
Secondary outcomes:
measure: Prevalence for binge eating disorder in liver transplant patients following alcoholic cirrhosis
timeFrame: 1 year
measure: Correlation between the BulimiaTest-Revised score and liver damage determined by the Fibroscan
timeFrame: 1 year
measure: Correlation between the Bulimia-Test score and the Alcohol Use Disorders Identification Test-Consumption score
timeFrame: 1 year
Other outcomes:
Locations:
city: Poitiers
country: France
facility: Centre Hospitalier Henri Laborit
city: Poitiers
country: France
facility: University Hospital of Poitiers (CHU de Poitiers)
Study officials:
References:
Clinical trial NCT02931019: The Effect of Head Position on the Intubating Condition Using Fiberoptic Bronchoscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intubation
Posture
Keywords: fiberoptic
intubation
posture
Lead sponsor: Chonnam National University Hospital
Sponsor class: OTHER
First posted: 2016-10-12
Enrollment: 54
Sex: ALL
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: For better view of fiberoptic intubation, the posture of neck is compared between neck flexion and extension.


Eligibility criteria: Inclusion Criteria:

* ASA class 1 or 2
* scheduled for general anesthesia with endotracheal intubation
* decided to join this clinical study voluntarily

Exclusion Criteria:

* history of difficult intubation
* anticipated the difficult intubation: Total airway score \> 6, upper lip bite test grade III, with cervical spine disease, history of head or neck surgery
* risk of aspiration

Primary outcomes:
measure: POGO score
timeFrame: a week (after get the picture)
Secondary outcomes:
Other outcomes:
Locations:
city: Hwasun
country: Korea, Republic of
facility: Chonnam National University Hwasun Hospital
state: Jeollanam-do
Study officials:
References:
citation: Park S, Lee HG, Choi JI, Lee S, Jang EA, Bae HB, Rhee J, Yang HC, Jeong S. Comparison of vocal cord view between neutral and sniffing position during orotracheal intubation using fiberoptic bronchoscope: a prospective, randomized cross over study. BMC Anesthesiol. 2019 Jan 5;19(1):3. doi: 10.1186/s12871-018-0671-9.
Clinical trial NCT00306319: Pharmacokinetic Interaction Study in Indonesian Tuberculosis Patients Indonesia
Official title: Pharmacokinetic Interaction Study of Rifampicin, Isoniazid and Moxifloxacin in Tuberculosis Patients in Bandung, Indonesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Tuberculosis
Keywords: Tuberculosis
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2006-03-23
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Pharmacokinetic study in TB patients to determine the effect of rifampicin on the pharmacokinetic profile of moxifloxacin.

Detailed description: Tuberculosis is an infectious disease that still causes many victims in the developing world, especially in Indonesia. Rifampicin, isoniazid and ethambutol are the cornerstone of the current treatment. The disadvantage of the current treatment is the long, six-months, duration of the treatment. This long duration contributes to suboptimal adherence to the TB drugs.Thus, there is a very urgent need to evaluate drugs that may help shortening TB treatment. The fluoroquinolone moxifloxacin has shown early bactericidal activity (EBA) in patients with pulmonary TB, and has shown rapid and reliable sterilization. Rifampicin is a strong inducer of the CYP enzymes, but it also induces phase II metabolism. As moxifloxacin is metabolized by phase II metabolism, rifampicin could cause a decrease in the plasma concentrations of moxifloxacin. Therefore, a pharmacokinetic interaction study is warranted.

Eligibility criteria: Inclusion Criteria:

* Indonesian AFB negative tuberculosis patients who are in the last two months of the continuation phase of their six-month-antituberculosis treatment.
* Subject is 18-55 years of age at the day of the first dosing of study medication.
* Subject has a normal ECG
* Subjects bodyweight is \>35kg
* Use of rifampicin and isoniazid

Exclusion Criteria:

* Pregnant or lactating
* History or condition that might interfere with drug absorption, distribution, metabolism or excretion, including ileus, gastric paresis, liver and renal dysfunction, diabetes mellitus.
* Presence of contraindications for moxifloxacin or use of drugs that are known to interact with moxifloxacin.
* Subject is not able and/or not willing to sign the informed consent form.

Primary outcomes:
measure: Pharmacokinetic (24 hrs) curves will be drawn
measure: at day 5 in period I and period II.
Secondary outcomes:
Other outcomes:
Locations:
city: Bandung
country: Indonesia
facility: Rumah Sakit Hasan Sadikin (RSHS)
Study officials:
affiliation: Radboud University (RUNMC)
name: R. Aarnoutse, PharmD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nijland HM, Ruslami R, Suroto AJ, Burger DM, Alisjahbana B, van Crevel R, Aarnoutse RE. Rifampicin reduces plasma concentrations of moxifloxacin in patients with tuberculosis. Clin Infect Dis. 2007 Oct 15;45(8):1001-7. doi: 10.1086/521894. Epub 2007 Sep 4.
Clinical trial NCT05693519: GastroIntestinal Cancer in Children and Adolescents
Official title: GastroIntestinal Cancer in Children and Adolescents (GICCA): a SEER Population-based Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gastrointestinal Cancer
Colorectal Cancer
Gastric Cancer
Hepatoblastoma
Hepatocellular Carcinoma
Burkitt Lymphoma
Neuroendocrine Tumors
Keywords: SEER
Gastrointestinal
Cancer
Malignant
Child
Pediatric
Adolescent
Lead sponsor: Leiden University Medical Center
Sponsor class: OTHER
Collaborators: name: Juliana Children's Hospital
First posted: 2023-01-23
Enrollment: 2500
Sex: ALL
Minimum age (years): 0
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients aged 0-24 years with a diagnosis of a primary gastrointestinal malignancy as their first primary malignancy in the SEER 17 database from 2000 until (and including) 2019.

Brief summary: The goal of this observational population-based cohort study is to investigate the clinical characteristics and outcomes of children and adolescents with primary gastrointestinal malignancies registered in the publicly available Surveillance, Epidemiology, and End Results (SEER) 17 database during 2000-2019.

Detailed description: The investigators aim to describe the patient and tumor characteristics, treatments, and outcomes of children and adolescents diagnosed with primary gastrointestinal malignancies, and to analyze these data for trends over time. In addition, the investigators want to explore independent prognostic factors for overall survival. Finally, the investigators want to describe subsequent primary malignancies diagnosed among patients from the study cohort, as well as to calculate their risk of developing a second primary cancer relative to the general population. Data on children (aged 0-17 years at diagnosis) and young people aged 18-24 years at diagnosis are analyzed separately. Special focus is laid on patients with primary carcinomas of the gastrointestinal tract; particularly colorectal carcinoma.

Eligibility criteria: Inclusion Criteria:

* Age at primary gastrointestinal cancer diagnosis \<25 years
* Diagnosis of a primary gastrointestinal malignancy as an individual's first primary malignancy

Exclusion Criteria:

* None

Primary outcomes:
measure: Overall survival
timeFrame: 2000-2019
Secondary outcomes:
measure: Standardized incidence of second primary malignancies
timeFrame: 2000-2019
Other outcomes:
Locations:
city: Leiden
country: Netherlands
facility: Leiden University Medical Center
state: South-Holland
city: The Hague
country: Netherlands
facility: Juliana Children's Hospital
state: South-Holland
Study officials:
affiliation: Leiden University Medical Center
name: Paul G. Kemps, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04454619: Pre-surgical Antisepsis Using an Alcoholic Solution of Chlorhexidine Digluconate and Potassium Sorbate
Official title: Effectiveness of Pre-surgical Hand Washing in Reducing Bacterial Load, Using an Alcoholic Solution of Chlorhexidine Digluconate and Potassium Sorbate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Antisepsis
Lead sponsor: Centro Ortopedico y Quirurgico del Pie
Sponsor class: OTHER
First posted: 2020-07-01
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Crossover Assignment Crossover design is used
Primary purpose: TREATMENT

Brief summary: The present study evaluates the effects of bactericidal load reduction after surgical hand scrub antisepsis using the reference antiseptic product propan-ol-1 60% as control versus a surgical hand scrub antisepsis with addition of a solution of chlorhexidine digluconate and potassium sorbate in order to test if pass the standard european norm 12791.

Detailed description: The investigators conducted a crossover clinical trial to evaluate the antiseptic effectiveness of preoperative surgical scrubbing using propan-ol-1 60% by scrub using the reference antiseptic product propan-ol-1 60% as control versus a surgical hand scrub antisepsis with addition of a solution of chlorhexidine digluconate and potassium sorbate in order to test if pass the standard european norm 12791. Samples will be taken from the hands of each volunteer after a surgical hands antiseptic.

Eligibility criteria: Inclusion Criteria:

* Participants without systemic pathologies, with healthy skin of the hands and short fingernails.
* They do not use substances with antibacterial action.

Exclusion Criteria:

* Taken antibiotics before 10 days of the intervention.
* Wear any jewellery on the hands

Primary outcomes:
measure: Change of bacterial load measured in CFU immediately after hand scrub
timeFrame: Change from bacterial load at 5 minutes
Secondary outcomes:
measure: Change of bacterial loadmeaured in CFU after 3 hours of hand scrub
timeFrame: Change from bacterial load at 3 hours
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Centro ortopedico y quirurgico del pie
state: Madrid.
Study officials:
affiliation: Universidad Complutense de Madrid
name: Ricardo Becerro de Bengoa Vallejo
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02122419: The Effect of Patient Position on Postdural Puncture Headache
Official title: Phase IV Study of Application Position During Spinal Anesthesia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy
Headache
Lead sponsor: Diskapi Yildirim Beyazit Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2014-04-24
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients records form patients who experienced headache after caesarean section with spinal anesthesia were retrospectively evaluated

Brief summary: We aimed to investigate the association between the position in which spinal anesthesia was performed and postdural puncture headache occurrence.

Detailed description: Records of patients who underwent caesarean section between January, 2013 and November, 2013 with spinal anesthesia will be retrospectively examined. Demographic data of patients, comorbid diseases, position of patient while performing spinal anesthesia, the number of spinal puncture attempts will be recorded.

Eligibility criteria: Inclusion Criteria:

* Patients older than 18 years were included

Exclusion Criteria:

* Conversion to general anesthesia was the exclusion criteria.

Primary outcomes:
measure: postdural puncture headache
timeFrame: postoperative first day
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Dışkapı Yıldırım Beyazıt Education and Research Hospital
Study officials:
affiliation: Ministery of Health
name: ibrahim öztürk, M.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dogan M, Turker H, Ugurlu M, Ergun F, Bozkurt M. Do peroperative supine and prone positions have an effect on postspinal headache incidence? Neurosciences (Riyadh). 2005 Jan;10(1):64-7.
citation: Gil NS, Lee JH, Yoon SZ, Jeon Y, Lim YJ, Bahk JH. Comparison of thoracic epidural pressure in the sitting and lateral decubitus positions. Anesthesiology. 2008 Jul;109(1):67-71. doi: 10.1097/ALN.0b013e31817b80df.
citation: Abel AS, Brace JR, McKinney AM, Friedman DI, Smith SD, Westesson PL, Nascene D, Ott F, Lee MS. Effect of patient positioning on cerebrospinal fluid opening pressure. J Neuroophthalmol. 2014 Sep;34(3):218-22. doi: 10.1097/WNO.0000000000000074.