louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04662138: Safety and Efficacy of Different Antiviral Regimens for Hepatitis C Virus Relapse
Official title: Safety and Efficacy of Directly Acting Antiviral Agents in Genotype 4 Hepatitis C Virus Relapse Among Egyptian Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hepatitis C
Relapse
Antivirals
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2020-12-10
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with HCV relapse after sofosbuvir plus either NS5A or protease inhibitor who will start another HCV treatment at Alexandria University Viral Hepatitis Treatment Unit or Alexandria University Liver Clinics in the period from 24/8/2020 to 23/8/2021.

Brief summary: The primary goal of hepatitis C virus (HCV) Direct Acting Antivirals (DAAs) is to achieve undetectable HCV RNA in the blood. A response that should be maintained for at least 12 weeks from completion of therapy. This is called sustained virological response (SVR) which corresponds to cure of HCV infection as risk of later relapse is very small. SVR is important to achieve improvement in liver necroinflammation and fibrosis and to decrease complications of cirrhosis.

Failing to achieve SVR after treatment requires another regimen for these experienced patients.

Real-world data are always needed to evaluate and improve our practices. Here investigators aim to assess tolerability and efficacy of different regimens used for management of genotype 4 HCV relapse.


Eligibility criteria: Inclusion Criteria:

* all patients with HCV relapse after sofosbuvir plus either Non-structural protein 5 A (NS5A) or protease inhibitor.

Exclusion Criteria:

* No exclusion criteria

Primary outcomes:
measure: Sustained virological response
timeFrame: 12 weeks after completion of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Alexandria University.
Study officials:
References:
Clinical trial NCT02527538: Prediction of Hypotension During Beach Chair Position Using Pleth Variability Index
Official title: Pleth Variability Index Predicts Hypotension in Beach Chair Position in Mechanically Ventilated Adults During General Anesthesia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hypotension
Lead sponsor: Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Sponsor class: OTHER
First posted: 2015-08-19
Enrollment: 57
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: age between 20 and 70 years who is planning to undergoing elective shoulder surgery under general anesthesia

Brief summary: The beach chair position for shoulder operation induces hypotension during general anesthesia. Hypotension is induced by decreased preload and contractility due to anesthesia. Masimo is a pulse oximetry which shows pleth variability index noninvasively. The pleth variability may predict the hypotension during beach chair position.

Detailed description: The beach chair position for shoulder operation induces hypotension during general anesthesia. Hypotension is induced by decreased preload and contractility due to anesthesia. Masimo is a pulse oximetry which shows pleth variability index noninvasively. The investigators put the masimo probe before general anesthesia and recorded the values before and after beach chair position, The values include arterial pressure, heart rate, blood pressure, perfusion index, pleth variability index.

The primary end point was the predictive value and threshold or pleth variability index for hypotension induced by the beach chair position. The occurrence of hypotension was counted by using vasopressor. The use of vasopressor was performed when mean blood pressure less than 65 mmHg or 20% of baseline.

The investigators planned to recruit 57 patients.

Eligibility criteria: Inclusion Criteria:

* elective shoulder surgery under general anesthesia

Exclusion Criteria:

* right heart failure
* morbid obesity (BMI \> 30)
* arrhythmia on preoperative electrocardiography
* pulmonary hypertension
* peripheral vascular disease or pulmonary disease
* pregnant

Primary outcomes:
measure: occurrence of hypotension defined as mean blood pressure less than 65 mmHg or 20% of baseline
timeFrame: 10 minutes after beach chair position
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine : Chung-Aung University Hospital
Study officials:
affiliation: Chung-Ang University Hosptial, Chung-Ang University College of Medicine
name: Chongwha Baek, Ph.D.
role: STUDY_DIRECTOR
References:
citation: Siswojo AS, Wong DM, Phan TD, Kluger R. Pleth variability index predicts fluid responsiveness in mechanically ventilated adults during general anesthesia for noncardiac surgery. J Cardiothorac Vasc Anesth. 2014 Dec;28(6):1505-9. doi: 10.1053/j.jvca.2014.04.010. Epub 2014 Aug 29.
Clinical trial NCT02587338: Cognitive Ability Training in Seniors
Official title: Verbesserung Kognitiver Fähigkeiten im Alter
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mild Cognitive Impairment
Keywords: Subjective Memory Impairment
tDCS
NIRS
Cognitive Training
Working Memory
Lead sponsor: Wuerzburg University Hospital
Sponsor class: OTHER
First posted: 2015-10-27
Enrollment: 38
Sex: ALL
Minimum age (years): 60
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study investigates the beneficial effects of prefrontal brain stimulation (with transcranial direct current stimulation \[tDCS\]) during working memory training in seniors with subjective memory impairments.The placebo-controlled double blinded study includes 50 elderly probands which were randomized into verum or sham tDCS.


Eligibility criteria: Inclusion Criteria:

* native german speaker
* between 60-70 years old
* subjective memory impairment

Exclusion Criteria:

* psychiatric, neurological diseases
* uncorrected hearing or vision deficits
* actual psychopharmaco intake
* metal parts in the head
* medical electronical implants

Primary outcomes:
measure: Neuropsychological Performance in Neuropsychological Test: Verbal Learning Memory Test (VLMT)
timeFrame: 4 weeks
Secondary outcomes:
measure: Brain Activation Measured With Near-infrared Spectroscopy (NIRS) During the Semantic Condition of the Verbal Fluency Task (VFT)
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Wuerzburg
country: Germany
facility: University hospital
Study officials:
affiliation: University of Würzburg
name: Martin J. Herrmann, PD Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT07003438: Study on the Efficacy and Safety of Fecal Microbiota Transplantation in the Treatment of Steroid - Dependent /Steroid-resistant Nephrotic Syndrome in Children
Official title: Study on the Efficacy and Safety of Fecal Microbiota Transplantation in the Treatment of Steroid - Dependent /Steroid-resistant Nephrotic Syndrome in Children
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: EARLY_PHASE1
Conditions: Steroid-Resistant Nephrotic Syndrome
Steroid-Dependent Nephrotic Syndrome
Lead sponsor: Shanghai Children's Hospital
Sponsor class: OTHER
First posted: 2025-06-04
Enrollment: 120
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this clinical trial was to understand whether FMT is effective in treating steroid-dependent/steroid-resistant nephrotic syndrome in children. It will also learn about the safety of FMT. The main question it was designed to answer was: Did FMT reduce participants '24-hour urine protein content? What medical problems did participants experience while using FMT? The researchers will compare FMT treatment with and without FMT on top of conventional treatment to see if FMT is effective in treating steroid-dependent/steroid-resistant nephrotic syndrome in children. Participants will receive 2 FMT treatments, 1 endoscopic injection under anesthesia, 1 oral fecal bacteria transplantation capsule intake, and follow-up visits (weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48) every 4 weeks from the beginning of medication to our renal specialist clinic for drug efficacy evaluation and safety testing. Blood and fecal samples were collected to determine the effects of fecal bacterial transplantation on intestinal flora, fecal metabolomics, and intestinal mucosal permeability.


Eligibility criteria: Inclusion Criteria:

* Age 2-18 years, steroid-dependent/steroid-resistant nephrotic syndrome, regardless of gender, with SDNS at steroid-dependent doses less than 0.5 mg/kg.d

Exclusion Criteria:

* Those with concurrent infections or diseases of other organ systems, and those with abnormal renal function.

Primary outcomes:
measure: 24h urinary protein
timeFrame: follow-up visits (weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48) every 4 weeks from the beginning of medication to our renal specialist clinic for drug efficacy evaluation and safety testing
measure: Gut microbiota
timeFrame: immediately Before FMT, immediately before second FMT, one month after second FMT
measure: Zonulin
timeFrame: immediately Before FMT, immediately before second FMT, one month after second FMT
Secondary outcomes:
measure: Serum creatinine
timeFrame: immediately Before FMT, immediately before second FMT, one month after second FMT
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06019338: A Study to Validate a Pain Diary for Patient With Trigeminal Neuralgia
Official title: A Study to Validate a Diary Developed by Noema Pharma That Will be Used for Future Trigeminal Neuralgia Clinical Research Studies to Capture Pain Dimensions.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Trigeminal Neuralgia
Lead sponsor: Noema Pharma AG
Sponsor class: INDUSTRY
First posted: 2023-08-31
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients or former patients with diagnosed trigeminal neuralgia

Brief summary: The aim of the study is to establish the validity of a patient reported diary in TN . The following objectives have been identified:

1. To generate evidence to support diary content validity by performing qualitative research studies with TN patients and Healthcare Professionals (HCPs).
2. To provide further support to the diary, sensitivity to change, known groups validity (ability to differentiate between severity groups), and construct validity.

Detailed description: This study will engage up to 20 participants with TN through patient associations or HCPs. The study will be conducted in English Speaking countries.

The study comprises the following parts :

* Participants Recruitment
* Completion of the Diary
* Qualitative interviews with participants
* Analysis of qualitative research to assess content validity
* Secondary analysis as a workshop with a panel of experts to finalize the diary The diary will be provided to each participant and to HCPs. Participants will be requested to follow the instructions, use the diary and provide their feedback on the diary.

Eligibility criteria: Inclusion Criteria:

* Male or Female aged of 40 years or more.
* Must be able to read, write, and speak English to complete the consent process and participate in an interview.
* Able and willing to provide consent for participation in the study, and to allow the study team to access their data entries including audio or video recordings. - - Participant with a current or previous diagnosis of TN
* Willing to participate in up to 30 minutes remote interviews or in-person interview (this interview will be recorded by the HCP)
* Committ to fill in the diary according to the HCP instruction

Exclusion Criteria:

* Not applicable

Primary outcomes:
measure: Measure of pain associated with Trigeminal Neuralgia
timeFrame: 2 weeks
measure: Concept elicitation of the diary content
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Kainzen Centre
state: California
city: London
country: United Kingdom
facility: ULC Research
Study officials:
affiliation: Noema Pharma AG
name: Clinical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT04049838: Ultrasound Guided Posterior Versus Lateral Transversus Abdominis Plan Block for Prolonged Postoperative Analgesic Effect in Children
Official title: Ultrasound Guided Posterior Versus Lateral Transversus Abdominis Plan Block for Prolonged Postoperative Analgesic Effect in Children . Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain, Postoperative
Lead sponsor: Kasr El Aini Hospital
Sponsor class: OTHER
First posted: 2019-08-08
Enrollment: 69
Sex: ALL
Minimum age (years): 1
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized control study
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Ultrasound Guided Posterior Versus Lateral Transversus Abdominis Plan Block for Prolonged Postoperative Analgesic Effect in Children

Detailed description: the investigators will compare the effect of posterior Transversus abdominis plan block versus the effect of lateral transversus abdominis plan bock regarding the duration of analgesia and patients satisfaction the study will be conducted on 69 children aged from 1 to 7 years presented for lower abdominal surgery.

Eligibility criteria: Inclusion Criteria:

* children from 1- 7 years
* scheduled to undergo lower abdominal surgery

Exclusion Criteria:

* bleeding disorders
* emergency surgery
* skin lesion at site of needle insertion

Primary outcomes:
measure: postoperative pain assessment by the CHEOPS score
timeFrame: the first 24 hours postoperative
Secondary outcomes:
measure: heart rate
timeFrame: at 2,4,8,12 and 24 hours postoperative
measure: Mean arterial blood pressure
timeFrame: at 2,4,8,12 and 24 hours postoperative
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr Al Aini
Study officials:
References:
Clinical trial NCT01086150: Use of Topical Lidocaine to Reduce Pain in Patients With Diabetic Neuropathy
Official title: Use of Topical Lidocaine (Lidoderm 5% Patch) to Reduce Pain in Patients With Diabetic Neuropathy: Does the Density and Subtype of Sodium Channels Affect Response?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Diabetic Peripheral Neuropathy
Lead sponsor: Albany Medical College
Sponsor class: OTHER
Collaborators: name: Endo Pharmaceuticals
First posted: 2010-03-12
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to see if an investigational drug known as the lidocaine 5% patch is safe and effective in reducing the symptoms of diabetic neuropathy, to examine how topical lidocaine affects the nerve endings, and to determine whether treatment with the lidocaine patch can prevent the potential progression to chronic diabetic neuropathy pain in subjects who did not report pain at the start of the study.


Eligibility criteria: Inclusion Criteria:

* Group 1: 18-70 years of age, non-diabetic with no nervous system disease (healthy control group)
* Group 2: 18-70 years of age with Type I or Type II diabetes with significantly painful diabetic neuropathy (VAS \> 40mm at Baseline)
* Group 3: 18-70 years of age with Type I or Type II diabetes with non- painful or insignificantly painful diabetic neuropathy (VAS \< 40mm at Baseline)

Exclusion Criteria:

* History of clinically significant liver disease, serious peripheral vascular disease, a blood clotting disorder, or any other medical condition felt to be exclusionary by the investigator
* Allergy to lidocaine
* Unwillingness to sign informed consent or any other reasons for which the investigator feels the subject cannot complete the study
* Women who are pregnant, breastfeeding or trying to become pregnant
* History of slow-healing diabetic foot ulcers
* Current skin or soft tissue lesions on the foot that will interfere with application of the lidocaine patch and or skin biopsies
* Subjects taking Class I antiarrhythmics
* HgA1c \> 11%
* Active cancer within the previous two years except treated basal cell carcinoma of the skin
* Co-morbidities that can produce neuropathy
* Subjects taking sodium channel blockers within one week of study treatment and throughout the study
* Subjects taking any other experimental drugs within 30 days prior to Screening Visit (Visit 1)
* Application of lidocaine patch to either foot within two weeks of Screening Visit (Visit 1)

Primary outcomes:
measure: Pain Scores From Composite Visual Analog Scale
timeFrame: baseline, 4 weeks
Secondary outcomes:
measure: Keratinocyte Immunoreactivity of Nav1.6, Nav1.7, CGRP
timeFrame: Baseline, 4 weeks
Other outcomes:
Locations:
city: Albany
country: United States
facility: Albany Medical College
state: New York
Study officials:
References:
Clinical trial NCT06907550: Mitochondrial DNA Deletions in Plasma as a Diagnostic Aid for Females Presenting With Symptoms of Endometriosis
Official title: Mitochondrial DNA Deletions in Plasma as a Diagnostic Aid for Females Presenting With Symptoms of Endometriosis
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Endometriosis
Lead sponsor: Pearsanta, Inc
Sponsor class: INDUSTRY
First posted: 2025-04-02
Enrollment: 1000
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Females between menarche and menopause presenting with symptoms suggestive of endometriosis and scheduled for a standard-of-care diagnostic laparoscopy

Brief summary: This study will investigate the clinical performance and diagnostic accuracy of the Mitomic® Endometriosis Test (MET) compared to laparoscopic diagnosis in a prospective clinical study in females presenting with symptoms suggestive of endometriosis. This study will recruit patients with suspected endometriosis who have been referred for a diagnostic laparoscopy. Patients will complete a questionnaire about their endometriosis symptoms and a sample of blood will be taken prior to their laparoscopy and sent to the laboratory for the MET to be run.

This study aims to first enroll 104 subjects to support the clinical validation necessary for launch of the test as an LDT. Following this, we plan a study extension with an aim to enroll up to 900 more (for a total of 1000) subjects to enable more precise estimation of performance characteristics, characterization of test performance in subtypes of endometriosis, to better understand the relationship between test results and secondary endpoints such as symptoms and demographic variables, and to establish a bank of samples to support future test development.


Eligibility criteria: Inclusion Criteria:

1. Be female, between menarche and menopause who present with symptoms of endometriosis at time of blood collection and are scheduled to undergo their first laparoscopic procedure for the diagnosis of endometriosis
2. Provide a blood sample prior to surgical procedure or administration of drugs related to the surgical procedure (i.e. anaesthetics, antibiotics)
3. Be fit to undergo all procedures listed in protocol
4. Be able to provide written informed consent

Exclusion Criteria:

1. Has had a prior surgical diagnosis of endometriosis at time of blood collection
2. Is unable to communicate in written and spoken English
3. Has any other condition, which in the opinion of the investigator, would make the subject not a suitable candidate for the study. This reason must be recorded on the CRF

Primary outcomes:
measure: Presence or absence of endometriosis
timeFrame: up to 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Pearsanta, Inc.
state: Virginia
Study officials:
affiliation: Pearsanta, Inc
name: Stephen A Varvel, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02406950: Sitagliptin and Endothelial Dysfunction
Official title: Preventive Effects of Sitagliptin on Endothelial Dysfunction Induced by Forearm Ischemia-Reperfusion Injury Model
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Healthy
Keywords: Sitagliptin
Endothelium
Ischemia-Reperfusion Injury
human
Lead sponsor: Kyunghee University Medical Center
Sponsor class: OTHER
First posted: 2015-04-02
Enrollment: 10
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: Over the years, numbers of cardioprotective drugs have been evaluated to attenuate lethal ischemia-reperfusion (IR) injuries. There is little study whether sitagliptin protects against endothelial dysfunction induced by IR injury in humans.

Detailed description: Glucagon-like peptide-1 (GLP-1) is a novel insulinotropic peptide which is rapidly degraded by the enzyme dipeptidyl peptidase-4 (DPP-4). In addition to its attractive merit in type 2 diabetes, interest in the cardioprotective effects of GLP-1 has been increased with various reports and evidence. Previously, the investigators could show exenatide, GLP-1 receptor agonist protects ischemic/reperfusion injury-induced endothelial dysfunction through opening of KATP (ATP-sensitive potassium) channels in human ischemic/reperfusion injury model. But, recent clinical studies showed 2 different DPP-4 inhibitors, alogliptin and saxagliptin, did not decrease major adverse cardiovascular events even though improving glycemic control. The investigators will investigate the role of sitagliptin in human ischemic/reperfusion (IR) injury model of forearm conductance vessels as previous described method.

Eligibility criteria: Inclusion Criteria:

* healthy volunteer age 20 to 40 years
* non-smoker

Exclusion Criteria:

* High blood pressure (\>140/90 mmHg) or any antihypertensive medications
* diabetes
* any cardiovascular disease
* kidney disease
* thyroid disease
* cerebrovascular disease
* liver disease (bilirubin level \>2 mg/dl)
* pregnancy
* body mass index \>25 kg/m2

Primary outcomes:
measure: The difference of FMD [brachial artery endothelium-dependent flow-mediated dilatation] after IR injury (brachial FMD before and after IR injury will be assessed)
timeFrame: 2 hours after study drug treatment
Secondary outcomes:
measure: The difference of FMD after IR injury in co-treatment of glibenclimide and sitagliptin ((brachial FMD before and after IR injury will be assessed)
timeFrame: 3.5 hours after study drug treatment
Other outcomes:
measure: Adverse events
timeFrame: 3 weeks
Locations:
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Hospital
Study officials:
affiliation: Kyunghee University Medical Center
name: Weon Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: