louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02904603: Immune Monitoring of Hepatitis C Under DAA Therapy
Official title: Prospective Monitoring of Immune Parameters in Patients With Hepatitis C Under Treatment With Direct Acting Antivirals
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hepatitis C
Lead sponsor: University of Regensburg
Sponsor class: OTHER
First posted: 2016-09-19
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients under DAA therapy \> 18 years monocentral.

Brief summary: Direct acting antivirals offer a new opportunity to monitor the immune response in Hepatitis C infection. In this study cytokine markers will be measured during therapy up to time point SVR 12 an correlated to clinical Parameters and regular laboratory findings.


Eligibility criteria: Inclusion Criteria:

* written consent, age, HCV-RNA positive, DAA therapy

Exclusion Criteria:

-

Primary outcomes:
measure: Change of IP10 and related cytokines during treatment (ng/ml)
timeFrame: 24 weeks (observation time under and after DAA therapy)
Secondary outcomes:
measure: SVR 12
timeFrame: 24 weeks (12 weeks treatment plus control 12 weeks after end of treatment)
measure: Change of inflammatory markers (ferritin ng/ml, CRP mg/l, PCT ng/ml) during treatment
timeFrame: 24 weeks (observation time under DAA therapy)
Other outcomes:
Locations:
city: Regensburg
country: Germany
facility: University of Regensburg
Study officials:
affiliation: Uiversity of Regensburg
name: Kilian Weigand
role: STUDY_CHAIR
References:
citation: Adenugba A, Hornung M, Weigand K, Peschel G, Junger H, Kupke P, Lang H, Marquardt JU, Zimmermann T, Geissler EK, Schlitt HJ, Werner JM. Ribavirin Improves NK Cell IFNgamma Response During Sofosbuvir-based DAA Therapy in HCV-infected Liver Transplant Recipients. Transplantation. 2021 Oct 1;105(10):2226-2238. doi: 10.1097/TP.0000000000003612.
citation: Hutchinson JA, Weigand K, Adenugba A, Kronenberg K, Haarer J, Zeman F, Riquelme P, Hornung M, Ahrens N, Schlitt HJ, Geissler EK, Werner JM. Predicting Early Viral Control under Direct-Acting Antiviral Therapy for Chronic Hepatitis C Virus Using Pretreatment Immunological Markers. Front Immunol. 2018 Feb 7;9:146. doi: 10.3389/fimmu.2018.00146. eCollection 2018.
Clinical trial NCT07004803: Virtual Reality on Pain and Fear Levels of Children With Primary Immunodeficiency
Official title: The Effect of Virtual Reality on Pain and Fear Levels of Children With Primary Immunodeficiency Applying Intravenous Immunoglobulin During Intravenous Access: A Crossover Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Primary Immunodeficiency Diseases (PID)
Keywords: Children
Virtual Reality
Primary Immunodeficiency
Nursing care
Administration, Intravenous
Lead sponsor: Karamanoğlu Mehmetbey University
Sponsor class: OTHER
Collaborators: name: Karamanoğlu Mehmetbey University
First posted: 2025-06-04
Enrollment: 32
Sex: ALL
Minimum age (years): 4
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: In this study, it is aimed to investigate the effect of virtual reality and tablet video viewing intervention on pain and fear levels and vital signs of children during peripheral venous catheter placement for intravenous immunoglobulin (IVIG) administration.


Eligibility criteria: Inclusion Criteria:

* Being between the ages of 4-11
* Being followed up with the diagnosis of Primary Immunodeficiency for at least 6 months
* To accept participation in the study voluntarily
* No additional chronic disease other than primary immunodeficiency

Exclusion Criteria:

* Organ failure is present
* Having a mental deficiency
* Having a disability to use VR Glasses
* Children with fever (\|\>37.5 C0)
* Children with severe dehydration

Primary outcomes:
measure: Children's Fear Scale
timeFrame: 5 minutes
measure: Wong-Baker Pain Scale
timeFrame: 5 minutes
measure: Children's Emotional Manifestation Scale
timeFrame: 5 minutes
Secondary outcomes:
measure: Vital Signs
timeFrame: 5 minutes
Other outcomes:
Locations:
city: Karaman
country: Turkey
facility: Karamanoglu Mehmetbey University
Study officials:
References:
Clinical trial NCT05531903: High-density Activation Mapping of the Slow Pathwayto Guide Catheter Ablation in Patients With Typical Atrioventricular Nodal Reentrant Tachycardia
Official title: High-density Activation Mapping of the Slow Pathway During Sinus Rhythm: a New and Simple Method to Guide Catheter Ablation in Patients With Typical Atrioventricular Nodal Reentrant Tachycardia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Supraventricular Tachycardia
Atrioventricular Nodal Re Entrant Tachycardia
Lead sponsor: Parc de Salut Mar
Sponsor class: OTHER
First posted: 2022-09-08
Enrollment: 119
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single group of intervention. A control group with absence of dual AVN phisiology to check lack of abnormal fragmented/slow conduction confluent zones.
Primary purpose: TREATMENT

Brief summary: Atrioventricular nodal reentrant tachycardia (AVNRT) is the most common supraventricular tachycardia inducible during an electrophysiological study. Although ablative therapy proved to be the treatment of choice, little is known about the components of the tachycardia circuit. The aim of this study is to detect the presence and patterns of specific electrograms representing slow pathway (SP) potentials and to explore Koch's triangle pattern activation during sinus rhythm and/or atrial extraestimulus with a high-density mapping catheter in an attempt to clarify a fast and safety catheter ablation strategy. We hypothesized that, in patients with dual atrioventricular nodal physiology, during sinus rhythm (SR), high-density mapping (HDM) catheters could identify the SP signals, making possible to delineate small areas of slow conduction associated to abnormal electrograms on Koch's triangle. On a second step, radiofrequency (RF) applications safety guided by the HDM obtained with this method, should interrupt the circuit far from the His region. Finally, SP signals should disappear after the RF procedure when performing a new 3D HDM. A control group of patients without AVN dual physiology should show absence of fragmented/slow conduction zones.


Eligibility criteria: Inclusion Criteria:

* Patients \> 18 yo with AVNRT observed after electrophysiological study

Exclusion Criteria:

* Patients \< 18 yo

Primary outcomes:
measure: Absence of reinduction of AVNRT after abolition of fragmented/slow conduction signals
timeFrame: one day
Secondary outcomes:
measure: Absence of AVNRT relapses
timeFrame: one month
measure: Percentage of patient without AVNRT reinduction after procedure
timeFrame: One day
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Jesús Ignacio Jiménez López
Study officials:
affiliation: Parc de Salut Mar
name: Jesús Ignacio Jimenez López, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00493103: TG Gene Mutations and Congenital Hypothyroidism
Official title: Congenital Hypothyroidism Due to Thyroglobulin Mutations in an Inbred Brazilian Family: A Novel Compound Heterozygous Constellation and Intronic Mutation Related to Fetal Goiter.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Congenital Hypothyroidism
Keywords: thyroglobulin gene
congenital hypothyroidism
gene mutations
fetal goiter
iodine nutrition
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2007-06-27
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: OTHER

Brief summary: The aim of this study was to identify mutations in the thyroglobulin gene that might be present in patients with fetal goiter and congenital goiter hypothyroidism.

Detailed description: Congenital goitrous hypothyroid is commonly linked to thyroglobulin (TG) gene mutations.We aim to identify mutations in the TG gene that might be present in patients with fetal goiter and congenital goiter hypothyroidism.Four related patients with congenital goiter hypothyroidism from an inbred family were studied.Recombinant human TSH stimulation test, DNA sequencing and protein computer analysis were performed.We identified a novel compound heterozygous constellation (IVS30+1G\>T/A2215D) in two siblings. It was also identified a homozygous intronic mutation (IVS30+1G\>T) in their cousins, one of them with fetal goiter. The mutation IVS30+1G\>T promotes an aberrant splicing and loss of the entire exon 30 (138 nt) in the resulting messenger RNA. The recent described mutation A2215D is located in the ACHE-like domain, which functions as a dimerization domain, facilitating efficient intracellular transport of the protein. Protein computer analysis suggested that the A2215D mutation causes TG structural alterations.A novel compound heterozygous constellation (IVS30+1G\>T/A2215D) and the previously described mutation (IVS30+1G\>T) that cause severe congenital hypothyroidism due to defective TG synthesis have been identified. The mutation IVS30+1G\>T may be related to fetal goiter and hypothyroidism due to TG instability and impaired TG export to the colloid. This study shows the efficiency of the use of rhTSH in the differential diagnosis of CH due to TG defective synthesis and the importance of molecular diagnosis of CH for possible intrauterine treatment, thereby avoiding damage to the neuropsychomotor system.

Eligibility criteria: Inclusion Criteria:

* Patients with congenital hypothyroidism due to thyroglobulin defective synthesis.

Exclusion Criteria:

* Patients with another disease.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Sao Paulo
name: Viviane Pardo
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Sao Paulo
name: Geraldo Medeiros-Neto
role: STUDY_DIRECTOR
References:
Clinical trial NCT06765603: Evaluating the Efficacy of the Combination of Multi-zonal Contact Lens and Atropine for Controlling Myopia Progression
Official title: Evaluating the Efficacy of the Combination of Multi-zonal Contact Lens and Atropine for Controlling Myopia Progression
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Myopia
Keywords: myopia intervention
Lead sponsor: Singapore National Eye Centre
Sponsor class: OTHER_GOV
First posted: 2025-01-09
Enrollment: 180
Sex: ALL
Minimum age (years): 7
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: RCT
Primary purpose: TREATMENT

Brief summary: The aim of the study is to explore efficacy of combination Atropine and multifocal CL. Randomized Control Trial including 4 arms: Atropine / multizonal CL; Atropine/ SV CL, Placebo drop/ multizonal CL; Placebo drop/ SV CL. Followed over 1 year with outcome measure of change in spherical equivalent and axial length.

Detailed description: see above

Eligibility criteria: Inclusion Criteria:

* Between 7 and 12 (inclusive) years of age at the time of screening.
* spherical equivalent of cycloplegic objective refraction (by autorefraction) range of -0.75 D to -4.50 D (inclusive) in each eye.
* Refractive cylinder less than 1.12 D (inclusive)
* Best-corrected visual acuity (BCVA) of 0.04 logMAR or better in each eye, with difference less than 0.20 logMAR between eyes.
* Have normal eyes (i.e., no ocular medications or infections of any type).

Exclusion Criteria:

* Past or current use of myopia control treatment or involvement in previous myopia control study
* Any current or seasonal use of ocular medication (eg. for allergy or chronic blepharitis).
* hypersensitivity or allergic reaction to atropine, cyclopentolate, topical anesthetics or study approved rewetting drop solutions available in local markets.
* previous history or signs of a contact lens-related corneal inflammatory event (e.g., past ulcer or scar) that may contraindicate contact lens wear.
* Any ocular allergies, infections or other ocular abnormalities that are known to interfere with contact lens wear and/or participation in the study. This may include, but not be limited to entropion, ectropion, extrusions, chalazia, recurrent styes, ocular hypertension, glaucoma, history of recurrent corneal erosions, aphakia, uveitis, severe keratoconjunctivitis sicca, keratoconus, keratoconus suspect, and pellucid marginal degeneration.
* Grade 3 or greater palpebral conjunctival observations or any other Grade 2 or greater slit-lamp findings (eg. edema, corneal neovascularization, corneal staining, conjunctival injection) on the ISO 11980 classification scale.
* Any central corneal scar or corneal distortion resulting from ocular diseases or previous hard or rigid permeable contact lens wear.

Primary outcomes:
measure: Change in spherical equivalent
timeFrame: 12 months
Secondary outcomes:
measure: Change in axial length
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06224803: Evaluation of Effects of Dibifree® on Regulation of Blood Sugar and HbA1c in Patients With Type II Diabetes
Official title: Evaluation of Effects of Dibifree® on Regulation of Blood Sugar and HbA1c in Patients With Type II Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type II Diabetes
Lead sponsor: Global Preventive Medicine Biotech Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-01-25
Enrollment: 56
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: At present, diabetic patients mainly use drugs to control blood sugar. However, drugs have side effects and the control effect varies among individuals. Even if diabetic patients can control their blood sugar well, long-term medication will still cause a series of complications, including retinopathy, nephropathy, diabetic foot, heart disease, etc. Vascular disease issues, etc.

This study will focus on the changes in HbA1c and blood sugar in patients with confirmed diabetes after taking "Dibifree®" food supplement.


Eligibility criteria: Inclusion Criteria:

1. Age: 20 years old (inclusive) or above, gender is not restricted
2. Diagnosed with type 2 diabetes
3. HbA1c \> 6.5%
4. Coagulation function and platelets are normal
5. Participants voluntarily join this treatment course and sign the informed consent form
6. Not taking other supplements containing blood sugar regulating properties for at least one month

Exclusion Criteria:

1. Women who are pregnant, lactating or planning to have children
2. Have factors that significantly affect the absorption of oral drugs, such as inability to swallow, chronic diarrhea, intestinal obstruction, etc.
3. Uncontrolled hypertension (\>180/110 mmHG)
4. People suffering from stroke, elderly dementia, Alzheimer's disease and other brain diseases
5. During this study, the subject used other drugs or treatments that may interfere with this study in addition to blood sugar control medications.
6. GOT\>4 times normal value; GPT\>4 times normal value
7. Creatinine\>4 times the highest normal value
8. Those who are determined by the project administrator to be unfit to participate in this clinical study

Primary outcomes:
measure: Concentration of HbA1c
timeFrame: per 30 days for 7 months
Secondary outcomes:
measure: Concentration of Blood Sugar
timeFrame: everyday for 7 months
Other outcomes:
Locations:
city: New Taipei
country: Taiwan
facility: Global Preventive Medicine Biotech Co., Ltd.
Study officials:
References:
Clinical trial NCT06665503: The Impact of Zinc and Probiotics in Preventing Pediatric Antibiotic-Associated Diarrhea in Southern Iran
Official title: The Impact of Zinc and Probiotics in Preventing Pediatric Antibiotic-Associated Diarrhea in Southern Iran
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Antibiotic-associated Diarrhea
Diarrhea
Keywords: antibiotic-associated diarrhea
children zinc, probiotics
zinc
probiotics
Lead sponsor: Hormozgan University of Medical Sciences
Sponsor class: OTHER
First posted: 2024-10-30
Enrollment: 165
Sex: ALL
Minimum age (years): 3
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomly assigned to three groups of equal size, exclusively receiving the standard antibiotic regimen or the zinc and probiotics groups
Primary purpose: PREVENTION

Brief summary: The Impact of Zinc and Probiotics in Preventing Pediatric Antibiotic-Associated Diarrhea in Southern Iran

Detailed description: The participants will be children aged 3 months to 3 years.The zinc group received oral zinc supplementation; 2.5 ml every 12 hours for children aged \<1 year and 5 ml every 12 hours for older children; the probiotics group received oral probiotics; 1 probiotic sachet; and the control group received nothing.

Eligibility criteria: Inclusion Criteria:

1. children aged 3 months to 3 years
2. prescribed antibiotics for various medical conditions

Exclusion Criteria:

1. Diarrhea, Dysentery
2. Underlying chronic disease

Primary outcomes:
measure: Rate of Antibiotic-Associated Diarrhea
timeFrame: 6 month
Secondary outcomes:
Other outcomes:
Locations:
city: Bandar Abbas
country: Iran, Islamic Republic of
facility: Hormozgan University of Medical Sciences
state: Hormozgan
Study officials:
affiliation: Hormozgan University of Medical Sciences
name: MohammadBagher Rahmati, Pediatrician
role: STUDY_DIRECTOR
References:
Clinical trial NCT02306603: Long-term Outcomes of Endoscopic Resection (ER) of Lesions of the Duodenum and Ampulla
Official title: Outcomes of Endoscopic Resection of Mucosal and Submucosal Lesions in the Duodenum and Ampulla
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Adenoma, Villous
Lead sponsor: Western Sydney Local Health District
Sponsor class: OTHER
First posted: 2014-12-03
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have Duodenal and ampullary adenomas which are amendable to Endoscopic Mucosal Resection

Brief summary: This research project, 'Outcomes of endoscopic resection of mucosal and submucosal lesions in the duodenum and ampulla'. The research project is aiming to determine the most effective and safe way to remove such lesions.

Detailed description: Endoscopic resection (ER) of superficial lesions of the duodenum and ampulla is a safe and effective surgery sparing modality in experienced hands. It is often curative of dysplastic lesions and is associated with minimal complications and high patient acceptance (1-5). Westmead Hospital has accumulated a significant amount of experience in the removal of such lesions; however, there is limited research to document the long term outcomes of patients undergoing endoscopic resection.The purpose of this study is to evaluate the long-term outcomes of ER of superficial lesions of the duodenum and ampulla.

Eligibility criteria: Inclusion Criteria:

\* Duodenal and ampullary lesion \> 10mm

* Lesion limited to the mucosal and/or submucosal layer (T1 lesion)
* Aged 18 years or older

Exclusion Criteria:

* Lesion less than 10mm
* Duodenal or ampullary lesion involves the muscularis propria (T2 lesion) on other staging modalities such as endoscopic ultrasonography (EUS)
* Aged younger than 18 years

Primary outcomes:
measure: Observed procedural data: Number of Participants with Adverse Events as a Measure of Safety and Tolerability Outcomes
timeFrame: 14 days
Secondary outcomes:
measure: Analysis of the costs of this procedure compared to previous treatments
timeFrame: 14 days
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: Westmead Hospital Endoscopy Unit
state: New South Wales
Study officials:
affiliation: Western Sydney Local Health District
name: Michael J Bourke, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sidhu M, Fritzsche JA, Klein A, Shahidi N, Vosko S, van Hattem WA, Tate DJ, Bourke MJ. Outcomes of thermal ablation of the defect margin after duodenal endoscopic mucosal resection (with videos). Gastrointest Endosc. 2021 Jun;93(6):1373-1380. doi: 10.1016/j.gie.2020.11.024. Epub 2020 Dec 4.
citation: Klein A, Qi Z, Bahin FF, Awadie H, Nayyar D, Ma M, Voermans RP, Williams SJ, Lee E, Bourke MJ. Outcomes after endoscopic resection of large laterally spreading lesions of the papilla and conventional ampullary adenomas are equivalent. Endoscopy. 2018 Oct;50(10):972-983. doi: 10.1055/a-0587-5228. Epub 2018 May 16.
Clinical trial NCT00032903: This is an Early Study to Investigate the Effect of Gimatecan® in Adults With Malignant Glioma.
Official title: Oral ST1481 in Adults With Malignant Glioma: a Phase I-II Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Malignant Glioma
Keywords: Malignant Glioma, Camptothecin, Pharmacokinetics
Lead sponsor: Sigma-Tau Research, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Rhode Island Hospital
First posted: 2002-04-08
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Gimatecan® is Sigma-Tau Research's new, potent, oral Topoisomerase I inhibitor. Drugs in this class play a crucial role in destroying DNA replication in tumors. We are conducting this study to determine the Maximum Tolerated Dose of our compound. In addition, we plan to assess the drug's ability to affect the evolution of malignant gliomas, when given as a capsule, rather than by intravenous injection.


Eligibility criteria: Inclusion criteria:

* Histologically confirmed diagnosis of a recurrent primary malignant glioma
* Life expectancy of at least 3 months with normal hematological, liver and renal function

Exclusion criteria:

* Pregnant and lactating patients
* Participation in any investigating drug study within 4 weeks preceding treatment start or concurrent treatment with any other anti-cancer therapy
* Gastrointestinal dysfunction that could alter absorption or motility

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
Study officials:
References: