louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05973721: Clinical Study of Phage Therapy for Chronic Constipation Efficacy and Safety
Official title: To Investigate the Clinical Efficacy and Safety of Phage Therapy for Chronic Constipation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pib Specific Phage
Intractable Constipation
Lead sponsor: Shanghai 10th People's Hospital
Sponsor class: OTHER
First posted: 2023-08-03
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The overall aim was to evaluate the efficacy of PiB-specific phages for the treatment of refractory constipation through clinical studies, primarily for the publication of scientific papers and to guide the development of phage therapies. The purpose of this study will be subdivided into three aspects from three aspects: target exposure level, target occupation, and functional effects after acting on the target, including:1) The distribution of PIB phage in the intestine of patients with refractory constipation;2) The killing effect of PIB phage on PIB bacteria in refractory constipation patients;And 3) therapeutic effect of PIB phage on patients with refractory constipation.


Eligibility criteria: Inclusion Criteria:

* Patients of both sexes, aged 18-70 years, with confirmed chronic constipation and positive fecal bacteria test for PIB, agreed to participate in this experiment and signed an informed consent.

Exclusion Criteria:

* Severe heart failure, hypertension, cerebrovascular disease (e.g. stroke, moyamoya disease, etc.); Secondary constipation caused by psychotropic drug abuse; Pregnant or lactating women.

Primary outcomes:
measure: To observe the curative effect of PIB phage on refractory constipation by defecation behavior of patients.
timeFrame: Baseline and six months after treatment
measure: The concentration of phage in feces was detected to evaluate the survival and survival ratio of active phage in the intestinal tract of patients.
timeFrame: Baseline and 24-48 hours after phage administration (first bowel movement)
measure: Real-time PCR was used to detect the nucleic acid of PIB bacteria and HPLC was used to detect the distribution of fecal PIB phage in the intestinal tract of patients with refractory constipation
timeFrame: Baseline and two weeks after treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Tenth People's Hospital
Study officials:
affiliation: Intestinal Microenvironment Treatment Center of General Surgery, Shanghai Tenth People's Hospital, Tenth People's Hospital of Tongji University
name: Hongliang Tian, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02597621: Biomarkers for Therapy Response in Drug-resistant Tuberculosis
Official title: Biomarkers for Therapy Response in Drug-resistant Tuberculosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tuberculosis, Multidrug-resistant
Lead sponsor: Research Center Borstel
Sponsor class: OTHER
First posted: 2015-11-05
Enrollment: 192
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with microbiologically confirmed pulmonary MDR-TB

Brief summary: Multi-center, observational, prospective cohort study including patients with multidrug-resistant tuberculosis at different sites in Germany.

The aim the study is the identification of biomarkers for therapy response.

Detailed description: The increasing rates of multidrug-resistant (MDR) tuberculosis (TB) are causing great concern. The current study that will be conducted at different centers in Germany. Biomarkers for treatment response during the course of the tuberculosis therapy will be evaluated. The study will be conducted with funding of the German Center for Infection Research (DZIF).

Eligibility criteria: Inclusion Criteria:

* Subjects with confirmed pulmonary MDR-TB
* Subject able and willing to give informed consent

Exclusion Criteria:

* HIV infection
* physical or mental inability preventing study participation at the discretion of the investigator
* member of a vulnerable or special population (prisoner, soldier, mentally ill, under guardianship)
* age \<18 years.

Primary outcomes:
measure: Identification of biomarkers for therapy response
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Borstel
country: Germany
facility: Research Center Borstel
state: Schleswig-Holstein
Study officials:
References:
citation: Heyckendorf J, Marwitz S, Reimann M, Avsar K, DiNardo AR, Gunther G, Hoelscher M, Ibraim E, Kalsdorf B, Kaufmann SHE, Kontsevaya I, van Leth F, Mandalakas AM, Maurer FP, Muller M, Nitschkowski D, Olaru ID, Popa C, Rachow A, Rolling T, Rybniker J, Salzer HJF, Sanchez-Carballo P, Schuhmann M, Schaub D, Spinu V, Suarez I, Terhalle E, Unnewehr M, Weiner J 3rd, Goldmann T, Lange C. Prediction of anti-tuberculosis treatment duration based on a 22-gene transcriptomic model. Eur Respir J. 2021 Sep 2;58(3):2003492. doi: 10.1183/13993003.03492-2020. Print 2021 Sep.
Clinical trial NCT06428721: The Preventive Role of Fractionated Laser Resurfacing Against Actinic Neoplasia in an At-Risk Geriatric Population
Official title: The Preventive Role of Fractionated Laser Resurfacing Against Actinic Neoplasia in an At-Risk Geriatric Population
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Actinic Keratoses
Aging
Non-Melanoma Skin Cancer
Lead sponsor: Wright State University
Sponsor class: OTHER
First posted: 2024-05-24
Enrollment: 80
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine if the Fractionated Laser Resurfacing (FLR) procedure can protect one forearm/wrist from precancerous actinic keratosis (AKs) as well as prevent skin cancer in older subjects with active AKs. This study builds on a similar study ongoing at the Dayton Veterans Administration dermatology clinic. This study is also testing if a photograph of the skin can be used to predict where the AKs and an skin cancers will form.


Eligibility criteria: Inclusion Criteria:

* Adult Males and Females aged 60 and older
* Have at least 5 AKs on each forearm/wrist, but no more than 10 to allow for easy monitoring
* Skin type fair (Fitzpatrick I-II)
* Females must be post-menopausal and not be on systemic hormone replacement therapy
* Able to comprehend procedures and risks

Exclusion Criteria:

* More than 10 AKs on an extremity
* AKs that are large (2-3+, hyperkeratotic grade 3 lesions)
* AKs that are very thick (\>3 mm)
* Medical history of diabetes
* History of poor wound healing or scarring
* Large tattoos that can interfere with study
* Other serious health issues and other skin diseases that could interfere with the study
* Recent (within 1 year) field therapies such as efudex cream or PDT to forearms/wrists.
* Planning to leave region in next 5 years
* Subjects with allergies to xylocaine will be excluded if they need this topical anesthetic.

Primary outcomes:
measure: Change from baseline in the number of actinic keratosis due to FLR treatment.
timeFrame: Up to 5 years
measure: Change from baseline in the number of non-melanoma skin cancers due to FLR treatment.
timeFrame: Up to 5 years
Secondary outcomes:
measure: Skin dysplasia change, in regards to actinic keratosis, from baseline due to FLR treatment.
timeFrame: Up to 5 years
measure: Skin dysplasia change, in regards to non-melanoma skin cancer, from baseline due to FLR treatment.
timeFrame: Up to 5 years
Other outcomes:
Locations:
city: Fairborn
country: United States
facility: Wright State Physicians
state: Ohio
Study officials:
affiliation: Wright State University
name: Jeffrey Travers, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05761821: Key Factors of Leadless Pacemaker Implantation With Implantation Site, Complications and Prognosis
Official title: Relationship Between Key Factors of Leadless Pacemaker Implantation With Implantation Site, Intraoperative Complications and Prognosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Complication of Surgical Procedure
Pacemaker Complication
Pacemaker Syndrome
Keywords: leadless pacemaker
complication
Prognosis
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2023-03-09
Enrollment: 300
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: Patients received implantation of leadless pacemaker

Brief summary: To investigate the relationship between key variables in leadless pacemaker implantation with implantation site, intraoperative complications and prognosis.

Detailed description: In this study, we aim to include patients implated with leadless pacemakers, collect key variables and other clinical data during implantation of leadless pacemakers, and observe the final implantation site, intraoperative complications and prognosis information of patients. This study aims to clarify the relationship between key variables in leadless pacemaker implantation with implantation site, intraoperative complications and prognosis, and provide data support for the standardization of leadless pacemaker implantation process in China.

Eligibility criteria: Inclusion Criteria:

* Patient received implantation of leadless pacemaker
* Patient agreed to join into this study and signed informed consent

Exclusion Criteria:

* Age \< 18 years
* Ventricular septal defect
* History of mechanical tricuspid valve replacement
* History of inferior vena cava filter placement
* Pregnant or plan to be pregnant within 2 years
* Life expectancy \< 1 year
* Patient was included in other studies that could introduce bias into this study

Primary outcomes:
measure: Serious adverse events
timeFrame: Day 0 (Time of implantation)-Day 7
Secondary outcomes:
measure: Device-related complications
timeFrame: Day 0 (Time of implantation)-Day 7
measure: Device-related complications
timeFrame: Day 0 (Time of implantation)-Year 2
measure: Serious adverse events
timeFrame: Day 0 (Time of implantation)-Year 2
measure: Re-intervention of devices
timeFrame: Day 0 (Time of implantation)-Year 2
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen Memorial Hospital of Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
name: Yangxin Chen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01084421: A Computer-Based Parent/Adolescent HIV Communication Intervention for Latinos
Official title: A Computer-Based Parent/Adolescent HIV Communication Intervention for Latinos
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV/AIDS
STD
Pregnancy
Keywords: Adolescents
Parents
Computer Based
Latino
Sexual Communication
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2010-03-10
Enrollment: 260
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to examine the efficacy of a brief culturally appropriate and theory-based parental communication intervention designed to improve parent-adolescent sexual communication and reduce adolescent sexual risk behavior.

Detailed description: Latino adolescents are at high risk for contracting HIV/AIDS. Few individual and even fewer parent interventions have been developed to address this persistent problem. Parent communication interventions provide an opportunity to enhance individual adolescent based approaches. However, there is a need for theory and culture based interventions focused on Latino parents. The program implemented in this study was designed for parents, to indirectly help reduce the health risks of their adolescents, including unintended pregnancy and STDs, including HIV/AIDS. The study has three aims regarding the examination of whether the computer based parental communication intervention is 1) associated with a greater increase in parents' comfort with, and quantity of communication; 2) associated with a greater increase in adolescents' intentions to abstain from sex and/or avoid unprotected intercourse and decreased self-reported intercourse and unprotected intercourse; and 3) feasible and acceptable to Spanish dominant Latino parents and their adolescent children.

Eligibility criteria: Inclusion Criteria:

* Latino parents who have adolescents 14 to 17 years of age
* Spanish dominant or bilingual

Primary outcomes:
measure: general parent-adolescent communication, parent-adolescent sexual risk communication, comfort with communication
timeFrame: pretest, 1 week, 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Detroit Hispanic Development Corporation (DHDC)
state: Michigan
Study officials:
affiliation: University of Michigan
name: Antonia M Villarruel, PhD,RN,FAAN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04269421: Return To Sport Activities in Patients Surgically Treated For Flat Foot in Paeditric Age
Official title: Return To Sport Activities in Patients Surgically Treated For Flat Foot in Paeditric Age
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Flat Feet
Surgery
Sports Physical Therapy
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2020-02-13
Enrollment: 80
Sex: ALL
Minimum age (years): 8
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The analysis will be performed on pediatric patients undergoing surgical treatment for correction of idiopathic flatfoot in the Orthopedics Pediatric department of the IRCCS Rizzoli Orthopedic Institute in the years 2016-2017.

Brief summary: The SURGERY of arthrosis of the subtalar joint, carried out between 9 and 12 years of age, the aim is to restore and maintain the physiological alignment between the talus and the calcaneus during bone maturation.

There are few articles in the literature that talk about the return to sport of pediatric patients after surgery. The aim of the study is to review patients operated on remotely kick heel and describe how they return in their sports (resilience, type of activities carried out, recovery times). The aim of this study is to evaluate the clinical and functional results of patients of age Pediatric treated in the investigator's SC Orthopedics Pediatric Traumatology department for flat feet with "calcaneostop" surgery. The study aims to describe the method of resuming sports activities, analyzing the timing and difficulties declared by patients after surgery, with the help of specific questionnaires.


Eligibility criteria: Inclusion Criteria:

* Idiopathic Flatfoot;
* Surgical treatment with arthrorisis of subtalar joint;
* Follow-up\> 48 months
* Completeness of the clinical-radiographic documentation.

Exclusion Criteria:

* Diagnosis of secondary flat valgus foot;
* Flat foot treated with other techniques;
* Incomplete clinical documentation;
* Patients who refuse to undergo the study

Primary outcomes:
measure: Number of Patiens Able to Return to Sport After Surgery
timeFrame: 1 year
Secondary outcomes:
measure: plantar arch index
timeFrame: 1 year
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS - Istituto Ortopedico Rizzoli
Study officials:
References:
Clinical trial NCT06761521: Monitoring of Implant Diseases: Diagnosis and Monitoring with AMMP-8 Test Technology
Official title: Monitoring of Implant Diseases: Diagnosis and Monitoring with AMMP-8 Test Technology: a 5-year Follow-up Study
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Peri-Implant Health
Peri-Implantitis and Peri-implant Mucositis
Keywords: Ammp-8
Peri-implant diseases
mucositis
prevention
maintenance
Lead sponsor: Lahanna oy
Sponsor class: OTHER
Collaborators: name: University of Helsinki
First posted: 2025-01-07
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: 68 patients underwent the aMMP-8 chair-side test as well as clinical traditional measurement methods. Those who had one or more implants in their mouth were selected as patients. The condition of the attachment tissues of these implants is monitored at a control visit after five years.

Detailed description: Patients who arrive for maintenance follow-up are included in the study. The trational measurement technique is used to follow the health of peri-implant tissues.

Eligibility criteria: Inclusion Criteria:

* the participation previously study implant patient

Exclusion Criteria:

* has not received antibiotic treatment within 6 months

Primary outcomes:
measure: Tratitional measurement
timeFrame: 5 years
measure: Traditional measure
timeFrame: through study completion, an average of 5 year
measure: Biomarker test
timeFrame: through study completion, an average of 5 year
Secondary outcomes:
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Department of Oral and Maxillofacial Diseases, Head and Neck Center
state: Uusimaa
Study officials:
affiliation: University of Helsinki
name: Timo Sorsa, Professor
role: STUDY_DIRECTOR
References:
citation: Lahteenmaki H, Umeizudike KA, Heikkinen AM, Raisanen IT, Rathnayake N, Johannsen G, Tervahartiala T, Nwhator SO, Sorsa T. aMMP-8 Point-of-Care/Chairside Oral Fluid Technology as a Rapid, Non-Invasive Tool for Periodontitis and Peri-Implantitis Screening in a Medical Care Setting. Diagnostics (Basel). 2020 Aug 5;10(8):562. doi: 10.3390/diagnostics10080562.
citation: Natto ZS, Almeganni N, Alnakeeb E, Bukhari Z, Jan R, Iacono VJ. Peri-Implantitis and Peri-Implant Mucositis Case Definitions in Dental Research: A Systematic Assessment. J Oral Implantol. 2019 Apr;45(2):127-131. doi: 10.1563/aaid-joi-D-18-00097. Epub 2018 Dec 17.
citation: Sorsa T, Tervahartiala T, Leppilahti J, Hernandez M, Gamonal J, Tuomainen AM, Lauhio A, Pussinen PJ, Mantyla P. Collagenase-2 (MMP-8) as a point-of-care biomarker in periodontitis and cardiovascular diseases. Therapeutic response to non-antimicrobial properties of tetracyclines. Pharmacol Res. 2011 Feb;63(2):108-13. doi: 10.1016/j.phrs.2010.10.005. Epub 2010 Oct 16.
citation: Tonetti MS, Greenwell H, Kornman KS. Staging and grading of periodontitis: Framework and proposal of a new classification and case definition. J Periodontol. 2018 Jun;89 Suppl 1:S159-S172. doi: 10.1002/JPER.18-0006.
Clinical trial NCT01821521: Investigate a Pharmacokinetics Between S-pantoprazole 20mg and Pantoprazole 40mg in Healthy Male Subjects
Official title: A Randomized, Open Label, Single-dose, 2x2 Crossover Study to Investigate a Pharmacokinetics Between S-pantoprazole 20mg and Pantoprazole 40mg in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Healthy Male Subjects
Lead sponsor: Ahn-Gook Pharmaceuticals Co.,Ltd
Sponsor class: INDUSTRY
First posted: 2013-04-01
Enrollment: 44
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Primary object : Evaluate pharmacokinetic property administered S-pantoprazole 20mg and Pantoprazole 40mg in healthy male subjects

Secondary object : Evaluate safety administered S-pantoprazole 20mg and Pantoprazole 40mg in healthy male subjects


Eligibility criteria: Inclusion Criteria:

* Adult healthy males 20 to 45 years at screening.
* BMI : 19kg/m2 \~ 26kg/m2
* Blood Pressure : "140 \> sitting SBP ≥ 90mmHg, 90 \> sitting DBP ≥ 60mmHg"

Exclusion Criteria:

* Have history of significant hepatic, renal, gastrointestinal, pulmonary, musculoskeletal, endocrine, neuropsychiatric, hematologic, cardiovascular diseases
* Have a gastrointestinal disease(ex : Crohn's disease, gastrointestinal ulcer)or surgery(except for Appendectomy, Hernia repair) affected the absorption of medications
* Have history of GERD, Gastric ulcer, Duodenal ulcer
* Hypersensitivity reactions to drugs or clinically significant hypersensitivity reactions in the history of benzimidazole(ex:pantoprazole, NSAID, antibiotic)
* Have a history of drug abuse
* Unusual diet affected the absorption, distribution, metabolism, excretion of medications
* Subject who treated with any investigational drugs within 90 days before the administration of investigational drug
* Subject who takes inhibitors and inducers of drug metabolizing enzyme (Barbiturates etc.) within 30days
* Previously donate whole blood within 60 days or component blood within 30 days or transfusion within 30 days
* Subject who have taken habitually caffeine (caffeine \> 5 units/day)
* Subject who have drunken habitually (alcohol \> 21 units/week, 1 unit = pure alcohol 10ml)or who are unable to quit drinking during this study or smoker
* Subjects deemed ineligible by investigator based on other reasons

Primary outcomes:
measure: Cmax
timeFrame: 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24 hours
measure: AUClast
timeFrame: 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24 hours
Secondary outcomes:
measure: AUCinf
timeFrame: 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24 hours
measure: Tmax
timeFrame: 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24 hours
measure: T1/2β
timeFrame: 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24 hours
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
References: