louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06286215: Registry of Patients With Plasma Cell Disorders
Official title: Registry of Patients With Plasma Cell Disorders
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Plasma Cell Disorders
Keywords: registry
plasma cell disorder
Lead sponsor: Siriraj Hospital
Sponsor class: OTHER
First posted: 2024-02-29
Enrollment: 750
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: plasma cell disorder patients

Brief summary: The goal of this observational study is to register patients with plasma cell disorders. The main questions it aims to answer are:

* The incidence of plasma cell disorders both before and after malignancy
* Time to progression of monoclonal gammopathy of undetermined significant (MGUS) or smoldering multiple myeloma (SMM) to light chain amyloidosis or multiple myeloma (MM)
* Progression free survival (PFS)
* overall survival
* factors influencing overall survival, progression-free survival, and time to progression
* Symptoms and signs of the disease during the diagnosis and relapse phases, including the causes of mortality in plasma cell disorder patients.
* genetic characteristics of plasma cell disorder
* cost-effectiveness of treatment in Thailand Participants will be collected the data of baseline diagnosis, treatment, treatment results of all admission and follow-up visits from hospital medical record.


Eligibility criteria: Inclusion Criteria:

* Both existing and newly diagnosed patients with plasma cell disorders, including monoclonal gammopathy of undetermined significance, smoldering multiple myeloma, POEMS, light chain amyloidosis, solitary plasmacytoma, and multiple myeloma, according to the diagnostic criteria of the International Myeloma Working Group 2014
* Aged 18 years and above

Exclusion Criteria:

* insufficient data needed for analysis

Primary outcomes:
measure: register the plasma cell disorder patients
timeFrame: 10 years
Secondary outcomes:
measure: incidence of plasma cell disorders
timeFrame: 10 years
measure: Time to progression
timeFrame: 10 years
measure: Progression free survival
timeFrame: 10 years
measure: overall survival
timeFrame: 10 years
measure: influencing factors
timeFrame: 10 years
measure: Symptoms and signs
timeFrame: 10 years
measure: genetic characteristics
timeFrame: 10 years
measure: cost-effectiveness
timeFrame: 10 years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03881215: Platelet Rich Plasma Following Hysteroscopic Adhesolysis
Official title: Platelet Rich Plasma Following Hysteroscopic Adhesolysis: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intra-uterine Adhesions
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2019-03-19
Enrollment: 160
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Platelet Rich Plasma Following Hysteroscopic Adhesolysis: A Randomized Clinical Trial


Eligibility criteria: Inclusion Criteria:

* Age: 18-40 years
* Grade III intra-uterine adhesions

Exclusion Criteria:

* Age \< 18 or \> 40 years.
* Hb \< 11 g/dL, platelets \< 150.000/mm3.
* Patient taking anticoagulant.
* Patient taking NSAID in the 10 days before procedure.
* Any significant comorbidity or psychiatric disorder that would compromise patient's consent.
* Active cervical or uterine infection.
* Undiagnosed genital bleeding.
* pregnancy.

Primary outcomes:
measure: Incidence of adhesion recurrence
timeFrame: 3 months
Secondary outcomes:
measure: Days of menses
timeFrame: 3 months
measure: Amount of menses
timeFrame: 3 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University Maternity Hospital
Study officials:
References:
Clinical trial NCT05495815: Proper Duration of Suppressive Antibiotic Therapy After Debridement, Antibiotics, and Implant Retention
Official title: Randomized Clinical Trial Determining Proper Duration of Suppressive Antibiotic Therapy After Total Joint Arthroplasty Debridement, Antibiotics, and Implant Retention
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Periprosthetic Joint Infection
Antibiotic Suppression
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
Collaborators: name: OrthoCarolina Research Institute, Inc.
name: University of Arkansas
name: OrthoMichigan
name: NYU School of Medicine
name: Sinai Hospital
name: MedStar Health
First posted: 2022-08-10
Enrollment: 438
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Multiple studies have demonstrated oral suppressive antibiotic therapy (SAT), after intravenous antibiotics, maximizes reoperation-free survival of total joint arthroplasty (TJA) debridement, antibiotics, and implant retention (DAIR) for acute periprosthetic joint infection (PJI). However, little is known regarding sequelae of SAT after DAIR for PJI. Prior studies have small or heterogeneous patient cohorts, variable antibiotic regimens, arrive at disparate conclusions, and do not establish antibiotic resistance risk.

The investigators propose a prospective randomized controlled multicenter study to expand on findings in a retrospective, multi-center pilot study. Study aims are to evaluate SAT after DAIR of acutely infected primary TJA regarding: 1) adverse drug reactions/intolerance; 2) reoperation for infection; and 3) antibiotic resistance.


Eligibility criteria: Inclusion Criteria:

* over 18 years-old
* underwent DAIR with modular component exchange for acute TJA PJI, as defined by Musculoskeletal Infection Society Criteria, with symptom duration less than 4 weeks
* on postoperative oral SAT for at least 3 months

Exclusion Criteria:

* underwent aseptic revision surgery
* had one-stage, 1.5-stage, or two-stage revision surgery
* did not have postoperative SAT
* did not have follow-up that allowed for evaluation of SAT sequelae

Primary outcomes:
measure: Reoperation for infection recurrence
timeFrame: 2 years after patient enrollment
Secondary outcomes:
measure: Antibiotic resistance, evidenced by change in antimicrobial sensitivity profile, developed by infecting organism after suppressive antibiotic therapy causing infection recurrence
timeFrame: At time of reoperation (within 2 years of patient enrollment)
measure: Adverse drug reaction or intolerance, defined as any symptom or laboratory value derangement requiring a change in, or discontinuation of, antimicrobial therapy
timeFrame: During antibiotic administration (up to 2 years after patient enrollment)
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
Study officials:
References:
Clinical trial NCT00652015: Molecular and Cellular Mechanisms of the In-stent-thrombosis
Official title: Molecular and Cellular Mechanisms of the In-stent-thrombosis. Is it Possible to Predict a In-stent-thrombosis Using Biomarkers?
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Patients With SAT or LT After Stent Implantation (PCI)
Keywords: in-stent-thrombosis
CD39
CD73
EPC
Lead sponsor: RWTH Aachen University
Sponsor class: OTHER
First posted: 2008-04-03
Enrollment: 0
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 having developed an SAT or LT after stent implantation using PTCA

Brief summary: In-Stent-Thrombosis is a rare but serious complication after implantation of stents during PTCA.

Detailed description: In this prospective, open, not-randomized, controlled single-center pilot study 80 patients having had an in-stent-thrombosis (40 sub-acute thromboses (SAT), 40 late thromboses (LT)) and a control group of 80 patients having not developed a thrombosis will be compared.

The aim of this study is the establishment of diagnostic markers vor prediction of SAT (detection of CD39- and CD73-activity, respectively)and of LT (EPC-number and function, respectively) correspondingly aiming at the early identification of patients with high risk for developing an in-stent-thrombosis.

Eligibility criteria: Inclusion Criteria:

* patients having developed an SAT or LT after stent implantation using PTCA

Exclusion Criteria:

* instabel coronary heart diseases,
* systemic autoimmune diseases,
* rheumatic diseases,
* tumors,
* impaired kidney or liver function,
* surgery within the last 3 months,
* pregnant or lactating women

Primary outcomes:
measure: The aim of this study is to establish diagnostic markers for prediction of SAT and LT, respectively, by identification of CD39 and CD73-activity and EPC-number and function, respectively.
timeFrame: may 08 to may 2010
Secondary outcomes:
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: RWTH University Hospital
Study officials:
affiliation: RWTH Aachen University
name: Burcin Özüyaman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04922515: Pancreatic Ductal Adenocarcinoma - Microbiome as Predictor of Subtypes
Official title: Pancreatic Ductal Adenocarcinoma - Microbiome as Predictor of Subtypes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pancreatic Cancer
Lead sponsor: University Medical Center Goettingen
Sponsor class: OTHER
First posted: 2021-06-10
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The prospective clinical trial "PDA-MAPS - Pancreatic ductal adenocarcinoma - Microbiome as Predictor of Subtypes" aims to investigate the prognostic and predictive power of the orointestinal and tumoral microbiome in PDAC patients and associate findings with genetic, transcriptional and clinical data, in particular with treatment response.

Detailed description: The prospective clinical trial "PDA-MAPS - Pancreatic ductal adenocarcinoma - Microbiome as Predictor of Subtypes" aims to investigate the prognostic and predictive power of the orointestinal and tumoral microbiome in PDAC patients and associate findings with genetic, transcriptional and clinical data, in particular with treatment response. Patients with histologically confirmed PDA are enrolled at primary diagnosis and prior to oncological or surgical treatment. Rectal and buccal microbiome swabs as well as detailed clinical records are obtained from all patients. Following DNA extraction, both 16S rRNA and metagenomic sequencing will be performed using ONT sequencing platform. All data and clinical records are centrally stored, visualized and integrated via tranSMART and SEEK platforms.

Eligibility criteria: Inclusion Criteria:

- Patients with pancreatic mass suspicious of pancreatic ductal adenocarcinoma

Exclusion Criteria:

* \< 18 years
* patients that cannot give informed consent
* pregnant and breastfeeding women

Primary outcomes:
measure: Progression free survival
timeFrame: 12 months upon study enrollment
Secondary outcomes:
measure: Molecular subtypes of pancreatic cancer
timeFrame: within 3 months of histological diagnosis
measure: Response to chemotherapy
timeFrame: up to 6 months after start of therapy
Other outcomes:
Locations:
city: Göttingen
country: Germany
facility: University Medical Centre Goettingen
city: Göttingen
country: Germany
facility: University Medical Centre Göttingen
Study officials:
affiliation: University Medicine Goettingen
name: Albrecht Neesse, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00757315: NdYag Laser for Acne Keloidalis Nuchae
Official title: Prospective, Controlled Study of the Efficacy of NdYag for Acne Keloidalis Nuchae
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acne Keloidalis Nuchae
NdYag Laser
AKN
Acne Keloidalis
AK
Dermatitis Papillaris Capillitii
Folliculitis Keloidalis Nuchae
Sycosis Nuchae
Acne Keloid
Keloidal Folliculitis
Lichen Keloidalis Nuchae
Folliculitis Nuchae Scleroticans
Sycosis Framboesiformis
Keywords: acne keloidalis nuchae
NdYag laser
AKN
acne keloidalis
AK
dermatitis papillaris capillitii
folliculitis keloidalis nuchae
sycosis nuchae
acne keloid
keloidal folliculitis
lichen keloidalis nuchae
folliculitis nuchae scleroticans
sycosis framboesiformis
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
First posted: 2008-09-23
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Acne Keloidalis Nuchae (AKN) is a long standing hair follicle disease with bumps and scars on the skin of the back of the head and neck. The purpose of this new study is to determine how well a hair removal laser (NdYag Laser) works in treating AKN.


Eligibility criteria: Inclusion Criteria:

* For inclusion, the subject must:

  1. Be at least 18 years old
  2. Be otherwise healthy
  3. Have a diagnosis of AKN with at least 10 papules/pustules and/or a non-keloidal plaque \> 7 cm2 in area.

Exclusion Criteria:

* Subject must not:

  1. Have AKN with a keloidal plaque \>3 cm in length
  2. Be using any other medications or undergoing any other procedures for the treatment of AKN
  3. Have used any topical medications or undergone any procedures for the treatments of AKN within two weeks of study enrollment
  4. Have used any oral medications for AKN within 4 weeks of study enrollment:
  5. Have serious, uncontrolled medical conditions
  6. Be pregnant at any time during the study.

Primary outcomes:
measure: reduction in severity of AKN as measured by a novel AKN severity scoring system which incorporates number of lesions, size of lesions, type of lesions and associated inflammation.
timeFrame: 6 months
Secondary outcomes:
measure: Treatment tolerability as measured by 0 to 10 pain scale
timeFrame: 6 months
measure: treatment safety
timeFrame: 6 months
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Henry Ford Medical Center, New Center One
state: Michigan
Study officials:
affiliation: Henry Ford Health Systems Dermatology Department
name: Iltefat H Hamzavi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Battle EF Jr, Hobbs LM. Laser-assisted hair removal for darker skin types. Dermatol Ther. 2004;17(2):177-83. doi: 10.1111/j.1396-0296.2004.04018.x.
citation: Shah GK. Efficacy of diode laser for treating acne keloidalis nuchae. Indian J Dermatol Venereol Leprol. 2005 Jan-Feb;71(1):31-4. doi: 10.4103/0378-6323.13783.
Clinical trial NCT02676115: Medipore Tape Study
Official title: The Use of Wound Taping Protocol to Improve Cosmetic Scar After Anterior Cruciate Ligament (ACL) Reconstruction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Scarring
Keywords: Cosmetic Wound Healing
anterior cruciate ligament (ACL)
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2016-02-08
Enrollment: 60
Sex: ALL
Minimum age (years): 15
Maximum age (years): 95
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a prospective, single-blinded, two-arm, randomized, parallel, pragmatic, effectiveness trial that will enroll patients undergoing arthroscopic anterior cruciate ligament reconstruction in order to evaluate the efficacy of using Medipore tape to improve cosmetic wound healing and scaring.


Eligibility criteria: Inclusion Criteria:

* All patients undergoing arthroscopic ACL reconstruction with bone-patella-tendon-bone autograft at the Ambulatory Surgical Center and Hospital for Joint Diseases will be eligible for enrollment.
* Patient is indicated for ACL reconstructive surgery with bone-patella-tendon-bone autograft

Exclusion Criteria:

* Subjects/Parents who are mentally impaired and are unable to give consent
* Patients with prior vertical anterior knee incisions
* Patients with known skin reactions to adhesive
* Patients with high risk for abnormal scar formation and keloids

Primary outcomes:
measure: Change in patients' own appraisal of their scar assessed quantitatively by change in Manchester Scar Scale (MSS) Score
timeFrame: 6 Months
measure: Quantitative Assessment of Scar using Patient and Observer Scar Assessment Scale (POSAS)
timeFrame: 6 Months
measure: Dermatology Life Quality Index (DLQI)
timeFrame: 6 Months
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: New York University Medical School
name: Eric Strauss, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02303015: Toxicity Attributed to Genetic Polymorphisms in Testicular Germ Cell Tumor Survivors
Official title: Toxicity Attributed to Genetic Polymorphisms in Testicular Germ Cell Tumor Survivors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Germ Cell Cancer
Keywords: Germ cell cancer
Late toxicity
Renal impairment
Cardiovascular disease
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2014-11-27
Enrollment: 430
Sex: MALE
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Danish patients with germ cell cancer diagnosed 1984-2007.

Brief summary: The purpose of this study is to identify genetic variations in survivors of testicular cancer and connect these variations to differences in risks of late effects.

Detailed description: Identification of late-effects through questionnaires and linkage to national registries. DNA samples will be gathered through buccal swabs or saliva kits and analysed with whole exome-sequencing.

Eligibility criteria: Inclusion Criteria:

* Danish citizen
* Diagnosed with germ cell cancer from 1984 to 2007
* Treated initially at a Danish hospital
* Treated with standard treatment regimens.

Exclusion Criteria:

* Treated initially at a foreign hospital

Primary outcomes:
measure: Renal toxicity (Identify genetic variations predicting renal toxicity)
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Dept. of Oncology, Rigshospitalet
Study officials:
affiliation: Rigshospitalet, Denmark
name: Gedske Daugaard, MD DMSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01902615: An Observational Study of Induction Therapy With Fuzeon (Enfuvirtide) in Combination With Antiretroviral Drugs in Patients With HIV-1 Infection
Official title: Multicenter, Observational, Retrospective Study to Assess the Therapeutic Effectiveness of a Strategy of Induction With Enfuvirtide Within an Optimized Regimen of Antiretroviral Drugs (ARV) in Patients Infected With HIV-1 in Routine Clinical Practice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infections
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2013-07-18
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with HIV-1 infection having received induction therapy with Fuzeon and antiretroviral drugs

Brief summary: This multicenter, retrospective, observational study will evaluate the therapeutic effectiveness of a strategy of induction with Fuzeon (enfuvirtide) within an optimized regimen of antiretroviral drugs in patients with HIV-1 infection in routine clinical practice.


Eligibility criteria: Inclusion Criteria:

* Adult patients, \>/= 18 years of age
* HIV-1+ infection
* Patients with a viral load \> 50 copies/ml who have received induction treatment with Fuzeon in combination with antiretroviral treatment
* Naïve for Fuzeon at initiation of induction treatment
* Antiretroviral treatment of at least 12 months duration

Exclusion Criteria:

* Patients who did not receive Fuzeon treatment

Primary outcomes:
measure: Response rate: Proportion of patients with reduction of viral load to < 50 copies/ml
timeFrame: approximately 24 months
Secondary outcomes:
measure: Duration of treatment with Fuzeon
timeFrame: approximately 24 months
measure: Time to undetectability, defined as time from initiation of treatment to first observation of viral load < 50 copies/ml
timeFrame: approximately 24 months
measure: Safety: Incidence of adverse events
timeFrame: approximately 24 months
measure: Treatment regimen: Antiretroviral drugs used
timeFrame: approximately 24 months
Other outcomes:
Locations:
city: Barcelona
country: Spain
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT06013215: Electrical Impulse Parameters and Neuronal Population in the Cochlear Implanted Patient-PULSE
Official title: PULSE - Paramètres de l'Impulsion électrique et Population Neuronale Chez le Patient implanté cochléaire - Etude en Ouvert, Non contrôlé, Non randomisée
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Sensorineural Hearing Loss
Keywords: hearing loss
cochlear implant
psychoacoustic
charge integration efficiency
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
First posted: 2023-08-28
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The cochlear implant provides good auditory performance despite high inter-individual variability, but performance in noise remains limited. Modification of the coding strategies could improve these performances. A better characterization of the remaining neuronal population by looking for the charge integration efficiency (which depends on the duration and the amplitude of the electrical pulse) would allow an optimization of the settings by adapting either the duration or the amplitude of the pulse according to the quality of the remaining neuronal population.

Detailed description: The cochlear implant provides good auditory performance despite high inter-individual variability, but performance in noise remains limited. Modification of the coding strategies could improve these performances. Currently, the intensity perceived by the patient is coded by the duration and the amplitude of the electrical impulse but companies have different approaches and fix one of the two parameters for the setting of the processors. A better characterization of the remaining neuronal population by looking for the charge integration efficiency (which depends on the duration and the amplitude of the electrical pulse) would allow an optimization of the settings by adapting either the duration or the amplitude of the pulse according to the quality of the remaining neuronal population.

Eligibility criteria: Inclusion Criteria:

* post-lingually deaf adults with at least one year of cochlear implant experience
* unilateral and bilateral cochlear implant recipients
* Oticon device with Neuro Zti array
* Patient affiliated to french social security
* Consent signed

Exclusion Criteria:

* Patients under court protection, guardianship or curatorship

Primary outcomes:
measure: Calculate the charge integration efficiency along the electrodes
timeFrame: 4 hours
Secondary outcomes:
measure: Questionnaire between Intensity discrimination and charge integration efficiency
timeFrame: 4 hours
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital, Tours
name: David Bakhos
role: PRINCIPAL_INVESTIGATOR
References: