louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00528307: Changes in Myocardial Perfusion During Chronic Multi Site Biventricular Versus Right Ventricular Apex Pacing in Patients With Normal Left Ventricular Function Undergoing His Bundle Ablation for Drug-refractory Atrial Fibrillation
Official title: Changes in Myocardial Perfusion During Chronic Multi Site Biventricular Versus Right Ventricular Apex Pacing in Patients With Normal Left Ventricular Function Undergoing His Bundle Ablation for Drug-refractory Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Atrial Fibrillation
Keywords: myocardial perfusion
His ablation
biventricular pacing
His bundle ablation for atrial fibrillation
Lead sponsor: R&D Cardiologie
Sponsor class: OTHER
First posted: 2007-09-12
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To determine whether Biventricular pacing in patients undergoing HIS bundle ablation for atrial fibrilation has beneficial effects on myocardial perfusion and left ventricularr ejection fraction.


Eligibility criteria: Inclusion Criteria:

* Normal to nearly normal LVF (EF \> 40%)
* Drug-refractory, persistent or permanent atrial fibrillation
* Referred for His ablation

Exclusion Criteria:

* Unwilling or unable to sign the informed consent
* Life expectancy \< 1year from non-cardiac causes
* Previous myocardial infarction
* Previous coronary bypass surgery
* Poor left ventricle function (EF\< 40%) from any cause
* Symptomatic obstructive coronary artery disease
* Poor ultra sound imaging quality.

Primary outcomes:
measure: Difference in size of myocardial perfusion abnormalities in the two treatment groups as measured with MPS.
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Nieuwegein
country: Netherlands
facility: St Antonius Hospital
state: Utrecht
Study officials:
affiliation: St. Antonius Hospital
name: Lucas VA Boersma, MD, PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02301507: Study of Cell Phone SMS to Improve Adherence to ART in HIV Positive Young Women
Official title: Evaluation of Texting Intervention to Improve Adherence to Antiretroviral Therapy (ART) in Young Women Infected With Human Immunodeficiency Virus (HIV)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infection
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2014-11-26
Enrollment: 7
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: There has been increasing use of technology in delivery of healthcare and increasing use of cellular phone and text messaging services to help with various healthcare related issues including but not limited to medication adherence and clinic attendance. Mobile phones technology has been used for healthcare delivery and prevention strategies such as smoking cessation. In the present era, cell phones have become part of daily life for most people even among those in lower economic groups. There have also been several studies looking at cell phone text messaging services to improve adherence to ART among HIV infected subjects but no studies have so far been done in HIV infected young women to help retention and adherence to care. The overall goal of this study is to evaluation of the impact of texting intervention to improve adherence to care and treatment in HIV infected young women.

Study Hypothesis:

Text message intervention will improve adherence to ART in HIV infected young women.


Eligibility criteria: Inclusion Criteria:

1. HIV-infected women who have been newly diagnosed within the past 1 year or who are just entering into care at Thomas Street Health Center.
2. Subjects must be 18 years or older.
3. Subjects must have cell phones with texting capability.
4. Ability to speak, read, or understand English or Spanish.
5. Must be willing and able to respond to text messages.

Exclusion Criteria:

1. Women who are unable to speak, read, or understand English or Spanish

Primary outcomes:
measure: Improve adherence to care and treatment in HIV infected young women. The outcome measure will be assessed by capturing kept medical appointments.
timeFrame: 6 months
Secondary outcomes:
measure: assess improvements in stigma and depression in HIV infected women. The outcome measure will be assessed by questionaires.
timeFrame: 3 months
Other outcomes:
Locations:
city: Houston
country: United States
facility: Thomas Street Health Center
state: Texas
Study officials:
References:
Clinical trial NCT00568607: Study on the Combination Regimen of Dexamethasone Ifosfamide Cisplatin Etoposide in Patients With NK/T Cell Lymphoma
Official title: Phase II Study of a Combination Chemotherapy of DICE in the Patients With NK/T Cell Lymphoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Lymphoma
Keywords: NK/T cell lymphoma
Response Rate
TTP
OS
Toxicities
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2007-12-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and tolerability of the combination chemotherapy of DICE in the patients with NK/T cell lymphoma.

Detailed description: Patients with NK/T cell lymphoma usually have a bad prognosis. These patients cannot be treated successfully with the conventional chemotherapy of CHOP.The investigators did this trial to evaluate the efficacy and tolerability of the combination chemotherapy of DICE in the patients with NK/T cell lymphoma.

Eligibility criteria: Inclusion Criteria:

* Age range 18-75 years old
* Histological confirmed NK/T cell lymphoma
* ECOG performance status less than 2
* Life expectancy of more than 3 months
* None of major drugs in the trial (IFO,VP16,DDP) has been previously used
* Normal laboratory values: hemoglobin \> 80 g/dl, neutrophil \> 2×109/L, platelet \> 100×109/L, serum creatine \< 1.5×upper limitation of normal (ULN), serum bilirubin \< 1.5×ULN, ALT and AST \< 2.5×ULN

Exclusion Criteria:

* Pregnant or lactating women
* Serious uncontrolled diseases and intercurrent infection
* The evidence of CNS metastasis
* History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix

Primary outcomes:
measure: Response rate
timeFrame: every two cycles
Secondary outcomes:
measure: TTP and OS
timeFrame: every two cycles
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Cancer Hospital
state: Shanghai
Study officials:
affiliation: Fudan University
name: Ye Guo, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03670407: Follicular Activation by Fragmentation of Ovarian Tissue
Official title: Follicular Activation by Fragmentation of Ovarian Tissue
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diminished Ovarian Reserve
Keywords: Premature Ovarian Failure
Infertility, Female
Ovarian tissue fragmentation
Lead sponsor: Podobnik Maternity and Gynecology Hospital
Sponsor class: OTHER
First posted: 2018-09-13
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to assess the chances of increasing the number of antral follicles in ovarian tissue of patients with diminished ovarian reserve by activation of primordial follicles through ovarian cortex fragmentation. Secondary objectives are to assess potential association with the number of oocytes retrieved and pregnancy rates after IVF.


Eligibility criteria: Inclusion Criteria:

1. previous ≥ 2 poor ovarian responds (≤ 3 retrieved oocytes) in an antagonist cycle with a minimum of 225 IU gonadotropins a day or corifollitropin 150 mcg) in patients \>35 i \<40 years
2. previous cycle with ≤ 3 retrieved oocytes) in an antagonist cycle with a minimum of 225 IU gonadotropins a day or corifollitropin 150 mcg) in patients \>35 i \<40 years with antral follicle count (AFC) ≤ 5 i/ili antiM¸ulelrian hormone (AMH) ≤ 6.5pmol/L
3. premature ovarian insufficiency according to European Society of Human Reproduction and Embryology (ESHRE) development group, 2015 in patients 18-40 years
4. undetectable AMH serum levels and follitropin (FSH) \>35 IU/ml in two serum samples separated by at least 4 weeks

Exclusion Criteria:

1. clinical/ultrasonographical signs of endometriosis
2. previous ovarian/pelvic surgery
3. previous gonadotoxic treatment
4. genito-urinary tract malformations
5. extreme male infertility ( \<10 000 progressively motile sperms in the semen sample)
6. inform consent unsigned -

Primary outcomes:
measure: Antral follicle count
timeFrame: 6 months
Secondary outcomes:
measure: The number of oocytes retrieved
timeFrame: 1 year
measure: Clinical pregnancy rate
timeFrame: 1 year
Other outcomes:
Locations:
city: Zagreb
country: Croatia
facility: Podobnik Maternity and Gynecology Hospital
Study officials:
affiliation: Podobnik Maternity and Gynecology Hospital
name: Miro S Alebić
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05270707: HyperArc Registry Study
Official title: HyperArc Registry Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Brain Metastases
CNS Neoplasm
CNS Disorder, Intracranial
Keywords: Stereotactic Radiosurgery
Lead sponsor: Varian, a Siemens Healthineers Company
Sponsor class: INDUSTRY
First posted: 2022-03-08
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any patient scheduled to be treated using the HyperArc method will be invited to participate, provided they meet other eligibility criteria.

Brief summary: The HyperArc registry is designed to collect data from which the efficacy of the HyperArc procedure can be assessed and compared to alternative treatments.

Detailed description: A significant percentage of newly diagnosed cancer patients will develop brain metastases. For many of these patients, stereotactic radiosurgery (SRS) is recommended as a primary treatment option. Concerns about complexity, patient safety, cost, and human resources can make SRS challenging. HyperArc radiotherapy addresses these challenges by introducing key technology and workflow elements to streamline multi-leaf collimator-based, non-coplanar SRS. HyperArc is designed to deliver SRS treatments from the TrueBeam linear accelerator platform. The HyperArc registry is designed to collect data from which the efficacy of the HyperArc procedure can be assessed and compared to alternative treatments.

Eligibility criteria: Inclusion Criteria:

* Received or scheduled to receive treatment using the HyperArc treatment method
* Age of legal adult according to local law
* Signed informed consent form, or, informed consent waived by the local ethics board/institutional review board

Exclusion Criteria:

* None, apart from not meeting Inclusion Criteria

Primary outcomes:
measure: Survival
timeFrame: follow until death, on average approximately 2 years
Secondary outcomes:
measure: Local tumor control
timeFrame: follow until death, on average approximately 2 years
measure: HyperArc Patterns of Care
timeFrame: Limited to course of treatment: up to 4 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama
state: Alabama
city: Bruce
country: Australia
facility: Icon Cancer Centre Canberra
state: Australian Capital Territory
city: Greenslopes
country: Australia
facility: Icon Cancer Centre Greenslopes
state: Queensland
city: Maroochydore
country: Australia
facility: Icon Cancer Centre Maroochydore
state: Queensland
city: Southport
country: Australia
facility: Icon Cancer Centre Gold Coast Private
state: Queensland
Study officials:
References:
Clinical trial NCT00377507: Catechin Mouth-washing for Removal of Intraoral Bacteria
Official title: A Clinical Trial of Tea Catechin Mouth-washing for Removal of Intraoral Bacteria in the Elderly
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Elderly
Keywords: catechin
elderly
mouth washing
disabled
colonized
Lead sponsor: University of Shizuoka
Sponsor class: OTHER
First posted: 2006-09-18
Enrollment: 36
Sex: ALL
Minimum age (years): 65
Maximum age (years): 95
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The Purpose of this study is to evaluate the effects of catechin mouth-washing on the removal of intraoral bacteria in the elderly

Detailed description: Catechins are the major components of tea flavonoids and recent in vitro experimental studies have revealed that tea catechin extracts induce bactericidal effects. However, a limited number of studies have been conducted on the clinical effects of tea catechin against bacterial infection and also the effects in the elderly is unclear. Based on these backgrounds, we designed a prospective randomized controlled study to evaluate the effects of catechin mouth washing on oral pathogenic bacterial detected in the elderly.

Eligibility criteria: Inclusion Criteria:

* aged over 65 years
* detected oral pathogenic bacterium and revalidated during the wash-out period
* without antibacterial medicine, other mouth-washing remedies during the study
* Obtained written informed consent before participation

Exclusion Criteria:

* possessing some infectious diseases in need of therapy
* possessing tea or catechin allergy
* diagnosed as inadequate for other reasons to participate the study by principal investigator

Primary outcomes:
measure: Removal of intraoral pathogenic bacteria identified before the study
timeFrame: After intervention
Secondary outcomes:
measure: Reduction of intraoral bacteria after the study
timeFrame: After intervention
Other outcomes:
Locations:
city: Higashi Murayama
country: Japan
facility: White cross nursing home
state: Tokyo
Study officials:
affiliation: University of Shizuoka
name: Hiroshi Yamada, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT06803407: Investigation of the Effectiveness of a Home Exercise Program
Official title: Investigation of the Effectiveness of a Home Exercise Program in Individuals with Temporomandibular Joint Disc Displacement with Reduction
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Temporomandibular Joint Disc Displacement
Lead sponsor: Karadeniz Technical University
Sponsor class: OTHER
First posted: 2025-01-31
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Temporomandibular joint disc displacement with reduction

Brief summary: The purpose of this study is to examine the effects of a home exercise program on individuals with temporomandibular joint disc displacement with reduction. Participants will be assessed at baseline and again after a four-week home exercise program.

Detailed description: Participants who meet the inclusion criteria will be randomly divided into 2 groups. The first group, called the study group, will receive a home exercise program and patient education. The second group, called the control group, will receive only patient education. Participants will be assessed at baseline and again after a four-week home exercise program.

Eligibility criteria: Inclusion Criteria:

* 18 and 65 years,
* who have had complaints related to TMJ for at least 3 months,
* who have been diagnosed with Temporomandibular joint disc displacement with reduction as a result of clinical and radiological evaluation by a dentist

Exclusion Criteria:

* Those with cognitive problems,
* any systemic joint or muscle disease (e.g. fibromyalgia, rheumatoid arthritis),
* serious systemic diseases,
* any neurological disorder (e.g. trigeminal neuralgia),
* pregnancy, breastfeeding,
* who have previously been treated for TMJ or orofacial muscle pain

Primary outcomes:
measure: Range of motion
timeFrame: an average one month
Secondary outcomes:
measure: Numeric Pain scale
timeFrame: an average one month
measure: Mandibular Function Impairment Questionnaire
timeFrame: an average one month
Other outcomes:
Locations:
city: Trabzon
country: Turkey
facility: Karadeniz Technical University
Study officials:
affiliation: Karadeniz Technical University
name: Nurhayat korkmaz, Msc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05372107: A Study of AG-80308 in Dry Eye Patients
Official title: A Multicenter, Double-Masked, Phase 1b Study Evaluating the Safety, Tolerability, and Dose-Response of Topical AG-80308 in Patients With Dry Eye Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Dry Eye Disease
Lead sponsor: Allgenesis Biotherapeutics Inc.
Sponsor class: INDUSTRY
Collaborators: name: ORA, Inc.
First posted: 2022-05-12
Enrollment: 84
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: This is a multicenter, double-masked, randomized, parallel-group study with topical AG-80308 eye drops in dry eye patients.


Eligibility criteria: Inclusion Criteria:

1. Male or female, 18 years of age or older at the screening visit
2. Diagnosis of dry eye disease in both eyes with or without meibomian gland disease

Exclusion Criteria:

1. Participation in any investigational study within 30 days prior to baseline or exposure to an investigational drug must be fully washed out (at least 5 half-lives)
2. Any ocular infection or inflammation within 30 days prior to the screening visit
3. Corneal disorder or abnormalities other than dry eye disease that impact normal spreading of the tear film (except superficial punctate keratitis)
4. History of chronic ocular allergy, systemic lupus erythematosus, rheumatoid arthritis, corneal ulcer/erosions, uveitis or dry eye due to Stevens Johnson syndrome, irradiation, alkali burns, cicatricial pemphigoid or vitamin A deficiency.
5. Use of contact lenses in either eye within 14 days of screening visit or planned use during the study
6. Use of the dry eye and/or meibomian gland disease medications/procedures within 2 to 8 weeks prior to the screening visit

Primary outcomes:
measure: Evaluation of adverse events (AEs) and serious AEs (SAEs)
timeFrame: Screening to 3 months
Secondary outcomes:
Other outcomes:
measure: Mean change from baseline in ocular surface staining
timeFrame: Screening to 3 months
measure: Mean change from baseline in dry eye symptoms
timeFrame: Screening to 3 months
measure: Mean change from baseline in Schirmer's test
timeFrame: Screening to 3 months
Locations:
city: Newport Beach
country: United States
facility: Eye Research Foundation
state: California
city: Raynham
country: United States
facility: Andover Eye Associates
state: Massachusetts
city: Clinton
country: United States
facility: Alpine Research Organization, Inc.
state: Utah
Study officials:
References:
Clinical trial NCT00642707: Study of PRO 140 by Subcutaneous Administration in Adult Subjects With HIV -1 Infection
Official title: A Phase 2a, Randomized, Double-blind, Placebo Controlled Study of PRO 140 by Subcutaneous Administration in Adult Subjects With Human Immunodeficiency Virus Type 1 Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: HIV -1 Infection
HIV Infections
Keywords: HIV
Treatment Naïve
Lead sponsor: CytoDyn, Inc.
Sponsor class: INDUSTRY
First posted: 2008-03-25
Enrollment: 44
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: The purpose of this study is:

1. To assess the antiviral activity of PRO 140
2. To assess the safety and tolerability of PRO 140
3. To generate additional PK, PD and safety data of PRO 140


Eligibility criteria: Inclusion Criteria:

1. Males \& females, age ≥ 18 years (or minimum adult age as determined by local regulatory authorities)
2. Screening plasma HIV-1 RNA ≥ 5,000 copies/mL
3. CD4+ lymphocyte cell count ≥ 300 cells/mm3 and no documented count \< or = 250 cells/mm3
4. Has not taken any antiretroviral therapy (ART) w/in 12 wks of Early Screening Visit
5. Exclusive CCR5-tropic virus as determined by Trofile™ Assay at Early Screening Visit
6. Clinically normal or "not clinically significant (NCS)" resting electrocardiogram
7. Women of reproductive potential must have a negative serum pregnancy test at Late Screening Visit \& a negative urine pregnancy test w/in 72 hrs prior to first dose of study medication, \& be non-lactating. Male \& female subjects must agree not to participate in a conception process from Early Screening Visit through Day 59.

Exclusion Criteria:

1. CXCR4 tropic virus or dual/mixed tropic (R5X4) virus determined by the Trofile™ Assay.
2. Females who are pregnant, lactating or breastfeeding, or who plan to become pregnant during the study.
3. History of active hepatitis within the previous 24 wks
4. Prior use of any entry, attachment, CCR5 co-receptor or fusion inhibitor, including PRO 140, experimental or approved.
5. Any immunization or vaccination (including influenza vaccine) within 30 days prior to administration of study drug.

Primary outcomes:
measure: Maximum Change in Viral Load Following Initiation of Treatment (Viral Load is Defined as HIV-1 Copies/mL and Expressed as log10 Copies/mL).
timeFrame: 59 days
Secondary outcomes:
Other outcomes:
Locations:
city: Tarrytown
country: United States
facility: Progenics Pharmaceuticals, Inc.
state: New York
Study officials:
affiliation: Progenics Pharmaceuticals, Inc.
name: Stephen Morris, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Jacobson JM, Thompson MA, Lalezari JP, Saag MS, Zingman BS, D'Ambrosio P, Stambler N, Rotshteyn Y, Marozsan AJ, Maddon PJ, Morris SA, Olson WC. Anti-HIV-1 activity of weekly or biweekly treatment with subcutaneous PRO 140, a CCR5 monoclonal antibody. J Infect Dis. 2010 May 15;201(10):1481-7. doi: 10.1086/652190.