louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05135533: Neuromodulation and Dynamic Balance in Stroke
Official title: Cranial-nerve Non-invasive Neuromodulation and Dynamic Balance in Chronic Stroke Survivors
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Stroke
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: Brooks Rehabilitation
First posted: 2021-11-26
Enrollment: 60
Sex: ALL
Minimum age (years): 22
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Portable Neuromodulation Stimulator (PoNS) is non-invasive stimulation device placed on the tongue to stimulate those brain regions understood to be important for maintaining balance. This research study aims to collect evidence that PoNS therapy along with balance training improves postural and walking stability post-stroke.


Eligibility criteria: Inclusion Criteria:

* At least six months since the onset of Ischemic or hemorrhagic stroke.
* Demonstrate residual paresis in the lower extremity (Fugl-Mayer lower extremity score \< 34).
* Are able to provide informed consent demonstrated by their ability to weigh the consequences of participating versus not participating in the study.
* Can walk at least 10 feet with and without assistive device.
* Functional Gait Assessment score \<22.

Exclusion Criteria:

* Pre-existing neurological disorders.
* Previous stroke affecting the other hemisphere .
* Severe arthritis or orthopedic problems that limit passive range of motion.
* Areas of recent bleeding or open wounds.
* Lack normal sensation on the tongue.
* Received treatment for cancer within the past year.
* Non-removable metal orthodontic devices.
* Oral health problems.
* Are sensitive to nickel, gold or copper.
* Chronic infectious diseases.
* Are pregnant.
* Have dementia

Primary outcomes:
measure: Change in gait speed
timeFrame: Pre-treatment, midpoint at four weeks, and post-treatment at 12 weeks
measure: Change in balance
timeFrame: Pre-treatment, midpoint at four weeks, and post-treatment at at 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Steven Kautz, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT00186433: A Longitudinal Study of Plasma EBV DNA in Nasopharyngeal Carcinoma From Both Endemic and Non-Endemic Patient Populations
Official title: A Longitudinal Study of Plasma EBV DNA in Nasopharyngeal Carcinoma From Both Endemic and Non-Endemic Patient Populations
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mouth Cancer
Lip Cancer
Throat Cancer
Lip Neoplasms
Head and Neck Cancers
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2005-09-16
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Having a new diagnosis of Nasopharyngeal carcinoma

Brief summary: 1. To determine the prognostic implication of plasma Epstein-Bar Virus (EBV) DNA concentrations, as measured by quantitative polymerase chain reaction (PCR) in patients with nasopharyngeal carcinoma (NPC).
2. To relate pretreatment plasma EBV DNA concentration to WHO classification of these tumors both in endemic and non-endemic areas.
3. To determine whether pretreatment plasma EBV DNA can serve as a prognostic factor for both endemic and non-endemic patient populations.


Eligibility criteria: Inclusion Criteria:

* Having a new diagnosis of Nasopharyngeal carcinoma.
* Being treated with either radiotherapy or chemoradiotherapy for this condition.

Exclusion Criteria:

* Age \<18 since NPC is a very rare condition in this age group and may have a different biological behavior
* Patients who are unable to provide informed consents for themselves.

Primary outcomes:
measure: Plasma Epstein-Bar Virus (EBV) DNA concentrations
timeFrame: every 6 months until end of study
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Quynh-Thu Le
role: PRINCIPAL_INVESTIGATOR
References:
citation: Le QT, Zhang Q, Cao H, Cheng AJ, Pinsky BA, Hong RL, Chang JT, Wang CW, Tsao KC, Lo YD, Lee N, Ang KK, Chan AT, Chan KC. An international collaboration to harmonize the quantitative plasma Epstein-Barr virus DNA assay for future biomarker-guided trials in nasopharyngeal carcinoma. Clin Cancer Res. 2013 Apr 15;19(8):2208-15. doi: 10.1158/1078-0432.CCR-12-3702. Epub 2013 Mar 4.
Clinical trial NCT00670033: Travoprost New Formulations in Patients With Open-Angle Glaucoma or Ocular Hypertension
Official title: Comparison of Safety and IOP-Lowering Efficacy of Three Alternative Travoprost Formulations to Vehicle and TRAVATAN® in Patients With Open-Angle Glaucoma or Ocular Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ocular Hypertension
Open-angle Glaucoma
Keywords: IOP
Open-angle glaucoma
Ocular Hypertension
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2008-05-01
Enrollment: 158
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 was to describe the safety and IOP-lowering efficacy of Travoprost New Formulations compared to TRAVATAN® and to vehicle in patients with open-angle glaucoma or ocular hypertension.


Eligibility criteria: Inclusion Criteria:

* Satisfy all informed consent requirements;
* Diagnosed with open-angle glaucoma or ocular hypertension;
* Able to discontinue use of all IOP-lowering medications for a minimum of 5 to 28 days prior to the Eligibility 1 Visit;
* IOP measurements in at least 1 eye as specified in protocol;
* Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

* Females of childbearing potential if pregnant, breastfeeding, or not using highly effective birth control measures;
* Any form of glaucoma other than open-angle glaucoma;
* Severe central visual field loss in either eye;
* Chronic, recurrent or severe inflammatory eye disease;
* Clinically relevant or progressive retinal disease such as retinal degeneration, diabetic retinopathy, or retinal detachment, in the opinion of the Investigator;
* Best-corrected visual acuity (BCVA) worse than 0.60 logarithm of the miniminum angle of resolution (logMAR);
* Intraocular surgery within the past 6 months;
* Ocular laser surgery within the past 3 months;
* Any abnormality preventing reliable applanation tonometry;
* Severe illness or any other conditions which would make the patient, in the opinion of the Investigator, unsuitable for the study;
* Other protocol-specified exclusion criteria may apply.

Primary outcomes:
measure: Mean change from baseline in intraocular pressure (IOP)
timeFrame: Baseline, Up to Week 4
Secondary outcomes:
measure: Mean intraocular pressure
timeFrame: Baseline, Up to Week 4
measure: Mean percent change from baseline in IOP
timeFrame: Baseline, Up to Week 4
Other outcomes:
Locations:
Study officials:
affiliation: Alcon Research
name: Theresa Landry, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00044733: Study Evaluating Gemtuzumab Ozogamicin in Acute Myelogenous Leukemia After Stem Cell Transplant
Official title: A Dose-Finding Study of the Safety of Gemtuzumab Ozogamicin as Single Agent Treatment of Patients With Relapsed Acute Myelogenous Leukemia After Autologous or Allogenic Hematopoietic Stem Cell Transplant (HSCT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Myelogenous Leukemia
Keywords: Leukemia
Stem Cell Transplant
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2002-09-06
Enrollment: 38
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: The primary objective of this study is to evaluate the safety of gemtuzumab ozogamicin in relapsed CD33-positive AML patients who received HSCT. If the MTD dose is not reached, 9 mg/m2 will be the maximum tested dose. A secondary objective is to assess efficacy in terms of the number of patients attaining a complete (CR) or morphological (CRp) remission.


Eligibility criteria: Inclusion Criteria

* Patients with CD33+ AML who have experienced relapse after autologous or allogeneic HSCT. Flow cytometry, performed at the study site, must demonstrate that the patient has AML that is CD33 positive, based on local laboratory criteria (Patients with history of MDS pretransplant will be eligible if their proportion of myeloblasts by marrow aspirate exceeds 5% at time of evaluation for Gemtuzumab Ozogamicin treatment)
* The patient must be greater than or equal to 60 days post-HCST
* Patients of all ages may be entered in this study

Exclusion Criteria

* Peripheral white blood count (WBC) greater than or equal to 30,000/uL at the time of initial Gemtuzumab Ozogamicin administration. (In order to reduce the peripheral blood count, patients may be treated with Hydroxyurea. Hydroxyurea must be discontinued 24 hours prior to Gemtuzumab Ozogamicin administration.)
* Known active central nervous system (CNS) or testicular leukemia at time of study entry.
* Prior therapy with anti-CD33 antibodies.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
state: Arkansas
city: Hartford
country: United States
state: Connecticut
city: Jacksonville
country: United States
state: Florida
city: Honolulu
country: United States
state: Hawaii
city: Olathe
country: United States
state: Kansas
city: Camden
country: United States
state: New Jersey
city: Trenton
country: United States
state: New Jersey
city: Buffalo
country: United States
state: New York
city: Rochester
country: United States
state: New York
city: Canton
country: United States
state: Ohio
city: Houston
country: United States
state: Texas
city: Charleston
country: United States
state: West Virginia
city: Madison
country: United States
state: Wisconsin
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06659133: Effect of Music On Pain and Anxiety Paddle Edometrial Biopsy
Official title: In Women Undergoıng Paddle Endometrıal Bıopsy Applıed Musıc Recıtal Effect On Paın And Anxıety
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gynecologic Nursing
Keywords: pain
anxiety
Lead sponsor: Adiyaman University Research Hospital
Sponsor class: OTHER
First posted: 2024-10-26
Enrollment: 64
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study was conducted as a randomized controlled trial to investigate the effect of music recital on pain and anxiety in women undergoing pipelined endometrial biopsy.
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study was conducted as a randomized controlled trial to investigate the effect of music recital on pain and anxiety in women undergoing pipelined endometrial biopsy.

Detailed description: This study was conducted as a randomized controlled trial to investigate the effect of music recital on pain and anxiety in women undergoing pipelined endometrial biopsy. The data were collected in the intervention room of the mixed service of a state hospital in Ankara between December 2023 and April 2024. Power analysis was performed with the G\*Power 3.1 program to determine the number of people to be included in the study. The study was conducted with a total of 64 women, 32 in the control group and 32 in the experimental group. The data were collected using the Personal Information Form, "Visual Comparison Scale" to assess the severity of pain, and "State and Trait Anxiety Scale" to determine the level of anxiety. The experimental group listened to acemashiran maqam music, while the control group received routine care. There was no significant difference between the control and experimental groups in the distribution of socio-demographic characteristics.

Eligibility criteria: Inclusion Criteria:

* Women aged 18 and over who underwent endometrial biopsy for the first time

Exclusion Criteria:

Those who did not fill out the consent form, Those who were illiterate, Those who were receiving inpatient treatment during the study, Those with psychiatric illness (dementia, psychosis, etc.), Those who were on regular medication (such as analgesics, anxiolytics or sedatives), Those who had communication problems (vision, hearing and perception problems), Women who were in pain before the procedure were not included.

Primary outcomes:
measure: anxiety
timeFrame: 30 min
Secondary outcomes:
Other outcomes:
Locations:
city: Adiyaman
country: Turkey
facility: Didem Simsek Kucukkelepce
Study officials:
References:
Clinical trial NCT04741633: Multi Dimensional Precise Exploration of Immunoconsolidation Therapy for Locally Advanced NSCLC After Chemo-radiotherapy
Official title: Multi Dimensional Precise Exploration of Immunoconsolidation Therapy for Locally Advanced Non-small Cell Lung Cancer After Chemo-radiotherapy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: NSCLC
Chemoradiotherapy
ctDNA
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2021-02-05
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with locally advanced NSCLC receiving radical concurrent chemoradiotherapy and subsequent immunoconsolidation therapy

Brief summary: The purpose of this study is to carry out a prospective observational study in patients with locally advanced NSCLC receiving radical concurrent chemoradiotherapy and follow-up immune consolidation therapy. By detecting ctDNA and TILs of the patients, we explored the value of blood dynamic monitoring of ctDNA in patients with prognosis stratification and treatment effect, and explored the patients before and after concurrent chemoradiotherapy and immune consolidation therapy The characteristics of DNA, RNA, T cells and other biomarkers were correlated with the efficacy and prognosis.


Eligibility criteria: Inclusion Criteria:

1. Non small cell lung cancer patients confirmed by pathology;
2. They were 18-80 years old;
3. The tumor could not be resected or could not tolerate surgery;
4. Planed to receive chemoradiotherapy and subsequent immunoconsolidation therapy;
5. Clinical stage III (AJCC, 8th Edition, 2017);
6. After systematic detection of non-small cell lung cancer core indicators including EGFR, ALK, ros1, KRAS, ntrk, TMB, etc;
7. Patient informed consent.

Exclusion Criteria:

1. After radiotherapy and chemotherapy, the disease progressed and immune maintenance therapy could not be carried out
2. It can not cooperate with the completion of baseline mutation screening and subsequent sample detection
3. Factors judged by other researchers not suitable for further study

Primary outcomes:
measure: Correlation between ctDNA dynamic detection and 1-year PFS rate after chemoradiotherapy
timeFrame: Six months after consolidation treatment
Secondary outcomes:
measure: PFS
timeFrame: Six months after consolidation treatment
measure: OS
timeFrame: Six months after consolidation treatment
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
Study officials:
References:
Clinical trial NCT01742533: Stem Cell Therapy Combined Hormone Replacement Therapy in Patients With Premature Ovarian Failure
Official title: A Phase Ι/Π Study of Human Cord Blood Mononuclear Cells and Human Umbilical Cord Mesenchymal Stem Cells Transplantation Combined With Hormone Replacement Therapy in Patients With Premature Ovarian Failure
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Premature Ovarian Failure，
Keywords: Hormone Replacement Therapy，
Premature Ovarian Failure，
Stem Cell Therapy
Lead sponsor: Shenzhen Beike Bio-Technology Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2012-12-05
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Premature ovarian failure (POF) refers the occurrence of amenorrhoea, elevated serum gonadotrophins and hypoestrogenism levels in female before the age of 40. It has important physical and psychological consequences/impact in those patients.

Premature ovarian failure (POF) is currently managed by non-physiological sex steroid regimens which are inadequate at optimizing uterine characteristics.

Human umbilical cord mesenchymal stem cells (hUCMSCs) and human cord blood mononuclear cells (hCBMNCs) have been shown to have the ability to modulate the immune response and enhance angiogenesis, suggesting the novel and promising therapeutic strategy for POF.

In this study, the safety and efficacy of hUCMSCs and hCBMNCs transplantation combined with Hormone Replacement Therapy will be evaluated in patients with Premature Ovarian Failure. Participants will be followed for an expected average of 48 weeks.


Eligibility criteria: Inclusion Criteria:

* Between age 18- 39 years, Female only.
* Diagnosed with Premature Ovarian Failure，and currently receiving Hormone Replacement Therapy;
* Willing to sign the Informed Consent Form.

Exclusion Criteria:

* Fragile X chromosome.
* polycystic ovary syndrome.
* HIV+.
* Autoimmune disease, e.g. lupus erythematosus, multiple sclerosis.
* Severe pulmonary and hematological disease, malignancy or hypo-immunity.
* Currently undertaking other treatment that may affect the safety/efficacy of stem cells.
* Pregnancy or lactation
* Enrollment in other trials in the last 3 months. • Other criteria the investigator consider improper for inclusion.

Primary outcomes:
measure: Serum Level of follicle-stimulating hormone
timeFrame: 48 weeks after treatment
Secondary outcomes:
measure: Uterine and Ovary characteristics of B ultrasound， including Uterine/Ovarian size and Blood Flow
timeFrame: 48 weeks after treatment
measure: Modified Kupperman Score
timeFrame: 48 weeks after treatment
measure: Incidence of Adverse Events and Serious Adverse Events
timeFrame: 48 weeks after treatment
Other outcomes:
Locations:
city: Shenzhen
country: China
facility: Shenzhen People's Hospital
state: Guangdong
Study officials:
References:
Clinical trial NCT06262451: Fecal Microbiota Transplant National Registry
Official title: Fecal Microbiota Transplant National Registry
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Fecal Microbiota Transplant
Keywords: FMT
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2024-02-16
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants will be eligible for participation regardless of age, race, ethnicity, or gender. Pediatric patients may participate if consent is given by a guardian.

Brief summary: A national data registry of patients receiving fecal microbiota transplantation (FMT) or other gut-related-microbiota products designed to prospectively assess short and long-term safety and effectiveness. Neonates will not be enrolled at any site for this study. The study data will derive from patient and donors past and present medical records, research records, and records about phone calls made as part of this research. The patient data will also be used from the records on visits.


Eligibility criteria: Recipient Inclusion Criteria :

* Ability to give informed consent
* Receiving FMT or other gut-related microbiota product within 90 days after providing consent
* Access to internet and/or telephone

Donor Inclusion Criteria:

* Ability to give informed consent
* Providing stool sample for FMT

Exclusion Criteria:

* Incarceration

Primary outcomes:
measure: To assess short-term and long-term safety of FMT and other gut-related-microbiota products
timeFrame: 10 years
Secondary outcomes:
measure: To characterize effectiveness of FMT and other gut-related-microbiota products.
timeFrame: 10 years
measure: To gather information on FMT practice in North America
timeFrame: 10 years
measure: To promote scientific investigation.
timeFrame: 10 years
measure: To aid practitioners and sponsors in satisfying regulatory requirements
timeFrame: 10 years
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Max Brondfield, MD
role: PRINCIPAL_INVESTIGATOR
References: