louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05815810: Novel Delivery Method of Transgender Voice Therapy Using a Mobile Application
Official title: Novel Delivery Method of Transgender Voice Therapy Using a Mobile Application
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Transitioning Voice of Transgender and Gender Diverse People
Keywords: Transgender
Voice therapy
Mobile Application
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: Ithaca College
First posted: 2023-04-18
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The investigators hypothesize that the mobile application they developed for transgender and gender diverse individuals (TGGD) will be equivalent or better than traditional speech therapy in improving voice quality. The investigators will measure both how the participants feel about their voices and how their voice actually sounds to see if the app is effective.

Detailed description: The ultimate objective of this study is to use Community-Based Participatory Research (CBPR) methods to develop an effective user-friendly, health literate, inclusive and accessible mobile application (app) to improve access to gender affirming voice modification training for transgender and gender diverse (TGGD) individuals. The immediate objectives are to understand the needs of TGGD individuals in voice care,and identify barriers to creating a pilot app with evidence-based educational content for VCMT and to evaluate subjective and objective voice outcomes of TGGD participants with app use compared to standard behavioral intervention with a speech pathologist.

Eligibility criteria: Inclusion Criteria:

* Identify as a transgender individual
* Be 18 years or older
* Be able to read and write in English
* Have an iOS Device

Exclusion Criteria:

* Identify as cisgender
* Experience hoarseness
* Experiencing any physical pain related to voice use

Primary outcomes:
measure: Change in Transsexual Voice Questionnaire (TVQ) Scores
timeFrame: Baseline, Week 4, Week 11
measure: Change in Transgender Self Evaluation Questionnaire (TSEQ) Scores
timeFrame: Baseline, Week 4, Week 11
measure: Change in Fundamental Frequency
timeFrame: Baseline, Week 4, Week 11
measure: Change in Formants
timeFrame: Baseline, Week 4, Week 11
Secondary outcomes:
measure: Usability of Mobile Application as measured by the Mobile Application Rating Scale (MARS)
timeFrame: Week 11
Other outcomes:
Locations:
city: Ithaca
country: United States
facility: Ithaca College
state: New York
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Anais Rameau, MD, MPhil
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00188110: Performance of the Water-Enema Computed Tomography (WE-CT)
Official title: Evaluation of the Water-Enema Computed Tomography for the Diagnosis of Colon Tumor
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colon Cancer
Keywords: Water-Enema Computed Tomography
colon tumor
coloscopy
suspicion of colon tumor
coloscopy or surgery
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
Collaborators: name: Ministry of Health, France
First posted: 2005-09-16
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The WE-CT is an innovative and easy practice imaging technique of colon tumors; it is based on the colon distension by a high volume of warm water and a multidetector CT acquisition after IV (intravenous) contrast, allowing image analysis including the wall thickness and enhancement, the pericolic adjacent spaces and the entire abdomen.

The goal of the study is the evaluation of its performances for the diagnosis of colon tumors.


Eligibility criteria: Inclusion Criteria:

* Written informed consent
* WE-TC indication for colon tumor suspicion
* Age \> 18 years

Exclusion Criteria:

* Pregnancy
* Patients under 65 years old and for whom the only WE-TC indication is familial antecedents of colon tumor, without clinical or para-clinical personal signs for this pathology
* Infected sigmoid diverticulosis
* Occlusive syndrome
* Anesthesia contraindications
* Anal incontinence
* Renal insufficiency (creatinine \> 150 micromol/L)
* Iode allergy
* Visceralgine contraindications
* Scania contraindications

Primary outcomes:
measure: To evaluate the performances of the WE-CT in patients suspected of having a colon tumor
Secondary outcomes:
measure: To show the CT findings in case of colon tumor and its pitfalls
measure: To demonstrate the advantages of the WE-CT compared to the CT and magnetic resonance (MR) colonography for the diagnosis and local staging of colon tumors
Other outcomes:
Locations:
city: Angers
country: France
facility: UH of Angers
city: Besancon
country: France
facility: UH of Besancon
city: Lyon
country: France
facility: UH of Lyon
city: Montpellier
country: France
facility: UH of Montpellier
city: Rennes
country: France
facility: UH of Rennes
Study officials:
affiliation: UH of Angers
name: Christophe Aube, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01542710: Bimatoprost/Timolol Versus Travoprost/Timolol
Official title: Bimatoprost/Timolol Versus Travoprost/Timolol Fixed Combinations in an Egyptian Population: A Hospital-Based Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glaucoma
Lead sponsor: Kasr El Aini Hospital
Sponsor class: OTHER
First posted: 2012-03-02
Enrollment: 80
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare 2 fixed combination medications in intraocular pressure lowering.

Detailed description: PURPOSE: To compare the efficacy of bimatoprost/timolol (BTFC) or travoprost/timolol (TTFC) fixed combinations on intraocular pressure (IOP) reduction in an Egyptian population.

METHODS: Patients with primary open angle glaucoma (POAG) were randomized to receive either BTFC or TTFC. IOPs were measured at baseline, 2 weeks, and 1, 2, 4, and 6 months. The primary outcome measures were the mean change in IOP from baseline

Eligibility criteria: Inclusion Criteria:

* Glaucoma

Exclusion Criteria:

* No other ocular diseases

Primary outcomes:
measure: Percentage of drop of intraocular pressures from baseline.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr El Aini Hospital
Study officials:
affiliation: Cairo University
name: Tamer A Macky, MD FRCS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03926312: Smart Device-based Cardiac Rehabilitation After Myocardial Intervention
Official title: Smart Device-based Cardiac Rehabilitation After Myocardial Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myocardial Infarction
Keywords: myocardial infarction
cardiac rehabilitation
smart device
remote monitoring
telemonitoring
low physical activity
risk factors control
Lead sponsor: Charles University, Czech Republic
Sponsor class: OTHER
Collaborators: name: Institute for Clinical and Experimental Medicine
First posted: 2019-04-24
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate the influence of cardiac rehabilitation based on smart band use and telemonitoring on functional capacity change and risk factors control among patients hospitalized for acute myocardial infarction.


Eligibility criteria: Inclusion Criteria:

1. Signed informed consent with the study
2. Men and women \>18 years of age
3. Patients ≥1 and ≤6 months after type I myocardial infarction
4. Physical inactivity before MI defined as the absence of moderate to vigorous exercise for at least 30 minutes 5 or more days a week

Exclusion Criteria:

1. Heart failure NYHA IIIB-IV
2. Planned coronary revascularization
3. Planned major surgery within the next 12 months
4. Inability to walk for any reason
5. Comorbidities that would preclude adherence to the rehabilitation program (e.g. arthrosis, active malignancy, major depression or other significant psychiatric disorder, cognitive impairment) - at the discretion of the physician
6. Life expectancy less than 12 months
7. Pregnancy
8. Inability to operate the smart-watch

Primary outcomes:
measure: Functional capacity change
timeFrame: 3 months
Secondary outcomes:
measure: Waist circumference
timeFrame: 3 months
measure: Body fat percentage
timeFrame: 3 months
measure: Smoking cessation
timeFrame: 3 months
measure: Lipid levels
timeFrame: 3 months
measure: Blood pressure
timeFrame: 3 months
measure: Glycated hemoglobin
timeFrame: 3 months
Other outcomes:
Locations:
city: Prague
country: Czechia
facility: Institute for Clinical and Experimental Medicine
state: CZEC
Study officials:
affiliation: Institute for Clinical and Experimental Medicine
name: Peter Wohlfahrt, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06565312: A Single Group Study to Evaluate the Effects of a Probiotic Vaginal Suppository on Vaginal Health.
Official title: A Single Group Study to Evaluate the Effects of a Probiotic Vaginal Suppository on Vaginal Health.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vaginal Health
Vaginal pH
Keywords: Vaginal suppository
Women's Health
Lead sponsor: Love Wellness
Sponsor class: INDUSTRY
Collaborators: name: Citruslabs
First posted: 2024-08-21
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This is a virtual single-group clinical trial lasting 8 weeks to evaluate the effects of a probiotic vaginal suppository on vaginal health. Participants will use the Flora Power suppository daily for 5 consecutive days when experiencing common signs of vaginal imbalance. They will complete questionnaires and vaginal pH tests before and after product use.


Eligibility criteria: Inclusion Criteria:

* Female at birth, aged 18+.
* Interested in maintaining a healthy vaginal environment.
* Experience common signs of vaginal imbalance (e.g., malodor, irritation).
* Willing to avoid other vaginal products and follow study protocol.

Exclusion Criteria:

* Recent surgeries or invasive treatments.
* Use of vaginal health products in the last 12 weeks.
* Allergies to product ingredients.
* Chronic health conditions impacting participation.
* Pregnant, breastfeeding, or trying to conceive.
* History of substance abuse or smoking.
* Currently participating in another clinical trial.

Primary outcomes:
measure: Effect on Vaginal pH and Health
timeFrame: Baseline, Day 6 (24 hours after the last suppository insertion)
measure: Effect on Vaginal pH and Health
timeFrame: Baseline, Day 6 (24 hours after the last suppository insertion)
Secondary outcomes:
measure: Participant Perception of Vaginal Freshness and Odor
timeFrame: Baseline, Day 2, Day 5
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: Citruslabs
state: California
Study officials:
References:
Clinical trial NCT00641212: Children, Perennial Allergic Rhinitis (PAR), l-t Growth
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Effect of Long-Term Treatment With Rhinocort Aqua (Budesonide) Nasal Spray in Children With Perennial Allergic Rhinitis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Perennial Allergic Rhinitis
Keywords: Allergic rhinitis
Perennial allergic rhinitis
Paediatric
Growth
budesonide
Rhinocort AQUA
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-03-24
Enrollment: 209
Sex: ALL
Minimum age (years): 4
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the effect of Rhinocort nasal spray with placebo on growth in children with perennial allergic rhinitis over 12 months.


Eligibility criteria: Inclusion Criteria:

* In the opinion of the investigator, is a candidate for treatment with nasal steroids based on a history of either a) inadequate control of symptoms with antihistamines, decongestants and/or immunotherapy, or b) prior successful treatment with nasal steroids.
* A documented history of at least one year of perennial allergic rhinitis.
* A positive response to a skin prick test for perennial allergens that must be present in the subject's environment.
* Height and weight within normal limits.

Exclusion Criteria:

* Any disease which may affect growth
* Sexual development later than Tanner stage I.
* Nasal candidiasis, rhinitis medicamentosa, acute or chronic sinusitis, influenza, upper respiratory tract infection or structural abnormalities of the nose (e.g., septal deviation, nasal polyps) symptomatic enough to cause significant nasal obstruction as judged by the investigator.

Primary outcomes:
measure: Change in height over a 12 month period
timeFrame: 3 monthly
Secondary outcomes:
measure: Change in growth velocity over a 12 month period.
timeFrame: 3 monthly
measure: Other safety - assessed by adverse event query
timeFrame: 3 monthly
Other outcomes:
Locations:
Study officials:
affiliation: AstraZeneca
name: Bertil Andersson
role: STUDY_DIRECTOR
References:
Clinical trial NCT03269812: Laparoscopic Assisted Pull-through Versus Other Surgical Procedures for Treatment of Hirschsprung Disease
Official title: Laparoscopic Assisted Pull-through Versus Other Surgical Procedures for Treatment of Hirschsprung Disease.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hirschsprung Disease
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-09-01
Enrollment: 60
Sex: ALL
Minimum age (years): 6
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the outcomes of laparoscopic pull-through concerning constipation, incontinence and enterocolitis in comparison of other surgical procedures for treatment of Hirschsprung disease.

Detailed description: Hirschsprung,s disease (HD) is a relatively common cause of intestinal obstruction in the newborn\[1,2\], The main goal in the treatment of patients with Hirschsprung,s disease is to resect the aganglionic segment and pull down the Normo-ganglionic bowel\[3\]. With the introduction of minimally invasive surgery, classic pull-through techniques were modified and improved with laparoscopy, because of the obvious advantages of laparoscopic-assisted pull-through operations in form of reduced pain and improved cosmoses this approach has gained much popularity\[4,5\].

Eligibility criteria: Inclusion Criteria:

1. Age from 6months to 3 years.
2. Both sexes.
3. Classic and long segment Hirshsprung.
4. Total a ganglionic colon.
5. Hirshsprung disease with leveling colostomy

Exclusion Criteria:

1. Patients \<6 months and \>3 years.
2. Short and Ultra-short Hirshsprung.
3. Recurrent cases of Hirshsprung.
4. Other contraindication of laparoscopy

Primary outcomes:
measure: Constipation
timeFrame: from one to three months after operation
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Tomuschat C, Zimmer J, Puri P. Laparoscopic-assisted pull-through operation for Hirschsprung's disease: a systematic review and meta-analysis. Pediatr Surg Int. 2016 Aug;32(8):751-7. doi: 10.1007/s00383-016-3910-5. Epub 2016 Jul 1.
citation: Taguchi T, Obata S, Ieiri S. Current status of Hirschsprung's disease: based on a nationwide survey of Japan. Pediatr Surg Int. 2017 Apr;33(4):497-504. doi: 10.1007/s00383-016-4054-3. Epub 2017 Jan 5.
Clinical trial NCT06068712: Proactive and Reactive Attention to Negative Templates
Official title: Proactive and Reactive Attention to Negative Templates
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: attention
visual search
electroencephalogram (EEG)
Lead sponsor: Lehigh University
Sponsor class: OTHER
First posted: 2023-10-05
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Within-Subjects Design
Primary purpose: BASIC_SCIENCE

Brief summary: EEG Measures during Visual Search Task. In this line of research, the researchers having participants receive a positive (target) template cue, negative (distractor) template cue, or neutral (non-informative) template cue. Note: This is a re-analysis of previously collected data.

Detailed description: When finding a search target, receiving a target cue or distractor cue can increase search efficiency compared to a neutral cue. The researchers are examining the neural basis of visual search when participants receive a positive (target) cue, negative (distractor) cue, or neutral (baseline) cue. Note: This is a re-analysis of previously collected data.

Eligibility criteria: Inclusion Criteria:

* normal or corrected to normal visual acuity, normal color vision, no history of neurological disorders

Exclusion Criteria:

-

Primary outcomes:
measure: Button Press Reaction Time
timeFrame: During Testing (single day)
measure: Button Press Accuracy
timeFrame: During Testing (single day)
measure: Proactive EEG Activity
timeFrame: During Testing (single day)
measure: Reactive EEG Activity
timeFrame: During Testing (single day)
Secondary outcomes:
Other outcomes:
Locations:
city: Bethlehem
country: United States
facility: Lehigh University
state: Pennsylvania
Study officials:
affiliation: Lehigh University
name: Nancy Carlisle, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06075212: Immune Reconstitution After Allo-HSCT and Blinatumomab
Official title: Immune Reconstitution After Allogeneic Hematopoietic Stem Cell Transplantation With Post-transplant Blinatumomab Maintenance Treatment
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Leukemia, Lymphoid
Lead sponsor: Sichuan University
Sponsor class: OTHER
First posted: 2023-10-10
Enrollment: 20
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Relapsed or refractory acute lymphoblastic leukemia (R/R ALL) patients undergoing allogeneic hemopoietic stem-cell transplantation (allo-HSCT).

Brief summary: The goal of this observation study is to test in relapsed or refractory acute lymphoblastic leukemia (R/R ALL) patients undergoing allogeneic hemopoietic stem-cell transplantation (allo-HSCT). The main question it aims to answer is:

• Effect of post-transplant blinatumomab treatment on immune reconstitution after transplantation.

Participants will undergo immune repertoire sequencing(IR-SEQ) before blinatumomab treatment, 6 months and 1 year after transplantation.

Researchers will compare patients who don't receive blinatumomab treatment after transplantation to see if TCR or BCR expression differs.


Eligibility criteria: Inclusion Criteria:

1. Aged 16-65 years old
2. KPS score \> 60 or ECOG score 0-2
3. diagnosed as B-ALL, a) disease status \> CR1 at the time of transplantation; Patients beyond CR1 or induction failure could be free of minimal residual disease (MRD). b) any residual disease, defined as \>0.01% leukemic cells by flow cytometry, BCR-ABL transcript ≥ 1 in 10000 by PCR, or high-risk genetic abnormality
4. neutrophil count ≥0.5×10\^9/L and platelet count ≥20×10\^9/L
5. creatinine clearance ≥30ml/min; Alanine aminotransferase/aspartate aminotransferase ≤5 times the upper detection limit; Total bilirubin ≤3 times the upper limit of detection
6. The first initiation of berintuzumab therapy was within 60-100 days after transplantation
7. without evidence of active acute graft-versus-host disease (aGvHD)

Exclusion Criteria:

1. With serious basic diseases of important organs, such as myocardial infarction, chronic cardiac insufficiency, decompensated liver dysfunction, renal dysfunction, gastrointestinal dysfunction, etc
2. With clinically uncontrolled active infection
3. Patients with central nervous system involvement before transplantation
4. Poor graft function (PGF) occurred after allo-HSCT
5. Patients with second allogeneic transplantation

Primary outcomes:
measure: T cell receptor expression
timeFrame: before blinatumomab treatment , 6 months and 1 year
measure: B cell receptor expression
timeFrame: before blinatumomab treatment , 6 months and 1 year
Secondary outcomes:
measure: T cell subsets count
timeFrame: before blinatumomab treatment , 6 months and 1 year
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00292812: Clinical Effects of a Nucleotides-Supplemented Infant Formula
Official title: The Clinical Effects of an Infant Formula Supplemented With Various Concentrations of Nucleotides
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nutritional Requirements
Keywords: Infant nutrition
Nucleotides
Infant formula
Lead sponsor: Soroka University Medical Center
Sponsor class: OTHER
Collaborators: name: Materna Laboratories
First posted: 2006-02-16
Enrollment: 150
Sex: ALL
Minimum age (years): 1
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The study hypothesis is that different concentrations of nucleotides' supplementation of an infant formula might affect differently growth and/or other clinical parameters in neonates.

Detailed description: Three groups of 50 newborn infants each, will be fed for 30 days an infant formula supplemented with either 4.9 mg/100 kcal or 10.6 mg/100 kcal of nucleotides or with no supplementation. Newborns will be monitored prospectively for the following outcome parameters:

* Growth percentiles.
* Behaviour and infantile colic.
* Bowel habits.
* Side effects.

Eligibility criteria: Inclusion Criteria:

* Healthy newborns aged 0-30 days.

Exclusion Criteria:

* Prematurity
* Chronic illness
* Failure to thrive
* Milk allergy

Primary outcomes:
measure: Growth percentiles, Behaviour and infantile colic, Bowel habits.
Secondary outcomes:
measure: Side effects.
Other outcomes:
Locations:
city: Beer-Sheva
country: Israel
facility: Soroka Medical Center
Study officials:
affiliation: Head, Pediatric GI and Nutrition Unit
name: Zvi Weizman, MD
role: PRINCIPAL_INVESTIGATOR
References: