louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05880589: Efficacy and Safety of Milk Secretory Supplement in Breast-feeding Volunteers
Official title: Efficacy and Safety of Milk Secretory Supplement Containing Fenugreek, Banana Flower, and Ginger Extract in Breast-feeding Volunteers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lactation
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
First posted: 2023-05-30
Enrollment: 24
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The objective of this study are to evaluate efficacy and safety of milk secretory supplement containing fenugreek, banana flower, and ginger extract in breast-feeding volunteers

Detailed description: There are 24 volunteers in this study. They are randomly divided into 2 groups which are milk secretory supplement group and placebo group. The volunteers take 2 tablets of the sample 2 times/day for 14 days. Amount of breast milk, calcium, iron, docosahexaenoic acid, quality of life, adverse reaction, and satisfaction before taking and after taking for 14 days.

Eligibility criteria: Inclusion Criteria:

* During lactation
* Using only breast pump
* No taking medicine or dietary that has an effect on milk secretary including domperidone, banana flower, fenugreek, and ginger in 48 hours
* No smoking and alcohol drinking
* Can read and write in Thai language
* Can meet researcher at the date of appointment
* No complication after delivering

Exclusion Criteria:

* Have uncontrolled diseases, cancer, or heart disease
* Have immunocompromised disease or use steroid in 2 weeks
* Allergic to fenugreek, banana flower, ginger, docosahexaenoic acid, iron, folate, and iodine
* Cannot follow the protocol

Primary outcomes:
measure: Amount of breast milk
timeFrame: 14 days
Secondary outcomes:
measure: Calcium in milk
timeFrame: 14 days
measure: Iron in milk
timeFrame: 14 days
measure: Docosahexaenoic acid in milk
timeFrame: 14 days
measure: Quality of life of volunteers
timeFrame: 14 days
measure: Skin reaction after taking supplement
timeFrame: 14 days
measure: Gastrointestinal reaction after taking supplement
timeFrame: 14 days
measure: Respiratory tract reaction after taking supplement
timeFrame: 14 days
measure: Satisfaction after taking supplement
timeFrame: 14 days
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Pornanong Aramwit
Study officials:
affiliation: Chulalongkorn University
name: Pornanong Aramwit, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04490889: Noninvasive Preimplantation Genetic Testing for Aneuploidy
Official title: Noninvasive Preimplantation Genetic Testing for Aneuploidy Using Cell Free DNA on Spent Culture Media
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Preimplantation Genetic Testing (PGT)
ICSI
Keywords: NiPGT-A
Cell free DNA (cfDNA)
SCM
Sensitivity
Lead sponsor: Mỹ Đức Hospital
Sponsor class: OTHER
Collaborators: name: My Duc Phu Nhuan Hospital
First posted: 2020-07-29
Enrollment: 218
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergo in vitro fertilization.

Brief summary: The study is conducted to evaluate the sensitivity and specificity of non-invasive preimplantation genetic testing for aneuploidy (NiPGT-A) using cell free DNA into spent culture medium (SCM).

Detailed description: Our study is a diagnostic study, recruit 218 biopsied blastocysts from couples undergoing intracytoplasmic sperm injection (ICSI) with Preimplantation genetic testing for aneuploidy (PGT-A) or Preimplantation genetic testing for structural rearrangements (PGT-SR) indication.

Oocyte retrieval, ICSI and embryo culture are performed by routine protocol.

On day 3, each embryo was washed and cultured in single droplets. TE biopsy was conducted and 10μl SCM of biopsied embryos are collected on day 5 or day 6. Both sample types undergo whole-genome amplification (WGA) using Quanti Flour ONE dsDNA system and DNA analysis by next-generation sequencing (NGS) using NextSeq High output 150 cycles kit.

Comparison of NGS results from trophectoderm (TE) biopsy and SCM is done to identify the sensitivity and specificity of the test.

A sample size of 218 day 5/day 6 embryos will be needed.

Eligibility criteria: Inclusion Criteria:

* Assisted Reproductive Treatment with ICSI indication
* Having PGT-A or PGT-SR indication
* Having an agreement to be enrolled into NiPGT-A study
* Having blastocyst to biopsy

Exclusion Criteria:

* In vitro maturation cycle

Primary outcomes:
measure: Sensitivity of NiPGT-A
timeFrame: 4 months after recruiting
measure: Specificity of NiPGT-A
timeFrame: 4 months after recruiting
Secondary outcomes:
measure: Successful amplification rate
timeFrame: 7 days after SCM collection
measure: Total concordance
timeFrame: 14 days after SCM collection
measure: Positive pregnancy rate
timeFrame: at 2 weeks after embryo transfer
measure: Clinical pregnancy rate
timeFrame: 5 weeks after embryo transfer
measure: Ongoing pregnancy rate
timeFrame: At 12 weeks' gestation
measure: Implantation rate
timeFrame: 3 weeks after embryo transfer
Other outcomes:
Locations:
city: Ho Chi Minh City
country: Vietnam
facility: My Duc Phu Nhuan Hospital
state: Phu Nhuan
city: Ho Chi Minh City
country: Vietnam
facility: My Duc Hospital
Study officials:
affiliation: Mỹ Đức Hospital
name: Lan N Vuong
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05513989: Modified Magill Forceps Facilitating Nasal Intubation for Children Undergoing Dental Operations
Official title: Modified Magill Forceps Facilitating Nasal Intubation for Children Undergoing Dental Operations
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Endotracheal Tube Wrongly Placed During Anesthetic Procedure
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2022-08-24
Enrollment: 200
Sex: ALL
Minimum age (years): 4
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: compare between Magill forceps and modified pediatric Magill forceps for nasotracheal intubation (which method is easier and better?).

Detailed description: Group A One hundred and ten patients for whom modified pediatric Magill forceps was used to assist nasotracheal intubation.

Group B One hundred and ten patients for whom Magill forceps was used to assist nasotracheal intubation.

For each patient, intubation time, number of intubation attempts, hypoxia (recognized when oxygen saturation decreases below 94%), pharyngeal trauma, and need for corkscrewing will be recorded.

Eligibility criteria: Inclusion Criteria:

* Patients with the American Society of Anesthesiology physical status of 1 or 2
* Age 4 to 8 years old.
* Elective dental surgeries.

Exclusion Criteria:

* Parental refusal to consent (absolute contraindication),
* Patients with aspiration risk.
* Known upper airway abnormalities.
* Those having difficult airway.

Primary outcomes:
measure: intubation time
timeFrame: just after anesthesia induction for 30 minutes
Secondary outcomes:
measure: number of intubation attempts
timeFrame: after anesthesia induction for 30 minutes
measure: hypoxia
timeFrame: after anesthesia induction for 30 minutes
measure: pharyngeal trauma
timeFrame: after intubation for 30 minutes
measure: need for corkscrewing
timeFrame: after anesthesia induction for 30 minutes
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain shams university
Study officials:
References:
Clinical trial NCT05335889: Wearable Sensors and Artificial Intelligence for Carbohydrate Counting
Official title: Feasibility of Using Wearable Sensors and Artificial Intelligence for Carbohydrate Counting in Chinese Americans With Type 2 Diabetes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2022-04-20
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Chinese Americans participants are targeted to test eButton accuracy is that most Chinese Americans live closely within the community (e.g., Chinatown) and use a handful of Asian stores as their main food sources, which reduces the complexity of their food choices. Thus, collecting data from this ethnic group can provide an in-depth validation of eButton closed-loop feedback concept without excessive experimental time.

Brief summary: This is a one-group pilot study where Chinese immigrants who are English speaking with T2D from NYU Langone Health and NYU Brooklyn Family Health Center (Sunset Park) will be recruited.

Detailed description: To evaluate the estimation accuracy using eButton, researchers will collect carbohydrate data via weighing food by registered dietitian nutritionist (RDN) ("gold standard") (2 days/week at research labs) and food diaries by participants (2 days/week at research labs and 3 days/ week at participant home). Then, the estimated carb grams will be compared head to head among each other. Assessment will be at 0 and 2 weeks, including surveys and qualitative audio interview.

Eligibility criteria: Inclusion Criteria:

* ≥18 years old
* Diagnosed with T2D at least one year prior
* Self-identified as first- or second-generation Chinese immigrants
* Feel comfortable communicating in English, the reason is that the questionnaires/surveys are validated in English
* Have a computer and internet connection

Exclusion Criteria:

* Plan frequent travel or vacations or plan to relocate in the next five weeks
* Have serious diabetes-related complications, physical illness, or mental illness (e.g., schizophrenia, bipolar disorder, or substance abuse) that would preclude participation
* Have severe cognitive impairments (e.g., dementia, intellectual disability)

Primary outcomes:
measure: Accuracy of Carbohydrate Counting using eButton (absolute error)
timeFrame: Day 14
measure: Accuracy of Carbohydrate Counting using eButton (relative error)
timeFrame: Day 14
measure: Proportion of participants who are fully compliant with eButton use
timeFrame: Day 14
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Yaguang Zheng, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06906289: Resumption of Enteral Feeding After Bowel Anastomosis
Official title: Comparison of Early Versus Late Resumption of Enteral Feeding After Small Bowel Anastomosis.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Enhanced Recovery After Surgery
Hospital Stay, Length of Stay in Hospital From Time of Surgery Till Discharge
Defecation
Vomiting, Postoperative
Anastomotic Leak
Flatus
Keywords: Enhanced Recover After Surgery
Hospital Stay
Postoperative vomiting
Anastomotic leak
Lead sponsor: Khyber Teaching Hospital
Sponsor class: OTHER
First posted: 2025-04-02
Enrollment: 204
Sex: ALL
Minimum age (years): 15
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Resumption of oral feeding after small intestine surgery is a matter of controversy .Some surgeons advocate early resumption while others don't.early feeding is initiated as soon as the patient recovers from effects of anaesthesia, while late resumption is started after 24-48 hours after surgery.Recent studies and guidelines suggest early feeding. The aim of this study is to compare the early and late resumption of oral feeding.


Eligibility criteria: Inclusion Criteria:

* All patients undergoing small bowel anastomosis for any indication in elective setting
* Patients of age between 15 to 65 years.
* All genders

Exclusion Criteria:

* Patient using glucocorticoids or other immunosuppressive drugs
* non conseting individuals
* Patient having history of gastrectomy

Primary outcomes:
measure: Time to passage of stool/flatus
timeFrame: Upto 2 weeks from surgery .From the time of surgery to passage of stool or flatus or death due to any cause, whichever comes first.
Secondary outcomes:
measure: Hospital stay
timeFrame: Upto 50 weeks postoperatively ,From surgery to discharge or death , whichever comes first.
measure: Vomiting
timeFrame: Upto 50 weeks postoperatively ,From surgery to discharge or death , whichever comes first.
Other outcomes:
Locations:
city: Peshawar
country: Pakistan
facility: Khyber Teaching Hospital
state: KPK
Study officials:
References:
Clinical trial NCT01868789: Weightbearing Assessment of Tarsal Instability
Official title: In-Vivo Physiologic Weight-Bearing Assessment of Tarsal Instability: Three-Dimensional Cone-Beam Computed Tomography Analysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adult-acquired Flatfoot Disorder (AAFD)
Keywords: Adult-acquired flatfoot disorder (AAFD)
flexible flatfoot
computed tomography (CT)
Lead sponsor: Orthopedic Foot and Ankle Center, Ohio
Sponsor class: OTHER
Collaborators: name: CurveBeam LLC
First posted: 2013-06-05
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to compare the average joint motion and joint axis orientation of the hindfoot bones between patients diagnosed with adult-acquired flatfoot disorder (AAFD) and a control group of patients without foot deformity, using weight-bearing CT technology.


Eligibility criteria: Symptomatic group:

Inclusion Criteria:

1. adult patients (ages 18 -80 years old) diagnosed with Stage 2 AAFD

Exclusion Criteria:

1. previous surgery
2. infection
3. tumor in the affected foot
4. pregnancy

Control group:

Inclusion Criteria:

1. adult patients (ages 18 -80 years old) without foot deformity

Exclusion Criteria:

1. history of previous foot and ankle surgery
2. foot deformity
3. known foot and ankle pathology
4. pregnancy

Primary outcomes:
measure: Change in Joint Motion Between Touch-down Bearing Navicular and Full-weight Bearing Navicular
timeFrame: 1 CT scan, one reading while touch-down bearing, one reading while full-weight bearing
measure: Change in Navicular Rotation Between Touch-down Bearing and Full-weight Bearing
timeFrame: 1 CT scan, one reading while touch-down bearing, one reading while full-weight bearing
Secondary outcomes:
Other outcomes:
Locations:
city: Westerville
country: United States
facility: Orthopedic Foot and Ankle Center
state: Ohio
Study officials:
affiliation: Orthopedic Foot and Ankle Center
name: Gregory C Berlet, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06241092: AI-Based Multimodal Multi-tasks Analysis Reveals Tumor Molecular Heterogeneity, Predicts Preoperative Lymph Node Metastasis and Prognosis in Papillary Thyroid Carcinoma
Official title: AI-Based Multimodal Multi-tasks Analysis Reveals Tumor Molecular Heterogeneity, Predicts Preoperative Lymph Node Metastasis and Prognosis in Papillary Thyroid Carcinoma: A Retrospective Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Papillary Thyroid Carcinoma; Molecular Heterogeneity; Multi-model Analysis; Artificial Intelligence; Lymph Node Metastases; Disease-free Survival
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2024-02-05
Enrollment: 256
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE

Brief summary: This study involved a comprehensive analysis of 256 PTC patients from Sun Yat-sen Memorial Hospital of Sun Yat-sen University (SYSMH) and 499 patients from The Cancer Genome Atlas. DNA-based next-generation sequencing (NGS) and single-cell RNA sequencing (scRNA-seq) were employed to capture genetic alterations and TME heterogeneity. A deep learning multimodal model was developed by incorporating matched histopathology slide images, genomic, transcriptomic, immune cells data to predict LNM and disease-free survival (DFS).


Eligibility criteria: Inclusion Criteria:

≥ 18 years of age Diagnosis of Papillary thyroid carcinoma at least one months before trial Willing to return for required follow-up (posttest) visits

Exclusion Criteria:

The patient requires valve or other likely surgery The patient is unable to carry out any physical activity without discomfort The patient had thyroid ache within three months prior to enrollment The patient refuses to give informed consent The patient is a candidate for coronary bypass surgery or something similar

Primary outcomes:
measure: Lymph node metastasis
timeFrame: 2021.10.1
Secondary outcomes:
measure: Disease-free survival
timeFrame: 2021.10.1
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
state: Guangdong
Study officials:
References:
Clinical trial NCT04938492: The Association Between Loneliness and Substance Use
Official title: The Association Between Loneliness and Substance Use
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid Use
Loneliness
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2021-06-24
Enrollment: 125
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 proposed study will determine if cognitive behavioral therapy will help improve loneliness in people who use opioids.

Detailed description: The proposed study will be the first to assess the cognitive, affective, and behavioral pathways by which loneliness impacts opioid use. Individuals with an opioid use disorder (OUD) reporting loneliness will be randomized to either a 6-session Cognitive- Behavioral Therapy for loneliness (CBT-L) or a 6-session education control condition, both delivered via telehealth. Telehealth delivery can be easily implemented and can increase reach and access to individuals not engaged in treatment. We will use an established brief CBT manual to address loneliness. We will assess loneliness, negative affect (i.e., depression and anxiety), and the quality and quantity of social interactions prior to, during, and after the intervention to evaluate the subsequent impact on opioid use trajectories. Participant will complete questionnaires pre-treatment, post-treatment, and at 1- and 2-months posttreatment.

Eligibility criteria: Inclusion Criteria:

* Must be ages 18+
* Understand English
* Have internet access
* Screen positive for an active OUD on the OUD Module of the Structured Clinical Interview for DSM-5 (Diagnostic \& Statistical Manual of Mental Disorder, 5th edition) Research Version (SCID-5-RV)
* Screen positive for loneliness by scoring at least a T-score \> 60 on the NIH Toolbox Loneliness Scale

Exclusion Criteria:

* Consistent with previously used telehealth-delivered assessments, we will exclude any participant with cognitive impairment as measured by the Blessed Orientation-Memory-Concentration Test (BOMC)
* Potential participants who are in the process of detoxifying as measured by the Subjective Opiate Withdrawal Scale will also be excluded

Primary outcomes:
measure: Mean Change in Loneliness
timeFrame: baseline to 2 months post-treatment
Secondary outcomes:
measure: Mean Change in Percent Days Abstinent From Opioids
timeFrame: baseline to 2 months post-treatment
measure: Mean Change in Percent Days Abstinent From Other Drugs
timeFrame: baseline to 2 months
measure: Mean Change in Social Support
timeFrame: baseline to 2 months post-treatment
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
Study officials:
References:
Clinical trial NCT02045992: Arrhythmic Effects of Hight Dose Caffeine
Official title: Effect of High-dose Caffeine on Cardiac Arrhythmias in Patients With Heart Failure - a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Arrhythmia
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
Collaborators: name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
First posted: 2014-01-27
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: Heart failure patients represent a group of individuals at higher risk for cardiac arrhythmias. There is a perception that caffeine consumption may represent an increase in this risk. Although the medical staff and health professionals suggest a reduction in the intake of this substance to patients considered at risk, there is no scientific proof for this recommendation.

Some animal studies suggest a possible association between arrhythmias and caffeine use with higher doses, but this finding did not appear in human studies. In particular, little is known about the association between caffeine consumption and arrhythmias in patients with heart failure, especially at higher doses of consumption.

More specific and safe guidelines on caffeine consumption are needed.


Eligibility criteria: Inclusion Criteria:

* Heart failure in NYHA functional class I-III
* LV Ejection fraction \<45%
* Age \> 18 y.o.
* Cardio-defibrillator implanted with normal functioning with at least 30 days.

Exclusion Criteria:

* Impossibility of take caffeine
* Inability to perform an exercise test
* Initial use of amiodarone in the last 2 months
* Unstable ventricular arrhythmias, shock or ATP in the last 60 days
* Hospitalization in the last two months due to decompensated heart failure

Primary outcomes:
measure: Arrhythmias
timeFrame: 6 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre
state: Rio Grande do Sul
Study officials:
References:
citation: Zuchinali P, Souza GC, Pimentel M, Chemello D, Zimerman A, Giaretta V, Salamoni J, Fracasso B, Zimerman LI, Rohde LE. Short-term Effects of High-Dose Caffeine on Cardiac Arrhythmias in Patients With Heart Failure: A Randomized Clinical Trial. JAMA Intern Med. 2016 Dec 1;176(12):1752-1759. doi: 10.1001/jamainternmed.2016.6374.