louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06348121: Impact of Probiotics on Children With ADHD
Official title: Efficacy of Bifidobacterium Animalis Subsp. Lactis and Lacticaseibacillus Rhamnosus Mixture in Children With ADHD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Attention Deficit Hyperactivity Disorder
Lead sponsor: Wecare Probiotics Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-04-04
Enrollment: 50
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study investigates WecProB (Bifidobacterium animalis subsp. lactis and Lacticaseibacillus rhamnosus) to evaluate their potential to improve symptoms and safety in children with ADHD.


Eligibility criteria: Inclusion Criteria:

1. Diagnosis of ADHD per DSM-5 criteria;
2. Age 6-12 years, gender-neutral;
3. IQ \>70 on intelligence testing;
4. Participant/guardian comprehension and voluntary consent.

Exclusion Criteria:

1. Those with a clear history of other serious neurological diseases, such as epilepsy, head trauma, encephalitis or meningitis, etc.;
2. Have taken antibiotics, probiotics or immunosuppressants within one month before starting the experiment;
3. Ongoing special diet, such as ketogenic diet, etc
4. BMI higher than the 90th percentile or lower than the 10th percentile for children of the same age and sex;
5. Those who have had symptoms of respiratory or digestive tract infection in the past month, such as fever, cough, diarrhea, etc.;
6. Those who have had inflammatory bowel disease in the past, such as ulcerative colitis, Crohn's disease, etc.;

Primary outcomes:
measure: Clinical symptoms of ADHD
timeFrame: 56 days
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT00628121: Clinical Pharmacological Study of GnRH Antagonist, Cetrorelix for Healthy Female Volunteer
Official title: Clinical Pharmacological Study of NS75A for Healthy Adult Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Premenopause
Keywords: infertility, menstrual cycle, LH surge
Lead sponsor: Nippon Kayaku Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Shionogi
name: AEterna Zentaris
First posted: 2008-03-04
Enrollment: 31
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: GnRH analogs are globally used for assisted reproduction in infertile patients. To date, in healthy female volunteers the pharmacokinetic and pharmacodynamic profiles of cetrorelix when administered in a single dose have been investigated in studies conducted using doses of 1, 3 and 5 mg. Studies performed in premenopausal female volunteers confirmed that cetrorelix rapidly suppresses luteinizing hormone (LH) and estradiol and shows dose-dependent prolongation of the duration of LH suppression. However, there have been few reports of studies of the relationship between the cetrorelix dosage and its effect on LH surge. In the present study, we investigated the effect of cetrorelix on LH surge when this drug was administered in single doses of 1, 2 and 3 mg.

Detailed description: To evaluate that effect on LH surge, we investigated the efficacy of cetrorelix in delaying the start of the LH surge in comparison with the control menstrual cycle when saline was administered, and also examined the mode of disappearance of pulsatile LH secretion during the cetrorelix administration menstrual cycle.

Eligibility criteria: Inclusion Criteria:

* a BMI of 18 years old and \<18 and 25 years old and \>25
* menstrual cycles was within the range of 25\~31 days

Exclusion Criteria:

* use of a drug (e.g., oral contraceptives, drugs for treatment of hyperprolactinemia, GnRH agonists, sex steroid hormones, psychoactive drugs, etc.)
* serious disease of the endocrine system, liver, kidney, heart, lung, digestive system, etc.
* a generalized drug allergy

Primary outcomes:
measure: Day of the LH surge
timeFrame: Saline administration menstrual cycle, cetrorelix administration menstrual cycle
Secondary outcomes:
measure: Serum LH concentrations
timeFrame: Saline administration menstrual cycle, cetrorelix administration menstrual cycle
Other outcomes:
Locations:
city: Sagamihara
country: Japan
facility: Kitasato University East Hospital
state: Kanagawa
Study officials:
References:
Clinical trial NCT02584621: Web-Based Adolescent Motivational Enhancement Study
Official title: Web-Supported Adolescent Motivational Enhancement to Reduce Alcohol Use
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Risk Behaviors
Health Care Services Quality of Care
Lead sponsor: Seattle Children's Hospital
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2015-10-22
Enrollment: 148
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The proposed study is a randomized controlled trial that compares the effectiveness of an electronic personalized health screening app incorporating motivational feedback (i.e. "Check Yourself") to usual care among moderate to high risk alcohol users. The purpose of this study is to determine whether Check Yourself is more effective than usual care in reducing alcohol consumption and binge drinking and improving quality of care among adolescents receiving school-based health clinic services.


Eligibility criteria: Inclusion Criteria:

* Eligible individuals will be 13-18 years old who are able to read and comprehend English.
* Participants who indicate alcohol use consistent with moderate to high risk on the Check Yourself App.

Exclusion Criteria:

Individuals will be excluded from the study if:

* They do not meet age requirements
* Do not have a study visit at a participating school-based health clinic
* Lack the means to complete follow-up interviews (i.e. have neither telephone or internet access)
* Are not able to read or comprehend English

Primary outcomes:
measure: Alcohol Use Frequency and Quantity
timeFrame: 2 months
measure: Adolescent report of whether alcohol was counseled on during health provider visit
timeFrame: 1 day
Secondary outcomes:
measure: Marijuana Use Frequency and Quantity
timeFrame: 2 months
measure: Adolescent Satisfaction with Care
timeFrame: 1 day
measure: Interval Receipt of Care for Substance Use
timeFrame: 2 months
measure: Adolescent Substance Use Problem Recognition
timeFrame: 1 day & 2 months
measure: Motivation for Substance Use Behavior Change
timeFrame: 1 day & 2 months
Other outcomes:
measure: Number of non-substance use health risk behaviors
timeFrame: 2 months
measure: Adolescent perceived support from their health care provider
timeFrame: 1 day
measure: Adolescent report of whether marijuana/other drug use was counseled on during health provider visit
timeFrame: 1 day
Locations:
city: Seattle
country: United States
facility: Interagency Teen Health Center
state: Washington
city: Seattle
country: United States
facility: Garfield Teen Health Center
state: Washington
city: Seattle
country: United States
facility: Nathan Hale Teen Health Center
state: Washington
Study officials:
References:
Clinical trial NCT01718821: Assessments on Current Pain Managements in Upper Gastrointestinal Cancer Patients
Official title: Assessments on Current Pain Managements in Upper Gastrointestinal Cancer Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain
Neuropathic Pain
Depression
Quality of Life
Upper GI Cancer
Lead sponsor: National Cheng Kung University
Sponsor class: OTHER
First posted: 2012-10-31
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Admitted patients or out patients in National Cheng Kung University Hospital (a medical center)

Brief summary: Pain is one of the most common symptoms associated with cancer. The approach to pain management compresses routine pain assessments, utilizes both pharmacologic and nonpharmacologic interventions, and requires ongoing reevaluation of the patient. Cancer pain can be well controlled in the vast majority of patients if the algorithms of pain control are systematically applied, carefully monitored, and tailored to the needs of the individual patient.This study is aimed to assess the current pain managements in upper gastrointestinal cancer patients in Taiwan. The effects of neuropathic pain and depression on the enrolled patients would also be assessed.


Eligibility criteria: Inclusion Criteria:

* with a diagnose of advanced upper GI cancer based on pathology or imaging studies
* could report pain intensities and answer questionnaires by him/herself

Exclusion Criteria:

* with major neurologic or psychiatric diseases
* could not report pain intensities and answer questionnaires by him/herself

Primary outcomes:
measure: Pain, assessed by BPI-SF.
timeFrame: Assessed at enrolled date (Day 1)
measure: Changes in pain, assessed by BPI-SF.
timeFrame: Baseline and 1 month.
Secondary outcomes:
measure: Depression, assessed by two stem questions.
timeFrame: Assessed at enrolled date (Day 1)
measure: Changes in depression, assessed by two stem questions.
timeFrame: Baseline and 1 month.
measure: Quality of life, assessed by EROTC QLQ C30.
timeFrame: Day 1
measure: Neuropathic pain, assessed by DN4 questions.
timeFrame: Day 1
measure: Changes in quality of life. Quality of life, assessed by EROTC QLQ C30.
timeFrame: Baseline and 1 month.
measure: Changes in neuropathic pain. Neuropathic pain, assessed by DN4 questions.
timeFrame: Baseline and 1 month.
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
Study officials:
affiliation: Institute of Clinical Pharmacy and Pharmaceutical Science, National Cheng Kung University
name: Yea-huei Kao Yang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05550064: Structured Contraceptive Counseling During Pregnancy
Official title: Evaluating Effects of Prepartum Structured Contraceptive Counseling to Increase Postpartum Use of Long-acting Reversible Contraception
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Contraception
Intrauterine Device
Contraceptive Implant
Long-acting Reversible Contraception
Counseling
Lead sponsor: Dalarna University
Sponsor class: OTHER
First posted: 2022-09-22
Enrollment: 160
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pregnant women will receive an intervention for structured contraceptive counseling from participating clinics. Follow-up will be through e-surveys at 6, 12, 18, and 24 months postpartum
Primary purpose: PREVENTION

Brief summary: Unintended pregnancy is common among women of fertile age, and also among those who have recently given birth. A Swedish study has shown that about 7.7% experience a new pregnancy, and that 2.5% will have an abortion between 12-24 months from childbirth.

This is a prospective observational intervention study, aiming to evaluate the effects of structured contraceptive counseling during pregnancy on uptake of contraception postpartum and more specifically on long-acting reversible contraceptive methods, and to identify and explore the provider's and patient's experiences of structured contraceptive counseling during pregnancy.


Eligibility criteria: Inclusion Criteria:

* 18 years or older, gestational week 30 or more, need for contraception 6 months or more after delivery

Exclusion Criteria:

- Language barrier that affects participation when an interpreter is not available, assisted fertilization, planned sterilization of partner, use of contraception for other purposes than pregnancy prevention.

Primary outcomes:
measure: Difference in proportions of LARC use 6 months postpartum among women receiving structured contraceptive counseling compared to standard care during pregnancy.
timeFrame: 6 months post partum
Secondary outcomes:
measure: New pregnancy
timeFrame: 6, 12, 18, and 24 months postpartum
measure: Outcome of new pregnancy
timeFrame: 6, 12, 18, nd 24 months postpartum
Other outcomes:
Locations:
city: Falun
country: Sweden
facility: Health Care Region Dalarna
city: Karlstad
country: Sweden
facility: Health Care Region Värmland
city: Uppsala
country: Sweden
facility: Health Care Region Uppsala
city: Örebro
country: Sweden
facility: Health Care Region Örebro Län
Study officials:
affiliation: Dalarna University
name: Niklas Envall, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03745521: Study of Longitudinal Observation for Patient With X-linked Hypophosphatemic Rickets/Osteomalacia in Collaboration With Asian Partners
Official title: An International, Multicenter, Prospective, Longitudinal Observational Study for Patient With X-linked Hypophosphatemic Rickets/Osteomalacia
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: X-Linked Hypophosphatemia
Keywords: XLH
Lead sponsor: Kyowa Kirin Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2018-11-19
Enrollment: 226
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with XLH independent of treatment regimen

Brief summary: Through observation of patients with X-linked hypophosphatemic rickets/osteomalacia (XLH) for up to 10 years, the study intends to collect data that allow achievement of the following objectives:

1. To determine medical characteristics of the disease and the disease process
2. To determine physical and psychological burden on patients as well as economic burden
3. To assess the efficacy and safety of the treatment of the disease


Eligibility criteria: Inclusion Criteria:

* Patients must meet at least one of the following:

  1. Documented PHEX gene mutation
  2. Documented PHEX gene mutation in at least one family member with X-linked genetic relationship
  3. Documented FGF23 \>30 pg/mL
* Typical clinical findings of rickets/osteomalacia
* Written informed consent obtained from patients aged \>=18 years or from parents or legally acceptable representatives of patients aged \<18 years

Exclusion Criteria:

* Participation in any clinical study (trial) at the time of informed consent
* Any patient whose participation in the study is considered inappropriate by the investigator or the subinvestigator

Primary outcomes:
measure: Height
timeFrame: After enrollment, patients will be observed annually or every 2 years for up to 10 years.
measure: The 6-Minutes Walking Test
timeFrame: After enrollment, patients will be observed annually for up to 10 years.
measure: Timed Up and Go Test(TUGT)
timeFrame: After enrollment, patients will be observed every 2 years for up to 10 years.
Secondary outcomes:
measure: Fracture
timeFrame: 10 years
measure: Radiography
timeFrame: After enrollment, patients will be observed annually or every 2 years for up to 10 years.
measure: Nephrocalcinosis
timeFrame: After enrollment, patients will be observed annually or every 2 years for up to 10 years.
Other outcomes:
Locations:
city: Osaka
country: Japan
facility: Osaka University Hospital
Study officials:
References:
citation: Kubota T, Fukumoto S, Cheong HI, Michigami T, Namba N, Ito N, Tokunaga S, Gibbs Y, Ozono K. Long-term outcomes for Asian patients with X-linked hypophosphataemia: rationale and design of the SUNFLOWER longitudinal, observational cohort study. BMJ Open. 2020 Jun 29;10(6):e036367. doi: 10.1136/bmjopen-2019-036367.
Clinical trial NCT03501121: Extended Follow up of the TARGIT-A Trial
Official title: Extended Follow up of the TARGIT-A Trial
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Neoplasm Female
Keywords: intra-operative radiation therapy
Lead sponsor: University College, London
Sponsor class: OTHER
First posted: 2018-04-18
Enrollment: 714
Sex: FEMALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who participated in the TARGIT-A trial (see NCT00983684).

Brief summary: All UK patients who participated in the TARGIT-A Trial were initially treated for early breast cancer between 2000-2012. A total of 3451 patients from 33 hospitals in 11 countries participated in the trial and a comparison was made between traditional radiotherapy given over several weeks (external beam radiotherapy, EBRT) with TARGeted Intraoperative radioTherapy (TARGIT-IORT) as a single dose given during the operation to remove the breast cancer. The trial was funded by the Health Technology Assessment (HTA) programme of the Department of Health, UK and sponsored by University College London. The results from this trial have been published in major medical journals and have already started changing the way breast cancer in treated around the world; please see www.targit.org.uk for more details. We would like to continue to collect data about the health status of all patients to enable us to learn about longer term differences in the effects of these treatments on health. An analysis of this information could improve treatment for patients with breast cancer. For this, HTA have granted us further funding.


Eligibility criteria: Inclusion Criteria:

* All patients who participated in the TARGIT-A trial (NCT00983684).

Exclusion Criteria:

* Any patient who has withdrawn consent for further follow-up, or died.

Primary outcomes:
measure: Long-term follow-up through direct patient contact
timeFrame: 60 months
Secondary outcomes:
measure: Long-term follow-up through national registries
timeFrame: Up to 20 years
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: University College London
city: Winchester
country: United Kingdom
facility: Royal Hampshire County Hospital
Study officials:
affiliation: University College, London
name: Jayant Vaidya
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06021964: Prospective Cohort Observational Study of Placenta Accreta Spectrum Disorders
Official title: Prospective Cohort Observational Study of Placenta Accreta Spectrum Disorders
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Placenta Accreta Spectrum Disorders,Previous Cesarean Section
Keywords: placenta accreta spectrum disorders；Previous cesarean section
Lead sponsor: Guangzhou Medical University
Sponsor class: OTHER
Collaborators: name: Peking University Third Hospital
name: Department of Obstetrics and Gynecology, Nanfang Hospital, Southern Medical University
name: Peking Union Medical College Hospital
name: TONGJI MEDICAL COLLEGE OF HUST
name: First Affiliated Hospital of Chongqing Medical University
name: West China Second University Hospital,Sichuan University / West China women's and children's Hospital
name: Peking University First Hospital
First posted: 2023-09-01
Enrollment: 1000
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pregnant women aged 18-45 who at least had one previous cesarean section

Brief summary: The incidence of placenta accreta spectrum disorders has shown an increasing trend worldwide due to the increase of cesarean section rate. Research on the outcomes of placenta accreta spectrum disorders primarily relies on retrospective analysis. The aim of this study was to establish a prospective, multicenter cohort in China in order to conduct further investigations on the clinical features, predictive capabilities, diagnostic methods, and pathogenesis of placenta accreta spectrum disorders.


Eligibility criteria: Inclusion Criteria:

1. Pregnant women aged 18-45;
2. at least one previous cesarean section ,regular antenatal examination and plan to give birth at research center
3. sign informed consent

Exclusion Criteria:

Irregular antenatal examination; Twins; Autoimmune diseases; Prepregnancy hypertension; Prepregnancy diabetes mellitus; Inheritance Sexual diseases; tumor; Abnormal liver and kidney function in early pregnancy

Primary outcomes:
measure: Incidence of placenta accreta spectrum disorders
timeFrame: baseline
Secondary outcomes:
measure: Preterm delivery Preterm delivery
timeFrame: baseline
measure: Blood lost during delivery
timeFrame: baseline
measure: Blood loss in the first 24 hours of delivery
timeFrame: baseline
measure: hysterectomy
timeFrame: baseline
measure: Blood transfusion
timeFrame: baseline
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Department of Obstetrics and Gynecology, Key Laboratory for Major Obstetric Diseases of Guangdong Province, Guangdong Provincial Clinical Research Center for Obstetrics and Gynecology，The Third Affiliated Hospital of Guangzhou Medical University
Study officials:
References:
Clinical trial NCT00941564: Comparative Ca Absorption and Tolerance in Healthy Term Infants Fed Milk-based Formulas With Different Fat Blends
Official title: "Comparative Calcium Absorption and Gastrointestinal Tolerance in Healthy Term Infants Fed Milk-based Formulas With Different Fat Blends"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Infant
Lead sponsor: Abbott Nutrition
Sponsor class: INDUSTRY
First posted: 2009-07-17
Enrollment: 33
Sex: ALL
Minimum age (years): 84
Maximum age (years): 159
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective is to assess the comparative calcium absorption and gastrointestinal (GI) tolerance in healthy normal term infants fed two commercially available powdered milk-based formulas which contain different fat blends.


Eligibility criteria: Inclusion Criteria:

* Infant in good health, full term, singleton birth and 84-156 days of age at enrollment. Male infants only to be enrolled for primary variable measures.
* Restrict use of certain medications or home remedies, herbal preparations, probiotics or rehydration/intravenous (IV) fluids.

Exclusion Criteria:

* Adverse maternal, fetal or infant medical history that is thought by the investigator to have potential for effects on tolerance, growth, and/or development.
* Infant has been treated with antibiotics 3 days prior to enrollment.
* Infant has received probiotics-containing products 3 days prior to enrollment.

Primary outcomes:
measure: Calcium absorption
timeFrame: 18 days
Secondary outcomes:
measure: Calcium retention, fat absorption, tolerance
timeFrame: 18 days
Other outcomes:
Locations:
city: Salvador
country: Brazil
facility: Department of Pediatrics, Federal University of Bahia
state: Bahia
Study officials:
affiliation: Abbott Nutrition
name: John Lasekan, PhD
role: STUDY_DIRECTOR
References:
citation: Souza CO, Leite MEQ, Lasekan J, Baggs G, Pinho LS, Druzian JI, Ribeiro TCM, Mattos AP, Menezes-Filho JA, Costa-Ribeiro H. Milk protein-based formulas containing different oils affect fatty acids balance in term infants: A randomized blinded crossover clinical trial. Lipids Health Dis. 2017 Apr 14;16(1):78. doi: 10.1186/s12944-017-0457-y.
citation: Leite ME, Lasekan J, Baggs G, Ribeiro T, Menezes-Filho J, Pontes M, Druzian J, Barreto DL, de Souza CO, Mattos A, Costa-Ribeiro H Jr. Calcium and fat metabolic balance, and gastrointestinal tolerance in term infants fed milk-based formulas with and without palm olein and palm kernel oils: a randomized blinded crossover study. BMC Pediatr. 2013 Dec 24;13:215. doi: 10.1186/1471-2431-13-215.