louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01073176: Training Executive, Attention and Motor Skills (TEAMS): Preliminary Studies
Official title: Training Executive, Attention and Motor Skills (TEAMS): Preliminary Studies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Attention Deficit Hyperactivity Disorder
Keywords: ADHD
Executive function
Preschool children
Treatment
Memory
Attention
Training
Cognitive enhancement
Lead sponsor: Queens College, The City University of New York
Sponsor class: OTHER
First posted: 2010-02-23
Enrollment: 30
Sex: ALL
Minimum age (years): 4
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Training Executive, Attention and Motor Skills (TEAMS) is a new research program for preschool children with Attention-Deficit/Hyperactivity Disorder (ADHD) that attempts to use game-like activities and physical exercise to promote the growth of neural processes that underlie the core features of the disorder (e.g., hyperactivity, impulsivity) as well as associated areas of difficulty (e.g., socialization, motor skills). These activities are implemented at home and in supervised playgroups at no cost to families and are coupled with extensive parental education about ADHD symptoms and associated impairments.


Eligibility criteria: Inclusion Criteria:

1. Be at least 4.0 and less than 6.0 years of age;
2. Receive a T-score on the Hyperactivity scale of the Behavior Assessment System for Children, Second Edition (BASC-2) of at least 65 (1.5 SD above the mean) by either teacher or parent rating, and a score of at least 60 (1 SD above the mean) by the other rater;
3. Meet diagnostic criteria for ADHD-C or ADHD-HI as ascertained using the Kiddie-SADS, which will be administered to the parent.

Exclusion Criteria:

1. Chronic medical illness or is taking systemic medication;
2. Diagnosed neurological disorder;
3. Full Scale IQ below 80 as measured by the Stanford-Binet - Fifth Edition Abbreviated Battery;
4. Diagnosis of autism, pervasive developmental disorder or post-traumatic stress disorder;
5. Determined to be physically aggressive with other children;
6. Parent enrolled in a parent management training program;
7. Not attending school or day

Primary outcomes:
measure: Daily Diary of Engagement in Games at Home
timeFrame: Weekly during intervention, 1 month follow-up, 3 month follow-up
Secondary outcomes:
measure: Attention Deficit Hyperactivity Disorder Rating Scale IV(ADHD-RS-IV)
timeFrame: Pre intervention, post intervention, 1 month follow-up, 3 month follow-up
measure: Parent Satisfaction Questionnaire
timeFrame: Post intervention, 1 month follow-up, 3 month follow-up
Other outcomes:
Locations:
city: Flushing
country: United States
facility: Queens College, City University of New York
state: New York
Study officials:
affiliation: Queens College, City University of New York
name: Jeffrey M Halperin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05510076: Evaluation of Different Surgical Approaches Used for Conservative Management of Placenta Accreta Spectrum in Sohag University Hospital
Official title: Evaluation of Different Surgical Approaches Used for Conservative Management of Placenta Accreta Spectrum in Sohag University Hospital
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Placenta Accreta Spectrum
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2022-08-22
Enrollment: 60
Sex: FEMALE
Maximum age (years): 51
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: community sample, any suspected case of PAS disorders.

Brief summary: The objective of this study is to evaluate different intra-operative procedures to control bleeding in cases of PAS disorders aiming to determine the best procedure regarding maternal morbidity and mortality post-operatively, and to evaluate the long-term effects of conservative management of PAS disorders.

Detailed description: The term "placenta accreta spectrum" (PAS), formerly known as "morbidly adherent placenta" or "abnormally invasive placenta," refers to the aberrant trophoblast invasion of all or a portion of the placenta into the myometrium of the uterus. according to the depth of the villous invasion into the myometrium, the spectrum is assorted into three groups: placenta accreta (villi attach to the myometrium without invading it), placenta increta (villi infiltrate the myometrium), and placenta percreta (villi pierce through the uterine serosa and may infiltrate the surrounding tissues). The optimal strategy for managing PAS disorders remains debatable. Conservative management of PAS disorders includes all techniques aimed at preserving the uterus. Because intraoperative bleeding from PAS disorders is frequently massive and dramatic, causing severe maternal morbidity and mortality, it is essential to have a well-planned, effective, and rapid approach to this surgical challenge.

Eligibility criteria: Inclusion Criteria:

* Women with at least one previous caesarean section and suspected PAS disorders by imaging studies

Exclusion Criteria:

* Patients with intraoperative spontaneous placental separation.
* Patients with a preoperative diagnosis of placenta percreta who chose to have an elective hysterectomy.
* Any other associated uterine pathology requiring hysterectomy.
* Coagulation disorders.

Primary outcomes:
measure: successful intervention procedure
timeFrame: 1 day
measure: maternal mortality and morbidity
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag University
Study officials:
References:
Clinical trial NCT00004376: Phase III Randomized, Double-Blind, Placebo-Controlled Study of Guanfacine for Tourette Syndrome and Attention Deficit Hyperactivity Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Tourette Syndrome
Keywords: Tourette syndrome
neurologic and psychiatric disorders
rare disease
Lead sponsor: Office of Rare Diseases (ORD)
Sponsor class: NIH
Collaborators: name: Yale University
First posted: 1999-10-19
Enrollment: 35
Sex: ALL
Minimum age (years): 7
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: OBJECTIVES:

I. Evaluate the safety and efficacy of the alpha-2 adrenergic agonist guanfacine in children and adolescents with Tourette syndrome or other chronic tic disorder, and attention deficit hyperactivity disorder.

Detailed description: PROTOCOL OUTLINE: This is a randomized, double-blind study. Patients are stratified by pubertal status.

There is a 7- to 14-day washout with a placebo prior to treatment for all patients.

The first group receives oral guanfacine 3 times a day for 8 weeks. The dose is gradually increased to minimize sedation; by day 14, most patients are stabilized and the dose is then increased as clinically indicated and tolerated.

The second group receives a placebo 3 times a day for 8 weeks. Patients in either group may be treated with guanfacine for an additional 8 weeks.

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

* Tourette syndrome or other chronic tic disorder meeting Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV) criteria
* DSM-IV diagnosis of attention deficit hyperactivity disorder (ADHD) Clinician's Global Impression for ADHD greater than 4 Hyperactivity Index of Conners Parent or Teacher Questionnaire standard score 65 or higher (1.5 standard deviation units)

--Prior/Concurrent Therapy--

* At least 2 weeks since medication for tics, ADHD, or obsessive compulsive disorder (4 weeks since neuroleptics or fluoxetine)
* No failure on prior guanfacine

--Patient Characteristics--

* Hepatic: No liver failure
* Renal: No renal failure
* Cardiovascular: No hypertension No other heart disease
* Pulmonary: No pulmonary disease
* Other: No Intelligence Quotient below 80 No current DSM-IV diagnosis of the following: Major depression Bipolar disorder Pervasive developmental disorder Psychotic disorder No seizure disorder No other significant medical condition No pregnant women

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Yale University
name: Lawrence Scahill
role: STUDY_CHAIR
References:
Clinical trial NCT02050776: Stem Cell Therapy in Limb Girdle Muscular Dystrophy
Official title: The Role of Cell Therapy in Modifying the Course of Limb Girdle Muscular Dystrophy- A Longitudinal 5-year Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Limb Girdle Muscular Dystrophy
Lead sponsor: Neurogen Brain and Spine Institute
Sponsor class: OTHER
First posted: 2014-01-31
Enrollment: 0
Sex: ALL
Minimum age (years): 15
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to study the effect of stem cell therapy on the course of the disease in patients with Limb Girdle Muscular Dystrophy.


Eligibility criteria: Inclusion Criteria:

* males and females
* age group of 15 years and above
* limb girdle muscular dystrophy diagnosed on the basis of clinical presentation
* Electromyographic and Nerve Conduction velocity findings

Exclusion Criteria:

* presence of respiratory distress
* presence of acute infections such as Human Immunodeficient Virus/Hepatitis B Virus/Hepatitis C Virus
* malignancies
* acute medical conditions such as respiratory infection, fever, hemoglobin less than 8, bleeding tendency, bone marrow disorder, left ventricular ejection fraction \< 30%
* pregnancy or breastfeeding

Primary outcomes:
measure: Functional Independence Measure
timeFrame: 6 months
Secondary outcomes:
measure: Manual Muscle Testing
timeFrame: 6 months
Other outcomes:
Locations:
city: Mumbai
country: India
facility: Neurogen brain and spine institute
state: Maharashtra
Study officials:
affiliation: Neurogen Brain and Spine Institute
name: Alok K Sharma, M.S., M.Ch
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sharma A, Sane H, Badhe P, Gokulchandran N, Kulkarni P, Lohiya M, Biju H, Jacob VC. A clinical study shows safety and efficacy of autologous bone marrow mononuclear cell therapy to improve quality of life in muscular dystrophy patients. Cell Transplant. 2013;22 Suppl 1:S127-38. doi: 10.3727/096368913X672136. Epub 2013 Sep 10.
Clinical trial NCT04832776: FOLFOXIRI Plus Cetuximab Versus FOLFOXIRI Plus Bevacizumab in Conversion Therapy of Right-sided Colon Cancer Liver Metastases
Official title: FOLFOXIRI Plus Cetuximab Versus FOLFOXIRI Plus Bevacizumab in Conversion Therapy of Right-sided Colon Cancer Liver Metastases
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Liver Metastasis Colon Cancer
Keywords: FOLFOXIRI
cetuximab
bevacizumab
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2021-04-06
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the efficacy of FOLFOXIRI plus Cetuximab and FOLFOXIRI plus Bevacuzumab in the conversion therapy of right-sided colon cancer liver metastases


Eligibility criteria: Inclusion Criteria:

* ECOG perfomance 0-1
* pathologically confirmed colorectal carcinoma, with RAS wild type
* inital unresectable liver metastases discussed by MDT
* prior no systemical therapy or exceed 6 months after the adjuvant chemotherapy of primary tumor surgery.
* without extraheptic metastatic lesions, except for locally controlled lung metastases (RFA or SBRT)
* adequate blood, liver and renal function
* expected survival longer than 6 months

Exclusion Criteria:

* with bleeding risk
* interestinal obstruction or disease
* uncontrolled hypertension and severe heart disease
* previous severe thrombotic events
* central nervous system metastases
* accompanied with other malignant tumor

Primary outcomes:
measure: ORR
timeFrame: up to 8 weeks
Secondary outcomes:
measure: R0 resection rate of liver metastases
timeFrame: up to 8 weeks
measure: NED rate
timeFrame: up to 8 weeks
measure: OS
timeFrame: up to 6 months
measure: PFS
timeFrame: up to 8 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Department of Colorectal Surgery Fudan University Shanghai Cancer Center
state: Shanghai
Study officials:
affiliation: Fudan University
name: Wen Zhang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06005376: Development of a Celiac Safe Food Additive
Official title: Development of a Celiac Safe Food Additive: An Intervention Study in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gluten Intolerance
Lead sponsor: Chalmers University of Technology
Sponsor class: OTHER
Collaborators: name: Gothia Forum - Center for Clinical Trial
name: Sahlgrenska University Hospital
First posted: 2023-08-22
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomised double-blind crossover intervention
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this clinical trial was to investigate if intestinal deamidation of gliadin from wheat bread could be hindered by adding a E304i/zinc additive. The study was a randomized double-blind 4-week crossover intervention in 20 healthy volunteers in which the participants ingested 2 bread rolls a day during the intervention weeks.

The question it aimed to answer was if there was a difference in blood levels of deamidated gliadin peptides after ingestion of the reference wheat bread compared with the wheat bread containing the food additive.


Eligibility criteria: Inclusion Criteria:

* Signed informed consent
* Body mass index between 18.5 to 32
* Age between 18-50 years
* No tobacco use

Exclusion Criteria:

* Celiac disease and other diagnosed enteropathies
* Gluten-free diet
* Dietary supplementation (minerals (calcium, zinc, vitamin D) and proteolytic enzymes, probiotics)
* Pregnancy or lactation
* Lack of suitability for participation in the study, for any reason, as judged by the medical doctor or the project PI.
* Withdrawn consent: Participant withdraws consent.
* Non-compliance: Participant fails repeatedly to comply with study protocol (diet, study visits and provide samples)

Primary outcomes:
measure: Levels of deamidated gliadin peptides in blood
timeFrame: Blood samples were drawn once weekly at day 7, 14, 21, 28
Secondary outcomes:
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Chalmers University of Technology
Study officials:
affiliation: Chalmers University of Technology, Dept of Life Sciences, Gothenburg 412 96, Sweden
name: Nathalie Scheers
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06062576: Clinical Observation and Mechanism Study of Yunnan Baiyao in Different Stages of Diabetic Foot
Official title: Clinical Efficacy Observation and Mechanism Study of Yunnan Baiyao in Different Stages of Diabetic Foot
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Diabetic Foot
Therapeutics
Keywords: Diabetic Foot
Therapeutics
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2023-10-02
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Yunnan Baiyao has been treating all kinds of wounds for 120 years, but the evidence of Evidence-based medicine that is truly convincing is insufficient, making its best application method unclear. This study explored the possible indications and use methods of Yunnan Baiyao in different stages of Diabetic foot, and obtained Evidence-based medicine evidence of clinical efficacy. Obtain the discarded tissues of Diabetic foot patients in the treatment and control groups of Yunnan Baiyao after wound debridement, conduct Transcriptome (BulkRNA seq) analysis and detection on the wound tissues, and analyze the related signal pathways and functional genes with significant differences, to help clarify the possible treatment targets of Yunnan Baiyao.


Eligibility criteria: Inclusion Criteria:

1. The age of the subjects is 18-80 years old;
2. Diagnose diabetes according to WHO standards;
3. Diagnosis of Diabetic foot;
4. Confirmed as one of the stages of infection progression and granulation growth;
5. Voluntarily participate in this study and sign an informed consent form.

Exclusion Criteria:

1. Severe diseases such as acute myocardial infarction, heart failure, hepatitis, shock, and respiratory failure have not been corrected yet;
2. Blood glucose is out of control, Glucose test#Fasting blood sugar\&gt;15mmol /L, Glycated hemoglobin\&gt;12%;
3. There is active bleeding inside the wound, and routine basic treatment plans cannot be implemented;
4. Serum albumin\&lt;20g/L; Hemoglobin\&lt;60g/L; Platelets\&lt;50 × 109/L;
5. Late stage subjects with malignant tumors;
6. Active period of autoimmune diseases;
7. Have a history of allergy to Yunnan Baiyao;
8. The subject is unable to cooperate or has mental disorders;
9. According to the judgment of the researcher, the subject has a clear reason that cannot be removed and affects wound healing, which is not suitable for this study or cannot comply with the requirements of this study.

Primary outcomes:
measure: 2-week reduction rate of wound area
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University 3rd Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT03599076: Wearable Sensors for Quantitative Assessment of Motor Impairment in Huntington's Disease Huntington's Disease
Official title: Wearable Sensors for Quantitative Assessment of Motor Impairment in Huntington's Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Huntington Disease
Lead sponsor: BioSensics
Sponsor class: INDUSTRY
Collaborators: name: University of Rochester
First posted: 2018-07-26
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Huntington's Disease

Brief summary: The principal means of measuring motor impairment in Huntington disease (HD) is the Unified Huntington's Disease Rating Scale (UHDRS) total motor score, which is subjective, categorical, requires significant training to administer correctly, and only captures impairments in clinic. In this Direct to Phase II SBIR we will develop a wearable sensor system for objective, sensitive, and continuous assessment of Huntington's chorea during activities of daily living. The developed technology could be used clinically to detect changes in motor function in response to medications, or could be used scientifically to expedite and reduce the cost of early stage pharmaceutical clinical trials.


Eligibility criteria: Inclusion Criteria:

* CAG expansion ≥ 36

Exclusion Criteria:

* N/A

Primary outcomes:
measure: Chorea severity score
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester
state: New York
Study officials:
References:
Clinical trial NCT04221776: Group Toilet Training of Healthy Children, in Daycare Centers (CRCT)
Official title: Implementing a New Method of Group Toilet Training in Daycare Centers: a Cluster Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Toilet Training
Child, Preschool
Keywords: Method
Lead sponsor: University Hospital, Antwerp
Sponsor class: OTHER
Collaborators: name: Universiteit Antwerpen
First posted: 2020-01-09
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evaluation of a new method of toilet training (TT), meaning TT in group in daycare centers, guided by a TT expert. Children are included based on signs of readiness for TT.

Detailed description: A cluster randomized controlled trial (CRCT) was established in daycare centers. Clusters of participants (per daycare center) were randomly allocated to an Intervention group or a Control group.

Evolution of the TT process was monitored in the daycare center until the child was considered to be fully toilet trained (or 'clean') during the day (this means wearing undergarments, conscious of the need to void and initiating toilet behavior without reminder of the parents with a maximum of one leakage a day \[9\]).

Daycare workers evaluated the TT process of all participating children on a weekly basis. Parents were asked to fill in an online questionnaire when their child was completely toilet trained.

Eligibility criteria: Inclusion Criteria:

* knowledge of the Dutch language
* aged between 18 and 30 months
* not yet toilet trained during the day and night (diaper dependent)
* Parents of the children had to be motivated to participate in the study and willing to invest time and effort in continuing the TT at home
* Children met at least two of the following three signs of readiness: the child expresses a need to evacuate and shows awareness of the need to void or to have a bowel movement; the child insists on completing tasks without help and is proud of new skills; or the child can pull clothes up and down in a TT related context

Exclusion Criteria:

* Children with urological, neurological, organical or behavior problems

Primary outcomes:
measure: Duration of toilet training
timeFrame: 6 weeks
Secondary outcomes:
measure: Effectiveness of toilet training
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Antwerp
country: Belgium
facility: University Hospital Antwerp
Study officials:
affiliation: University Hospital, Antwerp
name: Van Aggelpoel
role: PRINCIPAL_INVESTIGATOR
References:
citation: Van Aggelpoel T, De Wachter S, Neels H, Van Hal G, Roelant E, Vermandel A. Implementing a new method of group toilet training in daycare centres: a cluster randomised controlled trial. Eur J Pediatr. 2021 May;180(5):1393-1401. doi: 10.1007/s00431-020-03879-y. Epub 2020 Nov 23.