louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02680210: Self-defining Memories in Patients With a TBI
Official title: Self-defining Memories in Patients With a TBI and Their Relationships With Cognitive, Emotional and Behavioural Dimensions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Traumatic Brain Injuries
Neurobehavioral Manifestations
Cognition Disorders
Memory Deficits
Lead sponsor: Centre d'Investigation Clinique et Technologique 805
Sponsor class: OTHER
First posted: 2016-02-11
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study will be conducted over 18 months. The main objective of this study is to explore the relationships between autobiographical memory and specific cognitive measures, as well as emotional and behavioural measures in patients who have suffered a moderate to severe TBI. Secondary objectives are to assess the psychometric properties of a self-defining memories questionnaire and to characterize autobiographical memory in the TBI population.

Detailed description: A total of 40 participants (20 non-consecutive adults with a moderate or severe TBI and 20 volunteers with any history of neurological or psychiatric disease) will be recruited into the study. The duration of the protocol is 70 minutes. As regards the assessment, three questionnaires will be administered in order to evaluate self-defining memories, apathetic manifestations and anxio-depressive symptoms. In addition, four cognitive measures will be used to assess verbal episodic memory, working memory, cognitive flexibility and verbal fluency.

Eligibility criteria: Inclusion Criteria:

* patients with a moderate or severe TBI occurred at least 6 months ago (initial Glasgow Coma Scale score ≤ 12 or post-traumatic amnesia duration \> 1 week)
* patients ≥ 18 years old and who have signed a letter of information

Exclusion Criteria:

* history of neurological and/or psychiatric disease
* persistent motor, sensitive and instrumental disorders that could disturb the efficient evaluation of the participant
* patients who refused to participate in the study
* non affiliation to a social security scheme
* patients under guardianship or trusteeship
* pregnant woman

Primary outcomes:
measure: self-defining memory score
timeFrame: 20 minutes
Secondary outcomes:
measure: verbal episodic memory score
timeFrame: 20 minutes
measure: working memory score
timeFrame: 10 minutes
measure: cognitive flexibility score
timeFrame: 5 minutes
measure: verbal fluency score
timeFrame: 5 minutes
measure: apathy score
timeFrame: 5 minutes
measure: anxio-depressive score
timeFrame: 5 minutes
Other outcomes:
Locations:
city: Garches
country: France
facility: Hôpital Raymond Poincaré
state: Ile De France
Study officials:
affiliation: Hôpital Raymond Poincaré
name: Annabelle Arnould, psychologue
role: STUDY_CHAIR
References:
Clinical trial NCT05332210: Evaluate the Safety of HBM9161 (HL161) Subcutaneous Injection in Patients With Generalized Myasthenia Gravis
Official title: A Long-term Open-label Extension Study to Evaluate the Safety of HBM9161 (HL161) Subcutaneous Injection in Patients With Generalized Myasthenia Gravis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Myasthenia Gravis
Lead sponsor: Harbour BioMed (Guangzhou) Co. Ltd.
Sponsor class: INDUSTRY
First posted: 2022-04-18
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary study objective is to evaluate medium- and long-term safety of HBM9161 in combination with background treatment for gMG patients through the observation on adverse events and laboratory abnormalities during study period.


Eligibility criteria: Inclusion Criteria:

1. Completed the HBM9161.3 Phase 3 study
2. Signed written informed consent.
3. Suitable for continued treatment with HBM9161 as judged by the investigator.
4. Female patients of childbearing potential and male patients with female partners of childbearing potential can participate in this study, but reliable contraceptive measures must be taken (such as physical barrier contraception (patients and their partners), contraceptive pills or patches, spermicide and barrier or intrauterine device). Up to 60 days after the last dose.
5. A negative urine pregnancy at baseline must be observed for women of childbearing age.

Exclusion Criteria:

1. Had received any other clinical study drug since the administration of the study drug in the 9161.3 Phase 3 study.
2. Females who are pregnant or lactating or planning to become pregnant during the study period, or females of childbearing potential who are not using an effective method of contraception.

Primary outcomes:
measure: Incidence of AEs during the study
timeFrame: during the study，up to 24 weeks
Secondary outcomes:
measure: Proportion of patients with sustained improvement
timeFrame: during each treatment cycle (5-week treatment period + 4-week observation period, from the first dose of the cycle to Day 64 of the cycle)
measure: During the 24-week study, proportion of time that MG-ADL improved from baseline by 3 or more points
timeFrame: during the study，up to 24 weeks
measure: Proportion of time remained in Minimal Symptom Expression
timeFrame: during the study，up to 24 weeks
measure: Improvement of patients' quality of life
timeFrame: during the study，up to 24 weeks
measure: Incidence and duration of serum anti-HBM9161 antibodies and neutralizing antibodies
timeFrame: during the study，up to 24 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Huashan Hospital, Fudan University
state: Shanghai
Study officials:
References:
Clinical trial NCT05874310: Gene Therapy for Subjects With RPGR Mutation-associated X-linked Retinitis Pigmentosa
Official title: An Open-label, Single-center, Dose-escalation Clinical Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of Intraocular Administration of FT-002 in Subjects With RPGR Mutation-associated X-linked Retinitis Pigmentosa.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: X-Linked Retinitis Pigmentosa
Lead sponsor: Frontera Therapeutics
Sponsor class: INDUSTRY
Collaborators: name: Eye & ENT Hospital of Fudan University
name: Peking Union Medical College Hospital
name: Henan Provincial People's Hospital
First posted: 2023-05-24
Enrollment: 18
Sex: MALE
Minimum age (years): 8
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: X-linked retinitis pigmentosa patients
Primary purpose: TREATMENT

Brief summary: A clinical trial of gene therapy for patients with X-linked retinitis pigmentosa (XLRP).


Eligibility criteria: Inclusion Criteria:

1.Subjects that are willing and able to follow study procedures; 2.Males aged 8-45 years old at the time of signing the Informed Consent Form; 4.Subjects who are confirmed with variants of RPGR ;

Exclusion Criteria:

1.Have other retinal degenerative diseases, such as retinal degeneration caused by other known Inherited retinal disease gene variants or previously received an gene therapy product.

Primary outcomes:
measure: Incidence of AEs
timeFrame: from FT-002 administration through up to 1 years
Secondary outcomes:
measure: Change in visual function
timeFrame: from FT-002 administration through up to 1 years
measure: Change in retinal structure as assessed by Optical Coherence Tomography
timeFrame: from FT-002 administration through up to 1 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
city: Shanghai
country: China
facility: Eye & ENT hospital of Fudan university
state: Shanghai
Study officials:
affiliation: Eye & ENT Hospital of Fudan University
name: Gezhi Xu
role: PRINCIPAL_INVESTIGATOR
affiliation: Peking Union Medical College Hospital
name: Ruifang Sui
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06489210: A Comparison Between Posterior, Lateral and Medial Approaches for Ultrasound-guided Popliteal Block
Official title: A Comparison Between Posterior, Lateral and Medial Approaches for Ultrasound-guided Popliteal Block: A Randomized Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nerve Pain
Lead sponsor: Helwan University
Sponsor class: OTHER
First posted: 2024-07-05
Enrollment: 120
Sex: ALL
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Background: Popliteal block is a widely used technique to provide anesthesia or analgesia for below-knee surgical procedures. In this study, the investigators compare ultrasound-guided popliteal blocks via posterior, lateral, and medial approaches to find out the approach with the best outcome.

Detailed description: Methods: In this randomized, controlled clinical trial, one hundred and twenty ASA physical status of class I and II patients undergoing below-knee surgery were involved. These patients were divided into three equal groups at randomly based on the route assigned for the US-guided popliteal block: the posterior, lateral, and medial approach groups. In this study, technical characteristics \[number of attempts to get the proper injection site and block performance time\], anesthetic and analgesic characteristics \[success rate, block onset, potency, and duration, time to ask, and the consumed amount of postoperative analgesia\], discomfort rate in respect to position and needle insertion and the associated complications were recorded.

Eligibility criteria: Inclusion Criteria: This study included

* ASA physical status (PS) class I and II
* weighing 70-85 kg,
* undergoing elective below knee surgeries

Exclusion Criteria:

* patients who refused to participate in the study
* those having an allergy to local anesthetics
* peripheral neuropathy, coagulopathy
* diabetes mellitus
* severe hepatic
* renal impairment
* infection, mass and crush injury or open wound at the nerve block site
* patients receiving chronic analgesic therapy.

Primary outcomes:
measure: assessment of intraoperative and postoperative pain in different groups after intervention
timeFrame: 24 hours after operation
Secondary outcomes:
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Zagazig University Hospitals
Study officials:
References:
Clinical trial NCT00138710: Short-term Effects of Aromatase Inhibition in Obese Men
Official title: Short-term Effects of Aromatase Inhibition in Obese Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypogonadotrophic Hypogonadism
Obesity
Keywords: obesity
Hypogonadotrophic hypogonadism
aromatase inhibition
Lead sponsor: Rijnstate Hospital
Sponsor class: OTHER
First posted: 2005-08-30
Enrollment: 50
Sex: MALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this study, 50 obese men with a hormonal imbalance will be treated with letrozole or placebo for six months in order to examine the effects on the hormonal balance, and on weight loss. The study will also address the side effects and psychological effects of letrozole as compared to placebo.

Detailed description: The aim of the study is to establish the short-term efficacy and safety of aromatase inhibition in restoring and maintaining eugonadism in hypogonadotrophic hypogonadal men. Secondary aim is to detect the short-term somatic and psychological effects.

Study design: Double blind randomized placebo-controlled trial.

Treatment: 26 weeks of either letrozole or placebo. All patients will start on 1 tablet per week, dose adjustments will be performed if serum testosterone or estradiol are outside the target range. All men will be prescribed a mildly hypocaloric diet.

Endpoints: BMI, body weight, waist circumference, body composition, exercise capacity, serum levels of several hormone markers, glucose tolerance, psychological characteristics.

All patients will be measured 6 times during the study.

Eligibility criteria: Inclusion Criteria:

* BMI between 35 and 50
* Male sex
* Ages between 20 and 50
* Serum total testosterone under 10 nmol/l
* Serum luteinizing hormone (LH) under 9 mU/l
* Serum estradiol over 40 pmol/l

Exclusion Criteria:

* Comorbidity
* Serum prostate-specific antigen (PSA) over 4.0 U/l
* Discontinuation of smoking less than six months ago
* Medication known to affect hormonal parameters

Primary outcomes:
measure: Body weight
measure: Body mass index (BMI)
measure: Waist circumference
measure: Body composition
measure: Exercise capacity
measure: Serum levels of hormones
measure: Glucose tolerance
measure: Reported side effects
measure: Psychological characteristics (Symptom Checklist, intelligence quotient [IQ] NPV)
Secondary outcomes:
measure: Lipid profile
measure: Blood counts
measure: Bone markers
measure: Liver enzymes
Other outcomes:
Locations:
city: Arnhem
country: Netherlands
facility: Rijnstate Hospital
Study officials:
affiliation: Rijnstate Hospital, Arnhem, the Netherlands
name: Hans de Boer, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06296810: Adaptive DBS to Offset STN Dysregulation During Exercise in PD
Official title: Implementation of Adaptive DBS to Offset STN Dysregulation During Exercise and Reduce Exertion in Parkinson's Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Parkinson Disease
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2024-03-06
Enrollment: 10
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Persons with PD, who have a Medtronic DBS Sendight implant and a Percept IPG.

Brief summary: The investigators conduct a prospective study to evaluate the effects of exercise on Parkinson's Disease brain biomarkers detected with the PerceptTM PC neurostimulator.

Detailed description: The investigators will conduct a prospective study to evaluate the effects of exercise on Local Field Potential biomarkers detected from the subthalmic nuclues in Parkinson's Disease with the PerceptTM PC neurostimulator. Subsequently, adaptive Deep Brain Stimulation applied in response to low beta peak (L-beta; 13-20Hz) will be performed to evaluate feasibility of whether aDBS can offset the effects of exacerbation of parkinsonism during exercise performance and recovery.

Eligibility criteria: Inclusion Criteria:

Persons with PD who have a Medtronic DBS Sensight implant and a Percept IPG.

-

Exclusion Criteria:

Persons not meeting the above listed implant criteria Persons not meeting the age limit criteria Persons who are not able to complete the study exercise Persons not able to comprehend and consent to study participation.

Primary outcomes:
measure: identification of L-beta frequency peak power
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
Study officials:
References:
Clinical trial NCT05416710: Universal Germline Testing in the Community
Official title: Prospective Community Cancer Clinics-based Approach to Optimize Germline Testing in Cancer Patients in Rural Setting to Address Racial Disparities: UNIversal Germline Testing in the communitY (UNITY) Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cancer
Solid Tumor
Solid Tumor, Adult
Lead sponsor: Invitae Corporation
Sponsor class: INDUSTRY
First posted: 2022-06-13
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults with solid tumor cancer who are willing to undergo germline genetic testing and who can consent to the study.

Brief summary: This study seeks to enroll participants who have a diagnosis of a solid tumor cancer and are willing to undergo germline genetic testing for cancer risk. At baseline, patients will be asked to provide 2 types of blood samples: 1 tube for clinical genetic testing and 2 tubes for future research use. A tumor sample from a previous resection or biopsy will also be obtained and sent to the sponsor. The clinician will be asked to provide relevant medical history and demographic information to the sponsor in the form of electronic case report forms.

Detailed description: This study seeks to enroll adult participants who have a diagnosis of a solid tumor cancer and are willing to undergo germline genetic testing for cancer risk using Invitae's Multi-Cancer gene panel. At baseline, patients will be asked to provide 2 types of blood samples: 1 tube for clinical genetic testing and 2 tubes for future research use. A tumor sample from a previous resection or biopsy will also be obtained and sent to the sponsor. The participant's clinician will be asked to provide relevant medical history and demographic information to the sponsor in the form of electronic case report forms at 3 timepoints: 1 month following the results of the participants genetic testing, one year post genetic testing, and 2 years post genetic testing.

Eligibility criteria: Inclusion Criteria:

* Patient has consented to germline genetic testing
* Patient has a histologically confirmed diagnosis of a solid tumor cancer
* Patient is willing to release previously collected tissue sample
* Patient is willing to provide research blood samples
* Patient must be at least 18 years of age

Exclusion Criteria:

* Patient is unable to consent.
* Patient with hematologic malignancy

Primary outcomes:
measure: Rate of Pathogenic Germline Variants (PGV)
timeFrame: Will be assessed at baseline only.
Secondary outcomes:
Other outcomes:
Locations:
city: Rock Hill
country: United States
facility: Carolina Blood and Cancer Care Associates, PA'
state: South Carolina
Study officials:
References:
Clinical trial NCT00537810: Treatment of Binge Eating in Obese Patients in Primary Care
Official title: Treatment of Binge Eating in Obese Patients in Primary Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Obesity
Binge Eating
Keywords: Obesity
Binge eating
Sibutramine
Self-help
Primary care
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2007-10-01
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: This study will test the effectiveness of two empirically-supported but distinct treatments for recurrent binge eating in obese patients: 1) Cognitive Behavior Therapy, using a pure self-help approach and 2) sibutramine, an anti-obesity medication also found to have efficacy for binge eating. Self-help Cognitive Behavior Therapy and sibutramine will be administered alone and in combination in a primary care setting.


Eligibility criteria: Inclusion Criteria:

* Obese (BMI \>= 30)

Exclusion Criteria:

* Medication regimen that represents medical contraindication to sibutramine
* Serious unstable or uncontrolled medical conditions that represent contraindication to sibutramine
* Pregnancy

Primary outcomes:
measure: Binge Eating (Remission)
timeFrame: 4 months treatment; 6 and 12 month follow up post treatment
measure: BMI
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale Internal Medicine Associates (YIMA)
state: Connecticut
city: New Haven
country: United States
facility: Yale-New Haven Hospital (YNHH) Primary Care Center (PCC)
state: Connecticut
city: New Haven
country: United States
facility: Yale Psychiatric Research at Congress Place
state: Connecticut
Study officials:
affiliation: Yale University
name: Carlos M. Grilo, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Grilo CM, Masheb RM, White MA, Gueorguieva R, Barnes RD, Walsh BT, McKenzie KC, Genao I, Garcia R. Treatment of binge eating disorder in racially and ethnically diverse obese patients in primary care: randomized placebo-controlled clinical trial of self-help and medication. Behav Res Ther. 2014 Jul;58:1-9. doi: 10.1016/j.brat.2014.04.002. Epub 2014 May 2.
citation: Correction to Grilo et al. (2015). J Consult Clin Psychol. 2015 Aug;83(4):747. doi: 10.1037/ccp0000043.
citation: Grilo CM, White MA, Masheb RM, Gueorguieva R. Predicting meaningful outcomes to medication and self-help treatments for binge-eating disorder in primary care: The significance of early rapid response. J Consult Clin Psychol. 2015 Apr;83(2):387-94. doi: 10.1037/a0038635. Epub 2015 Jan 26.
Clinical trial NCT02490410: Effects of Whey Protein Intervention on Body Composition and Muscle Function in the Elderly With Sacropenia
Official title: A Double-blind Randomized Controlled Study About the Effects of Whey Protein Intervention on Body Composition and Muscular Function in the Elderly With Sacropenia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2015-07-03
Enrollment: 90
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to compare the effects of different dose of whey protein intervention(in a daily dose of 0g, 10g, 20g) on lean body mass,body fat composition and muscular function state in the elderly with sacropenia.


Eligibility criteria: Inclusion Criteria:

* People aged over 65 years.
* Usual gait speed less than 0.8m/s.
* Willing to participate in the study, consume the test product and perform all measurements.

Exclusion Criteria:

* nervous system disease.
* Other diseases with movement disorder such as stroke,fracture,arthritis.
* people who unconsciousness and can not complete questionnaire
* long-term regular use of protein and antioxidant.

Primary outcomes:
measure: lean body mass
timeFrame: up to 6 months
measure: muscular function state
timeFrame: up to 6 months
Secondary outcomes:
measure: plasma amino acid spectrum, especially branched chain amino acid spectrum
timeFrame: up to 6 months
Other outcomes:
Locations:
Study officials:
References: