louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00457912: Genetic Characterization of Individuals With Limb Girdle Muscular Dystrophy
Official title: Genetic Characterization of Individuals With Limb Girdle Muscular Dystrophy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Limb-Girdle Muscular Dystrophy
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
Collaborators: name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
name: Muscular Dystrophy Association
First posted: 2007-04-09
Enrollment: 277
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: any subject with clinical diagnosis of LGMD

Brief summary: The objective of this study is to identify and maintain a registry of well-characterized limb-girdle muscular dystrophy (LGMD) patients. Patients seen as part of this study may be candidates for future treatment trials based on their defined genetic classification of LGMD. In the course of this study, the investigators will perform a muscle biopsy and DNA testing in an unlimited number of patients with clinically diagnosed LGMD. The genetic testing will be extended to the family of the study subject in order to better understand true genetic defect.


Eligibility criteria: Inclusion Criteria:

* any subject with clinical diagnosis of LGMD
* must visit Columbus Children's Hospital for 2-day study visit
* muscle biopsy tissue must be available; either from previous biopsy, affected relative, or willing to have biopsy at Columbus Children's

Exclusion Criteria:

* diagnosis of a neuromuscular disorder other than LGMD
* unable to provide muscle tissue from previous or current biopsy
* incapable of giving consent and not having a legal guardian willing or able to do so

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
affiliation: The Research Institute at Nationwide Children's Hospital
name: Jerry R. Mendell, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04653012: Multi-level Approach of Brain Activity Using Intracranial Electrodes in Epileptic Patients
Official title: Multi-level Approach of Brain Activity Using Intracranial Electrodes in Epileptic Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Focal Epilepsy
Electrodes, Implanted
Cognitive Function
Neurophysiology
Keywords: Microelectrodes
Seizures
EEG
Lead sponsor: Institut National de la Santé Et de la Recherche Médicale, France
Sponsor class: OTHER_GOV
First posted: 2020-12-04
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The main goal of this project is to study the mechanisms of epileptic activities using intracranial macro and micro electrodes in epileptic patients undergoing pre-surgical investigation.

The recordings will also be used to study physiological mechanisms like sleep and different cognitive functions.


Eligibility criteria: Inclusion Criteria:

* Patients with focal drug-resistant epilepsy
* Patients who undergo a presurgical evaluation with intracranial electrodes in the videoEEG unit of the Neurology department at the Pitié-Salpêtrière hospital.
* Patients who have been informed and provided written informed consent to take part in the study

Exclusion Criteria:

* Contraindication for an intracranial investigation (with macro-electrodes) : intercurrent infectious syndrome, decompensated associated pathology (cardiac, pulmonary, renal, hepatic), patient with increased risk of infection (ex: under immunosuppressive therapy)
* Pregnant or parturient woman
* Breastfeeding woman
* Minor person or legally protected adult (tutelage, legal guardianship, maintenance of justice)

Primary outcomes:
measure: Identification of single unit changes at seizure emergence
timeFrame: Whole duration of the clinical inverstigation, until 4 weeks
measure: Identification of local field potential (LFP) changes at seizure emergence
timeFrame: Whole duration of the clinical inverstigation, until 4 weeks
Secondary outcomes:
measure: Comparison of single unit activity before seizure according to brain localization
timeFrame: Whole duration ofthe clinical inverstigation, until 4 weeks
measure: Identification of single unit changes during physiological brain activity
timeFrame: Whole duration ofthe clinical inverstigation, until 4 weeks
measure: Identification of LFP power changes during physiological brain activity
timeFrame: Whole duration ofthe clinical inverstigation, until 4 weeks
measure: Multilevel study of brain activity
timeFrame: Whole duration ofthe clinical inverstigation, until 4 weeks
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital de la Salpêtrière
Study officials:
References:
Clinical trial NCT04113512: Yoga Nasal Irrigation in the Treatment of Chronic Tension Type Headache
Official title: Yoga Nasal Irrigation in the Treatment of Chronic Tension Type Headache: Randomised Waitlist Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Tension-Type Headache
Lead sponsor: NMP Medical Research Institute
Sponsor class: OTHER
Collaborators: name: University of Rajasthan
name: Yog-Kulam
First posted: 2019-10-02
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the effectiveness of Yoga Nasal Irrigation (Jalaneti) on patients with chronic tension-type headache reducing pain and disability.


Eligibility criteria: Inclusion Criteria:

* Meeting the diagnostic criteria of chronic tension type headache as per International Classification of Headache Disorders, 3rd edition (beta version) (ICHD-3 beta criteria)
* Aged 18-60 years;
* Ability of understand and completing the headache dairy;
* Volunteering to the study
* Provide written informed consent.

Exclusion Criteria:

* Not having tension-type headache during the pervious 3 months or having less than 8 episode of tension type headache in serious month.
* Taking any prophylactic headache medication or complementary and alternative medicine in last 3 month;
* Secondary Headaches
* In pregnancy, lactation, or planning to be pregnant in 6 months
* Having nose bleeding disorders or recurrent infections;
* Psychiatric diagnosis or medication history

Primary outcomes:
measure: Headache Frequency
timeFrame: Change from baseline to 6 weeks
Secondary outcomes:
measure: Headache severity
timeFrame: Change from baseline to 6 weeks
measure: Duration of Headache
timeFrame: Change from baseline to 6 weeks
measure: Headache disability
timeFrame: Change from baseline to 6 weeks
Other outcomes:
Locations:
city: Jaipur
country: India
facility: Yoga Bhavan
state: Rajasthan
Study officials:
affiliation: Yog-Kulam
name: Neha Sharma, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Yog-Kulam
name: Jaydeep Joshi
role: STUDY_CHAIR
affiliation: University of Rajasthan, India
name: Placheril John, PhD
role: STUDY_CHAIR
affiliation: NMP Medical Research Institute, India
name: Shekhar Sharma
role: STUDY_DIRECTOR
References:
Clinical trial NCT01902212: Evaluation of an Oral Nutrition Supplement
Official title: Evaluation of an Oral Nutrition Supplement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastrointestinal Tolerance
Lead sponsor: Abbott Nutrition
Sponsor class: INDUSTRY
First posted: 2013-07-18
Enrollment: 25
Sex: ALL
Minimum age (years): 60
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The objective of this study is to capture gastrointestinal tolerance (GI) information on a nutrient dense oral nutritional supplement (ONS) in healthy elderly subjects.


Eligibility criteria: Inclusion Criteria:

Subjects will be eligible for the study if they meet all of the following inclusion criteria:

* Male or female ≥ 60 and ≤ 90 years of age.
* Body Mass Index (BMI) \> 20 but \< 35.

Exclusion Criteria:

Subjects will be excluded from the study if they meet any of the following criteria:

* History of diabetes
* Antibiotic use within 1 week prior to enrollment
* Undergone major surgery less than 3 months prior to enrollment.
* Current active malignant disease or was treated within the last 6 months for cancer.
* Immunodeficiency disorder.
* Myocardial infarction within the last 3 months.
* Chronic obstructive pulmonary disease (COPD).
* Allergy to any of the ingredients in the study product.
* Obstruction of the gastrointestinal tract or other major gastrointestinal disease.
* Dementia, brain metastases, eating disorders, history of significant neurological or psychiatric disorder.
* Unintentional weight loss or weight gain ≥ 5% in last 4 weeks.
* Taking medications/dietary supplements/substances that could profoundly modulate metabolism or affect GI motility.

Primary outcomes:
measure: Gastro-Intestinal Tolerance
timeFrame: Study Day (SD) 1-8
Secondary outcomes:
measure: ONS Consumption
timeFrame: SD 1-8
measure: Weight
timeFrame: Screening and SD 8
Other outcomes:
Locations:
city: Saint Herblain
country: France
facility: Biofortis Sas
Study officials:
affiliation: Abbott Nutrition
name: Jeffrey Nelson, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT05979012: Jazz Music and Mindfulness for Chronic Pain
Official title: Jazz Music and Mindfulness for Chronic Pain
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Chronic Pain
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
First posted: 2023-08-07
Enrollment: 90
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: Chronic pain, including spinal pain and osteoarthritis, is the leading cause of years lived with disability world-wide and the costliest health condition in the U.S. today. Compounding these concerns, opioid analgesics remain the primary pharmacological treatment for chronic pain. An estimated 21-29% of chronic pain patients receiving long-term opioid therapy develop opioid misuse, and opioid misuse portends addiction and overdose. Clearly, chronic pain patients need better, non-addictive treatment options designed to reverse the downward spiral of chronic pain.

Detailed description: Group Assignments

Participants will be randomized into one of three groups.

1. Jazz Group 1: Participants in this group will watch an introduction to jazz appreciation video prior to the 4-week intervention.
2. Jazz Group 2 (Mindful Jazz) Group: Participants in this group will watch a video on mindful listening to jazz.
3. Music Waitlist Group: Participants in this group will serve as a control and will not receive any intervention until the study is completed. They will complete a baseline survey and a follow-up survey at four weeks. Some videos will be sent to this group after the study is completed, without tracking their usage.

Intervention

All groups will complete a baseline and 4-week follow-up survey.

Participants in Jazz Group 1 and Jazz Group 2 will engage in daily listening 4-week intervention.They will have access to electronic audio recordings, with the order of listening labeled for each day. It is up to them if they want to listen to the daily recordings.

Eligibility criteria: Inclusion Criteria:

1. Are 18+
2. Live in the US
3. Are an English-proficient adult with a chronic pain diagnosis (no restrictions placed on type)
4. Have a pain rating of four or greater in average pain on a 0-10 numeric rating scale in the preceding week
5. Have had pain for at least 3 months and for at least 15 days in the preceding 30 days
6. Have moderate to severe anxiety based on GAD-7

Exclusion Criteria:

1. Are currently using or have used prescription opioids in the past 3 months to minimize a known treatment confound and increase sample homogeneity
2. Have a current cancer diagnosis

Primary outcomes:
measure: Pain Intensity portion of The Pain, Enjoyment of Life and General Activity (PEG) scale
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Irvine
country: United States
facility: University of California Irvine
state: California
Study officials:
References:
Clinical trial NCT01292512: Bereavement Management - Description, Assessment and Care
Official title: Bereavement Management. Description, Assessment and Care. A Randomized Controlled Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bereavement
Grief
Keywords: Bereavement management
Complicated grief
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Dæhnfeldt Foundation
name: TrygFonden, Denmark
name: Danish Cancer Society
First posted: 2011-02-09
Enrollment: 402
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This study aims to develop a risk assessment tool to identify bereaved in risk of complicated grief reactions and to implement a bereavement management programme in primary health care based on the Dual Process Model of coping with bereavement. Furthermore to enhance bereavement care in general practice and to enhance patients' self-management in bereavement care.

Detailed description: In Denmark alone there are approximately 55.000 deaths annually which leave approximately 200.000 bereaved close relatives. International studies show that 10-15% of bereaved persons develop complications following the death of a close relative. If those studies hold true, approximately 20 - 30.000 individuals annually will develop complications as a result of suffering a loss, and there is hardly any knowledge of how bereavement is treated or even legitimized in primary care and referred on to specialized (psychological or psychiatric) care. The field of bereavement is in need of studies that validate the theoretical underpinnings of the research area, enhanced assessment of predictive risk factors and updated intervention methods: in short a scientifically valid management programme.

Eligibility criteria: Inclusion Criteria:

* Newly bereaved from one of the inclusion facilities.
* 18 years or older.
* Danish citizen.
* Able to understand and speak Danish.
* Informed consent.
* Mentally able to cooperate

Exclusion Criteria:

* Patients with known substance abuse.
* Patients with recently (within 5 years) diagnosed psychopathological disorders that trigger psychotic episodes.

Primary outcomes:
measure: Effect of the intervention measured by an increase in the diagnosis of complicated grief.
timeFrame: 20 months
Secondary outcomes:
measure: Effect of the intervention measured by register-based data.
timeFrame: 20 months
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Research Unit for General Practice
Study officials:
affiliation: Research Unit for General Practice, Aarhus University, Denmark
name: Frede Olesen, Professor
role: STUDY_CHAIR
References:
citation: Guldin MB, Vedsted P, Jensen AB, Olesen F, Zachariae R. Bereavement care in general practice: a cluster-randomized clinical trial. Fam Pract. 2013 Apr;30(2):134-41. doi: 10.1093/fampra/cms053. Epub 2012 Sep 10.
Clinical trial NCT05262712: Crossmodal Learning in Therapeutic Processes (Task 2-2)
Official title: SFB TRR 169/A3 (2.FP) Crossmodal Learning in Health and Neurological Disease: Neurocomputational Representation and Therapeutic Application (Task 2-2)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Sensory Ataxia
Keywords: Vibro-tactile Stimulation
Neurorehabilitation
Ataxia
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
Collaborators: name: German Research Foundation
name: National Natural Science Foundation of China
First posted: 2022-03-02
Enrollment: 23
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: Interventional study of the effects of vibro-tactile feedback on behavioral deficits and learning during motor training in patients with sensory ataxia.


Eligibility criteria: Inclusion Criteria:

* Electrophysiological diagnosis of sensory ataxia
* Age \>= 18, \<=80
* Existing declaration of consent

Exclusion Criteria:

* Pregnancy
* Lacking capacity for consent

Primary outcomes:
measure: Change from baseline in Timed Up-and Go Test
timeFrame: One day before (baseline) and one day after seven days of motor training
Secondary outcomes:
measure: Change from baseline in 10-Meter-Walk Test
timeFrame: One day before (baseline) and one day after seven days of motor training
measure: Change from baseline in Berg-Balance-Scale
timeFrame: One day before (baseline) and one day after seven days of motor training
measure: Change from baseline in Postural-Sway Test
timeFrame: One day before (baseline) and one day after seven days of motor training
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg-Eppendorf, Neurologie
Study officials:
References:
Clinical trial NCT05821712: A New Mouthwash on Reducing Dental Plaque and Helping Prevent Gum Problems
Official title: Investigation of Clinical Efficacy of a New Mouthwash on Reducing Dental Plaque and Helping Prevent Gum Problems as Compared to a Control Mouthwash - a Six-month Study in Italy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Plaque
Gum Disease
Lead sponsor: Colgate Palmolive
Sponsor class: INDUSTRY
First posted: 2023-04-20
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This 6-month clinical study was designed to investigate clinical efficacy on plaque and gingivitis for the Meridol Base Mouthwash containing 0.2% zinc lactate, 0.17% amine fluoride and 0.0275% sodium fluoride as compared to a Negative Control Mouthwash containing 0.057% sodium fluoride after 3 and 6 months of product use.


Eligibility criteria: Inclusion Criteria:

* Subjects, ages 18-70, inclusive.
* Availability for the six-month duration of the clinical research study.
* Good general health.
* Initial gingivitis index of at least 1.0 as determined by the use of the Loe-Silness Gingival Index.
* Initial plaque index of at least 1.5 as determined by the use of the Quigley-Hein Plaque Index.
* Signed Informed Consent Form

Exclusion Criteria:

* Presence of orthodontic bands.
* Tumor(s) of the soft or hard tissues of the oral cavity.
* Advanced periodontal disease (purulent exudate, tooth mobility, and/or extensive loss of periodontal attachment or alveolar bone).
* Five or more carious lesions requiring immediate restorative treatment.
* Antibiotic use any time during the one-month period prior to entry into the study.
* Participation in any other clinical study or test panel within the one month prior to entry into the study.
* Dental prophylaxis during the past two weeks prior to baseline examinations.
* History of allergies to oral care/personal care consumer products or their ingredients.
* On any prescription medicines that might interfere with the study outcome.
* An existing medical condition that prohibits eating or drinking for periods up to 4 hours.
* History of alcohol or drug abuse.
* Self-reported pregnant or lactating subjects

Primary outcomes:
measure: Gingival inflammation
timeFrame: baseline
measure: Gingival inflammation
timeFrame: 3 months
measure: Gingival inflammation
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Clinica Odontoiatrica Montesani
state: Rome
Study officials:
affiliation: Clinica Odontoiatrica Montesani
name: Luigi Montesani, MD, DDS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04411212: G-CSF and PRP in Patients With Recurrent Implantation Failure
Official title: Granulocyte Colony-stimulating Factor and Platelet-rich Plasma Group in Patients With Recurrent Implantation Failure
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Infertility,Female
Keywords: IVF
Platelet-rich plasma
Granulocyte colony-stimulating factor
Recurrent implantation failure
Lead sponsor: Riyadh Fertility and Reproductive Health center
Sponsor class: OTHER
First posted: 2020-06-02
Enrollment: 112
Sex: FEMALE
Minimum age (years): 1
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this randomized controlled trial is to determine whether granulocyte colony-stimulating factor and platelet-rich plasma can be used to enhance the IVF-ET outcomes in patients with recurrent implantation failure


Eligibility criteria: Inclusion Criteria:

• Patients with history of three or more unsuccessful IVF-ET cycles with at least 2 good quality embryos transferred

Exclusion Criteria:

* Endometriosis
* Uterine anomalies
* Asherman syndrome

Primary outcomes:
measure: Clinical pregnancy rate
timeFrame: Five weeks after embryo transfer
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Riyadh Fertility and Reproductive Health center
Study officials:
affiliation: Riyadh Fertility and Reproductive Health center
name: Usama M Fouda, Prof.
role: STUDY_CHAIR
References:
Clinical trial NCT01184612: Effects of Motivational Interviewing in Prison
Official title: Motivational Interviewing Delivered by Existing Prison Staff: A Randomized Controlled Study of Effectiveness on Substance Use After Release
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Alcohol Abuse
Keywords: Inmates with heavy use of alcohol or drugs
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: the research committee of the National Prison and Probation Administration
First posted: 2010-08-19
Enrollment: 296
Sex: MALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: Motivational Interviewing (MI) is a communication style demonstrated to decrease drug and alcohol use. A five session MI intervention (BSF) was implemented in the Swedish correctional system. The intervention was delivered by counsellors with workshop only MI training (BSF) or by counsellors with workshop MI training followed by peer group supervision based on audio taped feedback (BSF+).

Aim was to examine whether BSF in prisons reduces drug and alcohol use more effectively than interviews conducted according to the usual planning interview routine (UPI).


Eligibility criteria: Inclusion Criteria:

* Born between 01-01-1954 and 31-12-1984;
* Conditional release no later than 30-06-2005 (this was extended to 19-09-2005 and again to 31-03-2006);
* Swedish or Norwegian speaker;
* Not having previously received BSF in remand or any other prison;
* Heavy use of alcohol or drugs, measured by the standard prison and probation system: 1= occasional use; 2= heavy use;
* ASI interview at intake;
* No order for deportation after release from prison

Exclusion Criteria:

-

Primary outcomes:
measure: number of days with substance use
timeFrame: of the last 30 days
Secondary outcomes:
measure: reported days of illegal activity
timeFrame: during the preceding 30 days
measure: number of days working
timeFrame: during the last 30 days
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska Institutet, Dep Clin Neuroscience
Study officials:
affiliation: Karolinska Institutet
name: Lars G Forsberg, Ph D
role: PRINCIPAL_INVESTIGATOR
References: