louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06682338: Psychological Impact of Armed Conflict on Sudanese Diabetic Patients 2024
Official title: Psychological Impact of Armed Conflict on Sudanese Diabetic Patients 2024
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psychological Impact of Armed Conflict
Diabetes Complications
Keywords: DASS-21
Sudan
Psychological
Armed conflict
Diabetics
Lead sponsor: Research and Publication office
Sponsor class: OTHER
First posted: 2024-11-12
Enrollment: 117
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Sudanese Diabetic Patients above 18 years old, of both genders, from Khartoum and Gezira states.

Brief summary: The study focused on Sudanese people with diabetes who experienced the ongoing war in Sudan. Some people were displaced and others were not. This would had an impact on their mental health. We have investigated this impact and any complications happened to them through Self-Administered questionnaire.


Eligibility criteria: Inclusion Criteria: Sudanese Diabetic Patients, both genders, above 18 years

-

Exclusion Criteria:

* Non Diabetic, pre-existing psychological disorder

Primary outcomes:
measure: Psychological Impact
timeFrame: April 2024 - July 2024
Secondary outcomes:
measure: Diabetes complications
timeFrame: April 2024 - July 2024
Other outcomes:
Locations:
city: Omdurman
country: Sudan
facility: Research and Publication Office, Dental Alumni and Students Affairs, Karary University
state: Khartoum
Study officials:
affiliation: Research and Publication Office, Dental Alumni and Students Affairs, Karary University
name: Alaa MAK Alshykh, BDS
role: STUDY_CHAIR
affiliation: Research and Publication Office, Dental Alumni and Students Affairs, Karary University
name: Mai AA Balal, BDS
role: STUDY_CHAIR
affiliation: International University of Africa / Omdurman Ahlia University
name: Mohamed HA Nasr, PhD
role: STUDY_DIRECTOR
affiliation: Federal Ministry of Health, Sudan
name: Afaf MH Jabir, BDS
role: STUDY_CHAIR
References:
Clinical trial NCT06072638: Mother-Baby Study - Eating in the Absence of Hunger (EAH)
Official title: Fundamental Biobehavioral Mechanisms Underlying the Integrated Development of Emotion, Attachment, and Nutritive Intake in the Mother-Infant Dyad
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Eating Behavior
Keywords: eating behavior
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2023-10-10
Enrollment: 120
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The study will test a model of biobehavioral mechanisms involved in the development of a system of emotion, attachment, and nutritive intake in the mother-infant dyad and the association of this system with maternal feeding behavior, child eating behavior, dietary intake, and adiposity.

To participate in this study the infant must also be enrolled in long-term observational study, NCT06039878.

Detailed description: This interventional task is done with children while they are in the long-term observational study, NCT06039878, at approximately ages 18 and 36 months. In the observational study there are 240 participants (120 mothers and 120 children). In this trial only data from the children is collected and therefore only 120 participants are listed.

Eligibility criteria: The child is a participant in the observational study (NCT06039878).

Primary outcomes:
measure: Kilocalories consumed
timeFrame: Up to approximately 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Julie Lumeng, MD
role: STUDY_CHAIR
References:
Clinical trial NCT03674138: Pharmacogenomic-Guided Antidepressant Drug Prescribing in Cancer Patients
Official title: Pharmacogenomic-Guided Antidepressant Drug Prescribing in Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Anxiety
Generalized Anxiety Disorder
Depressive Disorder
Major Depressive Disorder
Cancer
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
First posted: 2018-09-17
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: This is a prospective, randomized clinical trial to investigate the clinical impact of a preemptive pharmacogenomics strategy to guide antidepressant therapy in cancer patients. Those enrolled onto the clinical trial will be randomized to either DNA-guided choice of therapy or clinical management alone. Scores on self-reported measures of depressive and anxiety symptoms along with quality of life will be compared between cohorts.


Eligibility criteria: Inclusion Criteria:

* Patients with a cancer diagnosis
* Be 18 years of age or older
* Patients who rate depression or anxiety \> 5 based on a 10 point scale
* Patients expected to live greater than 6 months
* Serum bilirubin and creatinine \< 1.5x upper limit of normal
* AST and ALT \< 3 times upper limit of normal
* Willing and able to provide written informed consent
* Able to complete self-assessment questionnaires

Exclusion Criteria:

* Patients not diagnosed with cancer
* Antidepressant prescribing performed by a non-Moffitt psychiatrist after enrollment onto the clinical trial
* Known Pregnancy
* History of liver or allogenic stem cell transplant
* Patients with a known cognitive impairment (e.g., delirium, dementia, etc.) or psychological impairment (e.g., schizophrenia, bipolar disease, etc.) other than depressive and anxiety symptoms.

Primary outcomes:
measure: Change in depressive symptoms from baseline, as measured by the Hospital Anxiety and Depression Scale (HADS)
timeFrame: Baseline, week 12, month 12
measure: Change in anxious symptoms from baseline, as measured by the Hospital Anxiety and Depression Scale (HADS)
timeFrame: Baseline, week 12, month 12
Secondary outcomes:
measure: Quality of Life as measured by Functional Assessment of Cancer Therapy-General (FACT-G) Scale
timeFrame: 12 months
Other outcomes:
Locations:
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center and Research Institute
state: Florida
Study officials:
affiliation: H. Lee Moffitt Cancer Center and Research Institute
name: James K Hicks, PharmD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05594238: Leveraging Virtual Care Strategies to Improve Access and Treatment for Individuals With Alcohol Use Disorders
Official title: Leveraging Virtual Care Strategies to Improve Access and Treatment for Individuals With Alcohol Use Disorders (AUD)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alcohol Use Disorder
Keywords: Telehealth
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2022-10-26
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Participants are first randomly assigned to two interventions: either Telephone Engagement or Portal Engagement. Participants who do not meet the criteria for response at the post-test will be re-randomized into either enhanced first stage or a Telehealth MI-CBT program.
Primary purpose: TREATMENT

Brief summary: The purpose of this research study is to test new technology-driven programs to see if they might help people manage their health and health behaviors related to alcohol use and well-being. The programs focus on getting to know what's important to participants, reviewing or setting goals, and using different skills and behaviors to manage health. The study will help researchers learn about ways to deliver health information in a way that is useful and interesting.


Eligibility criteria: Inclusion Criteria:

* AUD
* past month heavy alcohol use
* internet access
* phone access
* able to provide informed consent

Exclusion Criteria:

* inability to speak or understand English
* conditions precluding informed consent or understanding of intervention or assessment content
* recent AUD treatment
* history of or at risk for complex alcohol withdrawal
* involvement in another ongoing study for alcohol/mental health/substance use treatment
* current cancer diagnosis/ currently receiving cancer treatment (other than skin cancers)
* PI discretion

Primary outcomes:
measure: AUD Treatment Initiation
timeFrame: 4-months post-enrollment
measure: AUD Treatment Engagement
timeFrame: 4-months post-enrollment
measure: Alcohol consumption days
timeFrame: 4-months post-enrollment
measure: Alcohol consumption days
timeFrame: 8-months post-enrollment
measure: Alcohol consumption days
timeFrame: 12-months post-enrollment
measure: Heavy drinking days
timeFrame: 4-months post-enrollment
measure: Heavy drinking days
timeFrame: 8-months post-enrollment
measure: Heavy drinking days
timeFrame: 12-months post-enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Erin E Bonar
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06327438: Effect of Complex Decongestive Therapy, Cryotherapy and Kinesio Taping in Patients With Post-mastectomy Lymphedema: A Randomized Control Trial
Official title: Complex Decongestive Therapy, Cryotherapy and Kinesio Taping in Patients With Post-mastectomy Lymphedema
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Neoplasms
Keywords: Complex Decongestive Therapy; Cryotherapy; Kinesio Taping; Lymphedema; Post-mastectomy
Lead sponsor: South Valley University
Sponsor class: OTHER
First posted: 2024-03-25
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized controlled study
Primary purpose: TREATMENT

Brief summary: To examine the efficacy of complex decongestive therapy (CDT), cryotherapy and kinesio taping (KT) in patients with post-mastectomy lymphedema

Detailed description: Sixty women diagnosed clinically by physician as post-mastectomy lymphedema, suffered from grade 2 and 3 lymphedema based on clinical investigations and their ages between 40 and 60 years were randomly assigned in single pre - post measurement study. They divided randomly into three groups of equal size (A, B \& C). The three groups received CDT program, group (A) (n=20) received CDT only, group (B) (n=20) received cryotherapy and group (C) (n=20) received KT

Eligibility criteria: Inclusion Criteria:

Patients aged between 40 to 60 years. They were grade 2 and 3 lymphedema. They had more than 2 cm difference at circumference measurement. They had unilateral arm lymphedema post-mastectomy. They had completed chemotherapy and radiotherapy.

Exclusion Criteria:

Skin infection. Current ischemia. Systemic edema due to impaired heart, kidney and liver function. Current metastases. Venous thrombosis.

Primary outcomes:
measure: Arm girth measurement is measured by Circumferential measurements
timeFrame: 12 consecutive weeks
measure: Pain severity is measured by VAS
timeFrame: 12 consecutive weeks
Secondary outcomes:
measure: The QOL is measured by SF-36
timeFrame: 12 consecutive weeks
measure: Range of motion (ROM) is measured by UG
timeFrame: 12 consecutive weeks
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Ragaee Saeed Mahmoud
state: Faisal
city: Faisal
country: Egypt
facility: Ragaee Saeed Mahmoud
state: Giza
Study officials:
References:
Clinical trial NCT04829838: Comparison of Efficacy of Phenytoin With Levetireacetam for the Management of Children With Status Epilepticus
Official title: Comparison of Efficacy of Phenytoin With Levetireacetam for the Management of Children With Status Epilepticus
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Status Epilepticus
Keywords: status epilepticus, children, phenytoin, levetireacetam
Lead sponsor: King Edward Medical University
Sponsor class: OTHER
Collaborators: name: King Edward Medical University
First posted: 2021-04-02
Enrollment: 244
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The purpose of studyis to compare the efficacy of phenytoin with levetiracetam for the management of children with status epilepticus.Study performa consists of demographic variables,exclusion criteria,history of epilepsy and efficacy achieved or not.

Detailed description: After getting informed consent 244 children with status epilepticus will be randomly classified into two groups.one group will receive levetireacetam and other group will be given phenytoin and their efficacy will be compared by observing them for breakthrough fits for next 48 hours.

Eligibility criteria: Inclusion Criteria:

* childen of age less than 12 years either gender admitted in pediatric emergency with status epilepticus

Exclusion Criteria:

* children already taking either of trial drug or failed treatment with either of trial drug.children with comorbid conditions

Primary outcomes:
measure: comparison of efficacy of levetireacetam with phenytoin for the management of children with status epilepticus
timeFrame: 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Ayesha Tariq
state: Punjab
Study officials:
affiliation: King Edward Medical University
name: Haroon Hamid, MBBS,FCPS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Smith DM, McGinnis EL, Walleigh DJ, Abend NS. Management of Status Epilepticus in Children. J Clin Med. 2016 Apr 13;5(4):47. doi: 10.3390/jcm5040047.
citation: Abend NS, Loddenkemper T. Pediatric status epilepticus management. Curr Opin Pediatr. 2014 Dec;26(6):668-74. doi: 10.1097/MOP.0000000000000154.
Clinical trial NCT00782938: The Role of Serum Anticholinergic Activity in ACVB Patients
Official title: Serum Anticholinergic Activity (SAA) and BIS-EEG as Potential Markers for Cognitive Ability and/or the Anticholinergic Medication in ACVB Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acetylcholine
Cognition
BIS-EEG
Lead sponsor: Heidelberg University
Sponsor class: OTHER
First posted: 2008-10-31
Enrollment: 100
Sex: ALL
Minimum age (years): 55
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: ACVB patients:

Ages Eligible for Study: 55 years to 90 years Genders Eligible for Study: Both Accepts Healthy Volunteers: No

Brief summary: Drugs with anticholinergic potential increase the risk of postoperative transient and persistent cognitive dysfunction especially in cardiac patients. The investigators main goal is to identify preoperative risk factors and to monitor postoperative patients' state in relation to SAA activity and bilateral BIS-EEG changes.


Eligibility criteria: Inclusion Criteria:

* written compliance to the study participation
* a good knowledge in German speech
* no red/ green blindness
* no previous neurological and/or psychiatric illness
* good ability to see and to hear
* Mini-Mental-State-Examination (MMSE) better than 25 points

Exclusion Criteria:

* no written compliance to the study participation
* bad knowledge in German speech
* red/ green blindness
* previous neurological and/or psychiatric illness
* no ability to see and to hear
* Mini-Mental-State-Examination (MMSE) lower than 25 points

Primary outcomes:
measure: Cognitive dysfunction measured by neurocognitive test battery
timeFrame: 3 month postsurgery
Secondary outcomes:
measure: SAA, BIS-EEG, descriptive patients' characteristics
timeFrame: 24 h postsurgery
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: University of Heidelberg, Department of Anesthesiology, Heidelberg Medical School
state: BW
Study officials:
affiliation: Department of Anesthesiology, University of Heidelberg
name: Eike Martin, Prof.
role: STUDY_CHAIR
References:
Clinical trial NCT04290338: Effects of PIOMI on Oral Feeding of the Premature Infants
Official title: Effects of the Premature Infant Oral Motor Intervention on the Oral Feeding Skills of the Premature Infants: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Feeding Disorder Neonatal
Lead sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Sponsor class: OTHER
First posted: 2020-02-28
Enrollment: 40
Sex: ALL
Minimum age (years): 25
Maximum age (years): 33
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: RCT characterized by the comparison between two groups (treated / untreated)
Primary purpose: SUPPORTIVE_CARE

Brief summary: Randomized controlled clinical trial aimed at evaluating the effects of the "Premature infant oral motor intervention" method on the oral feeding skills of the premature infants.

Detailed description: Numerous evidences emerge from the literature review on the usefulness of the PIOMI method to improve food skills in the premature infant. The goal of this study is to evaluate the effects of the PIOMI method by adding the gustatory stimulation to the original protocol.

Eligibility criteria: Inclusion Criteria:

* gestational age at birth between 25-33 weeks;
* clinical stability;
* possible presence of nasogastric or oro-gastric tube;
* non-invasive respiratory support (oxygen, high flows)

Exclusion Criteria:

* gestational age \<25 weeks or\> 33 weeks
* absence of clinical stability
* invasive respiratory support (CPAP)
* previous surgical interventions
* ongoing infections
* congenital and / or chromosomal diseases
* brain, metabolic, cardiac, gastrointestinal diseases
* presence of bronchopulmonary dysplasia

Primary outcomes:
measure: Mean volume
timeFrame: 7 days
Secondary outcomes:
measure: feeding efficiency
timeFrame: 3 days
measure: achievement of full oral feeding
timeFrame: 6 moths
measure: hospital stay time
timeFrame: 6 months
measure: transition time
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
name: Odoardo Picciolini
role: STUDY_DIRECTOR
References:
Clinical trial NCT04343638: Effect of Intraoperative Nociception Control Based on Analgesia Nociception Index (ANI) Monitoring on Stress Response During Total Laparoscopic Hysterectomy
Official title: Effect of Intraoperative Nociception Control Based on Analgesia Nociception Index (ANI) Monitoring on Stress Response During Total Laparoscopic Hysterectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patients Undergoing Total Laparoscopic Hysterectomy
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2020-04-13
Enrollment: 72
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The "Analgesia Nociception Index" (ANI; MetroDoloris Medical Systems, Lille, France), derived from an electrocardiogram (ECG) trace, has been proposed as a noninvasive guide to analgesia. The ANI monitor calculates HR variation with respiration, a response mediated primarily by changes in the parasympathetic nervous system (PNS) stimulation to the sinoatrial node of the heart. The aim of this study is to determine the relation between ANI monitor values and serum catecholamine levels. We will compare the serum catecholamine (norepinephrine, epinephrine) levels of conventional nociception control group and ANI-monitor guided nociception control group at the end of surgery.


Eligibility criteria: Inclusion Criteria:

1. patients undergoing total laparoscopic hysterectomy under general anesthesia (American society of anesthesiologists classification 1\~3)

Exclusion Criteria:

1. endometriosis
2. AP diameter of uterus \> 12cm
3. cognitive disorder
4. arrhythmia, pacemaker
5. chronic opioid use
6. diseases affecting autoimmune system (immune disease, diabetic neuropathy)
7. use of medications affecting ANI monitor (antimuscarinics, alpha-agonist, beta blocker)
8. illiteracy, foreigner

Primary outcomes:
measure: Serum catecholamine (norepinephrine, epinephrine) level at the end of surgery
timeFrame: at the end of surgery (skin closure)
Secondary outcomes:
measure: plasma inflammatory markers (IL-6, IL-10, HMGB1)
timeFrame: at the end of surgery (skin closure) and 1 hour after the end of surgery
measure: hormone level (cortisol, adrenocorticotropic hormone)
timeFrame: at the end of surgery (skin closure) and 1 hour after the end of surgery
measure: serum catecholamine (norepinephrine, epinephrine) level
timeFrame: 1 hour after the surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine, Severance Hospital
Study officials:
References: