louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01780519: The Cognitive Effects of Lorazepam in Healthy Older Individuals With TOMM40 Variable-length Polymorphisms
Official title: The Cognitive Effects of Lorazepam in Healthy Older Individuals With TOMM40 Variable-length Polymorphisms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Alzheimer's Disease (AD)
Keywords: Alzheimer's disease (AD)
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2013-01-31
Enrollment: 57
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The investigators' goal is to determine if certain tests of memory and attention, performed while sleepiness is induced by a single dose of lorazepam, can predict whether or not an individual is at risk for developing Alzheimer's disease.


Eligibility criteria: Inclusion criteria:

* Mini-Mental State Examination (MMSE) score of 28-30
* Hamilton Depression Rating Scale score of less than 10
* participants in longitudinal study of aging and have a TOMM40 genotype of S/S, VL/VL, S/VL, L/S or L/VL.

Exclusion criteria:

* Alzheimer's Disease or Mild Cognitive Impairment
* any significant medical, psychiatric, and neurological illnesses, e.g., impaired liver or kidney function, prior stroke, traumatic brain injury, memory impairment, cognitive impairment, parkinsonism, a lifetime history of schizophrenia, bipolar disorder, a psychoactive substance use disorder, or current major depression.
* known allergy to benzodiazepines
* current use (within the previous four weeks) of benzodiazepines or other medications known to interact with lorazepam, current use of sedating antihistamines, or current use of stimulant medications

Primary outcomes:
measure: Groton Maze Learning Test (GMLT) score
timeFrame: baseline to 5 hours
Secondary outcomes:
measure: Auditory Verbal Learning Test (AVLT) Long-term memory score
timeFrame: baseline to 5 hours
measure: Two Back Test (TBK)
timeFrame: baseline to 5 hours
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic
state: Arizona
Study officials:
affiliation: Mayo Clinic
name: Cynthia Stonnington, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01948219: ENTegral Artificial Larynx Clinical Trial
Official title: An Evaluation of the ENTegral Artificial Larynx (AL) in Patients Indicated for Total Laryngectomy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Total Laryngectomy
Lead sponsor: ProTiP Medical
Sponsor class: INDUSTRY
First posted: 2013-09-23
Enrollment: 2
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 objective of this clinical study is to evaluate the feasibility, safety and efficacy of the ENTegral Artificial Larynx (AL) in patients indicated for total laryngectomy.


Eligibility criteria: Inclusion Criteria:

* Age more than or equal to 18 years old
* Is indicated for total laryngectomy (first intention)
* Must be able to comply with study requirements
* Must be able to understand and be willing to provide written informed consent

Exclusion Criteria:

* Any condition that precludes the implantation of the ENTegral AL
* Existing coagulation disorder
* Contraindication for general anesthesia
* Tumoral extension outside of the larynx invading through extra-laryngeal structures
* Previous radiotherapy
* Life-expectancy \< 12 months
* Be pregnant of breastfeeding or intention to becoming pregnant during study

Primary outcomes:
measure: Feasibility of device implant procedure
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
measure: Quality of life
timeFrame: 1, 3, 6 months and 1 year
measure: Number of patients with adverse events
timeFrame: 1 year
measure: Dyspnea evolution
timeFrame: 1,2,3,6,9 months and 1 year
measure: Phonation evolution
timeFrame: 1,2,3,6,9 months and 1 year
measure: Implant use
timeFrame: 1,2,3,6,9 months and 1 year
Locations:
city: Yvoir
country: Belgium
facility: CHU Mont-Godinne
city: Strasbourg
country: France
facility: CHU Strasbourg
city: Toulouse
country: France
facility: CHU Toulouse
Study officials:
References:
Clinical trial NCT05754619: Emotions in the Communication and Relationship Styles of Parents With Hemophilic Children.
Official title: Le Emozioni Negli Stili di Comunicazione e Relazione di Genitori Con Figli Emofilici.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hemophilia A
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2023-03-06
Enrollment: 10
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: the study includes 20 caregivers, parents of childrens (10-18 yo) with Haemophilia

Brief summary: Severe hemophilia is a rare, inherited, X-linked disorder. Currently, standard therapy involves ev infusion of drugs from a very young age.

The diagnosis of hemophilia is a traumatic event for the parents, even before the unborn child. The management of the hemophilia patient involves the whole family. Also in relation to its heredity.Focus on the ways in which parents of children with hemophilia manage their emotional experience.

Detailed description: Severe hemophilia is a rare, inherited, X-linked disorder. Currently, standard therapy involves ev infusion of drugs from a very young age.The diagnosis of hemophilia is a traumatic event for the parents, even before the unborn child. The management of the hemophilia patient involves the whole family. Also in relation to its heredity.Focus on the ways in which parents of children with hemophilia manage their emotional experience.he diagnosis of hemophilia brings with it, in parents, fears, guilt, overprotective temptations that push us to act rather than to narrate the meaning of that need of ours, caregiving modes that risk engaging our operational side at the expense of recognizing ourselves and our feelings and emotions. We have no reason to think that that traumatic stimulus installs in us an atypical mode of resorting to our emotional intelligence. Therefore, it becomes even more significant to study parent-child communication processes on this target, to observe whether and how the adult's emotional area finds its place and expression. On the results of this work, the foundations could be laid for subsequent observational or interventional studies.

Eligibility criteria: Inclusion Criteria:

* Haemophilia A

Exclusion Criteria:

* No Informed Conset

Primary outcomes:
measure: The study aims to highlight the ways in which the caregivers of haemophiliac children and young people manage and express their emotional experience through interviews and reports
timeFrame: 1 month
Secondary outcomes:
measure: opportunity for mirroring the parents interviewed by which they construct participation in their child's life in the experience of illness with interview and questionnaire.
timeFrame: 3 months
Other outcomes:
Locations:
city: Roma
country: Italy
facility: FPG
Study officials:
affiliation: Fondazione Policlinico Universitario A.Gemelli IRCCS Rome
name: Raimondo De Cristofaro, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06520319: Head-to-head Study of 68Ga-MGS5 Versus 68Ga-DOTATATE PET/CT in Patients With Medullary Thyroid Carcinoma
Official title: Head-to-head Study of 68Ga-MGS5 Versus 68Ga-DOTATATE PET/CT in Patients With Medullary Thyroid Carcinoma: a Prospective Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Medullary Thyroid Carcinoma
Lead sponsor: First Affiliated Hospital of Fujian Medical University
Sponsor class: OTHER
First posted: 2024-07-25
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Cholecystokinin-2 (CCK2) receptor is overexpressed in more than 90% of MTC cases, and preclinical studies have shown that 68Ga-MGS5 (targeting CCK2) has good stability in vivo and is promising for diagnosis and staging of MTC. This prospective study will compare the diagnostic effects of 68Ga-MGS5 and 68Ga-DOTATATE on MTC primary foci, lymph node metastasis, and distant metastasis, and explore the effect of 68Ga-MGS5 PET/CT on the clinical staging (TNM staging) of MTC.

Detailed description: This study was planned to enroll 20 patients with suspected MTC and MTC recurrence who attended the First Hospital of Fujian Medical University from June 2023 onwards. Each patient completed PET/CT examination within 1 week, one 68Ga-DOTATATE PET/CT whole-body examination and two 68Ga-MGS5 PET/CT whole-body examinations (1 hour and 2 hours after injection, respectively). CCK2 immunohistochemical staining and expression scoring of primary foci and lymph node metastases were also performed.

Eligibility criteria: Inclusion Criteria:

* Patients of either gender, aged ≥ 18 years and ≤80 years.
* Patients with pathologic findings confirming the diagnosis of MTC
* Patients with MTC recurrence
* Signed written consent

Exclusion Criteria:

* Pregnant or breastfeeding female patients
* Patients with claustrophobic behavior
* The inability or unwillingness of the research participant, parent or legal representative to provide written informed consent

Primary outcomes:
measure: SUVmax and SUVpeak
timeFrame: through study completion, an average of 2 years
Secondary outcomes:
measure: immunohistochemistry
timeFrame: through study completion, an average of 2 years
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University
state: Fujian
Study officials:
affiliation: First Affiliated Hospital of Fujian Medical University
name: Weibing Miao
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04821219: Personalized Management of Pancreatic Adenocarcinoma Using Patient-Derived Tumoroids
Official title: Establishing a Platform for Personalized Approach to the Management of Pancreatic Adenocarcinoma Using Patient-Derived Tumoroids
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Pancreas Adenocarcinoma
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2021-03-29
Enrollment: 0
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: This study is designed to prospectively investigate the feasibility of establishing patient-derived tumoroids (PDT) as a platform for a personalized approach for response prediction and guide optimal neoadjuvant and/or adjuvant approach. PDT will be investigated to determine drug sensitivity, predict the response to chemotherapy agents and radiation therapy, and validate this response in treated patients, and to establish the feasibility of PDT as a platform for a personalized approach to guide multimodality treatment.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years of age.
* Have an ECOG Performance Status of ≤ 2.
* No evidence of distant metastasis on imaging.
* Histologic or cytologic proven adenocarcinoma of the pancreas.
* Providing informed consent prior to enrollment in the trial.

Exclusion Criteria:

* Failure to obtain additional core needle biopsies for generating PDTs.
* Females who are pregnant or plan to become pregnant.

Primary outcomes:
measure: Rate of the successful establishment of pancreatic patient-derived tumoroids (PDT)
timeFrame: 2 years
Secondary outcomes:
measure: Drug sensitivity and response prediction of chemotherapy agents in PDT
timeFrame: 2 years
measure: Drug sensitivity and response prediction of radiation therapy in PDT
timeFrame: 2 years
measure: PDT validation with a comparative analysis of patients' response to neoadjuvant chemotherapy and radiation
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
affiliation: Mayo Clinic
name: Panagiotis Anastasiadis, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03581019: Uterus Transplantation From Deceased Donor - Gothenburg III
Official title: Uterus Transplantation From Deceased Donor - Gothenburg III
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Absolute Uterine Factor Infertility
Transplantation
Mrk Anomaly
Keywords: infertility, uterus, transplantation, MRKH
Lead sponsor: Sahlgrenska University Hospital
Sponsor class: OTHER
First posted: 2018-07-10
Enrollment: 1
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Observational study
Primary purpose: TREATMENT

Brief summary: Deceased donor uterus transplantation will be offered to patients that have either been excluded from Gothenburg II because of donor criteria or because of early graft failure in Gothenburg I and II


Eligibility criteria: Inclusion criteria recipient

* initially included with IVF and excluded by donor issues of Gothenburg I or II
* initially included and excluded by early graft failure of Gothenburg I or II
* age \< 40 years
* no systemic disease
* no standing medication
* satisfactory ovarian reserve
* BMI \<35 and at BMI 30-35 waist circumference of \< 82 cm
* absolute uterine factor infertility
* psychological stable

Inclusion criteria donor

* brain death and suitable as multiorgan donor
* acceptance for donation of uterus from family or previously by patient
* age \<55 years
* at least one normal pregnancy and childbirth
* no previos malignancy
* no systemic disease
* no previous major surgery inn abdomen or on uterus

Primary outcomes:
measure: birth of healthy child
timeFrame: 1-5 years after transplantation
Secondary outcomes:
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital
city: Göteborg
country: Sweden
facility: Mats Brännström
Study officials:
affiliation: Göteborg University
name: Mats Brännström
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00421018: Optimization of Asthma Treatment Through Exhaled NO for Increased Asthma-Related Quality of Life (NOAK)
Official title: Optimization of the Anti-Inflammatory Treatment of Asthma Patients Through Exhaled NO Measurements for Increased Asthma-Related Quality of Life in Primary Health Care (NOAK)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Allergic Asthma
Keywords: Asthma
Allergy
Cytokines
Glucocorticoids
Inflammation
Nitric Oxide (NO)
Quality of Life
Self-Rated Health
Stress
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Region Stockholm
name: Aerocrine AB
name: Phadia AB
name: Meda AB
name: The Swedish Research Council
name: Swedish Council for Working Life and Social Research
name: Merck Sharp & Dohme LLC
name: Uppsala University
First posted: 2007-01-11
Enrollment: 187
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether use of exhaled NO (nitric oxide) to regulate the anti-inflammatory treatment leads to increased asthma-related quality of life in patients with allergic asthma


Eligibility criteria: Inclusion Criteria:

* Age 18-64
* Clinical diagnosis of Asthma
* Glucocorticoid treatment \> 6 months.
* Verified Allergy
* Read and speak Swedish

Exclusion Criteria:

* Smoking
* Current regular treatment with long-acting beta2-agonist
* Treatment with Singulair only or in combination with glucocorticoids
* Taking part in other research study
* Pregnancy or breast-feeding
* Unstable Asthma

Primary outcomes:
measure: Mini-AQLQ (Asthma-Related Quality of Life)
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Upplands Väsby
country: Sweden
facility: Runby Primary Health Care Center
Study officials:
affiliation: Uppsala University
name: Kjell Alving, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00150618: Safety and Efficacy of SPD503 in Treating ADHD in Children and Adolescents Aged 6-17
Official title: A Phase III, Randomized, Double-Blind, Multi-Center, Parallel-Group, Placebo-Controlled Safety and Efficacy Study of SPD503 in Children and Adolescents Aged 6-17 With Attention Deficit Hyperactivity Disorder (ADHD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Attention Deficit Disorder With Hyperactivity
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2005-09-08
Enrollment: 324
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the efficacy of SPD503 compared to placebo in the treatment of children and adolescents aged 6-17 with ADHD.


Eligibility criteria: Inclusion Criteria:

* Subjects with a primary diagnosis of ADHD
* Females of childbearing potential must have a negative serum beta human chorionic gonadotropin (HCG) pregnancy test
* Male or non-pregnant female subject who agrees to comply with any applicable contraceptive requirements

Exclusion Criteria:

* Subject has a current, uncontrolled, comorbid psychiatric diagnosis with significant symptoms such as severe comorbid Axis II disorders or severe Axis I disorders
* Subject weighs less than 55 lbs or is morbidly overweight with a BMI =\> 35
* Subject has a history of seizure during the last 2 years or a serious tic disorder, including Tourette's Disorder
* Subject is pregnant or lactating

Primary outcomes:
measure: Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS-IV) Score at 6 Weeks
timeFrame: Baseline and 6 weeks
Secondary outcomes:
measure: Change From Baseline in Conner's Parent Rating Scale-revised Short Version (CPRS-R) Score at 6 Weeks
timeFrame: Baseline and 6 weeks
measure: Number of Participants With Improvement in Clinical Global Impression-Improvement (CGI-I)
timeFrame: 6 weeks
measure: Number of Participants With Improvement in Parent Global Assessment (PGA)
timeFrame: 6 weeks
measure: Change From Baseline in Child Health Questionnaire-Parent Form (CHQ-PF50) Score at 6 Weeks
timeFrame: Baseline and 6 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References:
citation: Sallee FR, McGough J, Wigal T, Donahue J, Lyne A, Biederman J; SPD503 STUDY GROUP. Guanfacine extended release in children and adolescents with attention-deficit/hyperactivity disorder: a placebo-controlled trial. J Am Acad Child Adolesc Psychiatry. 2009 Feb;48(2):155-65. doi: 10.1097/CHI.0b013e318191769e.
Clinical trial NCT06586918: Perfusion Index Parameter
Official title: Verification of a Perfusion Index Parameter in Adult Volunteers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Perfusion; Complications
Lead sponsor: Medtronic - MITG
Sponsor class: INDUSTRY
First posted: 2024-09-19
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy Male or Female volunteers age ≥18 years, weighing greater than 40kgs.

Brief summary: To evaluate the association between the Perfusion index parameter and an independent measure of perfusion.

Detailed description: Perfusion index parameters measured with an Investigational Pulse Oximetry PCBA, paired with Market Released sensors, will be compared to perfusion levels measured by a FDA-cleared device equipped with a laser Doppler technology-based device for blood perfusion measurements. Continuous Perfusion index measurements will be taken during the test sequence.

Eligibility criteria: Inclusion Criteria:

1. Subjects ≥18 years of age
2. Subject is able to participate for the duration of the study
3. Subject is willing to sign an informed consent
4. Subject weighs \>40kg

Exclusion Criteria:

1. Previous injury or trauma to fingers or hands that may change blood flow or vascular supply and affect the ability to test sensors
2. Physiologic abnormalities that prevent proper application of pulse oximetry sensor
3. Severe contact allergies that cause a reaction to standard adhesive materials such as those found in medical sensors and electrodes.
4. Raynaud Syndrome
5. Repeated systolic blood pressure \> 140mmHg -

Primary outcomes:
measure: Perfusion Index (PI) correlation to doppler measurement
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Denver
country: United States
facility: Medtronic Clinical Physiology Lab
state: Colorado
Study officials:
affiliation: Medtronic Clinical Physiology Lab
name: Randall M Clark, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01007318: Safety and Efficacy Study of Single Port Laparoscopic Appendectomy in Acute Appendicitis
Official title: Prospective, Randomized Study of Single Port and Conventional Laparoscopic Appendectomy in Acute Appendicitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Appendicitis
Lead sponsor: Kyunghee University Medical Center
Sponsor class: OTHER
Collaborators: name: KyungHee University School of Medicine, Korea
First posted: 2009-11-04
Enrollment: 194
Sex: ALL
Minimum age (years): 7
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to investigate the safety and efficacy of single port laparoscopic appendectomy compared with conventional laparoscopic appendectomy in adults with acute appendicitis.

Detailed description: Laparoscopic appendectomy improved the postoperative functional outcomes in the treatment of acute appendectomy. In addition, recently single port laparoscopic surgery was introduced in the laparoscopy-dedicated center. When compared with conventional 3 port laparoscopic appendectomy, single port laparoscopic appendectomy was expected to be less painful, more rapid recovery of bowel function, and better cosmetic. In this prospective randomized trial, we tried to investigate the superiority of this new technique in adult patients with acute appendectomy.

Eligibility criteria: Inclusion Criteria:

* Clinically diagnosed acute appendicitis

Exclusion Criteria:

* Age less than 7 or more than 75 years old
* Gangrenous appendicitis
* Combined generalized peritonitis
* ASA score more than 3 point
* Pregnant women
* Cases requiring draining tube

Primary outcomes:
measure: Safety
timeFrame: 1 month
Secondary outcomes:
measure: Efficacy
timeFrame: 1 day
measure: Efficacy
timeFrame: 2 days
measure: Efficacy
timeFrame: 2 days
measure: Efficacy
timeFrame: 7 days
measure: Efficacy
timeFrame: 7 days
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University School of Medicine, Neo Medical Center
Study officials:
affiliation: Kyung Hee University School of Medicine
name: Suk Hwan Lee, MD. PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kang BM, Choi SI, Kim BS, Lee SH. Single-port laparoscopic surgery in uncomplicated acute appendicitis: a randomized controlled trial. Surg Endosc. 2018 Jul;32(7):3131-3137. doi: 10.1007/s00464-018-6028-0. Epub 2018 Jan 16.