louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01639586: Comparison for the Patient With Alzheimer Disease the Impact of Three Different Groups of Patient Care
Official title: Comparaison du Service Rendu à la Personne Atteinte d'Une Maladie d'Alzheimer et de l'Aidant Par Trois Types de Prises en Charge (Plateforme, Accueil de Jour et Groupe contrôle
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer Disease
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2012-07-12
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: One of the interests of the Alzheimer Plan 2008-2010 is to provide increase support to helping families. It's also of major to involve the patient in the most active treatment possible, encouraging social inter relationship as well as cognitive and behavioural stimulation activities.

In the frame of non drug related approaches to Alzheimer disease (AD), several research projects and actions have already been conducted, but no specific study concerning the efficiency of different types of respite care structures have been conducted so far in France. The present project concerns the thematic of the frame "Development and diversification of respite care structures".

A platform is defined in the Alzheimer Plan as a "diversified range of despite structures according to patients' needs and informal caregivers' expectations" providing several objectives:

Two objectives targeting the informal caregivers:

* offer spare time or tutored
* inform, support and accompany

Two objectives targeting the patients:

* encourage maintain of the patient social life and relationships and work together towards his/her psychological and emotional well-being
* contribute to improve functional cognitive and sensory capacities

The study COMPARSE suggests to compare for the patient - informal caregiver couple, the impact of three different groups of patient care on health profit; resit platform (P), the day care group (D), the control group without access to a respite structure (C).


Eligibility criteria: Inclusion criteria

* patient affect by Alzheimer disease or related pathology
* patient with an informal caregiver
* patient not using any respite structure
* signed informed consent (patient and informal caregiver)
* affiliate to social security

Exclusion criteria

* patient without informal caregiver
* patient include in another clinical protocol

Exclusion Criteria:

-

Primary outcomes:
measure: Analysis of the perceived and diagnosed health evolution of the patient
timeFrame: at baseline, one month and nine month
Secondary outcomes:
measure: Efficacity of the different structures
timeFrame: at baseline, one month and nine month
Other outcomes:
Locations:
city: Nice
country: France
facility: Le Duff
Study officials:
affiliation: Département de Santé Publique - CHU de Nice
name: Christian Pradier, PHD MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05282186: What the Nose Knows: Hedonic Capacity, Psychosocial Interventions and Outcomes in Schizophrenia
Official title: What the Nose Knows: Hedonic Capacity, Psychosocial Interventions and Outcomes in Schizophrenia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Schizophrenia
Keywords: olfaction
reward
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2022-03-16
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized cluster design with 19 service centers assigned to one of the two treatments.
Primary purpose: TREATMENT

Brief summary: This project proposes to conduct the first study of the predictive utility of olfactory hedonic measurement for targeted psychosocial rehabilitation in schizophrenia. The information gathered from the project is of considerable public health relevance, in that, through simple, reliable olfactory assessment, it will provide knowledge about which individuals are most likely to benefit from these psychosocial interventions. Such information is crucial for tailoring existing interventions and developing new approaches to optimize outcomes in schizophrenia.


Eligibility criteria: Inclusion Criteria:

1. age 18 to 65;
2. DSM-5 diagnosis of schizophrenia or schizoaffective or schizophreniform disorder

Exclusion Criteria:

1. the presence of a current organic brain syndrome;
2. a current and severe substance use disorder (DSM-5);
3. intellectual disability (DSM-5)

Primary outcomes:
measure: Change in Social Adjustment Scale II
timeFrame: Measurement at 0, 6, 12 months
measure: Change in Heinrich Quality of Life Scale
timeFrame: Measurement at 0, 6, 12 months
measure: Change in Social Skills Performance Assessment rating scale
timeFrame: Measurement at 0, 6, 12 months
Secondary outcomes:
measure: Change in NIH Toolbox® for Assessment of Neurological and Behavioral Function (NIH Toolbox)
timeFrame: Measurement at 0, 6, 12 months
measure: Change in Managing Emotions subscale of the Meyer-Salovey-Caruso Emotional Intelligence Test (MSCEIT)
timeFrame: Measurement at 0, 6, 12 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
References:
Clinical trial NCT02856386: Use of a Dietary Supplement to Support Digestive Health in Children With Chronic Diarrhea
Official title: Assessment of the Utility of a Dietary Supplement as an Adjunct to Standard of Care for Children With Chronic Diarrhea
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Antibiotic-associated Diarrhea
Lead sponsor: LiveLeaf Inc.
Sponsor class: INDUSTRY
First posted: 2016-08-04
Enrollment: 50
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Micronutrients missing in the diet may assist in supporting digestive health in children with chronic GI issues. This study will monitor changes in symptoms associated with digestive problems in children provided with a dietary supplement that will be taken in conjunction with the standard of care.

Detailed description: Children with GI symptoms have varying response to the standard of care treatments. A dietary supplement of polyphenols from green tea and pomegranate extracts provides micronutrients often missing from conventional American diets. The objective of this study is to monitor changes in GI symptoms when the supplement is provided alongside the standard of care for children with symptoms that have been present for more than two weeks.

Eligibility criteria: Inclusion Criteria:

* Out-patients with diagnosis of unresolved gastrointestinal distress
* Parent or guardian willing to administer the dietary supplement orally once daily for up to 21 days
* Parent or guardian willing to record changes in GI symptoms on a questionnaire
* Parent or guardian willing to bring the child for a clinic visit to close-out participation in the study

Exclusion Criteria:

* requires care in an ICU
* has documented intestinal stricture, stenosis, obstruction, or abscess
* has concomitant congenital diseases
* are immunodeficient
* has malformation of the GI tract
* is unable to swallow fluids
* parent or guardian is unable or unwilling to provide informed consent

Primary outcomes:
measure: Time to resolution of GI symptoms
timeFrame: 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02857686: Forearm Tourniquet With Small Dose Intravenous Lidocaine
Official title: Forearm Tourniquet With Small Dose Intravenous Lidocaine as a Substitute to Conventional Intravenous Regional Anaesthesia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Local Anaesthesia
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2016-08-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The safety and effectiveness of the "mini-dose" Bier block, a technique of i.v. regional anesthesia using low-dose lidocaine (1.5 mg/kg) without routine premedication, was evaluated in the emergency department treatment of pediatric upper extremity fractures and dislocations.

Detailed description: this study aimed at comparing IVRA with small dose lidocaine and forearm tourniquet with conventional IVRA with arm tourniquet and usual lidocaine dose

Eligibility criteria: Inclusion Criteria:

* ASA(American society of anesthesia) I, II , consent, forearm or arm surgery

Exclusion Criteria:

* ASA(American society of anesthesia) III or more, allergy, refusal

Primary outcomes:
measure: pain
timeFrame: 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
state: Giza
Study officials:
References:
Clinical trial NCT03638986: Comparison of the Two Validated German Versions of the "Tinnitus Functional Index" for Switzerland and for Germany
Official title: Prospektive Studie Zum Vergleich Der Beiden Validierten Deutschen Versionen Des "Tinnitus Functional Index" für Die Schweiz Und für Deutschland
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tinnitus, Subjective
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2018-08-20
Enrollment: 255
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with tinnitus

Brief summary: Tinnitus is defined as a perception of sound without any external sound source. Chronic tinnitus is a frequent condition that can affect the quality of life. The questionnaire "Tinnitus Functional Index (TFI)" promises to be the new gold standard in tinnitus evaluation. Due to the forward and backward translation of this questionnaire, there are two different German versions of TFI for Switzerland and Germany. Both German versions were validated. The aim of this study is to compare the two German versions of the TFI with each other and to recommend the better one for the further use in tinnitus evaluation for the German speaking population.


Eligibility criteria: Inclusion Criteria:

* Electronic given informed consent
* Older than 18 years
* Existing tinnitus
* Sufficient knowledge of the German language

Exclusion Criteria:

* Insufficient knowledge of the German language
* Impossibility to fulfill an online questionnaire due to cognitive or physical limitation
* No tinnitus
* Younger than 18 years

Primary outcomes:
measure: Comparison of the TFI sumscore of both German versions
timeFrame: 20 minutes
Secondary outcomes:
measure: Factor analysis of the two German TFI versions
timeFrame: 20 minutes
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Universitätsmedizin Berlin, Tinnituszentrum der Charité
city: Zürich
country: Switzerland
facility: University Hospital Zurich
state: Zurich
Study officials:
affiliation: Universityhospital Zurich, ENT Department
name: Nicole Peter, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Meikle MB, Henry JA, Griest SE, Stewart BJ, Abrams HB, McArdle R, Myers PJ, Newman CW, Sandridge S, Turk DC, Folmer RL, Frederick EJ, House JW, Jacobson GP, Kinney SE, Martin WH, Nagler SM, Reich GE, Searchfield G, Sweetow R, Vernon JA. The tinnitus functional index: development of a new clinical measure for chronic, intrusive tinnitus. Ear Hear. 2012 Mar-Apr;33(2):153-76. doi: 10.1097/AUD.0b013e31822f67c0.
citation: Peter N, Kleinjung T, Jeker R, Meyer M, Klaghofer R, Weidt S. Tinnitus functional index: validation of the German version for Switzerland. Health Qual Life Outcomes. 2017 May 5;15(1):94. doi: 10.1186/s12955-017-0669-x.
citation: Bruggemann P, Szczepek AJ, Kleinjung T, Ojo M, Mazurek B. [Validation of the German Version of Tinnitus Functional Index (TFI)]. Laryngorhinootologie. 2017 Sep;96(9):615-619. doi: 10.1055/s-0042-122342. Epub 2017 May 12. German.
Clinical trial NCT04673786: A Study to Compare the Efficacy and Safety of CT-P43 to Stelara in Patients With Plaque Psoriasis
Official title: A Randomized, Active-Controlled, Double-Blind, Phase 3 Study to Compare the Efficacy and Safety of CT-P43 to Stelara in Patients With Moderate to Severe Plaque Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Psoriasis
Lead sponsor: Celltrion
Sponsor class: INDUSTRY
First posted: 2020-12-17
Enrollment: 509
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: This study is a randomized, active-controlled, double-blind, phase 3 study to compare the efficacy and safety of CT-P43 to Stelara in patients with moderate to severe plaque psoriasis.

Detailed description: CT-P43, containing the active ingredient ustekinumab, is a human IgG1κ monoclonal antibody that is being developed as a biosimilar medicinal product to the reference product, Stelara. The purpose of this study is to demonstrate similar efficacy and safety of CT-P43 and Stelara in patients with moderate to severe plaque psoriasis.

Eligibility criteria: Inclusion Criteria:

- Patient has had diagnosis of plaque-type psoriasis for at least 24 weeks.

Exclusion Criteria:

* Patients diagnosed with forms of psoriasis other than plaque-type.
* Patients previously received ustekinumab or a biosimilar of ustekinumab.
* Patient who has allergies to the active substance or any of the excipients of ustekinumab or study drug, or patients with a hypersensitivity to immunoglobulin products or natural rubber and latex.

Primary outcomes:
measure: The Mean Percent Improvement From Baseline in PASI Score at Week 12
timeFrame: From baseline to Week 12
Secondary outcomes:
measure: The PASI Scores at Week 12
timeFrame: Week 12
measure: The Mean Percent Improvement From Baseline in PASI Score Through Week 52
timeFrame: Through Week 52
measure: The Number of Patients Achieving PASI 50, PASI 75, PASI 90, and PASI 100 Responses at Week 12
timeFrame: Week 12
measure: The Number of Patients With sPGA Score of Clear (0) or Almost Clear (1) at Week 12
timeFrame: Week 12
measure: The Change From Baseline in Dermatology Life Quality Index (DLQI) Through Week 52
timeFrame: Through Week 52
Other outcomes:
Locations:
city: Tartu
country: Estonia
facility: Clinical Research Centre
state: Tartu Country, Estonia
Study officials:
References:
Clinical trial NCT01865786: A Prospective, Observational Study of Pregnancy Outcomes Among Women Exposed to Truvada for PrEP Indication
Official title: A Prospective, Observational Study of Pregnancy Outcomes Among Women Exposed to Truvada for PrEP Indication Nested in the Antiretroviral Pregnancy Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infection
Keywords: FTC/TDF
Truvada
PrEP
Antiretroviral Pregnancy Registry
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2013-05-31
Enrollment: 99
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Number of Subjects and Subject Selection: 400 HIV-1 uninfected women who are exposed to FTC/TDF for PrEP during pregnancy stratified into 200 who decide to continue and 200 who choose to discontinue FTC/TDF for PrEP. A propensity score-matched comparison group of equal size (400 women) of HIV-positive pregnant women taking antiretrovirals.

All evaluable subjects enrolled into the APR who fulfill the inclusion criteria for the target cohort will be selected. Every year at the time of building the annual report for this study, a propensity score matched comparison group will be selected on a 1:1 ratio among all pregnant women on antiretrovirals.

Brief summary: This is a prospective, observational study to describe pregnancy outcomes among HIV-1 uninfected pregnant women who are taking emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) (Truvada®) for a pre-exposure prophylaxis (PrEP) indication nested in the Antiretroviral Pregnancy Registry (APR).

Information on subjects is provided to the APR prospectively (prior to the outcome of the pregnancy being known) through their healthcare provider, with follow-up obtained from the healthcare provider following determination of the pregnancy outcome.


Eligibility criteria: Key Inclusion Criteria:

* Pregnant women
* Part of the prospective arm of the APR Target Group Inclusion Criteria
* HIV-1 Negative
* Choosing to remain on FTC/TDF for PrEP during pregnancy or,
* Choosing to discontinue FTC/TDF for PrEP during pregnancy Comparison Group Inclusion Criteria
* HIV-1 Positive
* On antiretroviral therapy

Key Exclusion Criteria:

* This is an observational nested study and will monitor all reported exposures without intervention/exclusion.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Primary outcomes:
measure: Presence or absence of congenital malformations among infants born to HIV-1 uninfected women on FTC/TDF for PrEP
timeFrame: Year 1
Secondary outcomes:
measure: Pregnancy outcomes in HIV-1 uninfected women who choose to continue or discontinue FTC/TDF for PrEP during their pregnancy as well as HIV-infected women treated with antiretrovirals
timeFrame: Years 1, 2, and 3
Other outcomes:
Locations:
city: Wilmington
country: United States
facility: Antiretroviral Pregnancy Registry
state: North Carolina
Study officials:
affiliation: Gilead Sciences
name: Gilead Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT03971786: Sperm Parameters and Sexual Quality of Life
Official title: Sperm Parameters and Sexual Quality of Life
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Men Infertility
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2019-06-03
Enrollment: 400
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Infertility has important repercussions for couples in their emotional and sexual lives; the same is true of Assisted Procreation, which has an impact on the daily life of couples and a cost to society. Thus, fertility disorders are frequently associated with sexual dysfunction in both women and men (Khademi et al., 2008). In couples with male infertility, men have higher sexual dysfunction scores than couples with infertility without male aetiology (Smith et al., 2009).

To study the evolution of the sexual quality of life of infertile men before and after knowing their spermatic parameters


Eligibility criteria: Inclusion Criteria:

* Male patient presenting infertility status

Exclusion Criteria:

* none

Primary outcomes:
measure: Variability of quality of life scoring with Male Sexual Health scale
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Assistance Publique Hopitaux De Marseille
name: Emilie Garrido
role: STUDY_DIRECTOR
References:
Clinical trial NCT06587386: The Minimum Effective Dose (ED90) of Liposomal Bupivacaine for Preserving Motor Function
Official title: The Minimum Effective Dose (ED90) of Liposomal Bupivacaine for Preserving Motor Function After Interscalene Brachial Plexus Block: a Dose-finding Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Motion Sickness
Keywords: Shoulder surgery
Intermuscular sulcus brachial plexus block
Bupivacaine liposome
Effective dose
Lead sponsor: Affiliated Hospital of Jiaxing University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 54
Sex: ALL
Minimum age (years): 41
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: DIAGNOSTIC

Brief summary: Explore the minimum effective dose of liposomal bupivacaine for preserving motor function

Detailed description: Our research group plans to conduct a dose exploration experiment, using a biased coin design sequential method to explore the 90% minimum effective dose of bupivacaine liposomes for preserving motor function after intermuscular groove brachial plexus block surgery in shoulder arthroscopy.

Eligibility criteria: Inclusion Criteria:

Age 41-65 years ASA physical condition 1-3 BMI 18-30 kg/m2 undergoing arthroscopic shoulder surgery

Exclusion Criteria:

Inability to consent to the study pregnancy allergy to local anesthetics preexisting neuropathy cervical pathologies (i.e., herniated disc, myelopathy) chronic pain syndromes (defined as reflex sympathetic dystrophy or complex regional pain syndrome) severe respiratory conditions psychiatric or cognitive disorders that prohibit patients from adhering to the study protocol history of drug or alcohol abuse chronic opioid use (longer than 3 months or daily morphine equivalents more than 5mg/day for 1 month) contraindication for general anesthesia and/or interscalene nerve block and planned open shoulder arthrotomies Muscle related diseases

Primary outcomes:
measure: MD90 of motor function was preserved 72 hours after brachial plexus block
timeFrame: 72 hours after brachial plexus block
Secondary outcomes:
Other outcomes:
Locations:
city: Jiaxing
country: China
facility: Affiliated Hospital of Jiaxing University
Study officials:
affiliation: Affiliated Hospital of Jiaxing University
name: Qinghe Zhou
role: STUDY_CHAIR
References: