louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01473069: Two Week Study Evaluating Safety, Tolerability and Pharmacokinetics of Multiple Doses of JTK-853 in Healthy Subjects
Official title: A Phase 1, Randomized, Double-blind, Placebo-controlled Study Evaluating the Safety,Tolerability and Pharmacokinetics of Multiple Ascending Doses of JTK-853 Administered for Two Weeks in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Healthy
Keywords: JTK-853
Healthy subjects
Lead sponsor: Akros Pharma Inc.
Sponsor class: INDUSTRY
First posted: 2011-11-17
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to determine the safety, tolerability and pharmacokinetics of sequential ascending doses of JTK-853 administered for 14 days in healthy subjects and also to determine the effect of a single dose of ketoconazole on the steady-state pharmacokinetic profile of JTK-853 and its metabolite M2 (one cohort only).


Eligibility criteria: Inclusion Criteria:

1. Body Mass Index (BMI) ≥18.0 kg/m2 and ≤30.0 kg/m2
2. Non-smokers or subjects who have stopped smoking at least 6 months prior to the Screening Visit
3. Female subjects must be either surgically sterile or postmenopausal

Exclusion Criteria:

1. History or presence of cardiac disease, including a family history of long-QT syndrome or unexplained sudden death
2. Have used any prescription medication, herbal product, or over-the-counter (OTC) medication (except acetaminophen) within four weeks prior to Day -1

Primary outcomes:
measure: Number of subjects with adverse events
timeFrame: 3 weeks
Secondary outcomes:
measure: Maximum concentration (Cmax) of JTK-853 and metabolite M2
timeFrame: 3 weeks
measure: Time to reach peak or maximum concentration (tmax) for JTK-853 and metabolite M2
timeFrame: 3 weeks
measure: Area under the concentration-time curve during the dosing interval (AUCtau) for JTK-853 and metabolite M2
timeFrame: 3 weeks
measure: Elimination half-life associated with the terminal slope (λz) of a semilogarithmic concentration-time curve (t1/2) for JTK-853 and metabolite M2
timeFrame: 3 weeks
measure: Maximum concentration (Cmax) of JTK-853 and metabolite M2 after Ketoconazole administration
timeFrame: 3 weeks
measure: Area under the concentration-time curve during the dosing interval (AUCtau) for JTK-853 and metabolite M2 after ketoconazole administration
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Austin
country: United States
facility: PPD Phase I Clinic
state: Texas
Study officials:
affiliation: Akros Pharma Inc.
name: Shoji Hoshino, D.V.M
role: STUDY_DIRECTOR
References:
Clinical trial NCT02281669: Prospective Observational Study of Intralesional Treatment With Pentostam in Cutaneous Leishmaniasis Israeli Patients
Official title: Prospective Observational Study of Intralesional Treatment With Pentostam in Cutaneous Leishmaniasis Israeli Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cutaneous Leishmaniasis
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2014-11-02
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients arriving to the Geographic clinic or to the Skin clinic, diagnosed with Cutaneous leishmaniasis, and the treatment which is choosen by their physican is Pentostam injections.

Brief summary: Cutaneous leishmaniasis (CL) is endemic in Israel and is caused by Leishmania major or Leishmania tropica. CL is usually a benign disease and limited to the skin. One of the local treatment available is intralesional (IL) Pentostam injection. During the current study the investigators will monitor the adverse effects of this treatment and will follow up the recovery of the lesions after Pentostam injections.

Detailed description: Cutaneous leishmaniasis is usually treated by topical intervention. In more severe cases intralesional Pentostam injection may be applied. This treatment is extremely efficient but painful, however without the known adverse effects of IV Pentostam treatment.

In this study the investigators will follow systematically all leishmania patients who are receiving the intralesional treatment. A structured questionnaire will be filled up in each doctor visit.

The current study goal is to examine the adverse effects and the patient reaction to this treatment, and to follow the recovery of lesion(s) after this treatment including the number of IL injections which was needed.

Eligibility criteria: Inclusion Criteria:

* Cutaneous leishmaniasis patients
* Treatment by IL Pentostam
* Age above 18 years

Exclusion Criteria:

* Children and pregnant women will not participate in the study

Primary outcomes:
measure: Adverse effects
timeFrame: 1 year
Secondary outcomes:
measure: Lesion healing
timeFrame: 1 year
Other outcomes:
Locations:
city: Tel Hashomer
country: Israel
facility: Center of Geographic Medicine
Study officials:
affiliation: Sheba Medical Center
name: Eli Schwartz, M.D, DTMH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04039269: Long Term Memory Preoperative Preparation Reduce Post Operative Behavioral Change
Official title: Could Long Term Memory Created by Preoperative Video Information Reduce Post Operative Behavioral Change?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Behavior
Agitation
Keywords: Post operative Behavioral Changes
Pediatric
Long term memory
video
Lead sponsor: Prince of Songkla University
Sponsor class: OTHER
First posted: 2019-07-31
Enrollment: 192
Sex: ALL
Minimum age (years): 3
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The study is designed to test the hypothesis that long term memory created by preoperative video information can reduce the incidence of post operative behavioral changes.

Detailed description: Emergence agitation (EA) and Post operative behavioral change (PHC) are unpleasant experiences occurred in children after general anesthesia (GA). Previous study reported that the patient who had marked EA tended to have new-onset of postoperative maladaptive behavioral changes.Both pharmacologic and non pharmacologic interventions such as preoperative video information, hand held video games were used to reduce preoperative anxiety, EA and Post operative behavioral changes. In term of memory creation, short term memory (STM) was created. Later that the formation of memory trace requires time, and that this trace remains fragile until the long term memory formation process has been completed. In this study, the investigators hypothetize that long term memory created by preoperative video information can reduce the incidence of post operative behavioral changes.

Eligibility criteria: Inclusion Criteria:

* outpatient elective surgery
* aged between 3-14 years
* ASA physical status I-II

Exclusion Criteria:

* mental retardation
* patient's telephone contact not available
* emergency case
* having ICU admission plan postoperative

Primary outcomes:
measure: Incidences of post operative behavioral changes
timeFrame: up to3 months post operative period
Secondary outcomes:
measure: Incidences of Emergence agitation
timeFrame: evaluate PAED scale in the first 5 minutes after patient arrive PACU
measure: Parental's anxiety level at induction
timeFrame: Evaluate 15 minutes before start anesthesia induction
measure: Child's anxiety level at induction
timeFrame: mYpas will be evaluated immediately after the patient arrives into the operating room
Other outcomes:
Locations:
city: Hat-Yai
country: Thailand
facility: Faculty of Medicine, Prince of Songkla University
state: Songkhla
Study officials:
affiliation: Prince of Songkla University
name: Ngamjit Pattaravit, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03598569: Auto-evaluation of Dyspnea
Official title: Dyspnea Evaluated by a Qualified Examiner in Patients With Lung Diseases
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Diseases
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2018-07-26
Enrollment: 271
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all lung diseases

Brief summary: The primary aim of this study was to compare patients-rated evaluation and caregiver's assessment of dyspnea with the standard tools in pulmonology unit (Borg scale and visual analog scale) and the secondary aim was to performed an analysis depending on the diseases (lung cancer vs. other lung diseases) and to verify the agreement between the evaluation between both visual analog scale and modified Borg scale.


Eligibility criteria: Inclusion Criteria:

* age ≥18 and
* to have a diagnosis of acute or chronic respiratory disease

Exclusion Criteria:

* mental or cognitive disorders
* inability to understand the local language

Primary outcomes:
measure: visual analog scale
timeFrame: 3 seconds
measure: borg scale
timeFrame: 3 seconds
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Cliniques universitaires Saint-Luc
Study officials:
References:
Clinical trial NCT03588169: Representations of Oral Nutritional Supplementation (ONS) in Hospitals : Gender differences_observational Study
Official title: Representations of Oral Nutritional Supplementation (ONS) in Hospitals : Gender differences_observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Malnutrition
Oral Nutritional Supplementation
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2018-07-17
Enrollment: 118
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients hospitalised in the endocrinology, digestive surgery, pneumology and geriatrics departments of the Dijon University Hospital, with a prescription for ONS

Brief summary: Over 30% of hospitalized patients are malnourished. These figures range from 20% to 60% in geriatric units. Undernutrition results either from a decrease in energy intake, an increase in needs, an increase in losses or a combination of these three causes. As a factor in mortality, morbidity and lengthening the time of hospital stays, undernutrition induces health costs 45 to 102% higher than a person who is not undernourished. The nutritional management of patients initially includes hygieno-dietary advice, then the implementation of an oral nutritional supplementation (ONS). A recent study conducted by our teams highlighted the low ONS consumption among women compared to men (39.48% vs 73.41%). Interviews with patients showed that 13 out of 17 had a negative opinion of ONS.

The aim of this study is to show, on a larger scale, whether ONS consumption differs according to sex and if so, to highlight the obstacles to this consumption through the implementation of semi-directive interviews with patients. Ultimately, this research will lead to the implementation of alternative strategies to improve ONS consumption and to a better understanding of the obstacles to ONS consumption.


Eligibility criteria: Inclusion Criteria:

* patient who has given oral consent
* over 18 years
* orally fed
* with a prescription for ONS
* speaks and understands French
* hospital stay longer than 4 days

Exclusion Criteria:

* adult under tutelage
* pregnant or breastfeeding women
* cognitive disorders
* patient does not speak or understand French

Primary outcomes:
measure: Semi-structured individual interviews
timeFrame: 1 day on inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: Chu Dijon Bourogne
Study officials:
References:
Clinical trial NCT05014269: Phacoemulsification in Patients With Corneal Opacities
Official title: Phacoemulsification in Patients With Corneal Opacities Using Slit Illumination of the Surgical Microscope
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Senile Cataract
Keywords: Senile Cataract
Corneal opacity
Phacoemulsification
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-08-20
Enrollment: 10
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with visually significant senile cataract and corneal opacities

Brief summary: In this retrospective case series, the feasibility of performing phacoemulsification using slit illumination in eyes with corneal opacity was assessed.

Detailed description: Corneal opacity is often encountered in patients seeking senile cataract surgery in developing countries. Corneal opacity impairs the intraoperative visualization during cataract surgery which increases the risk of copmlications.

Several techniques were described to enhance the intraoperative visualization such as the use of anterior endoscopy, chandeiler retroillumination, and anterior chamber endoillumination. All these techniques require costly instrumentation.

the aim of this study was to assess the feasibility of performing phacoemulsification using slit illumination of the surgical microscope without the need of additional instruments, and report the visual outcome.

Eligibility criteria: Inclusion criteria:

* The presence of visually significant senile cataract.
* A recent history of progressive diminution of vision within few months.
* Stable density and size of a preexisting trachomatous corneal opacity that does not impair the pupil or lens visualization after pupillary dilatation.

Exclusion Criteria:

* History of trauma, infectious corneal ulcers, or intraocular surgery.
* Coexisting ocular diseases e.g. glaucoma, retinal detachment, and vitreous hemorrhage.

Primary outcomes:
measure: The rate of intra-operative complications of phacoemulsification in eyes with corneal opacities using the slit ilumination of the surgical microscope.
timeFrame: 3 months
Secondary outcomes:
measure: Visual outcome of phacoemulsification in eyes with corneal opacities
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05168969: Hyperekplexia in Patients With CTNNB1 Mutation
Official title: Hyperekplexia in Patients With Loss-of-function CTNNB1 Mutation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hyperekplexia
CTNNB1 Gene Mutation
Keywords: Hyperekplexia
CTNNB1
genetic disorder
psychomotor development
intellectual disability
neurological phenomenon
various visual defects
progressive spastic diplegia
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2021-12-23
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: CTNNB1 subjects

Brief summary: A few years ago, a new genetic disorder (OMIM # 615075) has been associated with loss-of-function variations in the CTNNB1 gene. The clinical features include a delayed psychomotor development usually leading to severe intellectual disability with or without autistic spectrum disorders, progressive spastic diplegia, and various visual defects. Among over 30 cases described worldwide, 2 were reported with an exaggerated startle response to sudden stimulus corresponding to a very rare neurological phenomenon called hyperekplexia. The investigators also have a 3rd patient carrying a CTNNB1 syndrome associated with hyperekplexia.

Detailed description: Hyperekplexia can impair daily life because the affected person will fall unexpectedly and stiffly, causing repeated head- or body- wounds. It may be treated empirically by various drugs. Hyperekplexia has so far not been associated with CTNNB1 variations.

In this study, we aim to describe the prevalence and clinical characteristics of hyperekplexia in CTNNB1 syndrome carriers, in order to improve diagnosis and thus treatment.

The investigators will recruit CTNNB1 subjects through health care providers and also by contacting the families through dedicated social media and databases. The families and health care providers will be invited to fill in a questionnaire related to hyperekplexia (clinical, pharmacological, and genetic data).

Eligibility criteria: Inclusion Criteria:

* Patient carrying a CTNNB1 syndrome showing an exaggerated startle response
* child whose parents have signed a consent form to participate in the study

Exclusion Criteria:

* Absence of molecular diagnosis
* Refusal to participate

Primary outcomes:
measure: Prevalence of hyperekplexia in CTNNB1 subjects
timeFrame: on the day of filling in the questionnaire
Secondary outcomes:
measure: Clinical features of hyperekplexia
timeFrame: on the day of filling in the questionnaire
Other outcomes:
Locations:
city: Saint-Étienne
country: France
facility: Chu Saint-Etienne
Study officials:
affiliation: Centre Hospitalier Universitaire de Saint Etienne
name: Laure MAZZOLA, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00156169: The Effect of the Alga Dunaliella Bardawil as a Source of 9-cis Retinoic Acid on Lipid Profile in Fibrate Treated Patients.
Official title: The Effect of the Alga Dunaliella Bardawil as a Source of 9-cis Retinoic Acid
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Low HDL Cholesterol
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2005-09-12
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The effect of fibrates on high density lipoprotein (HDL)-cholesterol levels is suggested to be mediated by its binding to peroxisome proliferator-activated receptor-g (PPARg). Upon ligand binding, PPARg heterodimerizes with the 9-cis retinoic acid receptor (RXR), and the heterodimer regulates gene expression. We assessed the hypothesis that a dual treatment with fibrate plus 9-cis b-carotene-rich powder of the alga Dunaliella bardawil, as a source of 9-cis retinoic acid, would improve the drug's effect on HDL-cholesterol levels.

patients with plasma HDL-cholesterol levels below 40 mg/dl and triglyceride (TG) levels above 200 mg/dl after fibrate treatment (for at least 6 weeks). are given four capsules of Dunaliella, providing 60 mg b-carotene/day. The all-trans to 9-cis b-carotene ratio in the capsules is about 1:1.


Eligibility criteria: Inclusion Criteria:

* age 18-70 years
* Fibrate treatment (for at least 6 weeks)
* HDL-Cholesterol lower than 40mg/dl.
* Triglyceride over 150mg/dl.

Exclusion Criteria:

* High CPK.
* Elevated liver functions.
* Active CHD.
* Smokers.
* Diabetes patients treated with Insulin or Avandia. HbA1C great than 8.5.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Sheba Medical Center
name: Ayelet Harari, Phd
role: STUDY_DIRECTOR
References:
Clinical trial NCT00832169: Investigation of Rate+Extent of Excretion of Radioactivity in Urine+Faeces After Oral Administration of [14C]AZD1386
Official title: An Open, Single Dose, Phase I Study of the Excretion of Radioactivity, Metabolism and Pharmacokinetics Following Oral Administration of [14C]AZD1386 to Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pain
Keywords: Pain
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-01-30
Enrollment: 6
Sex: MALE
Minimum age (years): 35
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The aim of this study is to get information about absorption, distribution, metabolism and excretion as well as the tolerability and safety of AZD1386 in healthy male volunteers.


Eligibility criteria: Inclusion Criteria:

* Body Mass Index of 18 - 30 and weight of 50 to 100 kilos.
* Healthy volunteer must have regular bowel movements (at least once daily)

Exclusion Criteria:

* History of psychiatric or somatic disease/condition, which may interfere with the objectives of the study as judged by the investigator.
* A family history of short QT syndrome or sudden cardiac death amongst first degree relatives.
* Any clinically important abnormalities in heart rhythm, conduction or morphology of resting ECG that may interfere with the interpretation of QTc interval changes.

Primary outcomes:
measure: Excretion (rate+extent) of radioactivity in urine+faeces following oral administration of [14C]AZD1386
timeFrame: Until >90% of predicted total radioactivity has been recovered
measure: Pharmacokinetics of total radioactivity in plasma + unchanged AZD1386 in plasma Metabolite profile in plasma+excreta
timeFrame: Predose, + postdose 0.5h, 1h, 2h, 4h, 6h, 8h, 12h, 24h, 48h, 72h, 96h, 120h, 144hPredose + postdose 1h, 4h, 8h, 24h for excreta from predose (baseline) + postdose from 0h continously until 144h
Secondary outcomes:
measure: AZD1386 metabolites in plasma+excreta if feasable
timeFrame: Predose, 1h, 4h, 8h 24h
measure: Safety + tolerability of AZD1386
timeFrame: Predose, 2h, 6h, 12h, 24h, 48h, 168h
Other outcomes:
Locations:
city: Macclesfield
country: United Kingdom
facility: Research Site
state: Cheshire
Study officials:
affiliation: AstraZeneca R&D, CPU Alderley Park, UK
name: Raj Chetty, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: AstraZeneca R&D, Södertälje, Sweden
name: Lars Ståhle, MD
role: STUDY_CHAIR
References: