louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06206629: Contralateral R1 in Amyotrophic Lateral Sclerosis
Official title: Evaluation of Contralateral R1 Component of the Blink Reflex in Patients With Amyotrophic Lateral Sclerosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Amyotrophic Lateral Sclerosis
Keywords: Amyotrophic lateral sclerosis
ALS
Electroneuromyography
ENMG
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2024-01-16
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients referred to the neurophysiology unit from the Hospices civils de Lyon, for a suspicion of motor neuron disease.

And healthy volunteers for the third group.

Brief summary: Amyotrophic lateral sclerosis (ALS) is a neurodegenerative disease affecting both upper and lower motor neurons. Electroneuromyography is an important tool for the diagnosis. Previous studies have shown that different components of the blink reflex, such as the latencies of homo- and contralateral R2 responses can be affected. Studies have found that a contralateral R1 component can appear in neurological diseases with affection of the central nervous system especially upper motor neuron, such as HTLV1 infection. Thus, you aim to determine if a contralateral R1 component could be present in ALS.


Eligibility criteria: Inclusion Criteria:

For patients

* Aged 18 to 99 years old
* Referred for suspected motor neuromuscular disease
* Collection of non-opposition

For healthy subjects:

* Aged 18 to 99 years old
* Absence of any neurological pathology
* Collection of non-opposition

Exclusion Criteria:

* Previous damage linked to another cause of the cranial nerves
* Prior brainstem lesions
* Persons deprived of liberty by a judicial or administrative decision
* Patient under judicial protection, unable to express consent

Primary outcomes:
measure: Presence of a contralateral R1 component on blink reflex evaluation.
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Bron
country: France
facility: Hôpital neurologique Pierre Wertheimer
state: Rhone
city: Nantes
country: France
facility: CHU de Nantes
Study officials:
References:
Clinical trial NCT04017429: Osteoplasty in Conjunction With Surgical Treatment of Mandibular Grade III Furcation Defects (FURC-III-OST)
Official title: Treatment of Grade III Furcation Defects in Teeth With Low Interproximal Crestal Bone Height, With and Without Osteoplasty, in Conjunction With Open Flap Debridement
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Furcation Defects
Periodontal Diseases
Lead sponsor: University of Oslo
Sponsor class: OTHER
First posted: 2019-07-12
Enrollment: 0
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Teeth with furcation grade III defects will be treated with open flap debridement, with or without osteoplasty. The study is designed to examine the effect of osteoplasty in the treatment of teeth with furcation grade III defects with open flap debridement.


Eligibility criteria: Inclusion Criteria:

* Periodontal disease stage III or IV according to 2018 criteria
* Undergoing periodontal therapy (active or supportive) and present 1 or more pair of bilateral mandibular molars affected by furcation involvement grade III with PPD\>4mm, and the furcation fornix must be above a tangential line from the distal to mesial interproximal crestal bone level on bitewing radiographs
* Competent to give consent

Exclusion Criteria:

* Previous radiotherapy to the jaws, current use of chemotherapy, systemic long-term corticosteroid treatment
* Present or past use of bisphosphonate treatment
* Pregnant or nursing subjects
* Patients classified as \> class II according to ASA classification
* Previous surgical therapy of included furcation defects
* Inhability to comprehend and respond to the quality of life questionnaire
* Dental restorations or prosthesis involving the furcation area
* Root fractures or suspected fractures/infractions
* Caries lesoins in the furcation area
* No systemic antibiotic treatment within 3 months prior to intervention

Primary outcomes:
measure: Sites with no signs of inflammation
timeFrame: 12 months after treatment
measure: Sites with no signs of inflammation
timeFrame: 24 months after treatment
Secondary outcomes:
measure: Changes in patient-reported quality of life (QoL)
timeFrame: Preoperatively compared to 24 months after treatment
measure: Changes in patient-reported quality of life (QoL)
timeFrame: Preoperatively compared to 12 months after treatment
measure: Loss of clinical attachment level
timeFrame: 12 months after treatment
measure: Loss of clinical attachment level
timeFrame: 24 months after treatment
measure: Number of participants with caries lesions
timeFrame: 24 months after treatment
measure: Radiographic changes
timeFrame: 12 months after treatment
measure: Radiographic changes
timeFrame: 24 months after treatment
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Institute of Clinical Dentistry, University of Oslo, Norway
Study officials:
References:
Clinical trial NCT02839629: Long-term Epidemiological Follow-up of Non-small Cell Lung Cancer in Scandinavia
Official title: Long-term Epidemiological Follow-up of Non-small Cell Lung Cancer in Scandinavia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-Small Cell Lung Cancer
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2016-07-21
Enrollment: 5657
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a diagnosis of NSCLC

Brief summary: A study to describe and evaluate patient characteristics and clinical outcomes in Subjects with diagnosed Non Small Lung Cell Cancer in Sweden, Norway and Denmark.


Eligibility criteria: Inclusion Criteria:

Patients with a histologically confirmed diagnosis of NSCLC (squamous, adenocarcinoma, not otherwise specified NSCLC \[NSCLC NOS\]) identified in the Cancer registers

Exclusion Criteria:

* Age under 18 years at time of diagnosis

Primary outcomes:
measure: Overall survival based on Response Evaluation Criteria in Solid Tumors (RECIST)
timeFrame: Approximately 2 years
measure: Progression free survival based on Response Evaluation Criteria in Solid Tumors (RECIST)
timeFrame: Approximately 2 years
measure: Time to progression based on Response Evaluation Criteria in Solid Tumors (RECIST)
timeFrame: Approximately 2 years
measure: Disease control rate; defined as total number of patients whose Best Overall Response(BOR)= Complete Response(CR), Partial Response(PR) or Stable Disease(SD), divided by total number of patients
timeFrame: Approximately 2 years
measure: Partial Response (PR) based on Response Evaluation Criteria in Solid Tumors (RECIST)
timeFrame: Approximately 2 years
measure: Complete response based on Response Evaluation Criteria in Solid Tumors (RECIST)
timeFrame: Approximately 2 years
measure: Percent of patients with an adverse event (AE)
timeFrame: Approximately 2 years
measure: Percent of patients with an adverse event (AE)
timeFrame: Approximately 2 years
Secondary outcomes:
measure: Body Mass Index (BMI) of NSCLC patients at diagnosis
timeFrame: At baseline visit
measure: Smoking habits of NSCLC patients at diagnosis
timeFrame: At baseline visit
measure: Age of NSCLC patients at diagnosis
timeFrame: At baseline visit
measure: NSCLC clinical subtype of NSCLC patients at diagnosis
timeFrame: At baseline visit
measure: Tumor node metastasis classification of NSCLC patients at diagnosis
timeFrame: At baseline visit
measure: Charlson Comorbidity index of NSCLC patients at diagnosis
timeFrame: At baseline visit
measure: Drug utilization after NSCLC diagnosis by line of therapy
timeFrame: Approximately 2 years
measure: Proportion of patients who receive surgery by stage at treatment
timeFrame: Approximately 2 years
measure: Proportion of patients who receive radiation by stage at treatment
timeFrame: Approximately 2 years
Other outcomes:
Locations:
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT03033329: Single Dose Escalation and Multiple Dose Escalation Trial of an Intravenous Formulation of MRX-4
Official title: A Randomized, Double-Blind, Placebo Controlled Three-Part Study of the Safety, Tolerability, and Pharmacokinetics of MRX 4 Administered Intravenously to Healthy Volunteers in Single Ascending and Multiple Ascending Dose Cohorts, and Bioavailability of Oral MRX-4 Versus Intravenous Administration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Safety
Lead sponsor: MicuRx
Sponsor class: INDUSTRY
Collaborators: name: Worldwide Clinical Trials
First posted: 2017-01-26
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A Phase 1 study of the safety, tolerability, and pharmacokinetics of a new oxazolidinone antibiotic. In Part 1 cohorts of healthy adults will participate in a single dose escalation study of increasing intravenous doses of MRX-4. In Part 2 cohorts of healthy adults will participate in a multiple dose escalation study of increasing intravenous doses of MRX-4 given twice daily for ten days. Part 3 is a crossover study of oral MRX-4 versus a comparable intravenous dose of MRX-4 to determine bioavailability.


Eligibility criteria: Inclusion Criteria:

* Healthy subjects

Exclusion Criteria:

* Underlying hepatic, renal, metabolic, hematologic, cardiovascular, or immunologic disorder

Primary outcomes:
measure: Safety of single and multiple ascending doses of MRX-4
timeFrame: Screening through end of study visit on Day 7 (Part 1), Day 17 (Part II) and Day 15 (Part III)
Secondary outcomes:
measure: Plasma concentration time data for MRX-4 and its metabolites
timeFrame: Pre-dose through 72 hours post dose
measure: Bioavailability of MRX-I and other MRX-4 metabolites
timeFrame: Pre-dose through 72 hours post dose
measure: Comparison of the pharmacokinetics of oral versus intravenous MRX-4 and its metabolites
timeFrame: Pre-dose through 72 hours post dose
measure: Elimination of MRX-4 and its metabolites in the urine following single dose adminstration
timeFrame: Pre-dose through 72 hours post dose
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06924229: Corneal Changes in Estrogen-Dependent Breast Cancer After Hormonal Treatment
Official title: Corneal Changes in Estrogen-Dependent Breast Cancer After Hormonal Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Braest Cancer
Dry Eye
Keywords: corneal changes
breast cancer
hormonal treatment
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2025-04-11
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Aromatase inhibitors (AI) therapy is the treatment of choice for estrogen receptor-positive breast cancer (BC). While AIs effectively suppress tumor growth, estrogen deprivation may have negative impacts on the eyes. This work evaluated the anterior segment changes in estrogen-dependent BC after hormonal treatment.

Detailed description: Aromatase inhibitors (AI) therapy is an important treatment for estrogen receptor-positive breast cancer (BC). This work evaluated the eye anterior segment changes in estrogen-dependent BC after hormonal treatment.

This cross-sectional study was conducted on female patients aged ≥18 who received treatment for BC. Patients were evaluated by a number of tests to determine the effects on the cornea and the lacrimal system

Eligibility criteria: Inclusion Criteria:

* Females diagnosed with breast cancer

Exclusion Criteria:

* uncontrolled diabetes , auto immune diseases

Primary outcomes:
measure: tear break up time test and shirmer test
timeFrame: 6 months
Secondary outcomes:
measure: Corneal thickness and endothelium hexagonality
timeFrame: 6 months
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag university
Study officials:
affiliation: Sohag University
name: Elshimaa abd almateen A mateen, Doctorate
role: STUDY_CHAIR
affiliation: mahmoud
name: alaa mahmoud m mahmoud
role: STUDY_CHAIR
affiliation: Sohag University
name: mohamed salah hamed s hamed, Doctorate
role: STUDY_DIRECTOR
References:
Clinical trial NCT00820729: Biomarkers in Pulmonary Hypertension Associated to Interstitial Lung Disease
Official title: The Prevalence of Pulmonary Hypertension and the Significance of Different Biomarkers in Chronic Interstitial Lung Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Interstitial Lung Disease
Pulmonary Hypertension
Biomarkers
Keywords: interstitial lung disease
pulmonary hypertension
biomarkers
NT-pro-BNP
von Willebrand factor
D-dimer
Exhaled NO
Troponin-t
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2009-01-12
Enrollment: 212
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Out-patients with interstitial pulmonary disease.

Brief summary: The presence of an abnormally increased pulmonary blood pressure worsens the prognosis of patients with interstitial pulmonary disease.

The aim of this study is to estimate the frequency of an increased blood pressure in the lungs among patient with interstitial pulmonary disease, and to evaluate the use of different biomarkers in diagnosis of the condition.

Detailed description: The presence of increased pulmonary blood pressure is established by echocardiography and confirmed by right heart catheterization.

The ability of NT-proBNP, vWf, troponin-t, D-dimer and exhaled NO to predict the presence of increased pressure in the pulmonary circulation is evaluated.

Eligibility criteria: Inclusion Criteria:

* Interstitial pulmonary disease

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Århus N
country: Denmark
facility: Department of Cardiology, Skejby sygehus
city: Århus
country: Denmark
facility: Department of Pulmonary Diseases, Århus Sygehus
Study officials:
References:
Clinical trial NCT01742429: Levoﬂoxacin and Bismuth-containing Therapy Versus Quadruple Therapy as Second-line Treatment of Resistant Helicobacter Pylori Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cure Rate of Helicobacter Pylori Infection
Keywords: Helicobacter pylori
second line treatment
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2012-12-05
Enrollment: 200
Sex: ALL
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To test the efﬁcacy of 14 day levoﬂoxacin and bismuth-containing second-line therapy for resistant Helicobacter pylori infection, to compare with the classical quadruple therapy.


Eligibility criteria: Inclusion Criteria:

* all patients had failed H.pylori therapies including clarithromycin, metronidazole and/or amoxicillin (if not allergic) before.

Exclusion Criteria:

* patients less than 18 years old,
* previous gastric surgery,
* pregnancy,
* lactation,
* major systemic diseases,
* administration of antibiotics,
* bismuth,
* antisecretory drugs in the preceding 8 weeks, or
* allergy to any one of the medication used in the quadruple regimens.

Primary outcomes:
measure: eradication rate
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Renji Hospital, Shanghai Jiao-Tong University School of Medicine
state: Shanghai
Study officials:
References:
Clinical trial NCT01683929: The Effects of Oral Glucose Compared to Sweetener Drinking on Hormonal/Metabolic Responses
Official title: The Effects of Oral Glucose Compared to Sweetener Drinking on Hormonal/Metabolic Responses and 24 Hour Macronutrient Consumption - A Double Blind, Cross-over Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Obesity
Overweight
Sugar consumption
Metabolic syndrome
Artificially sweetened foods and beverages
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2012-09-12
Enrollment: 12
Sex: ALL
Minimum age (years): 25
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SCREENING

Brief summary: The goal of this study is to determine the hormonal/metabolic reponse to ingestion of sugar compared to consuming artificial sweetened drink, and to evalute macronutrient consumption 24 hours post ingestion of the drinks.

We hypothesize that artificially sweetened (AS) consumption will lead to a relatively similar hormonal/metabolic responses as glucose consumption and therefore to secondary rise of caloric intake.

Detailed description: During the last two decades, the prevalence of overweight and obesity doubled. at the same time, individuals have increasingly turned to artificially sweetened (AS) foods and beverages in an attempt to lose weight, or control it.

several studies have found that there may be a connection between artificially sweetened food and beverages consumption and paradoxical weight gain and increased incidence of metabolic syndrome. the causal relationship between AS use and weight gain haven't been proven yet.

The participants will be invited to 2 meetings in which they will consume, in a randomized double blind way:

1. A beverage containing 75 gram glucose
2. A beverage containing 0.42 gram artificially sweetener (Aspartame, similar sweetness level)

During each meeting, the participants will drink the sweetened drink followed by blood work, as done in oral glucose challenge or tolerance test (OGTT / GTT).

Also, they will record their macronutrient\\caloric consumption during the 24 hour following the test.

Eligibility criteria: Inclusion Criteria:

* Adults, healthy, men and women, ages 25-35 years, without any chronic illnesses.

Exclusion Criteria:

* Family history of diabetes or overweight with BMI\> 27
* Use of drugs who can influence the glucose metabolism (exp: glucocorticoids).

Primary outcomes:
measure: Hormonal response
timeFrame: 3 hours
Secondary outcomes:
measure: food questionnaire
timeFrame: 24 hours
Other outcomes:
Locations:
city: Kfar Saba
country: Israel
facility: Meir Medical Center
city: Kfar-Saba
country: Israel
facility: Meir Medical Center
Study officials:
affiliation: Meir Medical Center, Kfar-Saba, Israel
name: Dan Nemet, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05279729: Efficacy of mHealth Apps for Health in a Low-income, Type II Diabetic, Hispanic Population
Official title: Efficacy of mHealth Apps for Health in a Low-income, Type II Diabetic, Hispanic
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Obesity
Keywords: diabetes
low income
mhealth
ehealth
Lead sponsor: San Diego State University
Sponsor class: OTHER
First posted: 2022-03-15
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the effectiveness of mobile health applications in improving health outcomes and the subsequent benefit of improving type II diabetes outcomes in a low socioeconomic Hispanic population. This study will involve a 6-month long commitment where participants will be expected to weigh themselves every morning, at the same time, and check their blood glucose readings daily before and after meals for at least three meals in the day.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with type II diabetes
* Between the age of 18-64
* BMI ≥ 27
* Individual annual income less than $47,520 \[Covered CA income guidelines and salary restrictions\]
* Hispanic and/or Latinx origin
* Monitors blood glucose regularly
* Owns or has access to a bathroom weight scale
* Owns a smartphone and willing to download mobile apps

Exclusion Criteria:

* Does not check blood glucose at least once per day
* On medications that promote weight gain such as antipsychotic, antidepressant, and steroid hormone medications.

Medications for diabetes such as insulin, thiazolidinediones or sulfonylureas are okay

Primary outcomes:
measure: Effectiveness of mHealth apps at reducing bodyweight assessed by bodyweight measurements over 6 months
timeFrame: 6 months
measure: Most effect intervention for weight loss in first 3 months
timeFrame: 6 months
measure: Most effective intervention for weight loss by 6 months
timeFrame: 6 months
measure: Self-efficacy in weight management assessed by Weight Management and Nutrition Knowledge questionnaire
timeFrame: 6 months
measure: Long term diabetes improvement via A1c
timeFrame: 6 months
Secondary outcomes:
measure: Quality of Life after using mHealth apps assessed by World Health Organization Quality of Life BREF questionnaire
timeFrame: 6 months
measure: mhealthy app preference assessed by questionnaire
timeFrame: 6 months
Other outcomes:
Locations:
city: San Diego
country: United States
facility: San Diego State University
state: California
Study officials:
References: