louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01273649: Therapeutic Effects of Cryotherapy on Arthrogenic Muscle Inhibition in Patients With Cruciate Ligament Reconstruction
Official title: Therapeutic Effects of Cryotherapy and Transcutaneous Nerves Stimulation on Arthrogenic Muscle Inhibition in Patients With Anterior Cruciate Ligament Reconstruction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anterior Cruciate Ligament Injury
Keywords: muscle activation
ACL reconstruction
cryotherapy
TENS
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2011-01-10
Enrollment: 30
Sex: MALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Anterior cruciate ligament(ACL) injury is one of the most common sport injuries. The major problem after ACL reconstruction or rehabilitation program is quadriceps weakness. Previous studies suggested that cryotherapy and transcutaneous electrical nerve stimulation(TENS) can effectively reduce the arthrogenic muscle inhibition caused by experimental swelling.

Objective:

To exam the effects of 12 weeks cryotherapy and TENS on arthrogenic muscle inhibition in subjects with ACL reconstruction.

Design:

Prospective study.

Subjects:

Male subjects with isolated ACL injury, age between 18\~40 years old are going to receive an ACL reconstruction surgery.

Methods:

Quadriceps activation level, quadriceps peak torque during maximal voluntary contraction and rate of force development are measure at presurgery, 3-month, 6-month after surgery. After surgery, subjects will receive 12 weeks, 3 days/week, training programs included 20 minutes cryotherapy and exercise training with TENS.

Data analysis:

Data will be analyzed using SPSS 13.0 software (SPSS Inc., Chicago, IL). One-way ANOVA will be used to analysis data.

Detailed description: Examination procedure:

1. Skin preparation and EMG setting.
2. Fill out knee joint function questionnaire.
3. Warmup with a stationary bike.
4. Single hop for distance.
5. MVIC test and EMG recording.
6. Endurance test.
7. Record surface EMG of vastus lateralis, vastus medialis, biceps femoris and semitendinosus during maximal voluntary contraction.

Eligibility criteria: Inclusion Criteria:

* Male subjects with isolated ACL injury, age between 18\~40 years old are going to receive an ACL reconstruction surgery.

Exclusion Criteria:

* meniscus lesion, bony fracture and osteochondral lesions

Primary outcomes:
measure: Muscle activation
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University
Study officials:
affiliation: National Taiwan University Hospital
name: HK Wang, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05492149: Pulmonary Rehabilitation for COPD Patients: Can Performance Predict Exacerbation?
Official title: Pulmonary Rehabilitation for COPD Patients: Can Performance Predict Exacerbation?
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: COPD
COPD Exacerbation
Pulmonary Rehabilitation
Lead sponsor: Groupe Hospitalier du Havre
Sponsor class: OTHER
First posted: 2022-08-08
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: COPD patients who referred to a pulmonary rehabilitation program

Brief summary: The aim of pulmonary rehabilitation is to improve exercise capacity and reduce dyspnoea. As well as improving the patient's overall condition, pulmonary rehabilitation provides a means to monitor the patient regularly. During physical exercise, the increased activity of the muscle system increases cardiac and respiratory output. If the patient's respiratory status deteriorates, as occurs, for example, before the onset of an exacerbation, exercise capacity could be reasonably expected to reduce. The investigators hypothesised, therefore, that changes in the physical capacity of patients with COPD during a rehabilitation session could provide a predictive indication regarding the risk of occurrence of exacerbation.


Eligibility criteria: Inclusion Criteria:

* Adult patients
* COPD patients

Exclusion Criteria:

* Patients who not performed not at least 5 sessions of the pulmonary rehabilitation program
* Occurence of an adverse event that prevents further rehabilitation
* Exacerbation in the previous month

Primary outcomes:
measure: Correlation between the decrease of performance during pulmonary rehabilitation session and the occurrence of pulmonary exacerbation.
timeFrame: From admission to the program or first documented session ; to completion of the pulmonary rehabilitation program or occurrence of an exacerbation, up to 104 weeks.
Secondary outcomes:
measure: Correlation between the decrease of performance during pulmonary rehabilitation session and the COPD Assessment Test (CAT) questionnaire score.
timeFrame: Through study completion, at every pulmonary rehabilitation session ; to completion of the pulmonary rehabilitation program or occurrence of an exacerbation, up to 104 weeks.
Other outcomes:
Locations:
city: Montivilliers
country: France
facility: Groupe Hospitalier du Havre
state: Groupe Hospitalier Du Havre
Study officials:
References:
Clinical trial NCT02539849: Effect of Prebiotic FOS on Intestinal Abundance of Faecalibacterium Prausnitzii in Patients With Crohn´s Disease
Official title: Effect of Prebiotic Fructo-oligosaccharides (FOS) on Intestinal Abundance of Faecalibacterium Prausnitzii in Patients With Crohn´s Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Crohn Disease
Lead sponsor: Hospital Universitari Vall d'Hebron Research Institute
Sponsor class: OTHER
Collaborators: name: AbbVie
First posted: 2015-09-03
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: FOS improve gut colonization by Faecalibacterium prausnitzii in patients with Crohn's disease

Detailed description: To demonstrate that FOS increases counts of Faecalibacterium prausnitzii in faecal samples from Crohn's disease patients

Eligibility criteria: Inclusion Criteria:

* Patients between 18 and 65 years old
* Crohn's disease patients
* Inflammatory activity confirmed by imaging techniques (colonoscopy or magnetic resonance imaging (MRI))
* Refractory inflammatory luminal disease (with or without perianal involvement) at any level of the gastrointestinal tract requiring therapy with adalimumab,according to standard clinical practice.
* Stable maintenance of any other medication (corticosteroids and / or immunosuppressants and/or 5-aminosalicylic acid (5-ASA)) for the past 4 weeks
* Screening tests required for a safe administration of anti tumour necrosis factor (anti-TNF) antibodies will be performed according to standard clinical practice

Exclusion Criteria:

* Subjects consuming prebiotic supplements (inulin, FOS, galactooligosaccharides (GOS)) in their regular diet.
* Antibiotic use within the past 2 months
* Previous anti-TNF therapy.

Primary outcomes:
measure: FOS increases counts of Faecalibacterium prausnitzii in faecal samples from Crohn's disease patients
timeFrame: 14 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Santiago de Compostela
country: Spain
facility: Hospital de Santiago
state: A Coruña
city: Hospitalet del Llobregat
country: Spain
facility: Hospital de Bellvitge
state: Barcelona
city: Barcelona
country: Spain
facility: Hospital Universitari vall d'Hebron
city: Girona
country: Spain
facility: Hospital Josep Trueta
city: Madrid
country: Spain
facility: Hospital La Princesa
Study officials:
References:
Clinical trial NCT04015349: Clinical Condition and Sleep Quality Factors Associated With Sleep Bruxism in Adults.
Official title: Clinical Condition and Sleep Quality Factors Associated With Sleep Bruxism in Adults: a Study Using Polysomnography.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sleep Bruxism, Adult
Keywords: grind
polysomnography
rhythmic masticatory muscle activity
sleep bruxism
Lead sponsor: Federal University of Pelotas
Sponsor class: OTHER
First posted: 2019-07-11
Enrollment: 240
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All records obtained from adults (aged 20 to 60 years) and elderly (aged \>60 years) who had undergone PSG at a private medical outpatients clinic from July 2017 to February 2018 were reviewed.

Brief summary: This cross-sectional study will evaluate the association between sociodemographic, occupational, clinical conditions, psychological (sense of coherence), sleep quality variables and SB diagnosed by PSG, the gold standard exam with audio-visual resources obtained at Pelotas Sleep Institute.

Detailed description: Sleep bruxism is defined as a masticatory muscle activity during sleep that is characterised as rhythmic (phasic) or non-rhythmic (tonic) and should be considered a risk factor rather than a disorder in otherwise healthy individuals.

The diagnosis of sleep bruxism often is challenging and despite the use of questionnaires, clinical exams and portable devices, based on current knowledge, the polysomnography with audio-video recordings emerges as the gold-standard criteria for a definite sleep bruxism diagnosis.

Included on the questionnaire there is a registration form, which contains: included: age at time of data collection , gender, marital status , and education level ; Occupational: individuals were asked about work outside home, and working hours; Clinical condition: body mass index, smoking; alcohol consumption; use of sleeping pills; respiratory allergy and Psychological: sense of coherence .

Eligibility criteria: Inclusion Criteria:

* All adults (aged 20 to 60 years) and elderly (aged \>60 years)

Exclusion Criteria:

* Inadequate cognitive capacity to understand and answer the questionnaires;
* Degraded PSG image quality;
* Questionnaires filled incorrectly;
* Participants who presented a history of epilepsy that could interfere in the results of polysomnography.

Primary outcomes:
measure: Patients with Sleep Bruxism by Polysomnography exams
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Pelotas
country: Brazil
facility: Federal University of Pelotas
state: RS
Study officials:
affiliation: Federal University of Pelotas
name: Noéli Boscato, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01498549: Cognitive Effects of Atomoxetine in Humans: Genetic Moderators
Official title: Cognitive Effects of Atomoxetine in Humans: Genetic Moderators
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Addiction
Keywords: Abstinent cocaine users
cognitive testing
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2011-12-23
Enrollment: 35
Sex: ALL
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The overall goal of this study is to determine if atomoxetine treatment improves selective cognitive functions in abstinent cocaine users, compared to healthy controls. The study will also test if a functional variation of the NET promoter polymorphic region (NETpPR) moderates the cognitive effects of atomoxetine.

Detailed description: This will be a double-blind, placebo-controlled, crossover study, with cocaine use (cocaine users vs. healthy controls) and NET AAGG4 status (L4/ L4 vs. L4/S4 or S4/ S4 genotype) as the between-subject factors. Similar to previous studies, we propose to compare individuals with two copies of the L4 allele to participants with at least one S4 allele because only less than two percent of the general population is homozygous for the S4 allele. Forty cocaine users and 40 healthy controls will participate in 3 test sessions, where they will be assigned to 40 mg atomoxetine, 80 mg atomoxetine, or placebo. Outcome measures will include physiological, subjective, and cognitive performance measures.

To date this study has 35 completers and currently in data analysis. (January 2016)

Eligibility criteria: Inclusion Criteria:

* Male and females, between the ages of 21 and 50;
* No current dependence or abuse of drugs of abuse or alcohol (except and tobacco);
* No current medical problems and normal ECG;
* For women, not pregnant as determined by pregnancy screening nor breast feeding, and using acceptable birth control methods.

Exclusion Criteria:

* Current major psychiatric illnesses including mood, psychotic, or anxiety disorders;
* History of major medical illnesses; including liver diseases, heart disease, or other medical conditions that the physician investigator deems contraindicated for the subject to be in the study;
* Known allergy to Atomoxetine;
* Use of Monoamine Oxidase inhibitor within the last month (clinically Atomoxetine administration is contraindicated with or within 2 weeks of discontinuation of Monoamine oxidase inhibitor therapy).

Primary outcomes:
measure: Rapid Visual Information Processing
timeFrame: 2 years
measure: Rapid Visual Information Processing: Mean Correct Response Latency
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: West Haven
country: United States
facility: Department of Veterans Affairs
state: Connecticut
Study officials:
affiliation: Yale University
name: Mehmet Sofuoglu, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00611949: Comparison of 2 Vials of Components of a Synthetic Geranium Oil
Official title: EPT 101: New Geranium Oil Formulation for the Treatment of Neuropathy Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neuropathic Pain
Keywords: Geranium oil
Neuropathy
Shingles
Herpes zoster
Lead sponsor: Pennington Biomedical Research Center
Sponsor class: OTHER
First posted: 2008-02-11
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine which component of an artificial geranium oil helps to reduce your neuropathy pain.

Detailed description: EPT 101 is a double-blind successive crossover study designed to determine which components of a synthetic geranium oil provide analgesic relief, with the objective of identifying and purifying the active substance. This is not a hypothesis-generating trial, nor is it confirming a hypothesis. The trial uses human volunteers in an efficacy-directed decomposition of a complex mixture.

Patients with a diagnosis of neuralgia or neuropathy who respond to geranium oil will test two vials of components of a synthetic geranium oil for application to the maximally painful area in succession. They will treat their condition in the clinic and fill out a patient diary on separate days. The primary objective is the patient opinion of which vial has greatest analgesic efficacy. Efficacy will be measured primarily by reduction in pain intensity summed over the first two hours, compared with the pain intensity during the 30 minutes preceding application.

Following the comparison of the first two vials, the vial judged efficacious will be decomposed into two further vials and the patients will repeat the evaluation described above. At least eight pair-wise comparisons will be required to determine and confirm which of the 100+ ingredients of a synthetic geranium oil are analgesic, provided there is only one such ingredient.

Eligibility criteria: Inclusion Criteria:

* You are eligible to participate in this study if you have completed the study EPT 100 and geranium oil relieves your neuropathy pain successfully.

Exclusion Criteria:

* You are ineligible to participate in this study if you have completed the study EPT 100 and geranium oil does not relieve your neuropathy pain successfully

Primary outcomes:
measure: Pain relief
timeFrame: 2 hrs. post-application
Secondary outcomes:
measure: Response to therapy at one hour, defined as reduction of pain summed over the first hour, compared between the two oils.
timeFrame: 1 hr. post-application
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
Study officials:
affiliation: Pennington Biomedical Research Center
name: Frank Greenway, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01219049: L-Tyrosine Supplementation in Patients With Fibromyalgia
Official title: L-Tyrosine Supplementation in Patients With Fibromyalgia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Fibromyalgia
Keywords: Diet
Fibromyalgia
Pain
Drug
Amino-acid
Fatigue
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2010-10-13
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients in the study, who have a diagnosis of fibromyalgia, will be randomly assigned to take the amino acid L-tyrosine or placebo (blank pill) for 3 weeks. They will fill out questionnaires about their symptoms and see if they have any improvement. The investigators hypothesis is that taking tyrosine will help alleviate the symptoms of fibromyalgia.

Detailed description: Fibromyalgia is a chronic pain syndrome with few treatment options available. The amino-acid L-tyrosine is the precursor for norepinephrine in the central nervous system (CNS). Norepinephrine in the CNS has important roles in pain and mood modulation and descending inhibition of pain pathways. By giving the precursor L-tyrosine in high doses we believe that we can increase levels of norepinephrine in the CNS. To study this question we designed a randomized blinded pilot study of 30 patients. Patients are randomly assigned to one of 3 groups (placebo, tyrosine 1000mg/day, and tyrosine 2000mg/day.) for 3 weeks. Patients then complete the Brief Pain Inventory (BPI) daily and the Fibromyalgia impact questionnaire (FIQ) on day 1 and day 21. Patients also complete a drug diary. They are monitored weekly for progress during the study.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of fibromyalgia
* Pain greater than 4/10
* Age greater than 18

Exclusion Criteria:

* Pregnant
* Age less than 18

Primary outcomes:
measure: Pain Score
timeFrame: daily for 21 days
measure: FIQ Score
timeFrame: Day 1
measure: FIQ Score
timeFrame: Day 21
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Mount Sinai School of Medicine
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Michael A Mazzeffi, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04558749: Anxiety and Depression Among Pregnant Women During COVID-19 Pandemic
Official title: Assessment of Anxiety and Depression Among Pregnant Women During COVID-19 Pandemic
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-09-22
Enrollment: 238
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: The study population comprised women that will attend their routine visit to the antenatal clinic. The study population will be recruited by using simple random sampling method after verbal consent will be obtained. Resident in the Department of Obstetrics and Gynaecology who will be trained to administer the questionnaire will interview women. Facemasks will be provided to the study population during the process of data collection.

Brief summary: Pregnancy and early parenthood are life changing periods characterized by intense emotions and a high vulnerability to emotional problems. Overall 10 - 20 % of pregnant women and women in early postpartum period suffer from mental health problems.

In the first months of 2020 , pregnant and breastfeeding women have also needed to face the COVID19 pandemic including the exceptional quarantine measures that have disturbed private and professional life . In addition to the fear of infection , these measures might have negatively impacted the emotional wellbeing of women . As depressive symptoms and anxiety in the pre and peripartum period have been associated with adverse maternal , neonatal and infant outcomes , the psychological impact of COVID19 , and its associated quarantine measures , on pregnant women and new mothers is cause for concern


Eligibility criteria: Inclusion Criteria:

All pregnant women presented to the Antenatal care clinic, will be included in the study irrespective of the gestational age of the pregnancy

Exclusion Criteria:

Women previously diagnosed with any psychiatric disorder.

Primary outcomes:
measure: The mean scores anxiety and depression among pregnant women during COVID-19 pandemic
timeFrame: one hour
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut Faculty of Medicine
Study officials:
References: