louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02211391: Nighttime Protein Intake on Overnight Lipolysis and Morning Fat Oxidation in Obese Men
Official title: The Effect of Nighttime Protein Intake on Overnight Lipolysis and Morning Fat Oxidation in Obese Men.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Nighttime Eating
Protein
Obesity
Lipolysis
Metabolism
Lead sponsor: Florida State University
Sponsor class: OTHER
First posted: 2014-08-07
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Single macronutrients will be consumed before sleep by obese men. Overnight lipolysis will be measured with the microdialysis technique by measuring glycerol concentration and blood flow in abdominal adipose tissue. Morning fat oxidation will be measured with indirect calorimetry.

The investigators hypothesize that carbohydrate intake will blunt the overnight lipolysis rate compared to casein protein and a non-caloric placebo. The investigators also hypothesize that casein and placebo will not be significantly different from each other in terms of overnight lipolysis.


Eligibility criteria: Inclusion Criteria:

* Healthy, sedentary overweight or obese (BMI ≥25 kg/m\^2; body fat ≥ 25% ) men

Exclusion Criteria:

* Men that have been exercising for more than 2 days per week for more than 45 minutes per session (within the past 6 months), have uncontrolled hypertension (Blood Pressure (BP)\>160/100 mmHg, diagnosed cardiovascular disease, stroke, diabetes, thyroid or kidney dysfunction, take cholesterol medication, or have any allergies to milk products will be excluded. Smokers will also be excluded.

Primary outcomes:
measure: Lipolysis
timeFrame: Change from day 1 to day 2 to day 3 of testing
Secondary outcomes:
measure: Resting Metabolic Rate (RMR)
timeFrame: Change from day 1 to day 2 to day 3
Other outcomes:
measure: Appetite
timeFrame: Change from Baseline to day 1, 2, and 3
measure: Blood hormones
timeFrame: Change from Baseline to day 1, 2, and 3
Locations:
city: Tallahassee
country: United States
facility: Institute of Sports Science and Medicine, Florida State University
state: Florida
Study officials:
affiliation: Florida State University
name: Michael J Ormsbee, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02874391: Use of Arterio-venous Fistula as First Choice for Intravenous Drug Administration in Kidney Transplant Recipients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Evaluate the Risks of Using Arteriovenous Fistula as First Choise for Drug Administration
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2016-08-22
Enrollment: 50
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: Kidney transplant recipients

Brief summary: Use of arteriovenous fistula for IV drug administration is controversial and often prohibited by nephrologists. However, we have been using this method in our department for years now in order to keep the patients 'veins for other fistulas in the future. The aim of this study is to evaluate our practice and maybe provide a justification for a larger multi-center study given the importance of this subject in patients with chronic renal failure.


Eligibility criteria: Inclusion Criteria:

* Age \> 18 years, functional AV fistula, new kidney transplant recipient

Exclusion Criteria:

* Prothetic AV fistula, Very recent AV fistula of less than 3 months

Primary outcomes:
measure: Evaluate the risk of complications of AV fistula
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU Angers
Study officials:
affiliation: University Hospital, Angers
name: Christelle Roux
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03269591: Electromagnetic Field Versus Diclofenac Drugs on Primary Dysmenorrhea
Official title: Electromagnetic Field Versus Diclofenac Drugs on Primary Dysmenorrhea: Arandomized Controlled Trial in the Egyptian Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Electromagnetic Field
Dysmenorrhea
Keywords: Dysmenorrhea
Pulsed electromagnetic field
Diclofenac
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-09-01
Enrollment: 50
Sex: FEMALE
Minimum age (years): 17
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Electromagnetic field versus diclofenac drugs on primary dysmenorrhea: Arandomized controlled trial in the Egyptian women

Detailed description: Background: Primary dysmenorrhea is one of the most common complaints of women and is also the most common gynecological problem worldwide. These cramps are recurrent and 90% adolescent girls and about 50% women suffer from it. Purpose of the study: to determine which is more effective in alleviating primary dysmenorrhea; pulsed electromagnetic field or diclofenac drugs. Methodology: The study was a randomized, double-blinded trial, fifty adult females participated in this study, were divided randomly into two groups equal in numbers: group (A) received pulsed electromagnetic field applied on pelvic region, 3 times per week for 3 months, 20 minutes per day and group (B) received diclofenac tablets, 50 mg only with onset of menstrual pain. All participants in both groups (A and B) were assessed pre- and post-treatment through measuring progesterone level in the blood, assessment of pain using visual analogue scale and physical as well as psychological symptoms by using menstrual symptom questionnaire.

Eligibility criteria: Inclusion Criteria:

-regular menstrual cycle 21-35 days lasting 3-7 days

Exclusion Criteria:

* Irregulars or infrequent menstrual cycles, Pacemaker, Myasthenia gravis, hyperthyroidism, active tuberculosis and psychosis

Primary outcomes:
measure: Visual analogue scale
timeFrame: three months
Secondary outcomes:
measure: Progesterone blood level
timeFrame: three months
measure: Menstrual symptom questionnaire
timeFrame: three months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01444391: inVENT-visIOn Study
Official title: A Clinical Study of the Acclarent Tympanostomy Tube Delivery and Iontophoresis Systems In-Office
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Otitis Media
Keywords: Tympanostomy tube placement
iontophoresis
Lead sponsor: Integra LifeSciences Corporation
Sponsor class: INDUSTRY
Collaborators: name: Acclarent
First posted: 2011-09-30
Enrollment: 42
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of the study is to evaluate the safety and efficacy of the Acclarent Tympanostomy Tube Delivery System (TDS) for the placement of Tympanostomy Tube TT(s) under local anesthesia delivered by iontophoresis in an office/clinic setting.


Eligibility criteria: Inclusion Criteria:

* Scheduled to undergo tympanostomy tube insertion
* At least 6 months old
* Behavioral capacity and cooperative temperament to undergo an awake procedure (based on physician judgement)
* No history of sensitivity or reaction to anesthesia chosen for the procedure

Exclusion Criteria:

* Pregnant or lactating females
* Significantly atrophic, bimeric, or completely atelectatic tympanic membrane
* Otitis externa
* Lacerations or abrasions to the external auditory canal or damaged or denuded skin in the auditory canal
* Cerumen impaction resulting in a significant amount of cleaning required to visualize the tympanic membrane
* Electrically sensitive subjects and subjects with electrically sensitive support systems (pacemakers, defibrillators, etc.)
* Anatomy that precludes sufficient visualization of and access to the tympanic membrane
* Anatomy that necessitates tympanostomy tube placement in the posterior half of the tympanic membrane

Primary outcomes:
measure: Number of Subjects With Procedural, Serious and Device-related Adverse Events.
timeFrame: Procedure through 2 weeks post-procedure
measure: Device Success
timeFrame: Day 0 (day of procedure)
Secondary outcomes:
measure: Procedure Success
timeFrame: Day 0 (day of procedure)
measure: Procedure Tolerability
timeFrame: Day 0 (day of procedure)
measure: Tube Retention
timeFrame: 2 weeks post-procedure
Other outcomes:
Locations:
city: Port Saint Lucie
country: United States
facility: South Coast Ear, Nose, & Throat
state: Florida
Study officials:
affiliation: South Coast Ear, Nose & Throat
name: Jacob W. Zeiders, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02234791: Mutation of the BTK Gene and Genotype-phenotype Correlation of Chinese Patients With X-Linked Agammaglobulinemia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Agammaglobulinemia, BTK
Lead sponsor: Shanghai Children's Medical Center
Sponsor class: OTHER
First posted: 2014-09-09
Enrollment: 100
Sex: MALE
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: XLA patients

Brief summary: X-linked agammaglobulinemia (XLA) is a humoral primary immunodeficiency in which affected patients have very low levels of peripheral B cells and a profound deficiency of all immunoglobulin isotypes. Mutations in the gene encoding for Bruton's tyrosine kinase (Btk) are responsible for most of the gammaglobulinemia.

We tend to investigate the gene mutation and clinical features of Chinese X-linked agammaglobulinemia (XLA) patients, and also examined the relationship between specific Btk gene mutations and severity of clinical presentation.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of XLA A.male patients with less than 2% CD19-positive B cells; B.recurrent bacterial infection; C.decreased or absent immunoglobulins in serum

Exclusion Criteria for all groups:

* Presence of other primary immunodeficiency syndromes that do not meet the clinical and laboratory criteria for XLA

Primary outcomes:
measure: times of pneumonia
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Children'S Medical Center
state: Shanghai
Study officials:
References:
Clinical trial NCT06797791: Assessment of Multifocal Continuous Theta Burst Transcranial Magnetic Stimulation (cTBS) Effects in Generalized Epilepsy Patients.
Official title: Multifocal Theta Burst Transcranial Magnetic Stimulation in Generalized Epilepsy Management.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Generalized Epilepsy
Keywords: TBS
cTBS
IGE
Generalized
Epilepsy
Theta
Burst
Transcranial
Magnetic
Stimulation
Continuous
Lead sponsor: Universitatea de Stat de Medicina si Farmacie Nicolae Testemiţanu
Sponsor class: OTHER
Collaborators: name: Johannes Gutenberg University Mainz
First posted: 2025-01-28
Enrollment: 14
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 goal of this clinical study is to assess the efficacy of multifocal theta burst transcranial magnetic stimulation in the prevention of epileptic seizures in adult patients with generalized epilepsy. The main questions it aims to answer are:

* How does multifocal continuous theta burst stimulation (cTBS) impact the frequency and severity of epileptic seizures?
* Does cTBS influence the quality of life in patients with generalized epilepsy?
* What is the safety and tolerability profile of the experimental multifocal cTBS protocol?


Eligibility criteria: Inclusion Criteria:

- Adult patients with generalized epilepsy (according to ILAE 2017 classification of epilepsy).

Exclusion Criteria:

* refusal to sign the informed consent;
* focal, combined or unknown epilepsy (according to ILAE criteria);
* drug-resistant form of epilepsy (according to ILAE definition);
* history or symptoms of renal or hepatic failure;
* history of oncological disorder;
* uncontrolled high blood pressure;
* cognitive impairment;
* psychiatric disorders;
* signs of structural brain injury or focal neurological symptoms;
* use of opioids or muscle relaxants;
* history of substance abuse;
* ferromagnetic implants in head and neck regions;
* cardiac pacemakers;
* pregnancy or lactation.

Primary outcomes:
measure: Seizure frequency
timeFrame: at 12 weeks
Secondary outcomes:
measure: Quality of Life in Epilepsy (QOLIE-31) Inventory
timeFrame: at 12 weeks
measure: Seizure Severity Questionnaire (SSQ)
timeFrame: at 12 weeks
measure: Patient Global Impression of Change (PGIC)
timeFrame: at 12 weeks
Other outcomes:
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
timeFrame: From start of intervention (Day 1) through 6 consecutive days (Day 6) of treatment
Locations:
city: Chisinau
country: Moldova, Republic of
facility: Emergency Medicine Institute
city: Chisinau
country: Moldova, Republic of
facility: Nicolae Testemițanu State University of Medicine and Pharmacy
Study officials:
References:
Clinical trial NCT01614691: Safety and Efficacy of SPARC1203 in Allergic Rhinitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Allergic Rhinitis
Lead sponsor: Sun Pharma Advanced Research Company Limited
Sponsor class: INDUSTRY
First posted: 2012-06-08
Enrollment: 159
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will assess safety and efficacy of SPARC1203 delivered via nasal spray in patients with allergic rhinitis


Eligibility criteria: Inclusion Criteria:

* Male and female patients aged 18 to 65 years (both inclusive) with history of seasonal allergic rhinitis and positive skin prick test

Exclusion Criteria:

* History or presence of perennial allergic rhinitis
* Upper or lower respiratory tract infection 2 weeks before Visit 2
* Significant pulmonary disease other than allergic rhinitis or mild asthma controlled by beta-2-agonists alone
* Immunizations or vaccinations within 4 weeks prior to Visit 1

Primary outcomes:
measure: Change in Total Nasal Symptom Score (TNSS)
timeFrame: Baseline and 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Hannover
country: Germany
facility: SPARC Site 1
Study officials:
References:
citation: Badorrek P, Hohlfeld JM, Krug N, Joshi A, Raut A. Efficacy and safety of a novel nasal steroid, S0597, in patients with seasonal allergic rhinitis. Ann Allergy Asthma Immunol. 2015 Oct;115(4):325-329.e1. doi: 10.1016/j.anai.2015.07.016. Epub 2015 Aug 11.
Clinical trial NCT02778191: Comparison of Concomitant Cisplatin Versus Carboplatin and 5-fluorouracil With Radiotherapy for Locally Advanced Head and Neck Squamous Cell Carcinoma
Official title: Comparison of Concomitant Cisplatin Versus Carboplatin and 5-fluorouracil With Radiotherapy for Locally Advanced Head and Neck Squamous Cell Carcinoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Head and Neck Squamous Cell Carcinoma
Keywords: Head and neck squamous cell carcinoma
cisplatin
carboplatin
5-fluorouracil
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
Collaborators: name: Amsterdam UMC, location VUmc
First posted: 2016-05-19
Enrollment: 413
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with locally advanced head and neck squamous cell carcinoma

Brief summary: Concomitant chemoradiotherapy improves overall survival in patients with locally advanced head and neck squamous cell carcinoma (LA-HNSCC) compared to radiotherapy alone. Cisplatin 100 mg/m2 at day 1, 22 and 43 is widely used but results in considerable acute and late toxicity. Three cycles of carboplatin plus 5-fluorouracil (5-FU) is an accepted alternative but both chemotherapy regimens have not been compared prospectively. The aim of this study is to compare tolerability, efficacy, toxicity and quality of life in patients with LA-HNSCC treated with concomitant cisplatin and carboplatin plus 5-FU.

Detailed description: This is a retrospective comparison of patients with LA-HNSCC treated with chemoradiotherapy at 2 tertiary care centers in the Netherlands (UMCG and VUmc), where one center routinely gives carboplatin plus 5FU (UMCG) and the other center (VUmc) uses high dose cisplatin as standard of care.

Eligibility criteria: Inclusion Criteria:

* Stage III-IV LA-HNSCC of hypopharynx, oropharynx, larynx, oral cavity
* Primary treatment with concomitant chemoradiotherapy consisting of three-weekly cisplatin or carboplatin plus 5-FU
* Age ≤ 70 years
* No previous treatment for head and neck cancer
* No distant metastases

Exclusion Criteria:

* Previous treatment for head and neck cancer
* Distant metastases

Primary outcomes:
measure: Chemotherapy completion rate
timeFrame: 1 year
Secondary outcomes:
measure: Overall survival
timeFrame: 1 year
measure: Progression free survival
timeFrame: 1 year
measure: Distant metastases
timeFrame: 1 year
measure: Grade 3-4 acute toxicity
timeFrame: 1 year
measure: Late toxicity
timeFrame: 1 year
measure: Quality of life
timeFrame: 1 year
measure: Quality of life
timeFrame: 1 year
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: VUmc
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
Study officials:
affiliation: UMCG
name: S. Oosting, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03164291: Effectiveness of Rifabutin in the Treatment of Mycobacterium Avium Complex
Official title: Clinical Efficacy of Rifabutin in the Treatment of Serious and Life Threatening Infections Due to Mycobacterium Avium Complex, or Drug Resistant Mycobacterium Tuberculosis, or Other Drug Resistant Mycobacterium
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Nontuberculous Mycobacterial Infections
Keywords: MAC and NTM
Lead sponsor: The University of Texas Health Science Center at Tyler
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2017-05-23
Enrollment: 170
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: Treatment of adults with chronic Mycobacterium avium-intracellulare complex lung infections who have failed or are intolerant of rifampin.

Rifabutin may be a reasonable alternative agent in patients who fail rifampin or or intolerant of rifampin.

Detailed description: Rifabutin dosage 150-300 mg daily( depending upon age, and clinical conditions) in NTM patients who fail treatment with rifampin.

Eligibility criteria: Inclusion Criteria:

* Adults age 18 and older with positive acid-fast bacilli smears and cultures for drug-resistant mycobacteria

Exclusion Criteria:

* Children less than 18 years of age
* Pregnancy
* Low platelet count, except with very serious disease

Primary outcomes:
measure: Clinical and microbiological outcomes (e.g. clinical symptoms, laboratory cultures)
timeFrame: 6 mos
Secondary outcomes:
measure: Microbiological Cultures
timeFrame: 1year
Other outcomes:
Locations:
city: Tyler
country: United States
facility: The University of Texas Health Science Center at Tyler
state: Texas
Study officials:
affiliation: The University of Texas Health Center at Tyler
name: Richard J Wallace, Jr, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Texas Health Science Center IRB Chair
name: William B Girard, MD
role: STUDY_CHAIR
References:
Clinical trial NCT06366191: Psychotrauma Prevention Algorithm : Randomized, Controlled Pilot Study
Official title: Psychotrauma Prevention Algorithm : Randomized, Controlled Pilot Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Psychological Trauma
Lead sponsor: Centre Hospitalier Universitaire de la Réunion
Sponsor class: OTHER
First posted: 2024-04-15
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: A randomized pilot study which proposes to patients having suffered a traumatic event to have either only the standard care or the standard care associated with adaptated psychotrauma watch and prevention system.


Eligibility criteria: Inclusion Criteria:

* Person who the vital prognosis has or could have been committed or having felt a threat to his physical and/or psychological integrity
* After a potentially traumatic event dating from a minimum of 72 hours to a maximum of 1 week
* for which the CUMP or the psychotrauma regulation platform has been requested
* having lived or being a direct witness of the event
* knowing how to read and write
* affiliate or beneficiary of a social security scheme
* having signed a consent

Non-inclusion Criteria:

* guardianship or curatorship
* unable to receive phone calls
* unable to go to a place for consultation

Primary outcomes:
measure: study acceptability rate
timeFrame: 6 months after inclusion
Secondary outcomes:
measure: Adherence of patient to the watch
timeFrame: 1 month after inclusion
measure: Adherence of patient to the health watch
timeFrame: 3 months after inclusion
measure: Patient satisfaction (quantitatif)
timeFrame: 3 months after inclusion
measure: Patient satisfaction (qualitatif)
timeFrame: 3 months after inclusion
measure: Strong points of the health watch
timeFrame: 3 months after inclusion
measure: Evolution of the patient journey in experimental arm
timeFrame: 3 months after inclusion
measure: Occurrence of post-traumatic stress disorder
timeFrame: 3 months after inclusion
measure: Complications associated with post-traumatic stress disorder
timeFrame: at inclusion
measure: Complications associated with post-traumatic stress disorder
timeFrame: 3 months after inclusion
measure: Complications associated with post-traumatic stress disorder
timeFrame: 3 months after inclusion
measure: Complications associated with post-traumatic stress disorder
timeFrame: 3 months after inclusion
Other outcomes:
Locations:
Study officials:
References: