louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00747383: How Improvement in Control of Diabetes Influences the Production of a Hormone Produced in the Gut Which Improves the Release and Action of Insulin.
Official title: Influence of Improving Glycaemic Control on Glucagon-Like-Peptide-1 Response to an Oral Glucose Load. Comparison of Sulphonylurea With DPP-4 Inhibition.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Keywords: Diabetes Mellitus
GLP1
DPP4
Lead sponsor: The Royal Bournemouth Hospital
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2008-09-05
Enrollment: 74
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: The study is aimed at Type 2 Diabetics who are taking Metformin, but whose Diabetes remains poorly controlled. There are two additional medications already in use, Glimepiride and Sitagliptin will be compared to assess levels of improvement in Diabetes control.


Eligibility criteria: Inclusion Criteria:

* Diabetes Mellitus
* Currently on Metformin but poor glycaemic control,

Exclusion Criteria:

* Under 18 years of age

Primary outcomes:
measure: Comparison of GLP-1 response at baseline and after 3 months treatment of both groups.
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Bournemouth
country: United Kingdom
facility: Royal Bournemouth Hospital
state: Dorset
Study officials:
affiliation: Royal Bournemouth Hospital
name: David Kerr
role: PRINCIPAL_INVESTIGATOR
affiliation: Royal Bournemouth Hospital
name: Joseph Begley
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01321983: Effects of Preoperative Inspiratory Muscle Training (IMT) in Obese Women Undergoing Open Bariatric Surgery
Official title: Effects of Preoperative Inspiratory Muscle Training (IMT) in Obese Women Undergoing Open Bariatric Surgery: Respiratory Muscle Strength, Lung Volumes and Diaphragmatic Excursion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Preoperative Inspiratory Muscular Training
Bariatric Surgery
Chest Physiotherapy
Postoperative Pulmonary Complications
Obesity
Lead sponsor: Universidade Federal de Sao Carlos
Sponsor class: OTHER
Collaborators: name: Meridional Hospital
name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
First posted: 2011-03-24
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT

Brief summary: OBJECTIVE: to determine whether preoperative inspiratory muscle training (IMT) is able to attenuate the impact of surgical trauma on the respiratory muscle strength, in the lung volumes and diaphragmatic excursion in obese women undergoing open bariatric surgery.

Therefore, the hypothesis of the present study was that preoperative IMT is able to attenuate the negative effects of surgical trauma on the respiratory muscle strength, in the lung volumes and diaphragmatic excursion, thus reducing the risk of PPC, in obese patients undergoing open bariatric surgery.

DESIGN: Randomized controlled trial. SETTING: Meridional Hospital, Cariacica/ES, Brazil. SUBJECTS: Thirty-two obese women undergoing elective open bariatric surgery were randomly assigned to receive preoperative inspiratory muscle training (IMT group) or usual care (control group).

MAIN MEASURES: Respiratory muscle strength (maximal inspiratory pressure - MIP and maximal expiratory pressure - MEP), lung volumes and diaphragmatic excursion.


Eligibility criteria: Inclusion Criteria:

* Female,
* Over 18 years of age,
* No smoking or respiratory disease.

Exclusion Criteria:

* Patients who refused to participate in the steps of the research protocol,
* Patients with a history of prior abdominal surgery,
* Patients who were unable to understand and perform the tests properly
* Patients who refused to sign the Informed Consent Term.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Cariacica
country: Brazil
facility: Meridional Hospital
state: Espirito Santo
Study officials:
References:
Clinical trial NCT02801383: Recombinant Human Interferon a-2b Gel for HPV-16 and/ or HPV-18 Gynecological Infections
Official title: Randomized, Double-blind, Parallel, Controlled Clinical Study to Evaluated the Efficacy and Safety of Recombinant Human Interferon Alpha-2b Gel (Yallaferon®) in HPV-16 and/or HPV-18 Infection
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Cervical HPV-16 and / or HPV-18 Infection
Lead sponsor: Lee's Pharmaceutical Limited
Sponsor class: INDUSTRY
First posted: 2016-06-15
Enrollment: 100
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: to assess the efficacy and safety of recombinant human interferon α-2b gel (Yallaferon®) for the treatment of patients with cervical HPV-16 and/or HPV-18 infections; to analyze the HPV type infections and clinical negative conversion.

Detailed description: 100 patients with positive HPV-16 and HPV-18 infection are randomized into interferon gel group and control group at ratio of 1:1 (50 patients in treatment group and 50 patients in control group). The patients in treatment group received 1g recombinant human α-2b interferon gel every other day for consecutive 6-10 courses of treatment, whereas no treatment was conducted in control group.

Eligibility criteria: Inclusion Criteria:

* Age 25 to 65 years of age with the sex life of female patients;
* HPV DNA typing test for HPV-16 and/ or HPV-18 positive in 1 month.

Exclusion Criteria:

* Patients with cervical intraepithelial neoplasia Ⅱ / Ⅲ, cervical cancer;
* Associated with fungal vaginitis, trichomonas vaginitis, HIV positive patients;
* Associated with acute, severe bacterial or viral infection;
* Autoimmune diseases;
* Within 3 months before screening patients used corticosteroids, immunosuppressants or other antiviral drugs;
* Allergies or allergy to the drug known ingredients;
* History of suffering CNS diseases, epilepsy and/or psychological disorder;
* Pregnant and lactating women;
* The researchers do not consider it appropriate clinical trials.

Primary outcomes:
measure: difference of HPV-16 and/ or HPV-18 DNA negative conversion rate
timeFrame: three months
Secondary outcomes:
measure: difference of HPV-16 and/ or HPV-18 DNA negative conversion rate
timeFrame: six months, nine months and twelve months
measure: The recurrent rate of HPV-16 and/ or HPV-18 DNA among patients with negative-conversion result between the two groups
timeFrame: 1 year
Other outcomes:
Locations:
city: Peking
country: China
facility: Peking University First Hospital
Study officials:
References:
Clinical trial NCT05436483: Preliminary Establishment of the Medical Reference Range of Serum Vitamin K2 in Chinese Healthy Adults
Official title: Preliminary Establishment of the Medical Reference Range of Serum Vitamin K2 in Chinese Healthy Adults
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Health, Subjective
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2022-06-29
Enrollment: 465
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy subjects

Brief summary: Osteocalcin is a type of vitamin K2-dependent protein, and many studies have confirmed that vitamin K2 has anti-osteoporosis effects, and has preventive and therapeutic effects on a variety of diseases such as nervous system, cardiovascular disease, immune disease, and glucose metabolism. However, as a pleiotropic vitamin and nutrient, vitamin K2 does not have an exact normal range like other vitamins, when it needs to be supplemented, and in what regimen. Different organizations have different opinions on the recommended intake of vitamin K. Thus, this study intends to preliminarily obtain the reference interval of serum vitamin K2 by conducting clinical research in healthy people in the Beijing-Tianjin-Hebei region, and analyzes different factors, such as gender, age, and place of residence, to compare their level differences and changing trends, and to provide data reference for the recommended intake of vitamin K2 for people with vitamin K2 deficiency.


Eligibility criteria: Inclusion Criteria:

* People aged over 18.
* People with normal routine blood test.
* Willing to participate in this study.

Exclusion Criteria:

* Subjects with congenital metabolic problems and endocrine diseases.
* Treatment with any investigational drug within the past 3 months.

Primary outcomes:
measure: Concentration of vitamin K2
timeFrame: During the procedure of regular physical checkups
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04909983: An Explorative Study of Treatment of Contact Dermatitis Due to DiabetesDevices
Official title: A Single Center Explorative Study of the Treamtent ofDiabetes Patients With Contact Dermatitits Caused byInsulin Infusion Pump or Glucose Monitor
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Contact Dermatitis Irritant
Type 1 Diabetes
Lead sponsor: Copenhagen University Hospital at Herlev
Sponsor class: OTHER
First posted: 2021-06-02
Enrollment: 17
Sex: ALL
Minimum age (years): 6
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A feasibility study of treatment with a occlusive medical device or patch in pediatric patients with type 1 diabetes suffering from irritative contact dermatitis due to diabetes devices.


Eligibility criteria: Inclusion Criteria:

* Signed informed consent, and for patients under the legal age consent by a legal guardian
* Clinically confirmed, active and evaluable irritant contact dermatitis (ICD)
* Age 6-20 at the time of signing the informed consent form (ICF)
* Ability to answer study questionnaires

Exclusion Criteria:

* Any type of skin irritation other than ICD
* Use of occlusive therapy for the treatment of their ICD, or unwilling to refrain from this treatment for duration of study
* For any other reason considered unsuitable by the investigator
* Pregnant or of child-bearing potential unwilling to use acceptable effective contraception

Primary outcomes:
measure: Response rate of active treatment versus standard of care
timeFrame: 8 days after active treatment compared to 8 days after standard of care
Secondary outcomes:
measure: Time to resolution of Irritative contact dermatitis
timeFrame: After 8 days
Other outcomes:
Locations:
city: Herlev
country: Denmark
facility: Pediatric Department, Herlev Hospital
Study officials:
affiliation: Pediatric Department, Herlev Hospital
name: Anna Korsgaard Berg, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03323983: Exploratory Study on Link Between Dynamic Hyperinflation and Lung Clearance Index in Cystic Fibrosis
Official title: Exploratory Study on Link Between Dynamic Hyperinflation and Lung Clearance Index in Cystic Fibrosis (Étude du Lien Entre la Distension Dynamique et l'Indice de Clairance Pulmonaire Dans la Mucoviscidose)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cystic Fibrosis
Lung Clearance Index
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2017-10-27
Enrollment: 12
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children between 10 to 17 years old with a diagnosis of cystic fibrosis

Brief summary: Recent improvements in cystic fibrosis management have enabled an important subset of patients to maintain normal spirometry. Nevertheless, even in these patients with normal spirometry, chest computed tomography (CT) might identify structural lung abnormalities such as bronchiectasis, mucus plugging, bronchiolitis and air trapping.

Lung clearance index (LCI) has been shown to correlate well with structural pulmonary alterations seen on CT even in CF patients with well-preserved spirometry. In cystic fibrosis, a high LCI is associated with a worse feeling of illness assessed by the Cystic Fibrosis Questionnaire-Revised (CFQ-R). School-aged CF patients with normal spirometry also have normal aerobic function as assessed by peak oxygen uptake (V̇O2) measured during symptom-limited incremental cardiopulmonary exercise test. However, the ability of LCI to predict ventilatory abnormalities appearing at exercise in CF patients has not been investigated. The investigators therefore aimed to compare physiological parameters at exercise between CF patients with elevated LCI (i.e., LCI above the upper limit of normal \[ULN\]) and patients with normal LCI, all with preserved spirometry.


Eligibility criteria: Inclusion Criteria:

* children between 10 to 17 years old with a diagnosis of cystic fibrosis confirmed by sweat test and genetic test
* pulmonary function test and incremental cardiopulmonary exercise test included in their follow-up
* lung function preserved (FEV1 greater than the lower limit of normal)
* affiliation to the French social security
* children and their legal guardians informed of the use of anonymised data

Exclusion Criteria:

* recent respiratory infection
* association with another obstructive respiratory disease, especially with asthma

Primary outcomes:
measure: The main objective is to explore the relationship between elevated lung clearance index and dynamic hyperinflation in cystic fibrosis patients with preserved pulmonary function.
timeFrame: day 1
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00523783: Seroquel Long-Term NIS for Schizophrenia Patients
Official title: 24-Week Naturalistic Observational Study of Efficacy of Quetiapine in Patients With Schizophrenia or Schizoaffective Disorder
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Schizophrenia
Schizoaffective Disorder
Keywords: Schizophrenia
Schizoaffective
quetiapine
long-term efficacy
Naturalistic
Observational
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2007-08-31
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE

Brief summary: To assess the efficacy of 24-week treatment with quetiapine in patients with schizophrenia or schizoaffective disorder


Eligibility criteria: Inclusion Criteria:

* The patient and the patient's legal representative (if any) must understand the nature of the study and must have given written consent
* The patient suffers from schizophrenia or schizoaffective disorder according to DSM-IV-TR
* The patient is between 18 and 65 years old(extremes included)
* On the basis of physical and neurological examination, medical history, the patient is, in the investigator's opinion, otherwise healthy
* If the subject is a female of childbearing potential, she must be not pregnant or breast-feeding and be using a reliable method of contraception. Reliable methods may include abstinence, hormonal contraceptives (eg,oral contraceptives or long-term injectable or implantable hormonal contraceptives), double-barrier methods (eg, condom and diaphragm, condom and foam, condom and sponge), intrauterine devices, and tubal ligation

Exclusion Criteria:

* The patients who have known hypersensitivity to quetiapine

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Research Site
state: Dongdamoon-gu
city: Seoul
country: Korea, Republic of
facility: Research Site
state: Kangnam-gu
city: Seoul
country: Korea, Republic of
facility: Research Site
state: Songpa-gu
Study officials:
affiliation: AstraZeneca Korea
name: Joon-Woo Bahn
role: STUDY_DIRECTOR
References:
Clinical trial NCT02698683: Lymphocyte Count as a Sign of Immunoparalysis and Its Correlation With Nutritional Status in Septic Pediatric Patients
Official title: Lymphocyte Count as a Sign of Immunoparalysis and Its Correlation With Nutritional Status in Septic Pediatric Intensive Care Patients: A Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lymphopenia
Keywords: Nutrition
Lymphocyte Count
Immunoparalysis
nutritional status of septic patients
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2016-03-04
Enrollment: 14
Sex: ALL
Minimum age (years): 1
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: pediatric septic patients

Brief summary: Participants were classified as normal or malnourished according to anthropometric measures. Serum albumin and zinc were recovered on the 1st and 7th days of hospitalization. Lymphocyte count was also recorded on the 1st and 7th days.

Detailed description: The investigators enrolled 14 consecutive patients with sepsis. Patients were classified as normal or malnourished according to anthropometric measures. As an additional evaluation of nutritional status, serum albumin and zinc were recovered on the 1st and 7th days of hospitalization. Lymphocyte count was also recorded on the 1st and 7th days. Investigators correlated nutritional status with lymphocyte count and zinc dosage.

Eligibility criteria: Inclusion Criteria:

* septic patients

Exclusion Criteria:

-

Primary outcomes:
measure: presence of lymphopenia
timeFrame: seven days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Delgado AF, Okay TS, Leone C, Nichols B, Del Negro GM, Vaz FA. Hospital malnutrition and inflammatory response in critically ill children and adolescents admitted to a tertiary intensive care unit. Clinics (Sao Paulo). 2008 Jun;63(3):357-62. doi: 10.1590/s1807-59322008000300012.
citation: Manzoli TF, Delgado AF, Troster EJ, de Carvalho WB, Antunes AC, Marques DM, Zamberlan P. Lymphocyte count as a sign of immunoparalysis and its correlation with nutritional status in pediatric intensive care patients with sepsis: A pilot study. Clinics (Sao Paulo). 2016 Nov 1;71(11):644-649. doi: 10.6061/clinics/2016(11)05.
Clinical trial NCT04769583: 14-day Quadruple Therapy Versus Triple Therapy in HP Eradication
Official title: A Double Blind Randomized Study for Treatment of Helicobacter Pylori Infection: 14-day Non-bismuth Quadruple Therapy Versus Triple Therapy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Gastritis H Pylori
Keywords: Breath Tests
Helicobacter pylori
Lead sponsor: Les Laboratoires des Médicaments Stériles
Sponsor class: INDUSTRY
First posted: 2021-02-24
Enrollment: 121
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: In this prospective randomized-controlled study, treatment-naive H. pylori-infected patients are randomized to receive either standard triple therapy or sequential therapy. The aim is to compare the efficacy of concomitant quadruple therapy with standard triple therapy as a first line treatment for H. pylori infection in Tunisian patients.

Detailed description: This study includes male and female patients aged between 18 and 65, with documented Hp infection and who have had no previous eradication treatment.The diagnosis of Hp infection was made through an anatomopathological study. Gastric biopsies were taken according to the Sydney protocol: two fundics in one pot, two antrals and one at the angle of the lesser curve in a second pot. The biopsies were studied by an experienced anatomopathologist.

The included patients were randomly divided into two treatment groups according to a 1: 1 ratio: the first group received concomitant quadruple therapy (QC) combining a double dose PPI (esomeprazole: 40 mg x 2 per day) with the amoxicillin (1 g x 2 per day), metronidazole (500 mg x 2 per day) and clarithromycin (500 mg x 2 per day) for 14 days. The second group received triple therapy (TT) combining a double dose PPI (esomeprazole: 40 mg x 2 per day) with amoxicillin (1 g x 2 per day) and clarithromycin (500 mg x 2 per day) for 14 days.

H. pylori eradication was assessed by the 13C-urea breath test 8 weeks after treatment.

Eligibility criteria: Inclusion Criteria:

* patients aged between 18 and 65, with documented Hp infection.

Exclusion Criteria: are excluded patients:

* With Cirrhosis.
* With Renal failure (serum creatinine\> 120 µmol / L).
* Having complicated peptic ulcer (stenosis or hemorrhage or perforation) in an acute phase.
* Having severe psychiatric disorders.
* Having had gastric surgery in their history.
* Having already received an HP eradication treatment.
* Having received an antibiotic within the last two weeks.
* Who are allergic to one of the antibiotics used in the anti-Hp cure.
* Who are drug addicted.

Primary outcomes:
measure: HP eradiction rate
timeFrame: 6 weeks after completion of study treatment
Secondary outcomes:
measure: percentage of adverse reactions
timeFrame: 3 months
Other outcomes:
Locations:
city: Monastir
country: Tunisia
facility: Fattouma Bourguiba Hospital
Study officials:
References:
Clinical trial NCT06285383: The Effects of Music on Neck Pain
Official title: The Effect of Listening to Music in Addition to Physiotherapy on Pain, Anxiety and Quality of Life in Patients With Chronic Neck Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Chronic
Lead sponsor: KTO Karatay University
Sponsor class: OTHER
First posted: 2024-02-29
Enrollment: 40
Sex: ALL
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The effects of passive music listening on pain, anxiety and quality of life in patients with chronic neck pain in addition to physical therapy will be examined.

Detailed description: The aim of the study was to investigate the effects of passive music listening in addition to physical therapy on pain, anxiety and quality of life in patients with chronic neck pain.There is no study in the literature examining the relationship between music listening and physical therapy in chronic back pain. Since our study will be the first to investigate the subject, we foresee that it is scientifically important and will shed light on future studies. In addition, national or international publications are planned after the study is completed.

Eligibility criteria: Inclusion Criteria:

* patients with neck pain for more than 3 months with pain severity of 5 or greater according to the visual analogue scale (VAS)

Exclusion Criteria:

* individuals who regularly take painkillers or anti-depressant and cortisone; and individuals having severe chronic illness and spine surgery were excluded from the study

Primary outcomes:
measure: Beck anxiety inventory
timeFrame: baseline and 4 weeks
measure: Visual Analogue Scale
timeFrame: baseline and 4 weeks
measure: Short form-36
timeFrame: baseline and 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Karatay
country: Turkey
facility: Mustafa Savaş Torlak
state: Eyalet/Yerleşke
Study officials:
References: