louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00868049: Study of Stomatognathic System of the Obese Subjects
Official title: Study of Stomatognathic System,Chewing and Deglutition Functions in the Obese Subjects
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Keywords: chewing
deglutition
orofacial motricity
obesity
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2009-03-24
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 58
Standard ages: ADULT
Accepts healthy volunteers: yes
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: twenty obese patients (6 Male /14 Female, mean age 32.2 ± 9.9, mean BMI 43,3 ± 9.6 Kg/m2) and twenty lean volunteer (4 Male / 16 Female mean age 30.7 ±6.7, mean BMI 22.3 ± 1.9 Kg/m2)

Brief summary: The aim is to identify differences in the stomatognathic system, mastication and deglutition functions between obese and normal weight subjects.

Detailed description: The aim of this study was to identify differences in the stomatognathic system between obese and normal weight subjects. The habitual chewing of a French bread and deglutition of solids and liquid was evaluated five times in obese subjects and controls. The tonus of the lips, tongue, cheeks, masseter and temporal muscles were evaluated by clinical observation and palpation and defined as either normal or reduced. Twenty obese patients (body mass index (BMI) \> 30kg/m2) and twenty volunteers of normal weight (BMI 18.5-24.9 Kg/m2) were evaluated.

Eligibility criteria: Inclusion Criteria:

* healthy adults male and female
* healthy dentate
* body mass index (BMI) higher than 30 Kg/m2 for the obesity group and (BMI) lower than 25/m2 for the normal weight group.

Exclusion Criteria:

* face deformity
* alterations in morphology of lips and tongue
* without teeth or with lack of one tooth (excluding third molars)
* Malocclusion Angle's Class II and III
* pain during chewing
* pathology of the temporomandibular joint
* neurological pathology

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Medical School of University of São Paulo
Study officials:
affiliation: Clinic Hospital of Medical School of University of São Paulo
name: Adriana B Figueiredo, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Valera FC, Trawitzki LV, Anselmo-Lima WT. Myofunctional evaluation after surgery for tonsils hypertrophy and its correlation to breathing pattern: a 2-year-follow up. Int J Pediatr Otorhinolaryngol. 2006 Feb;70(2):221-5. doi: 10.1016/j.ijporl.2005.06.005. Epub 2005 Jul 21.
Clinical trial NCT04860349: Is High Intensity Interval Training Effective to Reduce the Waist Circumference and Fat Percentage at Trunk Region
Official title: Effects of High Intensity Interval Training on Waist Circumference and Fat Percentage at Trunk Region Among Physically Inactive Overweight Young Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Physically Inactive
Adults
Lead sponsor: Universiti Tunku Abdul Rahman
Sponsor class: OTHER
First posted: 2021-04-26
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Overweight is a risk factor for a number of non-communicable diseases, and this risk doubles, if an individual is physically inactive. Various exercise interventional protocols in the past have been reported on treating overweight and obesity which helps to decrease the different anthropometric variables. Despite all these protocols, obese and overweight do not seem to benefit greatly by these exercise training programs, as lack of time is thought to the main reason for not engaging in healthful physical exercise. Research evidence has proven that people with a body mass index of more than 30 kg/m2 and waist circumference of more than 102 cm have 2-fold higher risk of waking fewer steps daily. Although physical exercise is thought to be very helpful in regulating the body weight, it is very important to identify the type of physical activity to effectively manage overweight and obesity. Aerobic exercise namely high intensity interval training have been reported to reduce the body mass, fat%, and waist circumference. Investigators believe that high intensity interval training would help in controlling the various anthropometric variables namely the body mass index, waist circumference, and fat% in trunk region in physically inactive overweight adults.


Eligibility criteria: Inclusion Criteria:

* Either gender
* Aged 18-25 years
* Physically Inactive

Exclusion Criteria:

* Any medical condition that restrict the participants to participate in physical exercise
* Blood pressure of more than 140/90 mmHg
* Participants taking any medication that causes drowsiness

Primary outcomes:
measure: Body Mass Index
timeFrame: Change from Baseline Body Mass Index at 4 weeks
measure: Waist Circumference
timeFrame: Change from Baseline Waist Circumference at 4 weeks
measure: Fat Percentage at Trunk Region
timeFrame: Change from Baseline Fat Percentage at Trunk Region at 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Kajang
country: Malaysia
facility: Universiti Tunku Abdul Rahman
state: Selangor
Study officials:
References:
Clinical trial NCT02541149: Annexin A2 as a Novel Diagnostic Marker in Hepatocellular Carcinoma
Official title: Evaluation of Annexin A2 as a Novel Diagnostic Marker for Hepatocellular Carcinoma in Egyptian Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatocellular Carcinoma (HCC)
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2015-09-04
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult Egyptian patients attending outpatient clinic for HCC , Ain Shams University Hospitals, Cairo Egypt (Group 1\&2)

Brief summary: This study aimed to investigate the clinical utility of Annexin A2 serum level as a novel diagnostic marker of hepatocellular carcinoma (HCC) and to correlate its level with alpha fetoprotein the current marker ofhepatocellular carcinoma (HCC).

Detailed description: This study was carried out in HCC clinic , Ain Shams University Hospitals, Cairo; Egypt and included :Group 1: Fifty patients with early stage hepatocellular carcinoma(BCLC stage A); Group 2:Twenty five patients with chronic liver disease diagnosed based on clinical, laboratory, and ultrasonographic investigations; Control Group: Fifteen healthy, age and sex-matched subjects with seronegative hepatitis viral markers .All groups were subjected to thorough history taking, full clinical examination, and laboratory investigations including viral hepatitis markers: HBsAg and HCV antibodies using ELISA technique and HCV RNA using real time PCR for HCV antibody positive patients, AFP by electrochemiluminescence and Annexin A2 estimation using ELISA technique.

Eligibility criteria: Inclusion Criteria:

* Inclusion criteria for HCC cases:

  1. Confirmed diagnosis of HCC according to the European association of study of liver diseases \[13\].
  2. Early stage HCC (Stage A), using the Barcelona Clinic Liver Cancer (BCLC) staging system, (single or 3 nodules \< 3cm PS 0) For all participants:.
* Informed consent from all participants before enrollment in the study.

Exclusion Criteria:

* For HCC patients:

  1-Imtermediate or advanced stage HCC as defined by BCLC 2. Major vascular tumor invasion or metastasis confirmed by radiological imaging studies.

  3. Patients with other suspected solid malignancies or metastatic liver tumors, 4. Other types of chronic liver diseases (CLD) such as autoimmune hepatitis and primary biliary cirrhosis.
* For all participants:

  * Refusal to participate in the study

Primary outcomes:
measure: serum Annexin A2 in patients with hepatocellular carcinoma, chronic liver disease and healthy subjects
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05928949: Pilates Exercises and Down Syndrome
Official title: Effect of Pilates Exercises on Balance and Gross Motor Co-Ordination In Children With Down Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Balance
Down Syndrome
Pilates Exercises
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-07-03
Enrollment: 30
Sex: ALL
Minimum age (years): 6
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Down syndrome is one of the genetic disorders that affect postural control and balance in children. Balance involves controlling the position of the body in space to achieve stability and orientation. pilates exercises are one of several techniques that are used to improve balance and postural control in adults and children.

the purpose of the study is To investigate the effect of Pilates exercises on balance and gross motor co-ordination in children with Down syndrome

Detailed description: Group A performed flexibility, strength, and endurance exercises that focused on the lower extremity and trunk muscles, exercise for postural stability in various positions and surfaces, including flexibility exercises for the hip, knee and calf muscle. Strengthening exercises included the core muscles, hip abductors, hip extensors hamstrings and quadriceps knee extension in high sitting. Postural control involved walking in all directions, exceeding the limits of stability in various positions such as kneeling, half kneeling, standing on rough and soft surfaces, Each session started with a warming up and cooling down of 5 minutes for each period and each session lasted for 45 minutes.

Group B received the same program of exercises given to group A in addition to 45 minutes of Pilates exercises to improve balance and gross motor coordination. Exercises were performed on a mat, a medical ball, and from a standing position, focusing on maintaining core contraction, spinal and pelvic alignment, and respiration rhythm. Ten repetitions of Pilates exercises will be performed with a 2-minute rest period between repetitions. Both groups will attended the intervention program three times/week for 3 months

Eligibility criteria: Inclusion Criteria:

* (1) diagnosed with Trisomy 21 through genetic testing, (2) aged 6 to 11 years and (3) able to follow a minimum of two-step instructions. The minimum motor ability of participants with DS was independent locomotion.

Exclusion Criteria:

* (1) medical condition that is contraindicated to moderate to vigorous physical activity such as cardiovascular problems, (2) orthopaedic instability, including those associated with DS (e.g. atlanto-axial instability) and (3) behavioural issues that hindered instruction.

Primary outcomes:
measure: balance
timeFrame: 3 months
measure: Bruininks-oseretsky test of motor proficiency-second version (BOT-2)
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty Of Physical Therapy
state: الجيزه
Study officials:
References:
Clinical trial NCT00195949: Laparoscopic Versus Open Pyloromyotomy for Infants With Idiopathic Hypertrophic Pyloric Stenosis
Official title: Laparoscopic Versus Open Pyloromyotomy for Infants With Idiopathic Hypertrophic Pyloric Stenosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertrophic Pyloric Stenosis
Keywords: Pyloric Stenosis
Laparoscopy
Idiopathic Hypertrophic Pyloric Stenosis
Lead sponsor: Children's Mercy Hospital Kansas City
Sponsor class: OTHER
First posted: 2005-09-20
Enrollment: 200
Sex: ALL
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Pyloric stenosis is a condition that develops in infants and that leads to an obstruction of the channel going out of the stomach. This study is being performed to determine if there is an advantage to the laparoscopic approach or the open approach for the surgical correction of the enlarged pylorus.

Detailed description: Pyloromyotomy for pyloric stenosis has traditionally been performed via an open technique. With advancements in minimally invasive surgery in infants a laparoscopic approach has been developed. These two approaches have never been critically evaluated with regard to superiority of one technique over the other. This is a prospective randomized trial involving infants with pyloric stenosis. It will enroll 100 patients in each arm (statistical and power analysis was performed by Steve Simon, PhD). Parental consent will be obtained and the patients will be randomized to undergo open or laparoscopic pyloromyotomy. Patient age at diagnosis, electrolyte disturbances at diagnosis, ultrasound findings, operative approach, length of pyloromyotomy, operative times, time to tolerating full feeds, number of emesis episodes, length of hospitalization, operative charges, and hospital charges will be collected for comparison between the groups.

Eligibility criteria: Inclusion Criteria:

* All infants less than 12 weeks of age who have undergone surgical consultation and abdominal ultrasound confirming the diagnosis of pyloric stenosis and whose parents have given consent for inclusion in the study.

Exclusion Criteria:

* All patients greater than 12 weeks of age, or without parental consent, or without pyloric stenosis will be excluded from the study.

Primary outcomes:
measure: Operative Time
Secondary outcomes:
measure: Time to full feeds
measure: Length of hospitalization
measure: Pain medication requirements
measure: Emesis episodes
measure: Complications
Other outcomes:
Locations:
city: Kansas CIty
country: United States
facility: Children's Mercy Hospital
state: Missouri
Study officials:
affiliation: Children's Mercy Hospital Kansas City
name: Daniel J Ostlie, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02766049: Study of Anti-HIV Cellular Therapy Based on Dendritic Cells Pulsed With Chemically Inactivated Virus
Official title: Phase I/II Study of Anti-HIV Cellular Therapy Based on Dendritic Cells Pulsed With Chemically Inactivated Virus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: HIV Infection
Keywords: HIV
immunotherapy
clinical trial
dendritic cell
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2016-05-09
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study was to assess tolerability and safety of three different formulations of an anti-HIV immunotherapy based on autologous dendritic cells (DCs) pulsed with HIV chemically inactivated with Aldrithiol™-2 (AT-2). Patients were chronically infected with HIV, naïve for antiretroviral drugs. A possible immunological and virological favorable impact was also assessed.


Eligibility criteria: Inclusion Criteria:

* patients with HIV infection;
* absence of antiretroviral therapy, antineoplastic therapy or the use of corticosteroids for at least six months prior to study entry;
* plasma viral load ≥ 1,000 copies / mL, stable (ie no variation \> 0.5 log) in the six months before the start of the study;
* blood CD4+ T cells ≥ 350 /mL, stable (ie no variation \> 25%) in the six months before the start of the study.

Exclusion Criteria:

* individuals without proper venous access for blood and apheresis collection procedure.
* use of drugs, alcohol, psychiatric disorder or any condition that interferes with the ability of patients to follow the requirements of the study;
* history of diagnosis of HIV infection \<01 years;
* pregnancy or breast-feeding;
* use of antiviral therapy, in anticancer therapies or corticosteroids six months prior to study start;
* presence of chronic diseases, such as infection with hepatitis B (HBV) and C (HCV), human T-lymphotropic virus (HTLV) I / II or any condition that promotes immune system dysfunction, with the exception of HIV infection.

Primary outcomes:
measure: Number of participants with ≥ grade 3 adverse events related to product
timeFrame: 51 weeks
Secondary outcomes:
measure: Number of participants with change in plasma viral load from baseline, over the observation period
timeFrame: Baseline to 51 weeks
measure: Number of participants with change in CD4+T cells from baseline, over the observation period
timeFrame: Baseline to 51 weeks
Other outcomes:
Locations:
Study officials:
affiliation: University of Sao Paulo
name: Alberto JS Duarte, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lu W, Arraes LC, Ferreira WT, Andrieu JM. Therapeutic dendritic-cell vaccine for chronic HIV-1 infection. Nat Med. 2004 Dec;10(12):1359-65. doi: 10.1038/nm1147. Epub 2004 Nov 28.
citation: Oshiro TM, de Almeida A, da Silva Duarte AJ. Dendritic cell immunotherapy for HIV infection: from theory to reality. Immunotherapy. 2009 Nov;1(6):1039-51. doi: 10.2217/imt.09.68.
Clinical trial NCT00134849: Hypertension in Management of Military Medicine
Official title: Hypertension in Management of Military Medicine
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Hypertension
Keywords: hypertension
Lead sponsor: United States Naval Medical Center, San Diego
Sponsor class: FED
First posted: 2005-08-25
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: RETROSPECTIVE

Brief summary: This study is a retrospective database review of primary care appointments of patients' charts with new diagnoses of hypertension.

Detailed description: Compare the degree of blood pressure control of patients with stage 1 (BP \< 130/80 mmHg) and stage 2 hypertension (BP \> 20/10 mm Hg above goal BP) before and after the release of the Seventh report of Joint Committee on Prevention, Detection, Evaluation and Treatment of High Blood Pressure (JNC 7) recommendations.

Eligibility criteria: Inclusion Criteria:

* Newly diagnosed hypertension

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Naval Medical Center San Diego
state: California
Study officials:
affiliation: United States Naval Medical Center, San Diego
name: Ryan C Maves, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06257849: Validity and Reliability of a Danish Version of the Banff Patella Instability Instrument (BPII 2.0-DK)
Official title: Validity and Reliability of a Danish Version of the Banff Patella Instability Instrument (BPII 2.0-DK)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Patella Dysplasia
Keywords: BPII 2.0
Patella instability
Knee
Questionnaire
Lead sponsor: Aarhus University Hospital
Sponsor class: OTHER
First posted: 2024-02-14
Enrollment: 65
Sex: ALL
Minimum age (years): 14
Maximum age (years): 40
Standard ages: CHILD
ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Patella instability

Brief summary: The Banff Patella Instability Instrument (BPII 2.0) is a disease-specific quality of life questionnaire designed to assess adults with patellar dislocations.

As the BPII 2.0 already is cross-cultural translate and adapted to Danish the examination of the the psychometric properties of the Danish version is still needed

The aim om this study is to determine validity and reliability of the Danish version BPII 2.0-DK in a Danish populations of patients with patellar dislocation.


Eligibility criteria: Inclusion Criteria:

* Danish Speaking
* Patella instability problems

Exclusion Criteria:

* None

Primary outcomes:
measure: Banff patella instability instrument (BPII 2.0)
timeFrame: Baseline, after 6-8 days
measure: Anterior knee pain scale (Kujala)
timeFrame: Baseline
measure: Victorian Institute of Sports Assessment - Patella questionnaire (VISA-P)
timeFrame: Baseline
measure: International knee documentation committee (IKDC)
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus N
country: Denmark
facility: Division of Sports Trauma, Palle Juul-Jensens Boulevard 99
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
Study officials:
References:
Clinical trial NCT01896349: Interpersonal Psychotherapy for Treatment Resistant Depression
Official title: Efficacy of Interpersonal Psychotherapy in Treatment Resistant Depression
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Treatment Resistant Depression
Keywords: Psychotherapy, Treatment Resistant Depression, depression
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
First posted: 2013-07-11
Enrollment: 74
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: The purpose of this study is to determine whether combination of antidepressant drugs plus interpersonal psychotherapy is superior to antidepressant drugs alone in treatment resistant depression.


Eligibility criteria: Inclusion Criteria:

* Primary diagnose of unipolar treatment resistant depression

Exclusion Criteria:

* Patients diagnose of: bipolar disorder, psychosis, high suicide risk, Intellectual disability, illicit drug dependence.
* Currently in or having received psychotherapy in the last 4 weeks

Primary outcomes:
measure: Hamilton Depression Scale (HAM-D) - continuous
timeFrame: End point week 19 and Week 24
Secondary outcomes:
measure: Beck depression Inventory (BDI)
timeFrame: End point week 19 and Week 24
Other outcomes:
measure: Clinical Global Impression - Severity Scale (CGI-S) / dichotomous
timeFrame: Endpoint (week-19) and week 24
measure: Whoqol brief - World Health Organization Quality of Life Instrument - Short version - Brazilian version
timeFrame: Endpoint week 19 and week 24
measure: Biological measures - BDFN, TBARS, TNF-alfa, IL-1, IL-6
timeFrame: End point week 19 and Week 24
Locations:
city: Porto Alegre
country: Brazil
facility: Federal University of Rio Grande do Sul / Hospital de Clínicas de Porto Alegre (HCPA)
state: RS
Study officials:
affiliation: Federal University of Rio Grande do Sul / Hospital de Clínicas de Porto Alegre
name: Marcelo PA Fleck, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Souza LH, Salum GA, Mosqueiro BP, Caldieraro MA, Guerra TA, Fleck MP. Interpersonal psychotherapy as add-on for treatment-resistant depression: A pragmatic randomized controlled trial. J Affect Disord. 2016 Mar 15;193:373-80. doi: 10.1016/j.jad.2016.01.004. Epub 2016 Jan 8.