louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02847416: A Study of Pressure and Flow Characteristics During Inspiration and Expiration Using BreatheMAX® in Healthy Subjects
Official title: to Explore the Characteristics of Mean Airway Pressure, Oscillatory Amplitude and Power Spectral Density (PSD) of Oscillatory Airway Pressure That Generate by Various Loaded and Flow Rate During Expiration and Inspiration in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Subjects
Lead sponsor: Khon Kaen University
Sponsor class: OTHER
First posted: 2016-07-28
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: the aim of this study are to explore the characteristics of mean airway pressure, oscillatory amplitude and power spectral density (PSD) of oscillatory airway pressure that generate by various loaded and flow rate during expiration and inspiration in healthy subjects and to explore the best loaded and flow rate for airway secretion clearance using the BreatheMAX® device

Detailed description: For inspiratory group, the resistive load 3, 4, 5, 6 and 7 cm H2O were test with three flow rate: 0.2, 0.4, and 0.6 L/sec in each load. In each flow rate, the subjects were instructed to inspire as deeply as possible with steady flow rate for 3 seconds with end-inspiratory pause for 2-3 seconds through the inspiratory circuit and follow by passive exhalation. For expiratory group, the resistive load and flow rate were test similar inspiratory group. In each flow rate, the subjects were instructed to inspire as deeply as possible through the nose with end-inspiratory pause for 2-3 seconds and partially forced exhalation with reach to 1/3 of expiratory reserve volume (ERV) for at least 3 seconds through expiratory circuit

Eligibility criteria: Inclusion Criteria:

* the healthy subjects
* able to breathe against resistive load with the BreatheMAX device
* good conscious and cooperation

Exclusion Criteria:

- fever

Primary outcomes:
measure: PSD of oscillatory airway pressure
timeFrame: 5 seconds during inspiration and expiration testing period
Secondary outcomes:
measure: mean airway pressure
timeFrame: 5 seconds during inspiration and expiration testing period
measure: oscillatory amplitude
timeFrame: 5 seconds during inspiration and expiration testing period
Other outcomes:
Locations:
city: Khon Kaen
country: Thailand
facility: Pulmonary research room of physical therapy department, Faculty of associated medical sciences, Khon Kaen University
Study officials:
affiliation: faculty of associated medical science, KhonKaen University, Thailand 40002
name: sujittra Kluayhomthong, master degree
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00686816: Weight Loss in Pre-diabetic, Obese Women
Official title: A Study Among Pre-diabetic, Obese Women to Evaluate the Weight Loss Effects of a Non-Digestible Fat Substitute
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Obesity
Keywords: pre-diabetic
obese
Lead sponsor: Procter and Gamble
Sponsor class: INDUSTRY
First posted: 2008-05-30
Enrollment: 80
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a six (6) month, single center, randomized, double-blind, parallel, controlled-feeding weight-loss study comparing two dietary groups (triglyceride and olestra) in pre-diabetic obese women.


Eligibility criteria: Inclusion Criteria:

* Premenopausal
* BMI 30-45 kg/meter squared
* waist circumference greater than 88 cm
* blood glucose level 5.8-6.9 mmol/l

Exclusion Criteria:

* Pre-diabetic
* pregnant
* nursing
* food preferences not compatible with the study diet
* allergies or food sensitivities with any of the study diet

Primary outcomes:
measure: weight loss
timeFrame: 3 months
Secondary outcomes:
measure: Weight maintained
timeFrame: 6 months
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Vasily Isakov, MD
Study officials:
affiliation: Russian Institue of Nutrition
name: Vasily Isakov, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04260516: The Effect of N-acetylcysteine on Oxidative Stress Status and Iron Overload in Thalassemia Major
Official title: The Effect of N-acetylcysteine on Oxidative Stress Status and Iron Overload in Thalassemia Major
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Thalassemia Major
Lead sponsor: Beni-Suef University
Sponsor class: OTHER
First posted: 2020-02-07
Enrollment: 100
Sex: ALL
Minimum age (years): 3
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two groups are followed up for study parameters for 3 months one group is the intervention group and the other is the control group
Primary purpose: TREATMENT

Brief summary: The effect of N-acetylcysteine as antioxidant and its effect on pretransfusion hemoglobin and iron overload in patients with thalassemia were compared to patients who didn't receive n-acetylcysteine after 3 months of study duration

Detailed description: N-acetylcysteine( NAC) is a widely used mucolytic drug and several studies had reported its efficacy as anti oxidant. Patients with thalassemia major are at great risk for oxidative stress due to excess of b-globin chains and iron overload. In this study the investigators compared the effect of NAC on oxidative status , pretransfusion hemoglobin levels and iron overload in thalassemia patients before and after treatment with NAC for 3 months and with that of patients who served as controls.

Eligibility criteria: Inclusion Criteria:

* Thalassemia major children on regular blood transfusion and iron chelation therapy

Exclusion Criteria:

* Renal or hepatic impairments
* Complicated thalassemia major
* Non adherence to therapy or follow up visits
* Change in the iron chelation dose within 3 months before enrollment or during study period

Primary outcomes:
measure: Oxidative stress index (pg/mmol)
timeFrame: 3 months
measure: Serum ferritin level ( mg/dl)
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Banī Suwayf
country: Egypt
facility: Heba Mostafa Ahmed
state: Beni Suef
Study officials:
affiliation: Beni-Suef University
name: Heba M Ahmed
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ozdemir ZC, Koc A, Aycicek A, Kocyigit A. N-Acetylcysteine supplementation reduces oxidative stress and DNA damage in children with beta-thalassemia. Hemoglobin. 2014;38(5):359-64. doi: 10.3109/03630269.2014.951890. Epub 2014 Sep 15.
Clinical trial NCT04787016: Effects of Pilates Training on Physical Performance of Cricketers
Official title: Effects of Pilates Training on Physical Performance of Cricketers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Core Strengthening
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2021-03-08
Enrollment: 20
Sex: MALE
Minimum age (years): 19
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study is designed to evaluate the effectiveness of Pilates training improves physical fitness of cricket players.

Detailed description: During the modern times, researchers have notably increased their knowledge, grounded on literature, with regards to the relationship between core stability and athletic performance. Number of research studies have also been completed that underline the benefits of core stability training on injury prevention or performance, but in combination with other training modalities such as speed, power, strength and agility. Although several studies have investigated core stability benefits in athletes but there are very limited studies have presented the role of Pilate training in increasing the core strength and stability of cricket players in order to maximize their performance in the game. This study will contribute in describing the effects of Pilate training in cricket players.

Eligibility criteria: Inclusion Criteria:

* Participants falling in this category would be recruited into the study. Active Male cricketers. Had practiced for at least 2 years Age group of 19-30 Players with normal BMI (ranging in between 18.5 to 24.9)

Exclusion Criteria:

* Participant failing to fall in this category would be excluded of the study. History of metabolic diseases.

History of recent fractures. Players taking substance inhibited (in and out of the competition) by WADA Had extreme discomfort on contracting the abdominal muscles.

Were spin bowlers.

Primary outcomes:
measure: To evaluate the effectiveness of Pilates training improves physical fitness of cricket players.
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: Riphah international University
state: Federal
Study officials:
References:
Clinical trial NCT00437216: Efficacy, Tolerance and Satisfaction With CLOBEX® Spray When Used as Monotherapy or Add-on Therapy in Plaque Psoriasis
Official title: Phase 4 Open-Label Multicenter Community-based 4-Wk Trial to Assess Efficacy, Tolerance to Tx & Patient Satisfaction w/ CLOBEX® Spray When Used as Mono- or Add-on Therapy to Existing Systemic/Topical Agents for Tx of Plaque Psoriasis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psoriasis
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2007-02-19
Enrollment: 2488
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community Sample

Brief summary: Evaluation of the effectiveness of Clobex® Spray, 0.05% when used as monotherapy or add-on therapy to existing systemic or topical anti-psoriatic agents.

Detailed description: Evaluation of the effectiveness of Clobex® Spray, 0.05% when used as monotherapy or add-on therapy to existing systemic or topical anti-psoriatic agents, as determined by the change in the target plaque severity (TPS) rating between Weeks 0 and 4.

Eligibility criteria: Inclusion Criteria:

* Moderate to severe plaque psoriasis between 3% and 20% of Body Surface Area (BSA) with a target plaque severity (TPS) of moderate to severe
* At least 1 target site (not on the palms or soles of the feet) with a TPS rating of moderate to severe and with 1 or more elevated, easily palpable, plaques having well-circumscribed margins, and at least 1 cm in diameter
* History of stable plaque psoriasis of greater than or equal to 3 months

Exclusion Criteria:

* Diagnosis of guttate, generalized pustular, erythrodermic, psoriatic arthritis, or nail psoriasis as the sole or predominant form of psoriasis
* Psoriatic arthritis that was not stable or might have required a change in medication during the 4-week study period
* Plaque psoriasis requiring treatment on the face, scalp, neck, groin, and armpits

Primary outcomes:
measure: Efficacy - Change in Target Plaque Severity rating
timeFrame: 4 weeks
Secondary outcomes:
measure: Efficacy - Self-Assessment of Quality of Life, Subject satisfaction
timeFrame: 4 weeks
measure: Safety - Evaluation of adverse events and tolerability
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Cedar Knolls
country: United States
facility: DHC Dimensional HealthCare, Inc. (Clinical Research Organization)
state: New Jersey
Study officials:
affiliation: Galderma Laboratories, LP
name: Ronald W Gottschalk, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01834716: Exercise in Asymptomatic Pre-Alzheimer's Disease Pilot Study
Official title: Exercise in Asymptomatic Pre-Alzheimer's Disease Pilot Study/ 18F-AV-45-A14 - CLINICAL EVALUATION OF FLORBETAPIR F 18 (18F-AV-45) Sponsor of 18F-AV-45-A14: Avid Radiopharmaceuticals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer's Disease Prevention
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2013-04-18
Enrollment: 16
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Researchers are trying to determine if cognitively normal subjects undergoing a moderate aerobic exercise program will accumulate less amyloid-ß (Aβ) concentration in their brain than subjects undergoing a non-aerobic exercise program, and further evaluating the safety and imaging characteristics of florbetapir F 18, the radioactive drug that will allow us to image changes in the brain amyloid-ß (Aβ).

Detailed description: After screening assessments have been completed, subjects will be randomized into one of two groups: aerobic exercise group and non-aerobic exercise group. All subjects will be trained on the Physical Activity Scale for the Elderly (PASE), using the Body Media armband, and exercise diary. Subjects will also complete an online food questionnaire.

Subjects assigned to the aerobic exercise group will work with an exercise trainer who will provide individual training (six half hour sessions) until they are proficient at the use of the equipment and understand goals. Subjects will return to Brooks Family YMCA at their convenience, but at a minimum of four times per week. Subjects will complete the exercise journal daily and the Physical Activity Scale for the Elderly (PASE) questionnaire on a monthly basis.

Subjects assigned to the non-aerobic exercise group will attend supervised classes on toning and stretching at a minimum of four times per week. Subjects will complete the exercise journal daily and the Physical Activity Scale for the Elderly (PASE) questionnaire on a monthly basis.

Eligibility criteria: * 65 years of age or older.
* Not diagnosed with memory problems.
* Do not exercise in which you sweat and/or raise your pulse rate more than 30 minutes two times per week.
* Able to walk ten blocks (about one mile).
* Willing to participate in weekly exercise classes at the Brooks YMCA for six months.
* Able to have an MRI and CT/PET scan.

Primary outcomes:
measure: Number of Subjects Retained at 6 Months
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Neill Graff-Radford, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05295316: Risk Factors of Primary Fibromyalgia
Official title: Risk Factors Recognition of Primary Fibromyalgia: a Case-control Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fibromyalgia
Keywords: Osteopathy
Lead sponsor: Studio Osteopatico Busto Arsizio
Sponsor class: OTHER
First posted: 2022-03-25
Enrollment: 94
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Female patients with or without fibromyalgia

Brief summary: Fibromyalgia (FM) is a condition with a different non-specific symptoms which lead to a difficult diagnosis. Study suggests that osteopathy can help in improving FM symptoms, nevertheless, it can be difficult to identify which patients may benefit. The knowledge of FM risk factor can be useful tool for osteopaths and other clinician to implement a targeted, fast and multidisciplinary treatment protocol for those kind of patient.


Eligibility criteria: Inclusion Criteria:

* female patients
* Patient from Piedmont
* age between 20 and 65 years old
* inform consent
* for case group primary or secondary fibromyalgia

Exclusion Criteria:

* systemic or rheumatic or neoplastic diseases
* for control group the presence of primary or secondary fibromyalgia

Primary outcomes:
measure: Incidence of 29 stressing events
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Novara
country: Italy
facility: OsteoMedical
Study officials:
affiliation: Accademia Italiana Medicina Osteopatica
name: Carolina Lavazza, MSc
role: STUDY_CHAIR
References:
Clinical trial NCT03841916: Relation Between Body Mass Index and Endometrial Thickness
Official title: The Relationship Between Transvaginal Ultrasound Endometrial Thickness and Body Mass Index and Pathology in Postmenopausal Bleeding
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Postmenopausal Bleeding
Lead sponsor: Aljazeera Hospital
Sponsor class: OTHER
Collaborators: name: Kasr El Aini Hospital
First posted: 2019-02-15
Enrollment: 200
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: women with postmenopausal bleeding

Brief summary: Postmenopausal Bleeding (PMB) is defined as recurrent attacks of bleeding occurring in women after menopause one year at least after stoppage of cycles \[

Detailed description: Premalignant lesions and malignant lesions most commonly complex hyperplasia with atypia and carcinoma of the endometrium are present in 1/3 of patients evaluated for postmenopausal bleed-ing, and so investigations for cases of postmeno-pausal bleeding are mandatory

Eligibility criteria: Inclusion Criteria:

* menopausal women (defined as minimum of 1 year of amenorrhea after the age of 45 years if only the amenorrhea is not related to pregnancy, medication or disease),

Exclusion Criteria:

* Women with chronic diseases as diabetes mellitus, hypertension or hematological disorders, those received hormone replacement therapy, Tamoxifen or anticoagulant therapy and women with adnexal massed detected by TVUS or apparent causes of bleeding from cervix or vagina e.g. ulcer were excluded.

Primary outcomes:
measure: the number of women who will have a relation between endometrial thickness and BMI
timeFrame: within 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Algazeerah and Kasralainy hospital
Study officials:
affiliation: Algazeerah hospital -Location (Giza -Egypt ) and National Research centre egypt
name: Mahmoud Alalfy, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03822416: Treating Smokers With Mental Illness
Official title: Treating Tobacco Dependence in Smokers With Severe Mental Illness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Smoking Cessation
Cigarette Smoking
Schizophrenia
Psychotic Disorders
Major Depressive Disorder
Bipolar Disorder I
Bipolar II Disorder
Mental Illness
Keywords: mental illness
tobacco treatment
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: Hennepin County Medical Center, Minneapolis
name: Brown University
First posted: 2019-01-30
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a smoking cessation study that will enroll smokers who have been diagnosed with a severe mental illness. The study will use a combination of intensive tobacco treatment counseling and nicotine replacement therapy to assist smokers in cutting back on and quitting smoking over the course of six months.

Detailed description: At the baseline measurement visit, participants will be asked to complete a survey and an interview. They will be randomly assigned to either the intervention or control group. Both groups will receive a smoking cessation manual and list of resources. The intervention group will also receive smoking cessation counseling and nicotine replacement therapy. Both groups will be seen for in-person assessments again at 8 weeks and 6 months post baseline.

Eligibility criteria: Inclusion Criteria:

* have a severe mental illness diagnosis
* be a daily smoker
* be willing to reduce the number of cigarettes smoked per day leading to a quit attempt
* want to try to quit smoking
* be willing to use nicotine replacement therapy
* be able to communicate in English

Exclusion Criteria:

* anyone who has had an active psychotic episode or been hospitalized due to suicidal ideation in the last six months
* pregnancy
* taking Chantix or Clozapine
* having a terminal illness

Primary outcomes:
measure: 7-Day Point Prevalence Abstinence
timeFrame: 8 weeks and 6 months post baseline
Secondary outcomes:
measure: Quit Attempts
timeFrame: 8 weeks and 6 months post baseline
measure: Smoking Reduction
timeFrame: 8 weeks and 6 months post baseline
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Harry Lando, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Busch AM, Nederhoff DM, Dunsiger SI, Japuntich SJ, Chrastek M, Adkins-Hempel M, Rinehart LM, Lando H. Chronic care treatment for smoking cessation in patients with serious mental illness: a pilot randomized trial. BMC Psychiatry. 2021 Feb 17;21(1):104. doi: 10.1186/s12888-021-03113-5.
Clinical trial NCT03717116: Early Prediction of Hypocalcemia After Thyroidectomy Using Postoperative Second Hour Parathormone
Official title: Early Prediction of Hypocalcemia After Thyroidectomy Using Postoperative Second Hour Parathormone
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hypocalcemia, Postoperative Parathormone
Keywords: hypocalcemia, parathormone, bone density
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2018-10-24
Enrollment: 110
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all patients with multinodular goiter, Graves, fine needle aspiartion biopsy with Bethesda 3-4 undergoing total thyroidectomy

Brief summary: Hypocalcemia is the most frequent complication in thyroid surgeries. Diagnosing this complication earlier will reduce longer hospital stay and will lead to an earlier intervention. The purpose of the study is to evaluate postoperative second hour parathyroid hormone measurement as a predictor for early stage hypocalcemia.


Eligibility criteria: Inclusion Criteria:

* patients with multinodular goiter, Graves, fine needle aspiartion biopsy with Bethesda 3-4 undergoing total thyroidectomy

Exclusion Criteria:

* pregnant women
* patients with thyroid cancer or previous neck dissection

Primary outcomes:
measure: postoperative parathormone level
timeFrame: postoperative 2. hour
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University
Study officials:
References: