louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02518763: Vitamin D Supplementation in Postmenopausal Women With Osteoporosis: Proposal of a Therapeutic Regimen in Practice
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Osteoporosis
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2015-08-10
Enrollment: 120
Sex: FEMALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The vitamin D deficiency (25OHD) is very common and affects about 80% of the population of French osteoporotic women over 50 years \[5\]. It contributes significantly to bone fragility and consequently the risk of fracture. To remedy this deficit, it is necessary to provide a suitable and sustainable supplementation. Changes in vitamin D deficiency ranging from undetectable to a 25OHD value very close to 30ng / ml lead to differences in therapeutic regimens, specific to each clinician in the absence of precise data in the literature. No consensus on supplementation dosages and methods have been proposed so far. Also, given the frequency of vitamin D deficiency including osteoporosis observed in the population, it became necessary to establish a single, uniform regimen for all patients with osteoporosis


Eligibility criteria: Inclusion Criteria:

* Postmenopausal women ≥ 50 years
* Osteoporosis with BMD T-score ≤ -2.7DS -2.5DS to at least one of the two main sites analyzed, with or without fracture
* having signed an informed consent

Exclusion Criteria:

* Taking a "loading dose" of vitamin D in the last six months (a daily intake in combination with calcium will not be a cause of exclusion but should be discontinued during the study).
* Taking an osteoporosis treatment combined with vitamin D in the same tablet (or Adrovance Fosavance \* \*)
* Treatment with thiazide diuretic
* Known malabsorption (celiac disease)
* Scalable Endocrine disorders: hyperthyroidism, hyperparathyroidism, hypoparathyroidism.
* Persistent or nephrolithiasis occurred in the previous 5 years
* known sarcoidosis
* Persons under guardianship or trusteeship
* Hypercalcemia and hypercalciuria
* 25OH vitamin D levels\> 50ng / ml

Primary outcomes:
measure: Serum 25 OH vitamin D concentration
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Caen
country: France
facility: University Hospital
Study officials:
References:
Clinical trial NCT05915663: Impact of the Choice of Gastric Tube Placement Sites on the Incidence of Ventilator Associated Pneumonia
Official title: Impact of the Choice of Gastric Tube Placement Sites on the Incidence of Ventilator Associated Pneumonia and Other Complications in the Intensive Care Unit
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Intubated Patient Requiring a Gastric Tube
Keywords: orogastric tube
nasogastric tube
Ventilator Associated Pneumonia
Lead sponsor: Centre Hospitalier le Mans
Sponsor class: OTHER
First posted: 2023-06-23
Enrollment: 2400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomised cluster and cross-over study
Primary purpose: OTHER

Brief summary: In intensive care, many gastric tubes are inserted on a regular basis. There are different practices in terms of the location of the gastric tube. In some cases, the tube is inserted through the nose and in others, it is inserted through the mouth.

In the literature and in practice, these gastric tubes create discomfort and complications that have an impact not only on the patient, but also on the treatments and the length of the patient's stay in hospital.

Nosocomial Ventilator Associated Pneumonia is the most serious common complication for patients intubated with a gastric tube. It is possible that placement site may have an impact on the risk of developing Ventilator Associated Pneumonia, particularly by increasing the risk of bacterial pullulation opposite the sinuses when the tube is placed via the nasal route.

Investigator hypothesises that placing the gastric tube orally will reduce the rate of ventilator-associated pneumonia compared with the nasal route in mechanically ventilated intensive care patients.


Eligibility criteria: Inclusion Criteria:

* patient in intensive care, intubated, ventilated
* Adult
* Requiring a gastric tube
* With an expected duration of mechanical ventilation of more than 48 hours
* Affiliated to social security
* Patient or relative consent or, failing that, emergency inclusion of the patient

Exclusion Criteria:

* Pregnant, breast-feeding or parturient women
* Patients under legal protection: curatorship and guardianship
* Contraindication to placing a gastric tube through the nose or mouth
* Patients who already have a gastric tube when they enter the service
* Patient intubated for more than 24 hours
* Patient intubated via the nasotracheal route

Primary outcomes:
measure: Compare impact of insertion site of gastric tube on the incidence of ventilator associated pneumoniae
timeFrame: Day 28
Secondary outcomes:
Other outcomes:
Locations:
city: Le Mans
country: France
facility: Centre Hospitalier Du Mans
Study officials:
References:
Clinical trial NCT03245463: Evaluation of Methods of Teaching Self-management Strategies to Patients With Symptomatic Knee Osteoarthritis
Official title: Evaluation of Different Methods of Teaching Self-management Strategies to Patients With Symptomatic Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Osteoarthritis, Knee
Lead sponsor: Hospital for Special Surgery, New York
Sponsor class: OTHER
First posted: 2017-08-10
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Symptomatic knee osteoarthritis greatly impacts the quality of life, mobility, independence, and even safety of the individuals who suffer from it. One of the most powerful tools for these patients can be education on self-care and self-management strategies that can be taught to a patient by a physician, physical or occupational therapist, or a nurse. These self-management strategies can help patients treat daily stiffness through exercise or manage flares of osteoarthritis. There is a lack of consensus on the best teaching methods to accomplish the goal of educating our patients. Feedback from both patients and providers regarding teaching methods is needed. This study will evaluate teaching methods on self-management strategies for patients who are undergoing hyaluronic acid injections for knee osteoarthritis.


Eligibility criteria: Inclusion Criteria:

* Patients of co-investigator physicians
* Age 18+ years
* Diagnosis of symptomatic knee osteoarthritis
* Scheduled for a hyaluronic acid injection into the knee
* Provider is available to administer teaching method

Exclusion Criteria:

* Patients who are already enrolled in the study
* Non-English speaking

Primary outcomes:
measure: Patient Satisfaction With the Teaching Method
timeFrame: 1 month post-injection
measure: Provider Satisfaction With the Teaching Method
timeFrame: 1 month post-injection
measure: Patient Satisfaction With the Teaching Method
timeFrame: 3 months post-injection
Secondary outcomes:
measure: Number of Patients Who Would Have Preferred a Different Method of Receiving Education.
timeFrame: 3 months post-injection
measure: Number of Patients Who Believed That the Education They Received Helped With the Care of Their Osteoarthritis
timeFrame: 3 months post-injection
measure: PROMIS Physical Health Score
timeFrame: 3 months post-injection
Other outcomes:
Locations:
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
Study officials:
affiliation: Hospital for Special Surgery, New York
name: James Wyss, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03300063: Treating Sleep Apnea Induced Hypoxemia With Oxygen in Acute Stroke Patients
Official title: Effects of Treating Sleep Apnea-Induced Hypoxemia With Low-Flow Oxygen in Acute Stroke Patients: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke, Acute
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2017-10-03
Enrollment: 6
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: We want to determine if treating acute ischemic stroke patients who have evidence of hypoxemia due to sleep apnea with low flow O2 during sleep might help improve clinical and functional outcomes.

Detailed description: Acute stroke patients will be tested for nocturnal hypoxemia using overnight oximetry. Those with evidence of hypoxemia will be randomized into two groups. One group will receive standard medical care. The other group will receive standard medical care as well as receiving low flow oxygen during sleep.

Eligibility criteria: Patients presenting to Mayo Clinic Hospital with acute ischemic stroke

Primary outcomes:
measure: Modified Rankin Score
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Melissa C Lipford
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00498563: Effects of Mild Hypobaric Hypoxia on Sleep and Post-sleep Performance
Official title: Investigation to Determine the Effects of Mild Hypobaric Hypoxia on Sleep and Post-Sleep Neurobehavioral Performance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Altitude
Hypoxia
Environmental Sleep Disorder
Keywords: high altitude
sleep
altitude illness
neurobehavioral manifestations
psychomotor performance
mood states
Lead sponsor: Oklahoma State University Center for Health Sciences
Sponsor class: OTHER
Collaborators: name: The Boeing Company
First posted: 2007-07-10
Enrollment: 34
Sex: MALE
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Hypobaric hypoxia (decreased oxygen supply to body tissues due to low atmospheric pressure) caused by exposure to high altitude disrupts sleep. Sleep deprivation is associated with degraded post-sleep performance of neurobehavioral tasks. The lowest altitude at which sleep and/or post-sleep performance are affected is not known. The study hypothesis is that sleep and/or post-sleep performance of neurobehavioral tasks will occur due to hypobaric hypoxia at altitudes of 8,000 or less.


Eligibility criteria: Inclusion Criteria:

* healthy
* age 30 to 60 years

Exclusion Criteria:

* sleep disorders or abnormal sleep patterns
* mood or psychiatric disorders including claustrophobia
* altitude exposure above 5,000 ft in the previous 2 months
* born or raised at terrestrial altitude 5,000 ft or greater
* conditions that would disqualify for FAA Medical Certificate
* acute medical conditions

Primary outcomes:
measure: Quality and quantity of sleep measured by actigraphy and polysomnography Neurobehavioral performance measured by Psychomotor Vigilance Test (PVT) and Automated Neurophysiologic Assessment Metrics Battery (ANAM)
timeFrame: 7 hours; 4 hours
Secondary outcomes:
measure: Mood State measured by Profile of Mood States (POMS) Symptoms of altitude illness measured by Environmental Symptoms Questionnaire (ESQ IV) and Lake Louise Symptom Scores (LLS)
timeFrame: 20 hours
Other outcomes:
Locations:
city: Tulsa
country: United States
facility: Oklahoma State University Center for Aerospace & Hyperbaric Medicine
state: Oklahoma
Study officials:
affiliation: The Boeing Company
name: J. Michael Muhm, M.D., M.P.H.
role: PRINCIPAL_INVESTIGATOR
affiliation: Oklahoma State University Center for Aerospace & Hyperbaric Medicine
name: Paul B Rock, DO, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02803463: Peritoneal Closure Versus Non Closure During Open Appendectomy
Official title: Peritoneal Closure Versus Non Closure During Open Appendectomy: a Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Appendicitis
Keywords: peritoneal closure
appendectomy
postoperative pain
life quality
Lead sponsor: Bezmialem Vakif University
Sponsor class: OTHER
First posted: 2016-06-17
Enrollment: 112
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: There has been no consensus over closure versus non closure of peritoneum during abdominal operations. The aim of this study is to compare the effect of peritoneal closure versus non closure over postoperative pain, early complications and life quality.

Detailed description: There has been no consensus over closure versus non closure of peritoneum during abdominal operations. in literature, few reports suggested that peritoneal closure may prolong the operation time, may increase the costs and has a probable aggravating effect on postoperative pain. In addition, there have been some reports that suggest non closure of peritoneum may not increase the postoperative complications. The need of further studies to clarify the effect of peritoneal closure versus non closure on postoperative pain and life quality especially has been specified in some literature. The aim of this study is to compare the effect of peritoneal closure versus non closure over postoperative pain, early complications and life quality.

Eligibility criteria: Inclusion Criteria:

* patients with acute appendicitis
* age between 18-65 years

Exclusion Criteria:

* preoperatively diagnosed intraabdominal abcess
* intraoperatively diagnosed free purulent fluid in abdominal cavity
* pregnancy
* malignancy history
* mental retardation
* chronical renal failure
* chronical liver disease
* diabetes mellitus
* patients' denial of participation to study

Primary outcomes:
measure: Visual analogue pain score
timeFrame: postoperative day 1
measure: Surgical Site Infection
timeFrame: postoperative 30 days
measure: Life Quality Score
timeFrame: postoperative day 10
Secondary outcomes:
measure: operation time
timeFrame: intraoperatively
measure: wound dehiscence
timeFrame: postoperative 30 days
measure: postoperative mortality
timeFrame: postoperative 30 days
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bezmialem Vakif University, Faculty of Medicine
Study officials:
affiliation: Bezmialem Vakif University
name: Huseyin K Bektasoglu, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bektasoglu HK, Hasbahceci M, Yigman S, Yardimci E, Kunduz E, Malya FU. Nonclosure of the Peritoneum during Appendectomy May Cause Less Postoperative Pain: A Randomized, Double-Blind Study. Pain Res Manag. 2019 May 23;2019:9392780. doi: 10.1155/2019/9392780. eCollection 2019.
Clinical trial NCT04957563: Clinical Utility of Olfactory Rehabilitation: Treatment for Pacients With Neurosensorial Anosmia
Official title: Clinical Utility of Olfactory Rehabilitation: Treatment for Pacients With Neurosensorial Anosmia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anosmia
Occupational Therapy
Brain Injuries, Traumatic
Keywords: occupational therapy
anosmia
brain injuries, traumatic
Lead sponsor: Universidad Rey Juan Carlos
Sponsor class: OTHER
First posted: 2021-07-12
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: control group and experimental group
Primary purpose: TREATMENT

Brief summary: The aim of our study was to compare the recovery of smell in people suffering posttraumatic olfactory impairment following a systematic olfactory rehabilitation performed by occupational therapists to natural recovery in a control posttraumatic group of patients.

Detailed description: Forty participants started the study: 20 for the control group and 20 for the treatment group. The mean of the time span between the traumatic event and the first visit in the rehabilitation group was longer than 22 months, time enough to wait any kind of spontaneous recovery.

In order to establish correct comparisons, the investigators analyzed whether both groups of participants (control group and treatment group) were homogeneous or not regarding the age, gender, time span between the traumatic event and the first visit to the office, brain damage and loss of conscience. Investigators administered visual analogic scale (VAS), CCCRC olfactory test and quality of life questionnaire (RSDI) to both groups at the beginning of the study and 12 months late

Eligibility criteria: Inclusion Criteria:

* Olfactory loss participants from institution to the Smell \& Tast Office, Otorhinolaryngology Unit, Hospital Universitario Fundación Alcorcón.

All participants provided written informed consent

Exclusion Criteria:

* No sign informed consent

Primary outcomes:
measure: CCCRC
timeFrame: 6 months
Secondary outcomes:
measure: RSDI
timeFrame: 6 months
Other outcomes:
Locations:
city: Alcorcón
country: Spain
facility: Hospital Universitario Fundación Alcorcón
state: Madrid
Study officials:
References:
Clinical trial NCT00380263: PACAP38´s (Pituitary Adenylate Cyclase-Activating Polypeptide) Headache Inducing Characteristics and Effects on the Cerebral Blood Flow
Official title: Basic Scientific Research Investigating PACAP38 Headache Inducing Effects in Migraine Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Migraine Without Aura
Lead sponsor: Danish Headache Center
Sponsor class: OTHER
First posted: 2006-09-25
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no

Brief summary: To investigate headache score and accompanying symptoms during and after infusion of PACAP38 i migraine patients

Detailed description: To investigate headache score and accompanying symptoms during and after infusion of PACAP38

Changes in regional cerebral blood flow (rCBF) in the area supplied by middle cerebral artery (MCA), blood flow in MCA, diameter of the superficial temporal artery (STA) and radial artery (RA)

Eligibility criteria: Inclusion Criteria:

* Healthy migraine patient without aura
* Aged 18-50
* 50-100 kg
* Fertile women must use safe contraceptives (IUD, oral contraceptives, surgical sterilisation and long lasting gestagen.

Exclusion Criteria:

* Tension type headache more than five times/month
* Other primary headaches
* Daily medication except contraceptives
* Drug taken within 4 times the halflife for the specific drug except contraceptives
* Pregnant or lactating women
* Exposure to radiation within the last year
* Headache within the last 48 hours before start of trial
* Hypertension
* Hypotension
* Respiratory or cardiac disease

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Glostrup
country: Denmark
facility: Dansih Headache Center
Study officials:
affiliation: Danish Headache Center
name: Henrik Schytz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03046563: The Applying of Acupressure and Abdominal Massage to Improving Constipation in Stroke Patients.
Official title: The Effectiveness of the Applying of Acupressure and Abdominal Massage to Improving Constipation in Stroke Patients.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acupressure
Abdominal Massage
Constipation
Stroke Patients
Keywords: acupressure
abdominal massage
constipation
stroke patients
Traditional Chinese medicine
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
First posted: 2017-02-08
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Experimental research design with two-group repeated-measure design. Experimental group was pressing the Hegu (LI 4), Zusanli (ST 36) , Tianshu(ST 25) and abdominal massage for eight minutes total, press once in the morning and afternoon, seven days total and two days for follow the trail. Control group was pressing sham ponits. Research tools to self semi-structured questionnaire collected data on patient's diet, activity, medication, defecation patterns, subjective defecation feelingauscultation bowel sounds like.

Detailed description: Experimental research design with two-group repeated-measure design. The investigators estimate there are recruit fifty patients from related rehabilitation hospital of a medical center in Taichung, central Taiwan, using randomization put patients in experimental group and control group. Experimental group Pressing the Hegu (LI 4), Zusanli (ST 36) , Tianshu(ST 25) and abdominal massage for eight minutes total, press once in the morning and afternoon, seven days total and two days for follow the trail. Control group was pressing sham ponits. Research tools to self semi-structured questionnaire collected data on patient's diet, activity, medication, defecation patterns, subjective defecation feelings, and auscultation bowel sounds like. The investigators expected the results of this study can provide clinical nursing care for stroke patients of reference, to improve quality of care, and increase acupressure to improve the empirical data of stroke in patients with constipation.

Eligibility criteria: Inclusion Criteria:

1. patients who were diagnosed as stroke, and in stability phase.
2. patients who had constipation symptoms.
3. patients whose platelets counts more than 150,000 / μ.

Exclusion Criteria:

1. Consciousness is not clear.
2. The physician diagnosed with irritable bowel syndrome.

Primary outcomes:
measure: defecation patterns
timeFrame: 9 days
Secondary outcomes:
measure: auscultation bowel sounds
timeFrame: 9 days
Other outcomes:
Locations:
Study officials:
References: