louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01477632: Bioavailability of Three Oral Formulations for Hormone Replacement Therapy in Postmenopausal Women
Official title: Single Dose, Three-way, Cross-over, Relative Bioavailability Study With 3 Oral Formulations for Hormone Replacement Therapy in Postmenopausal Women: 0.5 mg Estradiol + 0.1 mg Norethisterone Acetate, 0.5 mg Estradiol + 0.25 mg Norethisterone Acetate, and 1.0 mg Estradiol + 0.5 mg Norethisterone Acetate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Menopause
Healthy
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2011-11-22
Enrollment: 24
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Europe. The aim of this trial is to determine the extent of bioavailability of two low dose estradiol/norethisterone acetate (NETA) preparations with a marketed estradiol/norethisterone acetate (NETA) preparation.


Eligibility criteria: Inclusion Criteria:

* Healthy
* Postmenopausal
* Caucasian race
* Smoking (up to 5 cig./per day) is allowed
* Good state of health: evidenced by medical history, physical examination including gynecological examination, results of laboratory examination

Exclusion Criteria:

* Known or suspected allergy to trial products or related products
* Previous participation in this trial
* Previous estrogen and/or progestin hormone replacement therapy
* Known, suspected or history of breast cancer
* Systolic blood pressure (BP) at least 160 mm Hg and/or diastolic BP at least 100 mm Hg, currently treated or untreated
* Body Mass Index (BMI) above 35.0 kg/m\^2

Primary outcomes:
measure: Area under the curve (AUC(0-∞))
measure: Maximal concentration (Cmax)
measure: Time to maximum (tmax)
Secondary outcomes:
measure: Area Under the Curve (AUC) from dosing up to last sample
measure: Terminal half-life (t½)
Other outcomes:
Locations:
city: Neu-Ulm
country: Germany
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT00593632: A Controlled Trial of High Dietary Fiber Intake on Serum Lipids
Official title: A Controlled Trial of High Dietary Fiber Intake on Serum Lipids
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyperlipidemia
Keywords: low HDL
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
Collaborators: name: Attune Foods
First posted: 2008-01-15
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study evaluates high fiber diet intake in patients with hyperlipidemia.

Detailed description: Dietary fiber intake has been shown to have modest effect in lowering cholesterol. However, most of these studies were done with 20g/daily fiber intake. Not much is known about high dietary fiber intake (30-40 g/day) and serum cholesterol. Also, there have been small studies that have shown modest decrease in oxidative stress by increasing dietary fiber intake. The goal of our study is to determine the efficacy /safety of high dietary fiber intake in raising HDL, lowering LDL, and lowering oxidative stress in patients with hyperlipidemia.

Eligibility criteria: Inclusion Criteria:

* All primary and secondary prevention patients aged 18 to 80 years with known or newly diagnosed isolated hypercholesteremia or combined hyperlipidemia.
* Inclusion criteria include patients with HDL \< 35 mg/dL for a man or \< 45mg/dL for women irrespective of LDL level.

Exclusion Criteria:

* Any patients with unstable angina, untreated hypothyroidism, uncontrolled diabetes, other endocrine or metabolic diseases not actively treated, acute inflammatory diseases, severe gastrointestinal diseases, chronic renal insufficiency (GFR\<30), end stage renal disease, liver disease or other severe diseases such as cancer, triglyceride level greater than 600 mg/dL, pregnant females, chronic use of systemic corticosteroid, or anticoagulants.
* Patients who were recently started or recently had their lipid lowering medications changed within the last 4 weeks will be excluded.

Primary outcomes:
measure: To test whether 30-40g of daily dietary fiber increases HDL, lowers total cholesterol and LDL levels in patients at 12 weeks
timeFrame: 12 weeks
Secondary outcomes:
measure: To test whether Lipoprotein (a), triglyceride level, LDL: HDL ratio, fibrinogen, CRP, Urine f1 2 isoprostane and body weight will be lowered in patients after 12weeks.
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Wael A Jaber, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Cleveland Clinic
name: Leslie Cho, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02110732: Lactobacillus Rhamnosus GG in the Middle Ear and Adenoid Tonsil
Official title: Lactobacillus Rhamnosus GG in the Middle Ear and Adenoid Tonsil After Randomized, Double-blind, Placebo-controlled Oral Administration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Upper Respiratory Infection
Acute Otitis Media
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
Collaborators: name: Finnish Institute for Health and Welfare
First posted: 2014-04-10
Enrollment: 40
Sex: ALL
Minimum age (years): 1
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to evaluate the effect of oral administration of probiotic Lactobacillus rhamnosus GG in middle ear and adenoid tonsil.


Eligibility criteria: Inclusion Criteria:

* recurrent otitis media
* secretory otitis media
* chronic rhinitis
* recurrent sinusitis

Exclusion Criteria:

* significant illness

Primary outcomes:
measure: Lactobacillus Rhamnosus GG in Middle Ear Effusion and Adenoid Tonsil
timeFrame: After 3 weeks of oral consumption
Secondary outcomes:
measure: Presence of Bacterial Pathogens in Middle Ear Effusion Samples
timeFrame: After 3 weeks of oral consumption
measure: Presence of Rhinovirus and Enterovirus in Middle Ear Effusion Samples
timeFrame: After 3 weeks of oral consumption
Other outcomes:
Locations:
Study officials:
References:
citation: Tapiovaara L, Lehtoranta L, Swanljung E, Makivuokko H, Laakso S, Roivainen M, Korpela R, Pitkaranta A. Lactobacillus rhamnosus GG in the middle ear after randomized, double-blind, placebo-controlled oral administration. Int J Pediatr Otorhinolaryngol. 2014 Oct;78(10):1637-41. doi: 10.1016/j.ijporl.2014.07.011. Epub 2014 Jul 18.
Clinical trial NCT03085732: The Effect of Intraabdominal Saline Irrigation in Abdominal Hysterectomies
Official title: The Effect of Intraabdominal Saline Irrigation on Infectious Morbidities and Gastrointestinal Outcomes in Patients Undergoing Abdominal Hysterectomies for Benign Causes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gynecologic Surgery
Keywords: saline irrigation
abdominal hysterectomy
postoperative infectious morbidities
gastrointestinal disturbances
Lead sponsor: Kanuni Sultan Suleyman Training and Research Hospital
Sponsor class: OTHER
First posted: 2017-03-21
Enrollment: 100
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this prospective randomised clinic study is to investigate the effect of peritoneal cavity saline irrigation during abdominal hysterectomies on postoperative infectious morbidities and gastrointestinal disturbance. The participants will be randomised to either an irrigation of abdominal cavity or the control group after vaginal closure. Assignment to one of the two treatment groups will be determined using a computer generated random numbers. Primary outcome is the rate of postoperative infectious morbidities. Secondary outcome is the rate of gastrointestinal disturbances (nausea, vomiting), use of antiemetic drugs and pain score in the postoperative period. 100 patients in each treatment arm planned.


Eligibility criteria: Inclusion Criteria:

* patients undergoing hysterectomies for benign causes

Exclusion Criteria:

* patients who have diabetes mellitus patients undergoing hysterectomy for pelvic inflammatory disease or tuboovarian abscess

Primary outcomes:
measure: postoperative infectious morbidities
timeFrame: 10 day after hysterectomy operation
Secondary outcomes:
measure: gastrointestinal outcomes: nausea by questionnaire
timeFrame: postoperative first day
measure: gastrointestinal outcome: vomiting by questionnaire
timeFrame: postoperative first day
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Kanuni Sultan Suleyman Training and research hospital
Study officials:
References:
Clinical trial NCT00211432: Treatment of Pseudovitellium Detachment With Open-Label Anecortave Acetate Sterile Suspension (15 mg)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pseudovitellium Detachment
Eye Diseases
Lead sponsor: Manhattan Eye, Ear & Throat Hospital
Sponsor class: OTHER
Collaborators: name: Alcon Research
First posted: 2005-09-21
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to provide compassionate use of anecortave acetate sterile suspension of 15 mg for a series of five patients as a means to control pseudovitelliform detachment.


Eligibility criteria: Inclusion Criteria:

1. Clinical diagnosis of patients with pseudovitellium detachment.
2. Patients must be at least 18 years of age.
3. Visual acuity of 20/30 to 20/320 in study eye on the Early Treatment of Diabetic Retinopathy Study (ETDRS) visual acuity chart
4. Visual acuity of 20/800 or better in fellow eye on the ETDRS visual acuity chart

Exclusion Criteria:

1. Patient with significantly compromised visual acuity in the study eye due to concomitant ocular conditions.
2. Patients who have undergone intraocular surgery within the last 2 months.
3. Patient participating in any other investigational drug study.
4. Use of an investigational drug or treatment related or unrelated to their condition within 30 days prior to receipt of study medication.
5. Inability to obtain photographs to document choroidal neovascularization (CNV) (including difficulty with venous access).
6. Patient with significant liver disease or uremia.
7. Patient with known adverse reaction to fluorescein and indocyanine green or iodine.
8. Patient has a history of any medical condition which would preclude scheduled visits or completion of study
9. Patient has had insertion of scleral buckle in the study eye
10. Patient has received radiation treatment
11. Patient is on anticoagulant therapy with the exception of aspirin
12. Patient is pregnant or nursing.

Primary outcomes:
measure: Title: Treatment of Pseudovitellium Detachment With Open-Label Anecortave Acetate Sterile Suspension (15mg)
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Manhattan Eye, Ear & Throat Hospital
state: New York
Study officials:
affiliation: Manhattan Eye, Ear & Throat Hospital
name: Lawrence Yannuzzi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03651232: Prenatal Yoga for Pregnancy Related Back Pain
Official title: Prenatal Yoga for Pregnancy Related Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy Related
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
First posted: 2018-08-29
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a pilot feasibility study investigating prenatal yoga for pregnancy related back pain.


Eligibility criteria: Inclusion Criteria:

* uncomplicated pregnancies starting at 12-26 weeks of gestation
* pregnant women with and without back pain who had no regular yoga practice.

Exclusion Criteria:

* significant back pathology
* pregnancy complications
* non-English speaking
* otherwise were not able to participate (eg. transportation, scheduling issues)

Primary outcomes:
measure: feasibility of recruitment
timeFrame: baseline
Secondary outcomes:
measure: back pain disability
timeFrame: baseline, 4, 8, 12 weeks
measure: back pain severity
timeFrame: baseline, 4, 8, 12 weeks
measure: pregnancy symptoms
timeFrame: baseline, 4, 8, 12 weeks
measure: depression
timeFrame: baseline, 4, 8, 12 weeks
measure: quality of lfe
timeFrame: baseline, 4, 8, 12 weeks
measure: childbirth experience
timeFrame: postpartum visit
measure: mobility lab- speed
timeFrame: baseline, 4, 8, 12 weeks
measure: acceptability
timeFrame: 4,8, 12 weeks, postpartum
measure: mobility lab- double support
timeFrame: baseline, 4, 8, 12 weeks
measure: mobility lab- TUG
timeFrame: baseline, 4, 8, 12 weeks
measure: mobility lab- turn
timeFrame: baseline, 4, 8, 12 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Gloria Yeh
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02840032: Determination of Pneumothorax Post Lung Biopsy
Official title: Role of Ultrasonography in the Diagnosis of Pneumothorax Following Transbronchial Biopsy in LungTransplant Patients.
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Pneumothorax
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2016-07-21
Enrollment: 0
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Lung transplant patients who undergo routine bronchoscopic biopsy procedure for rejection determination

Brief summary: Bedside ultrasonography for detection of pneumothorax after transbronchial lung biopsies in lung transplant patients

Detailed description: The patients who undergo transbronchial forceps lung biopsies get a routine CXR after the biopsies are performed. The reason for CXR is to find out if pneumothorax occurred or not. CXR is required patient transportation and interpretation by the radiologist as well as time consuming. Instead, we are planning to perform bedside ultrasound to determine if pneumothorax occurred or not

Eligibility criteria: Inclusion Criteria:

* Any lung transplant patient who undergoes to bronchoscopic lung biopsy

Exclusion Criteria:

* Patients develop respiratory failure during the procedure

Primary outcomes:
measure: Determination of pneumothorax after transbronchial lung biopsy
timeFrame: 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Erhan Dincer
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06987032: Hemodynamics in Chronic Kidney Disease
Official title: Improving the Hemodynamic Profile Of Chronic Renal Patients by Use of Bioimpedance
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Kidney Failure
Lead sponsor: Ziekenhuis Oost-Limburg
Sponsor class: OTHER
First posted: 2025-05-23
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 206 patients with CKD stages 3-5 will be included from the outpatient clinic of Ziekenhuis Zuid-Oost Limburg in Genk (Belgium).

A healthy control group for the cross-sectional part will be recruited through visitors and/or personnel of Ziekenhuis Oost-Limburg in Genk (Belgium).

Brief summary: The goal of this observational study is to learn about the role of thoracic and whole body bioimpedance in the hemodynamic profile of patients with chronic kidney disease.

The main question it aims to answer is:

- Is bioimpedance-determined fluid status associated with kidney function decline in patients with chronic kidney disease stage 3 - 5 (non dialysis).

Detailed description: Participants will be measured during their regular visit to their treating nephrologist.

During a follow up of one year, 3 or 4 visits will be scheduled.

* Bioimpedance and blood pressure measurements will be achieved by non-invasive techniques.
* Blood sampling will as much as possible coincide with regular blood samplings for clinical purposes.
* All subjects will undergo echocardiography at baseline and after one year follow up.

Eligibility criteria: Inclusion Criteria:

* Prevalent non-dialysis patients with estimated glomerular filtration rate \< 60 ml/min (for chronic kidney disease subjects)
* Age \> 18 years
* Signed informed consent

Exclusion Criteria:

* Acute kidney injury
* estimated glomerular filtration rate \< 20ml/min directly post-nephrectomy
* Clinical conditions affecting bioimpedance measurements: limb amputation, impaired skin integrity, brain stimulator, pacemaker with low threshold or unipolar pacemaker.
* Clinical conditions affecting body composition: liver cirrhosis, active infectious disease or any acute cardiovascular event (defined as cerebrovascular event, myocard infarction, heart failure) during the 3 months before screening for inclusion
* Pregnancy

Primary outcomes:
measure: whole body fluid status
timeFrame: Baseline, every 3 months during 1 year
Secondary outcomes:
measure: identify the clinical factors associated with fluid overload during a longitudinal follow up
timeFrame: Baseline, every 3 months during 1 year
Other outcomes:
Locations:
city: Hasselt
country: Belgium
facility: Medicine and Life science
Study officials:
affiliation: University Hasselt
name: Pieter Vandervoort, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02323932: Perception of Intonation by Bimodal and Bilateral Cochlear Implant Users
Official title: Perception of Intonation by Bimodal and Bilateral Cochlear Implant Users
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hearing Loss
Lead sponsor: Bnai Zion Medical Center
Sponsor class: OTHER_GOV
First posted: 2014-12-24
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: The purpose of this study is to evaluate the benefit of bimodal hearing and bilateral cochlear implant hearing in comparison to unilateral cochlear implant hearing in the perception of speech intonation.

Detailed description: Bilateral hearing which is a fundamental characteristic of normal auditory system provides significant advantages in adverse listening conditions. In cochlear implant users, binaural hearing can be achieved via bilateral cochlear implant (CI/CI) or binaural-bimodal stimulation, i.e. a cochlear implant in one ear and a hearing aid in the other (CI/HA). It is assumed that CI/CI hearing and CI/HA hearing differ with respect to their physiological sources and functional benefit. Although both hearing prosthesis (CI/CI or CI/HA) lack several of the features needed to allow listeners to experience the full binaural advantage conferred by a normal-hearing auditory system it can, however, provide significant advantages over the use of a unilateral hearing prosthesis. Most of the accepted assessment clinical materials are not sensitive enough to evaluate the contribution of binaural hearing rehabilitation via CI/CI or CI/HA hearing for the perception of intonation. In a previous study the perception of intonation was evaluated in 29 adults CI/HA users via a closed-set format design with the same target talker. The results of the study showed small bimodal benefit. The test paradigm was apparently an easy task for the adult listeners and not sensitive enough to show the expected CI/HA bimodal benefit over cochlear implant alone.

The perception of correct intonation identification will be computed for each listener in each of the listening conditions. The amount of change in the fundamental frequency that was required in order to identify a question will be computed for each listener in each of the conditions. ANOVA with repeated measures will be used to assess the differences among the conditions for each group as well as the differences among the groups.

Eligibility criteria: Inclusion Criteria:

* Bilateral cochlear implant users
* Bilateral-bimodal users who use hearing aids for at least 75% of their waking hours.

Exclusion Criteria:

-

Primary outcomes:
measure: The amount of change in the fundamental frequency that was required in order to identify a question
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Bnzi Zion Medical Center
Study officials:
affiliation: Bnai Zion Medical Center
name: Michal Luntz, MD
role: PRINCIPAL_INVESTIGATOR
References: