louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01401946: Soy Isoflavone Tablets: Effects on Sleep, Quality of Life, Symptoms and Cognitive Function in Menopausal Women
Official title: Soy Isoflavone Tablets: Effects on Questionnaire and Actigraphic Measures of Sleep, Symptoms as Measured by the Women's Health Questionnaire and Cognitive Function as Measured by Computerized Cognitive Performance Tests in Menopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hot Flashes
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2011-07-26
Enrollment: 88
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study was done to elucidate relationships between midlife women's self-reported hot flashes, neuropsychological symptoms, cognitive performance or sleep.


Eligibility criteria: Inclusion criteria:

* At least 5 hot flash episodes and/or night sweats per 24 hours

Exclusion Criteria:

* Body mass index (BMI) more than 34 kg/m2
* Hypertension
* Shift work
* Psychiatric or medical conditions that would affect outcome measures
* More than 4 caffeine drinks per day
* More than 10 cigarettes per day
* More than than 7 alcohol drinks per week

Primary outcomes:
measure: Soy Isoflavone: Effects on Sleep, Symptoms, Quality of Life and Cognitive Function in Menopausal Women
timeFrame: Nine weeks
measure: Soy Isoflavone: Effects on Sleep, Symptoms, Quality of Life and Cognitive Function in Menopausal Women
timeFrame: 9 weeks
measure: Soy Isoflavone Tablets: Effects on Sleep, Quality of Life, Symptoms and Cognitive Function in Menopausal Women
timeFrame: 9 weeks
measure: Soy Isoflavone Tablets: Effects on Sleep, Quality of Life, Symptoms and Cognitive Function in Menopausal Women
timeFrame: 9 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham & Women's Hospital
state: Massachusetts
Study officials:
References:
Clinical trial NCT01811446: Evaluation of Muscle Activation Efficiency in Challenging Subjects
Official title: Evaluation of Muscle Stimulation Efficiency in Challenging Subjects: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
COPD
Lead sponsor: Niveus Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2013-03-14
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether muscle activation can be accomplished more effectively and comfortably in challenging subjects using novel configurations of an activation device. A novel device will be compared side by side with a market leading device.


Eligibility criteria: Inclusion Criteria:

* BMI \> 30 (Wing 1 of study)
* Non-hospitalized with confirmed diagnosis of COPD (Wing 2 of study)

Exclusion Criteria:

* Age \< 18 years
* Subject has an implanted pacemaker/defibrillator
* Subject diagnosed with epilepsy
* Subject has implanted metallic femoral rods
* Subject is chair- or bed-bound
* Subject has neuromuscular disease or abnormalities
* Subject BMI \> 45
* Evidence of disease or condition that, in the opinion of the investigator, may compromise the conduct of or results of the study

Primary outcomes:
measure: Intensity Required
timeFrame: During treatment
Secondary outcomes:
measure: Comfort
timeFrame: During treatment
Other outcomes:
Locations:
city: Mountain View
country: United States
facility: Fogarty Clinical Research
state: California
Study officials:
affiliation: El Camino Hospital
name: Bahman Nouri, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04837846: Multicenter Study Into Individualized Scanning for Coronary Artery Disease
Official title: Multicenter Study Into Individualized Scanning for Coronary Artery Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2021-04-08
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults with complaints of angina, referred for a clinically indicated CCTA scan

Brief summary: To evaluate intravascular attenuation of the coronary arteries and image quality in an individualized scan and CM injection protocol whereas both scan and injection parameters are tailored to the individual patient in a North American, European and Asian patient population.

To evaluate the radiation dose and contrast media dose of this individualized approach for CCTA in an American, European and Chinese patient population.

To evaluate the injection parameters required for an average American, European and Chinese patient population.


Eligibility criteria: Inclusion Criteria:

* To be eligible for the study: (All answers must be "YES" for subject to be eligible.)

  1. Referred for a clinically indicated CCTA scan.
  2. Patient aged older than 18.
  3. Subject must provide written informed consent prior to any study-related procedures being performed.
  4. Subject must be willing to comply with all clinical study procedures.
  5. Atypical or typical complaints of angina.
  6. No previous cardiovascular history.
  7. Possibility of 'flash' mode scan; patient heart rate below 70 beats per minute and regular rhythm.

Exclusion Criteria:

* The presence of the following excludes subjects from the study: (All answers must be "NO" for subject to be eligible.)

  1. Contraindications for CT coronary angiography, including:

     1. Inability to perform a breath hold for at least the expected scan time
     2. Unstable angina
     3. Hemodynamic instability
     4. Known history of CAD
     5. Pregnancy
     6. Renal insufficiency (defined as Creatinine \<1.5 mg/dL or GFR\<30 mL/min)
     7. Iodine allergy
  2. Insufficient cannula venous access (preferred 18G, minimal 20G cannula)
  3. Subject has an acute psychiatric disorder.
  4. Subject is unwilling to comply with the requirements of the protocol.
  5. Subject has previously entered this study.

Primary outcomes:
measure: Evaluation of Intravascular Attenuation
timeFrame: At time of CCTA scan
Secondary outcomes:
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Joseph U. Schoepf, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01897246: Computer Assisted Planning of Corrective Osteotomy for Distal Radius Malunion
Official title: Computer Assisted Planning of Corrective Osteotomy for Distal Radius Malunion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Extra-articular Distal Radius Malunions
Keywords: distal radius malunion
extra-articular
Lead sponsor: Christine M. Kleinert Institute for Hand and Microsurgery
Sponsor class: OTHER
Collaborators: name: AO Research Fund
First posted: 2013-07-11
Enrollment: 10
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 investigators are comparing post-operative patient-rated functional outcome between patients who undergo corrective osteotomy for extra-articular malunited distal radius fractures with and without computer assisted pre-operative planning and virtual osteotomy.


Eligibility criteria: Inclusion Criteria:

* Adult (over 18 yrs of age)
* Extra-articular malunion of the distal radius
* Fluent in English

Exclusion Criteria:

* Pregnant patients
* prisoners
* patients with impaired decision making ability
* patients with a bony deformity in the distal forearm contralateral to the one with distal radius malunion

Primary outcomes:
measure: Grip Strength
timeFrame: Up to 12 months
Secondary outcomes:
measure: Range of motion
timeFrame: Up to 12 months
measure: DASH Questionnaire
timeFrame: Up to 12 months
measure: Mayo Wrist score
timeFrame: Up to 12 months
measure: Gartland and Werley score
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Louisville
country: United States
facility: Christine M. Kleinert Institute of Hand and Microsurgery
state: Kentucky
Study officials:
affiliation: Christine M. Kleinert Institute of Hand and Microsurgery
name: Rodrgio Moreno, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01512446: Comparison of the Effect of an Ongoing Treatment With Alendronate or a Drug Holiday on the Fracture Risk in Osteoporotic Patients With Bisphosphonate Long Term Therapy
Official title: Comparison of the Effect of an Ongoing Treatment With Alendronate or a Drug Holiday on the Fracture Risk in Osteoporotic Patients With Bisphosphonate Long Term Therapy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Osteoporosis
Keywords: Osteoporosis
Osteoporotic fractures
Bisphosphonate
Pretreatment with bisphosphonates
Lead sponsor: Evangelisches Krankenhaus Lutherhaus gGmbH
Sponsor class: INDUSTRY
Collaborators: name: German Federal Ministry of Education and Research
First posted: 2012-01-19
Enrollment: 436
Sex: ALL
Minimum age (years): 60
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 evaluate the efficacy and safety of bisphosphonates in long term treatment of osteoporosis.

Detailed description: Is a continued treatment with alendronate for another two years after a preceding therapy with bisphosphonates of at least four years able to reduce the incidence of new osteoporotic fractures in patients at high fracture risk compared to a therapy-free interval?

Eligibility criteria: Inclusion Criteria:

* Postmenopausal women or men \> 60 years
* DXA T-Score at lumbar spine, total hip or femur neck \<-2,0 before the start of the bisphosphonate therapy or at baseline or at least one low trauma vertebral fracture grade 2-3 or multiple low trauma vertebral fractures independent of bone mineral densitiy
* Pretreatment with bisphosphonates for at least four years
* Risk for hip and vertebral fractures min. 30% according to DVO-guideline for osteoporosis 2009
* Signed informed consent

Exclusion Criteria:

* Other pharmacological treatment of osteoporosis during the last 48 months
* Other bone diseases
* Malabsorption syndromes
* Renal insufficiency with a calculated creatinine clearance \< 35 ml/min
* Diseases of the esophagus, delayed esophageal clearance
* UUnability to realise the intake instructions
* Hypocalcemia

Primary outcomes:
measure: Number of New Osteoporotic Fractures
timeFrame: From baseline to study termination (mean duration 5.6 months)
Secondary outcomes:
measure: Mortality
timeFrame: From baseline to study termination (mean duration 5.6 months)
measure: Combination of New Osteoporotic Fractures and Deaths
timeFrame: From baseline to study termination (mean duration 5.6 months)
Other outcomes:
Locations:
city: Essen
country: Germany
facility: Department of Internal Medicine III, Alfried Krupp Krankenhaus Essen Steele
Study officials:
affiliation: Alfried Krupp Krankenhaus Essen Steele
name: Johannes Pfeilschifter, Prof. Dr. med.
role: STUDY_DIRECTOR
References:
Clinical trial NCT02180646: Impact of Breakfast Composition on Glycemic and Incretin Responses in Individuals With Type 2 Diabetes
Official title: Effect of a High Protein Breakfast on Glycemic Control, Insulin Sensitivity, and Beta Cell Function in Individuals With Type 2 Diabetes (T2D)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Keywords: GLP-1
GIP
second meal phenomena
type 2 diabetes
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
Collaborators: name: American Egg Board
First posted: 2014-07-03
Enrollment: 12
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: This study examined the effect of a high protein or high carbohydrate breakfast on the glucose and insulin response following the breakfast meal, as well as the subsequent response following the lunch meal.

Detailed description: Twelve habitual breakfast consumers with type 2 diabetes (T2D) were recruited for the study. They completed two, 7-day conditions in random order with a minimum of a 7-day washout period between study days. They consumed either a high protein (PRO) or high carbohydrate (CHO) breakfast for 6 days of acclimatization, and on the seventh day, they reported to the lab at 0700 hours following a \~12 hour overnight fast and underwent forearm catheterization before a baseline blood draw. The participants consumed the respective breakfast at \~0730 hours. Four hours post-breakfast, subjects consumed a standard lunch meal. Blood samples were taken continuously throughout the 8-hour test day.

Eligibility criteria: Inclusion Criteria:

* 21-55 y of age
* body mass index (BMI) between 30-40 kg/m2
* weight stable for the prior 6 months
* non-smokers
* minimal alcohol consumption (\< 2 drinks per day)
* type 2 diabetic (diagnosed ≥ 2 y)
* a fasting glucose level above 120 mg/dL
* HbA1c between 6.5-9.0%

Exclusion Criteria:

* insulin
* β-blockers
* GLP-1 agonists (e.g. exenatide)
* dipeptidyl peptidase (DPP) inhibitors
* weight loss
* using weight-loss medications
* pregnant or lactating

Primary outcomes:
measure: Plasma Glucose Level Post-meal (AUC [0-4])
timeFrame: 0-240 and 240-480
Secondary outcomes:
measure: Post-meal Level of Glucose-dependent Insulinotropic Peptide (GIP) (AUC)
timeFrame: 0-240 and 240-480
Other outcomes:
measure: Post-meal Insulin Level (AUC [0-4])
timeFrame: 0-240 and 240-480
measure: Post-meal Glucagon-like Peptide-1 (GLP-1) Level (AUC )
timeFrame: 0-240 and 240-480
Locations:
Study officials:
References:
citation: Park YM, Heden TD, Liu Y, Nyhoff LM, Thyfault JP, Leidy HJ, Kanaley JA. A high-protein breakfast induces greater insulin and glucose-dependent insulinotropic peptide responses to a subsequent lunch meal in individuals with type 2 diabetes. J Nutr. 2015 Mar;145(3):452-8. doi: 10.3945/jn.114.202549. Epub 2014 Dec 24.
Clinical trial NCT02438046: Platelet Rich Fibrin in the Treatment of Palatal Wounds
Official title: Platelet Rich Fibrin in the Treatment of Palatal Wounds After Epithelialized Free Gingival Grafts Harvesting. A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Gingival Recession
Keywords: Connective Tissue Grafts
Wound healing
Biomaterials
Pain
Clinical Trials
Mucogingival Surgery
Lead sponsor: G. d'Annunzio University
Sponsor class: OTHER
First posted: 2015-05-08
Enrollment: 40
Sex: ALL
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this study it will be investigated the usefulness of Platelet-Rich Fibrin (PRF) on in the epithelialized connective tissue graft palatal donor site healing acceleration and in the patient's morbidity reduction. Forty patients, with at least one gingival recession will be treated by a coronally advanced flap (CAF) with connective tissue graft(CTG) resulting from the de-epithelialization of a free gingival graft. In the test group (20 patients) a quadruple layer of PRF membrane will be placed over the palatal wounds; conversely, the control group patients will be treated by an absorbable gelatin sponge. Patients will be monitored at 1, 2, 3 and 4 weeks after surgery for the complete re-epithelialization of the palatal wound (CWE), the alteration of sensibility (AS) around the wound area, the post-operative discomfort (D), and the changes of feeding habits (CFH) by a visual analogic scale (VAS) evaluation. Furthermore, the analgesics consumption and the existence of delayed bleeding from the palatal wound (DWB) during the first post-operative week will be assessed.


Eligibility criteria: Inclusion Criteria: are as follows:

* to have a single gingival recession to be treated by a mucogingival surgery intervention
* to be in good systemic health
* to have a good oral hygiene

Exclusion Criteria:

* no systemic diseases; no coagulation disorders; no medications affecting periodontal status in the previous 6 months; no pregnancy or lactation;
* no smoking habits;
* no periodontal surgery on the experimental sites;
* no inadequate endodontic treatment
* no tooth mobility at the site of surgery

Primary outcomes:
measure: The primary outcome is to assess the time needed to obtain a complete re epithelialization of the palatal wound
timeFrame: four weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Chieti
country: Italy
facility: G. d'Annunzio University
state: CH
Study officials:
References:
Clinical trial NCT05344846: The Effect of Guided Imagery on Bonding and Breastfeeding After Cesarean
Official title: The Effect of Guided Imagery on Bonding and Breastfeeding After Cesarean; A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breastfeeding
Lead sponsor: Ankara University
Sponsor class: OTHER
First posted: 2022-04-25
Enrollment: 64
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study is to evaluate the effect of guided imagery after cesarean section on mother-infant bonding and breastfeeding.

The study will be carried out in two different groups. The practice will start with meeting the women 6-10 hours after cesarean section. After the women are evaluated in terms of eligibility criteria for the research, the women who are eligible will be informed about the research and written informed consent will be obtained from the women who accept. The random distribution of women to the study groups will be carried out using the Block Randomization method. The following applications will be made to the groups.

Intervention Group; The individuals in this group will be provided with guided imagery application. Guided imagery will be applied to the participants in the hospital environment 6-10 hours after the cesarean section. Afterwards, guided imagery application will be requested every day for two weeks.

Control Group; The participants in the control group will perform routine care of the clinic.


Eligibility criteria: Inclusion Criteria:

* Nullipar
* Single birth
* Baby being with mother
* Gestational age 37-42 weeks
* Birth weight between 2500-4000 g
* APGAR score of 7 or higher in the 1st and 5th minutes
* The mother does not have a health problem that prevents breastfeeding
* Absence of conditions that prevent sucking, such as frenulum or palate problems

Exclusion Criteria:

* Participant's non-compliance with the research plan
* Interruption of breastfeeding for reasons such as health problems of the mother or baby
* Participants receive professional support for breastfeeding during the study process
* Hearing loss and deafness

Primary outcomes:
measure: Change in how to feed baby
timeFrame: Baseline, 7th day, 14th day
measure: Change in The Mother-to-Infant Bonding Scale
timeFrame: Baseline, 7th day, 14th day
measure: Change in Breastfeeding Self-Efficacy Scale
timeFrame: Baseline, 7th day, 14th day
Secondary outcomes:
measure: Change in Perception of Insufficient Milk Questionnaire
timeFrame: Baseline, 7th day, 14th day
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02114346: High Dose Atorvastatin for Preventing Contrast-induced Nephropathy
Official title: Evaluating the Effect of High Dose Atorvastatin (80 mg/d) Comparing With Placebo in Preventing Contrast-induced Nephropathy in Patients Undergoing Computed Tomography Coronary Angiography
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Contrast-Induced Nephropathy
Keywords: Computed Tomography Angiogram
Side Effects
Contrast-Induced Nephropathy
Prevention
Lead sponsor: Isfahan University of Medical Sciences
Sponsor class: OTHER
First posted: 2014-04-15
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study is to determine the efficacy of atorvastatin in the prevention of contrast-induced nephropathy in patients undergoing computed tomography coronary angiography. Investigators assume that atorvastatin is effective in this regard. Investigators include patients referring for elective computed tomography coronary angiography and allocate them to atorvastatin or placebo from 24 hours before to 48 hours after administration of contrast material. Investigators then measure serum creatinine and see if it is raised by ≥ 0.5 mg/dL or ≥ 25% of the baseline value.


Eligibility criteria: Inclusion Criteria:

* adult patients
* candidate of elective computed tomography angiogram
* willingness to participate

Exclusion Criteria:

* unstable angina or myocardial infarction, cardiac arrhythmia, seizures, acute renal failure, end-stage renal disease
* unstable serum creatinine
* unstable hemodynamic
* intravascular administration of contrast material in the past month
* using high dose atorvastatin in the past month,
* known hypersensitivity to atorvastatin

Primary outcomes:
measure: Plasma creatinine level
timeFrame: up to 48h after contrast injection
Secondary outcomes:
Other outcomes:
Locations:
city: Isfahan
country: Iran, Islamic Republic of
facility: Alzahra Hospital
Study officials:
affiliation: Isfahan University of Medical Sciences
name: Alireza Hajian, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Li Y, Liu Y, Fu L, Mei C, Dai B. Efficacy of short-term high-dose statin in preventing contrast-induced nephropathy: a meta-analysis of seven randomized controlled trials. PLoS One. 2012;7(4):e34450. doi: 10.1371/journal.pone.0034450. Epub 2012 Apr 12.