louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03825393: Association of Ferritin Levels With Clinical Parameters in Patients With Fibromyalgia Syndrome
Official title: Association of Ferritin Levels With Clinical Parameters in Patients With Fibromyalgia Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fibromyalgia
Keywords: Fibromyalgia Syndrome, Ferritin, Sleep
Lead sponsor: Tokat State Hospital
Sponsor class: OTHER_GOV
First posted: 2019-01-31
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This sectional study included 100 female patients older than 18 years of age who presented to Physical Treatment and Rehabilitation polyclinic in 2016-17 period.

Brief summary: The aim of the present study was to evaluate the association between ferritin levels and clinical parameters in patients with fibromyalgia syndrome.

Detailed description: This sectional study included 100 patients with non-anemic FMS diagnosis and 100 patients with non anemic non FMS diagnosis whose ferritin levels were measured within the last four weeks. The participants were evaluated using Fibromyalgia Impact Questionnaire (FIQ), Beck Anxiety Inventory (BAI), Beck Depression Inventory (BDI) and Pittsburg Sleep Quality Index (PSQI) as well as with a questionnaire form about descriptive characteristics. Serum ferritin level of \<30 ng/mL was considered iron deficiency.

Eligibility criteria: Inclusion Criteria:

* Fibromyalgi syndrome patients
* ferritin levels were measured within the last four weeks

Exclusion Criteria:

* parenteral or enteral iron usage in last four weeks
* hemoglobin level was less than 12 g/dl
* infection
* malignity
* active inflammatory arthritis
* serious skin variations
* serious peripheral vascular disease
* iron storing disorder
* pregnant or lactating patients

Primary outcomes:
measure: Pitsburgh Sleep Quality Index
timeFrame: 1 year
measure: Ferritin Level
timeFrame: 1 year
Secondary outcomes:
measure: Fibromyalgia Impact Questionnarie Scores
timeFrame: 1 year
measure: Beck Depression Inventory
timeFrame: 1 year
measure: Beck Anxiety Inventory
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: Doctor
name: sevil okan
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00642993: Efficacy and Safety Trial to Evaluate the Effect of SCH 497079 on Weight in Obese and Overweight Participants (Study P05483)(COMPLETED)
Official title: A Multicenter, Randomized, Parallel-Group, Placebo-Controlled, Efficacy and Safety Trial to Evaluate the Effect of SCH 497079 on Weight in Obese and Overweight Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Obesity
Overweight
Body Weight
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2008-03-25
Enrollment: 401
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 evaluate the effect of SCH 497079 on weight in obese and overweight participants. The primary measure of effectiveness is the change in body weight during treatment. Additional measures include waist circumference and body mass index (BMI). In addition, the safety of SCH 497079 in obese and overweight participants will be evaluated. The primary hypothesis is that treatment with SCH 497079 will be more efficacious than that with placebo with respect to the primary efficacy variable.

Detailed description: Following Screening, eligible participants will enroll in a Run-in Period. Participants who qualify for continuation in the study according to the entry criteria will be randomized to one of two treatment groups (SCH 497079 or placebo in a 2:1 ratio) with stratification according to gender.

Baseline measurements for the primary efficacy endpoint, as well as secondary endpoints will be evaluated at the Randomization Visit (Visit 3). Following randomization, participants will be treated for 12 weeks with double-blind study drug as adjunct to a 500 kcal deficit diet.

Participants will have scheduled visits after the Randomization Visit at 2 to 4 week intervals. Each participant will be encouraged to adhere to medication and dietary instructions.

Eligibility criteria: Inclusion Criteria:

* \>= 18 years of age, of either sex, and of any race.
* Obese or overweight participants.

Exclusion Criteria:

* Participants who have a history of major eating disorders, gastrointestinal (GI) surgery, active serious cardiovascular, pulmonary, endocrine, neurologic, infectious, GI, hepatic, renal, hematologic, immunologic or psychiatric disease or diabetes.

Primary outcomes:
measure: Mean Change From Baseline in Body Weight at Week 12
timeFrame: Baseline and Week 12
Secondary outcomes:
measure: Percentage of Participants Demonstrating a Weight Loss ≥5% at Week 12
timeFrame: Baseline and Week 12
measure: Percentage of Participants Demonstrating a Weight Loss ≥10% at Week 12
timeFrame: Baseline and Week 12
measure: Mean Change From Baseline in Waist Circumference at Week 12
timeFrame: Baseline and Week 12
measure: Mean Change From Baseline in Body Mass Index (BMI) at Week 12
timeFrame: Baeline and Week 12
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT02807493: Use of an Occlusal Support Device During the Second Stage of Labor
Official title: Use of an Occlusal Support Device During the Second Stage of Labor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy
Keywords: Pregnancy
Labor and Delivery
Occlusal Support Device
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2016-06-21
Enrollment: 347
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The primary objectives of this study are to determine if the use of an Occlusal Support Device (OSD)(Mouthguard) can reduce the duration and intensity of the second stage of labor, reduce the incidence of labor complications including Caesarian Sections and improve Apgar scores in newborns

Detailed description: Prolonged labor, especially during the second stage of active expulsive effort (the pushing phase), is associated with increased risk of maternal complications (e.g. tissue trauma, postpartum hemorrhage, intra-amniotic infection). Developing an effective method to assist and maximize maternal expulsion effort should be of great value in reducing the number of complications, also including cesarean section or instrumental deliveries. Past studies published in the dental literature have shown that specially designed oral appliances that support the dental occlusion may increase the isometric strength of different muscle groups. Increased strength of the neck muscles could improve efficiency of the Valsalva maneuver in increasing intra-uterine pressure, and thus decreasing the duration of phase II of labor. Nulliparous women with uncomplicated singleton pregnancy will be randomly assigned to either the study group (Dental appliance) or the no dental appliance group. Duration of labor will be measured for both phase I and phase II. Rates for cesarean section and instrument deliveries and other complications will be charted as well as Apgar scores .

Eligibility criteria: Inclusion Criteria:

* Nulliparous women
* Uncomplicated pregnancy
* Singleton pregnancy

Exclusion Criteria:

* Unable to provide informed consent or comply with study protocol,
* High risk and/or complicated pregnancy,
* Have multiple fetuses as diagnosed by ultrasound,
* Have extensive decay or multiple broken/missing teeth that will interfere with the fabrication of an OSD

Primary outcomes:
measure: Stage 2 Duration of Labor
timeFrame: Duration of labor
measure: Number of Participants With a Cesarian Section
timeFrame: Baseline
measure: Average Apgar Score
timeFrame: at minute 1 and minute 5
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: James E Gambucci, DDS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02784093: Use of Gastrografin in the Management of Fecal Impaction in Patients With Severe Chronic Constipation
Official title: Use of Gastrografin in the Management of Fecal Impaction in Patients With Severe Chronic Constipation: A Double-blinded Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Fecal Impaction
Keywords: Chronic Constipation
Fecal impaction
Gastrografin
Randomized Controlled Trial
Lead sponsor: Jinling Hospital, China
Sponsor class: OTHER
First posted: 2016-05-26
Enrollment: 83
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Fecal impaction (FI) is a common cause of lower gastrointestinal tract obstruction, and it is the result of chronic or severe constipation and most commonly found in the elderly population. Gastrografin is a water soluble contrast mediate that could act as an osmotic laxative. It has been shown to confer a therapeutic beneﬁt in adhesive small bowel obstruction (SBO). The investigators speculate that gastrografin administrated orally may be more effective than enema in the treatment of fecal impaction induced intestinal obstruction.


Eligibility criteria: Inclusion Criteria:

1. A confirmed presence of fecal impaction diagnosed based on the following conditions: large amount of hard stool (impacted faecaloma) in colon or rectum; abdominal radiography was performed for assessment.
2. Rome III criteria for chronic constipation present for ≥8 weeks.

Exclusion Criteria:

1. Patients with a history of colorectal surgery or an organic cause of constipation; pregnancy.
2. Patients with long-term medical conditions potentially associated with constipation (ie, cystic fibrosis, cerebral palsy, hypothyroidism, spinal and gastric anomalies).
3. Patients with medical or psychiatric illness.
4. Patients with abnormal laboratory data or thyroid function.

Primary outcomes:
measure: the proportion of patients having successful disimpaction
timeFrame: 6 days
measure: the time when patients having successful disimpaction
timeFrame: 6 days
Secondary outcomes:
measure: Wexner constipation score
timeFrame: 6 days
measure: Patient Assessment of Constipation-Symptoms (PAC-SYM) score
timeFrame: 6 days
measure: Patient Assessment of Constipation Quality of Life (PAC-QOL) score
timeFrame: 6 days
measure: adverse events and safety
timeFrame: 6 days
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University
state: Jiangsu
Study officials:
affiliation: Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University
name: Ning Li, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00726193: Study to Analyze the Effects of EBI OsteoGen™ on the Surgical Reconstruction of Tibia Non-unions
Official title: A Prospective Randomized Multi - Center Clinical Outcomes Collection Study To Analyze The Effect Of Ebi Osteogen™ Direct Current Stimulator On The Surgical Reconstruction Of Tibia Nonunions
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Tibia Fracture Non Union Bone
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2008-07-31
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: private practice patients

Brief summary: The purpose of this clinical outcomes collection study is to analyze the effect of the EBI OsteoGen™ Direct Current Stimulator upon surgical reconstruction of tibia nonunion (no visible progressive signs of healing) fracture in a prospective database.

Detailed description: This clinical outcomes collection study is to analyze the effect of the EBI OsteoGen™ Direct Current Stimulator upon surgical reconstruction of tibia nonunion (no visible progressive signs of healing) fracture in a prospective database.

Eligibility criteria: Inclusion Criteria:

1. Diagnosis of a tibia nonunion.
2. Male or female between ages of 18 and 75 years old, inclusive

Exclusion Criteria:

1. Subject has open wounds or underlying osteomyelitis.
2. Subject has associated multiple traumas, and/or fractures that are not anatomically reduced or lose reduction at later time points.
3. If female, subject is pregnant, plans on becoming pregnant during the duration of this clinical outcomes collection study or lactating.
4. Subject has an implanted unipolar pacemaker.
5. Subject has active cancer.
6. Subject has severe peripheral vascular disease (ABI \<0.4)

Primary outcomes:
measure: The primary outcome measure for this trial will be the percentage of successful tibia unions achieved
timeFrame: 8 Months
Secondary outcomes:
measure: Mean AOFAS Score (% Change From Baseline), Foot Function Index (% Change from Baseline), SF-36 Health Survey (Change from Baseline)
timeFrame: 8 Months
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Orthopedic Foot and Ankle Center
state: Ohio
Study officials:
affiliation: Biomet Spine
name: Joel Batts
role: STUDY_DIRECTOR
References:
Clinical trial NCT03005093: The Turkish Feeding/Swallowing Impact Survey
Official title: Reliability and Validity of the Turkish Feeding/Swallowing Impact Survey
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Deglutition Disorder
Dysphagia
Outcome Assessment
Quality of Life
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2016-12-29
Enrollment: 117
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Caregivers of pediatric patients with swallowing disorders

Brief summary: The purpose of this study is to test the reliability and validity of the Turkish Feeding/Swallowing Impact Survey among caregivers of pediatric patients with swallowing disorders.

Detailed description: The purpose of this study is to test the reliability and validity of the Turkish Feeding/Swallowing Impact Survey among caregivers of pediatric patients with swallowing disorders.The internal consistency, test-retest reliability, and criterion validity of T-EAT-10 will be investigated. The internal consistency will be assessed using Cronbach's alpha. Intraclass correlation coefficient (ICC) value with 95 % confidence intervals will be calculated for test-retest reliability. The criterion validity of the scale will be determined by assessing the correlation between the Turkish Feeding/Swallowing Impact Survey and Karaduman Chewing Performance Scale, Tongue Thrust Rating Scale, Pediatric version of the Eating Assessment Tool. The validity will also be determined by completion of the Turkish Feeding/Swallowing Impact Survey before and after swallowing rehabilitation of pediatric patients.

Eligibility criteria: Inclusion Criteria:

* Having a child with swallowing disorders aged between 6 months-18 years

Exclusion Criteria:

* Having a child without swallowing disorders
* Having a child with swallowing disorders aged below 6 months

Primary outcomes:
measure: The Turkish Feeding/Swallowing Impact Survey
timeFrame: 6 months
Secondary outcomes:
measure: The Karaduman Chewing Performance Scale
timeFrame: 6 months
measure: Tongue Thrust Rating Scale
timeFrame: 6 months
measure: Pediatric version of the Eating Assessment Tool
timeFrame: 6 months
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacetttepe University
Study officials:
affiliation: Hacettepe University
name: SELEN SEREL ARSLAN, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05105893: Effect of Date Fruit Consumption in Later Pregnancy
Official title: Effect of Date Fruit Consumption in Later Pregnancy on Length of Gestation Labor and Delivery of Nulliparous Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Labor Long
Keywords: Dates
labour
period of gestation
delivery
Lead sponsor: Pak Emirates Military Hospital
Sponsor class: OTHER
First posted: 2021-11-03
Enrollment: 142
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: EFFECT OF DATE FRUIT CONSUMPTION IN LATER PREGNANCY ON LENGTH OF GESTATION LABOR AND DELIVERY OF NULLIPAROUS WOMEN

Detailed description: This randomized, controlled study was conducted at the Gynecology and Obstetrics department of Pak Emirates Military Hospital for Six months duration from Jan 2021 to June 2021. Ethical consent for the study was taken from the Ethical Committee. All participants have signed the written consent. Healthy primigravida's at more than 37 weeks of gestation with no prenatal complications (low-risk pregnancies) or chronic diseases were invited to contribute in the analysis.

The criteria of exclusion included all primigravida and non-primigravida with prenatal problems. Prenatal complications included placenta praevia, rupture of membranes, multiple pregnancies, diabetes, hypertension and additional health problems, fetal abnormalities, fetal growth restriction or any contraindication to delivery by vagina.

The females who met the eligibility criteria were contacted and provided information related to the analysis. In the preliminary phase of contact with potential volunteers, the study was presented as a participant's usage of dates to expedite delivery. The randomization arrangement was performed by means of sealed envelopes numbered from 1 to 10, equally allocated by randomization to the date-consumers and the group of control. Therefore, they will be allocated to dates consumer or control group recipients.

Eligibility criteria: Inclusion Criteria:

* All primigravidas at 37 or more weeks gestation with low risk pregnancies

Exclusion Criteria:

* Any antenatal complications Preterm pregnancies

Primary outcomes:
measure: Effect of date fruit consumption in later pregnancy on length of gestation
timeFrame: 6 months
measure: Effect of date fruit consumption in later pregnancy on labour and delivery
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: PEMH
state: Punjab
Study officials:
affiliation: Resident
name: Salma Nisar
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01503593: Using Combination of Synthetic Bone Substitutes During Extractions
Official title: Phase 3 Study of Using Combination of Bi Phasic Calcium Phosphate and Bu Phasic Calcium Sulphate During Extractions
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Periodontitis
Dental Caries
Alveolar Bone Losses
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2012-01-04
Enrollment: 40
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 study was designed to assess the effectiveness of conservation ridge preservation (horizontal and vertical dimension) after tooth extraction with and without combination of bone substitutes based on synthetic (calcium sulfate mixed with phosphate.

Detailed description: Using the combination of these two bone substitute is taken in order to diminish the alveolar ridge alternations after tooth extraction. the investigator will measure the horizontal and vertical changes (primary outcome) and the adverse effects (secondary outcome)in 4 months period

Eligibility criteria: Inclusion Criteria:

1. Patients over age 18.
2. Patients who require extraction of teeth for Periodontal or other dental reasons (up one tooth in each quarter when there are existing adjacent teeth).

Exclusion Criteria:

1. Inability to pass informed consent procedure
2. Pregnant women
3. Breastfeeding women
4. Patient taking medications that affect bone metabolism such as bisphosphonates
5. Extractions sites contaminated
6. Smoking over 10 cigarettes a day
7. Patients with removable prostheses

Primary outcomes:
measure: The change of the dimension of the alveolar ridge
timeFrame: Immediatly after tooth extraction (up to 10 minutes after the extraction) and 4 monthes after extraction
Secondary outcomes:
measure: Post operative adverse effects
timeFrame: immediate after the extraction and until 4 monthes after
Other outcomes:
Locations:
Study officials:
affiliation: Rambam Health Care Campus, Haifa, Israel
name: Yaniv Mayer, D.M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03762993: Controlled Phonation and Vocal Rest Programs After Acute Vocal Exertion in Healthy Adults
Official title: Vocal Restoration Programs After Acute Vocal Exertion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Purdue University
Sponsor class: OTHER
First posted: 2018-12-04
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Within Subject Design
Primary purpose: TREATMENT

Brief summary: The proposed research will investigate the most effective strategy to reduce vocal exertion reported by speakers in noisy environments. Repeated vocal exertion can lead to voice problems and therefore identifying effective strategies can lead to better prevention of acquired voice disorders. This study will compare the effects of vocal rest and controlled phonation both before and after vocal exertion. The investigators hypothesize that vocal rest and controlled phonation will mitigate the negative effects of vocal exertion.


Eligibility criteria: Inclusion Criteria:

* within age range

Exclusion Criteria:

* Voice Disorders
* Strong gag reflex
* Craniofacial disorders
* Cognitive Impairments
* Head and Neck Cancer
* Hearing Difficulties
* Dentition problems that prevent an oral scope being placed in mouth

Primary outcomes:
measure: Phonation Threshold Pressure
timeFrame: 2.5 hours
Secondary outcomes:
measure: Lung Volume Excursion
timeFrame: 2.5 hours
Other outcomes:
Locations:
city: West Lafayette
country: United States
facility: Purdue University
state: Indiana
Study officials:
affiliation: Purdue University
name: Preeti Sivasankar
role: PRINCIPAL_INVESTIGATOR
References: