louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00895973: A Trial of Bed Versus Stirrups Delivery in Nulliparous Women for Prevention of Perineal Lacerations
Official title: A Randomized Trial of Bed Versus Stirrups Delivery in Nulliparous Women for Prevention of Perineal Lacerations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Perineal Lacerations
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2009-05-11
Enrollment: 214
Sex: FEMALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The investigators hypothesize that the rate of perineal lacerations in nulliparous women will be reduced by a simple change in common obstetrical delivery practice, i.e., bed delivery versus conventional delivery in obstetrical stirrups.

Detailed description: This is a randomized controlled trial of bed delivery in the supine position versus conventional delivery in obstetrical stirrups. It will include nulliparous women presenting in active labor to the L\&D East (low risk) Unit at Parkland Hospital, \> 370/7 weeks gestation, with singleton fetuses in cephalic presentation. The primary outcome variable is any perineal laceration. Secondary outcomes measures include (1) 3rd or 4th degree lacerations and (2) any lacerations in subgroup comparisons between study arms.

Eligibility criteria: Inclusion Criteria:

* Nulliparous women presenting in active labor to Parkland L\&D East Unit
* ≥ 370/7 weeks gestation
* Singleton fetus in cephalic presentation
* ≥ 4 cm but ≤ 8 cm of cervical dilation
* No medical or obstetrical complication

Exclusion Criteria:

* Women with any obstetric or medical complication of pregnancy, such as pregnancy related hypertension, diabetes, labor induction
* Prior history of perineal trauma requiring surgical repair or known congenital perineal malformation
* Non-English or non-Spanish speaking

Primary outcomes:
measure: Any perineal laceration (first through fourth degree)
timeFrame: Immediately post delivery
Secondary outcomes:
measure: Third and fourth-degree perineal lacerations
timeFrame: Immediately post delivery
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Parkland Memorial Hospital
state: Texas
Study officials:
affiliation: UT Southwestern Medical Center
name: Marlene M Corton, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02316873: Rhythm and Music to Rehabilitate Reading Disorders
Official title: Rhythm and Music to Rehabilitate Reading Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Reading Disability
Keywords: music training, rhythm
Lead sponsor: Aix Marseille Université
Sponsor class: OTHER
Collaborators: name: WHO Collaborating Centre for Maternal and Child Health, Trieste
name: University of Roma La Sapienza
First posted: 2014-12-15
Enrollment: 48
Sex: ALL
Minimum age (years): 8
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether music training is an effective treatment of reading disorders

Detailed description: Introduction: Children with dyslexia show deficits in temporal processing, both in language and in music. Musical activity increases phonological awareness, word segmentation, working memory, as well as reading abilities in children with typical development, a compelling evidence for a role of music training in fostering brain plasticity. Within this theoretical framework, we investigate the hypothesis that music training, by improving temporal processing and rhythm abilities, improves phonological awareness and reading skills in children with dyslexia.

Methods: The study is a prospective, multicenter, open randomized controlled trial, consisting of test, rehabilitation and re-test

Eligibility criteria: Inclusion Criteria:

* Italian native language
* Reading performance (accuracy and/or speed) failed on at least two of three school grade standardized Italian tests: text, words, pseudowords (cut-offs: z-score \<-1.8 standard deviations from the mean for speed scores, a score \<5th percentile in the accuracy scores).
* Hearing and neurological examination within normal range
* Normal or corrected-to-normal visual acuity
* General IQ \>85 at Wechsler Intelligence Scale for Children III.

Exclusion Criteria:

* Presence of comorbidity involving Attentional Deficit Disorders with Hyperactivity (ADHD)
* Presence of comorbidity involving Specific Language Impairment (SLI)
* Presence of comorbidity involving Oppositional Defiant Disorder (ODD)
* Severe emotional-relational impairments
* Previous formal musical or painting education for more than one year, other on-going treatment.
* Presence of other diseases (i.e. diabetes , cystic fibrosis, asthma...) that could influence the performance in cognitive and executive functions.

Primary outcomes:
measure: Pseudoword reading test
timeFrame: six months
Secondary outcomes:
measure: Reading text
timeFrame: six months
measure: Phonological awareness
timeFrame: six months
measure: Word reading
timeFrame: six months
Other outcomes:
Locations:
Study officials:
References:
citation: Flaugnacco E, Lopez L, Terribili C, Montico M, Zoia S, Schon D. Music Training Increases Phonological Awareness and Reading Skills in Developmental Dyslexia: A Randomized Control Trial. PLoS One. 2015 Sep 25;10(9):e0138715. doi: 10.1371/journal.pone.0138715. eCollection 2015.
Clinical trial NCT06324773: Prevalence of Postpartum Family Planning and Its Association With Spousal Joint Decision-Making in Family Planning
Official title: Prevalence of Postpartum Family Planning Uptake and Its Association With Joint Spousal Decision-Making in Family Planning: A Community-Based Cross-Sectional Study in Rural Sindh, Pakistan
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postpartum Family Planning
Lead sponsor: Aga Khan University
Sponsor class: OTHER
First posted: 2024-03-22
Enrollment: 524
Sex: ALL
Minimum age (years): 15
Maximum age (years): 49
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Married women of reproductive age (18-49) who gave birth a year ago and registered in the Maternal and Newborn Health Registry in Thatta District Sindh, Pakistan.

Brief summary: This community-based cross-sectional study investigates the prevalence of postpartum family planning (PPFP) uptake and its association with joint spousal family planning decision-making among married women in rural Sindh, Pakistan. The study, conducted in Thatta District with a population of approximately 0.98 million people, addresses sociodemographic challenges including high fertility rates, maternal and newborn mortality, and low contemporary contraception use. Targeting married women aged 18-49 who gave birth within the past year, the research utilizes data from the Global Network's Maternal and Newborn Health Registry. Data collection involves a pretested questionnaire administered by trained female data collectors. Statistical analysis includes descriptive statistics and logistic regression using STATA 17. The study aims to fill knowledge gaps regarding factors influencing PPFP uptake, particularly the role of joint decision-making in family planning. Findings could inform targeted interventions to enhance maternal and child health, contribute to existing knowledge, and guide policymakers and healthcare providers in addressing the unmet need for family planning in rural Pakistan.


Eligibility criteria: Inclusion Criteria:

* Women who are married and gave birth a year ago
* Living within the Maternal Neonatal Health Registry catchment area for at least one year.
* Women who will give their consent.

Exclusion Criteria:

* Pregnant women.
* Women who are critically ill and who face significant cognitive barriers that hinder their understanding and participation in the study.

Primary outcomes:
measure: Prevalence of Postpartum Family Planning Uptake
timeFrame: In past one year
measure: Frequency of spousal joint decision making for uptake of postpartum family planning
timeFrame: In past one year
measure: Comparison between spousal joint decision making is using postpartum family planning method and non-users.
timeFrame: in past one year
Secondary outcomes:
Other outcomes:
Locations:
city: Thatta
country: Pakistan
facility: Thatta
state: Sindh
Study officials:
References:
Clinical trial NCT02111473: The Effect of Testosteron Replacement Treatment on the Fibroblast Growth Factor-23, Asymmetric Dimethylarginine and Vitamin D Levels in the Congenital Hypogonadotropic Hypogonadism
Official title: Phase 4 Study of Effect of Testosteron Replacement Treatment on the Fibroblast Growth Factor-23, Asymmetric Dimethylarginine and Vitamin D Levels in the Congenital Hypogonadotropic Hypogonadism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypogonadism
Keywords: endothelial dysfunction
bone mineral metabolism
testosteron replacement treatment
Lead sponsor: Gulhane School of Medicine
Sponsor class: OTHER
First posted: 2014-04-11
Enrollment: 49
Sex: MALE
Minimum age (years): 18
Maximum age (years): 28
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study is designed to answer the following questions:

1) What is the effect of testosteron replacement treatment on the endothelial dysfunction.

2/ What is the effect of testosteron replacement on the bone mineral metabolism.

Detailed description: this is an interventional study which is examine the effect of testosteron replacement treatment on the endothelial dysfunction and bone mineral metabolism in hypogonadotropic hypogonadal patients.

Eligibility criteria: Inclusion Criteria:

* Men
* Congenital hypogonadism
* Treatment Naive

Exclusion Criteria:

* Previous history of androgen replacement
* Hypertension
* Diabetes mellitus

Primary outcomes:
measure: the effect of testosteron replacement treatment on the Fibroblast Growth Factor-23.
timeFrame: 6 months
measure: the effect of testosteron replacement treatment on the asymmetric dimethylarginine.
timeFrame: 6 months
measure: the effect of testosteron replacement treatment on the vitamin D levels.
timeFrame: 6 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gulhane School of Medicine
Study officials:
References:
Clinical trial NCT00816673: Sleep Inducing And Maintaining Efficacy Of Circadin In Elderly Insomniacs
Official title: Phase II Study of Sleep Inducing And Maintaining Efficacy Of Circadin In Elderly Insomniacs.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Primary Insomnia
Keywords: Insomnia
Primary insomnia
sleep latency
non restorative sleep
sleep quality
Double-Blind
Placebo Controlled
Parallel-Group
Sleep Laboratory Study
Lead sponsor: Neurim Pharmaceuticals Ltd.
Sponsor class: INDUSTRY
First posted: 2009-01-05
Enrollment: 40
Sex: ALL
Minimum age (years): 55
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this placebo controlled study is to investigate the effect of 2 mg melatonin Slow Release (Circadin®) on the sleep/wake cycle in elderly insomniac out-subjects, aged 55 years or more.

Detailed description: Circadin® is a newly developed slow release galenic formulation of melatonin, producing overall levels of melatonin comparable to those observed in a control population, when administered to patients with deficiency in melatonin; thus it deserves more clinical and paraclinical investigations for establishing efficacy in inducing and maintaining sleep and for safety. Since, on the one hand, the endogenous substance melatonin has beneficial effects on sleep in man and, on the other hand, there is a decrease in melatonin secretion in elderly people, substitution therapy in elderly insomniacs would be a desirable therapy.

The aim of this placebo controlled study was to investigate the effect of 2 mg Melatonin Slow Release (Circadin®) on the sleep/wake cycle in elderly insomniac out-subjects, aged 55 years or more. Sleep was assessed by means of polysomnography (hypnographic results), all-night sleep EEG spectral analysis (functional and quantitative results of sleep EEG), actimetry (SomnitorTM), wake EEG and sleep/wake quality questionnaires. Vigilance and cognitive skills were assessed by means of psychomotor and neurocognitive tests derived from the Leeds psychomotor test battery (vigilance and arousal) and TEA battery (attention).

Eligibility criteria: Inclusion Criteria:

* Healthy male and female, aged ≥ 55 years, suffering from primary insomnia according to DSM-IV criteria (307.42)

Exclusion Criteria:

* According to DSM-IV, subjects belonging to the following groups are excluded: 780.59; 307.45; 307.47; 780.xx (Appendix 2);
* Use of benzodiazepines or other hypnotics during the preceding 1 month with a frequency of more than 2 times a week and lasting more than 2 weeks;
* Severe neurological, psychiatric or sleep disorders;
* Other serious diseases;
* Taking more than 1/2 l of alcohol, more than 3 cups of coffee or more than 10 cigarettes per day .
* Subjects who need beta blockers as a treatment.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Centre Hospitalier De Rouffach
country: France
facility: FORENAP
Study officials:
affiliation: Forenap
name: Jean Paul MACHER, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06190873: The Effect of Telephone Education on Fear of Movement and Quality of Life in Patients With Lumbar Disc Herniation Surgery.
Official title: Effect of Telephone Training on Fear of Movement and Quality of Life in Patients With Lumbar Disc Herniation Surgery: Randomized Controlled Study.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Spine Disease
Spinal Deformity
Keywords: life quality
telehealty
tele nursing
kinezyofobi
Lead sponsor: Çanakkale Onsekiz Mart University
Sponsor class: OTHER
First posted: 2024-01-05
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: There will be two groups, one is the control group and the other is the intervention group.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim is to quantify the fear of movement and quality of life of telephone education on lumbar disc herniation surgery.

Detailed description: In the randomized controlled study, patients will be randomized into two categories: experimental and control groups. The experimental group will receive intervention via online information for 6 weeks after discharge. The control group will not be given online training other than standard nursing care. At the end of 6 weeks, the difference between fear of movement and quality of life between the two groups will be examined.

Eligibility criteria: Inclusion Criteria:

* being over 18 years old
* knowing how to read and write Turkish
* No hearing or speech impairment
* Having lumbar disc herniation surgery for the first time
* having a personal cell phone
* being discharged 5 days after surgery

Exclusion Criteria:

* being under 18 years old
* being illiterate
* having a hearing and speech disability
* not having a personal cell phone
* staying in the hospital for more than 5 days after surgery

Primary outcomes:
measure: movement fear scale
timeFrame: six week
Secondary outcomes:
measure: quality of life scale
timeFrame: six week
Other outcomes:
Locations:
city: Çanakkale
country: Turkey
facility: Çanakkale Mehmet Akif Ersoy Devlet Hastenesi
Study officials:
References:
Clinical trial NCT04795973: Efficacy of Intermittent Fasting on Metabolic Disease
Official title: Efficacy of Intermittent Fasting on Metabolic Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Individuals With Metabolic Disease
Keywords: Intermittent Fasting
metabolic disease
Lead sponsor: Beijing Chao Yang Hospital
Sponsor class: OTHER
First posted: 2021-03-12
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Adults aged between 18 to 75 years old
Primary purpose: TREATMENT

Brief summary: To elucidate the health effects, and further explore the research on safety. This study was conducted among adults with metabolic disease by using the intermittent fasting for 4 weeks. The aim of this study is to provide scientific basis for the IF used as a new prevention and control technology for metabolic disease.

Detailed description: In this trail, participants with metabolic disease were enrolled for 4-week intermittent fasting intervention. The intermittent fasting plains include time-restricted fasting and 5:2 project. For TRF regimen, participants are allowed to eat ad libitum from 7am to 5pm and fast in other time. For 5:2 project, chose two non-consecutive days per week to eat very little and eat ad libitum the other 5 days of the week. Serum samples and feces samples were collected before and after intervention for analysis.

Eligibility criteria: Inclusion Criteria:

* Adults aged between 18 to 75 years old with metabolic disease

Exclusion Criteria:

* diet therapy before participation
* pregnancy
* severe hepatic diseases
* severe nephropathy
* organic digestive diseases
* autoimmune diseases
* cancer
* infectious diseases, including pulmonary tuberculosis and AIDS
* alcoholism
* continuous antibiotic use for over 3 days within 3 months prior to enrollment
* continuous use of a weight-loss drug for over 1 month
* gastrointestinal surgery

Primary outcomes:
measure: plasma alanine aminotransferase (ALT)
timeFrame: Change from Baseline ALT at 4 weeks
measure: aspartate aminotransferase (AST)
timeFrame: Change from Baseline AST at 4 weeks
measure: plasma triglyceride levels (TG)
timeFrame: Change from Baseline TG at 4 weeks
measure: gamma-glutamyltransferase (GGT)
timeFrame: Change from Baseline GGT at 4 weeks
measure: alkaline phosphatase (ALP)
timeFrame: Change from Baseline ALP at 4 weeks
measure: height
timeFrame: Change from Baseline height at 4 weeks
measure: weight
timeFrame: Change from Baseline weight at 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Chao-yang Hospital, Capital Medical University
state: Beijing
Study officials:
affiliation: Beijing Chao-Yang Hospital, Capital Medical University, Beijing 100020, China
name: Guang Wang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01028573: A Study Comparing PEG-3350 (Miralax) and Gatorade With PEG-ELS (Golytely) for Bowel Preparation Prior to Colonoscopy
Official title: A Randomized, Controlled, Single-Blind Study Comparing the Efficacy, Tolerability and Safety of PEG-3350 (Miralax) and Gatorade With PEG-ELS (Golytely) for Bowel Preparation Prior to Colonoscopy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bowel Preparation for Colonoscopy
Keywords: bowel preparation
colonoscopy
Lead sponsor: Southern California Institute for Research and Education
Sponsor class: OTHER
First posted: 2009-12-09
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study to to see how well Miralax (PEG-3350) and Gatorade cleans the colon before a colonoscopy and how easy it is to take compared to Golytely (PEG-ELS) bowel preparation solution. Another purpose is to see if taking half of the bowel preparation solution on the evening before the colonoscopy and half on the morning of the colonoscopy will result in a cleaner colon than taking all of the bowel preparation solution on the evening before.


Eligibility criteria: Inclusion Criteria:

* 18-80 years in age
* Undergoing full colonoscopy for colorectal cancer screening or colon polyp/cancer surveillance or other diagnostic purpose

Exclusion Criteria:

* Allergic to polyethylene glycol
* Pregnant or lactating
* Baseline abnormalities of relevant serum electrolytes including Sodium, Potassium, Calcium, Magnesium and phosphorus
* Congestive Heart Failure NY Heart Assn, Grades III and IV
* Liver Cirrhosis Childs Pugh Class B or C
* Serum Creatinine greater than 1.5
* Previous alimentary tract surgery
* Ongoing symptoms of abdominal pain, bloating, nausea or constipation
* Ileus, suspected bowel obstruction, toxic colitis or megacolon, severe ulcerative colitis

Primary outcomes:
measure: Quality of bowel prepreparation/cleanliness scored using the Boston Bowel Preparation Scale
timeFrame: two years
Secondary outcomes:
Other outcomes:
Locations:
city: Long Beach
country: United States
facility: VA Long Beach Healthcare System
state: California
Study officials:
affiliation: VA Long Beach Healthcare System
name: Mazen Jamal, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06881173: The Effectiveness of Bu Zhong Yi Qi Tang in Patients with Myasthenia Gravis
Official title: Efficacy of Meridian Energy and Heart Rate Variability in Patients with Ocular Myasthenia Gravis by Using Chinese and Western Medicine Treatment
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Myasthenia Gravis
Lead sponsor: National Taipei University of Nursing and Health Sciences
Sponsor class: OTHER
First posted: 2025-03-18
Enrollment: 112
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Research Background: According to the Myasthenia Gravis Foundation of America (MGFA, 2015), the estimated prevalence of myasthenia gravis is 14-20 per 100,000 people, with a higher prevalence in young female individuals compared to males. However, as individuals age, especially after the age of 50, the prevalence in males becomes higher than in females. myasthenia gravis patients often experience varying degrees of disability, leading to the need for long-term medical care, medication, and lifestyle adjustments. This also gives rise to subsequent challenges in caregiving, affecting both the patients' families and society.

Detailed description: :This study aims to assess the effectiveness of using a combination of traditional Chinese and Western medicine,to improve the meridian energy and autonomic nervous system function of myasthenia gravis patients.

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with ocular myasthenia by a doctor
* Western medicine prescriptions only take oral Mestinon (Pyrido stigmine Bromide)
* Patients over 20 years old
* Can understand and understand Those who can speak Mandarin or Taiwanese
* those with a clear state of consciousness and no diagnosis of mental illness
* patients and their families who are willing to receive precise integrated treatment of traditional Chinese and Western medicine.

Exclusion Criteria:

* Patients with liver failure or kidney failure
* Allergy symptoms to traditional Chinese medicine, such as skin itching and redness
* Patients with malignant tumors
* Patients currently undergoing radiotherapy and chemotherapy
* Pregnant
* Cardiac rhythm device implementer

Primary outcomes:
measure: meridian energy
timeFrame: 12 weeks
measure: autonomic nervous system function
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Shin Kong Wu Ho-Su Memorial Hospital
Study officials:
affiliation: project leader
name: Ju-Han Liu
role: STUDY_CHAIR
References: