louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06621238: The Effect of Musıc on Labor Paın, Anxıety and Breastfeedıng Success
Official title: Effect of Musıc Lıstened to Prımarıparous Women Who Have Delıvered by Cesarean Sectıon on Paın, Status Anxıety and Breastfeedıng Success
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Labor Pain
Anxiety
Breast Feeding
Post Operative Pain
Lead sponsor: Ataturk University
Sponsor class: OTHER
First posted: 2024-10-01
Enrollment: 140
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study is to examine the effects of music played to primiparous women who had a cesarean section on pain, state anxiety and breastfeeding success.


Eligibility criteria: Inclusion Criteria:

* Caesarean section
* Live birth

Exclusion Criteria:

* Risky pregnancy
* Twin pregnancy
* Newborn with cleft palate, cleft lip

Primary outcomes:
measure: Postpartum Pain
timeFrame: Within the first hour after birth
measure: State Anxiety
timeFrame: Within the first hour after birth
measure: Breastfeeding Success
timeFrame: Within the first hour after birth
Secondary outcomes:
Other outcomes:
Locations:
city: Mardin
country: Turkey
facility: Mardin Education and Research Hospital
state: Artuklu/Mardin
Study officials:
affiliation: sibel.ozturk@atauni.edu.tr
name: Sibel ÖZTÜRK, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: ascelebi@beu.edu.tr
name: Ayşegül ŞAHİSN ÇELEBİ, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01643538: Social Goals and Individual Incentives to Promote Walking in Older Adults
Official title: Social Goals and Individual Incentives to Promote Walking in Older Adults (Way to Walk II)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Activity
Keywords: physical activity
adults age 65 and older
financial incentives
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Robert Wood Johnson Foundation
First posted: 2012-07-18
Enrollment: 94
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The goal of this randomized and controlled trial is to test whether a financial incentive of a donation to achieve a social goal is more effective to motivate and sustain a daily walking habit than the same dollar value given to an older adult. The investigators will achieve this using a novel computer platform utilizing a digital pedometer-internet interface.


Eligibility criteria: Inclusion Criteria:

* Adult 65 years of age and older
* Can read and speak English
* Access to a personal computer with high-speed internet connection and functional Universal Serial Bus (USB) port for the study duration
* Able to walk 1/4 mile (i.e., 2 to 3 blocks) without stopping
* No pedometer use in last 30 days

Exclusion Criteria:

Major medical conditions including:

* serious heart and lung diseases
* diabetes requiring insulin therapy
* severe arthritis
* neurologic disorders
* dementia
* heavy alcohol use
* recent knee or spinal surgery

Primary outcomes:
measure: mean proportion of days that step per day goals were attained
timeFrame: 16 weeks
Secondary outcomes:
measure: mean number of steps per day
timeFrame: 16 weeks
measure: mean proportion of days that step per day goals were attained during follow-up
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Karen Glanz, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pennsylvania
name: Jason Karlawish, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Harkins KA, Kullgren JT, Bellamy SL, Karlawish J, Glanz K. A Trial of Financial and Social Incentives to Increase Older Adults' Walking. Am J Prev Med. 2017 May;52(5):e123-e130. doi: 10.1016/j.amepre.2016.11.011. Epub 2017 Jan 3.
Clinical trial NCT02407938: Normal Values for Esophageal High Resolution Manometry in an Advanced Protocol Including Liquid Swallows and a Solid Test Meal
Official title: Normal Values for Esophageal High Resolution Manometry in an Advanced Protocol Using a Test Meal
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: dysphagia
reflux symptoms
retrosternal pain
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2015-04-03
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Normal values for measurements of high resolution manometry in a protocol which includes isolated liquid swallows in upright and recumbent position, free drinking of water, a solid test meal and a postprandial observational period will be determined.

Detailed description: The investigators will recruit healthy volunteers and ask for study participation. After providing informed consent, participants will be questioned using standardized questionnaires assessing symptoms of reflux, dysphagia, gastrointestinal symptom burden and depression. Participants will be tested using our advanced protocol for high resolution esophageal manometry. This protocol includes individual liquid swallows, free drinking of water, a standardized test meal (200g rice) and a postprandial observational period. Normal values for liquid and solid swallows will be determined.

Eligibility criteria: Inclusion Criteria:

* Healthy volunteers without gastrointestinal co-morbidity

Exclusion Criteria:

* Inability or unwillingness to provide informed consent
* Any relevant current or past gastrointestinal morbidity (including diseases relevant previous surgery).
* Relevant gastrointestinal symptoms
* Relevant medication (as specified below) within the last 4 weeks
* Age below 18 years

Primary outcomes:
measure: Values for HRM data (IRP, DCI, DL) in healthy volunteers
timeFrame: 1 hour
Secondary outcomes:
measure: discomfort on a VAS from 1-10 for each type of measurement
timeFrame: 1 hour
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Division of Gastroenterology, University Hospital Zurich
Study officials:
References:
citation: Ang D, Misselwitz B, Hollenstein M, Knowles K, Wright J, Tucker E, Sweis R, Fox M. Diagnostic yield of high-resolution manometry with a solid test meal for clinically relevant, symptomatic oesophageal motility disorders: serial diagnostic study. Lancet Gastroenterol Hepatol. 2017 Sep;2(9):654-661. doi: 10.1016/S2468-1253(17)30148-6. Epub 2017 Jul 3.
citation: Hollenstein M, Thwaites P, Butikofer S, Heinrich H, Sauter M, Ulmer I, Pohl D, Ang D, Eberli D, Schwizer W, Fried M, Distler O, Fox M, Misselwitz B. Pharyngeal swallowing and oesophageal motility during a solid meal test: a prospective study in healthy volunteers and patients with major motility disorders. Lancet Gastroenterol Hepatol. 2017 Sep;2(9):644-653. doi: 10.1016/S2468-1253(17)30151-6. Epub 2017 Jul 3.
Clinical trial NCT04872738: Patient Experiences with the COVID-19 Vaccination After Breast Cancer Treatment
Official title: Patient Experiences with the COVID-19 Vaccination After Breast Cancer Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer Related Lymphedema
Covid19
Keywords: Breast Cancer
Vaccination
Lymphadenopathy
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2021-05-04
Enrollment: 670
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with a history of breast cancer

Brief summary: This study aims to elicit patient experiences, choices, and side effects associated with the COVID-19 vaccine after breast cancer surgery. Lymph node swelling is a known and common side effect of both the Moderna and Pfizer COVID-19 vaccines. This is the body's normal reaction to the vaccine. It is worrisome that lymph node swelling after the vaccine mimics that found in breast cancer which has spread to the lymph nodes. This side effect will cause worry and anxiety amongst patients as a result. For patients who have had lymph node removal (axillary lymph node dissection or sentinel lymph node biopsy) and are at risk of lymphedema, the investigators are concerned that the lymph node swelling may tax the lymphatic system and incite lymphedema in those at risk or worsen it in those with BCRL. Fear of lymphedema is high in this population and the investigators need to better understand what risk, if any, lymph node swelling after the COVID-19 vaccine imparts to BCRL risk.

Detailed description: * Hypothesis 1: Patients will choose to receive the vaccine on the arm contralateral to axillary lymph node removal, or in the lower extremity if they have had bilateral axillary lymph node removal
* Hypothesis 2: Patients with a history of breast cancer will experience axillary lymph node swelling after receiving the COVID-19 vaccine at the same rate as the general population
* Hypothesis 3: Patients with axillary surgery who develop lymph nodes swelling in the ipsilateral side might be at increased risk of developing lymphedema

Eligibility criteria: Inclusion Criteria:

* Female patients who are
* ≥18 years of age and have a
* History of breast cancer For the MGH site, patients must have
* Received some breast cancer treatment at MGH or its affiliates
* Received perometry measurements to measure arm volume at MGH

Exclusion Criteria:

* None

Primary outcomes:
measure: COVID-19 Vaccination on Contralateral Arm
timeFrame: 0 to 6 months
measure: Lymph Node Swelling after mRNA COVID-19 Vaccine
timeFrame: 0 to 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital Cancer Center
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Alphonse G Taghian, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05416138: Theta Phase-specific TMS to Modulate Prefrontal Activity
Official title: The Effects of Closed-loop TMS-EEG on Immediate Prefrontal Activity and Approach/Avoidance Behavior
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Approach/Avoidance Behavior
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2022-06-13
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to evaluate the causal link between the phase of ongoing theta oscillations in the prefrontal cortex and approach/avoidance (Ap/Av) behavior in adults using theta phase-specific transcranial magnetic stimulation (TMS).

Detailed description: Approach/avoidance (Ap/Av) behavior is a reliable marker of the emotional processes in the human brain and a robust predictor of mood disorders. Although existing scientific studies found a correlation between the approach/avoidance behavior and ongoing theta activity (3-7 Hz) in the left dorsolateral prefrontal cortex, the causal evidence of the phase-dependent role and strength of association between the prefrontal theta oscillations and approach/avoidance behavior are still unclear. Here, we will monitor brain oscillations in real-time non-invasively using electroencephalography during the approach/avoidance test and modulate theta peaks or troughs with transcranial magnetic stimulation. These data will provide novel understanding of the mechanisms of emotional processing in human brain.

Eligibility criteria: Inclusion Criteria:

1. Age between 18 and 65 years old.
2. Confident level of English language.

Exclusion Criteria:

1. Chronic condition that requires pharmacological treatment over the course of study participation.
2. Metallic or electric implant in the head, neck, or chest area or otherwise MRI-noncompatible implants.
3. History or evidence of seizures, head injuries with loss of consciousness, chronic neurological or mental disorder.
4. Pregnancy or breast-feeding.
5. History or evidence of alcohol or drug addiction.

Primary outcomes:
measure: Reaction times in the Approach/Avoidance test
timeFrame: Immediate effect during stimulation
Secondary outcomes:
measure: Amplitude of TMS evoked potentials
timeFrame: Immediate effect during stimulation
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Alexander Opitz, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02649738: Corneal Tissue Inlay for Keratoconus
Official title: Use of Preserved Corneal Tissue Inlay to Treat Keratoconus
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Keratoconus
Keywords: keratoconus
corneal tissue inlay
Lead sponsor: Cornea and Laser Eye Institute
Sponsor class: OTHER
First posted: 2016-01-07
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will evaluate the outcomes of placing preserved corneal tissue within the keratoconic cornea in order to enhance thickness, stability, and optical conformation.

Detailed description: The objective of this study is to evaluate the outcomes of placing preserved corneal tissue within the corneal stroma in keratoconus patients as a means of enhancing thickness, stability, and optical conformation.

Eligibility criteria: Inclusion Criteria:

* Be at least 18 years of age, male or female, of any race
* Provide written informed consent and sign a HIPAA form
* Willingness and ability to follow all instructions and comply with schedule for follow-up visits
* For females: Must not be pregnant
* Having topographic evidence of keratoconus which is graded as moderate or severe keratoconus.

Exclusion Criteria:

* Contraindications, sensitivity or known allergy to the use of the test article(s) or their components
* If female, pregnant
* Eyes classified as either normal, atypical normal, keratoconus suspect or mild keratoconus on the severity grading scheme
* Previous ocular condition (other than refractive error) in the eye to be treated that may predispose the eye for future complications For example: a history of corneal disease (e.g., herpes simplex, herpes zoster keratitis, corneal melt, corneal dystrophy, etc.)
* A history of delayed corneal healing in the eye to be treated
* Have used an investigational drug or device within 30 days of the study

Primary outcomes:
measure: Corneal tissue inlay for keratoconus
timeFrame: 6 months
measure: Corneal tissue inlay for keratoconus
timeFrame: 6 months
measure: Corneal tissue inlay for keratoconus
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Teaneck
country: United States
facility: Cornea and Laser Eye Institue - Hersh Vision Group
state: New Jersey
Study officials:
affiliation: Cornea and Laser Eye Institute
name: Peter Hersh, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05009238: Effect of l S Exercises on Balance and Spatiotemporal Gait Parameters in P M Women
Official title: Effect of Lumbar Stabilization Exercises on Balance and Spatiotemporal Gait Parameters in Postmenopausal Women
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postmenopausal
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-08-17
Enrollment: 30
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Menopause is a natural process in women's life with hormonal fluctuations that cause physical and emotional symptoms such as(Hot flashes, insomnia, physical in activity, unstable mood, difficulties in memory and concentration, anxiety, stress, irritability, unstable body mass, sexual dysfunction, feelings of sadness, infertility, and depression).

Balance disturbances are common in the community as a whole and increase in frequency with age. The risk of falling increases from age 45 in women and peaks in the 55-59-year age group. Around the time of the menopause, estrogen production decreases dramatically and bone loss accelerates, which predisposes for fractures if a fall occurs.


Eligibility criteria: Inclusion Criteria:

* Post-menopausal women: Their age will be ranged between 45-59 years old, with low back pain.

Exclusion Criteria:

* Infection disease or fever.
* Foot ulcers.
* Foot infection or undergoing foot surgery.
* Recent fracture in foot and toes with unhealed wounds.
* Thrombotic disease of lower extremities.
* Deep proprioception loss.
* Peripheral neuropathy.
* Gout or advanced arthritis affecting the foot and toes.

Primary outcomes:
measure: Step length
timeFrame: about 6 weeks.
measure: step symmetry
timeFrame: about 6 weeks.
measure: walking speed
timeFrame: about 6 weeks.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06478238: Calcium Folinate Treatment of Spastic Paraplegia 56
Official title: A Prospective Single Arm Clinical Trial of Calcium Folinate in the Treatment of Spastic Paraplegia 56
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Hereditary Spastic Paraplegia
Lead sponsor: Shanghai 6th People's Hospital
Sponsor class: OTHER
First posted: 2024-06-27
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: SPG56 is one of the complicated and early-onset HSP subtypes caused by genetic mutations in CYP2U1. So far, there is no standardized and specific clinical therapy for SPG56. The goal of this clinical trial is to explore the efficacy and safety of calcium folinate in the treatment of SPG56 patients.

This study is prospective, open-label and single arm and this trial will last for 6 years. A total of 10 patients will participate and they will receive calcium folinate treatment and professional clinical evaluation regularly.


Eligibility criteria: Inclusion Criteria:

1. Patients meet the clinical diagnostic standard of hereditary spastic paraplegia (HSP);
2. Spastic paraplegia type 56 (SPG56) was diagnosed by CYP2U1 pathogenic mutation;
3. Patients are willing to participate in clinical trials and able to understand and comply with the research program.

Exclusion Criteria:

1. Patients are allergic to the drugs involved in the study;
2. Other neurological diseases likely affecting the evaluation of study treatment;
3. Other medical conditions such as: heart disease, tumor, blood disease, liver disease, kidney disease, etc. in the past 1 year;
4. Pregnancy or lactating women or subjects who are unable to use appropriate contraception during the trial;
5. Participating in another study drug trial and used the investigational drug in the past 30 days;
6. Subjects have poor compliance or other factors that are not suitable for participating in the clinical trial.

Primary outcomes:
measure: GMFM-88
timeFrame: At the end of the 5-year follow-up period
Secondary outcomes:
measure: SPRS score
timeFrame: At the end of the 5-year follow-up period
measure: MMSE score
timeFrame: At the end of the 5-year follow-up period
measure: Laboratory indicators
timeFrame: At the end of the 5-year follow-up period
measure: Cranial CT/MRI
timeFrame: At the end of the 5-year follow-up period
measure: Gait examination
timeFrame: At the end of the 5-year follow-up period
measure: MoCA score
timeFrame: At the end of the 5-year follow-up period
measure: High density electroencephalogram
timeFrame: At the end of the 5-year follow-up period
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai 6th People's Hospita
state: Shanghai
Study officials:
References:
Clinical trial NCT00000108: Effects of Training Intensity on the CHD Risk Factors in Postmenopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Coronary Disease
Keywords: exercise
Lead sponsor: National Center for Research Resources (NCRR)
Sponsor class: NIH
First posted: 2000-01-19
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this research is to find out whether training at different exercise intensities reduces the risk of developing cardiovascular disease (CVD) to a different extent. Heart attacks and stroke are the leading cause of death in older women. Reduced variability of the heart rate and increased dips and swings in blood pressure are risks factors that predict the chance of developing CVD as are increased levels of clotting protein fibrinogen and plasminogen activator inhibitor 1, and high levels of LDL-cholesterol (\>160mg/dl). We will be measuring all of these risk factors and any changes in your body fat level before you start training and after 15 and 30 weeks of training in the form of walking. At the present time the effects of exercise intensity on these factors are not well understood. This study will add to the basic understanding of these issues and allow us to recommend to postmenopausal women optimal exercise intensities to lose body fat and reduce the risk of developing CVD.


Eligibility criteria: Inclusion Criteria:

* Postmenopausal and preferably on hormone replacement therapy
* In good general health
* Have a body mass index (BMI, weight in kg/height in m2) of between 25 and 40
* Exercise less than 20 min/day two days a week

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: 3060G Central Campus Recreation Bldg 401 Washtenaw Ave.
state: Michigan
Study officials:
References: