louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05013645: Evaluation of Skin Hydration in Adults With Dry Skin Using a Moisturizer With an Added Sterilized Probiotic
Official title: Evaluation of Skin Hydration in Adults With Dry Skin Using a Moisturizer With an Added Sterilized Probiotic
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Skin
Keywords: Probiotic
Lead sponsor: Florida State University
Sponsor class: OTHER
Collaborators: name: Dermatology Associates of Tallahassee
name: Quorum Innovations
First posted: 2021-08-19
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Double-blind placebo-controlled clinical trial to evaluate the effectiveness of a sterilized probiotic on skin health and hydration in adults with dry skin.

The goal of the study is to determine if the addition of a skin-conditioning probiotic to a standard gel product will moisturize the skin, support a healthy skin microbiome, and be readily tolerated by adults with dry skin.


Eligibility criteria: Inclusion Criteria:

1. Provision of a signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability to attend study visits for the duration of the study
3. English-speaking
4. 18-90 years of age
5. Score of a 2 or higher in one of the four areas assessed on the Dry Skin Area and Severity Index (DASI)

Exclusion Criteria:

1. Current self-reported pregnancy or active intent to conceive
2. Current lactation
3. Fever within 7 days of study enrollment
4. Self-reported use of systemic antibiotics (oral or injectable) in the past 6 weeks.
5. Any clinically significant medical or psychological disorder, condition, or disease that in the opinion of the investigator exposes the subject to unacceptable risk by participating in the study or interferes with the subject's ability to complete the study.

Primary outcomes:
measure: Corneometer Measurements
timeFrame: Study Days 1, 14, 28, 35
measure: Tewameter Measurements
timeFrame: Study Days 1, 14, 28, 35
Secondary outcomes:
measure: Skin microbiome analysis
timeFrame: Study Days 1, 28
measure: Change in Skindex16 Quality of Life over study days 1, 14, 28, 35
timeFrame: Study Days 1, 14, 28, 35
measure: Change in Dry Skin Area and Severity Index (DASI) between study days 1 and 28
timeFrame: Study Days 1, 28
measure: Change in Dryness Self Assessment (D-VAS) over study days 1, 14, 28 and 35
timeFrame: Study Days 1, 14, 28, 35
measure: Change in Itchiness Self Assessment (I-VAS) over study days 1, 14, 28 and 35
timeFrame: Study Days 1, 14, 28, 35
Other outcomes:
Locations:
city: Tallahassee
country: United States
facility: Dermatology Associates of Tallahassee
state: Florida
Study officials:
affiliation: Florida State University College of Medicine and Quorum Innovations
name: Eva Berkes, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02154945: Retinal Nerve Fiber Layer and Macular Thickness Changes During Pregnancy
Official title: Retinal Nerve Fiber Layer and Macular Thickness Changes During Pregnancy by Optical Coherence Tomography: Prospective, Observational, Nonrandomized Controlled Study
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Pregnancy
Retinal Nerve Fiber Layer Thickness
Macular Thickness
Lead sponsor: The Baruch Padeh Medical Center, Poriya
Sponsor class: OTHER_GOV
First posted: 2014-06-04
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pregnant patients

Brief summary: Purpose:

Primary: to prospectively measure Retinal Nerve Fiber Layer (RNFL) and macular thickness changes during pregnancy by Optical coherence tomography

Secondary: The effect of pregnancy abnormalities on RNFL and macular thickness in participants who develop systemic or ocular complications during the study period.

Detailed description: There are several known ophthalmic physiologic changes in pregnancy:

1. Refractive Change: progesterone-mediated changes in fluid content partially accounts for refractive change of lens and cornea; myopic shift of less than 1 D was observed in in 15% of participating pregnant women
2. Night vision decreased mainly with low serum vitamin A levels in pregnant women.
3. Fall of the IOP in second half of pregnancy (about 10% drop)
4. Corneal changes (increased thickness; decreased sensitivity) = contact lens intolerance

The retina and optic nerve are considered part of central nervous system, the retina and choroid are highly vascularized. Due to changes in CSF and brain volume, vascular and fluid changes all over the pregnant woman's body we expect to find changes in RNFL and macular thickness during pregnancy.

Eligibility criteria: Inclusion Criteria:

* 1st trimester (6-14w) pregnant healthy women
* No known medical problems related to their current pregnancy on recruitment
* Age 18-45yrs
* No known retinal or optic nerve disease
* Refraction between +3.0 and -4.0 diopters
* Agrees to participate in the study

Exclusion Criteria:

* Retinal or optic nerve disease
* Refractive errors more than +3.0 and -4.0.
* If already finished 14w gestation when recruited to the 1st OCT examination
* Known to have HTN or DM before gestation
* Ocular media abnormality that obscures OCT view or examination

Primary outcomes:
measure: Retinal nerve fiber layer(RNFL) and Macular thickness by Optical coherence tomography(OCT) during pregnancy
timeFrame: 1 year
Secondary outcomes:
measure: Effect of systemic and ocular diseases on Retinal Fiber Layer and Macula during pregnancy
timeFrame: 1 year
Other outcomes:
Locations:
city: Poriya
country: Israel
facility: Baruch Padeh Medical Center
state: Lower Galeli
Study officials:
affiliation: Baruch Padeh Medical Center
name: Nakhoul Fa Nakhoul, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT07015645: Long-Term Outcomes of Hypopituitarism Following Gamma Knife Radiosurgery for Pituitary Adenomas
Official title: Long-Term Outcomes of Hypopituitarism Following Gamma Knife Radiosurgery for Pituitary Adenomas
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Long Term
Hypopituitarism
Gamma Knife Radiosurgery
Pituitary Adenomas
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2025-06-11
Enrollment: 137
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This retrospective cohort study will be conducted in the Department of Neurosurgery, Al-Azhar University Hospital.

Brief summary: This study aims to assess long-term outcomes of hypopituitarism following gamma knife radiosurgery (GKRS) for pituitary adenomas.

Detailed description: Pituitary adenomas (PAs) are one of the most common intracranial neoplasms, accounting for 10-20% of diagnosed brain tumors.

Initial gamma knife radiosurgery (GKRS) can be an alternative treatment for selected NFPA patients with comorbidities, documented growth small tumors, cavernous sinus invasion, or advanced age.

Hypopituitarism is one of the most common complications of radiosurgery (Cordeiro et al., 2018). Long-term follow-up is crucial to assess new pituitary deficits. Typically, hypopituitarism presents within the first 2-4 years after the treatment with radiosurgery, but the risk of pituitary insufficiency increases to up to 80%. Reports on the highest incidence of new-onset hypopituitarism also mentioned the longest follow-up period.

Eligibility criteria: Inclusion Criteria:

* Age ≥18 years.
* Both sexes.
* Patients treated with gamma knife radiosurgery (GKRS).

Exclusion Criteria:

* Patients with inadequate endocrine follow-up (\<12 months).
* Patients who had undergone previous radiation therapy.
* Pituitary insufficiency which presents before gamma knife radiosurgery (GKRS).
* Patients without visible glands.

Primary outcomes:
measure: Prevalence of new-onset hypopituitarism
timeFrame: 5 years post-procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Damietta
country: Egypt
facility: Al-Azhar University (Damietta)
Study officials:
References:
Clinical trial NCT00567645: Sympathetic Innervation of the Heart and Cardiac Resynchronization Therapy(CRT)
Official title: Identification of the Role of Sympathetic Innervation in Heart Failure Patients Treated With Cardiac Resynchronization Therapy. A Pilot Study
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Sympathetic Innervation
Chronic Heart Failure
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
First posted: 2007-12-05
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: chronic heart failure patients with CRT

Brief summary: The purpose of this study is to assess whether baseline sympathetic innervation in patients with chronic heart failure (CHF) is predictive for response to cardiac resynchronization therapy (CRT). And to assess whether response to CRT coincides with restoration of regional sympathetic innervation.


Eligibility criteria: Inclusion Criteria:

* Indication for CRT
* Stable optimal medication
* Non ischemic cardiomyopathy

Exclusion Criteria:

* Age less then 18 years
* Previous CRT
* Clinically relevant valvular heart disease or coronary artery disease
* Acute or chronic infection
* Untreated clinical hypo- or hyperthyroidism or \< 3 months euthyroidism
* Uncontrolled hypertension, defined as a systolic blood pressure \> 160 mm Hg and/or a diastolic blood pressure \> 95 mm Hg
* A concurrent medical condition (i.e. alcohol or drug abuse or a severe progressive extra cardiac disease or M. Parkinson) or is unlikely to comply with the protocol
* Participation to a previous protocol involving radioactivity in the past year
* Pregnancy

Primary outcomes:
measure: sympathetic innervation in patients with chronic heart failure (CHF)
timeFrame: 6 months
Secondary outcomes:
measure: NYHA class Echocardiographic parameters: LVEDD, LVESD, LVEF, LVESV,IVMD, and septal to lateral delay Hospitalization for heart failure Maximal oxygen consumption NT pro-BNP changes
timeFrame: 6 months
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
Study officials:
affiliation: University Medical Center Groningen, departmen cardiology
name: Isabelle C. Van Gelder, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02938845: Does Minimally Invasive Surgery Reduce Anxiety?
Official title: Factors Related to Patients' Anxiety Before and After Hysterectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Lead sponsor: Zeynep Kamil Maternity and Pediatric Research and Training Hospital
Sponsor class: OTHER
First posted: 2016-10-19
Enrollment: 74
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study was to identify factors that may contribute to anxiety of patients undergoing total abdominal hysterectomy(TAH) or total laparoscopic hysterectomy(TLH) before and after the operation. Thus, we aimed to learn whether anxiety levels change according to the type of hysterectomy.

Detailed description: Hysterectomy is the most common gynecological procedure worldwide. . There has been a increasing interest towards to more minimally invasive procedures in the past decade. Hysterectomy operation anxiety is a complex phenomenon affected by various parameters. Patients' anxiety may be affected by their age, gender, educational status,type of operation and personality. Each patient's anxiety was measured using Spielberger's State-Trait Anxiety Inventory immediately before, immediately after the operation.

Eligibility criteria: Inclusion Criteria:

undergone hysterectomies for benign reasons.

Exclusion Criteria:

malignancy, additional operation beside hysterectomy( such as salpingo-oophorectomy), history of two or more previous caesarean sections, history of previous abdominal surgery, autoimmune disease, coagulation disorders, with known systemic or psychiatric disease, those receiving any regular sedative medication at the time of the procedure

Primary outcomes:
measure: STAI-S's Inventory
timeFrame: change from immediately before operation to immediately after the operation.
measure: STAI-T's Inventory
timeFrame: change from immediately before operation to immediately after the operation.
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Zeynep Kamil Woman and Child Diseases Education and Research Hospital
Study officials:
References:
citation: Lopez-Jornet P, Camacho-Alonso F, Sanchez-Siles M. Assessment of general pre and postoperative anxiety in patients undergoing tooth extraction: a prospective study. Br J Oral Maxillofac Surg. 2014 Jan;52(1):18-23. doi: 10.1016/j.bjoms.2013.01.004. Epub 2013 Jan 26.
citation: Muglali M, Komerik N. Factors related to patients' anxiety before and after oral surgery. J Oral Maxillofac Surg. 2008 May;66(5):870-7. doi: 10.1016/j.joms.2007.06.662.
citation: Flory N, Bissonnette F, Binik YM. Psychosocial effects of hysterectomy: literature review. J Psychosom Res. 2005 Sep;59(3):117-29. doi: 10.1016/j.jpsychores.2005.05.009.
Clinical trial NCT06543745: Safety and Impact of Low Resistance Exercise Training on Quality of Life in Pulmonary Arterial Hypertension
Official title: Safety and Impact of Low Resistance Exercise Training on Quality of Life in Pulmonary Arterial Hypertension
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pulmonary Arterial Hypertension
Frailty
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2024-08-09
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: OTHER

Brief summary: The purpose of the study is to learn more about how low-resistance training impacts frailty and the quality of life of people with pulmonary arterial hypertension (PAH). Low-resistance training is an evidence-based approach that may help patients improve their functional ability.

Detailed description: Patients with pulmonary arterial hypertension and their caregivers will be asked to participate in the study. The study consists of a baseline in-person visit (week 1) where quality of life and physical performance will be assessed, and subjects will be shown low-resistance training exercises to perform at home. The exercises will then be performed at home, as instructed, for 12 weeks. At week 12, subjects return for a follow-up in-person visit, where quality of life and physical performance will be reassessed. Patients and caregivers will also be asked to participate in separate exit interviews, where investigators will ask how they felt about the resistance training.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of PAH: idiopathic, heritable, associated with connective tissue disease, congenital heart disease, human immunodeficiency virus, drug- or toxin, or portopulmonary hypertension
* On stable PAH therapy for 3 months

Exclusion Criteria:

* World Health Organization (WHO) functional class IV
* Left ventricular ejection fraction \< 40% (via transthoracic echocardiogram (TTE) within one year of screening)
* Moderate or severe concomitant lung disease: Chronic Obstructive Pulmonary Disease (COPD) or interstitial lung disease
* Enrollment in a clinical trial
* Recent hospitalization (within 4 weeks of screening)
* Inability to perform the Short Physical Performance Battery or wheelchair bound

Primary outcomes:
measure: Adverse Events
timeFrame: Between baseline and 12-week follow-up
measure: Feasibility of Recruitment
timeFrame: Through study completion, an average of twice per year
measure: Feasibility of Study
timeFrame: Through study completion, an average of twice per year
measure: Short Performance Physical Battery (SPPB) and emPHasis-10 (E10) scores
timeFrame: Between baseline and 12-week follow-up
measure: Patient/ Caregiver Exit Interview
timeFrame: Upon conclusion of the 12-week follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsyvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Nadine Al-Naamani, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02491645: Comparison of Effectiveness of Home Based Sensory Interventions Along With Standard Therapy Versus Standard Therapy Alone in Autistic Children With Sensory Processing Abnormalities
Official title: Comparison of Effectiveness of Home Based Sensory Interventions Along With Standard Therapy Versus Standard Therapy Alone in Autistic Children With Sensory Processing Abnormalities :An Open Label Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autistic Children With Sensory Processing Abnormalities
Keywords: Autistic spectrum disorder
Sensory processing abnormalities
Sensory interventions
occupational therapy
Lead sponsor: PGIMER
Sponsor class: UNKNOWN
First posted: 2015-07-08
Enrollment: 40
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Around 69-95% of children with Autistic Spectrum Disorder are known to have sensory processing abnormalities .Tackling these problems would help in better quality of life, both for the parents and the children. Sensory integration therapy, an individualized clinic based therapy have been shown to have a positive effect on those children with sensory abnormalities. Hence the investigators are doing this study , to primarily look into the efficacy and feasibility of home based sensory interventions in autistic children with sensory processing abnormalities.


Eligibility criteria: Inclusion Criteria:

1. Children between the age group of 3-12years with autistic spectrum disorder as per DSM -V criteria along with CARS and those having sensory abnormalities as screened by short sensory profile 2 will be included in the study group
2. Parents who agreed for home based sensory intervention therapy with strict adherence to same and to refrain from initiation of any new treatments including medications during study period

Exclusion Criteria:

1. Children with epileptic syndromes with language regression(LKS)
2. Children with features of ASD but having underlying structural(TS), neurometabolic or primary epilepsy as etiology
3. Children with uncontrolled seizures (seizures in the last 06 months)
4. Children whose parents do not give consent for the study
5. Children for whom follow up would not be feasible

Primary outcomes:
measure: 1. Comparison of change in total score on 10 item Likert scale (as rated by parents)
timeFrame: 3 months
Secondary outcomes:
measure: 1. Comparison of change in health related quality of life using PedsQL ( Pediatric quality of life inventory) questionnaire
timeFrame: 3 months
measure: 2. Comparison of change in overall functional outcome using CGAS (Children's global assessment scale) questionnaire
timeFrame: 3 months
Other outcomes:
Locations:
city: Chandigarh
country: India
facility: Dr Hansashree P
Study officials:
affiliation: Post Graduate Institute of Medical Education and Research, Chandigarh
name: Dr Hansashree Padmanabha, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00353847: Acupuncture for Treatment of Chronic LBP, RCT, Single Blinded
Official title: A Randomized, Single Blind, Controlled Clinical Trial to Evaluate the Pain Relief Efficacy, Functional Improvement and Safety of Acupuncture in Patients With Chronic Low Back Pain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Chronic Low Back Pain
Keywords: acupuncture, RCTs, chronic LBP
Lead sponsor: Korea Institute of Oriental Medicine
Sponsor class: OTHER_GOV
First posted: 2006-07-19
Enrollment: 50
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: The purpose of this study is to determine whether acupuncture is effective and safe in the treatment of chronic LBP.

Detailed description: The purpose of this study is as follows:

1. pain : VAS
2. Function : Roland Disability Scale
3. Side effect
4. Validity

Eligibility criteria: Inclusion Criteria:

* Having chronic, non-specific, LBP of at least 3 months' duration over 20 years old.
* Back pain must be the chief complaint
* Having normal neurological test
* Having signature voluntarily an IRB-approved consent form at enrollment

Exclusion Criteria:

* Potential spinal disease (e.g. a spinal tumor, infection or fracture etc)
* Other diseases (e.g. bleeding disease, dementia,epilepsy, neurogenic disorder etc)
* Planned or got lumbar surgery
* The prior use of acupuncture within the past 6 months
* Inflammatory arthritis
* The current use of systematic corticosteroids, narcotics, anticoagulants, muscle relaxants
* The involvement in legal problem related to LBP
* Refusal to be randomized

Primary outcomes:
measure: Visual Analogue Scale, RDQ scale
Secondary outcomes:
measure: Patient Global Assessment
Other outcomes:
Locations:
city: Gwangju
country: Korea, Republic of
facility: Wonkwang University Hospital
Study officials:
affiliation: Professor of College of Oriental Medicine, Wonkwang University
name: Youngdal Kwon, MD, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: