louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02777294: Evaluation of Web-Based CBT for Rape Victims
Official title: Evaluation of Web-Based CBT for Rape Victims
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PTSD
Lead sponsor: East Carolina University
Sponsor class: OTHER
Collaborators: name: Boston University
name: University of Houston
First posted: 2016-05-19
Enrollment: 87
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Rape is unfortunately a common experience among women, affecting between 13 and 20%. In addition, up to 50% of all rape victims experience significant and persistent psychological distress. While cognitive-behavioral interventions have been found to be successful at alleviating distress among victims; the majority do not seek out these services, often because of feelings of stigma and self-blame. One potential method for circumventing these barriers is through online administered treatment. Thus, the current project is designed to conduct an initial evaluation of a 12 to 16-week, therapist-facilitated, multi-media, cognitive-behavioral, online intervention tailored specifically for rape victims. The effectiveness of this program at ameliorating distress among college women who have experienced rape and have current posttraumatic stress disorder (PTSD) was evaluated. Reductions in psychological distress was the primary outcome and was assessed at post-intervention and at three and six month follow-up periods. The effectiveness of the intervention was compared to a psycho-educational website.


Eligibility criteria: Inclusion Criteria:

* Current rape-related PTSD
* Regular access to a computer
* English language literacy
* Experience of completed rape at age 14 years or older

Exclusion Criteria:

* No current PTSD
* Current psychotherapy
* Lack of stability on psychotropic medication (\< 3 months)
* Lack of literacy in English
* Current substance dependence
* Current elevated suicidality
* Severe acute distress
* No experience of completed rape after age 14

Primary outcomes:
measure: Change in PTSD symptoms (PTSD Symptom Scale Interview)
timeFrame: Change in PTSD symptoms from baseline to 3 months post intervention
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02697994: Sterile Water Injections For Pain Relief İn Labor
Official title: Intradermal Sterile Water Injections for Labour Pain: A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Labour Pain
Back Pain
Keywords: Sterile Water Injection
Midwifery
Lead sponsor: University of Beykent
Sponsor class: OTHER
First posted: 2016-03-03
Enrollment: 168
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: ABSTRACT Introduction: In addition to pain caused by uterine contractions in labour, in 33% of women, continuous and severe back pain is observed. In management of this pain, sterile water injection is considered to be an effective method. Aim of this study is assessment of effectiveness and satisfaction of this method among Turkish women in which analgesic methods are not extensively used in labour and rates of cesarean section exponentially increases.

Material and Methods: 168 termed, healthy women who admitted to Istanbul Gaziosmanpaşa-Taksim Training and Research Hospital with labour pain and had severe back pain were randomized into 4x0.1 ml sterile water and 4xdry Injection groups. Injections were applied to Michaelis Rhomboid region in sacral region. Pain scores were assessed at 10th, 30th, 60th, 120th and 180th minutes with Visual Analog Scale (VAS). Additionally, need for epidural analgesia, APGAR score, mode of delivery, time of delivery, maternal satisfaction and breastfeeding scores were assessed.


Eligibility criteria: Inclusion Criteria:

* Aged between 18-35
* 37-42 weeks of gestation
* Expecting vaginal delivery
* Cephalic presentation
* Single, healthy fetus
* Spontaneous onset of labor
* Active phase of first stage of labor (3-7 cm cervical dilatation)
* Severe low back pain (VAS\>7cm)
* Required pain relief

Exclusion Criteria:

* Gestation \<37 weeks
* Multiple pregnancy
* Malpresentation
* Second stage labour
* Pharmacological analgesia prior to SWI
* Back pain assessed by VAS \<7
* Women whose labour would be considered high risk

Primary outcomes:
measure: Pain scores-30
timeFrame: at 30 mins after interventions
Secondary outcomes:
measure: Pain scores-10
timeFrame: at 10 mins after interventions
measure: Pain scores-60
timeFrame: at 60 mins after interventions
measure: Pain scores-90
timeFrame: at 90 mins after interventions
measure: Pain scores-120
timeFrame: at 120 mins after interventions
measure: Pain scores-180
timeFrame: at 180 mins after interventions
measure: APGAR score of neonate
timeFrame: at 5 mins after birth
measure: Maternal satisfaction
timeFrame: at 1 hour after birth
measure: Rates of breastfeeding-1
timeFrame: at 1 hour after birth
measure: Rates of breastfeeding-24
timeFrame: at 24.hours after birth
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01774994: Arginine and Nitric Oxide (NO) Metabolism in Healthy Human Volunteers
Official title: Arginine and Nitric Oxide (NO) Metabolism in Healthy Human Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: volunteers
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2013-01-24
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Investigation of arginine and NO metabolism in healthy subjects is important as a reference for alterations in arginine-NO metabolism in patients. Moreover, this study will indicate the changes during aging and gender-related differences. Although data on arginine metabolism exist in literature, data are limited to young healthy male subjects. Since patients with suspected changes in arginine metabolism, e.g. sepsis and cancer patients are often elderly and also women, knowledge of arginine metabolism in these groups is needed.


Eligibility criteria: Inclusion Criteria:

* Written informed consent
* Age 18-25 years (young); 50-70 years (middle aged/elderly)

Exclusion Criteria:

* Diabetes mellitus type I
* Livercirrhosis, pancreatitis, malignancies
* Hypertension (diastolic blood pressure \>95 mmHg or systolic blood pressure \>160 mmHg)
* History of gastrointestinal complaints
* Recent involuntary weight loss (more than 10 % in 6 months or more than 5 % in one month)
* Pregnancy (pregnancy test is done in female subjects)
* Use of medication that can affect arginine metabolism (nitrovasodilators and corticosteroids)
* Subjects with "high activity level"

Primary outcomes:
measure: whole body NO synthesis
timeFrame: 2 hours
Secondary outcomes:
measure: whole body protein metabolism
timeFrame: 2 hours
measure: whole body arginine metabolism
timeFrame: 2 hours
measure: blood parameters
timeFrame: 2 hours
Other outcomes:
Locations:
Study officials:
name: Nicolaas E Deutz, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Luiking YC, Ten Have GA, Wolfe RR, Deutz NE. Arginine de novo and nitric oxide production in disease states. Am J Physiol Endocrinol Metab. 2012 Nov 15;303(10):E1177-89. doi: 10.1152/ajpendo.00284.2012. Epub 2012 Sep 25.
citation: Luiking YC, Engelen MP, Deutz NE. Regulation of nitric oxide production in health and disease. Curr Opin Clin Nutr Metab Care. 2010 Jan;13(1):97-104. doi: 10.1097/MCO.0b013e328332f99d.
Clinical trial NCT06915194: SMART Pilot Trial of Glycemic Screening Outreach
Official title: SMART Pilot Trial of Glycemic Screening Outreach
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Overweight (BMI &gt; 25)
Obesity
Keywords: diabetes screening
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2025-04-08
Enrollment: 105
Sex: ALL
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: SCREENING

Brief summary: Approximately 130 million Americans have prediabetes or type 2 diabetes (T2D) but remain unscreened and/or unaware of their diagnosis. While prediabetes/T2D screening, also known as glycemic screening, is endorsed in national guidelines, there is almost no research on how to increase screening rates, or evaluations of interventions testing the effectiveness of screening promotion strategies. The American Medical Association has published prediabetes quality measures that apply to UCLA Health as well as all other health systems, specifically tracking the percentage of adult patients with risk factors for T2D due for glycemic screening for whom the screening process was initiated. However, there is no current systemic effort underway at UCLA, or most other health systems, to encourage glycemic screening. We are proposing a pilot trial of the first SMART (Sequential Multiple Assignment Randomized Trial) for glycemic screening. Our SMART experiment will provide preliminary feasibility and acceptability data for a larger, multisite trial that will provide vital guidance to optimize screening approaches for a growing number of screening-eligible patients so that they may seek earlier detection, treatment, and/or access to lifestyle programs and interventions for T2D or prediabetes.


Eligibility criteria: Inclusion Criteria:

* Overweight or obese

Exclusion Criteria:

* Existing type 2 diabetes, A1c drawn within past 3 years

Primary outcomes:
measure: Hemoglobin A1c
timeFrame: 90 days
Secondary outcomes:
measure: Acceptability survey
timeFrame: 90 days
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California, Los Angeles
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Obidiugwu K Duru, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03028194: Postpartum Uterine Curettage in the Recovery From Preeclampsia/Eclampsia
Official title: Effects of Postpartum Uterine Curettage in the Recovery From Preeclampsia/Eclampsia: A Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pre-Eclampsia
Eclampsia
Keywords: Pre-eclampsia
Eclampsia
Postpartum uterine curettage
Lead sponsor: Saint Thomas Hospital, Panama
Sponsor class: OTHER
First posted: 2017-01-23
Enrollment: 442
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Use of Postpartum uterine curettage in reducing hospitalization time or in improving the clinical evolution of the patient with preeclampsia/eclampsia.

Detailed description: To evaluate if postpartum uterine curettage improved the clinical and laboratory parameters in patients with preeclampsia or eclampsia.

A total of 442 patients with preeclampsia/eclampsia were randomized to postpartum curettage (223) or no procedure (219). Systolic and diastolic blood pressure were recorded and analyzed at hours 6, 12, 24 and 48. Also, several laboratory values and diuresis were evaluated.

Eligibility criteria: Inclusion Criteria:

* Gestational age 24 weeks or more.
* Preeclampsia/eclampsia

Exclusion Criteria:

* Epilepsy or seizures previous to pregnancy.
* Renal disease
* Heart disease
* Liver disease

Primary outcomes:
measure: Systolic and diastolic blood pressure
timeFrame: 6 hours
measure: Systolic and diastolic blood pressure
timeFrame: 12 hours
measure: Systolic and diastolic blood pressure
timeFrame: 24 hours
measure: Systolic and diastolic blood pressure
timeFrame: 48 hours
Secondary outcomes:
measure: Laboratory results (hypertensive disorder profile: hemoglobin, hematocrit, platelets, renal or liver function tests).
timeFrame: 6 hours
measure: Laboratory results (hypertensive disorder profile: hemoglobin, hematocrit, platelets, renal or liver function tests).
timeFrame: 12 hours
measure: Laboratory results (hypertensive disorder profile: hemoglobin, hematocrit, platelets, renal or liver function tests).
timeFrame: 24 hours
measure: Laboratory results (hypertensive disorder profile: hemoglobin, hematocrit, platelets, renal or liver function tests).
timeFrame: 48 hours
measure: Seizures
timeFrame: 48 hours
Other outcomes:
Locations:
city: Panama
country: Panama
facility: Saint Thomas H
city: Panama
country: Panama
facility: Saint Thomas Maternity Hospital
Study officials:
affiliation: Saint Thomas Hospital, Panama
name: Osvaldo Reyes, MD
role: STUDY_CHAIR
References:
Clinical trial NCT06189794: Effects of Rosa Damascena and Frankincense Essential Oils in Labor
Official title: Effects of Rosa Damascena and Frankincense Essential Oils in Labor
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Labor Pain
Keywords: Aromatherapy
Childbirth Problems
Rosa damascena
Frankincense
Comfort
Lead sponsor: Balikesir University
Sponsor class: OTHER
First posted: 2024-01-05
Enrollment: 39
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized controlled study aims to compare effects of different essential oils in labor pain, anxiety and childbirth comfort. The main questions it aims to answer are:

Is it effective using rosa damascena oil during labor? Is it effective using frankincense oil during labor? Which essential oil is more effective during labor Researchers will compare aromatherapy oils groups to see labor pain, anxiety and childbirth comfort levels of pregnant women.

Detailed description: During childbirth; pain, anxiety, and comfort level of women have a critical importance for a positive childbirth experience. So this study aims to compare the effects of different essential oils on labor pain, anxiety and labor comfort. In some studies, rosa damascena was found effective for labor pain. However, there are limited studies about comfort level and anxiety level of women during labor. So we aimed to investigate whether rosa damascena oil was effective for labor comfort and anxiety level or not. Samely it will be investigated frankincense oil was effective for labor comfort and anxiety level or not. Also which essential oil was more effective during labor will be analyzed.

Eligibility criteria: Inclusion Criteria:

- Pregnant women who are at latent phase of labor

Exclusion Criteria:

* Complicated pregnancy (preeclampsia, hypertension, diabetes etc.)
* Women who will have planned cesarean section
* Asthma or any other respiratory disease
* Allergies to Rosa Damascena or Frankincense oil

Primary outcomes:
measure: labor pain
timeFrame: 3 hours
measure: childbirth comfort
timeFrame: 3 hours
measure: anxiety
timeFrame: 3 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Balıkesir
country: Turkey
facility: Balikesir University Hospital
Study officials:
affiliation: Balikesir University Hospital
name: Tuba Kızılkaya, Asst.Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05244694: Impact of Insulin on Sympathetic Nervous System-mediated Peripheral Vasoconstriction
Official title: Impact of Insulin on Sympathetic Nervous System-mediated Peripheral Vasoconstriction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Vasoconstriction
Healthy
Insulin Resistance
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
First posted: 2022-02-17
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this project is to determine if hyperinsulinemia attenuates sympathetic nervous system-mediated vasoconstriction in the human leg.


Eligibility criteria: Inclusion Criteria:

* healthy adult men and women;
* 18-45 years of age;
* BMI 18-30 kg/m2;
* non-pregnant/non-breastfeeding;
* non-nicotine users;

Exclusion Criteria:

* taking any medications known to affect metabolic, respiratory, cardiovascular, and/or autonomic functions

Self-reported history of:

* hepatic, renal, pulmonary, cardiovascular, or neurological disease;
* stroke or neurovascular disease;
* bleeding/clotting disorders;
* sleep apnea or other sleep disorders;
* diabetes;
* smoking;
* history of alcoholism or substance abuse, excessive alcohol consumption;
* hypertension;
* active cancer;
* autoimmune disease;
* immunosuppressant therapy

Primary outcomes:
measure: Amount of leg blood flow
timeFrame: Change from baseline at minute 60
Secondary outcomes:
measure: Amount of muscle sympathetic nerve activity (MSNA)
timeFrame: Change from baseline at minute 60
measure: Amount of cerebral blood flow
timeFrame: Change from baseline at minute 60
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of Missouri
state: Missouri
Study officials:
affiliation: University of Missouri-Columbia
name: Jacqueline L Limberg, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05938894: Train Your Brain - Executive Function
Official title: The Effect of Executive Function Training on Diet and Attitudes
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Overweight and Obesity
Keywords: Normal weight
Lead sponsor: USDA Grand Forks Human Nutrition Research Center
Sponsor class: FED
First posted: 2023-07-11
Enrollment: 630
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this research is to test if playing games designed to improve an individual's executive function can change their views about the types of foods they eat. Executive function is a set of mental processes that people use every day to make decisions - such as what kinds of foods they choose to eat and when and where they eat those foods.

Detailed description: The purpose of this study is to determine whether executive function (EF) training concurrently improves attitudes, perceptions, and consumption of nutrient-dense foods (i.e., fruits, vegetables) while worsening the same of nutrient-poor foods. In effect, the aim is to test whether EF training can promote the substitution of nutrient-poor foods with fruits and vegetables (FV), as the Dietary Guidelines for Americans (DGA) recommends regular consumption of FV as part of a healthy dietary pattern. Given the health benefits associated with consuming FV, EF training that effectively promotes increased FV intake may benefit health. For example, FV consumption is associated with the reduced risk of all-cause mortality, cardiovascular disease, diabetes, cancer, and eye and skin health. Moreover, FV consumption is associated with better mental and cognitive health.

Eligibility criteria: Inclusion Criteria:

* BMI 23-38 kg/m2
* US citizenship
* Not currently dieting to lose weight and no weight loss or gain of \>2 kg over the past 3 months
* No tobacco or e-cigarette use
* Not pregnant or lactating or planning to become pregnant while participating in the study

Exclusion Criteria:

* Not a US citizen
* Currently dieting to lose weight
* Weight loss of \>2 kg over the past 3 months
* Tobacco or e-cigarette use
* Pregnant or lactating or planning to become pregnant while participating in the study
* A history of bariatric surgery
* Diagnosis of major medical or psychiatric condition that would interfere with participation, including not being physically able to play the games, or a current eating disorder

Primary outcomes:
measure: Change in response time
timeFrame: Week 0, Week 9
measure: Change in percent correct
timeFrame: Week 0, Week 9
Secondary outcomes:
Other outcomes:
Locations:
city: Grand Forks
country: United States
facility: USDA Grand Forks Human Nutrition Research Center
state: North Dakota
Study officials:
affiliation: USDA Grand Forks Human Nutrition Research Center
name: Shanon Casperson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00751894: Pegfilgrastim for Stem Cell Mobilization in Children (Meg-5)
Official title: Haematopoietic Progenitor Cell Mobilization in Children With Malignancies: Evaluation of Pegfilgrastim at 200µg/kg After Chemotherapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Solid Malignancies
Keywords: Children
cancer
Bone marrow transplantation
Stem cell mobilization
G-CSF
Children with solid malignancies
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
Collaborators: name: Amgen
First posted: 2008-09-12
Enrollment: 30
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Primary purpose: TREATMENT

Brief summary: Hypothesis : pegfilgrastim at 200 µg/kg between 12 and 18 days after previous chemotherapy provides an efficient stem cell mobilization in children with malignancies Design: phase 2 study. Judgment criterion: percentage of children achieving at least 5x10e6 CD34 cells with a standard apheresis (less than 3 blood volume processed

Detailed description: Patients: consecutively referred for HSC mobilization. 12 to 18 days after the previous chemotherapy. No haematological growth factor during the 8 previous days.

Mobilization: one sc injection of 200 µg/kg pegfilgrastim (Neulasta, Amgen) Evaluation during the study: CD34 circulating cells from day 3 to day 7 ; AE recording Judgment criterion: percentage of children achieving at least 5x10e6 CD34 cells with a standard apheresis (less than 3 blood volume processed) Analysis: sequential Bayesian study

Eligibility criteria: Inclusion Criteria:

* 0 to 18 years
* solid malignancy
* Lansky score \>70%
* 12 to 18 days since the beginning of the last chemotherapy cycle
* no administration of any hematopoietic growth factor in the previous 8 days

Exclusion Criteria:

* clinical or biological conditions precluding the mobilization or collection procedure

Primary outcomes:
measure: percentage of children achieving at least 5x10e6 CD34 cells with a standard apheresis (less than 3 blood volume processed)
timeFrame: less than 3 blood volume processed
Secondary outcomes:
measure: Side effects Number of apheresis required to achieved a graft of at least 5x10e6 CD34 cells
timeFrame: at least 5*10e6CD34cells
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Etienne Merlin, DR
role: PRINCIPAL_INVESTIGATOR
References: