louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05407103: Acupressure and Comfort at Childbirth
Official title: The Impact of Applying Various Forms of Acupressure on Women's Hand During Labor on Their Childbirth Comfort: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Labor
Keywords: Pain, Labor, Comfort
Lead sponsor: Ondokuz Mayıs University
Sponsor class: OTHER
First posted: 2022-06-07
Enrollment: 129
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Aims: Non-pharmacological methods employed for management labor pain also help pregnant women to cope with labor pain and increase their childbirth comfort. The aim of this study is to determine the effect of cold and hot acupressure applications, applied to the acupressure point LI4 of primiparous women during labor, on their childbirth comfort.

Methods: This study was designed a randomized controlled experimental study. The sample consisted of 129 healthy pregnant women including 44 pregnant women in the hot acupressure group, 44 pregnant women in the cold acupressure group, and 41 pregnant women in the control group. The "Personal Information Form", the "Labor Monitoring Form", the "Visual Analog Scale", and the "Childbirth Comfort Questionnaire" were all used to gather the data.


Eligibility criteria: Inclusion Criteria:

* Being a primipara
* Having intact membranes
* No skin diseases (such as urticaria...),
* No use of narcotic drugs
* Having a term pregnancy
* Having a single fetus at vertex position
* Planning to have vaginal delivery
* Having contractions and ongoing regular augmentation
* Having recent augmentation starting periods
* Being in the latent phase (0-3 cm dilatation)
* Having no history of high-risk pregnancy
* Not using analgesic drugs to reduce pain during delivery
* Having no systemic and neurologic diseases
* Having no contraction anomaly (hypotonic or hypertonic contractions)

Exclusion Criteria:

• Having any of the above criteria

Primary outcomes:
measure: Comfort
timeFrame: through study completion, an average of 1month
Secondary outcomes:
measure: Labor pain
timeFrame: through study completion, an average of 1month
Other outcomes:
Locations:
city: Tokat
country: Turkey
facility: Health Research and Training Hospital of Tokat Gaziosmanpaşa University
Study officials:
References:
Clinical trial NCT03628703: Response Inhibition in Tourette Syndrome
Official title: Using Repetitive Transcranial Magnetic Stimulation to Modulate Response Inhibition in Tourette Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tourette Syndrome
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
First posted: 2018-08-14
Enrollment: 10
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Tics are the hallmark symptoms in Tourette Syndrome. Patients with Tourette Syndrome have difficulties controlling unwanted movements. The ability to control the motor system involves the pre-supplementary motor area (pre-SMA) in the brain. In this study, we will use Transcranial Magnetic Stimulation to modulate the pre-SMA and determine effect on the ability to stop an unwanted action in a behavior task (stop signal task).


Eligibility criteria: Inclusion Criteria:

* Tourette Syndrome

Exclusion Criteria:

* Autism spectrum disorder
* Mood disorder
* Epilepsy
* Implanted medical device (e.g. pacemaker, shunt, pumps)

Primary outcomes:
measure: Stop Signal Reaction Time (SSRT)
timeFrame: 30 minutes after Repetitive Transcranial Magnetic Stimulation (as it takes about 30 minutes to complete the modified Slater-Hammel stop signal task)
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Steve W. Wu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00005403: Heart Disease and the Black Health Disadvantage
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Heart Diseases
Coronary Disease
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Sponsor class: NIH
First posted: 2000-05-26
Sex: MALE
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: To utilize national population data sets prepared by the National Center for Health Statistics, to (1) examine the current Black disadvantage in cardiovascular (CV) health, (2) explore potential clinical and epidemiologic causes, (3) incorporate emerging knowledge of new risk factors and (4) compare trends in medical treatment and risk factors for the four sex-race groups.

Detailed description: BACKGROUND:

The Black health disadvantage remains a pressing public health issue in the United States. According to the Department of Health and Human Services 'Black and Minority Health Report', 65,000 excess deaths occur each year among Blacks when compared to the mortality experience of whites. Cardiovascular diseases make by far the largest contribution to this loss of life, accounting for over 30 percent of the excess. Despite improvements in CV mortality for all four major sex-race groups during the 1970's, the trends in heart disease in the United States began to diverge. A 50 percent slowing of the decline in coronary mortality occurred among Blacks from 1978-1986, compared to whites, and the gap in life expectancy between the races has widened. As noted in the 'Report', despite the widespread recognition of the importance of the problem, our knowledge regarding the causes of these differentials in CV disease was inadequate. To address this problem, the Report recommended support for 'innovative uses of current data' and 'cross-comparisons from different data sets', emphasizing the unique contribution population-based studies can make to 'understanding the health status and needs of minority populations'. Given the deterioration of the Black health status relative to the majority population, these recommendations took on new urgency.

DESIGN NARRATIVE:

Several separate analyses were conducted of prevalence surveys, epidemiologic followup studies, hospitalization surveys and vital statistics. These separate analyses were subsequently combined into a comprehensive description of the clinical and epidemiologic determinants of the Black CV disadvantage, and its future trends.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility criteria: No eligibility criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Liao Y, Cooper RS. Continued adverse trends in coronary heart disease mortality among blacks, 1980-91. Public Health Rep. 1995 Sep-Oct;110(5):572-9; discussion 570-2.
Clinical trial NCT05915403: Frequency of Sexual Intercourse,Women With Fibromyalgia
Official title: The Effect of Frequency of Sexual Intercourse on Symptoms in Women With Fibromyalgia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fibromyalgia
Pain
Depression
Lead sponsor: Konya Beyhekim Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2023-06-23
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: tertiary healthcare facility

Brief summary: Does frequency of sexual intercourse affect symptom severity in female patients with fibromyalgia?


Eligibility criteria: Inclusion Criteria:

\* Female patient with fibromyalgia

Exclusion Criteria:

* Uncontrollable systemic disease (cardiovascular, pulmonary, hepatic, renal, hematological),
* Major psychiatric disease,
* Endocrine disease,
* Pregnancy
* Menopausal status,
* Antihypertensive, antidepressant, anxiolytic, antiepileptic drugs use

Primary outcomes:
measure: Visual Analog Scale
timeFrame: 1 week
measure: frequency of sexual intercourse
timeFrame: 3 mounths
measure: Fibromyalgia Impact Questionnaire
timeFrame: 1 week
Secondary outcomes:
measure: Beck Depression Inventory
timeFrame: 1 week
measure: Widespread Pain Index
timeFrame: 1 week
measure: Symptom Severity Scale
timeFrame: 1 week
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Konya Beyhekim Research and Training Hospital
state: Selçuklu
Study officials:
References:
citation: Maunder L, Schoemaker D, Pruessner JC. Frequency of Penile-Vaginal Intercourse is Associated with Verbal Recognition Performance in Adult Women. Arch Sex Behav. 2017 Feb;46(2):441-453. doi: 10.1007/s10508-016-0890-4. Epub 2016 Nov 14.
citation: Blaicher W, Gruber D, Bieglmayer C, Blaicher AM, Knogler W, Huber JC. The role of oxytocin in relation to female sexual arousal. Gynecol Obstet Invest. 1999;47(2):125-6. doi: 10.1159/000010075.
citation: Burleson MH, Trevathan WR, Todd M. In the mood for love or vice versa? Exploring the relations among sexual activity, physical affection, affect, and stress in the daily lives of mid-aged women. Arch Sex Behav. 2007 Jun;36(3):357-68. doi: 10.1007/s10508-006-9071-1.
citation: Ainsworth BE, Haskell WL, Herrmann SD, Meckes N, Bassett DR Jr, Tudor-Locke C, Greer JL, Vezina J, Whitt-Glover MC, Leon AS. 2011 Compendium of Physical Activities: a second update of codes and MET values. Med Sci Sports Exerc. 2011 Aug;43(8):1575-81. doi: 10.1249/MSS.0b013e31821ece12.
Clinical trial NCT00510003: Assessment of Pruritus Improvement With Pimecrolimus Treatment on the Areas Affected by Mild-to-moderate AD, in Patients 2- to 11- Year-old
Official title: A Multicenter, 3-week, Randomized, Double-blind, Parallel-group, Vehicle-controlled Study to Evaluate the Efficacy and Safety of Pimecrolimus Cream 1% in Pediatric Patients With Mild to Moderate Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Atopic Dermatitis
Keywords: Atopic dermatitis, children, pimecrolimus, eczema
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2007-08-01
Enrollment: 117
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the efficacy and safety of pimecrolimus cream 1% in relation to the improvement of pruritus in pediatric patients (2- to 11- year-old) with mild to moderate atopic dermatitis.


Eligibility criteria: Inclusion Criteria:

* Male or female.
* Age: between 2 - 12 years.
* Outpatients with diagnosis of atopic dermatitis
* Atopic dermatitis affecting ≥ 5% of Total Body Surface Area at Baseline Investigator's Global Assessment score of 2 (mild) or 3 (moderate).
* Baseline visit pruritus (itching) severity assessment score of 2 (moderate) or 3 (severe).
* Patients or patient's legal guardian who has been informed of the study procedures and has signed the informed consent form approved for the study prior to starting any study related procedures, including washout (in case that it would be necessary).

Exclusion Criteria:

* Patients being breast-fed by women receiving systemic or prohibited medication.
* Children with known hypersensitivity to study medication.
* Children who received phototherapy or systemic therapy (immunosuppressants, cytostatics) known to affect atopic dermatitis within the previous month or topical therapy (tar, topical corticosteroids), systemic corticosteroids, systemic antibiotics or leukotriene antagonists within the previous week.
* Children who received investigational drugs within 8 weeks prior to first application of study medication.
* Children who had concurrent skin disease or active bacterial, viral or fungal infection.
* Immunocompromised children (e.g., lymphoma, AIDS, Wiskott-Aldrich Syndrome) or children with a history of malignant disease.

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Change in pruritus Visual Analogic Scale (VAS) with respect to the basal score between and within treatment groups, daily evaluation.
Secondary outcomes:
measure: • Reduction ≥ 50% in pruritus VAS with respect to basal score (responding patients) between groups and within groups (daily evaluation). • Change in sleep quality VAS in the pimecrolimus group with respect to the basal score (daily evaluation), and
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharma AG, Basel, Switzerland
name: Novartis
role: STUDY_CHAIR
References:
Clinical trial NCT02133703: Decision Support Following Genetic Testing for Breast-Ovarian Cancer Susceptibility
Official title: Decision Making Interventions for Women Receiving Uninformative BRCA1/2 Test Results or Positive BRCA1/2 Test Results
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Ovarian Cancer
Keywords: Genetic counseling
genetic testing
BRCA1
BRCA2
Hereditary breast cancer
Hereditary ovarian cancer
Lead sponsor: Georgetown University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: National Human Genome Research Institute (NHGRI)
First posted: 2014-05-08
Enrollment: 369
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This non-therapeutic trial is for women who have received results of genetic testing for BRCA1/2 mutations. The trial compares decision support tools designed to facilitate informed decision making regarding risk management following testing to usual care. The researchers will test separate decision support tools for women who receive positive test results and women who receive negative/inconclusive test results. Among women who receive a positive test result, an interactive decision support intervention will be compared to a print intervention. Among women who receive an inconclusive result, an interactive intervention will be compared to usual care.


Eligibility criteria: Inclusion Criteria:

* Undergo BRCA1/2 genetic counseling and testing at one of four study sites
* Receive positive or uninformative test results
* English speaking

Exclusion Criteria:

* Newly diagnosed breast cancer patients who have not yet initiated definitive breast cancer treatment
* Previous bilateral mastectomy

Primary outcomes:
measure: Knowledge
timeFrame: 1-month post randomization
measure: Decision Conflict
timeFrame: 1-month post-randomization
measure: Decision Satisfaction
timeFrame: 12-months post-randomization
measure: Psychological Distress
timeFrame: 1-month post randomization
measure: Health Related Quality of Life
timeFrame: 12-months post randomization
measure: Utilization of breast and ovarian cancer risk management options
timeFrame: 12-months post-randomization
Secondary outcomes:
measure: Knowledge
timeFrame: 3-months post randomization
measure: Psychological Distress
timeFrame: 3-months post-randomization
measure: Decisional Conflict
timeFrame: 3-months post-randomization
Other outcomes:
Locations:
city: Washington
country: United States
facility: Georgetown University Medical Center/Lombardi Comprehensive Cancer Center
state: District of Columbia
Study officials:
affiliation: Georgetown University
name: Marc D Schwartz, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06833203: Adding Amantadine to Pregabalin on Occurrence of Post-thoracotomy Pain Syndrome
Official title: Effectiveness of Adding Amantadine to Pregabalin on Occurrence of Post-thoracotomy Pain Syndrome; Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Amantadine
Pregabalin
Post-thoracotomy Pain Syndrome
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-02-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study aims to evaluate the additive effect of Amantadine to Pregabaline in the development of post-thoracotomy pain syndrome.

Detailed description: Lung cancer is still the most common cause of cancer-related deaths, and lung resection surgeries could be the primary therapeutic option. Hence, the number of thoracotomy procedures is progressively increasing, as well as the development of post-thoracotomy pain syndrome (PTPS).

Pregabalin is one of the drugs that can reduce the excitability of the dorsal horn neurons. It is a γ-aminobutyric acid analogue that binds to α2-δ subunits of the voltage-gated calcium channels in the central nervous system.

Amantadine (1-aminoadamantane) is NMDA receptor antagonists. NMDA receptors were found to have role in the development of central sensitization, acute opioid tolerance, and opioid induced hyperalgesia.

Eligibility criteria: Inclusion Criteria:

* Age (18-65) years.
* Both sexes.
* American Society of Anesthesiologists (ASA) Physical status II, III.
* Body mass index (BMI): (20-40) kg/m2.
* Cancer patients undergoing posterolateral thoracotomy incision for cancer lung, mesothelioma or other lung resection procedures.

Exclusion Criteria:

* Patients with known sensitivity or contraindication to drug used in the study.
* History of psychological disorders and/or chronic pain and drug abuse patients.
* Previous administration of antidepressants, anticonvulsants, or opioids before surgery.
* Patient refusal.
* Severe respiratory or cardiac disorders.
* Advanced liver or kidney disease.

Primary outcomes:
measure: Incidence of occurrence of post-thoracotomy pain syndrome
timeFrame: 12 weeks postoperatively
Secondary outcomes:
measure: Patient's Quality of life
timeFrame: 12 weeks postoperatively
measure: Patient's activity level
timeFrame: 12 weeks postoperatively
measure: Total amount of morphine consumption
timeFrame: 48 hours postoperatively
measure: Total amount of fentanyl consumption
timeFrame: Intraoperatively
measure: Patient Global Impression of Change (PGIC)
timeFrame: 12 weeks postoperatively
measure: Incidence of side effects of Pregabalin
timeFrame: 12 weeks postoperatively
measure: Incidence of side effects of Pregabalin
timeFrame: 12 weeks postoperatively
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
References:
Clinical trial NCT01894503: Safety and Performance of the Steroid-Releasing S8 Sinus Implant
Official title: A Clinical Evaluation of the Safety and Performance of the Steroid-Releasing S8 Sinus Implant When Used in Post-Sinus Surgery Patients With Recurrent Sinus Polyps
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Sinusitis
Lead sponsor: Intersect ENT
Sponsor class: INDUSTRY
First posted: 2013-07-10
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Bilateral in-office placement of the S8 Sinus Implant (mometasone furoate, 1350 mcg) in the ethmoid sinuses
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to assess the safety and performance of the steroid-releasing S8 Sinus Implant when used in post-sinus surgery patients who presented with recurrent sinus obstruction.

Detailed description: The S8 PK study was a single-center, open label study treating 5 adult (18 years or older) patients diagnosed with chronic sinusitis, who had undergone prior bilateral total ethmoidectomy and later presented with recurrent nasal obstruction/congestion symptoms and bilateral ethmoid polyposis. The S8 PK study assessed the safety, implant delivery to the ethmoid sinus, and systemic exposure to mometasone furoate (MF) by measuring plasma MF and cortisol concentrations through 30 days post-procedure.

Eligibility criteria: Key Inclusion Criteria:

* 18 years of age or older
* Diagnosis of chronic sinusitis
* Prior bilateral total ethmoidectomy
* Recurrent sinus obstruction due to polyps grade 2 or higher

Key Exclusion Criteria:

* Required use of mometasone furoate within 2 weeks prior to implant procedure
* Significant scarring or adhesions of the sinus

Primary outcomes:
measure: Number of Sinuses With Successful Implant Delivery
timeFrame: End of baseline procedure
Secondary outcomes:
measure: Number of Patients With Plasma Mometasone Furoate Concentration >LLOQ
timeFrame: Days 3, 7, 14, 21 and 30
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: Sacramento ENT
state: California
Study officials:
affiliation: Sacramento ENT
name: Randall Ow, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04880603: Utility of Restrata With Split-thickness Skin Graft to Reconstruct the Forearm Donor Site
Official title: Utility of Restrata With Split-thickness Skin Graft to Reconstruct the Forearm Donor Site
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Head and Neck Cancer
Lead sponsor: Nebraska Methodist Health System
Sponsor class: OTHER
Collaborators: name: Acera Surgical, Inc.
First posted: 2021-05-11
Enrollment: 5
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Adult patients undergoing a radial forearm free flap or ulnar forearm free flap will be randomized to the use of the Restrata graft in combination with split-thickness skin graft for reconstruction. Photos will document whether the Restata graft aids in the healing.


Eligibility criteria: Inclusion Criteria:

* All patients age 19 or greater that will undergo radial forearm free flap or ulnar free flap.
* Photo documentation of wound bed at two weeks and four weeks must be obtainable either by physician or patient.

Exclusion Criteria:

* Active systemic immunosuppression (active use of high-dose steroids (≥40mg prednisone daily or equivalent) or other immunosuppressive medications OR medical conditions causing immunosuppression, i.e. human immunodeficiency virus etc).
* Diabetes mellitus with most recent Hemoglobin A1c ≥10.0 within 30 days prior to surgery.
* Morbid obesity (BMI \>40).
* Inability to maintain wrist immobilization for full planned period.
* Severe malnutrition (prealbumin levels \<10 mg per dL within 30 days prior to surgery OR BMI \<15 (very severely underweight).
* Other conditions felt to significantly impair wound healing per surgeon discretion

Primary outcomes:
measure: Tendon exposure
timeFrame: 4 weeks post-operation
measure: Percentage of surface area
timeFrame: 4 weeks post operation
Secondary outcomes:
Other outcomes:
Locations:
city: Omaha
country: United States
facility: Nebraska Methodist Hospital
state: Nebraska
Study officials:
affiliation: Nebraska Methodist Hospital
name: Robert Lindau, MD
role: PRINCIPAL_INVESTIGATOR
References: