louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05380258: The Effect of Chewing Gum and Use of Stress Balls on Perception of Labor Pain, Fear of Birth, and Duration of Delivery
Official title: The Effect of Chewing Gum and Use of Stress Balls on Perception of Labor Pain, Fear of Birth, and Duration of Delivery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Labor Pain
Birth Satisfaction
Duration of Birth
Keywords: chewing gum,
stress ball
labor pain
satisfaction
Lead sponsor: Kastamonu University
Sponsor class: OTHER
First posted: 2022-05-18
Enrollment: 96
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study was conducted as a randomized controlled experimental study. This study was planned to determine the effects of chewing gum and using a stress ball on the perception of labor pain, duration of labor and birth satisfaction. The population of the study consisted of primiparous mothers who applied to the hospital. This study was planned to determine the effects of chewing gum and using a stress ball on the perception of labor pain, duration of labor and birth satisfaction. The study was carried out in two stages. In the first stage, the data were collected in the delivery room, and in the second stage, the postpartum satisfaction levels of the mothers were measured in the postpartum service. The sample number of the investigators' study was determined as 96. Visual analog scale, birth satisfaction scale and birth follow-up form were used for the data of our study.


Eligibility criteria: Inclusion Criteria:

* Being primiparous to be in due time
* To have spontaneous vaginal delivery
* Ability to communicate verbally be between the ages of 18-35
* Not having a risky pregnancy
* Having a single fetus in the vertex position
* Having started contractions and continuing regularly
* Being in the latent phase of action (0-4 cm dilatation)
* Not having used any analgesia or using any pain medication to reduce pain during labor

Exclusion Criteria:

* Mothers who have a cesarean section decision
* Risky Pregnant
* Multiple Pregnancies
* Multiparous pregnant women

Primary outcomes:
measure: labor pain
timeFrame: Visual Analog scale I for labor pain was applied in 0-3 cm , Visual Analog Scale II in 4-5 cm and Visual Analog Scale III was applied in 6-8 cm cervical dilatation. The study continues through study completion, an average of 1 year
measure: Duration of labor
timeFrame: A birth follow-up form was used from the beginning of cervical dilatation to delivery.
measure: birth satisfaction
timeFrame: satisfaction form used postpartum at the 4th hour
Secondary outcomes:
Other outcomes:
Locations:
city: Merkez
country: Turkey
facility: Şahika Şimşek Çetinkaya
state: Kastamonu
Study officials:
References:
Clinical trial NCT06060158: Feasibility of Internet Group CBT-I for Gyn Oncology Patients
Official title: Feasibility of Internet-Delivered Group Cognitive Behavioral Therapy for Insomnia in Gynecologic Oncology Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2023-09-29
Enrollment: 5
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a pilot feasibility study looking at delivering small group therapy online.
Primary purpose: TREATMENT

Brief summary: The goal of this study is to evaluate the feasibility and acceptability of delivering cognitive behavioral therapy for insomnia (CBT-I) to gynecologic cancer patients in an internet-based small-group setting.

Secondary objectives:

1. To compare insomnia symptoms before and after intervention.
2. To evaluate any changes in quality of life symptoms while undergoing the intervention.
3. To evaluate the duration of symptoms improvement after the intervention is complete.

Detailed description: This is a pilot feasibility study looking at delivering CBT-I to gynecologic cancer patients. This study will be completed via a novel internet based small group platform. Twelve eligible participants will meet weekly for 6 weeks while undergoing the CBT-I program.

Eligibility criteria: Inclusion Criteria:

1. English-speaking women greater than 18 years old who present to UC Davis Comprehensive Cancer Center for treatment or surveillance of gynecologic cancer
2. Must have access to internet
3. Be able to connect via secure web-based platform
4. Be able to complete online questionnaires
5. Moderate or severe insomnia
6. Have access to a mobile device or computer

Exclusion Criteria:

1. Participants without ability to connect with both audio and visual through secure web-based platform
2. Participant is currently taking sleep medication prescribed by their provider for sleep disturbance or insomnia - Patients taking over the counter medications or supplements are eligible
3. Participants with remote history of insomnia, but not currently having symptoms of insomnia
4. Have other reasons for poor sleep

Primary outcomes:
measure: Attendance
timeFrame: 6 weeks
measure: Acceptability
timeFrame: 24 weeks
Secondary outcomes:
measure: Insomnia symptoms
timeFrame: 24 weeks
measure: Changes in quality of life symptoms
timeFrame: 24 weeks
measure: Sleep Quality
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: University of California, Davis Comprehensive Cancer Center
state: California
Study officials:
affiliation: University of California, Davis
name: Hui Chen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05518058: Electromyography Triggered Functional Electrical Stimulation on Stroke Patients
Official title: Effect of Electromyography Triggered Functional Electrical Stimulation on Stroke Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Lead sponsor: Delta University for Science and Technology
Sponsor class: OTHER
First posted: 2022-08-26
Enrollment: 30
Sex: MALE
Minimum age (years): 45
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: my study aims to apply treatment program for postural instability in stroke patients.

Detailed description: my study include two groups: first group receive physical therapy exercise program followed by balance exercise program.

the second group receive the same physical therapy exercise program followed by balance exercise program conducted with electromyography triggered functional electrical stimulation

Eligibility criteria: Inclusion Criteria:

* stroke patients
* normal body mass index
* mild spasticity

Exclusion Criteria:

* musculoskeletal deformities
* cognitive abnormalities
* cardiovascular diseases

Primary outcomes:
measure: Postural stability
timeFrame: 2 months
Secondary outcomes:
measure: dynamic balance
timeFrame: 2 months
Other outcomes:
Locations:
city: Damietta
country: Egypt
facility: Hend Elsharkawy
state: Texas
Study officials:
References:
Clinical trial NCT03964558: Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]-Acebilustat (CTX-4430)
Official title: An Open Label, Single-Dose, Single-Period Study Designed to Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]-Acebilustat (CTX-4430) in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Heathy Volunteers
Lead sponsor: Celtaxsys, Inc.
Sponsor class: OTHER
Collaborators: name: Quotient Sciences
First posted: 2019-05-28
Enrollment: 6
Sex: MALE
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This is a single-centre, open-label, non-randomised, single oral dose study in healthy male subjects. It is planned to enroll and dose 6 subjects. Subjects will be admitted to the clinical unit on the evening of Day 1 prior to investigational medicinal product (IMP) administration. Subjects will be dosed on the morning of Day 1 and it is planned that they will remain resident in the clinic until up to 168 hour after dosing (up to Day 8). It is planned that subjects will be released as a group when all subjects have achieved a mass balance cumulative recovery of \>90% or if \<1% of the dose administered has been collected in urine and faeces within 2 separate, consecutive 24 hour periods.


Eligibility criteria: Inclusion Criteria:

• Body mass index of 18.0 to 35.0 kg/m2

Exclusion Criteria:

* Regular alcohol consumption \>21 units per week (1 unit = ½ pint beer, or a 25 mL shot of 40% spirit, 1.5 to 2 Units = 125 mL glass of wine, depending on type)
* Current smokers and those who have smoked within the last 12 months. A breath carbon monoxide reading of greater than 10 ppm at screening
* Radiation exposure, including that from the present study, excluding background radiation but including diagnostic x-rays and other medical exposures, exceeding 5 mSv in the last 12 months or 10 mSv in the last 5 years. No occupationally exposed worker, as defined in the Ionising Radiation Regulations 2017, shall participate in the study

Primary outcomes:
measure: Mass balance recovery of total radioactivity in all excreta: amount excreted (Ae) and Ae as a percentage of the administered dose (%Ae), cumulative recovery (CumAe), and cumulative recovery expressed as a percentage of the administered dose (Cum%Ae)
timeFrame: Day 10
Secondary outcomes:
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: Quotient Sciences
Study officials:
References:
Clinical trial NCT03287258: Perineal Preparation for Pregnant Ladies.
Official title: Digital Perineal Massage and Pelvic Floor Muscle Exercise as an Antenatal Program for Prevention of Perineal Trauma in Elderly Women, a Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Delivery; Trauma
Pelvic Floor; Perineal Rupture, Obstetric
Pelvic Floor Muscle Weakness
Keywords: perineal massage
health education
perineal tear
episiotomy
pelvic floor muscle exercise
Lead sponsor: Kasr El Aini Hospital
Sponsor class: OTHER
First posted: 2017-09-19
Enrollment: 400
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Pregnant participants will be recruited at the obstetrics outpatient clinic during their visits 4 weeks before the due date. They are randomized into two groups. The first group will be educated to do digital perineal massage. They will be also educated to do pelvic floor muscle exercises and will receive the usual education program for strengthening the pelvic floor. The second group will receive the usual education program for strengthening the pelvic floor. Occurrence of perineal laceration will be reported at time of delivery.

Detailed description: Pregnant participants will be recruited at the obstetrics outpatient clinic during their visits 4 weeks before the due date. They are randomized into two groups. The first group will be educated to do digital perineal massage. They will be also educated to do pelvic floor muscle exercises and will receive the usual educational pelvic floor dysfunction prevention program for strengthening the pelvic floor. The second group will receive the usual education program for strengthening the pelvic floor. Occurrence of perineal laceration will be reported at time of delivery.

Eligibility criteria: Inclusion Criteria:

* Pregnant women ≥ 35 years old
* Primigravida or multi gravida

Exclusion Criteria:

* History of chronic constipation
* History of chronic cough
* Current or past urinary or anal incontinence
* History of genital prolapse before pregnancy
* History of neuromuscular disorders or connective tissue disorders
* History of medical disorders
* History of preterm or precipitate labour
* History of premature preterm rupture of membranes.
* Genital infections

Primary outcomes:
measure: perineal tears Proportion of perineal tears will be assessed by an investigator who will attend the participant delivery
timeFrame: At 15 minutes from delivery
Secondary outcomes:
measure: episiotomy need Proportion of participants who need episiotomy at time of delivery will be assessed by an investigator
timeFrame: At 15 minutes from delivery
measure: Duration of the second stage of labour
timeFrame: 2 hours
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: KasralainiH
Study officials:
affiliation: KasrAlainiH
name: Amira Dieb, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02829658: Use of Care Services by Patients With Borderline Personality Disorder
Official title: Use of Care Services by Patients With Borderline Personality Disorder
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Borderline Personality Disorder
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2016-07-12
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: First, four groups were composed: BPD, other PD, control groups for PD and other PD. The first two groups were recruited from a screening of inpatients including a self-administered questionnaire (Personality Disorder Questionnaire 4+). Matched controls (age, sex) composed the 3rd and 4th group (BPD control and other PD control). They were randomly chosen in the health database insurance previously used.

Brief summary: Borderline personality disorder (BPD) is characterized by a pervasive pattern of instability and impulsivity. Several North American prospective studies support the high level of mental health care utilization in this population. There is little data in other systems of health organization, such as France. Furthermore, little is known on the variables associated with the mental health service utilization among BPD patients.

The main objective was to compare the utilization of mental health care among BPD patients, to the general population and patients with another personality disorder (PD) and to describe the demographic and clinical factors associated with the group of patients who use the most health care.


Eligibility criteria: Inclusion Criteria:

* Affiliated with the health insurance
* Inpatient Psychiatry

Exclusion Criteria:

* Patient in forced hospitalization
* chronic psychotic disorder, mania or hypomania state, known mental retardation.
* Patient does not speak or read French

Primary outcomes:
measure: Compare data among BPD Patients and general population
timeFrame: during five years previously to the inclusion
Secondary outcomes:
measure: Hospitalizations
timeFrame: During five years previously to the inclusion
measure: Demographics data
timeFrame: Inclusion
Other outcomes:
Locations:
city: Toulouse
country: France
facility: University Hospital of Toulouse
Study officials:
affiliation: University Hospital, Toulouse
name: CAILHOL Lionel, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cailhol L, Thalamas C, Garrido C, Birmes P, Lapeyre-Mestre M. [Mental health service utilization among borderline personality disorder patients inpatient]. Encephale. 2015 Apr;41(2):115-22. doi: 10.1016/j.encep.2014.10.008. Epub 2014 Dec 17. French.
Clinical trial NCT04363658: Efficacy Study of Hydrocephalus Surgery by Methods of Neuroelectrophysiology
Official title: Efficacy Study of Shunt Operation in Patients With Disorder of Consciousness of Post-traumatic Hydrocephalus (PTH) by Methods of Neuroelectrophysiology
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hydrocephalus
Keywords: neuroelectrophysiology
hydrocephalus
disorder of consciousness
Lead sponsor: Xiangya Hospital of Central South University
Sponsor class: OTHER
First posted: 2020-04-27
Enrollment: 65
Sex: ALL
Minimum age (years): 16
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patient age from 16 to 70 years

Brief summary: The symptoms of hydrocephalus containing consciousness condition with muscle tone in some patients will be relieved, after the cerebrospinal fluid release test is carried out. Neuroelectrophysiology in patients with disorders of consciousness of post-traumatic hydrocephalus (PTH) can establish the association with consciousness and muscle tone to a certain extent, and predict the shunt effect of PTH with disorders of consciousness.


Eligibility criteria: Inclusion Criteria:

Patients with disorder of consciousness in traumatic brain injury. The presence of hydrocephalus through image examination.

Exclusion Criteria:

Patients who cannot tolerate shunt surgery. Sedation maintained by greater than 0.15mg/kg/hour of midazolam or the infusion dose of propofol higher than 4mg/kg/hour.

Patients who are participating in drug research or other clinical trials.

Primary outcomes:
measure: Score of glasgow outcome scale in 6 months after shunt operation
timeFrame: 6 months
Secondary outcomes:
measure: Score of glasgow outcome scale in 6 months after shunting under different ventricular pressure
timeFrame: 6 months
measure: Revised coma recovery scale (CRS-R) in 1 week after shunting
timeFrame: 1 week
measure: Modified Ashworth Scale (MAS) in 1 week after shunting
timeFrame: 1 week
measure: Revised coma recovery scale (CRS-R) in 1 month after shunting
timeFrame: 1 month
measure: Modified Ashworth Scale (MAS) in 1 month after shunting
timeFrame: 1 month
Other outcomes:
Locations:
city: Pleasanton
country: United States
facility: Nicolet EEG
state: California
Study officials:
References:
Clinical trial NCT01242358: Capnography During Percutaneous Endoscopic Gastrostomy (PEG)
Official title: Clinical Value of Advanced Patient Monitoring Using Capnography With Analysis of the Integrated Pulmonary Index During Percutaneous Endoscopic Gastrostomy.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: In the Study the Value of Capnography for Avoiding Complications During Sedation for PEG is Evaluated.
Keywords: hypoxaemia - capnography - integrated pulmonary index - PEG
Lead sponsor: Ruhr University of Bochum
Sponsor class: OTHER
First posted: 2010-11-17
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: In this randomized controlled trial the utility of capnography gets evaluated. Hypoxemia may occur during sedation with midazolam and propofol. Whether hypoxemia may be prevented by an additional capnographic monitoring is subject of the study.


Eligibility criteria: Inclusion Criteria:

* 18 Years and older
* Scheduled for PEG with propofol sedation

Exclusion Criteria:

* No informed consent
* ASA V
* Emergency endoscopy
* Preexisting hypotension, bradycardia or hypoxemia

Primary outcomes:
measure: Hypoxemia
timeFrame: From the beginning to the end of the PEG procedure, i.e. from 0h to approximately 2h
Secondary outcomes:
measure: Further complications
timeFrame: From the beginning to the end of the PEG procedure, i.e. from 0h to approximately 2h
Other outcomes:
Locations:
city: Bochum
country: Germany
facility: Ruhr Universität Bochum
city: München
country: Germany
facility: Technische Universität München
city: Wiesbaden
country: Germany
facility: Deutsche Klinik für Diagnostik
Study officials:
affiliation: Ruhr-Universität Bochum
name: Andrea Riphaus, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vargo JJ, Zuccaro G Jr, Dumot JA, Conwell DL, Morrow JB, Shay SS. Automated graphic assessment of respiratory activity is superior to pulse oximetry and visual assessment for the detection of early respiratory depression during therapeutic upper endoscopy. Gastrointest Endosc. 2002 Jun;55(7):826-31. doi: 10.1067/mge.2002.124208.
Clinical trial NCT00136058: Trial of Osteoporosis Intervention Strategies in Hip Fracture Patients
Official title: Randomized Trial of Osteoporosis Intervention Strategies in Hip Fracture Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoporosis
Keywords: osteoporosis
hip fracture
Lead sponsor: University of Alberta
Sponsor class: OTHER
Collaborators: name: Alberta Heritage Foundation for Medical Research
First posted: 2005-08-26
Enrollment: 250
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The objective of this study is to determine if an intervention with a fracture manager to arrange bone densitometry after a hip fracture is more effective in diagnosing and treating osteoporosis when compared to "usual care". "Usual care" consists of no intervention to arrange bone mineral density (BMD) testing or therapy other than what normally occurs in the community. The investigators postulate that a fracture manager will be more effective in getting BMD done and in starting appropriate therapy.

Detailed description: All hip fracture patients in the Edmonton area will be screened for eligibility (mini-mental status \>20, not on active osteoporosis pharmacologic therapy). All patients will have informed consent obtained. Patients will be randomized to 2 groups:

* Group 1: Active intervention. The fracture manager will arrange for bone densitometry (DEXA) to be done 3-6 months after the fracture. If the patient meets standard criteria for osteoporosis, therapy with a bisphosphonate (alendronate or risedronate) will be instituted by the study physicians.
* Group 2: Usual care. Patients will receive basic information about calcium and vitamin D and osteoporosis and told to follow up with their family doctor. At 6 months, patients will be contacted to determine if they have had a BMD done or started on active (drug) osteoporosis therapy. If not, the fracture manager will arrange the BMD and if appropriate therapy will be started by the study physicians.

All patients will be followed for 1 year. The primary endpoints are the number of patients who get a BMD and the number who are started on active osteoporosis therapy.

Eligibility criteria: Inclusion Criteria:

* Ages 50 or over; males or females.
* Reside in the community or have access to bone densitometry
* Hip fracture
* Patient can consent or proxy consent available
* No contraindications to bisphosphonates

Exclusion Criteria:

* Patient refuses consent process
* Already receiving active drug therapy for osteoporosis other than calcium and vitamin D
* Dementia or delirium
* Pathological fracture
* Chronic corticosteroid therapy

Primary outcomes:
measure: the number of patients who get a BMD and the number who are started on active osteoporosis therapy
Secondary outcomes:
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
Study officials:
affiliation: University of Alberta
name: Donald W Morrish, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: