louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05590910: The Effects of a Music Intervention on Stress, Anxiety and Academic Performance on Nursing Students
Official title: The Effects of a Music Intervention on Stress, Anxiety, and Academic Performance Among New Undergraduate Nursing Students
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress
Keywords: Music, anxiety
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
First posted: 2022-10-21
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized controlled approach will explore the effects music has on stress and anxiety levels and academic performance among undergraduate nursing students.
Primary purpose: OTHER

Brief summary: This study is examining the effect of listening to music on personal variables such as stress, anxiety, and academic performance. Previous research has shown that listening to music can help in reducing the effects of anxiety and stress.

Detailed description: Students will be divided and randomized into two recording groups: 1.) Music Intervention Group, 2.) Non-Music Control Group. The music intervention group will receive a 15-minute music intervention and variables such as heart rate, blood pressure, anxiety, and academic performance will be measured. The non-music control group will not receive the intervention; however, the same variables will be measured.

Eligibility criteria: Inclusion Criteria:

* 18 years and older
* Enrolled at UT Health San Antonio School of Nursing clinical course
* First semester undergraduate nursing student

Exclusion Criteria:

* Under 18 years
* Second, third or fourth semester undergraduate nursing student

Primary outcomes:
measure: Heart Rate Measurement
timeFrame: Baseline (pre-intervention), Time 2 (post intervention, approximately 30 minutes from baseline) and study end (approximately 45 minutes from baseline)
measure: Blood Pressure Measurement
timeFrame: Baseline (pre-intervention), Time 2 (post intervention, approximately 30 minutes from baseline) and study end (approximately 45 minutes from baseline)
measure: State Trait Anxiety Inventory (STAI)
timeFrame: Baseline (pre-intervention), Time 2 (post intervention, approximately 30 minutes from baseline) and study end (approximately 45 minutes from baseline)
measure: Academic Performance
timeFrame: Baseline to study end (approximately 45 minutes from baseline)
Secondary outcomes:
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: The University of Texas Health Science Center at San Antonio
state: Texas
Study officials:
affiliation: University of Texas Health Science Center San Antonio
name: Jorgie A Contreras, MSN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02277210: Follicular Flushing in Patients With Suboptimal Responses
Official title: Effect of Follicular Flushing on the Ongoing Pregnancy Rate in Patients Who Developed Four or Fewer Follicles of 14mm Following Standard Ovarian Stimulation for In-vitro Fertilization Treatment - A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Infertility
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2014-10-28
Enrollment: 4
Sex: FEMALE
Maximum age (years): 42
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the present study is to determine the effect of follicular flushing on the ongoing pregnancy rate in patients who developed four or fewer follicles of 14mm following standard ovarian stimulation for IVF.

Detailed description: Oocyte aspiration under the guidance of transvaginal ultrasound is an integral part in IVF treatment. Follicular flushing has been advocated. However, subsequent data from randomized trials failed to demonstrate any benefits with routine follicular flushing in normally responding patients. Instead, it has been shown to prolong the operating time, increase the procedure-related pain and analgesics requirement. Most of the IVF centers no longer perform routine follicular flushing in normally responding patients.

The potential role of follicular flushing in patients with a limited number of developing follicles is conflicting based on the recently published randomized trials. The aim of the present study is to determine the effect of follicular flushing on the ongoing pregnancy rate in patients who developed four or fewer follicles of 14mm following standard ovarian stimulation for IVF.

Eligibility criteria: Inclusion Criteria:

1. Age of women \<43 years
2. Normal uterine cavity on saline sonogram
3. Endometrial thickness \>=8mm on the day of hCG

Exclusion Criteria:

1. Planned not to have fresh embryo transfer
2. Cycle cancelled prior to hCG administration
3. Natural cycle IVF
4. Presence of hydrosalpinges on scanning which are not surgically treated
5. Presence of endometrial polyps on scanning
6. Undergoing preimplantation genetic diagnosis

Primary outcomes:
measure: ongoing pregnancy rate
timeFrame: 10 weeks of gestation
Secondary outcomes:
measure: number of oocytes retrieved
timeFrame: on the day of retrieval
measure: number of embryo available for transfer
timeFrame: on the day of embryo transfer
measure: clinical pregnancy rate
timeFrame: 6 weeks of gestation
measure: operation time of the retrieval
timeFrame: on the day of retrieval
measure: pain score of retrieval
timeFrame: on the day of retrieval
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Department of Obstetrics and Gynaecology
state: Hong Kong
Study officials:
affiliation: The University of Hong Kong
name: Ernest HY Ernest Ng, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05025410: Remimazolam and Remifentanil Without Neuromuscular Blocking Agent
Official title: General Anesthesia Using Remimazolam and Remifentanil Without Neuromuscular Blocking Agent: Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myoma;Uterus
Polyp Endometrium
Unspecified Condition Associated With Female Genital Organs and Menstrual Cycle
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2021-08-27
Enrollment: 38
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult woman scheduled for gynecological surgery under general anesthesia

Brief summary: Remimazolam is a novel drug approved for induction and maintenance of general anesthesia. This study aims to check the appropriate dose and patient response by administering remimazolam and remifentanil in surgery that does not require a neuromuscular blocking agents.


Eligibility criteria: Inclusion Criteria:

* Adult woman scheduled for gynecological surgery under general anesthesia
* American Society of Anesthesiology grade 1 or 2
* When using a laryngeal mask airway to maintain general anesthesia

Exclusion Criteria:

* Underlying diseases: liver, kidney, brain nervous system, glaucoma
* Patients with BMI greater than 30 and less than 18.5
* Patients diagnosed with sleep apnea
* Alcohol or drug dependent patients
* Patients with severe or acute respiratory failure
* Lactose intolerance
* Dextran 40 hypersensitivity
* Patients in shock or coma

Primary outcomes:
measure: Remimazolam induction dose
timeFrame: During the anesthesia induction (from initiation of anesthesia until the insertion of laryngeal mask airway)
measure: Remimazolam maintenance dose
timeFrame: During the anesthesia maintenance (from the insertion of laryngeal mask airway until stopping remimazolam infusion)
Secondary outcomes:
measure: Use of rescue midazolam
timeFrame: During the anesthesia (from initiation of anesthesia until stopping remimazolam infusion)
measure: Use of rescue rocuronium
timeFrame: During the anesthesia (from initiation of anesthesia until stopping remimazolam infusion)
measure: Use of flumazenil
timeFrame: During the anesthesia recovery (from stopping remimazolam infusion until the recovery of consciousness)
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
Study officials:
References:
citation: Park I, Cho M, Nam SW, Hwang JW, Do SH, Na HS. Total intravenous anesthesia induced and maintained by a combination of remimazolam and remifentanil without a neuromuscular blocking agent: a prospective, observational pilot study. BMC Anesthesiol. 2022 Jul 26;22(1):237. doi: 10.1186/s12871-022-01779-2.
Clinical trial NCT02061410: Effects of Neuromuscular Electrical Stimulation (NMES) in Patients With Knee Osteoarthritis
Official title: Diagnosis and Treatment of Muscle Inhibition of the Extensor Muscles of the Knee in Elderly
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: Elderly
Lead sponsor: Federal University of Rio Grande do Sul
Sponsor class: OTHER
First posted: 2014-02-12
Enrollment: 20
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the effects of neuromuscular electrical stimulation (NMES) on neuromuscular and functional parameters in elderly with knee osteoarthritis.

The hypothesis is that NAMES is able to strengthen the quadriceps muscle and to improve healthy status of elderly with knee osteoarthritis.


Eligibility criteria: Inclusion Criteria:

* women, minimum age of 50 years;
* clinically diagnosed with knee OA;
* no contraindications to execute maximal knee extension tests (e.g., cardiorespiratory complications);
* no previous musculoskeletal or joint injuries besides knee OA;
* no hip or knee surgery;
* no neurological problems.

Primary outcomes:
measure: Peak torque change
timeFrame: Baseline and 9th intervention week
measure: Electromyographic activation change
timeFrame: Baseline and 9th intervention week
measure: Muscle architecture change
timeFrame: Baseline and 9th intervention week
Secondary outcomes:
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Exercise Research Laboratory, School of Physical Education, Federal University of Rio Grande do Sul
state: RS
Study officials:
affiliation: Federal University of Rio Grande do Sul
name: Marco A Vaz, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00042510: Safety and Efficacy of G17DT Immunogen in the Treatment of Gastric and Gastroesophageal Cancer
Official title: Open-Label,Multicenter Study of G17DT Immunogen in Combination w/ Cisplatin and 5-FU in Subjects w/ Metastatic or Locally Recurrent Gastric or Gastroesophageal Cancer Previously Untreated With Chemotherapy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Stomach Neoplasms
Esophageal Neoplasms
Keywords: Gastroesophageal cancer
Gastric cancer
Lead sponsor: Cancer Advances Inc.
Sponsor class: INDUSTRY
First posted: 2002-08-01
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will test whether the G17DT Immunogen, when administered in combination with chemotherapy, is an effective and safe treatment for gastric cancer.


Eligibility criteria: Inclusion criteria:

* Clinical diagnosis with gastric or gastroesophageal cancer
* Karnofsky performance status score of at least 70
* Life expectancy of at least 3 months

Exclusion criteria:

* Prior treatment with chemotherapy or anticancer immunotherapy
* Bone marrow transplant within past year
* Chronic use of corticosteroids, except for inhaled corticosteroids used for asthma or chronic obstructive pulmonary disease
* Central nervous system metastases
* Immunodeficiency
* Hypercalcemia

Primary outcomes:
measure: To evaluate the effects of G17DT in combination with cisplatin and 5-FU chemotherapy on tumor response assessed by radiographic means.
timeFrame: Through Week 29
Secondary outcomes:
measure: To evaluate the clinical efficacy of G17DT in combination with cisplatin and 5-FU chemotherapy as measured by time to disease progression, best overall response and survival.
timeFrame: Through Week 29
Other outcomes:
Locations:
Study officials:
affiliation: U.S. studies
name: Jaffer A Ajani, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Non U.S. studies
name: Vladimir Moiseyenko, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04510610: Camrelizumab Plus Decitabine in Anti-PD-1 Treatment-naive Patients With Relapsed/Refractory Classical Hodgkin Lymphoma
Official title: An Open-label, Multicenter, phase2/3 Study of Camrelizumab Plus Decitabine in Anti-PD-1 Treatment-naive Patients With Relapsed/Refractory Classical Hodgkin Lymphoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Hodgkin Lymphoma
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2020-08-12
Enrollment: 100
Sex: ALL
Minimum age (years): 12
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is an open-label, Phase 2/3，multicenter and single-arm clinical trial of Camrelizumab plus decitabine for Anti-PD-1 treatment-naive patients with relapsed or refractory Hodgkin Lymphoma. The primary objective of this study is to evaluate the long-term response duration with Camrelizumab plus decitabine in relapsed or refractory Hodgkin Lymphoma.


Eligibility criteria: Inclusion Criteria:

* 1 Subjects must have histological confirmation of relapsed or refractory Hodgkin lymphoma (HL).
* 2 12 to 75 years of age.
* 3 ECOG performance of less than 2.
* 4 Life expectancy of at least 3 months.
* 5 Subjects with lymphoma must have at least one measureable lesion \>1 cm as defined by lymphoma response criteria.
* 6 Subjects must have received at least two lines of prior regimens without Anti-PD-1 antibody treatment history, and must be off therapy for at least 4 weeks prior to Day 1. Subjects with autologous hematopoietic stem-cell transplantation are eligible which must be more than 3 months.
* 7 Subjects must have adequate marrow, live, renal and heart functions.

Exclusion Criteria:

* 1 Subjects with any autoimmune disease or history of syndrome that requires corticosteroids or immunosuppressive medications.
* 2 Serious uncontrolled medical disorders or active infections, pulmonary infection especially.
* 3 Active alimentary tract hemorrhage or history of alimentary tract hemorrhage in 1 month .
* 4 Prior organ allograft.
* 5 Women who are pregnant or breastfeeding.
* 6 Women with a positive pregnancy test on enrollment or prior to nvestigational product administration.
* 7 Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness.

Primary outcomes:
measure: duration of response
timeFrame: 5 years
measure: Progression free survival
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Biotherapeutic Department and Hematology Department of Chinese PLA General Hospital
Study officials:
References:
Clinical trial NCT02912910: Changes in Central Arterial Pressure When Comparing Nifedipine/Labetalol for Routine Hypertension Control in Pregnancy
Official title: Changes in Central Arterial Pressure When Comparing Nifedipine and Labetalol for Routine Hypertension Control in Pregnancy
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Hypertension
Lead sponsor: St. Louis University
Sponsor class: OTHER
First posted: 2016-09-23
Enrollment: 0
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women in our clinics in addition to admitted to our antepartum units will be screened for inclusion criteria.

Brief summary: To study central blood pressure changes caused by commonly used high blood pressure medications in pregnancy.

Detailed description: Central blood pressures in addition to pulse wave velocity will be attained prior to medication, and then every 30 minutes for 4 hours (total of 9 readings). Sphygmomanometer readings will be completed at the same time (total readings 9). These readings are all related to the study.

Nursing will have the opportunity to to record the routine sphygmomanometer readings for their routine vitals if they chose to do so.

Their participation will be complete after the 4 hour assessment is complete.

Eligibility criteria: Inclusion Criteria:

* Singleton pregnancy
* Women with hypertensive disease in pregnancy who are currently being treated with nifedipine xl or labetalol

Exclusion Criteria:

* Multiple pregnancy
* Currently on multiple anti-hypertension medications
* Narcotic use
* Irregular heart rhythms or arrhythmias
* Peripheral arterial disease, leg artery disease
* Reynaud's phenomena
* Intense cold/hypothermia
* If there is a wound at location of where central arterial cuff would be placed or tonometer for carotid assessment
* Known sensitivity to labetalol or nifedipine
* Severe tachycardia (\>120)
* Greater than 1st degree heart block
* Severe asthma
* Congestive heart failure or heart disease
* Lupus
* Inability to adequately monitor BP
* Currently receiving magnesium sulfate

Primary outcomes:
measure: central blood pressure changes
timeFrame: every 30 min for 4 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: St. Louis University
name: Jennifer Goldkamp
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06740110: Bone Material's Histomorphometric Analysis In Socket Preservation
Official title: A Histomorphometric Analysis of Bone Formation With Two Different Bone Graft Material in Adult Patients Required Socket Preservation After Tooth Extraction
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Socket Preservation
Lead sponsor: Medical Inventi S.A.
Sponsor class: INDUSTRY
First posted: 2024-12-18
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This prospective, multicentre, split-mouth randomized controlled, single blinded (participant) trial aims to compare the investigational medical device with standard of care in dental treatment addressing the preservation of bone loss after tooth extraction.


Eligibility criteria: Inclusion Criteria:

* Patients over 18 years old with full legal capacity, male and female;
* Patients with ability to understand the proposed surgical treatment and to understand and sign the informed consent;
* Patients who are willing and able to comply with scheduled visits, treatment and other trial procedures;
* Patients who respect the follow-up recalls.

Exclusion Criteria:

* Presence of bone lesions;
* Patients with alcohol or substance abuse;
* Patients with smoking habits (more than 10 cigarettes per day);
* Patients presenting physical and/or mental handicap that impede an adequate oral hygiene;
* Pregnant or breast feeding women;
* Patients currently participating in any other clinical investigation.

Primary outcomes:
measure: Evaluation of quantify the new bone formation via histomorphometric analysis following tooth extraction with GBR procedure.
timeFrame: 6 months
Secondary outcomes:
measure: Evaluation of (serious) adverse events (S)AEs.
timeFrame: 13 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03613610: Radio-frequency Ablation in Knee Osteoarthritis by Three Needles Technique
Official title: Three Needles Approach... A New Technique of Genicular Nerve Radio-frequency Ablation for Pain Relief in Advanced Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: Genicular nerve radio-frequency ablation
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2018-08-03
Enrollment: 50
Sex: ALL
Minimum age (years): 35
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The study is designed to evaluate and compare the efficacy of three needles approach as a new technique in radiofrequency neurotomy of genicular nerve versus the traditional single needle approach as a treatment of advanced knee osteoarthritic pain. Primary outcome:

1. Pain intensity via the visual analogue score (VAS).
2. Function and pain via the Oxford Knee Score. Evaluated after 6 months of the procedure

Secondary outcome:

1. Failure rate.
2. Incidence of any complication.
3. Total analgesic requirement during the period of follow up.


Eligibility criteria: Inclusion Criteria:

* 1- Age 35-85 years old 2- Patients with stage 3 or higher OA-related radiological changes based on Kellgren-Lawrence (K/L) rating scale 3- Knee pain for at least 3 months 4-Patients are clinically unresponsive to conservative treatment modalities (physical therapy and rehabilitation practices, orally administered analgesics and anti-inflammatory drugs).

Exclusion Criteria:

* 1- Patients with other causes of pain as radiculopathy, neurological disorders or intermittent claudication. 2- Previous knee trauma. 3- Previous knee surgery. 4- Patients received intra-articular injection during the previous three months.

  5- Acute knee pain. 6- Crystal arthropathy. 7- Joint effusion. 8- Serious neurological or psychiatric disorders. 9- On anticoagulant medication. 10- Any other connective tissue disorder that affects the knee joint. 11- skin infection at the site of injection. 12-patient refusal.

Primary outcomes:
measure: Visual analogue score
timeFrame: 6 months after the procedure
measure: Oxford knee score
timeFrame: 6 months after the procedure
Secondary outcomes:
measure: Failure rate
timeFrame: 6 months after the procedure
measure: Incidence of complication
timeFrame: 6 months after the procedure
Other outcomes:
Locations:
city: Minya
country: Egypt
facility: Faculty of Medicine, minia university
Study officials:
affiliation: Minia University
name: Omyma Sh Mohamed, Ass. prof.
role: STUDY_DIRECTOR
affiliation: Assist university
name: And El raheem Ma Mohamed, Lecturer
role: STUDY_CHAIR
affiliation: Minia University
name: Sarah Mo Omar, Lecturer
role: STUDY_CHAIR
affiliation: Minia University
name: Alaa Fo Gaber, Resident
role: PRINCIPAL_INVESTIGATOR
References: