louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06172608: Effect of Educational Program on Parental Stress of Parents of Children With CHD
Official title: Effect of Educational Program on Parental Stress of Parents of Children With Congenital Heart Disease Undergoing Cardiac Surgery: Quasi Experimental Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Congenital Heart Defect
Keywords: Congenital Heart disease, parental stress
Lead sponsor: Zhengzhou University
Sponsor class: OTHER
First posted: 2023-12-15
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Congenital Heart disease accounts for about one third of the all congenital anomalies. In last decades' huge advancements occurred in treatment and diagnosis. More and more surgeries are being done which causes stress in parents and affects their mental health. Some studies have reported that about one third of the parents of children with CHD remain in stress even after surgery is being done. The goal of this trial is to evaluate effect of educational intervention on mental health of parents of children with congenital heart disease undergoing cardiac surgery compared to the parents who get usual care and pamphlets of the same information.

The investigators are including parents of children with CHD who are already diagnosed with CHD and are undergoing cardiac surgery.


Eligibility criteria: Inclusion Criteria:

1. Parents of children with congenital heart disease
2. Patient is scheduled for elective cardiac surgery and not had any surgery before.
3. Willing to participate in the study

Exclusion Criteria:

1. Parents of CHD who have other critical conditions along with CHD
2. Parents able to understand local languages (Urdu and Pashto)

Primary outcomes:
measure: Parental stress in parents of children with congenital Heart disease
timeFrame: [Time Frame: INTERVENTION group (I) Baseline (beginning of the study); at 1 day of discharge time and 12 weeks after discharge from hospital].
Secondary outcomes:
measure: Changes on parental QoL
timeFrame: [ Time Frame: INTERVENTION group - Baseline (beginning of the study); at 1 day of time of discharge and 12 weeks after intervention. CONTROL group - baseline; at time of discharge and 12 weeks after intervention.]
Other outcomes:
measure: Depression in parents of children with CHD
timeFrame: [Time Frame: INTERVENTION group (I) Baseline (beginning of the study); at 1 day of discharge time and 12 weeks after discharge from hospital]
measure: Anxiety in parents of children with CHD
timeFrame: [Time Frame: INTERVENTION group (I) Baseline (beginning of the study); at 1 day of discharge time and 12 weeks after discharge from hospital]
Locations:
city: Zhengzhou
country: China
facility: Zhengzhou University,
state: Henan
Study officials:
References:
Clinical trial NCT00775008: Media Effects Study on Health-Related Content
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Processing Health Information
Keywords: weight loss, health information, e-health
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
First posted: 2008-10-17
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: A media lab study will be conducted to determine the mechanism by which podcasting may exert an effect. This study will examine both physiological (heart rate, skin conductance, etc.) and psychosocial (knowledge, perceived control, elaboration, etc.) measures in participants listening to a podcast on health versus reading health content on the Web. We hypothesize that podcasting will create a greater physiological response than the Web. There will also be more elaboration in the podcasting group. Podcasting will produce greater feelings of control. Changes in knowledge will be greater in the Web group.


Eligibility criteria: Inclusion Criteria:

* 18 years or older
* Be willing to be randomized to either the podcast or Web condition
* Able to attend the intervention session

Exclusion Criteria:

* Not living in the Chapel Hill area

Primary outcomes:
measure: Physiological response
timeFrame: 1 hour
Secondary outcomes:
measure: Psychosocial response
timeFrame: 1 hour
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: UNC-Chapel Hill
state: North Carolina
Study officials:
References:
Clinical trial NCT04686708: COVID-19 Pandemic and General Surgery Emergencies
Official title: Impact of the COVID-19 Pandemic on Emergency General Surgery Outcomes: a Single-center Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Emergencies
Keywords: COVID-19
emergency treatment
general surgery
pandemic
Lead sponsor: Gulhane Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2020-12-29
Enrollment: 750
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All consecutive patients admitted during the first six months of the pandemic and patients admitted during the same period in 2019 at the department of general surgery, Gulhane Training and Research Hospital

Brief summary: A retrospective analysis of emergency general surgical admissions during the first six months of the pandemic (from March 11 to September 11, 2020) and the same period in 2019, will be conducted.

Detailed description: The volume and disease severity of emergency general surgery admissions between the first six-month period of the pandemic and the similar time period in the prepandemic period in 2019 will be compared.

Patients admitted during the first six months of the COVID-19 pandemic, from March 11 to September 11, 2020, will be included. As a comparison group, similar data will be collected on patients admitted to the general surgery department during the same period in 2019. Patient and disease characteristics, including demographics, initial leukocyte and C-reactive protein levels, diagnosis, treatment strategies, complications, duration of hospital stay, 30-day rehospitalization rate, and 30-day reoperation rate will be reviewed. Complications will be classified according to Clavien-Dindo classification. Tokyo Guidelines 2018/2013 will be used to assess the severity of the acute cholecystitis.

After the patients are divided into two groups: (1) prepandemic period and (2) pandemic period, descriptive statistics will be presented as the medians and ranges, and frequencies (%). Associations between variables will be evaluated using the Mann-Whitney U test (for continuous variables) or Pearson's chi-square and Fisher exact tests (for categorical variables), where appropriate.

Eligibility criteria: Inclusion Criteria:

* Patients aged 18 years and older
* Patients admitted during the first six months of the pandemic, from March 11 to September 11, 2020, and patients admitted during the same period in 2019

Exclusion Criteria:

* Patients younger than 18 years
* Patients positive for COVID-19
* Patients required elective surgery
* Patients re-operated because of a postoperative complication of an elective surgical procedure

Primary outcomes:
measure: Incidence of general surgical emergencies
timeFrame: 6 months
Secondary outcomes:
measure: Complication rate
timeFrame: 1 month
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gulhane Training and Research Hospital
Study officials:
References:
Clinical trial NCT01161238: Amputee Residual Limb Volume Fluctuation
Official title: Measuring and Controlling In-Socket Residual Limb Volume Fluctuation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Amputation
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2010-07-13
Enrollment: 28
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: people with lower limb amputation that are ambulatory

Brief summary: The goal of this project is a useful clinical instrument for diagnosis and treatment of residual limb volume fluctuation in individuals who use prosthetic limbs. One hypothesis to be tested is that the instrument effectively measures short and long term volume fluctuations in individuals with trans-tibial amputation. Another hypothesis to be tested is that when subjects add a sock or insert to the prosthesis residual limb volume decreases, and when they remove the sock or insert residual limb volume increases.


Eligibility criteria: Inclusion Criteria:

* trans-tibial amputees who have a regular prosthetist and who wear the prosthesis at least five hours per day.

Exclusion Criteria:

* Inability to ambulate continuously with a prosthesis (with or without the use of an assistive device such as a cane or walker) for 10 minutes indoors on a level walkway. 2. Inability to shift from horizontal to vertical posture in 30 seconds.

Primary outcomes:
measure: Residual limb fluid volume
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington, Bioengineering Department
state: Washington
Study officials:
References:
citation: Sanders JE, Harrison DS, Allyn KJ, Myers TR. Clinical utility of in-socket residual limb volume change measurement: case study results. Prosthet Orthot Int. 2009 Dec;33(4):378-90. doi: 10.3109/03093640903214067.
Clinical trial NCT05344638: A Clinical Trial to Evaluate the Safety and Efficacy of "AG1904" in Acute Bronchitis
Official title: A Multicenter, Randomized, Double-Blind, Parallel, Active-controlled, Phase III Clinical Trial to Evaluate the Efficacy and Safety of AGS Compared to AGU for Acute Bronchitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Bronchitis
Lead sponsor: Ahn-Gook Pharmaceuticals Co.,Ltd
Sponsor class: INDUSTRY
First posted: 2022-04-25
Enrollment: 220
Sex: ALL
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A Multicenter, Randomized, Double-Blind, Parallel, Active-controlled, Phase III Clinical Trial to Evaluate the Efficacy and Safety of AGS Compared to AGU for Acute Bronchitis


Eligibility criteria: Inclusion Criteria:

* Both gender, 19 years ≤ age ≤ 75 years
* BSS(Bronchitis Severity Score) ≥ 5point at Visit 2 (Randomized Visit)
* Patients without fever based on Visit 2(Randomized Visit)
* Those who can comply with the requirements of clinical trials
* Written consent voluntarily to participate in this clinical trial

Exclusion Criteria:

* Patients with respiratory and systemic infections requiring systemic antibiotic therapy
* Patients with bleeding tendency or coagulation disorder
* Patients who investigators determines to severe respiratory disease that would interfere with study assessment
* Those who have participated in other clinical trials within 4 weeks before participating in clinical trials
* In case the investigator judges that it is not suitable for the subject of this clinical trial for other reasons

Primary outcomes:
measure: Bronchitis Severity Total Score(BSS) change of Visit 3 compared to Visit 2
timeFrame: Visit 1 (-3 day), Visit 2 (0 day), Visit 3 (7 day)
Secondary outcomes:
measure: Individual symptom score of Bronchitis Severity Score(BSS) of Visit 3 compared to Visit 2
timeFrame: 7days
measure: Treatment response rate at Visit 3
timeFrame: 7days
measure: Integrative Medicine Outcome Scale (IMOS)
timeFrame: 7days
measure: Integrative Medicine Patient Satisfaction Scale (IMPSS)
timeFrame: 7days
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Konkuk University Medical Center
Study officials:
References:
Clinical trial NCT06301438: Dalpiciclib in HR+/HER2- ABC
Official title: Efficacy and Safety of Dalpiciclib in HR+/HER2- Advanced Breast Cancer: a Real-world Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Advanced Breast Cancer
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2024-03-08
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hormone receptor-positive and human epidermal growth factor receptor 2-negative advanced breast cancer

Brief summary: To evaluate the efficacy and safety of dalpiciclib in patients with HR-positive/HER2-positive advanced breast cancer.


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed advanced breast cancer
* Hormone receptor-positive and human epidermal growth factor receptor 2-negative
* ECOG 0-1

Exclusion Criteria:

* Pregnant or breastfeeding
* History of immunodeficiency

Primary outcomes:
measure: Progression-Free Survival
timeFrame: From the date of starting dalpiciclib to the date of first documentation of progression or death (up to approximately 1 years)
Secondary outcomes:
measure: Adverse events
timeFrame: From the date of starting dalpiciclib to the end of the treatment (up to approximately 1 year)
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Renji Hospital, School of Medicine, Shanghai Jiaotong University
Study officials:
affiliation: Renji Hospital, School of Medicine, Shanghai Jiaotong University
name: Wenjin Yin
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00849238: Mycophenolate Mofetil Maintenance Therapy for Liver Transplantation
Official title: Mycophenolate Mofetil Maintenance Therapy for Liver Transplantation Following Campath-1H Induction
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Primary Liver Transplant
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2009-02-23
Enrollment: 0
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The rationale for this study is to determine if Campath-1H can be used in liver transplant recipients to induce a state of immunological unresponsiveness that would not only eliminate the need for calcineurin inhibitors maintenance therapy, but also reduce corticosteroids utilization, decreasing the incidence of acute cellular rejection and perhaps reduce the severity of histologic recurrence of certain autoimmune diseases responsible for causing liver failure. The investigator propose a randomized prospective open label trial in 50 liver transplant recipients who will received a calcineurin inhibitors free immunosuppressive protocol that consist of a single dose of Campath-1H as an induction therapy in association with maintenance mycophenolate mofetil (CellCept®) and low dose steroids. The second group will receive a standard immunosuppressive regimen, which consists of IV steroid induction therapy and maintenance steroids, together with tacrolimus at a full therapeutic dose with no induction antibody therapy.


Eligibility criteria: Inclusion Criteria:

1. Male or female subjects;
2. Ages 45 years and older;
3. Are to receive a liver transplant.

Exclusion Criteria:

1. Recipients of a multi-organ transplant;
2. known hypersensitivity to daclizumab, CellCept®, or prednisone;
3. therapy with an investigational medication within 4 weeks of study entry;
4. history of malignancies within the past 5 years and/or lymphoma, excluding adequately treated skin carcinoma (basal or squamous cell), or other than exclusion #9;
5. history of a psychological illness or condition such as to interfere with the patient's ability to understand the requirements of the study;
6. history of HIV infection;
7. females who are pregnant or nursing;
8. subject is receiving systemic corticosteroids for other medical conditions for which the physician feels that discontinuation of corticosteroids is contraindicated;
9. T2 or higher hepatocellular carcinoma

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00040638: Phase 2 Study of TLK286 Administered Weekly in Advanced Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Carcinoma, Non-small-cell Lung
Lead sponsor: Telik
Sponsor class: INDUSTRY
First posted: 2002-07-04
Enrollment: 40
Sex: ALL
Minimum age (years): 18
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 effectiveness of TLK286 in the treatment of advanced non-small cell lung cancer.


Eligibility criteria: Inclusion Criteria:

* Histologic or cytologic diagnosis of non-small cell lung carcinoma
* Progressed while on or after treatment on platinum-based regimen
* Patients may not have had more than one prior cytotoxic chemotherapy regimen
* Stage IV or IIIB
* Age at least 18 years
* Adequate liver and kidney function
* Adequate bone marrow function

Exclusion Criteria:

* Pregnancy or lactation
* Unstable medical conditions
* Chemotherapy, hormonal therapy, radiotherapy, radiopharmaceuticals or immunotherapy within 3 weeks of TLK286
* CNS metastasis unless controlled by treatment

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Arizona Cancer Center
state: Arizona
city: Los Angeles
country: United States
facility: UCLA Medical Center
state: California
city: Houston
country: United States
facility: M.D. Anderson Cancer Center
state: Texas
Study officials:
References:
Clinical trial NCT00404638: Treatment of Enuresis Nocturna by Circular Muscle Exercise (Paula Method)
Official title: Treatment of Enuresis Nocturna by Circular Muscle Exercise (Paula Method)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Monosymptomatic Enuresis Nocturna
Keywords: Enuresis Nocturna
Paula Method
Circular muscle exercise
Sphincter
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2006-11-29
Enrollment: 40
Sex: ALL
Minimum age (years): 5
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Several treatment modalities for children suffering from monosymptomathic nocturnal enuresis are available including drugs, alarms, acupuncture, pelvic floor training and biofeedback. The aim of this study is to to test if Paula Method (circular muscle exercise) can be an another treatment modality.

Detailed description: Paula method is based on circular muscle exercises. The theory behind the Paula method is that all sphincters in the human body work simultaneosly, mutually affecting one another possibly mediated by "oscillation" of the spinal cord. According to this theory, exercising the ring muscles in a certain area of the body will result in strengthening the circular muscles in other areas. This method was found to to be efficacious for treatment of urinary stress incontinence in women.

Eligibility criteria: Inclusion Criteria:

1. age- 7 to 15 years old suffering from monosymptomatic enuresis nocturna
2. informed consent

Exclusion Criteria:

1. UTI
2. neurological diseases or syndromes
3. metabolic disesaes
4. congenital disease or malformation of the urinary tract

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Petach- Tikva
country: Israel
facility: Campus Rabin
city: Petach-Tikva
country: Israel
facility: Campus Golda Hospital
Study officials:
affiliation: Schneider Children Hospital , Israel
name: Herman A Cohen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Caldwell PH, Codarini M, Stewart F, Hahn D, Sureshkumar P. Alarm interventions for nocturnal enuresis in children. Cochrane Database Syst Rev. 2020 May 4;5(5):CD002911. doi: 10.1002/14651858.CD002911.pub3.
Clinical trial NCT05039138: EFFECT OF NEUROMUSCULAR TRAINING ON SHOULDER FUNCTION
Official title: EFFECT OF NEUROMUSCULAR TRAINING ON SHOULDER FUNCTION IN PATIENTS WITH SHOULDER IMPINGEMENT SYNDROME: A DOUBLE BLINDED RANDOMIZED CONTROLLED TRIAL
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: NMT
Keywords: NMT= NEUROMUSCULAR TRAINING
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-09-09
Enrollment: 34
Sex: ALL
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will be conducted to compare the effect of neuromuscular training versus traditional strength training in terms of shoulder joint function, proprioception accuracy and isometric external and internal rotator muscles strength in patients with SIS, it will be conducted at the out-patient clinic of physical therapy in Pharos University in Alexandria, Egypt

Detailed description: Double-blinded randomized controlled trial (patient and research assistant (the examiner of all patients) will be blinded).

Participants:

Thirty-four patients of both genders will be selected through non-probability sampling diagnosed as Neer's stage II SIS and their age range from 25-45 years will be randomly assigned to 1 of 2 groups. Each patient will sign an informed consent before starting the study (Appendix III).

Eligible patients will be recruited by physical therapist via referral from the treating orthopedic surgeon who will diagnose SIS based on clinical and radiological examination.

Group I (control): it includes 17 patients who will receive traditional strength training program.

Group II (experimental): it includes 17 patients who will receive upper extremity neuromuscular training exercises

Eligibility criteria: Inclusion Criteria:

* Patient age from 25-40 with a clinical diagnosis of Neer's stage II SIS (Consigliere et al., 2018).

Shoulder pain for at least three months (Heron et al., 2017) Painful arc of movement during flexion or abduction (Heron et al., 2017). Positive Neer's or Kennedy- Hawkins Test (Heron et al., 2017). Pain on resisted external rotation, abduction or Empty Can Test (Ager et al., 2019).

Exclusion Criteria:

Symptoms of cervical radiculopathy. Diagnosed inflammatory disorder. Neurological disorder. Widespread pain condition. Evidence of complete RC tear (positive drop arm test). Previous surgery to the affected shoulder.

:

Primary outcomes:
measure: SPADI (The Shoulder Pain and Disability Index)
timeFrame: 6 weeks
measure: Inclinometer
timeFrame: 6 weeks
measure: Hand held dynamometer
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: