louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03346564: Ritual Training Program in HNC Patients
Official title: Effects of a Ritual Training Program in the Head and Neck Cancer Patients: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Education
Cognitive Change
Keywords: Head and neck cancer
Ritual training
disfigurement
body image
Lead sponsor: Ministry of Science and Technology, Taiwan
Sponsor class: OTHER_GOV
First posted: 2017-11-17
Enrollment: 100
Sex: MALE
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: To evaluate the effects of a ritual training program in head and neck cancer (HNC) patients.

Detailed description: The purpose of this study will to evaluate the effects of a ritual training program on disfigurement, self-esteem, social interaction, and body image in head and neck cancer (HNC) patients.

A prospective, repeated measures, randomized controlled therapeutic intervention design was employed. The experimental group will receive a ritual training program, and the control group will receive routine care. Patients will be assessed at three time points: baseline assessment (T0), and then at 1, 2, and 3-months (T1, T2, and T3) after participating in the ritual training program or routine care.

Eligibility criteria: Inclusion Criteria:

* \> 20 years old,
* newly diagnosed first occurrence of HNC,
* completion of treatment and more than 3 months post-treatment

Exclusion Criteria:

* recurrence

Primary outcomes:
measure: Disfigurement
timeFrame: Change from Baseline Disfigurement at 6 months
measure: Body Image
timeFrame: Change from Baseline Body Image at 6 months
measure: Social Interaction
timeFrame: Change from Baseline Social Interaction at 6 months
measure: Depression
timeFrame: Change from Baseline Depression at 6 months
measure: Self-Esteem
timeFrame: Change from Baseline Self-Esteem at 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00399464: Efficacy and Safety of SL77.0499-10 (Alfuzosin) Versus Placebo and Tamsulosin in Japanese Patients With Benign Prostatic Hyperplasia
Official title: Efficacy and Safety of SL77.0499-10 10mg Once Daily in Comparison With Placebo and Tamsulosin Hydrochloride 0.2mg in Patients With Lower Urinary Tract Symptoms Related to Benign Prostatic Hyperplasia (BPH).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Prostatic Hyperplasia
Keywords: Benign Prostatic Hyperplasia
Adrenergic alpha-Antagonists
alfuzosin
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2006-11-14
Enrollment: 1177
Sex: MALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of the study is to demonstrate the superiority of SL77.0499-10 10mg once daily over placebo and the non-inferiority versus tamsulosin hydrochloride after 12 weeks treatment in terms of the efficacy in patients with lower urinary tract symptoms related to BPH.

The secondary objective is to assess the safety of SL77.0499-10 in patients with lower urinary tract symptoms related to BPH in comparison with placebo and tamsulosin hydrochloride.


Eligibility criteria: Inclusion Criteria:

* Japanese;
* Having a symptomatic BPH diagnosed clinically by digital rectal examination and ultrasonography within the last 6 months;
* Suffering for at least 6 months from lower urinary tract symptoms related to BPH.

Exclusion Criteria:

* Patients with mental disorders or who cannot be relied upon to understand the trial requirements and comply with the treatment regiment;
* Inpatient;
* Patients having participated in a clinical trial within the previous 6-month;
* Patients previously treated with SL77.0499-10;
* Patients whose I-PSS total score do not meet ≥ 13;
* Patients whose urinary peak flow rate (PFR) do not meet 5.0-12.0mL/s for a voided volume of at least 150mL;
* Patients whose residual urine are \> 200mL;

The investigator will evaluate whether there are other reasons why a patient may not participate.

Primary outcomes:
measure: Change in I-PSS (International Prostate Symptom Score) total score from baseline to endpoint (Day 84 or last available post-baseline assessment)
Secondary outcomes:
measure: Efficacy: Change in I-PSS total score from baseline to each visit
measure: Change in Quality Of Life score from baseline to each visit
measure: Change from baseline to endpoint of residual urine volume and urinary Peak Flow
measure: Safety:Adverse events
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Sanofi-Aventis
Study officials:
affiliation: Sanofi
name: ICD CSD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02289664: Videolaryngoscopy During Child Intubation
Official title: A Comparison of Coopdech, Intubrite, and CoPilot Video-laryngoscopes With Macintosh Laryngoscope for Tracheal Intubation in Pediatric Patients During Resuscitation. Randomized Crossover Manikin Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cardiac Arrest
Keywords: intubation
Lead sponsor: International Institute of Rescue Research and Education
Sponsor class: OTHER
First posted: 2014-11-13
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: We hypothesized that the video-laryngoscopes are beneficial for intubation of pediatric manikins while performing CPR. In the current study, we compared effectiveness of three video-laryngoscopes and Macintosh (MAC) laryngoscopes during pediatric resuscitation with and without chest compressions using an child manikin.


Eligibility criteria: Inclusion Criteria:

* Give voluntary consent to participate in the study
* minimum 1 year of work experience in health care

Exclusion Criteria:

* Not meet the above criteria
* Wrist or Low back diseases

Primary outcomes:
measure: Success of intubation
timeFrame: 1 MONTH
Secondary outcomes:
measure: Intubation time
timeFrame: 1 MONTH
measure: POGO score
timeFrame: 1 mONTH
measure: Cormack-Lehane grading
timeFrame: 1 MONTH
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: International Institute of Rescue Research and Education
state: Masovia
Study officials:
affiliation: Institute of Cardiology
name: Lukasz Szarpak
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05069064: Effect of Music on Pain and Satisfaction in Infertile Patients Undergoing Hysterosalpingography
Official title: Effect of Music on Pain and Satisfaction in Infertile Patients Undergoing Hysterosalpingography: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hysterosalpingography
Lead sponsor: Cairo University
Sponsor class: OTHER
Collaborators: name: Hospital El Gezeera
First posted: 2021-10-06
Enrollment: 108
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study is to demonstrate the value of music in infertile patients undergoing hysterosalpingography on patients' level of pain and satisfaction.


Eligibility criteria: Inclusion Criteria:

* Infertility; patients aged 19 to 42 years; candidate for hysterosalpingography.

Exclusion Criteria:

* Severe dysmenorrhea; pelvic infections; drug sensitivity; unwillingness to participate in the study; presence of psychiatric disorders, use of psychotropic medications; secondary infertility.

Primary outcomes:
measure: pain During contrast medium injection
timeFrame: 5 minutes
Secondary outcomes:
measure: pain after hysterosalpingography
timeFrame: 10 minutes
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05227664: A Study of AK117/AK112 in Metastatic Triple-Negative Breast Cancer
Official title: A Phase II Study of AK117/AK112 in Combination With Chemotherapy for Patients With Previously Untreated Metastatic Triple-Negative Breast Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Metastatic Triple-negative Breast Cancer
Locally Advanced Triple-negative Breast Cancer
Lead sponsor: Akeso
Sponsor class: INDUSTRY
First posted: 2022-02-07
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial is a Phase II study. The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of AK117/AK112 administered with chemotherapy in participants with locally advanced or metastatic triple-negative breast cancer (TNBC) who have not received prior systemic therapy for metastatic breast cancer (mBC).


Eligibility criteria: Inclusion Criteria:

* Metastatic or locally advanced, histologically documented TNBC characterized by absence of human epidermal growth factor 2 (HER2), estrogen receptor (ER), and progesterone receptor (PR) expression
* No prior chemotherapy or targeted systemic therapy for inoperable locally advanced or metastatic TNBC
* Eligible for taxane monotherapy
* A representative formalin-fixed, paraffin-embedded tumor specimen in paraffin blocks, or at least 5 unstained slides with an associated pathology report documenting ER, PR, and HER2 negativity.
* Eastern Cooperative Oncology Group performance status of 0 or 1
* Measurable disease as defined by RECIST v1.1
* Adequate hematologic and end-organ function

Exclusion Criteria:

* Known central nervous system (CNS) disease, except for asymptomatic CNS metastases
* Leptomeningeal disease
* Pregnancy or lactation
* History of autoimmune disease
* Prior allogeneic stem cell or solid organ transplantation
* Positive test for human immunodeficiency virus
* Active hepatitis B or hepatitis C
* Receipt of a live, attenuated vaccine within 30 days prior to randomization, during treatment

Primary outcomes:
measure: Objective response rates (ORR)
timeFrame: Up to approximately 2 years
measure: Number of participants with adverse events (AEs)
timeFrame: Up to approximately 2 years
Secondary outcomes:
measure: Disease control rate (DCR)
timeFrame: Up to approximately 2 years
measure: Duration of response (DOR)
timeFrame: Up to approximately 2 years
measure: Time to response (TTR)
timeFrame: Up to approximately 2 years
measure: Progression-free survival (PFS)
timeFrame: Up to approximately 2 years
measure: Overall survival (OS)
timeFrame: Up to approximately 2 years
Other outcomes:
Locations:
city: Changsha
country: China
facility: Hunan Cancer Hospital
city: Xiangyang
country: China
facility: Xiangyang Central Hospital
Study officials:
References:
Clinical trial NCT00884364: Exercise During Chemotherapy for Patients With Hematological Malignancies
Official title: Exercise During Chemotherapy for Patients With Hematological Malignancies
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Hematological Diseases
Hematological Malignancies
Keywords: Lymphoma
Leukemia
Multiple myeloma
Hodgkin´s disease
Exercise
Sport
Fatigue
Hematological neoplastic diseases
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2009-04-20
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The trial will evaluate the effects of aerobic exercise in patients undergoing chemotherapy for the treatment of a hematological neoplastic disease.


Eligibility criteria: Inclusion Criteria:

* Hematological malignant disease
* Current chemotherapy
* Understanding of written German

Exclusion Criteria:

* Cardiorespiratory, metabolical, osteoarticular or immunological disorders which can be aggravated by exercise
* Pathological stress-ECG at recruitment

Primary outcomes:
measure: Fatigue
timeFrame: At recruitment and after 12 weeks
Secondary outcomes:
measure: Complications
timeFrame: At recruitment and after 12 weeks
measure: Physical performance
timeFrame: At recruitment and after 12 weeks
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Section Sports Medicine, Charité Universitätsmedizin Berlin, Hindenburgdamm 30
Study officials:
affiliation: Charite University, Berlin, Germany
name: Fernando Dimeo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06001164: Double-bundle Versus Single-Bundle Anterior Cruciate Ligament Reconstruction
Official title: Double-bundle Versus Single-Bundle Anterior Cruciate Ligament Reconstruction: A Prospective Randomized Study With 15-Year Results
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ACL Injury
Lead sponsor: Tampere University Hospital
Sponsor class: OTHER
First posted: 2023-08-21
Enrollment: 153
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare double-bundle and single-bundle techniques for ACL reconstruction in a long-term 15-year follow-up. Our hypothesis is that the DB technique is better than the SB technique.


Eligibility criteria: Inclusion Criteria:

* To be eligible for the study, patients had to meet certain criteria, including primary ACL reconstruction, closed growth plates, and no ligamentous injuries to the contralateral knee.

Exclusion Criteria:

-

Primary outcomes:
measure: osteoarthritis (OA)
timeFrame: 15 years
measure: Pivot shift
timeFrame: 15 years
measure: KT-1000 arthrometer difference
timeFrame: 15 years
measure: Lysholm score
timeFrame: 15 years
measure: IKDC subjective evaluation. Scale 0-100 (100=best)
timeFrame: 15 years
measure: IKDC objective score. Scale 1-4 (1=best)
timeFrame: 15 years
measure: graft failures
timeFrame: 15 years
measure: Range on motion (ROM) of the knee
timeFrame: 15 years
measure: One leg hop test
timeFrame: 15 years
Secondary outcomes:
Other outcomes:
Locations:
city: Tampere
country: Finland
facility: Department of Orthopaedics, Tampere University Hospital
Study officials:
References:
Clinical trial NCT05095402: Biomechanics of Lumbar Region in Low Back Pain
Official title: Evaluation of the Relationship Between Lumbar Lordosis Angle and Lumbar Muscle Thickness With Non-Specific Low Back Pain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Low Back Pain
Keywords: Low Back Pain
Lumbar Lordosis Angle
Magnetic Resonance Imaging
Muscle Thickness
Lead sponsor: Karabuk University
Sponsor class: OTHER
First posted: 2021-10-27
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study included a total of 96 individuals, 43 males, and 53 females, who applied to the Department of Radiology of the Karabuk University Training and Research Hospital between March-June 2019 with complaints of LBP.

Brief summary: The purpose of this study was to examine the relationship between non-specific low back pain (NSLBP) and lumbar lordosis angle (LLA) and lumbar muscle thickness (LMT) by evaluating magnetic resonance images (MRI) in individuals with LBP.

Detailed description: The study included a total of 96 individuals, 43 males, and 53 females, who applied to the Department of Radiology of the Karabuk University Training and Research Hospital between March-June 2019 with complaints of LBP. Individuals' sociodemographic information and medical history were recorded using the LBP assessment form. The Oswestry LBP Disability Questionnaire was used for LBP. Thickness measurements of muscle (m.) psoas major, m. multifidus, m. quadratus lumborum and m. erector spinae were taken on MRI corresponding to the L3-L4 vertebra level. Cobb Angle method was used for LLA determination. Measurements were made in three repetitions using the Radiant DICOM viewer program, and their averages were recorded.

Eligibility criteria: Inclusion Criteria:

* The age range of 18-65
* Having non-specific LBP
* Volunteering to participate in the study

Exclusion Criteria:

* Having any psychiatric and mental problems
* The presence of any disc, bone, and muscular pathology in the lumbar region
* Having any previous operation on the lumbar region

Primary outcomes:
measure: Disability caused by low back pain assessed by Oswestry Low Back Pain Disability Questionnaire
timeFrame: 6 months
measure: Lumbar lordosis angle
timeFrame: 6 months
measure: Muscles thickness measurements
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Karabük
country: Turkey
facility: Karabuk University
Study officials:
affiliation: Karabuk University
name: Ali dagli
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04481802: The Effect of RadiaAce Gel in the Prevention and Treatment of Radiation Dermatitis in Breast Cancer Patients
Official title: The Effect of RadiaAce Gel Versus Biafine in the Prevention and Treatment of Radiation Dermatitis in Breast Cancer Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Radiation Dermatitis
Keywords: Radiation dermatitis
breast cancer
Lead sponsor: AceTech
Sponsor class: INDUSTRY
First posted: 2020-07-22
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Radiation dermatitis (RD) is one of the most common side effects of Radiation therapy (RT) and 95% of patients receiving RT may experience some form of radiation dermatitis.

A wide variety of topical, oral, and intravenous agents are used to prevent/treat Radiation dermatitis but currently there is no gold standard in the prevention and management of this condition and no treatment can be explicitly recommended.

RadiaAce Gel is a wound dressing Hydrogel (Acemannan Hydrogel) for the management of RD which provides optimal moist wound environment necessary to the healing process.

Based on its composition as well as the supporting data on safety and performance of the functional ingredient Acemannan in wound healing, RadiaAce may well be suited to complement the prevention and therapy of radiation dermatitis.

The primary aim of the study is to evaluate the safety and performance of RadiaAce as compare to Biafine in reducing the proportion of breast cancer patients that experience grade 2 or higher RD as measured by the RTOG scoring system


Eligibility criteria: Inclusion Criteria:

1. Female patients
2. Age \> 18
3. Patients with histologically-confirmed diagnosis of breast cancer
4. Patients after breast lumpectomy and that scheduled to receive radiotherapy
5. Patients to receive minimum of 40.05 Gy to primary field
6. Must be able to comply with treatment schedule
7. Study-specific signed informed consent prior to randomization

Exclusion Criteria:

1. Inflammatory or connective tissue disorders of the skin
2. Mental incompetence, including psychological or addictive disorders which would preclude completion of questionnaires
3. Previous radiation therapy to the breast
4. Tumour involvement of the skin
5. Rash, ulceration or open wound in treatment field
6. Known skin allergy or sensitivity to Aloe Vera or Biafine
7. Current lactation
8. Pregnancy
9. Any other reason that, in the opinion of the investigator, prevents the subject from

Primary outcomes:
measure: Skin assessment (RD grade)
timeFrame: 10 weeks
measure: Pain (VAS)
timeFrame: 10 weeks
measure: Patient's assessment of the skin condition (DLQI questioner)
timeFrame: 10 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Assuta
state: Tel Aviv District
Study officials:
affiliation: Director of radiotherapy Institute
name: Meirav Ben David, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03852602: Preemptive Analgesia for Postoperative Pain Control for Dental Treatment Under General Anesthesia
Official title: Preemptive Analgesia for Postoperative Pain Control for Dental Treatment Under General Anesthesia in Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain, Postoperative
Lead sponsor: Aydin Adnan Menderes University
Sponsor class: OTHER
Collaborators: name: Inonu University
First posted: 2019-02-25
Enrollment: 70
Sex: ALL
Minimum age (years): 3
Maximum age (years): 7
Standard ages: CHILD
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children who will be treated under general anesthesia because of lack of chairside cooperation.

Brief summary: The aim of this study was to compare the analgesic-treated children with analgesic prior to the treatment and to compare the postoperative analgesic needs of children undergoing dental treatment under general anesthesia.

Detailed description: The investigator's study included patients who were admitted to Inonu University and Adnan Menderes University, Faculty of Dentistry, Department of Pediatric Dentistry in 2019 and decided to perform dental treatment under general anesthesia. Patients 1 to 7 years of age with dental treatment between February 28 and June 1, 2019 will be included.

Patients who underwent analgesic 15 minutes after the induction of general anesthesia from the patients, and those who made painkillers 15 minutes before the end of the treatment will constitute the control group. Paracetamol 15 mg / kg IV will be given in 50 ml of saline.

The demographic data of the children to be included in the study such as age, gender, type of dental intervention, duration of operation, postoperative pain scores, recovery times will be recorded and compared.

Eligibility criteria: Inclusion Criteria:

* To be treated under general anesthesia
* No systemic disease
* To have at least one painful dental procedure in the upper and lower jaw (pulpectomy, pulpotomy

Exclusion Criteria:

* Patients with mental or physical disabilities of any disease
* Patients who have not undergone painful dental intervention under general anesthesia

Primary outcomes:
measure: Postoperative dental pain
timeFrame: An average of 24 hours postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Aydin
country: Turkey
facility: Sultan KELES
Study officials:
affiliation: Aydin Adnan Menderes University
name: Sultan Keles, Dr.
role: STUDY_CHAIR
References:
citation: Kharouba J, Hawash N, Peretz B, Blumer S, Srour Y, Nassar M, Sabbah M, Safadi A, Khorev A, Somri M. Effect of intravenous paracetamol as pre-emptive compared to preventive analgesia in a pediatric dental setting: a prospective randomized study. Int J Paediatr Dent. 2018 Jan;28(1):83-91. doi: 10.1111/ipd.12311. Epub 2017 Jun 15.