louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04014686: 12 Weeks of Resistance Band Exercise Impacts on Metabolic Syndrome Progression in Postmenopausal Women
Official title: Impacts of 12 Weeks of Resistance Band Exercise Training on Insulin Resistance, Blood Lipids, Body Composition, and Blood Pressure in Postmenopausal Women With Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome
Dyslipidemias
Insulin Resistance
Hypertension
Keywords: postmenopausal
exercise
Lead sponsor: Pusan National University
Sponsor class: OTHER
Collaborators: name: Dong-Eui University
name: University of Nebraska
First posted: 2019-07-10
Enrollment: 36
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: exercise intervention group, control group
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study was to examine the impacts of a 12-week resistance band exercise program on insulin resistance, blood lipid profiles, body composition, and blood pressure in postmenopausal women with obesity.

Thirty-six postmenopausal women participated in this study. Participants were randomly allocated into the resistance band training group (EX, n = 18) or the control group (CON, n = 18). The EX group performed a resistance band exercise training program 60 minutes per day, 3 times per week, for 12 weeks. The CON group did not participate in any exercise, dietary, or behavioral intervention. Blood glucose, insulin, homeostatic model of insulin resistance (HOMA-IR), blood lipids, blood pressure, and body composition were measured before and after 12 weeks of EX or CON.


Eligibility criteria: Inclusion Criteria:

* postmenopausal (cessation of menses for at least 12 consecutive months)
* abdominal obesity (waist \> 80 cm)

Exclusion Criteria:

* current smoker (smoking within 6 months of participation)
* cardiovascular disease
* renal disease
* pulmonary disease
* thyroid disease

Primary outcomes:
measure: Glucose
timeFrame: 12 weeks
measure: Insulin
timeFrame: 12 weeks
measure: Percentage of Body Fat
timeFrame: 12 weeks
measure: Waist circumference
timeFrame: 12 weeks
Secondary outcomes:
measure: Systolic blood pressure
timeFrame: 12 weeks
measure: Diastolic blood pressure
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Omaha
country: United States
facility: The University of Nebraska at Omaha
state: Nebraska
Study officials:
References:
Clinical trial NCT04500886: Evaluate the Efficacy and Safety of PEG-rhG-CSF in Patients With Hemophagocytic Syndrome
Official title: A Single-center, Open-label, Controlled Clinical Study to Evaluate the Efficacy and Safety of Jinyouli®(PEG-rhG-CSF) for the Recovery of Neutropenia After Chemotherapy in Patients With Hemophagocytic Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hemophagocytic Syndrome
Lead sponsor: CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Beijing Friendship Hospital
First posted: 2020-08-05
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Hemophagocytic syndrome (HPS), also known as hemophagocytic lymphohistiocytosis (HLH), is an immune mediated life-threatening disease. There is no uniform recommendation for salvage treatment of HLH. Based on the results of current clinical trials, the marketing situation of the drug in China, and the use requirements of pegylated recombinant human granulocyte stimulating factor(PEG-rhG-CSF), this study was conducted in patients who received the DEP rescue therapy or dexamethasone combined with VP-16 maintenance therapy. The aim of this study was to evaluate the efficacy and safety of PEG-rhG-CSF(Jinyouli®) for the recovery of neutropenia after chemotherapy in patients with hemophagocytic syndrome.


Eligibility criteria: Inclusion criteria：

1. Age ≥ 18 years old, ≤ 70 years old;
2. Patients with hemophagocytic syndrome diagnosed by HLH-2004 diagnostic criteria;
3. Patients who plan to receive rescue treatment or maintenance treatment;
4. The expected survival time is more than 1 month;
5. Patients sign informed consent form.

Exclusion Criteria：

1. Patients who have received bone marrow or hematopoietic stem cell transplantation in the past 3 months;
2. Patients with brain metastases;
3. Patients who are allergic to this product or other biological products derived from genetic engineering E. coli;
4. People with mental or nervous system disorders who cannot cooperate;
5. Pregnant or lactating female patients; women who refuse to accept contraceptive measures ;
6. Researchers determine unsuited to participate in this trial.

Primary outcomes:
measure: Duration of grade IV neutropenia
timeFrame: From date of randomization until the date of the study completion，up to 1 year.
Secondary outcomes:
measure: The recovery time of neutrophils after chemotherapy
timeFrame: From date of randomization until the date of the study completion，up to 1 year.
measure: Neutrophil dynamic changes
timeFrame: From date of randomization until the date of the study completion，up to 1 year.
measure: Efficacy evaluation of salvage therapy
timeFrame: From date of randomization until the date of the study completion，up to 1 year.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Friendship Hospital
Study officials:
affiliation: Beijing Friendship Hospital
name: Zhao Wang, PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02384486: Efficacy of Training Programme to Reduce Stress
Official title: Evaluating the Efficacy of a Proposed Training Programme to Reduce Stress in Mothers of Children With Autism Spectrum Disorder (ASD) in Saudi Arabia: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder (ASD)
Lead sponsor: University of Nottingham
Sponsor class: OTHER
First posted: 2015-03-10
Enrollment: 67
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: This study aims to reduce stress in mothers of children with autism in Saudi Arabia. The researcher has designed a training programme for mothers whose children are young and just in their early stage at the autism organisations they are attending. The programme will include stress reduction tips, behavioural modification strategies for children with autism, and financial resources available to parents (how they can access government funding). The study will have two parts. Part one involves conducting an experiment by dividing the participants into two groups, one group will receive the training and the other group will wait until the end of the study then they will also receive the same training. Both groups will fill questionnaire at the beginning of the study, then after the first group finishes training, and then again 6 weeks later. Part two of the study will involve interviewing mothers of the first group who attended the training session. They will be interviewed by the researcher asking them about their experience with the training programme and their suggestions for future improvements. Mothers will be given a training manual at the beginning of the training. Training involves attending five sessions, one of which is a face to face session at the autism organisation their children are attending and the other four sessions will be through a Smartphone application called whatsapp which is widely used in Saudi Arabia.


Eligibility criteria: Inclusion Criteria:

* Mothers aged 18 years or over
* mothers of ASD children who are in the early intervention stage (first year in the programme) at autism organizations in Saudi Arabia

Exclusion Criteria:

* Mothers whose children with ASD are not in the early intervention stage or did not joint autism organization

  * Mothers who will not be willing to commence to the full duration of the trial
  * Mothers who will not be able to use whatsapp in their smart phones

Primary outcomes:
measure: Parent Stress Index Short From (PSI-SF)
timeFrame: 10 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Jeddah
country: Saudi Arabia
facility: Voluntary sector ASD organization no.1
Study officials:
References:
citation: Hemdi A, Daley D. The Effectiveness of a Psychoeducation Intervention delivered via WhatsApp for mothers of children with Autism Spectrum Disorder (ASD) in the Kingdom of Saudi Arabia: A randomized controlled trial. Child Care Health Dev. 2017 Nov;43(6):933-941. doi: 10.1111/cch.12520. Epub 2017 Sep 20.
Clinical trial NCT00405886: Neramexane for Tinnitus
Official title: A Randomised, Double-Blind, Placebo-Controlled, Clinical Dose-Ranging Trial to Evaluate Efficacy and Safety of a NMDA Antagonist for Oral Administration in Patients With Subjective Tinnitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Tinnitus
Lead sponsor: Merz Pharmaceuticals GmbH
Sponsor class: INDUSTRY
First posted: 2006-11-30
Enrollment: 431
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Tinnitus is commonly referred to as "ringing of the ears" - the perception of sounds in the absence of an external source of acoustic signals. Tinnitus may represent a severe disease and symptoms include depression, sleeping difficulties, decreased sound tolerance and hearing loss. One hypothesis is that tinnitus is caused by an increased activity of NMDA glutamate and dysfunctional alpha9/alpha10 acetylcholine receptors in the inner ear and central nervous system. Neramexane may alleviate tinnitus symptoms due to its NMDA and alpha9/alpha10 nACh receptor blocking activity. The purpose of this study is to assess the safety and efficacy of Neramexane compared with placebo in patients with subjective tinnitus.


Eligibility criteria: Inclusion Criteria:

* main inclusion criterion: persistent, subjective, uni- or bilateral tinnitus

Exclusion Criteria:

* main exclusion criterion: intermittent or pulsatile tinnitus

Primary outcomes:
measure: Change from baseline in tinnitus severity at the endpoint visit
timeFrame: Week 16
measure: Comparison of adverse events (type, severity, seriousness, frequency, relatedness) between treatment arms
timeFrame: From baseline until week 20
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
city: Munich
country: Germany
Study officials:
affiliation: Ludwig-Maximilians - University of Munich
name: Markus Suckfüll, MD PhD Ass. Prof.
role: STUDY_CHAIR
References:
citation: Suckfull M, Althaus M, Ellers-Lenz B, Gebauer A, Gortelmeyer R, Jastreboff PJ, Moebius HJ, Rosenberg T, Russ H, Wirth Y, Krueger H. A randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of neramexane in patients with moderate to severe subjective tinnitus. BMC Ear Nose Throat Disord. 2011 Jan 11;11:1. doi: 10.1186/1472-6815-11-1.
citation: Gortelmeyer R, Schmidt J, Suckfull M, Jastreboff P, Gebauer A, Kruger H, Wittmann W. Assessment of tinnitus-related impairments and disabilities using the German THI-12: sensitivity and stability of the scale over time. Int J Audiol. 2011 Aug;50(8):523-9. doi: 10.3109/14992027.2011.578591.
Clinical trial NCT03823586: AQUApay (AQUA Predictive Ability in Youths): Study on the Predictive Ability of the Questionnaire AQUA© in Children and Adolescents
Official title: AQUApay (AQUA Predictive Ability in Youths): Study on the Predictive Ability of the Questionnaire AQUA© in Children and Adolescents
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Young Athletes
Lead sponsor: Istituto per la Ricerca e l'Innovazione Biomedica
Sponsor class: OTHER
First posted: 2019-01-30
Enrollment: 133
Sex: ALL
Minimum age (years): 7
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Athletes aged 7 to 14 years old, recruited from several sport associations located in the city of Palermo (Italy).

Brief summary: Allergic diseases like asthma, rhinitis, conjunctivitis and dermatitis are very frequent in athletes, even if those complaining allergic symptoms do not always receive a medical diagnosis. Many athletes already start competitive sport activities in pediatric age, but allergy screening tests are usually not performed when assessing eligibility to sport practice. Therefore, the objective of the present study is assessing the predictive ability of the Allergy Questionnaire for Athletes (AQUA©), pediatric version, to predict the atopic status in young athletes.


Eligibility criteria: Inclusion Criteria:

- Athletes, males or females, 7 to 14 years old

Exclusion Criteria:

* Use of systemic antihistamines or long term or high dose corticosteroids in the last two weeks;
* Poor understanding of written or spoken Italian;
* Lack of written informed consent.

Primary outcomes:
measure: Atopic status
timeFrame: Day 0
Secondary outcomes:
measure: Psychological well-being
timeFrame: Day 0
Other outcomes:
Locations:
city: Palermo
country: Italy
facility: Institute of Biomedicine and Molecular Immunology (IBIM), National Research Council
state: Sicily
Study officials:
References:
citation: Fasola S, Ferrante G, Malizia V, Bommarito N, Del Giacco S, Bonini M, Baiardini I, Bellafiore M, La Grutta S. Validity and repeatability of the Pediatric Allergy Questionnaire for Athletes (AQUAped) for the screening of atopy. Pediatr Allergy Immunol. 2021 Apr;32(3):437-444. doi: 10.1111/pai.13410. Epub 2020 Dec 2.
Clinical trial NCT00713986: Non-Pharmacologic Interventions to Relief Pain in Healthy Newborns Submitted to Vaccination to Hepatitis B
Official title: Non-Pharmacologic Interventions to Relief Pain in Healthy Newborns Submitted to Vaccination to Hepatitis B: a Comparison Between Skin-to-Skin Contact, Glucose 25% and Both of Them
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain
Analgesia
Keywords: Pain
Newborn Infant
Analgesia
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2008-07-14
Enrollment: 640
Sex: ALL
Minimum age (years): 12
Maximum age (years): 72
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Acute procedural pain in neonates may be alleviated by non-pharmacological procedures. This study objective is to test the efficacy regarding pain attenuation of 3 interventions (skin-to-skin contact versus glucose 25% versus skin to skin associated to glucose 25) versus control in healthy newborn infants submitted to intra-muscular vaccination for Hepatitis B at 48-72 hours of life.


Eligibility criteria: Inclusion Criteria:

* Written informed consent.
* Gestational age of 37 0/7 to 41 6/7 weeks.
* Patients cared in rooming-in, with post-natal age of 12 to 72 hours of life.
* Adequate for gestational age and healthy infants.
* No other painful stimuli before study except for Vitamine K injection soon after birth.
* Interval from last feeding between 30 and 60 minutes.

Exclusion Criteria:

* Mothers that used opioid at gestation labor or birth.
* Delivery under general anesthesia.
* Apgar score less than seven in the 1st or 5th minute of life.
* Neonates that received any venous, arterial, capillary or spinal puncture.
* Any congenital malformation or CNS abnormality.

Primary outcomes:
measure: Neonatal pain scales: Neonatal infant pain Scale (NIPS), Neonatal Facial Coding System (NFCS) and Premature Infant Pain Profile (PIPP)
timeFrame: before the pain procedure (atrest), during cleaning of the region, at injection, and 2 minutes after injection
Secondary outcomes:
measure: Physiologic pain assessment variables: heart rate and oxygen saturation
timeFrame: before the pain procedure (atrest), during cleaning of the region, at injection, and 2 minutes after injection
Other outcomes:
Locations:
Study officials:
affiliation: Federal University of Para and Federal University of São Paulo
name: Aurimery G Chermont
role: PRINCIPAL_INVESTIGATOR
affiliation: Federal University of São Paulo
name: Ruth Guinsburg
role: STUDY_DIRECTOR
References:
citation: Chermont AG, Falcao LF, de Souza Silva EH, de Cassia Xavier Balda R, Guinsburg R. Skin-to-skin contact and/or oral 25% dextrose for procedural pain relief for term newborn infants. Pediatrics. 2009 Dec;124(6):e1101-7. doi: 10.1542/peds.2009-0993.
Clinical trial NCT02045186: Monitoring of Oral Human Papillomavirus Infection (HPV) in HPV-positive Oropharyngeal Squamous Cell Carcinoma (OPSCC)
Official title: Monitoring of Oral HPV Infection in HPV-positive Oropharyngeal Squamous Cell Carcinoma During and After Chemoradiotherapy (CRT)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Carcinoma, Squamous Cell
Head and Neck Neoplasms
Oropharyngeal Neoplasms
Keywords: Human Papilloma Virus
Oropharynx
Oropharyngeal Squamous Cell Carcinoma
Squamous Cell Carcinoma
Radiation Therapy
Chemotherapy
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2014-01-24
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of this research study is to determine whether and when patients with human papilloma virus positive squamous cell cancer of the oropharynx treated with radiation and chemotherapy clear their human papilloma virus infection.


Eligibility criteria: Inclusion Criteria:

1. ≥ 18 years of age (no upper age limit)
2. AnyT, AnyN, M0 squamous cell carcinoma of the oropharynx
3. Biopsy proven squamous cell carcinoma that is HPV positive via standard pathological assessment of tumor tissues in pathology department at the treating institution
4. Scheduled for definitive CRT as primary treatment of their oropharynx cancer

Exclusion Criteria:

1. Prior history of radiation therapy to the head and neck
2. Prior history of mucosal head and neck cancer.
3. Not willing or able to comply with study specific procedures

Primary outcomes:
measure: Proportion of patients with HPV-positive OPSCC undergoing CRT who are clear of their oral HPV infection at each time-point
timeFrame: 2 years post-CRT of last enrolled patient
Secondary outcomes:
measure: Time to HPV clearance for patients with HPV-positive OPSCC undergoing CRT
timeFrame: 2 years post-CRT of last enrolled patient
measure: Number of aneuploidy cells as measured by FISH (Florescent in-situ hybridization) and the mRNA copy number for HPV E6 and HPV E7 at each time-point
timeFrame: 2 years post-CRT of last enrolled patient
measure: Clinical outcomes of interest (local control, loco-regional control, distant metastasis-free survival, and overall survival (OS)) in patients with HPV-positive OPSCC undergoing CRT
timeFrame: 2 years post-CRT of last enrolled patient
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill, Department of Radiation Oncology
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Bhishamjit Chera, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02520986: Carbon Dioxide Laser vs. Electrocoagulation for the Therapy of Condyloma
Official title: Carbon Dioxide Laser Ablation Versus Electrocoagulation - a Prospective, Randomized Multicenter Trial Comparing Two Surgical Treatments in Women Undergoing Therapy for Condyloma Acuminata
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Condylomata Acuminata
Keywords: Sexually transmitted disease
Genital Warts
Venereal Warts
Lead sponsor: Zydolab - Institute of Cytology and Immune Cytochemistry
Sponsor class: OTHER
Collaborators: name: Ruhr University of Bochum
First posted: 2015-08-13
Enrollment: 114
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In a randomized clinical trial of 114 women undergoing Treatment for condyloma acuminata, two surgical methods, the carbon dioxide laser Ablation and the excision by electrocoagulation, will be compared. The primary outcome of the study is the cosmetic result judged by the Patient 6 weeks after Treatment using a 11-step visual analogue scale (VAS), secondary outcomes are intervention time, operative complications, subjects and users satisfaction, postoperative pain and recurrence of genital warts.


Eligibility criteria: Inclusion Criteria:

* informed consent
* women with anogenital affection of condyloma acuminata

Exclusion Criteria:

* significant language barrier
* pregnancy
* unwillingness to participate
* the use of blood thinner or known coagulation disorder
* the use of immunosuppressive medicament
* HIV-Infection
* malignant diseases
* local therapy within 8 weeks before Treatment
* wound healing disorder

Primary outcomes:
measure: Cosmetic result
timeFrame: 6 weeks
Secondary outcomes:
measure: users satisfaction
timeFrame: 30 minutes
measure: Operation time
timeFrame: 20 minutes
measure: Postoperative pain
timeFrame: 5 hours
measure: Subjects satisfaction
timeFrame: 6 weeks
measure: Recurrence of genital warts
timeFrame: 12 months
measure: Operative complications
timeFrame: 14 days
measure: Subjects satisfaction
timeFrame: 12 weeks
measure: Cosmetic result
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Herne
country: Germany
facility: Department of Obstetrics and Gynecology of the Ruhr University Bochum
state: NRW
Study officials:
affiliation: Zydolab - Institute of Cytology and Immune Cytochemistry
name: Ziad Hilal, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01279486: Clearblue Home Pregnancy Test Consumer Study
Official title: Clearblue Home Pregnancy Test Consumer Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy
Keywords: Pregnancy,
Lead sponsor: SPD Development Company Limited
Sponsor class: INDUSTRY
First posted: 2011-01-19
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Volunteers requesting a pregnancy test

Brief summary: Approximately 120 female volunteers requesting a pregnancy test will be recruited locally to the UK trial centre.

Volunteers will be required to use the Clearblue Pregnancy Test according to the product instructions, and provide a urine sample from the same void.

Trained technicians will conduct a second test from the urine sample.

Detailed description: Approximately 120 female volunteers attending the study site requesting a pregnancy test will be recruited locally to the UK trial centre.

Volunteers will be required to use the Clearblue Pregnancy Test according to the product instructions, and provide a urine sample from the same void.

Trained technicians will conduct a second test from the urine sample to evaluate performance between consumer and technician testing.

Eligibility criteria: Inclusion Criteria:

* 18-45 year old
* Female
* Requesting a pregnancy test

Exclusion Criteria:

Primary outcomes:
measure: Consumer Agreement
timeFrame: During testing approximately 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Bedford
country: United Kingdom
facility: Bedford General Hospital
state: Bedfordshire
city: Milton Keynes
country: United Kingdom
facility: Brook clinic
Study officials:
affiliation: National Health Service, United Kingdom
name: Kanagaratnam Shanmugaratnam
role: PRINCIPAL_INVESTIGATOR
References: