louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05448612: Comparative Effect of ART and MET on Pain, ROM and Functional Disability in AC Patients With Trigger Points
Official title: Comparative Effect of Active Release Technique and Muscles Energy Technique on Pain, ROM and Functional Disability in Adhesive Capsulitis Patients With Trigger Points
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Adhesive Capsulitis
Keywords: Adhesive capsulitis
Trigger points
Active release technique
Muscle energy technique
Lead sponsor: University of Lahore
Sponsor class: OTHER
First posted: 2022-07-07
Enrollment: 74
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study to determine the Comparative effect of active release technique and muscle energy technique on pain, ROM and functional disability in adhesive capsulitis patients with trigger points.

Detailed description: 74 participants are included in this study in two groups and 37 for each group. Group A for active release technique along with conventional therapy and Group B for muscles energy technique along with conventional therapy.

Eligibility criteria: Inclusion Criteria:

* Both male and female.
* Participants having unilateral adhesive capsulitis.
* Participants with sub-acute adhesive capsulitis.
* Participants having age of 40-60 years.

Exclusion Criteria:

* Patient with cervical radiculopathy.
* Fractures of upper limb.
* Thoracic outlet syndrome.
* Post-traumatic.

Primary outcomes:
measure: Numerical pain rating scale
timeFrame: Change from Baseline in pain to 6 week
measure: Universal Goniometry
timeFrame: Change from Baseline in range of motion to 6 week
measure: Shoulder Pain and Functional Disability Index
timeFrame: Change from Baseline in disability to 6 week
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Spot Rehab
Study officials:
affiliation: UOL
name: Shahzadi Sumbal Naz, Dpt
role: STUDY_CHAIR
References:
Clinical trial NCT04690712: Health Education Provided to Primary School Students
Official title: The Effect of Health Education Provided to Primary School Students on Screening Results
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nurse's Role
Health Behavior
Lead sponsor: KTO Karatay University
Sponsor class: OTHER
First posted: 2020-12-31
Enrollment: 400
Sex: ALL
Minimum age (years): 7
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Health screening was done to the experimental group with one group. Surveys were conducted. Later, health education was given to this group. Six months later, the same group was screened for health again and a questionnaire was applied.
Primary purpose: SCREENING

Brief summary: This study was conducted in a primary school in turkey.It was aimed to examine the effects of health education given to children in primary school period.As a result, it has been seen that education can be effective.

Detailed description: Investigation of the Effects of Health Education Provided to Saraçoğlu Toki Mustafa Çetin Primary School Students on Health Screening Results The aim of this study is to find the effect of health education given to primary school students on health screening results.

The research is a pre-test and post-test quasi-experimental model with a single subject group. Saracoglu Toki Mustafa Cetin Primary School is that located in Turkey; It was held between September 2019 and March 2020. It was aimed to reach the entire universe, not choosing the sample. The pre-test screening was completed with 460 students and the post-test screening with 400 students. An Introductory Information Form and Screening Test Application Form were used to collect data. After the health education was given by the researchers using visual, auditory materials and drama technique, the results were evaluated.

Eligibility criteria: Inclusion Criteria:

* All students who regularly attend school at Saraçoğlu TOKI Primary School and who had no communication problems and whose parents gave their research approval were included in the study.

Exclusion Criteria:

* Students who could not attend school were excluded from the study.

Primary outcomes:
measure: Screening Tests Application Form
timeFrame: 6 months
measure: Introductory Information Form
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Karatay
country: Turkey
facility: Berna Bayır
state: Konya
Study officials:
affiliation: KTO Karatay University
name: Berna Dr Bayır, 1
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01341912: Study to Investigate the Long-term Efficacy and Safety of Human-cl rhFVIII in Previously Treated Patients (PTPs)
Official title: Clinical Study to Investigate the Long-Term Efficacy, Safety and Immunogenicity of Human-cl rhFVIII in Previously Treated Patients With Severe Haemophilia A - Extension Study to GENA-01
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Severe Hemophilia A
Lead sponsor: Octapharma
Sponsor class: INDUSTRY
First posted: 2011-04-26
Enrollment: 3
Sex: MALE
Minimum age (years): 12
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to study the long-term efficacy, safety and tolerability of Human-cl rhFVIII in previously treated patients with severe hemophilia A.


Eligibility criteria: Inclusion Criteria:

* Completion of GENA-01 study with at least 50 Exposure Days (EDs) and at least 6 months study participation and immediate enrollment into GENA-11

Exclusion Criteria:

* Development of FVIII inhibitors (\<=0.6 BU), during the course of the GENA-01 study
* Development of any severe liver or kidney disease (ALT and AST level \> 5 times of upper limit of normal, creatine \>120 micro mol/L) during the course of the GENA-01 study

Primary outcomes:
measure: Long-term Immunogenicity
timeFrame: up to 3 years
Secondary outcomes:
measure: To Determine Long-term Efficacy of Human-cl rhFVIII in the Treatment of Bleeding Episodes and in Surgical Prophylaxis
timeFrame: up to 3 years
Other outcomes:
Locations:
city: Washington
country: United States
facility: Georgetown University
state: District of Columbia
city: Sofia
country: Bulgaria
facility: Haematological Hospital SHAT "Joan Pavel"
Study officials:
References:
Clinical trial NCT04783012: Patient Removal of Catheters After Urogynecologic Surgery
Official title: Patient Removal of Urinary Catheters After Urogynecologic Surgery: A Randomized Non-Inferiority Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Retention Postoperative
Patient Satisfaction
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
First posted: 2021-03-04
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Management of postoperative urinary retention often requires the use of indwelling catheters. The purpose of this study is to see if patient removal of catheters at home is non-inferior to standard office removal.

Detailed description: Voiding trials are a routine part of Urogynecologic surgery. Management of postoperative urinary retention often requires the use of indwelling catheters. However, patients often view the need for catheters as the worst part of their surgical experience, and follow-up voiding trials in the office utilize excess healthcare resources. Many Urology practices allow patient removal of catheters after procedures, though this has not been formally studied. The purpose of this study is to see if patient removal of catheters at home is non-inferior to standard office removal.

Eligibility criteria: Inclusion Criteria:

* All women undergoing prolapse or anti-incontinence surgery who fail their voiding trials prior to discharge
* 18+ years old

Exclusion Criteria:

* Non-English speaking
* Pregnant
* Elevated PVR (\>150 mL) or dependent upon catheterization to void pre-operatively
* Urethral bulking injection surgery
* Intra-operative complication requiring prolonged catheterization
* Unable or unwilling to remove catheter at home

Primary outcomes:
measure: Risk of Urinary Retention in the Early Postoperative Period
timeFrame: 2-5 days postoperatively
Secondary outcomes:
measure: Number of nursing calls and office visits for urinary issues in the six week postoperative period
timeFrame: 6 week postoperative period
Other outcomes:
Locations:
city: Hillsborough
country: United States
facility: UNC Hillsborough Hospital
state: North Carolina
city: Raleigh
country: United States
facility: UNC Rex Hospital
state: North Carolina
Study officials:
affiliation: UNC Chapel Hill
name: Ijeoma Agu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: UNC Chapel Hill
name: Jennifer M Wu, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00976612: Nilotinib Pharmacokinetics (PK) in Gastrointestinal Stromal Tumor (GIST): Nilotinib PK
Official title: Pharmacokinetic Study of Nilotinib in Patients With Metastatic or Unresectable Gastrointestinal Stromal Tumor Showing Failure to Both Imatinib and Sunitinib
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastrointestinal Stromal Tumors
Keywords: Gastrointestinal stromal tumor
pharmacokinetics
nilotinib
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2009-09-14
Enrollment: 17
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with metastatic or unresectable gastrointestinal stromal tumor who failed to imatinib and sunitinib.

Brief summary: In patients who are receiving nilotinib, nilotinib plasma levels will be measured after 1 month of nilotinib treatment. The relationship between surgery type and nilotinib pharmakokinetic properties will be investigated in this study.


Eligibility criteria: Inclusion Criteria:

* Patients with metastatic or unresectable gastrointestinal stromal tumor
* Patients receiving nilotinib after failure to imatinib and sunitinib

Primary outcomes:
measure: nilotinib pharmacokinetics
timeFrame: Up to 3years
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Asan Medical Center
name: Yoon-Koo Kang, M.D., PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06722612: Chemotherapy Combined With Targeted Therapy for High-risk HER2 Positive and Lymph Node Negative Early Breast Cancer
Official title: Cohort Study of Chemotherapy Combined With Targeted Adjuvant Therapy for High-risk HER2 Positive and Lymph Node Negative Early Breast Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: HER2-positive Breast Cancer
Keywords: Taxane
target therapy
carboplatin
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2024-12-09
Enrollment: 2916
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: invasive breast cancer, pathological staging was T2, N0, HER2 positive, and accompanied by one of the high-risk factors (G3, or hormone receptor negative)

Brief summary: Human epidermal growth factor receptor 2 (HER2) positive breast cancer is a molecular subtype with high malignancy and easy recurrence and metastasis. The emergence of HER2 targeted drugs has greatly improved the prognosis and survival of such patients. At present, for HER2 positive breast cancer patients with negative lymph nodes, chemotherapy drugs combined with trastuzumab is the current standard treatment scheme, and in most cases, chemotherapy uses a combination of two drugs, while the main beneficiaries of the target treatment of trastuzumab and pertuzumab are concentrated in the group of patients with positive lymph nodes. Can the use of target therapy to de-escalation chemotherapy and further achieve a strategy of high efficacy and low toxicity. It is planned to explore the efficacy and safety of T1-T2, HER2 positive early breast cancer patients with negative lymph nodes to achieve chemotherapy reduction based on risk stratification.


Eligibility criteria: Inclusion Criteria:

* 1) Treated in Peking University People's Hospital and underwent radical resection with hospitalization records;
* 2) Postoperative pathology confirmed invasive breast cancer, pathological staging was T2, N0, HER2 positive, and accompanied by one of the high-risk factors (G3, or hormone receptor negative);
* 3) Has signed and agreed to participate in the PKUPH breast disease cohort study.

Exclusion Criteria:

* 1) Lack of clinical and pathological data (such as imaging data and pathological data);
* 2) Preoperative neoadjuvant therapy;
* 3) Patients with metastatic breast cancer or bilateral breast cancer;
* 4) Failure to perform radical surgery.

Primary outcomes:
measure: disease free survival
timeFrame: 5 years
Secondary outcomes:
measure: invasive disease free survival
timeFrame: 5 years
measure: distant disease free survival
timeFrame: 5 years
measure: breast cancer specific survival
timeFrame: 5 years
measure: overall survival
timeFrame: 5 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT04404712: FAAH Availability in Psychiatric Disorders: A PET Study
Official title: FAAH Availability in Psychiatric Disorders: A PET Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: EARLY_PHASE1
Conditions: Post Traumatic Stress Disorder
Alcohol Use Disorder
Psychosis
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2020-05-27
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The aim of the present study is to examine Fatty Acid Amide Hydrolase (FAAH) availability in humans, including healthy individuals and across a spectrum of psychiatric disorders in which alterations in the endocannabinoid system are observed.

Detailed description: This study involves in vivo examination of FAAH availability, implicated both in the pathophysiology and therapeutics of disorders including PTSD, substance use disorders (e.g., alcohol use disorder, cannabis/cannabinoid use disorder, nicotine use disorder), psychotic disorders including schizophrenia, and mood disorders. The endocannabinoid system is a neuromodulatory system that has been implicated across a wide range of psychiatric disorders and may be implicated in the regulation of mood, appetitive behaviors, sleep, and cognition. Thus, alterations in the ECS have wide ranging implications. Finally, the ECS is being explored as a novel therapeutic target for several psychiatric disorders. Additionally, the test/retest reliability of the radiotracer, \[11C\]MK-3168, will be studied in up to 10 healthy control individuals.

Eligibility criteria: Inclusion Criteria:

* Between the ages of 18 and 65 years, inclusive
* Good physical health as determined by history, physical and laboratory examinations, ECG, and vital signs

PTSD Inclusion Criteria:

* Diagnosis of Post-Traumatic Stress Disorder

AUD Inclusion Criteria:

* Diagnosis of Alcohol Use Disorder

Psychosis Inclusion Criteria:

* Diagnosis of psychotic disorder such as Schizophrenia, Schizoaffective disorder

Exclusion Criteria:

* Presence of ferromagnetic metal in the body or heart pacemaker
* Women with a positive pregnancy test or women who are lactating

Primary outcomes:
measure: Total distribution of [11C]MK-3168 in the brain
timeFrame: PET scan day
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Connecticut Mental Health Center
state: Connecticut
Study officials:
affiliation: Neuroscience Research Training Program (NRTP); Office of Cooperative Research; Psychiatry; Schizophrenia Research Clinic; Yale University
name: Mohini Ranganathan, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04623112: Use of Frequency Compression in Severe-profound Hearing Loss Adults
Official title: Do Severe-profound Hearing Impaired Adults Perform Better in Speech Perception With Frequency Compression Switched on or Off or Fitted to Hearing Loss
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Frequency Compression
Severe-profound Hearing Impairment
Lead sponsor: University College, London
Sponsor class: OTHER
First posted: 2020-11-10
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the functional benefits of frequency compression vs no frequency compression or fitted to hearing loss in severe-profound hearing impaired adults with high frequency hearing losses. Thus, assessing whether hearing aids for this patient population can be adapted to improve speech perception.

Detailed description: Frequency compression is a feature available on some digital hearing aids, which is aimed at increasing the audibility of high frequency sounds. It works by taking sounds above a fixed start frequency and compresses it into lower frequencies where residual hearing is better.

Eligibility criteria: Inclusion Criteria:

1. Participants must be over 18 years of age- This study is looking at the use of frequency compression \& its effects of speech perception in adults.
2. No ear surgery that would make it impossible to fit a hearing aid- To ensure limited confounding variables.
3. No history of ear surgery within the last 12 months- To ensure limited confounding variables.
4. No history of ear infection(s) within the last 6 months- To ensure no contraindications and limited confounding variables to testing.
5. No otoscopic abnormality making it impossible to fit a hearing aid- To ensure no contraindications to testing.
6. Bilateral severe-profound hearing impairment with air conduction thresholds \>71dBHL within the frequency range of 250Hz to 4 kHz- To analyse the effects of frequency compression on speech perception within this patient population.
7. Post lingual deafness, with good spoken English- To ensure reliability of speech testing.
8. Previous bilateral digital hearing aid experience (6+ months)- To ensure limited confounding variables.
9. Written consent required.

Exclusion Criteria:

1. Participants under the age of 18 years.
2. History of ear surgery making it impossible to fit a hearing aid.
3. History of ear surgery within the last 12 months.

Primary outcomes:
measure: CHEAR Auditory Perception Test
timeFrame: 4 weeks post hearing aid fitting with adapted hearing aid feature
measure: Adaptive Bamford-Kowal-Bench Test
timeFrame: 4 weeks post hearing aid fitting with adapted hearing aid feature
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: UCL Ear Institute
name: Deborah Vickers, Phd
role: STUDY_CHAIR
References:
Clinical trial NCT03731312: Variability of Daily Iodine Intake: The Effects of Intra- and Inter-individual Variability in Iodine Nutrition Studies
Official title: Variability of Daily Iodine Intake: The Effects of Intra- and Inter-individual Variability on Estimated Intake in Iodine Nutrition Studies
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Iodine Deficiency
Keywords: Iodine
Urinary iodine concentration
Lead sponsor: Swiss Federal Institute of Technology
Sponsor class: OTHER
First posted: 2018-11-06
Enrollment: 206
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy women of reproductive age and residents of Switzerland since at least 12 months

Brief summary: Iodine status in populations is assessed using urinary iodine concentration (UIC) measured in spot urine samples. The iodine intake is classified as deficient, sufficient, or excessive iodine based on the median UIC (mUIC). However, this approach has limitations, as it does not quantify the prevalence of individuals with habitually deficient or excess iodine intakes. The EAR cut-point method has the potential to quantify prevalence of iodine deficiency and excess. However, little is known about the effects of the inter- and intra-individual variance of UIC.

The aim of the study is to quantify the intra-individual variability in dietary iodine intake. The overall goal is to estimate the prevalence of iodine deficiency and excess in the study population and propose sample size recommendations for future iodine nutrition population studies. The results will provide evidence guiding international recommendations for iodine nutrition studies.


Eligibility criteria: Inclusion Criteria:

* Non-pregnant
* Non-lactating
* Non-smoking
* Residence in Switzerland ≥12 months
* Generally healthy
* No family history of goiter
* No exposure to iodine containing contrast agents during the last 12 months - Informed consent given

Exclusion Criteria:

* Participant is not able to understand the study information or procedure, e.g. due to linguistic barriers

Primary outcomes:
measure: Estimated daily urinary iodine excretion
timeFrame: 7 days
Secondary outcomes:
measure: Measured daily iodine excretion
timeFrame: 1 day
measure: Thyroid function test TSH
timeFrame: 1 day
measure: Thyroid function test total T4
timeFrame: 1 day
measure: Thyroid function test Tg
timeFrame: 1 day
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: ETH Zurich
Study officials:
affiliation: ETH Zurich
name: Jessica Rigutto-Farebrother, PhD
role: PRINCIPAL_INVESTIGATOR
References: