louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05313516: OKKO Space Academy to Check Children's Vision at Home
Official title: OKKO Space Academy App: Families Checking Their Child's Vision at Home During Amblyopia Treatment
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Amblyopia
Lead sponsor: Moorfields Eye Hospital NHS Foundation Trust
Sponsor class: OTHER
First posted: 2022-04-06
Enrollment: 100
Sex: ALL
Minimum age (years): 3
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of this study is to determine the feasibility of the OKKO Space Academy app as a vision measuring and home-monitoring tool for children aged 3-8 years undergoing amblyopia treatment.

There are three objectives to this work:

1. Determine the feasibility of the OKKO Space Academy app for use between clinic visits from the child's and family perspective (i.e., acceptability, usability and engagement).
2. Assess the variability in day-to-day OKKO Health measurements between clinic visits (e.g., do the interim OKKO home vision measurements predict improvements in visual acuity?)
3. Explore agreement between the OKKO Space Academy measures of visual acuity against in-clinic measurements (usual standard of care), including an exploration of intra- and inter-session repeatability.


Eligibility criteria: Inclusion Criteria:

* Age 3.01 - 8.99 years with amblyopia
* Currently undergoing or at first visit to start amblyopia patching treatment
* Vision is fully corrected in glasses
* Visual acuity between -0.02 and 0.98 logMAR
* Have daily access to an approved smartphone or tablet
* Parent/child able to read and understand English
* Patient (child) able to understand spoken English

Exclusion Criteria:

* Parent not able to read and understand English
* Patient (child) not able to understand spoken English
* Parent/child not willing to participate
* Parent unable to give consent
* Any other ocular comorbidities
* Child has cognitive impairment or intellectual disability

Primary outcomes:
measure: Feasibility and acceptability of home monitoring using the OKKO Health app
timeFrame: 3 months
measure: Engagement of home monitoring using the OKKO Health app
timeFrame: 3 months
measure: Variability in app data.
timeFrame: 3 months
measure: Visual acuity
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Moorfields Eye Hospital
Study officials:
References:
Clinical trial NCT00585416: Study of CGC-11047 in Patients With Metastatic Hormone Refractory Prostate Cancer
Official title: A Phase II Study of CGC-11047 in Patients With Metastatic Hormone Refractory Prostate Cancer (47-02-001)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Prostate Cancer
Keywords: Prostate Cancer
Hormone Refractory
Metastatic
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: Progen Pharmaceuticals
First posted: 2008-01-03
Enrollment: 23
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this research is to determine the effectiveness of CGC-11047 in subjects with metastatic hormone refractory prostate cancer as measured by changes in PSA.


Eligibility criteria: Inclusion Criteria:

* Metastatic hormone refractory prostate cancer.
* Eastern Cooperative Oncology Group (ECOG) Performance status of 0-1.
* testosterone \<50ng/dL. Patients must continue primary androgen deprivation with an LHRH analogue if they have not undergone orchiectomy.
* Progressive disease after androgen deprivation.

Exclusion Criteria:

* Patients whose clinical condition would make chemotherapy clearly indicated.
* Patients who have received systemic chemotherapy for the treatment of metastatic disease.
* Peripheral neuropathy \> Grade 1
* Prior anti-angiogenic therapy, including thalidomide.
* Patients with inadequate recovery from any prior surgical procedure, or patients having undergone any major surgical procedure or radiation within 4 weeks prior to study entry.
* Patients who have received radiopharmaceuticals (strontium, samarium) within 8 weeks prior to enrollment.
* Patients with known brain metastases or history of brain metastases.
* History of stroke within 6 months of treatment or other significant neurological limitations.
* Patients who have received more than 2 prior investigational treatments.
* Uncontrolled intercurrent illness
* Patients with a history of a myocardial infarction within the prior 6 months or, hospitalizations for decompensated congestive heart failure within the prior 6 months, or history of significant / symptomatic cardiac arrhythmias

Primary outcomes:
measure: Efficacy
timeFrame: 8 weeks
Secondary outcomes:
measure: Safety
timeFrame: Throughout and for 28 days post drug
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin Hospital and Clinics
state: Wisconsin
Study officials:
References:
Clinical trial NCT00707616: Common Genetic Variation and Type 2 Diabetes
Official title: The Effect of Diabetes-associated Gene Variation on Glucose Metabolism in Humans
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pre-diabetes
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: University of Padova
First posted: 2008-07-01
Enrollment: 190
Sex: ALL
Minimum age (years): 35
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy, non-diabetic

Brief summary: Type 2 diabetes is a common metabolic disorder arising from a complex interaction between genetic predisposition and the environment. The development of this disorder is preceded by impaired glucose tolerance and elevated fasting glucose which also carry adverse cardiovascular risk. To date a few common genetic variants have been reliably associated with predisposition to type 2 diabetes. However, it is uncertain how these genes interact to alter insulin secretion and insulin action prior to the development of type 2 diabetes. We propose to utilize an established population-based cohort to determine how common genetic variants associated with type 2 diabetes alter the response to an oral glucose challenge in people without overt type 2 diabetes. This will enable us to understand how common variants alone or in combination alter whole-body glucose physiology and predispose to type 2 diabetes.


Eligibility criteria: Inclusion Criteria:

* Fasting blood glucose \< 126mg/dL

Exclusion Criteria:

* Fasting blood glucose \> 126mg/dL

Primary outcomes:
measure: Disposition Index
timeFrame: 2 hr
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Adrian Vella, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01655316: Oral Verapamil in Acute Paroxysmal Supra Ventricular Tachycardia(PSVT) Recurrence Control
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Paroxysmal Supraventricular Tachycardia
Lead sponsor: Tehran University of Medical Sciences
Sponsor class: OTHER
First posted: 2012-08-01
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: PSVT is a common rhythm disorder in emergency department which can be recurrent in some cases.

Intravenous Adenosine is the drug of choice in PSVT control in acute settings but is a very short acting agent.

Providing a complementary medication to decrease the rate of recurrence of PSVT after its initial control will be promising.

This study evaluates the role of the oral Verapamil in recurrence control of PSVT in emergency situations.


Eligibility criteria: Inclusion Criteria:

* Age\>18 years old
* PSVT on emergency department presentation

Exclusion Criteria:

* Instability in hemodynamic status
* Allergy to Verapamil

Primary outcomes:
measure: Recurrence Control
timeFrame: 2 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01795716: Bioequivalence Study of Mesylate Imatinib Capsule in Chronic Myeloid Leukemia Body
Official title: Bioequivalence Study of Mesylate Imatinib Capsule in Chronic Myeloid Leukemia Body
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic Myeloid Leukemia
Lead sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2013-02-21
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 1. purpose: To conduct the relative bioavailability study of a single dose and multiple doses of imatinib mesylate capsule (Jiangsu Chia-Tai Tianqing Pharmacy Co. Ltd.) versus Glivec (Novartis Pharma Stein AG).
2. Experimental Design： Two-period crossover design
3. Test drug: imatinib mesylate capsule Reference drug: Glivec
4. Sample size：20

Detailed description: To conduct the relative bioavailability study of a single dose and multiple doses of imatinib mesylate capsule(Jiangsu Chia-Tai Tianqing Pharmacy Co. Ltd.) versus Glivec (Novartis Pharma Stein AG) and compare the bioequivalence and pharmacokinetics of the two products in 20 patients with chronic myeloid leukemia.

Eligibility criteria: Inclusion Criteria:

* Patients with chronic myeloid leukemia;
* Age: 18-65 years,gender:both.
* Weight: standard weight ± 20% within, and avoid weight disparity is too large;
* No previous radiation therapy, chemotherapy, or surgery within 1 weeks before treatment with imatinib;
* Performance status 0 to 3 (WHO scale); Life expectancy greater than 3 months;
* No other malignancy;
* Adequate hepatic, renal, and bone marrow function (WBC≥3.0×109/L，ANC≥1.5×109/L，PLT≥80×109/L. Serum bilirubin≤1.5×the institutional upper limit of normal, ALT、ALP≤2.5×the institutional upper limit of normal, creatinine≤1.5×the institutional upper limit of normal);
* Ability to understand objectives of the study, the study procedure, the pharmacological properties of the drug and possible adverse reactions and the willingness to sign a written informed consent.

Exclusion Criteria:

* Suffering from heart, liver, kidney disease or severe acute and chronic gastrointestinal diseases;
* Pregnant or lactating women and be sensitive to drug;
* Subjects are thought unsuitable for the study by investigators;
* Inability to comply with protocol or study procedures in the opinion of the investigator;
* Attending other clinical trials or attended other clinical trials 3 months ago.

Primary outcomes:
measure: Area Under Curve (AUC) Time Frame: Predose, 0.5,1,1.5,2,3,5,8,12,24,48,72hours Post-dose
timeFrame: predose, 0.5,1,1.5,2,3,5,8,12,24,48,72hours post-dose
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Jiaotong University School of Medicine Ruijin Hospital
Study officials:
affiliation: Shanghai Jiaotong University School of Medicine Ruijin Hospital
name: Shen Zh xiang, doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04772716: Surgical Outcome at HFSUH
Official title: Postoperative Complication and Associated Factors Among Patients Operated at Hiwot Fana Specialized University Hospital, Ethiopia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgical Outcome
Keywords: outcome
Lead sponsor: Haramaya Unversity
Sponsor class: OTHER
First posted: 2021-02-26
Enrollment: 352
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all patient admitted surgical ward and underwent surgical intervention

Brief summary: the study was conducted on already intervened hospital patients with surgical management and their final outcome was followed from the chart of the patients.

Detailed description: It was a prospective chart review of operated patient at Hiwot fana specialized hospital for different emergency as well elective surgeries. The study subjects signed informed written consent and their data collected anonymously. the follow up protocol was until discharge from hospital the longest date as 30 days.

Eligibility criteria: Inclusion Criteria:

* all operated patients at surgical ward

Exclusion Criteria:

* patients operated at other facilities and transferred here. readmission within a month of discharge

Primary outcomes:
measure: post operative complications
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Harar
country: Ethiopia
facility: HFSUH
state: Harari NS
Study officials:
References:
Clinical trial NCT03753516: Pelvic Floor Support After Laparoscopic Hysterectomy for Benign Conditions: A Randomized Controlled Trial Comparing Vaginal Cuff Closure Techniques
Official title: Pelvic Floor Support After Laparoscopic Hysterectomy for Benign Conditions: A Randomized Controlled Trial Comparing Vaginal Cuff Closure Techniques
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pelvic Organ Prolapse
Lead sponsor: Walter Reed National Military Medical Center
Sponsor class: FED
First posted: 2018-11-27
Enrollment: 58
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: The purpose of this study is to learn about the effect of different vaginal cuff closure techniques on pelvic support after laparoscopic hysterectomy and robotic assisted laparoscopic hysterectomy for benign gynecologic conditions.


Eligibility criteria: Inclusion Criteria:

* Women over 18 years of age undergoing total laparoscopic hysterectomy and robotic assisted total laparoscopic hysterectomy for benign disease.
* Subjects must be able to self-consent.
* Department of Defense beneficiary

Exclusion Criteria:

* Patients will be excluded if they undergo a concurrent procedure for prolapse.
* If the indication for the procedure is a malignancy.
* Those that plan to leave the area in less than 1 year will not be included.
* Pop-Q Point C of \>-4

Primary outcomes:
measure: Pelvic Organ Prolapse - Quantification Point C
timeFrame: 6-8 weeks post op
measure: Pelvic Organ Prolapse - Quantification Point C
timeFrame: 1 year post op
Secondary outcomes:
measure: Vaginal Cuff Dehiscence
timeFrame: 1 year
measure: Vaginal Cuff Abscess
timeFrame: 1 year
measure: Vaginal Cuff Cellulitis
timeFrame: 1 year
measure: Vaginal Cuff bleeding
timeFrame: 1 year
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: Walter Reed National Military Medical Center
state: Maryland
Study officials:
References:
Clinical trial NCT04527016: Airway Microbiota Based Treatment of Asthma in Preschool Children
Official title: Effects of Airway Microbiota and Blood Eosinophils Based Therapy or Treatment Using Current Clinical Guidelines in Recurrent Preschool Wheeze
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Asthma in Children
Keywords: preschool wheeze
airway microbiota
Lead sponsor: Children's Hospital of Fudan University
Sponsor class: OTHER
First posted: 2020-08-26
Enrollment: 120
Sex: ALL
Minimum age (years): 1
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Airway microbiota pattern may related the preschool asthma exacerbation. This is a single-center, randomized-controlled trial, the study will compare the management of preschool wheeze determined by airway microbiota phenotype and blood eosinophils level to the management using current clinical guidelines.

Detailed description: In this study, participants will be children aged 1-5 years who have recurrent wheezing and will be allocated to one of two treatment groups, either current clinical care or airway microbiota and blood eosinophils phenotype based management for 3 months.They will be followed up for one year after the intervention. The primary outcome is the frequency of unscheduled healthcare visit for wheezing, the secondary outcome parameters are events of severe wheezing requiring oral or intravenous steroids, events of emergency department visit and hospital admissions, the changes of Test for Respiratory and Asthma Control in Kids (TRACK) score and Paediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ) score.

Eligibility criteria: Inclusion Criteria:

* physician diagnosed recurrent wheeze（at least 3 episodes of wheezing or at least one course of oral steroids in the last 6 months）

Exclusion Criteria:

* Any congenital heart disease diagnosed by a physician
* Any chronic respiratory condition other than preschool wheeze (bronchopulmonary dysplasia, bronchiolitis obliteran, congenital airway and lung malformations, bronchomalacia, chronic aspiration) diagnosed by a physician
* Received antibiotic last 6 weeks

Primary outcomes:
measure: Frequency of unscheduled healthcare visits for wheezing
timeFrame: from baseline to one year follow-up
Secondary outcomes:
measure: Frequency of severe wheezing requiring oral or intravenous steroids
timeFrame: from baseline to one year follow-up
measure: Frequency of emergency department visit
timeFrame: from baseline to one year follow-up
measure: Frequency of hospital admissions
timeFrame: from baseline to one year follow-up
measure: The changes of TRACK score
timeFrame: from baseline to one year follow-up
measure: The changes of PACQLQ score
timeFrame: from baseline to one year follow-up
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Children's Hospital of Fudan University
state: Shanghai
Study officials:
References:
Clinical trial NCT06451016: Effects of Vitamin D Supplementation on Muscle Function Among Grave's Disease Patients
Official title: Effects of Vitamin D Supplementation on Muscle Function Among Grave's Disease Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Graves Disease
Lead sponsor: Frontier Medical and Dental College, Abbotabad
Sponsor class: OTHER
First posted: 2024-06-10
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Introduction:

A deficit in vitamin D may be involved in the development and presentation of Graves' disease (GD). Lack of vitamin D and GD are linked to deteriorating quality of life (QoL) and weakening of the muscles. Our goal was to look at the possible advantages of vitamin D supplementation for the improvement of thyroid-related QoL and muscle function in GD patients, as well as the possible drawbacks of anti-thyroid drugs (ATD).

Methodology:

A multicenter randomized controlled experiment with single-blinding was carried out with 48 patients who had been diagnosed with Graves' illness. The participants were split into two groups n=24 patients in each group. In addition to standard ATD, Group A received either 70 μg (2800 IU) of vitamin D daily or a corresponding placebo. Investigator measured muscular function and isometric strength at baseline, three, and nine months.


Eligibility criteria: Inclusion Criteria:

* Grave's Disease
* either starting or about to start anti-thyroid medication (ATD)

Exclusion Criteria:

* Chronic granulomatous disease
* hypercalcemia
* poor renal function (eGFR \< 45 ml/min)
* the presence of malignant disease

Primary outcomes:
measure: Muscle Strength
timeFrame: base line and after 3months
Secondary outcomes:
Other outcomes:
Locations:
city: Abbottābād
country: Pakistan
facility: Frontier Medical and Dental College
state: KPK
city: Abbottābād
country: Pakistan
facility: Frontier Dental
state: Sindh
Study officials:
References:
Clinical trial NCT04740216: Effects of Exercise Therapy Adjuvant Device on Head and Neck Cancer Patients in the Treatment of Cancer Therapy Induced Trismus
Official title: A Randomized Feasibility Trial to Test Exercise Therapy Plus Jaw Device to Prevent Trismus in Patients With Head and Neck Cancer Receiving Radiation-Based Therapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Maximum Interincisal Opening
Keywords: trismus
head and neck cancer
radiotherapy
maximum interincisal opening
Lead sponsor: Taipei Medical University
Sponsor class: OTHER
First posted: 2021-02-05
Enrollment: 130
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Trismus is traditionally considered being a late effect of cancer therapy with functional deficits becoming clear in the first year after completing radiation therapy. These deficits can rapidly progress to a state of functional impairment. The most common treatment for trismus is physical therapy comprising an active range of motion (ROM) exercises, hold and relax techniques. Once trismus has developed, it may be hard to reverse. Thus, prevention with a program of self-care is important for managing this side effect. This study want to test the effect with adjunctive devices plus exercise to prevent trismus.


Eligibility criteria: Inclusion Criteria:

1. Age is greater than or equal to 20 years old.
2. Those who are able to communicate in Mandarin and Taiwanese and have no reading or listening or writing disabilities can fill out the questionnaire by themselves or with the assistance of the researcher.
3. Diagnosed with head and neck cancer, and is expected to receive head and neck radiation therapy for the first time.
4. A clear consciousness, no severe cognitive impairment or mental symptoms.
5. Willing to participate in this research and obtain consent.

Exclusion Criteria:

1. People with known temporomandibular joint disorders.
2. The maximum opening degree is less than or equal to 25 mm.
3. Those who have received radiotherapy for the head and neck in the past.
4. Those who have been diagnosed by a physician for poor wound healing after surgery and unable to perform mouth-opening rehabilitation exercises.

Primary outcomes:
measure: The change of maximum interincisal opening (MIO)
timeFrame: baseline, 2 weeks, 4 weeks, 6 weeks, 8weeks, 10 weeks, 12 weeks, 6 months.
Secondary outcomes:
measure: The change of fatigue level
timeFrame: baseline, 2 weeks, 4 weeks, 6 weeks, 8weeks, 10 weeks, 12 weeks, 6 months.
measure: Quality of life (QOL)
timeFrame: baseline, 2 weeks, 4 weeks, 6 weeks, 8weeks, 10 weeks, 12 weeks, 6 months.
Other outcomes:
Locations:
Study officials:
References: