louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02809885: Hepatitis E Virus Infection in Pediatric Transplantation, a Prevalence Study
Official title: Hepatitis E Virus Infection in Pediatric Transplantation, a Prevalence Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Transplantation
Keywords: Hepatitis E
Pediatric
Transplantation
Prevalence
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2016-06-22
Enrollment: 226
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: Hepatitis E virus (HEV) is an emerging disease. The genotype 1 and 2 are predominant in Asia and Africa, and are responsible for recurrent epidemics. Genotype 3 is the main genotype found in Europe and North America and is responsible for sporadic infections except for travel associated diseases.

HEV had a principally asymptomatic form. However, it was recently demonstrated that it could lead to a chronic form, especially in immunosuppressed patients. Moreover, in liver transplanted patients the infection could mimic a rejection and lead to the loss of the transplant. In other immunosuppressed patients, chronic hepatitis lead to cirrhosis and its well-known complications (ascitis, digestive hemorrhage, liver failure...). There is a lack of information about the prevalence of this disease.

In Canada the incidence of HEV infection was high (15-86% for liver transplanted children with liver tests disturbed). In Germany the prevalence was lower: 3,2% in liver \& kidney transplanted children whereas 7,4% in control. It was shown in a retrospective study that in liver (and liver+kidney) transplanted children the prevalence in Lyon was around 8,3%.

This study will determined in a prospective approach the HEV prevalence in kidney, lung, heart and bone marrow transplanted children in Lyon.


Eligibility criteria: Inclusion Criteria:

* \<18 years old
* transplantation (heart, kidney, lung or bone marrow)
* protocol acceptance by family
* social security available

Exclusion Criteria:

* protocol rejection by family

Primary outcomes:
measure: Hepatitis E virus prevalence in pediatric transplanted patients
timeFrame: Day 1
measure: Hepatitis E virus prevalence in pediatric transplanted patients
timeFrame: 6 months
Secondary outcomes:
measure: Correlation between HEV prevalence and the different types of transplantation
timeFrame: Day 1
measure: Correlation between HEV prevalence and the different types of transplantation
timeFrame: 6 months
Other outcomes:
Locations:
city: Bron
country: France
facility: Hospices Civils de Lyon
Study officials:
References:
Clinical trial NCT01342185: Efficacy of Medical Ozone Therapy in Patients With Chronic Hepatitis B
Official title: A Randomized, Controlled, Open-label, Multicenter Clinical Study of Treatment of Chronic Hepatitis B With TY-CZ-9999 Ozone Therapy System
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Chronic Hepatitis B
Keywords: Medical ozone therapy
chronic hepatitis B
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
Collaborators: name: Tianyi medical instruments limited company, Ningbo, China
First posted: 2011-04-27
Enrollment: 189
Sex: ALL
Minimum age (years): 16
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 verify the effectiveness and safety of medical ozone therapy system in treatment of chronic hepatitis B.

Detailed description: Total of 189 patients with compensated chronic hepatitis B will be divided equally and randomly into three arms. Patients in arm I and II treated with medical ozone therapy with different medical ozone generators, one was made in Tianyi medical instruments limited company and the other in Germany. Sixty-three patients of arm III treated with Diammonium glycyrrhizinate Capsules, common used liver protective herb drug. The term of therapy is 12 weeks. Virology response, biochemistry response and hepatitis B viral serological response will be studied at the end of 12 weeks treatment.

Eligibility criteria: Inclusion Criteria:

1. Male or female, not less than 16 years old；
2. HBsAg positive for over 6 months；
3. ALT over 2×ULN, TBIL less than 80µmol/L and serum HBV DNA over 10000copies/ml。

Exclusion Criteria:

1. Patient has a history of hemorrhagic or hemolysis disease;
2. Patient has any history of clinical signs/symptoms of hepatic decompensation or serious metabolic hepatic disease;
3. Patient is co-infected with HIV or HCV;
4. Patient is treated with anti-virus drug like interferon or nucleoside analogue in recent 6 months;
5. Patient is treated with immunosuppressive agent for long time, including patient has a history of organ transplantation;
6. Pregnancy;
7. Current alcohol or drug abuse;
8. Difficulty to draw blood through veins;
9. Patient has a history of carcinoma, or finding suggestive of possible hepatocellular carcinoma (HCC), or AFP over than 100ng/ml;
10. Patient has a history of any severe physical disease such as cardio-vascular, kidney events, hyperthyroidism or serious electrolyte disturbance;
11. Patient is enrolled in any other clinical trials.

Primary outcomes:
measure: HBV DNA
timeFrame: week 12
Secondary outcomes:
measure: HBeAg
timeFrame: week12
Other outcomes:
Locations:
city: GuangZhou
country: China
facility: Nanfang Hospital
state: Guangdong
Study officials:
affiliation: Nanfang Hospital, Southern Medical University
name: yabing guo, professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01881685: Fetal Intrapartum Heart Rate FHR/ECG Study
Official title: Fetal Intrapartum Heart Rate FHR/ECG Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Abnormality in Fetal Heart Rate or Rhythm
Lead sponsor: Mindchild Medical Inc.
Sponsor class: INDUSTRY
First posted: 2013-06-20
Enrollment: 400
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women in labor who are having their fetus' heart rate monitored continuously

Brief summary: The objective of the study is to evaluate the association between certain markers in the blood of neonatal brain injury and specific Fetal Heart Rate monitoring findings using the device under study.

Detailed description: The purpose of the study is to:

1. evaluate the association between serologic markers of neonatal brain injury and the specific FHR monitoring findings using the investigational device;
2. investigate the relationship between selective serotonin reuptake inhibitor (SSRI) antidepressants and the QT interval of the fetal heart. Specifically, examine the potential association between maternal SSRI use and the fetal QT interval,and;
3. develop the capacity to measure uterine contractions during labor using non-invasive electrodes that measure the electrical signal from the uterine muscle.

For this study, the investigational device will not be used to diagnose or treat as it will be used in concert with the current standard of care monitors.

Eligibility criteria: Inclusion Criteria:

* Pregnant women in their third trimester and Women in labor (the progressive effacement and dilatation of the cervix) who are having their fetus' heart rate monitored continuously will form the eligible population for recruitment into our study
* 18 years old or older
* Women with the diagnosis of fetal intrauterine growth restriction may be included.

Exclusion Criteria:

* Speakers of languages other than English
* Gestational age less than 24 weeks 0 days

Primary outcomes:
measure: Quantitative FHR patterns predictive of adverse neonatal outcome
timeFrame: During Labor
Secondary outcomes:
measure: Uterine contraction measurement
timeFrame: During Labor
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Akron
country: United States
facility: Summa Center for Women's Health Research
state: Ohio
Study officials:
affiliation: Summa Center for Women's Health Research
name: Timothy Drake, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02934685: IG-VMAT for Localized Prostate Cancer
Official title: A Phase III Randomized Study of Hypofractionated Image-guided Volumetric Modulated Arc Radiotherapy (IG-VMAT) Versus Conventionally Fractionated IG-VMAT in Patients With Localized Prostate Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Prostate Cancer
Keywords: Prostatic Neoplasms
radiotherapy
Lead sponsor: Beijing Hospital
Sponsor class: OTHER_GOV
First posted: 2016-10-17
Enrollment: 60
Sex: MALE
Minimum age (years): 50
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To determine if hypofractionated IG-VMAT (70 Gy in 28 fractions over 5.6 weeks) will result in disease-free survival (DFS) that is no worse than DFS following conventionally fractionated IG-VMAT (80Gy in 40 fractions over 8 weeks) in patients treated for localized prostate cancer. Analysis the local progression, disease-specific survival (DFS), freedom from biochemical recurrence (FFBR), and overall survival (OS) of two groups. Observe the incidence of GI and GU toxicity.


Eligibility criteria: Inclusion Criteria:

* Age 50-79
* Histologically confirmed prostate adenocarcinoma
* Clinical stage T1-3N0M0 according to the AJCC 6th edition
* Gleason score must be \>5
* KPS \>70
* No radical surgery or cryosurgery for prostate cancer

Exclusion Criteria:

* Prior or concurrent invasive malignancy (except non-melanomatous skin cancer) or lymphomatous/hematogenous malignancy unless continually disease free for a minimum of 5 years. (For example, carcinoma in situ of the bladder or oral cavity is permissible)
* Evidence of distant metastases
* Previous radical surgery (prostatectomy) or cryosurgery for prostate cancer
* Previous pelvic irradiation, prostate brachytherapy, or bilateral orchiectomy
* Previous or concurrent cytotoxic chemotherapy for prostate cancer

Primary outcomes:
measure: Biochemical progression free survival
timeFrame: up to 18 months
Secondary outcomes:
measure: Incidence of "acute" adverse events as assessed by NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v. 4.0
timeFrame: From the start of radiation therapy (RT) to first occurrence of worse severity of adverse event within 30 days after the completion of RT
measure: Time to "late" grade 2+ adverse events as assessed by NCI CTCAE v. 4.0
timeFrame: From the date of completion of RT to the date of first grade 2 or above adverse event occurring 30 days after the completion of RT
measure: Overall Survival
timeFrame: up to 5 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Hospital
Study officials:
affiliation: Beijing Hospital
name: Gaofeng Li, director
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01611285: Uphold Versus Robotic Surgery for Pelvic Prolapse Repair: A Decision Analytic Approach
Official title: Uphold Versus Robotic Surgery for Pelvic Prolapse Repair: A Decision Analytic Approach
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pelvic Organ Prolapse
Keywords: UPHOLD
robotic surgery
decision analysis
FDA
decision node
outcome node
Lead sponsor: Atlantic Health System
Sponsor class: OTHER
Collaborators: name: Boston Scientific Corporation
First posted: 2012-06-04
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 20 patients who underwent either robotic surgery or the UPHOLD procedure to treat pelvic organ prolapse from 2009-2010

Brief summary: Within the general objective of investigating optimal medical techniques for pelvic prolapse repair, this study proposes to: (1) test the hypothesis that the UPHOLD procedure is more cost effective than robotic surgery for pelvic prolapse repair (2)using formal decision analysis as the comparative strategy

Detailed description: The cumulative incidence of pelvic organ prolapse was approximately 2% in 2001. Given the aging demographics in the U.S., the incidence of prolapse is projected to increase to 30% or more for women aged 60 years and older and become of greater concern to both patients and physicians. The demand for gynecologic services is predicted to increase by more than 45% in the next ten years. Prolapse is related to childbirth, aging, defects in collagen, and smooth muscle structure and strength. Etiology includes intra-abdominal pressure from obesity, with obesity becoming an ever increasing factor in the US.

Treatment Choice of Patients:

Patients choose between pessary, surgery, and expectant management based on: age, prior prolapse surgery, preoperative pelvic pain scores, and pelvic organ prolapse severity. These are difficult decisions for patients.

When it comes to choosing between destinctive interventions with subtle advantages and disadvantages, patients typically want to hear their physician's views of the scientific merits of each procedure. Informed consent becomes extremely difficult when issues of cost-effectiveness are at hand. Thus, the proposed project.

Eligibility criteria: Inclusion Criteria:

* Female
* Underwent either UPHOLD procedure or Robotic Surgery for Pelvic Organ prolapse

Exclusion Criteria:

* Other vaginal procedure to correct prolapse

Primary outcomes:
measure: Surgical cure versus failure of prolapse repair
timeFrame: within 12 months of patients surgery
Secondary outcomes:
measure: Financial costs of outcomes
timeFrame: within 12 months of patients surgery
Other outcomes:
Locations:
city: Morristown
country: United States
facility: Atlantic Health System Department of Urogynecology
state: New Jersey
Study officials:
affiliation: Atlantic Health System
name: Patrick Culligan, MD FACOG FACS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01387685: Treatment of Pelvic Organ Prolapse by PIVS Versus Surgeon Cut Mesh
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Pelvic Floor Prolapse
Lead sponsor: Western Galilee Hospital-Nahariya
Sponsor class: OTHER_GOV
First posted: 2011-07-04
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women who underwent surgery for pelvic floor prolapse who underwent surgery by eithe surgeon-cut-mesh or by PIVS

Brief summary: Women with pelvic floor prolapse who underwent surgery with mesh will be enrolled. The investigators will compare data from the chart, telephone interviews and physical examinations between those who underwent mesh placement to those who underwent placement of PIVS.


Eligibility criteria: Inclusion Criteria:

* Women who underwent surgery for pelvic floor prolapse

Exclusion Criteria:

* Women who did not have surgery for pelvic floor prolapse.

Primary outcomes:
measure: Satisfaction with study outcome
timeFrame: six to twelve months after surgery
Secondary outcomes:
measure: Side effects of the surgery: pain, vaginal erosion by tape, bleeding
timeFrame: Within six to twelve months after study
Other outcomes:
Locations:
city: Nahariya
country: Israel
facility: Department of Obstetrics and Gynecology, Western Galilee Hospital
city: Tel Aviv
country: Israel
facility: Dr Neuman clinic
Study officials:
References:
Clinical trial NCT05873985: The Acute Effect of Dynamic Taping on Upper Body Posture.
Official title: The Acute Effect Of Dynamic Taping Applied To The Neck And Back Region On Upper Body Posture In Asymptomatic Male Individuals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dynamic Tape
Postural; Defect
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2023-05-24
Enrollment: 51
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: double-blind randomized controlled trial
Primary purpose: PREVENTION

Brief summary: The aim of this study was to evaluate the acute effect of Dynamic tape on cervical and thoracic region posture in asymptomatic male individuals.

Detailed description: Fifty-one asymptomatic individuals between the ages of 18 and 32 years were included in the study. The participants in this study were randomised into two groups, named "Dynamic Taping" (mean age± sd: 23.28±3.41 yrs, n=25) and "Sham Taping" (mean age± sd: 25.15±4.13 yrs, n=26). In the Dynamic taping group, tapes were applied with optimal stretching, while in the Sham taping group, tapes were applied without any stretch. All measurements were done before taping and 30 minutes after taping. Craniovertebral, cranio-horizontal and sagittal shoulder angles were calculated with photographic posture analysis, while thoracic kyphosis was evaluated with a digital inclinometer (JTech IQ Pro™, ABD).

Eligibility criteria: Inclusion Criteria:

* between the ages of 18-40 years,
* male gender,
* not having any injuries to the neck and back region in the last 3 months

Exclusion Criteria:

* Individuals who were allergic to taping,
* had neurological or rheumatological disorders
* felt discomfort after starting the study

Primary outcomes:
measure: Photographic Posture Assessment
timeFrame: 5 minutes before tape
measure: Photographic Posture Assessment
timeFrame: 15 minutes after tape
measure: Cranio-horizontal angle (Before)
timeFrame: 5 minutes before tape
measure: Cranio-horizontal angle (after)
timeFrame: 15 minutes after tape
measure: Craniovertebral angle (before)
timeFrame: 5 minutes before tape
measure: Craniovertebral angle (after)
timeFrame: 15 minutes after tape
measure: Sagittal shoulder posture angle ( Before)
timeFrame: 5 minutes before tape
measure: Sagittal shoulder posture angle (after)
timeFrame: 15 minutes after tape
Secondary outcomes:
measure: Thoracic kyphosis angle (Before)
timeFrame: 5 minutes before tape
measure: Thoracic kyphosis angle (after)
timeFrame: 15 minutes after tape
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gazi University
Study officials:
References:
Clinical trial NCT02174185: Compare the Quality of Life Between Patients With Conduit Diversions or Orthotopic Neobladders
Official title: A Prospective and Comparative Study of Health-related Quality of Life (HRQoL) in Patients With Conduit Diversion or Orthotopic Neobladder
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bladder Cancer
Keywords: bladder cancer
conduit diversion
orthotopic neobladder
health-related quality of life
validated questionnaire
Lead sponsor: Huazhong University of Science and Technology
Sponsor class: OTHER
First posted: 2014-06-25
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All eligible patients in Wuhan Union Hospital, Huazhong University of Science and Technology.

Brief summary: The aim of this study is to compare the health-related quality of life (HRQoL) between patients underwent conduit diversion and orthotopic neobladder after radical cystectomy. The investigators plan to use validated HRQoL questionnaires to learn about how the different urinary diversion operations affect the HRQoL of people living with bladder cancer. The findings from this study may help doctors and patients choosing the proper operation type.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of muscle invasive bladder cancer
* Must be scheduled for radical cystectomy and subsequent conduit diversion or orthotopic neobladder
* Must be able to provide informed consent
* Must be 18 years of age or older
* May have had received intravesical neoadjuvant, adjuvant chemotherapy or immunotherapy

Exclusion Criteria:

* Follow-up data not obtained at Wuhan Union Hospital

Primary outcomes:
measure: Change from baseline in HRQoL of bladder cancer patients with different types of urinary diversions
timeFrame: Preoperative baseline and 3, 6, 12, 18 months postoperatively
Secondary outcomes:
measure: Score differences between the two groups of patients in the relevant domains from three various validated tools of HRQoL
timeFrame: Preoperative baseline and 3, 6, 12, 18 months postoperatively
measure: Score changes of each patient group during the follow-up
timeFrame: Preoperative baseline and 3, 6, 12, 18 months postoperatively
measure: Objective examination outcomes
timeFrame: Preoperative baseline and 3, 6, 12, 18 months postoperatively
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Department of Urology, Wuhan Union Hospital, Huazhong University of Science and Technology
state: Hubei
Study officials:
affiliation: Department of Urology, Wuhan Union Hospital, Huazhong University of Science and Technology
name: Xiaoping Zhang, MD, PhD
role: STUDY_DIRECTOR
affiliation: Department of Urology, Wuhan Union Hospital, Huazhong University of Science and Technology
name: Hangchuan Shi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05253885: Smartphone Addiction in Relation to Trunk Position Sense, Fatigue and Insomnia in Adolescences
Official title: Smartphone Addiction in Relation to Trunk Position Sense, Fatigue and Insomnia in Adolescences
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Adolescent Behavior
Smartphone Addiction
Lead sponsor: October 6 University
Sponsor class: OTHER
First posted: 2022-02-24
Enrollment: 200
Sex: FEMALE
Minimum age (years): 17
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: - Adolescents with age between 17 and 18 years old with Smartphone addiction scale (short version) higher than 33

Brief summary: The aim of the study is to evaluate the relationship between smartphone addiction and trunk position sense, insomnia and fatigue in adolescents. Sample size will be determined after a pilot study conducted on a small sample of adolescents. Digital goniometer will be used to evaluate trunk position sense, insomnia severity index will be used to evaluate insomnia severity and fatigue will be measured by fatigue severity scale.


Eligibility criteria: Inclusion Criteria:

* Adolescents with age between 17 and 18 years old.
* BMI between 16.4 and 24.8 kg/m2
* Smartphone addiction scale (short version) higher than 33
* Smartphone users of 4-5 inches screen size smartphones, weighing 140-160 grams and dimensions less than 159\*79\*9 mm.

Exclusion Criteria:

* Visual or hearing defects.
* Congenital abnormalities.
* Neurological abnormalities
* Musculoskeletal abnormalities

Primary outcomes:
measure: Trunk position sense
timeFrame: Single measurement (instant measure)
measure: Insomnia severity index
timeFrame: Single measurement (instant measure)
measure: Fatigue severity scale
timeFrame: Single measurement (instant measure)
Secondary outcomes:
Other outcomes:
Locations:
city: Al Ḩayy Ath Thāmin
country: Egypt
facility: October 6 University hospital
state: Giza
Study officials:
affiliation: Cairo University
name: Elham E Salem, Professor of Physical Therapy
role: STUDY_CHAIR
affiliation: Cairo University
name: Walaa A Abdelnabie, Professor of Physical Therapy
role: STUDY_DIRECTOR
References: