louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02778997: Prospective Shunt Complication Study
Official title: Prospective Shunt Complication Study (Pro-ShuCS)
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Shunt; Complications, Ventricular (Communicating)
Keywords: Shunt
CSF
Dysfunction
Complication
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2016-05-20
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All adult patients with CSF shunt

Brief summary: Complications in patients with cerebrospinal fluid (CSF) shunts are common. Thus, these patients are frequently admitted for suspicion of a shunt dysfunction (SD). However, the symptoms of a SD are often unspecific and the required diagnostics are time consuming, expensive, invasive and may involve radiation exposure. In a prospective observational study it is planned to find out, how often a suspected shunt dysfunction is found, which kinds of shunt dysfunction are seen and if there is a correlation between the shunt dysfunctions and the age of the shunt. Furthermore, it is intended to find out, if there are symptom-patterns specific for certain shunt dysfunctions.

Detailed description: All patients who are admitted for suspected shunt-dysfunction will be included. Patient data, detailed data about the shunt, patient's symptoms and all findings will be recorded in the CRF. After 4-8 weeks all patients will be followed-up to add missing data and correct initial findings with the benefit of a retrospective view. After 2 years, data will be analyzed.

Eligibility criteria: Inclusion Criteria:

* Age \>= 18
* State after implantation of a CSF shunt

Exclusion Criteria:

* refusion participation in the study

Primary outcomes:
measure: Confirmation of Shunt Dysfunction (yes/no)
timeFrame: 4-8 weeks after first presentation
measure: Kind of Shunt Dysfunction (infection/disruption/kinking/obstruction/others)
timeFrame: 4-8 weeks after first presentation
measure: Alternate Diagnosis (multiple diagnoses possible)
timeFrame: 4-8 weeks after first presentation
measure: Time Span after Shunt Implantation (months)
timeFrame: 4-8 weeks after first presentation
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Dept. of Neurosurgery, Zurich University Hospital
city: Zurich
country: Switzerland
facility: Zurich University Hospital
Study officials:
affiliation: Zurich University Hospital, Dept. of Neurosurgery
name: Luca Regli, MD
role: STUDY_DIRECTOR
affiliation: Zurich University Hospital, Dept. of Neurosurgery
name: Lennart H Stieglitz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05250297: Physical Activity and Symptom Disturbance Regarding Cross-Trimester
Official title: Pregnant Women's Intention and Behavioral Regarding Cross-Trimester Regular Exercise-Based on the Theory of Planned Behavior
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy Related
Lead sponsor: Mackay Medical College
Sponsor class: OTHER
First posted: 2022-02-22
Enrollment: 277
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The participants were recruited from the prenatal outpatient departments of hospitals in Taipei, Taiwan.

Brief summary: This study will explore pregnant women's regular exercise intentions and behavior across trimesters (from first trimester, second trimester to third trimester).

Detailed description: Based on the TPB, this study will explore pregnant women's regular exercise intentions and behavior across trimesters (from first trimester, second trimester to third trimester). Moreover, the study will explore the effect factors, predictors and transition factors regarding pregnant women's regular exercise intention and behavior across trimesters.

Eligibility criteria: Inclusion Criteria:

* Inclusion criteria were women in 8-16 weeks of gestation with a singleton pregnancy who had no obstetric or medical complications

Exclusion Criteria:

* Excluded were those who had American college of Obstetrics and Gynecology (ACOG) absolutely contraindication exercise, such as insulin-dependent diabetes, gestational diabetes, hypertension, and multiple-gestation pregnancies

Primary outcomes:
measure: Change of physical activity across different trimesters of pregnancy
timeFrame: The data were collected before the intervention to childbirth: <16 week gestation, second trimester (24-28 weeks), third trimester (>36 weeks)
measure: Change of symptom distress across different trimesters of pregnancy
timeFrame: The data were collected before the intervention to childbirth: <16 week gestation, second trimester (24-28 weeks), third trimester (>36 weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: Department of Nursing
Study officials:
affiliation: Mackay Medical College
name: Ching-Fang Lee, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01802697: Safety Study on IdeS in Healthy Volounteers
Official title: A Phase i Single Center Study to Evalute the Safety, Tolerability and Pharmacokinetics of Intravenous IdeS After Administration of Single Ascending Doses in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: volunteers
Lead sponsor: Hansa Biopharma AB
Sponsor class: INDUSTRY
First posted: 2013-03-01
Enrollment: 29
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a first in man study to assess safety and tolerability of the IgG cleaving enzyme Immunoglobuli G degrading enzyme of streptococcus pyogenes (IdeS).

Detailed description: A phase I study (11-HMedIdeS-01, EudraCT no. 2012-000 969-21) first in man single ascending dose study in 29 healthy subjects to investigate if IdeS is safe and well tolerated in doses up to 0.24 mg/kg body weight (BW).

Eligibility criteria: Inclusion Criteria:

* Ability to understand and sign informed consent
* BMI 19-30

Exclusion Criteria:

* Clinically significant disease
* Positive HIV, hepatistis B or C

  * Drug abuse
* Smoking
* Use of medication except paracetamol

Primary outcomes:
measure: Safety as measured by adverse events
timeFrame: 64 days
Secondary outcomes:
measure: Peak plasma concentration of IdeS
timeFrame: 7 days
Other outcomes:
measure: Total IgG concentration
timeFrame: 64 days
Locations:
city: Lund
country: Sweden
facility: Clinical Trial Unit, FoU centrum Skåne, Skåne University hospital
Study officials:
affiliation: Clinical Trial Unit, SUS, Lund, Sweden
name: Ulf Malmqvist, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Winstedt L, Jarnum S, Nordahl EA, Olsson A, Runstrom A, Bockermann R, Karlsson C, Malmstrom J, Palmgren GS, Malmqvist U, Bjorck L, Kjellman C. Complete Removal of Extracellular IgG Antibodies in a Randomized Dose-Escalation Phase I Study with the Bacterial Enzyme IdeS--A Novel Therapeutic Opportunity. PLoS One. 2015 Jul 15;10(7):e0132011. doi: 10.1371/journal.pone.0132011. eCollection 2015.
Clinical trial NCT05580497: Soft Robotics for Infants With Cerebral Palsy
Official title: Soft Robotics for Improved Standing and Walking in Infants With Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cerebral Palsy
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2022-10-14
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Children with spastic cerebral palsy suffer from significant weakness that contributes to abnormal posture and movement. It is thought that this arises due lack of frequency sufficient tension to encourage normal muscular growth underlying the need for early intervention to encourage walking. The failure of muscle growth to keep pace with bone growth is most evident in the bi-articular muscles and contributes to joint contractures and gait abnormalities such as toe-walking and flexed-knee gait.

Recently, our research team has developed a novel, lightweight (0.2kg at knee joint) and portable (energetically autonomous) Soft Wearable Robotic Knee System that can provide active powered knee assistance and synchronized proprioceptive feedback for the gait training of stroke patients' standing and walking.


Eligibility criteria: Inclusion Criteria:

* capable of understanding the proposed exercises;
* aged 2 to 15 years;
* maximum weight 75 kg;
* children with no deformations that could prevent the use of the exoskeleton;
* Gross Motor Function Classification System (GMFCS) levels I to III;
* able to signal pain or discomfort.

Exclusion Criteria:

* unhealed skin lesions in the lower limbs;
* aggressive or self-harming behaviors;
* severe cognitive impairment.

Primary outcomes:
measure: Gross Motor Function Classification System
timeFrame: Within one month after the last training session
Secondary outcomes:
measure: 6-Minute-Walk Test
timeFrame: Within one month after the last training session
measure: 10-Meter-Walk Test
timeFrame: Within one month after the last training session
measure: Timed Up and Go test
timeFrame: Within one month after the last training session
measure: Five Times Sit to Stand Test
timeFrame: Within one month after the last training session
measure: Berg Balance Scale
timeFrame: Within one month after the last training session
Other outcomes:
Locations:
city: Shatin
country: Hong Kong
facility: Department of Biomedical Engineering, The Chinese University of Hong Kong
Study officials:
affiliation: Department of Biomedical Engineering, The Chinese University of Hong Kong
name: Raymond Tong, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00149097: Role of the Autonomic Nervous System in HIV-Lipodystrophy
Official title: Autonomic Nervous System Activity in the Pathogenesis of the Lipodystrophy Syndrome in HIV-Infected Patients.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infections
Lipodystrophy-Syndrome
Lead sponsor: Hannover Medical School
Sponsor class: OTHER
Collaborators: name: Hector-Stiftung
First posted: 2005-09-08
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with confirmed HIV infection and no active opportunistic infection during the last 2 months.

Brief summary: The study aims to characterise the influence of the autonomic nervous system activity on the development of the lipodystrophy syndrome in HIV-infected patients by measuring heart rate variability and various metabolic pathways in HIV patients receiving highly active antiretroviral therapy.


Eligibility criteria: Inclusion Criteria:

* HIV-infection
* Age above 18 years
* No AIDS defining event during last 6 months
* No infection during last 6 weeks
* No concommitant drug interfering with insulin sensitivity and ANS-activity

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Hannover
country: Germany
facility: Hannover Medical School
Study officials:
affiliation: Hannover Medical School
name: Georg MN Behrens, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fliers E, Sauerwein HP, Romijn JA, Reiss P, van der Valk M, Kalsbeek A, Kreier F, Buijs RM. HIV-associated adipose redistribution syndrome as a selective autonomic neuropathy. Lancet. 2003 Nov 22;362(9397):1758-60. doi: 10.1016/s0140-6736(03)14858-1.
Clinical trial NCT01174797: Evaluation of Microvolt T-Wave Alternans(MTWA) Testing for the Detection of Active Ischemia
Official title: Evaluation of Microvolt T-Wave Alternans Testing for the Detection of Active Ischemia in Patients With Known or Suspected Coronary Artery Disease: A Feasibility Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Lead sponsor: Cambridge Heart Inc.
Sponsor class: INDUSTRY
First posted: 2010-08-04
Enrollment: 186
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with known or suspected CAD who are scheduled to undergo routine exercise MPI or stress echocardiography testing for the detection of active ischemia in a cardiology practice or hospital setting.

Brief summary: MTWA-CAD is a feasibility study designed to evaluate Microvolt T-Wave Alternans (MTWA) testing for the purpose of detecting active ischemia in patients with known or suspected coronary artery disease (CAD). MTWA is a subtle, alternating pattern in the T wave portion of the surface electrocardiogram (ECG) that is associated with increased risk of ventricular tachyarrhythmias and sudden cardiac arrest (SCA).

Detailed description: Ischemia, a common trigger for arrhythmias, is a well-documented cause of repolarization alternans. Human studies have shown that active ischemia can be associated with visible as well as microvolt-level T-wave alternans. While MTWA testing is traditionally used to evaluate arrhythmic risk, this known association with ischemia may allow MTWA testing to be used as a diagnostic tool to detect underlying CAD. The MTWA-CAD study will assess the feasibility of this concept by measuring MTWA during routine nuclear stress testing or stress echocardiography with treadmill exercise. This is a feasibility study designed to verify preliminary observations under controlled environments and to generate hypotheses, endpoints, and sample sizes for future investigations.

Eligibility criteria: Inclusion Criteria:

* Age 18 or above, or of legal age to give informed consent specific to state and national law
* Willing and capable of providing informed consent
* Willing and capable of undergoing a SPECT MPI exercise test (or stress echo) at an approved clinical investigational center
* In normal sinus rhythm at the time of the exercise test
* A life expectancy of more than 6 months

Exclusion Criteria:

* In atrial fibrillation at the time of the exercise test
* Left bundle branch block (precludes ST segment measurement)
* Pacemaker-dependent
* Life expectancy of less than 6 months
* Pregnancy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bridgeport
country: United States
facility: Connecticut Clinical Research, LLC
state: Connecticut
city: Tomball
country: United States
facility: Northwest Houston Heart Center
state: Texas
Study officials:
affiliation: Connecticut Clinical Research, LLC
name: Edward J Kosinski, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02656797: Topical Liposomal Amphotericin B Gel Treatment for Cutaneous Leishmaniasis
Official title: Topical Liposomal Amphotericin B Gel Treatment for Cutaneous Leishmaniasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Leishmaniasis
Keywords: Leishmania major
Leishmania tropica
Amphotericin B
Lead sponsor: Soroka University Medical Center
Sponsor class: OTHER
First posted: 2016-01-15
Enrollment: 13
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: Comparison between placebo gel treatment to topical liposomal amphotericin B gel treatment for cutaneous leishmaniasis of Leishmania species major and tropica.

Detailed description: Randomized, double blind, placebo controlled study. The study will include 108 patients with cutenous leishmaniasis of Leishmania species major and tropica, confired by Polymerase Chain Reaction of a sample from a lesion.

Cure rate will be compared between patients treated with Amphotericin-B 0.4% Liposomal Gel and patients treated with placebo gel preparation.

Eligibility criteria: Inclusion Criteria:

* Cutenous leishmaniasis confirmed by PCR (Leishmania species major or tropica)
* 1 to 5 lesions
* Signed informed consent

Exclusion Criteria:

* Facial lesions
* Significant co-morbidity
* Pregnancy or breast-feeding at enrollment
* Previous treatment for leishmaniasis

Primary outcomes:
measure: Complete re-epithelization
timeFrame: Day 28 from enrollement
Secondary outcomes:
measure: Lesion size
timeFrame: Day 28 and day 56 from enrollement
measure: Complete re-epithelization
timeFrame: Day 28 from enrollement
measure: Skin manifestations
timeFrame: Day 28 and day 56 from enrollement
measure: Evidence of lesihmania infection
timeFrame: Day 56 from enrollement
Other outcomes:
Locations:
city: Beer Sheva
country: Israel
facility: Soroka University Medical Center
Study officials:
affiliation: Soroka University Medical Center
name: Amir Horev, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06261697: Relationship Between Smartphone Addiction and Temporomandibular Joint Disorders Among Adults in Egypt.
Official title: A Web-based Survey -Relationship Between Smartphone Addiction and Temporomandibular Joint Disorders Among Adults in Egypt: Cross Sectional Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Temporomandibular Disorders
Smartphone Addiction
Keywords: TMJ disorders
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-02-15
Enrollment: 296
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: community sample

Brief summary: Cross sectional study to investigate the relation between Smartphone addiction and temporomandibular disorders among youth population in Egypt. An online- based questionnaire study. A 296 participants who are Egyptians with age between18 and 35 years old without prior neck and upper extremity related diseases, orofacial trauma or surgeries, history of rheumatoid arthritis or congenital musculoskeletal problems. An online- based questionnaire will be sent through different social media platforms, it will include three screens, the first includes the consent form, the second includes the demographic data (year of birth, current educational status, gender and geographic information ), and the third page includes questionnaires

.


Eligibility criteria: Inclusion Criteria:

* both males and females adults
* Their ages between18 and 35 years old
* ability to use Smartphone

Exclusion Criteria:

* any neck and upper extremity related diseases
* orofacial trauma or surgeries
* history of Rheumatoid arthritis
* congenital musculoskeletal problems.

Primary outcomes:
measure: Fonseca Anamnestic Index (FAI) questionnaire
timeFrame: 2 months
measure: Smartphone Addiction Scale-Short version (SAS-SV) questionnaire
timeFrame: 2 months
measure: Patient Health Questionnaire (PHQ)
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03718897: Identification of Prognostic Gene Mutations in Biliary Tract Cancer Using Whole Genome Sequencing
Official title: Identification of Prognostic Gene Mutations in Biliary Tract Cancer Using Whole Genome Sequencing
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Biliary Tract Cancer
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2018-10-25
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: During the study period, all patients who were diagnosed with biliary tract cancer via endoscopic retrograde cholangiopancreatogram at Seoul National University Hospital will be enrolled. The investigators will perform whole genome sequencing of biopsy specimens from patients with biliary tract cancer and analyze the gene mutations associated with patient survival. And additionally, the presence or absence of blood circulating tumor DNA and associated gene mutation will be analyzed.

Brief summary: The purpose of this study is to investigate genetic mutations affecting prognosis using whole genome sequencing in patients with biliary tract cancer.

Detailed description: Recently, as genome technology such as next-generation sequencing has progressed, precision medicine using genetic analysis in lung cancer, colorectal cancer, and melanoma has been actively studied. The need for such precision medicine is also increasing in biliary tract cancer patients. Although whole genome sequencing is relatively costly, it is known to provide more accurate information than other methods such as exome analysis and RNA sequencing in identifying promoter mutations, regulatory regions, and structural variants. Pancreatic cancer and melanoma have been studied by whole genome sequencing, but there is no previous study using whole genome sequencing method in biliary tract cancer.

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with biliary tract cancer via endoscopic retrograde cholangiopancreatogram

Exclusion Criteria:

* Pregnancy
* Other active tumors within 5 years
* Coagulopathy
* Severe mental illness

Primary outcomes:
measure: Overall survival rate
timeFrame: 48 months
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Ji Kon Ryu, MD, phD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04762797: Management Strategy of Polypoid Lesions of the Gallbladder
Official title: Management Strategy of Polypoid Lesions of the Gallbladder: a Single-center Retrospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Polyp Gallbladder
Keywords: gallbladder polyp; laparoscopic cholecystectomy; polypectomy
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2021-02-21
Enrollment: 672
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: surgical candidates of laparoscopic cholecystectomy or laparoscopic polypectomy.

Brief summary: We retrospectively review a single-center cohort of gallbladder polyps from January 2015 to May 2020. Univariate and multivariable analyses were performed to extract potential risky factors of neoplastic polyps. Also, a comparison was conducted between laparoscopic cholecystectomy (LC) and laparoscopic polypectomy (LP) to explore factors affecting surgeons' decision on LC or LP.


Eligibility criteria: Inclusion Criteria:

Surgical indications for LC included polyp diameter over 10 millimeters, or polyps accompanied by GB stones, or consideration of neoplastic polyps. Surgical indications for GB-preserving surgery included GB with normal emptying function and polyp diameter smaller than 10 millimeters, or consideration of benign non-neoplastic polyps, or asymptomatic polyps.

Exclusion Criteria:

Those do not fit for laparoscopic surgery.

Primary outcomes:
measure: Pathological diagnosis of polyps
timeFrame: Up to two weeks after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
Study officials:
affiliation: Peking Union Medical College Hospital
name: Qiang Qu, Doctor
role: STUDY_DIRECTOR
References: