louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01027975: Comparison of Laparoscopic Nissen Versus Thal Fundoplication in Children
Official title: Long-term Outcome of Laparoscopic Nissen Fundoplication Compared With Laparoscopic Thal Fundoplication in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastroesophageal Reflux Disease
Keywords: laparoscopy
fundoplication
Nissen
Thal
children
operative treatment of gastro-oesophageal reflux disease in children
Lead sponsor: Oxford University Hospitals NHS Trust
Sponsor class: OTHER
First posted: 2009-12-09
Sex: ALL
Minimum age (years): 1
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: Laparoscopic fundoplication is increasingly performed in paediatric surgery. Many types of fundoplication are performed, each has advantages and disadvantages. The Nissen operation is the most frequently performed procedure in the U.K., however it can be associated with post-operative dysphagia. The relative benefits between Nissen and other fundoplication techniques in children are still uncertain.

The aim of our study was to compare the long-term outcomes following laparoscopic Nissen fundoplication with laparoscopic Thal fundoplication in children.


Eligibility criteria: Inclusion Criteria:

* Gastro-oesophageal reflux unresponsive to medical treatment, or those who had serious complications (e.g. apnoea, aspiration pneumonia, oesophagitis)

Exclusion Criteria:

* Patients who had previous anti-reflux surgery, previous open abdominal surgery, if parents declined to participate into study

Primary outcomes:
measure: Recurrence of symptoms sufficiently severe to justify the need for additional revisional surgery (i.e. failure of the original surgery)
measure: Early death following surgery directly related to the fundoplication technique
Secondary outcomes:
measure: The resumption of symptoms bad enough to necessitate the re-introduction of anti-reflux medication (but not sufficiently bad to require revisional surgery) i.e. "intention to treat"
measure: Post-operative complications (e.g. post-operative dysphagia)
Other outcomes:
Locations:
city: Oxford (Headington)
country: United Kingdom
facility: Department of Paediatric Surgery, John Radcliffe Hospital NHS Trust
state: Oxford
Study officials:
affiliation: John Radcliffe Hospital, Department of Paediatric Surgery, Oxford,United Kingdom
name: Hugh W Grant, MD
role: STUDY_DIRECTOR
affiliation: John Radcliffe Hospital, Department of Paediatric Surgery, Oxford, United Kingdom
name: Rainer Kubiak, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kubiak R, Andrews J, Grant HW. Long-term outcome of laparoscopic nissen fundoplication compared with laparoscopic thal fundoplication in children: a prospective, randomized study. Ann Surg. 2011 Jan;253(1):44-9. doi: 10.1097/SLA.0b013e3181fc98a0.
Clinical trial NCT02756975: Prostate Core Needle Biopsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Biopsy
Prostate
Complication
Lead sponsor: Modarres Hospital
Sponsor class: OTHER
First posted: 2016-04-29
Enrollment: 240
Sex: MALE
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Prostate tissue biopsy is performed with either transrectal or transperineal approach. These two methods are usually based on tissue sampling with an ultrasound-guided core needle biopsy. Transperineal prostate biopsy can be done either with a conventional noncoaxial technique or with a coaxial technique. In conventional transperineal technique, biopsy needle is inserted repeatedly for each tissue sampling. Alternatively, a coaxial needle can be placed over the perineum; then, the direction of the biopsy can be changed by tilting the coaxial needle. In this prospective study, the investigators sought to compare the procedural time and the complication rate of coaxial technique with those of noncoaxial technique in transperineal prostate biopsy.


Eligibility criteria: Inclusion Criteria:

* an elevated prostate-specific antigen (PSA) level
* suspicious digital rectal examination

Exclusion Criteria:

* a history of prostate cancer
* clinical findings of acute or chronic prostate inflammation
* a history of urogenital procedures

Primary outcomes:
measure: complication ratio
timeFrame: within 48 hours after the procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Rasht
country: Iran, Islamic Republic of
facility: Department of Radiology, Poursina Hospital, Guilan University of Medical Sciences
state: Guilan
Study officials:
References:
citation: Novella G, Ficarra V, Galfano A, Ballario R, Novara G, Cavalleri S, Artibani W. Pain assessment after original transperineal prostate biopsy using a coaxial needle. Urology. 2003 Oct;62(4):689-92. doi: 10.1016/s0090-4295(03)00483-7.
citation: Chang DT, Challacombe B, Lawrentschuk N. Transperineal biopsy of the prostate--is this the future? Nat Rev Urol. 2013 Dec;10(12):690-702. doi: 10.1038/nrurol.2013.195. Epub 2013 Sep 24.
Clinical trial NCT00930475: Everolimus (RAD001) and Carboplatin in Pretreated Metastatic Breast Cancer
Official title: Everolimus (RAD001) in Combination With Intravenous Carboplatin in Taxane- and Anthracycline-pretreated Patients With Progressive Metastatic Breast Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Breast Cancer
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: KKS Netzwerk
name: Novartis Pharmaceuticals
First posted: 2009-06-30
Enrollment: 54
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is an open-label, mono-center phase I/II study designed to determine the maximum tolerated dose (MTD) and dose-limiting toxicities (DLT) of RAD001 in combination with carboplatin in taxane- and anthracycline-pretreated patients with progressive metastatic breast cancer. Additionally, the study is designed to characterize the safety, the tolerability and efficacy of this study.

Detailed description: During the phase I part the study will include at least 3 patients at each dose-level until MTD is reached. Each cohort will consist of newly enrolled patients. Intra-patient dose escalation is not permitted. Once MTD is reached a total of 6 patients will be treated at MTD (phase I). For the phase II the minimax two-stage design will be applied. After testing the drug on 16 patients in the first stage of phase II, the trial will be terminated if 1 or fewer respond (SD, PR, CR). If the trial goes on to the second stage, a total of 34 patients will be studied during the phase II part.

Eligibility criteria: Inclusion Criteria:

* adult female patients
* at least two prior chemotherapies due to metastatic or inoperable breast cancer
* Karnofsky performance status of at least 60%
* pretreatment with at least one taxane and one anthracycline

Exclusion Criteria:

* previous treatment with mTOR-inhibitors, carboplatin, cisplatin or oxaliplatin
* inadequate organ function including bone marrow function
* bleeding tumours
* known uncontrolled metastases in CNS or carcinomatous meningosis
* patients who have been treated during the last five days with inhibitors or inducers of CYP3A
* serious pulmonary, neurological, endocrinological or other disorders interfering with this study medication, especially patients with known lung fibrosis, emphysema or severe COPD

Primary outcomes:
measure: Phase I: dose limiting toxicity
timeFrame: after three weeks
measure: Phase II: response rate
timeFrame: every six weeks
Secondary outcomes:
measure: Phase I: adverse events
timeFrame: after three weeks
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité, university medicine, Berlin, CCM
Study officials:
References:
Clinical trial NCT04719975: The Electrophysiological Signature of the Mental Fatigue-induced Impairment in Endurance Performance
Official title: The Electrophysiological Signature of the Mental Fatigue-induced Impairment in Endurance Performance
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mental Fatigue
Electroencephalography
Lead sponsor: Vrije Universiteit Brussel
Sponsor class: OTHER
First posted: 2021-01-22
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized, blinded, counter-balanced, cross-over design
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this project is to provide further insights into the neurophysiology behind the MF-induced impairment in endurance performance. The aim is to perform a randomized controlled trial in which we partly replicate studies of Marcora et al. (2009) and Bigliassi et al. (2017), while extensively monitoring brain activity during the entire protocol (i.e. both cognitive and physical tasks) by using EEG.


Eligibility criteria: Inclusion Criteria:

* Healthy (No neurological or cardiovascular disorders)
* Male or female
* No medication
* Non-smoker
* Between 18 and 35 years old
* Recreational athlete population (performance level 2 or 3 for men according to De Pauw et al. (2013) and performance level 2 or 3 for woman according to Decroix et al. (2016)

Exclusion Criteria:

* Injuries over the last 6 months
* Suffering from any cardiovascular condition
* Use of medication
* Suffering from other health conditions at the time of testing
* Use of caffeine or alcohol 24 hours prior to each trial
* Heavy efforts 24 hours prior to each trial

Primary outcomes:
measure: Electroencephalogram data
timeFrame: 1 hours 30 minutes - 2 hours
measure: Reaction Time Flanker Task
timeFrame: Total of 10 minutes
measure: Accuracy Flanker Task
timeFrame: Total of 10 minutes
measure: Reaction Time Stroop Task
timeFrame: 60 minutes
measure: Accuracy performance Stroop Task
timeFrame: 60 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Brussel
country: Belgium
facility: Human Physiology and Sports Physiotherapy Research Group
state: Elsene
Study officials:
References:
Clinical trial NCT01577875: Comparison of Narrow Band Imaging With or Without Magnifying Colonoscopy
Official title: A Prospective Clinical Study to Evaluate Narrow Band Imaging and Magnifying Colonoscopy for the Histologic Prediction of Colorectal Polyps
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intestinal Polyps
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2012-04-16
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The aim of this study is to evaluate the usefulness of magnifying colonoscopy with narrow band imaging.

Detailed description: The accuracy of histologic prediction for the colorectal polyps with the use of narrow band imaging is evaluated between the test group with magnifying colonoscopy and the control group without magnifying colonoscopy.

Eligibility criteria: Inclusion Criteria:

* Subjects with colorectal polyps which are in need of EMR

Exclusion Criteria:

* pregnancy, IBD, colorectal cancer, etc.

Primary outcomes:
measure: Accuracy of colorectal polyp histologic prediction with NBI colonoscopy plus magnification
timeFrame: After 1 week
Secondary outcomes:
measure: Sensitivity of the endoscopic histologic prediction with NBI plus magnification
timeFrame: 1 Week
measure: Specificity of the endoscopic histologic prediction with NBI plus magnification
timeFrame: 1 Week
measure: Positive predictive value of the endoscopic histologic prediction with NBI plus magnification
timeFrame: 1 Week
measure: Negative predictive value of the endoscopic histologic prediction with NBI plus magnification
timeFrame: 1 Week
Other outcomes:
Locations:
city: Jongno-gu
country: Korea, Republic of
facility: SNUH
state: Seoul
Study officials:
affiliation: SNUH Internal Medicine
name: Kyoung Sup Hong, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01115075: Oscillations of Dietary Fat/Carbohydrate Intake Over Interval of 3 to 4 Days
Official title: Oscillations in Dietary Fat Intake and Leptin Changes Among People Who Record Dietary Intake Accurately: the Dietitian Study II
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Leptin
Changes in leptin may precede the
phasing of oscillations of dietary fat intake
Lead sponsor: Pennington Biomedical Research Center
Sponsor class: OTHER
First posted: 2010-05-04
Enrollment: 16
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to understand the mechanisms for oscillations of dietary fat/carbohydrate intake and how fat intake affect insulin resistance and liver fat over interval of 3 to 4 days.

Detailed description: You will be expected to keep diet records for 17 consecutive days. You will start with a fasting screening visit (only water allowed). A physical exam and Medical history it taken at screening visit. Your body composition will be gathered by CT and Dexa Scan. Blood and urine will be collected for a chemical profile and other determinations. Questionnaires will be administered along with an accelerometer to be worn for the remainder of the study. The final day you will return the dietary records, accelerometer, and a few procedures will be performed as weight.

Eligibility criteria: Inclusion Criteria:

* You are a dietitian or a senior level or graduate level dietetics student
* You are between the ages of 21-55 years inclusive and a nonsmoker
* you are not a restrictive diet or strenuous exercise regimen
* You typically eat several meals per day

Exclusion Criteria:

* You have an eating disorder or history
* You abuse alcohol or other substances, and consume no more than 3 alcoholic drinks per day
* You have no current regular use of some over-the-counter medication or prescription medication, excluding headache medicines, blood pressure medications, etc.
* You have gained/lost more than 10 pounds of body weight in the last year
* You have recently had or anticipating significant life changes during the course of your participation in the study.
* You have an eating disorder or history
* You have a major psychiatric illness or history
* You have no serious current clinical disease or surgical condition that may interfere with the study.

Primary outcomes:
measure: Mechanisms for oscillations of dietary fat/carbohydrate intake
timeFrame: 17 consecutive days (11 visits on site)
Secondary outcomes:
measure: Energy Intake
timeFrame: 17 days
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
Study officials:
References:
Clinical trial NCT04344275: The Immediate Effects of Kinesio-Taping on Scapular Muscle Endurance and Strength in Asymptomatic Subjects
Official title: The Immediate Effects of Kinesio-Taping on Scapular Muscle Endurance and Strength in Asymptomatic Subjects: A Single-Blind, Randomized, Placebo-Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asymptomatic Subjects
Keywords: Kinesio-taping
Scapula
Endurance
Muscle strength
Fatigue
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2020-04-14
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study was to investigate the immediate effects of Kinesio-taping (KT) on scapular muscle endurance and strength and compared to placebo Kinesio-taping in asymptomatic subjects.

Detailed description: Thirty-nine asymptomatic subjects (20 females and 19 males, mean age 20.46±1.09 years, mean BMI 21.99±3.02 kg/m2) were included in this study. Subjects were randomly allocated to KT (with the muscle facilitation technique) and placebo-KT (without any technique and tension). Scapular isometric muscle endurance was measured with a scapular muscle endurance test. The strength of the upper, middle, and lower trapezius, and serratus anterior was assessed using a hand-held digital dynamometer. Data were analyzed with 2x2 \[groups (KT and Placebo-KT) x time (pre- and post-intervention)\] mixed-model ANOVA.

Eligibility criteria: Inclusion Criteria:

* An age range of 18 to 25 years,
* The ability to participate voluntarily.

Exclusion Criteria:

* Shoulder injuries in the last year, previous shoulder surgery, shoulder dislocation, and having performed upper-body exercises within the 24 hours before each evaluation session. - Diagnosed with cardiovascular or neurological disease

Primary outcomes:
measure: Scapular endurance test
timeFrame: 1 day
measure: Muscle strength test
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gazi University
state: Yenimahalle
Study officials:
affiliation: Gazi University
name: Zeynep HAZAR KANIK, PhD, PT
role: STUDY_CHAIR
References:
Clinical trial NCT05176275: PET / CT Imaging and Safety in Patients With Lymphoma Treated With CD19 Car-t Cells
Official title: PET / CT Imaging and Safety of the 68Ga-NOTA-RP25 Molecular Probe in Patients With Lymphoma Who Have Received Prior Therapy Containing CD19 CAR-T Cells
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lymphoma
Lead sponsor: The First Affiliated Hospital of Soochow University
Sponsor class: OTHER
First posted: 2022-01-04
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The proliferation and distribution of CD19 CAR-T cells in lymphoma patients are investigated 68Ga-NOTA-RP25 by PET / CT imaging.

Detailed description: The purpose of this study is to monitor the proliferation and distribution of CD19 CAR-T cells in lymphoma patients by using a novel specific PET tracer 68Ga-NOTA-RP25 for monitoring the proliferation of CAR-T cells.

Eligibility criteria: Inclusion Criteria:

* 1. The subjects voluntarily signed the informed consent form and were able to complete the test according to the protocol requirements; 2. Over 18 years old, male or female; 3. Diagnosed as lymphoma and intended to receive CD19 car-t treatment; 4. ECOG score is 0-1; The estimated survival time shall not be less than 3 months;

Exclusion Criteria:

* 1. Participate in other clinical trials other than CAR-T treatment at the same time or within 28 days. If participating in a non intervention clinical trial, it can be included in this study; 2. Patients with a history of allergy; 3. Patients who cannot tolerant PET / CT imaging； 4. Patients who are using anticoagulant drugs or need to use anticoagulant drugs during the study;

Primary outcomes:
measure: SUV value of radioactive material uptake in the region of interest
timeFrame: 1 month
Secondary outcomes:
measure: Safety evaluation index
timeFrame: 1 month
Other outcomes:
Locations:
Study officials:
affiliation: The First Affiliated Hospital of Soochow University
name: Liyan Miao
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00519675: Alitretinoin in the Treatment of Chronic Hand Eczema
Official title: Open Label Treatment of Patients With Chronic Hand Dermatitis Who Have Participated in a Previous Clinical Trial Involving Oral Alitretinoin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Eczema
Keywords: Chronic hand eczema
Chronic hand dermatitis
Patients with chronic hand eczema, who are refractory to topical corticosteroids
Lead sponsor: Basilea Pharmaceutica
Sponsor class: INDUSTRY
First posted: 2007-08-23
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: 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 investigate the safety and efficacy of alitretinoin in chronic hand eczema that is refractory to topical corticosteroids.

Detailed description: Chronic hand eczema is a frequent and distressing disease. The course of the disease is of chronic-relapsing nature. In a phase III study alitretinoin was clinically effective for patients with severe chronic hand eczema refractory to topical treatment. This study investigates the safety and efficacy of alitretinoin who previously have participated in a clinical trial involving alitretinoin.

Eligibility criteria: Inclusion Criteria:

* Previous participation in therapeutic trials involving chronic hand eczema
* Relapse of chronic hand eczema, defined as 75% of the baseline initial total lesion symptom score

Exclusion Criteria:

* Patients whose disease is adequately controlled by standard non-medicated skin care and topical corticosteroid therapy

Primary outcomes:
measure: Safety assessments
Secondary outcomes:
measure: Efficacy (Physicians Global Assessment)
Other outcomes:
Locations:
city: Paris
country: France
city: Saint Etienne
country: France
city: Berlin
country: Germany
city: Dresden
country: Germany
Study officials:
affiliation: Basilea Pharmaceutica
name: Jürgen Maares, MD
role: STUDY_DIRECTOR
References: