louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05082597: Clinical Outcome of Extracorporeal Shock Wave Therapy in Patient With Axillary Web Syndrome
Official title: Clinical Outcome of Extracorporeal Shock Wave Therapy in Patient With Axillary Web Syndrome-A Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Axillary Web Syndrome
Breast Cancer
Lymphedema
Extracorporeal Shock Wave Therapy
Lead sponsor: Taichung Veterans General Hospital
Sponsor class: OTHER
First posted: 2021-10-19
Enrollment: 30
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Axillary web syndrome(AWS) is common complication of breast cancer surgery. Overall, AWS affects more than a half of the patient receiving axillary lymph node dissection. The symptoms of AWS include pain, limited function and range of motion. Geater risk of secondary lymphedema was found if the patient developed AWS during the first postoperative year.

ESWT was used for treating myofascial pain for decades. Low energy ESWT combined with complex decongestive therapy had a benefit on shoulder joint ROM and skin thickness improvement in patients with BCRL in recently studies. Investigators wonder if ESWT can also be applied to patients with axillary web syndrome for increasing ROM and relieving pain.

The aim of this study was to evaluate the therapeutic effects of low energy ESWT in patients with axillary web syndrome.


Eligibility criteria: Inclusion Criteria:

1. Axillary web syndrome patient
2. Unilateral breast cancer and received related operation(mastectomy/ALND/SLND)
3. Completion of beast related chemotherapy or radiotherapy
4. Age with 20-65 years old

Exclusion Criteria:

1. Ongoing metastasis or recurrence of the breast cancer
2. Other cancer history
3. Lymphatic transplantation or reconstruction
4. Wound, infection or trauma over affected arm
5. Coagulopathy or poor circulation
6. Pregnancy
7. Oral anticoagulant using

Primary outcomes:
measure: Shoulder range of motion
timeFrame: 2 months
measure: Pain score
timeFrame: 2 months
Secondary outcomes:
measure: Muscle strength
timeFrame: 2 months
measure: Upper limb functional score
timeFrame: 2 months
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
state: Republic Of China(R.O.C)
Study officials:
References:
Clinical trial NCT02654197: Potential Adverse Developmental and Nutritional Consequences of Helicobacter Pylori Infection in Israeli Children
Official title: Potential Adverse Developmental and Nutritional Consequences of Helicobacter Pylori Infection in Israeli Children
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Helicobacter Pylori Infection
Iron Deficiency Anemia
Child Development
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2016-01-13
Enrollment: 600
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy children aged 6-12 years residing in the catchment areas of primary care clinics in the Hadera sub-district of Israel.

Brief summary: The investigators believe that there is an association between H. pylori infection and nutritional status and between H. pylori infection and cognitive development. The current study will examine this association in Israeli children, aged 6-12 years.


Eligibility criteria: Inclusion Criteria:

* Informed consent by parents/guardians and children

Exclusion Criteria:

* Growth retardation history
* History of prior therapy for H. pylori irradiation
* Hematological disorders
* Developmental delays

Primary outcomes:
measure: Changes in means of differences in height
timeFrame: Two years
measure: Changes in means of differences in weight
timeFrame: Two years
measure: Changes in means of differences in body mass index
timeFrame: Two years
Secondary outcomes:
measure: Changes in Iron Biomarkers
timeFrame: Two years
Other outcomes:
measure: Changes in Intelligence quotient (IQ) scores
timeFrame: Two years
Locations:
city: Hadera
country: Israel
facility: Hillel Yaffe Medical Center
Study officials:
References:
Clinical trial NCT03531697: Study of Loteprednol Etabonate in Adults Undergoing Bilateral Cataract Surgery
Official title: A Randomized, Single-blind, Cross-over Study of Loteprednol Etabonate in Adults Undergoing Bilateral Cataract Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Inflammation Following Ocular Surgery
Keywords: Loteprednol Etabonate
Lead sponsor: Sandoz
Sponsor class: INDUSTRY
First posted: 2018-05-22
Enrollment: 381
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: This study will assess the bioequivalence of Loteprednol Etabonate and the reference listed drug (RLD)


Eligibility criteria: Inclusion Criteria:

* Subjects must have a need for cataract surgery in both eyes and can be dosed in the surgical eyes.
* Non-pregnant, non-lactating females, or women who are post-menopausal (defined as at least 12 months natural, spontaneous amenorrhea), or are naturally or surgically sterile (hysterectomy; bilateral oophorectomy; bilateral tubal ligation with surgery at least 6 weeks prior to study initiation). Females of childbearing potential must have a confirmed absence of pregnancy according to a negative urine pregnancy test and must be using one of the following acceptable birth control methods: Intrauterine device in place for at least 90 days. Barrier method (condom or diaphragm) with spermicide. Stable hormonal contraceptive for at least 90 days prior to study and through study completion. Abstinence (if the subject becomes sexually active during the study she must agree to use the barrier method of birth control \[condom or diaphragm and spermicide\] for the duration of the study).
* Male subjects should use medically reliable contraception methods such as condom or vasectomy.
* Subjects are able to perform the activities required by the study protocol and have provided written informed consent.

Exclusion Criteria:

* Subjects having an IOP less than 5 mmHg or greater than 24 mmHg.
* Known or suspected allergy or hypersensitivity to loteprednol etabonate or any ingredient in the formulation or container, or to other corticosteroids, including an increase in IOP after steroid instillation.
* Subjects unable to tolerate instillation of study product by the investigator or qualified staff.
* Use of other investigational drugs within 30 days prior to dosing and for the duration of the study.
* Subject has used any medication, by any route, containing loteprednol etabonate within 7 days prior to Visit 1.

Primary outcomes:
measure: Pharmacokinetic (PK) assessed by Area Under the Curve (AUC)
timeFrame: upon study completion, up to 1 year
measure: Pharmacokinetic (PK) assessed by rate of drug absorption (Cmax)
timeFrame: upon study completion, up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Multiple Locations
country: Canada
facility: Sandoz Investigative Site
Study officials:
affiliation: Sandoz
name: Sandoz
role: STUDY_DIRECTOR
References:
Clinical trial NCT03913897: The Effect of Virtual Reality and Kaleidoscope on Pain and Anxiety Levels During Venipuncture in Children
Official title: Adiyaman University
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Pain
Keywords: acute pain
blood collection
nursing
children
distraction
Lead sponsor: Adiyaman University Research Hospital
Sponsor class: OTHER
First posted: 2019-04-12
Enrollment: 135
Sex: ALL
Minimum age (years): 4
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: Aim: The study was carried out in randomized control to determine the effect of two different distractions on pain and anxiety during blood collection.

Methods: The population of the study consisted of children between ages of 4-10 years who applied for venipuncture to a training and research hospital in Turkey between July and December 2018. A total of 139 children were included in the study, 46 of them with virtual reality goggles and 43 of them with control group. Information Form, Child Anxiety Scale, Visual Analogue Scale and Wong Baker Pain Scale were used in the collection of data.


Eligibility criteria: Inclusion Criteria:

* being aged between 4 and 10 years for the child,
* applying for health control purpose,
* not having any chronic, mental or neurological illness,
* not using any analgesic in the last 6 hours before the venipuncture procedure.

Exclusion Criteria:

-having a chronic, mental or neurological illness,

Primary outcomes:
measure: Children Fear Scale
timeFrame: 1 minute
Secondary outcomes:
measure: Visual Analogue Scale
timeFrame: 1 minute
measure: Wong Baker Face Pain Scale
timeFrame: 1 minute
Other outcomes:
Locations:
city: Adiyaman
country: Turkey
facility: Adiyaman University
Study officials:
References:
Clinical trial NCT06051097: Metabolic Syndrome and Obstructive Sleep Apnea
Official title: Relationship Between Metabolic Syndrome and Obstructive Sleep Apnea
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sleep Apnea
Metabolic Syndrome
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-09-22
Enrollment: 80
Sex: ALL
Minimum age (years): 22
Maximum age (years): 77
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: This study was conducted in the pulmonology department at kasrelainy hospital.Itincluded 80 patients who came to the sleep lab unit for polysomnography.Each patient was subjected to full history taking including(sex,age,smoking history,presence of diabetes or hypertension),thorough clinical examination with emphasis on waist, neck \& hip circumference and blood pressure measurements,Laboratory investigations including: Lipid profile\&Diabetic profile(HBA1C).In addition to ESS and stop-bang score questionnaire

Brief summary: Background:Metabolic syndrome is a disorder characterized by abdominal obesity,hypertension,increased triglycerides ,decreased HDL cholesterol and increased blood glucose. Accumulating evidence strongly indicates that insulin resistance and an increased amount of abdominal fat are the pathogenic factors for the characteristics of metabolic syndrome. Studies indicate that sleep apnea may be a manifestation of the metabolic syndrome.

Subjects and methods:This study was conducted in the pulmonology department at kasrelainy hospital. It included 80 patients who came to the sleep lab unit for polysomnography. Each patient was subjected to full history taking including(sex,age,smoking history,presence of diabetes or hypertension),thorough clinical examination with emphasis on waist, neck\&hip circumference and blood pressure measurements,Laboratory investigations including :Lipid profile\& Diabetic profile(HBA1C).In addition to ESS and stop bang score questionnaire.


Eligibility criteria: Inclusion Criteria:

* Patients fulfilled the criteria of OSA ( obstructive sleep apnea) in the form of symptoms suggestive of OSA (daytime sleepiness/daytime fatigue/headache/snoring)and with AHI ( apnea-hyponea index) ≥5.

Exclusion Criteria:

1. Cerebro-vascular accident within the preceding 30 days.
2. Patients on sedatives.
3. Patients on anti-psychotics

Primary outcomes:
measure: Predictors of metabolic syndrome among OSA patients
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr alainy school of medicine
Study officials:
References:
Clinical trial NCT01593397: Adiponectin Polymorphisms, Insulin Resistance, and Pharmacokinetics in Obesity
Official title: Adiponectin Polymorphisms, Insulin Resistance, and Pharmacokinetics in Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Obesity
Keywords: Obesity
Insulin Resistance
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Institute of General Medical Sciences (NIGMS)
First posted: 2012-05-08
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The primary objective of this study is to determine the influence of insulin resistance on drug metabolism and response in obese subjects. The investigators hypothesize that expression of adiponectin (a hormone secreted by fat tissue), and specific variants in the adiponectin gene can predict the insulin resistance and drug response among obese subjects.

Detailed description: The following study will hypothesizes that insulin resistance causes changes in drug metabolism, elimination, and effect. We will differentiate the insulin resistant phenotype amongst obese individuals on the basis of both laboratory (fasting insulin, triglycerides, fasting glucose) analysis, and quantitative and qualitative adiponectin expression. We will determine the effect of insulin resistance on the pharmacokinetics and pharmacodynamics of anesthetic induction agents and opioids, using propofol and fentanyl as examples.

Eligibility criteria: Inclusion Criteria:

* Inclusion criteria include patients of adult age
* American Society of Anesthesiologists Class I, II, or III, and undergoing elective surgical procedures requiring general anesthesia
* Body mass index greater than 35

Exclusion Criteria:

* Patients with evidence of hepatic, renal, or cardiovascular dysfunction
* History of difficult tracheal intubation, or adverse reaction to anesthesia shall be excluded from the study
* Patients taking prescribed or over-the-counter anxiolytics, narcotics, or sleeping aids, will also be excluded

Primary outcomes:
measure: plasma concentration of drugs fentanyl and propofol
timeFrame: measured for 12 hours (beginning of anesthesia to 12 hours after)
Secondary outcomes:
measure: Adiponectin plasma protein levels
timeFrame: measured once (immediately before the operation)
measure: Adiponectin gene polymorphisms
timeFrame: measured once per study (immediately before the operation)
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine, Department of Anesthesia
state: California
Study officials:
affiliation: Stanford University
name: Jerry Ingrande, M.D., M.S.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05820997: Paravertebral Block Vs No Block in Open Pancreaticoduodenectomy
Official title: Paravertebral Block Vs No Block in Open Pancreaticoduodenectomy: Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Pancreaticoduodenectomy
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2023-04-20
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to compare intra and postoperative pain control between Paravertebral block vs no block in open pancreaticoduodenectomy. Length of stay, and complications will also be recorded. For this study the investigator plans to randomize to obtain objective data for clinical decisions and improve patient outcomes. Following surgery patients in both groups, data will be collected from the first 48 hours after surgery and at discharge.


Eligibility criteria: Inclusion Criteria:

* Patients willing and have signed consent.
* Nonpregnant adults undergoing open pancreaticoduodenectomy via standard upper midline incision without contraindications to para vertebral block (PVB)

Exclusion Criteria:

* Not able or unwilling to sign consent.
* Currently pregnant or lactating.
* Patients with chronic pain, requiring daily opiate use at time of surgery.
* Patients intolerant of opiates, NSAIDS, acetaminophen or local anesthetics.

Primary outcomes:
measure: Mean post-operative pain score
timeFrame: First 48 hours after surgery
Secondary outcomes:
measure: Hospital Length of Stay
timeFrame: Approximately 2-4 days
measure: Number of subjects with a bowel obstruction
timeFrame: Approximately 2-4 days
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic Florida
state: Florida
Study officials:
affiliation: Mayo Clinic
name: John Stauffer, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04170205: Causes Associated With Small Fiber Neuropathy (SFN).
Official title: Retrospective Study of Causes Associated With Small Fiber Neuropathies.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Small Fiber Neuropathy
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2019-11-20
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with clinical symptomatology in favour of SFN who have been subjected to skin histological examination for SFN

Brief summary: Small fiber neuropathy (SFN) is an injury of cutaneous nerve fibers, mainly by a decrease in their density within the cutaneous tissue. The symptomatology associated with this SFN is broad with symptoms that are essentially sensory, but also autonomic. The etiologies of SFN are numerous (diabetes, drug, infectious, immunological...) and clinically non-specific, justifying a broad etiological assessment. The appearance of staged skin biopsies in the SFN balance sheet has greatly helped to improve diagnosis.

Despite this, a significant part of SFN remains without associated etiology and is considered idiopathic.

As the distribution of the different causes of SFN remains a missing data to date, the completion of this cohort study by one of the SFN reference centres should make it possible to establish the prevalence of SFN causes over a large population.

Only patients with clinical symptoms that may be related to SFN and who have been sampled for SFN, positive or not, will be eligible for recruitment.

The result of the anatomopathological sampling will allow patients to be separated into two groups, with or without SFN.

The main judgement criteria will be the prevalence of etiologies associated with SFN: diabetes, medication, systemic lupus erythematosus, Gougerot-Sjögren syndrome, amylosis, dysthyroidism, alcoholism, vitamin B12 deficiency, HIV infection, hepatitis C, paraneoplastic syndrome, hereditary disease (Fabry disease, Friedreich ataxia,...), idiopathic, others.


Eligibility criteria: Inclusion Criteria:

* Age of majority (\>18 years old)
* Clinically managed patient at Brest University Hospital
* Patient who had a skin biopsy with anatomopathological examination for SFN performed at the University Hospital of Brest

Exclusion Criteria:

* Under age of majority (\<18 years old)
* Patient not followed at Brest University Hospital
* Refusal to participate to the study

Primary outcomes:
measure: Prevalence of etiologies associated with SFN
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Brest
country: France
facility: CHRU de Brest
Study officials:
References:
Clinical trial NCT02014805: Postoperative Conformal Radiotherapy for Stage II-III B Type Thymoma
Official title: A Multi-institutional, Randomized Controlled Trial of Postoperative Conformal Radiotherapy for Stage II-III B Type Thymoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Thymoma
Keywords: postoperative
conformal
radiotherapy
thymoma
Lead sponsor: ChineseAMS
Sponsor class: UNKNOWN
Collaborators: name: Beijing Hospital
name: 309th Hospital of Chinese People's Liberation Army
First posted: 2013-12-18
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
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 determine whether postoperative conformal radiotherapy are effective in the treatment of Masaoka stage II-III B type thymoma.

Detailed description: The role of postoperative radiotherapy in thymoma is controversial. Some retrospective studies were for the radiotherapy, but others were against. However, more inherent biases existed in these trials. Resection, Masaoka stage and pathology were widely accepted as the prognostic factors for thymoma. Furthermore, the frequency of local failure after radical resection was still high in Masaoka stage II-III B type thymoma. With the conformal technique appearing, conformal radiotherapy can escalate the dose without increasing the risk of normal tissue toxicities.

Eligibility criteria: Inclusion Criteria:

* Age 18-75, Zubrod-ECOG-WHO 0-2, the interval of surgery to radiotherapy \< 2months, Masaoka stage II-III and WHO B type thymoma

Exclusion Criteria:

* No second primary tumor, no serious comorbidity, no neoadjuvant anticancer treatment, no adjuvant chemotherapy.

Primary outcomes:
measure: 3 year local control rate
timeFrame: 3 year after the end of all enrollment
Secondary outcomes:
measure: 3 year failure-free and overall survival
timeFrame: 3 year after the end of all enrollment
Other outcomes:
measure: rate of acute and late radiation toxicity
timeFrame: within 3 year after the end of all enrollment
measure: quality of life score
timeFrame: within 3 years after all enrollment
Locations:
city: Beijing
country: China
facility: Cancer hospital, Chineses Academy of Medical Sciences
Study officials:
affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
name: Qinfu Feng, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03526705: The Effect of NB-UVB on Interleukin-36 Levels in Psoriasis
Official title: The Effect of NB-UVB on Interleukin-36 Levels in Psoriasis Lesional Skin
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Psoriasis
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-05-16
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Psoriasis is an immune-mediated skin disease that affects 1-2 % of the population. Several cytokines have been found to be involved in the complex pathogenesis of this disease. Il- 36 is one of the cytokines sharing in psoriasis pathogenesis, as its levels are elevated in psoriatic plaques. Cathepsin G is known to activate Il- 36 and promote inflammation in psoriasis.NB-UVB is one of the important treatment modalities for psoriasis.

The aim of this study is to detect the effect of NB-UVB on the lesional levels of IL-36 in psoriasis.

Detailed description: 25 psoriasis patients will receive 26 sessions of phototherapy (NB-UVB). Patients will receive 3 sessions per week. Tissue levels of IL-36 and Cathepsin G will be assessed in skin lesions before starting treatment and after completing the 26 sessions.

Eligibility criteria: Inclusion Criteria:

* Patients with psoriasis vulgaris of both sexes
* Age between 18 and 60 years old.

Exclusion Criteria:

* Pregnant females
* Patients receiving systemic treatment or topical treatment for psoriasis within the past two months.
* Patients having other dermatological diseases.

Primary outcomes:
measure: changes in Il-36 levels in 25 psoriasis patients after 26 sessions of NB-UVB
timeFrame: 6 months
Secondary outcomes:
measure: changes in cathepsin G levels in 25 psoriasis patients after 26 sessions of NB-UVB psoriasis
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
References: