louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01283074: An Observational Study of Pegasys (Peginterferon Alfa-2a) in Patients With HbeAg-negative Chronic Hepatitis B (Perseas)
Official title: Prognostic Factors of Long-term Response to Treatment With Pegylated Interferon Alfa-2a in Patients With HbeAg-negative Chronic Hepatitis B. (Perseas)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis B, Chronic
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2011-01-25
Enrollment: 107
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: Patients with chronic hepatitis B on treatment with Pegasys

Brief summary: This observational, multi-center, open-label study will evaluate the prognostic factors of long-term-response and the safety of Pegasys (peginterferon alfa-2a) in patients with HbeAg-negative chronic hepatitis B. Data will be collected for 96 weeks.


Eligibility criteria: Inclusion Criteria:

* Adult patients, \>/=18 years of age
* Diagnosis of HBeAg-negative chronic hepatitis B with compensated hepatic disease, virus multiplication, raised alanine amino transferase results and/or fibrosis

Exclusion Criteria:

* Co-infection with hepatitis A, C or D
* Co-infection with human immunodeficiency virus (HIV)
* Severe hepatic dysfunction or decompensated liver disease

Primary outcomes:
measure: Percentage of patients with combined (virological and biochemical) response
timeFrame: 48 weeks after end of treatment
Secondary outcomes:
measure: Normalization of serum alanine aminotransferase
timeFrame: 12 months
measure: Safety (Incidence of adverse events)
timeFrame: 12 months
Other outcomes:
Locations:
city: Alexandroupolis
country: Greece
city: Athens
country: Greece
city: Athens
country: Greece
city: Athens
country: Greece
city: Athens
country: Greece
city: Athens
country: Greece
city: Athens
country: Greece
city: Larissa
country: Greece
city: Patra
country: Greece
city: Piraeus
country: Greece
city: Piraeus
country: Greece
city: Rhodes
country: Greece
city: Thessaloniki
country: Greece
city: Thessaloniki
country: Greece
city: Thessaloniki
country: Greece
city: Thessaloniki
country: Greece
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Goulis I, Karatapanis S, Akriviadis E, Deutsch M, Dalekos GN, Raptopoulou-Gigi M, Mimidis K, Germanidis G, Drakoulis C, Triantos C, Zintzaras E, Bakalos G, Papatheodoridis G. On-treatment prediction of sustained response to peginterferon alfa-2a for HBeAg-negative chronic hepatitis B patients. Liver Int. 2015 May;35(5):1540-8. doi: 10.1111/liv.12725. Epub 2014 Nov 20.
Clinical trial NCT04504474: Network Analysis of Adult MDD and ADHD
Official title: Network Analysis of Co-morbid Symptoms of Adult Major Depressive Disorder and Attention-deficit Hyperactivity Disorder in an Outpatient Population
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: ADHD
Lead sponsor: Health Sciences North Research Institute
Sponsor class: OTHER
First posted: 2020-08-07
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We will gather a recruitment of 500 male and female outpatients from the Psychiatric Outpatient Clinic at Kirkwood Site attached to Health Sciences North.

Brief summary: The study is an investigation to determine co-morbid symptoms between adult major depressive disorder (MDD) and adult attention-deficit hyperactivity disorder (ADHD) using a novel statistical technique called network analysis.


Eligibility criteria: Inclusion Criteria:

* participants have a diagnosis of MDD or ADHD or both
* participants are competent to consent to the study

Primary outcomes:
measure: Co-morbidity
timeFrame: September 8, 2021
measure: Network reliability
timeFrame: September 8, 2021
measure: Central symptoms
timeFrame: September 8, 2021
Secondary outcomes:
Other outcomes:
Locations:
city: Sudbury
country: Canada
facility: Kirkwood Site - Health Sciences North
state: Ontario
Study officials:
References:
Clinical trial NCT01604174: Interactive Virtual Telerehabilitation After Total Knee Arthroplasty
Official title: Effectiveness of an Interactive Virtual Telerehabilitation System in Patients After Total Knee Arthroplasty. A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: knee
osteoarthritis
arthroplasty
rehabilitation
Lead sponsor: Parc de Salut Mar
Sponsor class: OTHER
First posted: 2012-05-23
Enrollment: 140
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: The purpose of this clinical trial is to compare the effectiveness of a new interactive virtual telerehabilitation (IVT) system with the conventional program in the rehabilitation of patients after total knee arthroplasty.

Detailed description: Patients are distributed into two treatment groups: 1) Group I (control): standard clinical protocol of TKA rehabilitation consisting of 1-hour sessions for 10 days; and 2) Group II (IVT): 1-hour IVT sessions for 10 days (5 sessions under a therapist's supervision to verify the absence of medical complications + 5 sessions performed at home). The IVT is an interactive virtual software-hardware platform that facilitates the development of remote rehabilitation therapy for multiple diseases. Patients receive information required to perform exercise and the therapist remotely monitors the patient's performance. For the purpose of this trial, the IVT system was designed for lower limb motor recovery in patients undergoing TKA.

Eligibility criteria: Inclusion Criteria:

* Post-TKA active range of motion: flexion 80º and extension -10º
* ABsence of stiffness
* Ability to walk with the use of a walking aid
* Ability to read and understand Spanish
* Ability to understand and accept the trial procedures and to sign an informed consent form in accordance with national legislation

Exclusion Criteria:

* Sensory, cognitive and/or praxic impairment
* Concomitant medical conditions that may influence the rehabilitation process
* Discharge destination other than home
* Patients with any local or systemic complication (e.g., surgical wound infection, suspicion of deep vein thrombosis...) in the three-month follow-up period

Primary outcomes:
measure: Active knee extension/flexion
timeFrame: Change from baseline to 2 weeks
Secondary outcomes:
measure: Muscle strength
timeFrame: Baseline to 2 weeks
measure: Pain
timeFrame: Baseline to 2 weeks
measure: Functional capacity
timeFrame: Baseline to 2 weeks
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital del Mar (PSMAR)
Study officials:
affiliation: Parc de Salut Mar
name: Jose M Muniesa, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Parc de Salut Mar
name: Ferran Escalada, Md, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00669474: Unicentric Comparing Study of Suction Curettage With Standard BOTOX Injection in the Treatment of Patients With Essential Axillar Hyperhidrosis: Comparing of Efficacy, Duration of Effectiveness, and Adverse Events.
Official title: Unicentric Comparing Study of Suction Curettage With Standard BOTOX Injection in the Treatment of Patients With Essential Axillar Hyperhidrosis: Comparing of Efficacy, Duration of Effectiveness, and Adverse Events.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Essential Axillary Hyperhidrosis
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
Collaborators: name: Allergan
First posted: 2008-04-30
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Part 1: patients with essential hyperhidrosis are treated one time with suction curettage in both axillae.

Part 2: patients with axillary hyperhidrosis receive one treatment with suction curettage in one axilla, and at the same time one treatment with BOTOX injections in the other axilla.


Eligibility criteria: Inclusion Criteria:

* 18 to 75 years
* Persistent bilateral primary axillary hyperhidrosis
* Hidrosis interferes with daily activities of patient
* Gravimetrically minimal 50 mg spontaneous sweat production in each axilla, measured during 5 minutes in room temperature in calm condition
* signed informed consent
* patient can and shall continue the trial until the end, and will follow the instructions correcly
* women in reproductive period had a pregnancy test

Exclusion Criteria:

* Medical condition that can be dangerous by treatment with BOTOX, including myastenia gravis, Lambert-Eaton syndrome, ALS, and each other disease that can interfere with the neuromuscular function
* Secundary hyperhidrosis (for example secundary on hyperthyroid problems, lymfoma, malaria)
* Known allergy against study medication, his components, local anesthesia or iodium
* Use of aminoglycosids, curare-like products, or other products which can interfere with the neuromuscular function during the study
* Use of therapy for hyperhidrosis with Aluminium chlorid during the study
* Infection or skin disease in the area to treat
* Participation in an other therapeutic study on the same time
* Botuline toxine treatment in the last 4 months
* Women who can or who want to become pregnant
* Women in reproductive period who don't use the appropriate contraception
* Patients in a situation of which the researchers decide it can be dangerous, or can interfere with the study

Primary outcomes:
measure: Effectiviness and duration of effect of both treatments
timeFrame: 1 year
Secondary outcomes:
measure: Adverse events of both treatments
timeFrame: 1 year
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital Ghent
Study officials:
affiliation: University Hospital, Ghent
name: Katia Ongenae, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03846674: Depression Symptoms Among Ever Married Females Attending Primary Health Care Units in Dairut City
Official title: Depression Symptoms Among Ever Married Females Attending Primary Health Care Units in Dairut City
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Depressive Symptoms
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-02-20
Enrollment: 400
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: The city has a total population of 92144 and total numbers of families 20942.There are two primary health care centers in Dairut city that provide the primary care services.

* Medical Centre (MC) covers the Eastern part of Dairut City.
* Maternal and child care center west Dirout (MCCC) covers the Western part of the city.

Brief summary: Depression is defined as a cluster of specific symptoms with associated impairment. The clinical and diagnostic features of the disorder are broadly similar in adolescents and adults.

Nevertheless, depression in adolescents is more often missed than it is in adults, possibly because of the prominence of irritability, mood reactivity, and fluctuating symptoms in adolescents.

While depression is the leading cause of disability for both males and females, the burden of depression is 50% higher for females than males. In fact, depression is the leading cause of disease burden for women in both high-income and low- and middle-income countries.

Detailed description: The prevalence of depression in children is low (\<1% in most studies) with no sex differences, and then rises substantially throughout adolescence.

Okasha found that the lifetime prevalence of depression in urban and rural Egyptian populations to be 11.4 and 19.7% Several studies show that depression during adolescence is a risk factor of academic failures, marriage struggles, suicide attempts, interpersonal conflicts, unemployment, drug abuse; it is also a strong predictor of adulthood depression.

Girls married too early are also more likely to experience domestic violence, abuse and forced sexual relations.

Similarly early married females when interact with new individuals after marriage are unable to deal them psychologically which is mostly due to the bad behaviours shown from in-laws towards them thus leading to lower self-esteem, increasing their risk of clinical depression which on extreme aspect can cause suicidal attempts.

Eligibility criteria: Inclusion Criteria:

* Married
* Divorced
* Separated
* Widow

Exclusion Criteria:

* Cases diagnosed with mental disorders
* History of mental disorders
* Family history of mental disorders

Primary outcomes:
measure: Depression symptoms among ever married females attending primary health care units in Dairut City
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Asyut
country: Egypt
facility: Primary health care center
Study officials:
affiliation: Assiut University
name: Ahmed K Ibrahim
role: STUDY_CHAIR
References:
Clinical trial NCT03055182: Oxygenation of Paravertebral Muscles During Exercise in Chronic Low Back Pain Patients
Official title: Oxygenation of Paravertebral Muscles During Exercise in Chronic Low Back Pain Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Low Back Pain
Rehabilitation Program
Muscular Weakness
Keywords: Isokinetic
oxygenation
deoxygenation
aerobic metabolism
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2017-02-16
Enrollment: 36
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: BASIC_SCIENCE

Brief summary: The study evaluate paraspinal aerobic metabolism of chronic low back pain patients and healthy people during an original and standardized isokinetic protocol.

The aim of this study is to determine a potential alteration of muscular aerobic metabolism in low back pain patients, in order to establish the underlying cause of pain and muscular fatigability characterizing low back pain patients. Then, the aim is to determine if functional rehabilitation program can improve it.

the unit of care have access to metabolic adaptations in measuring the muscular oxygenation and the pulmonary oxygen consumption, using near infrared spectroscopy and gas analyser.


Eligibility criteria: Inclusion Criteria:

* For Low back pain patients: suffering from low back pain for at least 3 month
* For control subject: no back pain in the past year

Exclusion Criteria:

* Chronic cardiovascular, pulmonary, metabolic, neurologic disease

Primary outcomes:
measure: Deoxyhemoglobin
timeFrame: 20 minutes
Secondary outcomes:
measure: Oxygen consumption
timeFrame: 20 minutes
measure: Work rate
timeFrame: 10 minutes
measure: Rate of perceived exertion
timeFrame: 10 minutes
measure: Pain
timeFrame: 10 minutes
measure: Muscular blood volume
timeFrame: 20 minutes
measure: Sorensen test
timeFrame: 20 minutes
Other outcomes:
Locations:
city: Lille
country: France
facility: Hôpital Swyngedhauw, CHRU
Study officials:
affiliation: University Hospital, Lille
name: André Thevenon, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03962920: Personalized Treatment of Urogenital Cancers Depends on the Microbiome
Official title: Personalized Treatment of Urogenital Cancers Depends on the Microbiome
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Microbial Disease
Lead sponsor: Zealand University Hospital
Sponsor class: OTHER
First posted: 2019-05-24
Enrollment: 28
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized controlled trial where patients undergoing surgical treatment for urogenital cancers will be randomized in a two arms study: surgical treatment + antibiotics OR surgical treatment + placebo.


Eligibility criteria: Inclusion Criteria:

* Biopsy verified diagnosis of urological cancer, localized disease

Exclusion Criteria:

* Hospitalization within three months of surgery
* Antibiotics within three months of surgery
* Infectious disease, including UTI's within three months of surgery
* History of cancers of the genitourinary tract
* Diabetes

Primary outcomes:
measure: recurrence rate after surgical treatment of tumour
timeFrame: 5 years after treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Roskilde
country: Denmark
facility: Zealand University Hospital
Study officials:
References:
Clinical trial NCT01804920: D-Serine Treatment For Tardive Dyskinesia
Official title: D-SERINE TREATMENT FOR TARDIVE DYSKINESIA
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Schizophrenia and Schizoaffective Disorder
Tardive Dyskinesia
Lead sponsor: Herzog Hospital
Sponsor class: OTHER
First posted: 2013-03-05
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Presently no generally effective treatments for tardive dyskinesia (TD) are available. D-serine is a naturally occurring amino acid that acts in-vivo as positive allosteric modulator at the glycine site associated with the glutamatergic NMDA receptor. Previous studies have suggested that D-serine may improve motor symptoms, including dyskinesias, which are caused by treatment with presently used antipsychotics drugs.

The hypothesis under investigation in the present study is that D-serine adjuvant treatment may improve TD in schizophrenia patients diagnosed with this disorder.


Eligibility criteria: Inclusion Criteria:

1. age 18-70;
2. diagnosis of schizophrenia/schizoaffective disorder according to DSM-IV criteria; diagnosis will be made on the basis of SCID interview and information from medical records, previous treating psychiatrists, and family informants;
3. history of ≥3 months antipsychotic drugs treatment and present stable dose antipsychotic treatment for at last 4 weeks;
4. fulfillment of Schooler-Kane TD research criteria on a first evaluation performed 2-12 weeks prior to study entrance and on a subsequent evaluation performed prior to allocation to experimental treatment.

Exclusion Criteria:

1. meeting criteria for other DSM-IV Axis I diagnoses;
2. presence of a neurological disorder or history of significant head injury;
3. substance abuse or alcoholism during entire lifetime;
4. are judged clinically to be at suicidal or homicidal risk;
5. female patients who are pregnant or lactating; female patients who are not pregnant or lactating, if sexually active, must be using medically accepted means of contraception.

Primary outcomes:
measure: Change in AIMS total score
timeFrame: biweekly during a period of 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Herzog Hospital
Study officials:
affiliation: Herzog Hospital
name: Uriel Heresco-Levy, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04480320: Sonography-guided Pericapsular Never Group Block for Hip Arthroplasty
Official title: Sonography-guided Pericapsular Nerve Group Block for Hip Arthroplasty
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Arthroplasty
Nerve Block
Analgesia
Keywords: Pericapsular Nerve Group
PENG
hip arthroplasty
Postoperative analgesia
quadriceps strength
Lead sponsor: Guangzhou First People's Hospital
Sponsor class: OTHER
First posted: 2020-07-21
Enrollment: 71
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: In this study, the investigator will examine the efficacy of Pericapsular nerve group (PENG) block in hip arthroplasty as a post-operative pain management technique, study the analgesia, opioid-sparing effects and motor-blocking effects of the PENG block

Detailed description: PENG Block group (PG) will receive 0.5%Ropivacaine in 20 ml of saline. Sham Block group (SG) will receive 20 ml of saline Patient will be sedated with IV midazolam before nerve block. After peripheral nerve block ,general anesthesia will be conducted using sufentanyl, propofol and rocuronium for induction and propofol and sevoflurane for maintenance. Tests will be operated after procedure，and recorded up to 48 hours after surgery.

Eligibility criteria: Inclusion Criteria:

* Patients scheduled for hip arthroplasty

Exclusion Criteria:

* allergy to local anesthetics
* infection at the injection site
* patients receiving opioids for chronic analgesic therapy
* other lower limb neuropathies
* inability to comprehend visual analog scale (VAS)
* preexist cognitive dysfunction

Primary outcomes:
measure: Highest VAS score in recovery room
timeFrame: before recovery room discharge(up to 2 hours after surgery end)
Secondary outcomes:
measure: VAS at rest
timeFrame: day0 ,day1 ,day2
measure: highest VAS at period
timeFrame: day0 ,day1 ,day2
measure: quadriceps strength
timeFrame: day0 , day1 ,day2
measure: total opioid consumption
timeFrame: up to 2 days after surgery
measure: PONV rate
timeFrame: day0 ,day1 ,day2
measure: Fall incident happened
timeFrame: up to 2 days after surgery
measure: Nerve block range
timeFrame: day0 , before discharge from PACU(up to 2 hours after surgery end)
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangzhou First Municipal People's Hospital
state: Guangdong
Study officials:
References:
citation: Zheng J, Pan D, Zheng B, Ruan X. Preoperative pericapsular nerve group (PENG) block for total hip arthroplasty: a randomized, placebo-controlled trial. Reg Anesth Pain Med. 2022 Mar;47(3):155-160. doi: 10.1136/rapm-2021-103228. Epub 2021 Dec 6.