louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03888417: TPE in Rennes Hospital
Official title: Tolerance of Therapeutic Plasma Exchange Performed in the Rennes University Hospital 2011-2018
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Therapeutic Plasma Exchange
Keywords: TPE
therapeutic plasma exchange
Side Effects
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2019-03-25
Enrollment: 190
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All adult patients who underwent TPE in Rennes University Hospital 2011-2018

Brief summary: To assess the indications, tolerance and side effects of therapeutic plasma exchange (TPE) performed at a University Hospital over 8 years

Detailed description: Indications were recorded from the patients electronic chart. Side effects were identified from the review of TPE monitoring forms completed prospectively by the nurse who performed the TPE during the course of the procedure

Eligibility criteria: Inclusion Criteria:

* All adult patients who underwent TPE in Rennes University Hospital 2011-2018

Exclusion Criteria:

* Absence of the monitoring sheet during the EP session
* Refusal of patient participation after receipt of the information letter
* Persons over the age of majority who are subject to legal protection (protection of justice, guardianship, guardianship)

Primary outcomes:
measure: Frequency of side effects during Therapeutic plasma exchange
timeFrame: The inclusion day (retrospective study)
Secondary outcomes:
Other outcomes:
Locations:
city: Rennes
country: France
facility: Centre Hospitalier Universitaire de Rennes
Study officials:
affiliation: Rennes University Hospital
name: Christophe CAMUS, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Coirier V, Lesouhaitier M, Reizine F, Painvin B, Quelven Q, Maamar A, Gacouin A, Tadie JM, Le Tulzo Y, Camus C. Tolerance and complications of therapeutic plasma exchange by centrifugation: A single center experience. J Clin Apher. 2022 Feb;37(1):54-64. doi: 10.1002/jca.21950. Epub 2021 Nov 17.
Clinical trial NCT05968417: Myeloma Novel Drug Discovery Ver 1.2
Official title: Investigation of the Activity of Novel Compounds for the Treatment of Myeloma and Mechanisms of Drug Resistance to Current Therapies
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Multiple Myeloma
Lead sponsor: Institute of Cancer Research, United Kingdom
Sponsor class: OTHER
Collaborators: name: Royal Marsden NHS Foundation Trust
First posted: 2023-08-01
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants who have a diagnosis, or suspected diagnosis, of myeloma or related plasma cell disorder

Brief summary: Myeloma is a bone marrow cancer with over 5000 patients diagnosed in the UK each year. Researchers are committed to improving understanding of myeloma and developing more effective treatments with fewer side effects in order to improve patient outcomes. In order to do this, researchers are collecting samples of blood and bone marrow to test the activity of potential new treatments in the laboratory and to understand what may be the cause of some treatments not working.


Eligibility criteria: Inclusion Criteria:

1. Participants who have a diagnosis, or suspected diagnosis, of myeloma or related plasma cell disorder
2. Participants who are undergoing a peripheral blood or bone marrow aspirate sampling for diagnostic, staging or follow-up purposes, before, whilst or after receiving anti-myeloma treatment
3. Participants aged 18 years of age or above
4. Participants willing to consent to an additional sample being taken at the time of their peripheral blood or bone marrow aspirate sampling

Exclusion Criteria:

1. Participants unable to provide consent
2. Participants with known active infectious diseases (e.g. HIV, Hepatitis B/C, COVID) that pose a risk to the use of the sample in the laboratory

Primary outcomes:
measure: Cell viability
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: London Borough of Sutton
country: United Kingdom
facility: The Royal Marsden NHS Foundation Trust
Study officials:
References:
Clinical trial NCT01275924: Tightrope or Screw Fixation of Acute Tibiofibular Syndesmotic Injury
Official title: Tightrope or Screw Fixation of Acute Tibiofibular Syndesmotic Injury. Randomised Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Syndesmotic Injury of the Ankle
Keywords: Syndesmosis
Injury
Ankle
Fracture
Lead sponsor: Sykehuset Asker og Baerum
Sponsor class: OTHER
Collaborators: name: Oslo University Hospital
First posted: 2011-01-13
Enrollment: 97
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: Syndesmotic injuries are common and often associated with unstable ankle fractures. The most common treatment is with a syndesmotic screw through the fibula and tibia which is later removed, usually after 10-12 weeks. The Tightrope Syndesmosis Repair Kit (Arthrex; Naples, Florida). is used for the same indication, it consists of a heavy suture placed across the syndesmosis which has been looped and tightened through cortical button anchors on either side of the ankle. It does not need removal and thus avoids subsequent surgery. This trial compares these two treatment methods for syndesmotic injuries of the ankle.

Detailed description: Patients 18-70 years presenting to one of the two hospitals with an acute syndesmotic injury are eligible for inclusion. 50 patients are randomised to two treatment groups: One group receives a Tightrope (R) fixation and the other receives a quadricortical screw fixation which is removed after 12 weeks. Follow-up intervals are at 6 weeks, 6, 12 and 24 months with standardised CT scans postoperatively and at 12, 24 months and 5 years clinical end-ponts/scores.

Eligibility criteria: Inclusion Criteria:

* 18 to 70 years
* Acute syndesmotic injury with or without Weber type C fracture

Exclusion Criteria:

* Prior injury of the same ankle
* Severe injury of same leg affecting rehabilitation
* Symptomatic osteoarthritis of same ankle
* Open injury
* Decubital injury affecting surgical site
* Dementia or unable to sign informed consent
* Neuropathic conditions affecting same leg

Primary outcomes:
measure: OTA Score (Modified American Orthopaedic Foot and Ankle Society ankle hind foot score)
timeFrame: 5 years
Secondary outcomes:
measure: Olerud-Molander Ankle (OMA) Score
timeFrame: 5 years
measure: Dorsiflexion angle
timeFrame: 5 years
measure: Health-related quality of life (EQ-5D)
timeFrame: 5 years
measure: CT measurements of syndesmotic distance
timeFrame: 5 years
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
city: Rud
country: Norway
facility: Baerum Hospital, Vestre Viken
Study officials:
affiliation: Baerum Hospital, Vestre Viken, Norway
name: Wender Figved, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04280224: NK Cells Treatment for COVID-19
Official title: Clinical Investigation of Natural Killer Cells Treatment in Pneumonia Patients Infected With 2019 Novel Coronavirus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Novel Coronavirus Pneumonia
Lead sponsor: Xinxiang medical university
Sponsor class: OTHER
Collaborators: name: First Affiliated Hospital of Xinjiang Medical University
First posted: 2020-02-21
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Since december 2019, acute respiratory disease due to 2019 novel coronavirus (2019-nCoV) emerged in Wuhan city and rapidly spread throughout China. There is no confirmed antivirus therapy for 2019-nCoV infection. Natural killer (NK) cells are innate lymphocytes that may serve as useful effectors against danger infection. The purpose of this clinical investigation is to evaluate the safety and efficiency of NK Cells in combination with standard therapy for pneumonia patients infected with 2019-nCoV.


Eligibility criteria: Inclusion Criteria:

* 1. Male or female, aged at 18 years-65 years old
* 2. Pneumonia that is judged by chest radiograph or computed tomography
* 3. Laboratory confirmation of NCP infection by reverse-transcription polymerase chain reaction(RT-PCR) from any diagnostic sampling source

Exclusion Criteria:

* 1. Pregnancy or breastfeeding
* 2. Known HIV, HBV or HCV infection
* 3. Patients with malignant tumor, other serious systemic diseases and psychosis
* 4. Patients who are participating in other clinical trials
* 5. Inability to provide informed consent or to comply with test requirements

Primary outcomes:
measure: Improvement of clinical symptoms including duration of fever
timeFrame: Measured from day 0 through day 28
measure: Improvement of clinical symptoms including respiratory frequency
timeFrame: Measured from day 0 through day 28
measure: Number of participants with treatment-related adverse events evaluated with CTCAE,version 4.0
timeFrame: Measured from day 0 through day 28
Secondary outcomes:
measure: Time of virus nucleic acid test negative
timeFrame: Measured from day 0 through day 28
measure: CD4+ and CD8+ T cell count
timeFrame: Measured from day 0 through day 28
measure: Rate of mortality within 28-days
timeFrame: Day 28
measure: Size of lesion area by thoracic imaging
timeFrame: Measured from day 0 through day 28
Other outcomes:
Locations:
city: Xinxiang
country: China
facility: The First Affiliated Hospital of Xinxiang Medical University
state: Henan
Study officials:
References:
Clinical trial NCT01156324: The Impact of an Online Stress Management Program on In Vitro Fertilization (IVF) Outcome
Official title: The Impact of an Online Stress Management Program on IVF Outcome
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Infertility
Keywords: IVF
Stress management
Lead sponsor: Boston IVF
Sponsor class: OTHER
First posted: 2010-07-02
Enrollment: 0
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of this study is to determine the impact of an online stress management program, which combines stress reduction and prevention strategies with personal care products/rituals which have relaxation properties, on pregnancy rates and psychological distress in women undergoing IVF for the first time.

Detailed description: The relationship between stress and infertility has remained a subject of controversy for many years. Recent research indicates that stress has a strong negative impact on pregnancy rates in women undergoing in vitro fertilization (IVF). In addition, stress is the most common reason given by women who voluntarily terminate treatment.

In a recent study, women who participated in a group mind/body treatment program had higher pregnancy rates than control subjects. The impact of an online stress management program has never been studied in the infertile population. An online intervention would be far more accessible for many infertility patients.

Eligibility criteria: Inclusion Criteria:

* female Boston IVF patients
* day three FSH 12 or below
* day three estradiol 80 pg/ml or below
* able to read, understand and sign the informed consent in English
* using own eggs (not egg donor)
* willing and able to comply with study requirements
* must be well versed in using a personal computer and the internet and must have access to an internet-connected computer seven days per week

Exclusion Criteria:

* prescription antipsychotic medication
* previous diagnosis of borderline or narcissistic personality disorder
* previous or concurrent participation in a mind/body group

Primary outcomes:
measure: Clinical Pregnancy Rates
timeFrame: 1 year
Secondary outcomes:
measure: Psychological Status
timeFrame: 1 year
Other outcomes:
Locations:
city: Waltham
country: United States
facility: Boston IVF
state: Massachusetts
Study officials:
affiliation: Boston IVF
name: Alice D Domar, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01179724: Comparison of Proton Pump Inhibitor and H2 Receptor Blocker on Prevention of Bleeding From Iatrogenic Ulcer After Endoscopic Submucosal Dissection for Gastric Neoplasms: A Prospective Randomized Controlled Trial
Official title: Comparison of Proton Pump Inhibitor and H2 Receptor Blocker on Prevention of Bleeding From Iatrogenic Ulcer After Endoscopic Submucosal Dissection for Gastric Neoplasms: A Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Delayed Bleeding
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2010-08-11
Enrollment: 206
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: after endoscopic submucosal dissection(ESD) of early gastric cancer, conventional proton pump(PPI) inhibitors and H2 receptor antagonists have a controversial effect on preventing bleeding from artificial ulcers. the aim of this study was to investigate whether a stronger acid suppression (high dose PPI) more effectively prevents bleeding after ESD


Eligibility criteria: Inclusion Criteria:

* the patients who agreed informed consent
* gastric adenoma or early gastric cancer which is eligible for conventional ESD indication

Exclusion Criteria:

* recent drug history of PPI, H2 rector antagonist, bismuth and antibiotics within 4 weeks
* recent drug history of anticoagulant or antiplatelet agent within 7 days
* s/p subtotal gastrectomy
* recurred gastric adenoma or cancer
* pregnant or breast feeding patients

Primary outcomes:
measure: bleeding incidence after ESD
timeFrame: time to occur delayed bleeding within one month after ESD
Secondary outcomes:
measure: the size of healing ulcer after ESD
timeFrame: follow up endoscopy for the healing of iatrogenic ulcer after one month ESD
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
References:
Clinical trial NCT02040324: Laryngeal Mask Airway in Lower Abdominal Surgery
Official title: Comparison of Lung Function in Patients After Lower Abdominal Surgery Exceeding 2hrs Under the Use of Laryngeal Mask vs. Endotracheal Tube for Airway Management
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Lower Abdominal Surgery
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2014-01-20
Enrollment: 100
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: We measure in this study lung function of 100 patients immediately after major lower abdominal surgery. We compare lung function, when either endotracheal intubation, or laryngeal masks are used for airway protection during surgery. The hypothesis is that the use of laryngeal masks is associated with less impairment of lung function in the immediate postoperative phase.


Eligibility criteria: Inclusion Criteria - patients scheduled for elective retropubic radical prostatectomy

Exclusion Criteria:

- increased risk of aspiration due to hiatal hernia, morbid obesity, or facial malformations

Primary outcomes:
measure: The change between pre- and postoperative forced expiratory volume in one second (FEV1) in lung function
timeFrame: one day prior to surgery, 1 hour after surgery (recovery room), at day one after surgery
Secondary outcomes:
measure: Vital capacity (VC) measured by spirometry.
timeFrame: one day prior to surgery, i hour after after surgery (recovery room), at day one after surgery
measure: Forced vital capacity (FVC)
timeFrame: one day prior to surgery, one hour after surgery (recovery room), at day one after surgery
measure: mid-expiratory flow (MEF 25, 50, 75)
timeFrame: one day prior to surgery, one hour after surgery, at day one after surgery
measure: Peak expiratory flow (PEF)
timeFrame: one day prior to surgery, one hour after surgery (recovery room) , at day one after surgery
Other outcomes:
Locations:
Study officials:
affiliation: Universitätsklinikum Hamburg-Eppendorf
name: Daniel A Reuter, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02962024: Does Local Morphine Add to Local Anesthetics in Serratus Anterior Plane Block Has a System Analgesic Effect?
Official title: Does Local Morphine Add to Local Anesthetics in Serratus Anterior Plane Block for Post Mastectomy Pain Has a System Analgesic Effect? A Clinical and Pharmacokinetics Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Complications
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2016-11-11
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: the investigators aim is to investigate and explore the effect 10 mg morphine added to local anesthetics in serratus anterior plane block for post mastectomy pain management after modified radical mastectomy in patients with breast cancer with assessment of its serum level if it will be absorbed systemically or not?


Eligibility criteria: Inclusion Criteria:

* (ASA) class I-II
* body weight of 50 - 90 kg

Exclusion Criteria:

* a history of bleeding diathesis,
* relevant drug allergy, opioid dependence,
* sepsis, prior surgery in the supraclavicular, infraclavicular or axillary regions, alcohol or drug abuse , patients with advanced cardiovascular disease

Primary outcomes:
measure: serum morphine level after local injection
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Assuit
country: Egypt
facility: South Egypt Cancer Instuite
Study officials:
affiliation: South Egypt Cancer Instuite, Assuit, Assuit university
name: fatma EL sherif
role: STUDY_DIRECTOR
References:
citation: El Sherif FA, Abd El-Rahman AM, Othman AH, Shouman SA, Omran MM, Hassan NA, Hassan SB, Aboeleuon E. Analgesic Effect of Morphine Added to Bupivacaine in Serratus Anterior Plane Block Following Modified Radical Mastectomy. Only a Local Effect? Randomized Clinical Trial. J Pain Res. 2020 Mar 31;13:661-668. doi: 10.2147/JPR.S236336. eCollection 2020.
Clinical trial NCT06274424: Hair Cortisol and Symptoms in Children With Psychopathology During CBT
Official title: Association Between Hair Cortisol and Symptoms in Children With Psychopathology During CBT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Child Behavior Problem
Keywords: Children
group cognitive behavioral therapy
hair cortisol concentration
internalizing symptoms
externalizing symptoms
sleep disturbance symptoms
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
First posted: 2024-02-23
Enrollment: 100
Sex: ALL
Minimum age (years): 6
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study aims to examine the relationship between hair cortisol concentration and behavior and sleep disturbance symptoms in children with psychiatric disorders. It also investigates potential changes in hair cortisol and symptomatology after group-based cognitive behavior therapy. Furthermore, the study explores the effects of any alterations in hair cortisol concentration levels on potential behavior and sleep disturbance symptom change over the course of the study.


Eligibility criteria: Inclusion Criteria:

* symptoms of anxiety or depression
* deficiencies in emotional and behavioral skills impairing functioning
* sufficient social and cognitive skills to participate in group work.

Exclusion Criteria:

* excessive physical aggression
* excessive physical restlessness
* severity of psychiatric symptoms requiring individual psychotherapy (e.g., acute suicidality).

Primary outcomes:
measure: Hair Cortisol Concentration
timeFrame: Before and after the group cognitive behavioral intervention (duration from pre-GCBT to post-GCBT circa 4.7 months), and at a 7-month follow-up
measure: Parent- and teacher rated internalizing and externalizing symptoms
timeFrame: Before and after the group cognitive behavioral intervention (duration from pre-GCBT to post-GCBT circa 4.7 months), and at a 7-month follow-up
measure: Child-rated internalizing symptoms
timeFrame: Before and after the group cognitive behavioral intervention (duration from pre-GCBT to post-GCBT circa 4.7 months), and at a 7-month follow-up
measure: Parent-rated sleep disturbance symptoms
timeFrame: Before and after the group cognitive behavioral intervention (duration from pre-GCBT to post-GCBT circa 4.7 months), and at a 7-month follow-up
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06296524: Effect of Footcore Exercises on Navicular Drop and Plantar Pressure Distribution in Asymptomatic Individual With Flatfoot
Official title: Effect of Footcore Exercises on Navicular Drop and Plantar Pressure Distribution in Asymptomatic Individual With Flatfoot: A Pilot RCT
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Flatfoot
Keywords: Footcore, Harris Mat, Plantar pressure.
Lead sponsor: Maharishi Markendeswar University (Deemed to be University)
Sponsor class: OTHER
First posted: 2024-03-06
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Pes Planus is a medical condition in which arch of the foot is flattened, causing the entire sole of the foot to contact the floor. For those with flat feet, footcore exercises might be an effective non-invasive therapy. Footcore exercises aim to strengthen the intrinsic foot muscles that maintain the foot arch, enhance foot function and reduce the risk of injury in persons with flatfoot.

Detailed description: A pilot, random research with 10 participants was undertaken. Two groups, Experimental group and Control group, were randomly selected among the subjects. Participant completed the informed consent form before the navicular drop test and Harris Mat was used to measure the foot pressure. Footcore exercises and conventional therapy was given for four weeks ,twice a day for 6 days. While the Control group just received conventional treatment, the Experimental group combined Footcore exercise with it. The data will be analyzed using SPSS 26.0 software.

Eligibility criteria: Inclusion Criteria:

1. Individuals having flat feet.
2. those with a height difference of ≥ 10 mm during the navicular drop test.
3. No history of foot or ankle surgery.

Exclusion Criteria:

1. Any lower limb injury
2. Healing fracture of lower limb33
3. Any neuromuscular disorder 25
4. Recent surgery
5. Any open wound.

Primary outcomes:
measure: Navicular Drop Test
timeFrame: 1 month
measure: Harris Mat for Plantar Pressure Distribution
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Ambala
country: India
facility: MMIPR
state: Haryana
Study officials:
affiliation: MMIPR
name: Mousumi Saha, MPT
role: PRINCIPAL_INVESTIGATOR
References: