louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01553422: Relation Between Intrabdominal Pressure and Collapsibility Index of Inferior Vena Cava Before and After Fluid Therapy
Official title: Assessment of Relation Between Intrabdominal Pressure and Collapsibility Index of Inferior Vena Cava by Emergency Ultrasonography Before and After Fluid Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Abdominal Compartment Syndrome
Keywords: Intrabdominal Pressure
Emergency Bedside Ultrasonography
Abdominal Compartment Syndrome
Lead sponsor: Isfahan University of Medical Sciences
Sponsor class: OTHER
First posted: 2012-03-14
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This study assess the relation between intra abdominal pressure and collapsibility index of inferior vena cava in emergency bedside ultrasonography before and after fluid therapy.


Eligibility criteria: Inclusion Criteria:

* Body Mass index less than 30
* Written agree of the patient to participate in the study

Exclusion Criteria:

* neurogenic bladder or any documented previous surgery on bladder, spastic or contractile bladder
* large abdominal hernia
* patients who received neuromuscular blocking agents
* Patients with abdominal respiration due to chest pain

Primary outcomes:
measure: Emergency bedside Ultrasonography assessment of Inferior Vena cava collapsibility index before and after fluid therapy
timeFrame: "up to 36 weeks"
Secondary outcomes:
Other outcomes:
Locations:
city: Isfahan
country: Iran, Islamic Republic of
facility: Emergency department, Alzahra General Hospital
Study officials:
affiliation: Isfahan University of Medical Sciences
name: KEIHAN GOLSHANI, M.D.
role: STUDY_CHAIR
References:
Clinical trial NCT03087422: Text Message (SMS) to Help Cancer Patients in Chemotherapy Treatment
Official title: An Intervention Based on Text Message (SMS) to Help Cancer Patients in Chemotherapy Treatment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cancer
Side Effect
Lead sponsor: Federal University of Pelotas
Sponsor class: OTHER
First posted: 2017-03-22
Enrollment: 80
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: SUPPORTIVE_CARE

Brief summary: This study evaluates the text message (SMS) with orientation to help the management of chemotherapy treatment.

Detailed description: The investigators developed an app (called ChemotherApp) for Android that automatically sends text messages with homecare orientation to cancer patients in intervention group. The main features of this app are: to register information such as name, number of cellphone, gender, and chemotherapy schedule of the patient. Other feature is to register the orientation that will be sent to patients by text messages. Daily, the app send a registered orientation to each patient.

Eligibility criteria: Inclusion Criteria:

* Cancer patients who will start chemotherapy treatment in Hospital Escola of Federal University of Pelotas.

Exclusion Criteria:

* Illiterate patients; Patients who do not have their own cell phone

Primary outcomes:
measure: Change from Chemotherapy Side Effects - QLQ-C30 EORTC questionnaire
timeFrame: Up to 4 month
Secondary outcomes:
measure: Change from Anxiety and Depression - HADS (Hospital Anxiety and Depression Scale) questionnaire
timeFrame: Up to 4 month
Other outcomes:
measure: Change from ECOG (The Eastern Cooperative Oncology Group) scale - performance status - well-being
timeFrame: Up to 4 month
Locations:
city: Pelotas
country: Brazil
facility: Federal University of Pelotas
state: RS
Study officials:
References:
citation: Rico TM, Dos Santos Machado K, Fernandes VP, Madruga SW, Santin MM, Petrarca CR, Dumith SC. Use of Text Messaging (SMS) for the Management of Side Effects in Cancer Patients Undergoing Chemotherapy Treatment: a Randomized Controlled Trial. J Med Syst. 2020 Sep 30;44(11):193. doi: 10.1007/s10916-020-01663-x.
Clinical trial NCT04760522: Genome-based Management of Patients in Precision Medicine (Ge-Med) Towards a Genomic Health Program
Official title: Genome-based Management of Patients in Precision Medicine (Ge-Med) Towards a Genomic Health Program
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Rare Diseases
Genetic Predisposition to Disease
Keywords: Rare Diseases
Genetic Predisposition
Whole Exome Sequencing (WES)
Whole Genome Sequencing (WGS)
Familial cancer syndromes
Polygenic Risk Scores (PRS)
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2021-02-18
Enrollment: 12000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The GE-MED APPROACH project will enroll patients (n = appr. 12.000) with unclear molecular cause of the disease, suspected genetic cause of the disease without detailed molecular analysis like Whole Exome Sequencing (WES).

The novelty of this study is to integrate genomic health concepts into immediate clinical care. To achieve these goals, a novel structure for the Triple P (3P) concept of personalized medicine (Personalized, Predictive, Preventive) integrated into a well-established health care system and associated with novel decentralized Disease Analysing Task Forces (DATF) will be implemented.

The overall goal of this study is to implement, for the first time, Whole Genome Sequencing (WGS) analysis as a first line diagnostic test for all clinical indications such as Rare Disease (RD )and familial cancer syndromes.


Eligibility criteria: Inclusion Criteria:

* Unclear molecular cause of the disease
* Suspected genetic cause of the disease

Exclusion Criteria:

* Missing informed consent of the patient and if applicable the legal representative
* Previously performed WES or panel analysis

Primary outcomes:
measure: Number of WGS analysis
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Tübingen
country: Germany
facility: University Hospital Tübingen
Study officials:
affiliation: University Hospital Tübingen
name: Olaf Rieß, Prof. Dr.
role: STUDY_DIRECTOR
References:
Clinical trial NCT05751122: Effects of Dynamic Flex Cast With Neurodevelopmental Treatment on Gross Motor Functions in Cerebral Palsy
Official title: Effects of Dynamic Flex Cast With Neurodevelopmental Treatment on Gross Motor Functions in Children With Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Keywords: Ankle joint
Cerebral Palsy
Spasticity
Dynamic cast
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2023-03-02
Enrollment: 60
Sex: ALL
Minimum age (years): 3
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study aims to determine the effects of dynamic flex cast with neurodevelopmental treatment on gross motor functions and gait in children with cerebral palsy.

Detailed description: The study aims to determine the effects of dynamic flex cast with neurodevelopmental treatment on gross motor functions and gait in children with cerebral palsy. Combination of Dynamic flex cast with neurodevelopmental treatment will be a novel potential treatment to improve gross motor functions in cerebral palsy. We shall try to fill the gaps of previous studies. It will help in facilitating children to perform their activities, restoring normal ranges and treatment of spasticity in cerebral palsy.

Eligibility criteria: Inclusion Criteria:

* Children with cerebral palsy
* Age 3-8 years
* Spastic diplegic/ hemiplegic CP
* Ankle dorsiflexion 5-10 degrees
* GMFCS level 1-3
* Modified Ashworth's scale level 1+ - 3

Exclusion Criteria:

* Congenital foot deformities
* Cognitive impairments
* Secondary orthopedic, auditory and severe visual impairments
* Unwilling patients or parents
* Recent surgical interventions

Primary outcomes:
measure: Gross Motor Function Measure-88
timeFrame: 12 weeks
measure: Clinical Gait Assessment Scale
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Swābi
country: Pakistan
facility: Chal foundation, Bacha Khan Medical Complex
state: KPK
Study officials:
affiliation: Riphah International University
name: Abrish Abbasi, MS-NMPT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01809522: Does Posterior Reconstruction of the Rhabdosphincter Improve Early Recovery of Continence After Robotic-Assisted Radical Prostatectomy?
Official title: Does the Posterior Reconstruction of the Rhabdosphincter Improve Early Recovery of Continence After Robotic-Assisted Radical Prostatectomy? A Multicenter Randomized Controlled Trial. A Phase III Open-label Prospective International Multicenter Randomized Controlled Study for the Evaluation of the Efficacy of PRR, in Patients Subjected to RALP, Measured in Terms of Early Recovery of the Continence.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Urinary Incontinence
Keywords: Robotic-assisted radical prostatectomy
Urinary continence
Posterior reconstruction of the rhabdosphincter
Posterior musculofascial plate reconstruction
Lead sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Sponsor class: OTHER
First posted: 2013-03-12
Enrollment: 1500
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The present study is a multicenter randomized, controlled trial, whose aim is to verify the effect of the posterior reconstruction of the rhabdosphincter after robot-assisted radical prostatectomy on early recovery of urinary continence.


Eligibility criteria: Inclusion Criteria:

* Age ≥18 and ≤ 80 years;
* Biopsy proven clinically localized prostate cancer;
* Informed consent obtained and signed;
* Understanding of, and willingness to comply with, the study procedures.

Exclusion Criteria:

* Pre-operative incontinence;
* Salvage prostatectomy (defined as a prostatectomy prescribed after the failure of a different primary treatment);
* Surgical posterior plane at the peri - rectal fat, without preserving an edge of the Denonvilliers;
* History of psychiatric or addictive disorder or other medical condition that, in the opinion of the investigator, would preclude the patient from meeting the trial requirements;

Primary outcomes:
measure: Urinary continence
timeFrame: 12 months
Secondary outcomes:
measure: Oncologic radicality
timeFrame: 12 months
measure: Sexual potency
timeFrame: 12 months
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico
Study officials:
References:
Clinical trial NCT00968422: A Study of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ABT-384 in Elderly Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Pharmacology
Drug Safety
Phase 1 Clinical Trials
Pharmacokinetics
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2009-08-31
Enrollment: 28
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objectives of this study are to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of ABT-384 in elderly subjects.


Eligibility criteria: Inclusion Criteria:

1. Age is 65 years or greater
2. Judged to be in a condition of general good health based on the results of medical history, physical examination, vital signs, laboratory profile and a 12-lead ECG

Exclusion Criteria:

1. Use of protocol-prohibited medications within 2 weeks prior to study drug administration.
2. Positive urine drug screen for non-prescribed drugs of abuse including alcohol.
3. Receipt of any drug depot by injection within 30 days prior to study drug administration.
4. Receipt of any investigational product within 6 weeks prior to study drug administration.
5. History of significant sensitivity or allergy to any drug.
6. History of drug or alcohol abuse within 2 years.
7. Positive test result for HBV, HCV or HIV.
8. Estimated creatinine clearance \< 30 mL/min.
9. Donation or loss of 5 mL/kg or more blood volume or receipt of any blood product within 8 weeks prior to study drug administration.
10. Current enrollment in another clinical study.

Primary outcomes:
measure: Safety and Tolerability Assessments (i.e., ECG, clinical laboratory tests, vital signs, weight, AE assessment, physical and brief neurological examinations)
timeFrame: Days -2 through 84
measure: Assess Pharmacokinetics (i.e., ABT-384 and possible metabolite levels) and Pharmacodynamics (i.e., biomarkers of drug effect)
timeFrame: Days -1 through 27
Secondary outcomes:
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Site Reference ID/Investigator# 23024
state: Florida
Study officials:
References:
Clinical trial NCT04182022: Financially Sustainable Remote Treatment for Alcohol Abuse: Feasibility
Official title: Financially Sustainable Remote Treatment for Alcohol Abuse: Feasibility
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Use Disorder
Lead sponsor: Virginia Polytechnic Institute and State University
Sponsor class: OTHER
First posted: 2019-12-02
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Directly reinforcing abstinence from alcohol with monetary incentives is an effective treatment for alcohol dependence, but barriers in obtaining frequent, verified biochemical measures of abstinence limit the dissemination of this treatment approach. The goal of this feasibility study is to use a breathalyzer and cost-controlling deposit contracts to facilitate a contingency-management intervention to reduce alcohol use that requires no in-person contact between the participants and the study staff during the intervention phase.


Eligibility criteria: Inclusion Criteria:

* At least 18 years old
* Provide written informed consent
* Meet Diagnostic and Statistical Manual criteria for alcohol use disorder
* Express a desire to cut down or quit drinking
* Be willing to pay a $75 deposit toward their incentive fund

Exclusion Criteria:

* Pregnant or lactating
* Meet Diagnostic and Statistical Manual criteria for other substance use disorder (except caffeine or nicotine)
* Score 23 or greater on the Alcohol Withdrawal Symptom Checklist
* Have immediate plans to move out of the area

Primary outcomes:
measure: Percent days abstinent from alcohol during intervention
timeFrame: Percent days abstinent is the aggregate measure throughout the 21-day intervention period
measure: Treatment acceptability
timeFrame: Baseline, one day after treatment end, and at a one-month follow-up
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Koffarnus MN, Kablinger AS, Kaplan BA, Crill EM. Remotely administered incentive-based treatment for alcohol use disorder with participant-funded incentives is effective but less accessible to low-income participants. Exp Clin Psychopharmacol. 2021 Oct;29(5):555-565. doi: 10.1037/pha0000503. Epub 2021 Jun 10.
Clinical trial NCT00135122: Prednisolone in the Treatment of Withdrawal Headache in Probable Medication Overuse Headache
Official title: Medication Overuse Headache: A Randomised Double Blind Study of Prednisolone or Placebo in Withdrawal Therapy (Phase 3), and a Randomised 1 Year Follow up by Neurologist or General Physician After Successful Withdrawal Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Headache
Keywords: migraine
analgesics
tension type headache
Lead sponsor: Sorlandet Hospital HF
Sponsor class: OTHER_GOV
First posted: 2005-08-25
Enrollment: 100
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: The purpose of this study is to determine whether prednisolone is more effective than placebo in the first six days after initiation of medication withdrawal therapy for a medication overuse headache. Another purpose is to study whether patients followed by a neurologist 1 year after withdrawal do better than patients followed by a general practitioner.

Detailed description: Data published BoeMG,Mygland A,Salvesen R; Neurology 2007 Jul 3;69(1):26-31

Eligibility criteria: Inclusion Criteria:

* Chronic daily headache and medication overuse fulfilling International Headache Society (IHS)-II criteria

Exclusion Criteria:

* Pregnancy
* Age under 18 and over 70 years
* Major mental disorders

Primary outcomes:
measure: The primary endpoint was a calculated mean headache (MH), based on number of days with headache and mean intensity of headache during the first six days after withdrawal.
timeFrame: 6 days
Secondary outcomes:
measure: number of days with zero or mild headache, days with moderate to strong headache, days without headache, Use of antiemetic drugs ,staying drug-free during the entire period.
timeFrame: 1 month
Other outcomes:
Locations:
city: Kristiansand
country: Norway
facility: Sørlandet Sykehus HF
state: Vest-Agder
Study officials:
affiliation: University of Tromso
name: Rolf Salvesen, Professor
role: STUDY_CHAIR
References:
citation: Boe MG, Mygland A, Salvesen R. Prednisolone does not reduce withdrawal headache: a randomized, double-blind study. Neurology. 2007 Jul 3;69(1):26-31. doi: 10.1212/01.wnl.0000263652.46222.e8. Epub 2007 May 2.
Clinical trial NCT06978322: Comparative Study Between Immediate Surgery Versus Neoadjuvant Chemotherapy for Management of Resectable Pancreatic Cancer
Official title: Comparative Study Between Immediate Surgery Versus Neoadjuvant Chemotherapy for Management of Resectable Pancreatic Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Surgery
Neoadjuvant Chemotherapy
Management
Resectable Pancreatic Cancer
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2025-05-18
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This prospective and retrospective study will be conducted on 30 patients with resectable pancreatic cancer.

Brief summary: This trial aimed to determine whether neoadjuvant chemoradiotherapy improves overall survival compared with upfront surgery, both followed by adjuvant chemotherapy in patients with resectable and borderline resectable pancreatic cancer.

Detailed description: Pancreatic cancer is one of the solid cancers with the poorest treatment outcomes, and there is an urgent need to improve its treatment outcomes. Among these, resectable pancreatic cancer is known to show relatively good treatment outcomes with surgical resection, but the 5-year survival rate is still about 20%, which is still unsatisfactory.

Neoadjuvant therapy may increase the proportion of patients that actually receive chemotherapy and thereby improve survival. Furthermore, neoadjuvant therapy may increase the microscopically margin-negative (R0) resection rate and may identify patients with rapidly progressive disease who can be spared futile surgery.

Eligibility criteria: Inclusion Criteria:

* Computed tomography (CT) with pancreatic protocol + vascular mapping
* Histopathologically proven malignant by CT-guided or endoscopic ultrasound (EUS)-guided biopsy Resectable pancreatic cancer means no contact of the tumor with the Superior mesenteric artery, Celiac axis \& Common hepatic artery, and contact of the tumor but ≤90° contact with the superior mesenteric vein \& portal vein.

Exclusion Criteria:

* Borderline resectable \& locally advanced pancreatic cancer
* Tumor at the tail of the pancreas.
* Metastatic pancreatic cancer
* Unfit patients for surgery.

Primary outcomes:
measure: Overall survival rate
timeFrame: 1 year post-procedure
Secondary outcomes:
measure: Achieve of R0 Resection
timeFrame: 1 year post-procedure
measure: Disease free survival
timeFrame: 1 year post-procedure
measure: Time to locoregional recurrence
timeFrame: 1 year post-procedure
measure: Time to distant metastasis
timeFrame: 1 year post-procedure
measure: Incidence of postoperative complications
timeFrame: 1 year post-procedure
Other outcomes:
Locations:
city: Minya
country: Egypt
facility: Minia University
Study officials:
References:
Clinical trial NCT04218422: Battlefield Acupuncture for Pain in Hidradenitis Suppurativa
Official title: Battlefield Acupuncture to Treat Pain in Hidradenitis Suppurativa
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hidradenitis Suppurativa
Keywords: acupuncture
pain
battlefield acupuncture
hidradenitis
Lead sponsor: Wayne State University
Sponsor class: OTHER
First posted: 2020-01-06
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Blinded, randomized trial
Primary purpose: TREATMENT

Brief summary: The investigators will investigate battlefield acupuncture as a treatment for the pain of hidradenitis suppurativa.

Detailed description: Participants will report their pain level daily for 4 weeks. At week 2 and 3, they will get acupuncture in the ears.

Eligibility criteria: Inclusion Criteria:

* age 18 years or older
* dermatologist-confirmed diagnosis of hidradenitis suppurativa
* significant pain from hidradenitis at least twice weekly
* stable treatment regimen for hidradenitis during study period

Exclusion Criteria:

* disease or disfigurement of the ear that prevents battlefield acupuncture of the ears
* other chronic pain that will interfere with the ability to rate hidradenitis pain

Primary outcomes:
measure: Change in Pain Numerical Rating Score
timeFrame: Average Score from scores Recorded daily for 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Dearborn
country: United States
facility: WSUPG Dermatology
state: Michigan
Study officials:
References:
citation: Horvath B, Janse IC, Sibbald GR. Pain management in patients with hidradenitis suppurativa. J Am Acad Dermatol. 2015 Nov;73(5 Suppl 1):S47-51. doi: 10.1016/j.jaad.2015.07.046.