louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01787630: To Evaluate the Technique and Effects of Separating the Prostate and Rectum With Hyaluronic Acid During Radiotherapy
Official title: Initiating Phase II-III Study to Evaluate the Technique and Effects of Separating the Prostate From the Rectum With Hyaluronic Acid During Radiotherapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Prostatic Cancer
Keywords: Prostatic cancer
Radiotherapy
Hyaluronic acid
Lead sponsor: Umeå University
Sponsor class: OTHER
Collaborators: name: University Hospital, Umeå
First posted: 2013-02-08
Enrollment: 81
Sex: MALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The dominating problem after local radiotherapy of prostate cancer is rectal toxicity. If the rectum could be completely moved out of the treated volume, a substantial decrease of rectal toxicity seems reasonable. In this study we will develop and evaluate a new transrectal injection technique where hyaluronic acid (HA) is injected in the space between the prostate and the rectum prior to external beam radiotherapy to increase the physical distance between prostate and rectum.


Eligibility criteria: Inclusion Criteria:

* Histologically verified prostatic cancer
* Low or intermediate risk prostatic cancer
* Lymph node negative
* Suitable for radiotherapy

Exclusion Criteria:

* Earlier treatment for prostatic cancer
* Unable to co-operate or suffering from any other form of disease that would interfere with the planned treatment

Primary outcomes:
measure: Remaining volume of HA
timeFrame: 24 month after end of radiotherapy
Secondary outcomes:
measure: Quality of life
timeFrame: 24 month after end of radiotherapy
Other outcomes:
Locations:
city: Kalmar
country: Sweden
facility: Department of oncology, Kalmar Hospital
city: Sundsvall
country: Sweden
facility: Department of oncilogy, Sundsvall Hospital
city: Umeå
country: Sweden
facility: Department of oncology, University Hospital
Study officials:
affiliation: Umea university, dept of oncology
name: Anders Widmark, Prof MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03701425: Impact of Interventions With a Diet and Exercise on the Cardio-metabolic Status in Multi-risk Population
Official title: Impact of Interventions With a Diet and Exercise on the Cardio-metabolic Status in Multi-risk Population
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cardiovascular Diseases
Metabolic Syndrome x
Mediterranean Diet
Lead sponsor: Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado
Sponsor class: OTHER_GOV
First posted: 2018-10-10
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The diseases derived from Metabolic Syndrome caused 75% of the total deaths. It is more profitable to invest in prevention than in the treatment of most cardiovascular diseases. Several institutions consider prevention as one of the main priorities in public health.

Patients with Metabolic Syndrome, undergoing Mediterranean diet and exercise program, will have lower fat mass, greater lean mass and muscle strength; in addition to the lower expression of proinflammatory biomarkers, compared to those subjected to standard diet and exercise.

OBJECTIVE: To evaluate the changes in body composition and cardiovascular risk in the population with metabolic syndrome undergoing a Mediterranean diet program and / or controlled physical activity.

Design: Experimental, longitudinal design, controlled clinical trial, randomized. Population with Metabolic Syndrome in which the effect of Mediterranean diet and / or controlled physical activity will be compared on anthropometric parameters, body composition, cardiometabolic risk and plasma biomarkers.


Eligibility criteria: Inclusion Criteria:

* Patients with a diagnosis of metabolic syndrome.
* Patients diagnosed with overweight.
* Patients diagnosed with obesity.
* Patients with a diagnosis of systemic arterial hypertension.
* Patients diagnosed with type 2 diabetes mellitus.
* Patients with dyslipidemia.

Exclusion Criteria:

* Recent myocardial infarction
* Pregnancy
* Lactation
* In pharmacological treatment for weight loss.
* Cancer.
* Chronic kidney disease
* Liver failure
* Heart failure.
* Chronic obstructive pulmonary disease
* Depression
* Malabsorption syndrome
* Chronic diarrhea

Primary outcomes:
measure: Measure the profiles of body composition in the different groups.
timeFrame: 3 months
measure: Measure the profiles of pro inflammatory biomarkers.
timeFrame: 3 months
measure: Compare the profiles of body composition and proinflammatory biomarkers after the follow-up between the different groups in patients with metabolic syndrome.
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: National Medical Center "20 de Noviembre", ISSSTE
Study officials:
References:
Clinical trial NCT05251025: Myofascial Release and Sustained Stretching in Spastic CP Children
Official title: Comparative Effects of Myofascial Release and Sustained Stretching on Hamstring Flexibility in Spastic Cerebral Palsy Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Keywords: Spastic cerebral palsy
Passive Sustained Stretching
Myofascial Release
MAS
Goniometer
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2022-02-22
Enrollment: 26
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this research was to find and compare the effects of Myofascial Release Technique and Passive Sustained Stretching on Hamstrings Flexibility in Children with Spastic Cerebral Palsy.

Detailed description: Randomized Clinical Trials done at DHQ Sahiwal. 26 spastic CP children of age 6-12 years were taken by random sampling technique from DHQ Sahiwal. 13 were allocated to each group. Study duration was of 6 months. Sampling technique applied was non probability convenience sampling technique Group A received Passive Sustained Stretching along with conventional treatment. Whereas Group B received MFR along with conventional treatment. Both these groups received treatment for 6 weeks. The baseline and post treatment score of MAS, Goniometer (AKET to measure popliteal angle) and GMFCS -88 were evaluated. Data analysis was done by using the SPSS version 21.

Eligibility criteria: Inclusion Criteria:

* Age range from 6 to 12 years were included.
* Both genders were included.
* Ambulatory subjects with or without ambulatory aids.
* Diagnosed children with Spastic CP.
* CP patients with grade 3 on modified Ashworth scale for hamstrings were included

Exclusion Criteria:

* Children with visual or auditory defects.
* Children with cognitive dysfunction.
* Subjects who had severe limitations in passive range of motion at lower extremities specially hamstrings due to surgery or any other complication.
* Children with other types of Cerebral Palsy such as Ataxic CP, Dyskinetic CP etc.

Primary outcomes:
measure: Modified Ashworth Scale (MAS)
timeFrame: 6th week
measure: Gross Motor Function Classification System
timeFrame: 6th week
measure: Active Knee Extension Test
timeFrame: 6th week
Secondary outcomes:
Other outcomes:
Locations:
city: Sahiwal
country: Pakistan
facility: District Head Quarter Hospital
state: Punjab
Study officials:
affiliation: Riphah International University
name: Sara Aabroo, PPDPT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02518425: Improvement in Acoustic Voice Characteristics in Functional Dysphonia After Therapy
Official title: Which Instrumental Acoustic Voice Parameters Indicate Vocal Improvement After Voice Therapy in Patients With Functional Dysphonia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Functional Voice Disorder
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2015-08-07
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with functional voice disorders

Brief summary: In a retrospective analysis of already existing clinical assessment data from patients with functional voice disorders the following aspects will be sampled, encoded and analysed: Outcomes pre and post treatment of

1. subjective voice symptoms measured by Voice Handicap Index (VHI-9i),
2. perceptual voice symptoms according to Grading-Roughness-Breathiness-Asthenia-Strain Scale (GRBAS Scale),
3. instrumental acoustic analysis parameters Jitter (%), speaking voice profile: mean and range of speaking pitch and intensity, max. intensity and mean pitch of calling voice, singing voice: min./max. and range of pitch and intensity, maximum phonation time, Dysphonia Severity Index (DSI).


Eligibility criteria: Inclusion Criteria:

* informed consent; patients 20 to 70 years with functional voice disorder; -diagnostics and voice therapy at University Hospital Zurich;
* full pre- and post treatment voice assessment (videostroboscopy, subjective self- assessment, instrumental acoustic and perceptual analysis).

Exclusion Criteria:

* known neurologic and psychiatric disease,
* hearing disorder,
* surgery of the head and neck area or intubation (for any reason) in last 18 months.

Primary outcomes:
measure: Instrumental acoustic voice parameters
timeFrame: Before (initial diagnosis) and after voice therapy, expected average of 11-20 weeks after initial diagnosis)
Secondary outcomes:
measure: Subjective voice symptoms
timeFrame: Before (initial diagnosis) and after voice therapy, expected average of 11-20 weeks after initial diagnosis)
measure: Perceptual voice symptoms
timeFrame: Before (initial diagnosis) and after voice therapy, expected average of 11-20 weeks after initial diagnosis)
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Clinic for Otorhinolaryngology University Hospital Zurich
state: ZH
Study officials:
affiliation: University Hospital Zurich, Department of Otorhinolaryngology
name: Joerg E Bohlender, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06879925: Physiological and QoL Benefits of Qi-Gong in Post-acute Sequelae of Covid-19
Official title: The Effects of Qi-gong on Physiology and Quality of Life in Patients with Post-acute Sequelae of Covid-19
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: PASC Post Acute Sequelae of COVID 19
Lead sponsor: National Taipei University of Nursing and Health Sciences
Sponsor class: OTHER
First posted: 2025-03-17
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Experimental Group:QIGONG Control Group
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this clinical trial is to determine whether Qi-Gong can improve physiological function and quality of life (QoL) in individuals with post-acute sequelae of SARS-CoV-2 infection (PASC).

Study Objectives:

To assess whether Qi-Gong improves physiological function in individuals with PASC.

To evaluate whether Qi-Gong enhances quality of life in individuals with PASC.

Study Design:

If a comparison group is included, researchers will compare Qi-Gong with standard care to assess its effectiveness.

Participant Involvement:

Practice Qi-Gong three times per week for three months. Record physiological data monthly.


Eligibility criteria: Inclusion Criteria:

* PASC
* above 20 y/o

Exclusion Criteria:

* Those who cannot cooperate
* Severe schizophrenia

Primary outcomes:
measure: Pulmonary Function Test (Forced vital capacity)
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: Pulmonary Function Test (FEV1)
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: Pulmonary Function Test (FVCFEV1)
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: Heart rate variability
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: Heart rate variability
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: Heart rate variability
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: Heart rate variability
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: Quality of Life(The short version of the World Health Organization Quality of Life ，WHOQOL-BREF)
timeFrame: From enrollment to the end of treatment at 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: Renhe nursing home
city: Taipei
country: Taiwan
facility: Fuxi nursing home
Study officials:
affiliation: National Taipei University of Nursing and Health Sciences
name: Mei-Hua Wang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00590525: Inflammation as a Predictor in Cardioversion of Atrial Fibrillation
Official title: Inflammation as a Predictor in Cardioversion of Atrial Fibrillation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Keywords: hsCRP
Lead sponsor: Creighton University
Sponsor class: OTHER
First posted: 2008-01-10
Enrollment: 45
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Consecutive patients undergoing DC cardioversion at The Cardiac Center electrophysiology lab who meet these criteria will be enrolled.

Brief summary: The laboratory test, C-Reactive Protein (CRP), has become well established as a marker of inflammation. Recently a high CRP level (indicating an increase in inflammation) was identified as a risk factor for atrial fibrillation. We are conducting this study with patients such as yourself with atrial fibrillation who are planning to undergo cardioversion to determine what sort of relationship exists between CRP levels and atrial fibrillation. We will then look at success rates of converting atrial fibrillation to normal sinus rhythm, compared to patients' CRP levels.


Eligibility criteria: Inclusion Criteria

* Atrial fibrillation patients referred for DC cardioversion
* On stable medical therapy

Exclusion Criteria

* Known chronic inflammatory states such as infections, rheumatoid arthritis or known vasculitides.
* Patients having undergone recent surgery or who are on steroid therapy for any reason will be excluded.

Primary outcomes:
measure: We hypothesize that a higher hsCRP is associated with higher failure rates in patients undergoing cardioversion for atrial fibrillation
timeFrame: 1 month
Secondary outcomes:
measure: secondary endpoint will be if a new inflammatory disease state is diagnosed at the one-month mark.
timeFrame: 1 month
Other outcomes:
Locations:
city: Omaha
country: United States
facility: Creighton University Medical Center
state: Nebraska
Study officials:
affiliation: Creighton University
name: Susan Schima, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02188225: Comparison of Acupuncture and Fluoxetine on Quality of Life in Menopausal Women
Official title: Comparison of the Effects of Acupuncture and Fluoxetine on Quality of Life in Menopausal Women
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hot Flash
Quality of Life
Keywords: Hot flash
Acupuncture
Fluoxetine
Quality of life
Lead sponsor: Gonabad University of Medical Sciences
Sponsor class: OTHER
First posted: 2014-07-11
Enrollment: 140
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to comparison the effect of acupuncture and Fluoxetine on improvement quality of life among menopausal women.

Detailed description: This clinical trial is designed in two arm include acupuncture and fluoxetine group to evaluate the effect of these intervention on improvement quality of life among menopausal women.

Eligibility criteria: Inclusion Criteria:

* Last menstrual cycle 12 months ago
* natural menopause
* 4 episodes of hot flash daily
* follicle stimulating hormone (FSH)= 30-110 IU/L , E2\<18pg/ml
* thyroid-stimulating hormone(TSH)= 0.4-4/0 IU/ml
* No using of herbal agent for treatment of hot flash
* having score in Beck depression Inventory\<10
* No existence of any medical problems and using drugs

Exclusion Criteria:

* Not completing all acupuncture sessions
* Not completing fluoxetine admission
* Withdraw the study

Primary outcomes:
measure: Quality of life in menopausal women
timeFrame: 3 months after start sampling
Secondary outcomes:
Other outcomes:
Locations:
city: Gonabad
country: Iran, Islamic Republic of
facility: Gonabad University of Medical Sciences
state: Khorasan Razavi
city: Mashhad
country: Iran, Islamic Republic of
facility: Narjes Bahri
state: Razavi Hkorasan Privience
Study officials:
affiliation: Gonabad University of Medical Sciences
name: Narjes Bahri, PhD Student
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00712725: MK3207 for Treatment of Acute Migraines (3207-005)
Official title: A Phase IIb, Multicenter, Randomized, Double-blind, Placebo-Controlled Dose-finding Study of MK3207 in the Treatment of Acute Migraine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Migraine
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2008-07-10
Enrollment: 676
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: The purpose of the study is to demonstrate the effectiveness and appropriate dosage level of MK3207 in the treatment of acute migraine.


Eligibility criteria: Inclusion Criteria:

* Men and Women from 18 to 65 years of age
* 1+ year history of migraine that typically last from 4 to 72 hours if untreated
* Had from 2 to 8 moderate or severe migraine attacks per month in the last 2 months
* Not pregnant or planning to become pregnant in next 6 months

Exclusion Criteria:

* Pregnant or breast-feeding, or planning to become pregnant in next 6 months
* Cannot distinguish migraine attacks from tension type headaches
* Migraines are mild or resolve without medication in less than 2 hours
* More than 15 headache-days per month or have taken medication on more than 10 days per month in the last 3 months
* Basilar type or hemiplegic migraine headaches
* More than 50 years old when migraines began
* History of cardiovascular disorder within last 6 months

Primary outcomes:
measure: Pain Freedom (PF)
timeFrame: 2 hours postdose
Secondary outcomes:
measure: Pain Relief (PR)
timeFrame: 2 hours postdose
measure: Absence of Photophobia
timeFrame: 2 hours postdose
measure: Absence of Phonophobia
timeFrame: 2 hours postdose
measure: Absence of Nausea
timeFrame: 2 hours postdose
measure: Sustained Pain Freedom (SPF)
timeFrame: 2-24 hours postdose
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Hewitt DJ, Aurora SK, Dodick DW, Goadsby PJ, Ge YJ, Bachman R, Taraborelli D, Fan X, Assaid C, Lines C, Ho TW. Randomized controlled trial of the CGRP receptor antagonist MK-3207 in the acute treatment of migraine. Cephalalgia. 2011 Apr;31(6):712-22. doi: 10.1177/0333102411398399. Epub 2011 Mar 7.
Clinical trial NCT05191225: Ultrafast Truxima Infusion in Non-Hodgkin's Lymphoma: Txagorapid Study
Official title: Ultrafast Truxima Infusion in Non-Hodgkin's Lymphoma: Txagorapid Study - Intervention Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Non-Hodgkin's Lymphoma
Lead sponsor: Bioaraba Health Research Institute
Sponsor class: NETWORK
First posted: 2022-01-13
Enrollment: 48
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: * Rapid infusion group After the administration of intravenous premedication (usually dexchlorpheniramine 5 mg IV and paracetamol 1 g IV), rituximab will be administered at standard dose (375 mg/m2 diluted in 250 ml of saline) administered in one hour, divided into: 10 first minutes at 450 mg/hour, and 50 minutes later at 720 mg/hour.
* Ultrarapid infusion group After the administration of the premedication, the dose of rituximab will be administered at standard dose administered in half an hour, divided into: 10 first minutes at 450 mg/hour, and 20 minutes later at 1800mg/hour.
* Ultrarapid plus infusion group After the administration of the premedication, the dose of rituximab will be administered at the standard dose administered in half an hour, divided into: 10 first minutes at 450 mg/hour, and 20 minutes later at 1800mg/hour.
Primary purpose: TREATMENT

Brief summary: The objective of this pilot study is therefore to assess the safety of Truxima ultrafast infusion within 30 minutes in patients with non-Hodgkin's lymphoma.


Eligibility criteria: Inclusion Criteria:

* Patients who have tolerated the maximum rate of intravenous administration of rituximab (400 mg/h) in the first or second infusion.
* The last rituximab infusion must have occurred within the last 3 months.
* All patients receiving rituximab can be included, regardless of whether they receive rituximab as monotherapy or in combination with chemotherapy and regardless of the line in which they are receiving it.
* Patients will be included in both induction and maintenance treatment.
* All patients must sign the informed consent form.

Exclusion Criteria:

* Patients with initial absolute lymphocyte count \>10x10\^3 cells/µL.
* Patients who have presented hypersensitivity and severe adverse effects (grade II or higher) in the first or second infusion.
* Severe heart failure (NYHA class III-IV) or uncontrolled severe cardiac disease.
* Respiratory failure, severe uncontrolled COPD/asthma.
* Patients allergic to premedication: acetaminophen or polaramine.
* Severe active infection.
* Pregnant patients.
* Refusal to participate.

Primary outcomes:
measure: Infusional reactions
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Vitoria-Gasteiz
country: Spain
facility: Hospital Universitario Araba- Sede Txagorritxu
state: Alava
Study officials:
affiliation: Bioaraba Health Research Institute
name: Laida Cuevas Palomares
role: PRINCIPAL_INVESTIGATOR
References: