louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03409263: Austrian Registry on Transjugular Intrahepatic Portosystemic Shunts
Official title: Österreichisches Register (inklusive Biobank) Für Transjuguläre Intrahepatische Portosystemischem Shunts (TIPS): AUTIPS (AUstrian TIPS Study)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Portal Hypertension
Keywords: Cirrhosis
Advanced chronic liver disease
Ascites
Variceal hemorrhage
Transjugular intrahepatic portosystemic shunt
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
Collaborators: name: Austrian Association of Gastroenterology and Hepatology
First posted: 2018-01-24
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Inpatients or outpatients who are scheduled for TIPS implantation, or who have recently undergone TIPS implantation and are visiting outpatienc clinics for control visits/surveillance

Brief summary: Patients with TIPS will be recruited in this prospective registry study. The clinical course will be documented and biomarkers for prediction of complicatiosn will be assessed.

Detailed description: Patients with advanced chronic liver disease may develop portal hypertension, which is the main cause for most complications and deaths of patients with liver cirrhosis. Implantation of a transjugular intrahepatic portosystemic shunt (TIPS) leads to instantaneous alleviation of portal hypertension, but may cause hepatic encephalopathy. Stent grafts, as well as patient stratification and medical surveillance, have drastically improved over the past decades. However, there are few data on long-term outcome after TIPS implantation.This prospective registry study will assess the clinical course of patients after undergoing TIPS intervention and biomarkers for complications after TIPS implantation.

Eligibility criteria: Inclusion Criteria:

* Age 18-99 years
* Portal hypertension
* Anticipated or past implantation of a transjugular intrahepatic portosystemic shunt (TIPS)
* Informed consent

Exclusion Criteria:

* Retraction of consent

Primary outcomes:
measure: Transplant-free survival
timeFrame: 0-10 years
Secondary outcomes:
measure: Assessment of portalhypertensive complications
timeFrame: 0-10 years
measure: Assessment of hepatic encephalopathy
timeFrame: 0-10 years
measure: Assessment of Patient Reported Quality of Life (SF36v2)
timeFrame: 0-10 years
measure: Assessment of Patient Reported Quality of Life (CLDQ)
timeFrame: 0-10 years
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
affiliation: Medical University of Vienna
name: Thomas Reiberger, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06859463: Muscle Function and Tenderness Differences in Headache Patients
Official title: Muscle Function and Tenderness in Migraine, Tension-Type Headache, and Posttraumatic Headache Patients: a Cross-Sectional Study
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Migraine
Tension Headache
Posttraumatic Headache
Lead sponsor: Danish Headache Center
Sponsor class: OTHER
First posted: 2025-03-05
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Migraine, tensional-type headache, and posttraumatic headache patients who are between 18-65 years old and have at least 10 days of headache per month

Brief summary: This cross-sectional study aims to compare muscle function of the neck, and shoulder and muscle tenderness in three groups of headache patients: migraine, tension-type headache, and posttraumatic headache. The study will evaluate muscle tenderness through the Total Tenderness Score (TTS) and muscle function through maximum voluntary isometric contraction (MVIC) and rate of force development (RFD). Additionally, functional assessments such as the Cranio-Cervical Flexion Test (CCFT) and Ito Test will be performed.


Eligibility criteria: Inclusion Criteria:Criteria: Inclusion Criteria:

* Aged 18 to 65 years.
* Diagnosis of migraine, tension-type headache, or posttraumatic headache, occurring at least 10 days per month.
* For tension-type headache patients, maximum of 3 days per month with migraine.

Exclusion Criteria:

* Pregnancy.
* Significant psychiatric comorbidities (e.g., severe depression).
* Medication-overuse headache.
* Severe osteoarthritis in the neck or shoulder, or cervical disc herniation.

Exclusion Criteria:

-

Primary outcomes:
measure: Primary Outcome Measure: 1.Rate of Force Development (RFD)
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Danish Headache Center
state: Region H
Study officials:
References:
Clinical trial NCT06170463: Insulin Sensitizers Role in Control of PCOS Vicious Cycle.
Official title: Combined Insulin Sensitizers as Double-Weapon to Detonate PCOS-induced Vicious Circle
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2023-12-14
Enrollment: 210
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: PCOS is a common and complex disease affecting women of reproductive age. It is characterized by its complex pathological symptoms and mechanisms resulting in endocrine and metabolic dysfunction. PCOS is highly associated with various metabolic and endocrinal disorders. Metformin is mainly used for its glucose-lowering effects for treatment and prevention of type-2 diabetes mellitus (DM), gestational DM, and PCOS. Myo-inositol (MI) protects against MAFLD through reduction of hepatic accumulation of triglycerides.


Eligibility criteria: Inclusion Criteria:

* Age;
* Residence;
* level of education \& type of work;
* Marital and fertility statuses, and if infertility was the main complaint;
* Presence of risk factors as sedentary lifestyle;
* Emotional stress and family history of PCOS;
* Obesity-related medical disorders especially DM or MAFLD;
* History of previous treatment for PCOS and its outcomes;
* Menstrual pattern such as infrequent menstrual periods.

Exclusion Criteria:

* Women had other manifestations of metabolic syndrome:
* Cardiac manifestations of PCOS;
* Maintained on other therapies or prepared for /received laparoscopic intervention for PCOS;
* Receiving scheduled exercise, lipid-lowering therapies, or maintained on diabetogenic drugs for any other indications;
* Had morbid obesity with body mass index (BMI) \>35 kg/m2;
* Causes other than PCOS for infertility, manifest DM, hepatic or pancreatic diseases.

Primary outcomes:
measure: Improvement of mensural pattern
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Zagazig university
state: Ash Sharqia Governorate
Study officials:
References:
Clinical trial NCT04233463: The Effect of Oral Polymeric Diet Enriched With TGF-beta 2 (Modulen) on Clinical Response and Mucosal Healing in Adult Patients With Newly Diagnosed Crohn's Disease
Official title: The Effect of Oral Polymeric Diet Enriched With TGF-beta 2 (Modulen) on Clinical Response and Mucosal Healing in Adult Patients With Newly Diagnosed Crohn's Disease: a Prospective, Randomized Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Crohn Disease
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2020-01-18
Enrollment: 50
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 aim of this study is to evaluate prospectively a possible effect of an oral polymeric diet enriched with TGF-beta 2 (Modulen) as compared to Budesonide (one of the commonly accepted treatments for Crohn's disease) on clinical response, mucosal healing and intestinal microbiota in adult patients with newly diagnosed Crohn's disease using a capsule endoscopy.


Eligibility criteria: Inclusion Criteria:

* Newly diagnosed Crohn's Disease
* Mild to moderate severity

Exclusion Criteria:

* Patients who received systemic steroid or Budesonide or biological treatment
* Recent bowel surgery
* Colostomy, ileostomy
* Short bowel syndrome
* Obstructive symptoms
* Pregnancy, lactation
* Cardiac pacemaker or defibrillator
* Swallowing problems
* Uncontrolled metabolic diseases or any other condition that can be exacerbated by steroids

Primary outcomes:
measure: Efficacy of Modulen Diet
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Hillel Yaffe Medical Center
Study officials:
affiliation: Hillel Yaffe Medical Center
name: Baruch Ovadia, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00219063: A Clinical Study to Compare an Aliskiren Based Hypertensive Regimen With a Ramipril Based One Followed by a Randomized Withdrawal.
Official title: A 26 Week, Double-blind, Randomized, Multicenter, Parallel Group, Active-controlled Study Comparing Aliskiren to Ramipril With Optional Addition of Hydrochlorothiazide, Followed by a 4 Week Double-blind, Randomized, Placebo-controlled Withdrawal in Patients With Essential Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Keywords: Hypertension, aliskiren, blood pressure, Ramipril, hydrochlorothiazide
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-09-22
Enrollment: 844
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: To compare the aliskiren regimen versus the ramipril regimen on reduction in Blood Pressure.


Eligibility criteria: Inclusion Criteria

* Patients with essential hypertension
* Patients who are eligible and able to participate in the study

Exclusion Criteria

* Severe hypertension
* History or evidence of a secondary form of hypertension
* History of Hypertensive encephalopathy or cerebrovascular accident. Other protocol-defined inclusion exclusion criteria also apply.

Primary outcomes:
measure: Change from baseline in diastolic blood pressure after 26 weeks
Secondary outcomes:
measure: Change from baseline in systolic blood pressure after 26 weeks
measure: Change from baseline in diastolic blood pressure after 6 weeks and 12 weeks
measure: Change from baseline in systolic blood pressure after 6 weeks and 12 weeks
measure: Blood pressure control target of < 140/90 mmHg after 6, 12, and 26 weeks
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Novartis Pharmaceuticals
state: New Jersey
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Andersen K, Weinberger MH, Egan B, Constance CM, Ali MA, Jin J, Keefe DL. Comparative efficacy and safety of aliskiren, an oral direct renin inhibitor, and ramipril in hypertension: a 6-month, randomized, double-blind trial. J Hypertens. 2008 Mar;26(3):589-99. doi: 10.1097/HJH.0b013e3282f3ad9a.
Clinical trial NCT00285363: Quality of Life Among Children and Adolescents With Cancer
Official title: Quality of Life Among Children and Adolescents With Cancer
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Cancer
Keywords: cancer
quality of life
adolescents
Lead sponsor: Children's Mercy Hospital Kansas City
Sponsor class: OTHER
First posted: 2006-02-02
Enrollment: 0
Sex: ALL
Minimum age (years): 9
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE

Brief summary: This descriptive study aims to allow children and adolescents who have cancer to self-evaluate their quality of life. It is hypothesized that treatment affects quality of life in the areas of physical and social functioning. It is further hypothesized that these effects dissipate within 6 months after treatment is completed.

Detailed description: Study participants will include all children and adolescents (aged 7 to 21 years old) currently receiving care from the Hematology/Oncology Clinic at the CMHC, which will serve as the study site. These individuals will be identified by the health care professionals working in the clinic. Specific study criteria will include only those individuals who (1) can read or write in the English language (due to limited availability of translators); (2) appear to not possibly suffer psychological harm by participating (as determined by any health care professional working in the Clinic); and (3) do not have a health condition and/or medical need that supersedes study participation. The weekly list of appointments will be reviewed by the researchers who already work in the Clinic for appropriateness (JH, JB and KS). To prevent participation coercion, solicitation for participation will be provided through the Child Life Specialist (CLS). The CLS is known to each participant and will function as a data collector for this study.

Eligibility criteria: Inclusion Criteria:Study participants will include all children and adolescents (aged 7 to 21 years old) currently receiving care from the Hematology/Oncology Clinic at the CMHC, which will serve as the study site. These individuals will be identified by the health care professionals working in the clinic. Specific study criteria will include only those individuals who (1) can read or write in the English language (due to limited availability of translators); (2) appear to not possibly suffer psychological harm by participating (as determined by any health care professional working in the Clinic); and (3) do not have a health condition and/or medical need that supersedes study participation. -

Exclusion Criteria: (1) Those electing not to participate; (2) those with no guardian available to consent or (3) those not yet diagnosed with a cancer condition.

-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Children's Mercy Hospitals and Clinics
state: Missouri
Study officials:
affiliation: University of Missouri, Kansas City
name: Peggy Ward-Smith, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05165563: Treatment Time Comparing Digital & Conventional Workflows
Official title: Comparison of Treatment Time Between Digital and Conventional Workflows for Treatment With Posterior Implant Restorations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Implant
Keywords: Clinical Research
Dental Implant
Digital Workflow
Crowns
Treatment time
Lead sponsor: Mahidol University
Sponsor class: OTHER
Collaborators: name: Align Technology, Inc.
First posted: 2021-12-21
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Digital and conventional workflows for treatment of implant single crowns, and also the material used.
Primary purpose: TREATMENT

Brief summary: This randomized controlled trial (RCT) analyzed monolithic single-unit implant restorations out of lithium disilicate (LS2) or polymer-infiltrated ceramic networks (PICN) in a chairside digital workflow (Test) and a conventional protocol (Control). The primary outcome was to investigate the treatment time of the overall operation. The null hypothesis of this RCT was that both workflows had comparable results with respect to the defined outcomes.


Eligibility criteria: Inclusion Criteria:

* The participants having a transmucosal implant system (Straumann TL RN/WN, Institut Straumann, AG, Basel, Switzerland) were placed in a single-tooth gap in the area of premolar or molar regions in the maxilla and mandible with existing interproximal and antagonist contacts.
* general medical health is healthy or has a well-controlled systemic disease.
* general oral health has shown no sign of infection or unsuccessfully treated diseases such as chronic periodontitis.

Exclusion Criteria:

* smoking more than 10 cigarettes per day.
* pregnancy.
* psychiatric disorder
* history of radiation therapy at the head and neck area.
* history of chemotherapy.
* history of bony pathologies such as osseous dysplasia, odontogenic cyst or tumor, etc.

Primary outcomes:
measure: Treatment time
timeFrame: First visit to prosthesis delivery visit, through study completion, an average of 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Faculty of dentistry, Mahidol University
Study officials:
References:
citation: Joda T, Bragger U. Time-Efficiency Analysis Comparing Digital and Conventional Workflows for Implant Crowns: A Prospective Clinical Crossover Trial. Int J Oral Maxillofac Implants. 2015 Sep-Oct;30(5):1047-53. doi: 10.11607/jomi.3963.
Clinical trial NCT05966363: Comparison of Cone Beam Irradiation Versus Multi-detector Scanner for Ear Imaging
Official title: Comparison of Cone Beam Irradiation Versus Multi-detector Scanner for Ear Imaging
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Irradiation; Adverse Effect
Keywords: irradiation
TDM
Cone Beam
CT
CBCT
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2023-07-28
Enrollment: 35
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients are recruited during a consultation in the ENT department, either as part of a pre-cochlear implant assessment, or as part of a prescription for a CT scan of the petrous bone by the Besançon University Hospital ENT department department to be carried out at Besançon University Hospital.

Brief summary: The primary objective of this study is to compare the irradiation between Cone Beam and CT of the petrous bone.

The primary endpoint is the measurement of equivalent doses per organ of interest (eyes, ears, thyroid and external genitalia).

The investigators have set up a prospective monocentric study. The investigators will measure irradiation of these different organs using nanodots placed on the patient during imaging.

The results of these measurements will be compared between Cone Beam (performed in the Besançon University Hospital ENT department for cochlear implant position checks) and CT (all indications combined).


Eligibility criteria: Inclusion Criteria:

* Adult or child patients of any gender and any age, including the pediatric population, receiving a CT scan of the petrous bone performed at Besançon University Hospital and prescribed in the Besançon University Hospital ENT department, or receiving a CBCT as part of an intraoperative check of cochlear implant position.
* Women menopausal for at least 24 months, surgically sterilized, or, for women of childbearing age, using an effective contraceptive method (oral contraceptives, contraceptive injections, intra-uterine devices, double-barrier method, contraceptive patches).
* Subject's non-opposition to study participation
* Affiliation with a French social security scheme or beneficiary of such a scheme.

Exclusion criteria are :

* Legal incapacity or limited legal capacity
* Subject unlikely to cooperate with the study and/or poor cooperation anticipated by the investigator.

Primary outcomes:
measure: CT and CBCT induced Irradiation in ear imaging in adults with adult protocol
timeFrame: 9 month
Secondary outcomes:
measure: CT and CBCT induced Irradiation in ear imaging in children with Pediatric protocol
timeFrame: 9 month
measure: CT and CBCT induced Irradiation in ear imaging in adults with pediatric protocol
timeFrame: 9 month
Other outcomes:
Locations:
city: Besançon
country: France
facility: CHU de Besançon
Study officials:
References:
Clinical trial NCT05369663: Personal Protective Equipment Effects
Official title: Effects of Personal Protective Equipment on Speech Acoustics
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Speech Disorders
Voice Disorders
Keywords: speech acoustics
Lead sponsor: Istanbul Medeniyet University
Sponsor class: OTHER
First posted: 2022-05-11
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy individuals. Based on health caregiving people (doctors, nurses)

Brief summary: Severe acute respiratory syndrome coronavirus-2 transmits through droplets; thus, oral, nasal, and conjunctival mucosas are related to contamination, and wearing personal protective equipment (PPE) is strongly suggested. Several communication problems between the patient and healthcare workers related to PPE use are reported. In this study, investigators aimed to investigate changes in the acoustic parameters of speech sounds when different PPE are used.

Detailed description: It was planned as a cross-sectional study enrolled 18 healthy male and female participants. After the informed consent, participants were asked to pronounce a \[ɑː\] vowel for at least 3 seconds for voice quality estimation. Afterward, all Turkish vowels were produced for a minimum of 200 ms. Finally, three Turkish fricative consonants (\[f\], \[s\], \[ʃ\]) were produced in consonant/vowel/consonant format and in different vowel contexts within a carrier sentence. Recordings were repeated for the following conditions: no PPE, surgical-mask, N99-mask, face shield, surgical-mask+faceshield, and N99+faceshield. All recordings were analyzed with proper statistical methods.

Eligibility criteria: Inclusion Criteria:

* native Turkish speakers

Exclusion Criteria:

* having an acute respiratory system infection history of any vocal fold surgery

Primary outcomes:
measure: The change on voice acoustics due to different personal protective equipments use
timeFrame: 1 months
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Medeniyet University
Study officials:
affiliation: Istanbul Medeniyet University
name: ahmet mutlu
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gama R, Castro ME, van Lith-Bijl JT, Desuter G. Does the wearing of masks change voice and speech parameters? Eur Arch Otorhinolaryngol. 2022 Apr;279(4):1701-1708. doi: 10.1007/s00405-021-07086-9. Epub 2021 Sep 22.