louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01735799: THE ASSOCIATION BETWEEN FATTY LIVER (NAFLD) DISEASE AND PCOS
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Polycystic Ovarian Syndrome,
Nonalcoholic Fatty Liver Disease
Lead sponsor: Ziv Hospital
Sponsor class: OTHER_GOV
First posted: 2012-11-28
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients - women who will be diagnosed with PCOD following their initial referal to our fertility clinic. Controls - normal ovulatory women who approached our fertility clinic due to either unexplained or male factor infertility.

Brief summary: Since both pathologies (PCOS and NAFLD) involve disturbed carbohydrate economy, which revolve around insulin resistance, it is tempting to examine the specific "liver profile" of women with PCOD. Furthermore, it would be of great importance if lean women who suffer from PCOD would be revealed to shere cardiovascular risks with their more overweight peers.

Patients - women who will be diagnosed with PCOD following their initial referal to our fertility clinic. Controls - normal ovulatory women who approached our fertility clinic due to either unexplained or male factor infertility.

Workup - history for menstrual pattern; Clinical evaluation for features of hyperandrogenism; ultrasonographic documentation of ovarian morphology; follicular phase hormonal profile for validation of the diagnosis and for ruling out other pathologies which may cause anovulation.

Liver profiling - The following blood tests will be used for the biochemical profiling: fasting glucose and insulin, CRP, HDL-cholesterol, triglycerides, AST, ALT, GGT, LDH, alkaline phosphatase, total bilirubin, direct bilirubin, ferritin, HBA1C and micro albumin ratio.

FibroScan® will be used to measure liver stiffness.


Eligibility criteria: Workup - history for menstrual pattern; Clinical evaluation for features of hyperandrogenism; ultrasonographic documentation of ovarian morphology; follicular phase hormonal profile for validation of the diagnosis and for ruling out other pathologies which may cause anovulation.

Liver profiling - The following blood tests will be used for the biochemical profiling: fasting glucose and insulin, CRP, HDL-cholesterol, triglycerides, AST, ALT, GGT, LDH, alkaline phosphatase, total bilirubin, direct bilirubin, ferritin, HBA1C and micro albumin ratio.

FibroScan® will be used to measure liver stiffness, as previously described

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Safed
country: Israel
facility: Liver Clinic, ZIv Medical Center
Study officials:
References:
Clinical trial NCT06262399: Long-Term Follow-Up (LTFU) of Subjects Treated With NTLA 2002
Official title: Long-Term Follow-Up of Subjects Treated With NTLA 2002
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Hereditary Angioedema
Lead sponsor: Intellia Therapeutics
Sponsor class: INDUSTRY
First posted: 2024-02-16
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participating sites in an Intellia-sponsored clinical study of NTLA-2002.

Brief summary: This is a follow-up study of subjects who received NTLA-2002 in a previous clinical trial as an observational evaluation of the long-term effects of the investigational therapy.


Eligibility criteria: Inclusion Criteria:

1. A subject has completed or discontinued from an Intellia-sponsored or -supported treatment protocol in which a complete or partial dose of NTLA-2002 was received.
2. A subject has provided informed consent for the LTFU study.
3. A subject is willing to attend study visits, complete protocol-required follow-up schedule, and comply with the study requirements.

Exclusion Criteria:

None

Primary outcomes:
measure: Incidence of treatment-related Adverse Events (AEs); incidence of treatment-related Serious Adverse Events (SAEs); incidence of treatment-related Adverse Events of Special Interest (AESIs) defined per protocol
timeFrame: up to 15 years
Secondary outcomes:
measure: To evaluate the long-term efficacy of NTLA-2002 in previously treated subjects
timeFrame: up to 15 years
measure: Change from baseline in consumption of on-demand HAE medications for reported HAE attacks
timeFrame: up to 15 years
measure: Change from baseline in healthcare utilization for HAE attacks
timeFrame: up to 15 years
measure: Change from baseline in QoL parameters as measured by the MOXIE Angioedema-QoL instrument.
timeFrame: up to 5 years
measure: Change from baseline in QoL parameters as measured by the EQ-5D-5L instrument.
timeFrame: up to 5 years
measure: Change from baseline in QoL parameters as measured by the WPAI:GH instrument.
timeFrame: up to 5 years
Other outcomes:
Locations:
city: Grenoble
country: France
facility: Centre National de Reference - Grenoble
city: Lille
country: France
facility: Hôpital Claude Huriez
city: Amsterdam
country: Netherlands
facility: University of Amsterdam Academic Medical Center
city: Auckland
country: New Zealand
facility: New Zealand Clinical Research
city: Cambridge
country: United Kingdom
facility: Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital
Study officials:
References:
Clinical trial NCT05627999: Trans-anal Eco-doppler Evaluation of Haemorrhoidal Vascularization After Percutaneous Hemorrhoidal Artery Embolization. A Pilot Study.
Official title: Trans-anal Eco-doppler Evaluation of Haemorrhoidal Vascularization After Percutaneous Hemorrhoidal Artery Embolization. A Pilot Study.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Haemorrhoidal Bleeding
Lead sponsor: Ospedale Civile Ca' Foncello
Sponsor class: OTHER
First posted: 2022-11-28
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive patients assessed at the Division of General Surgery 1, Treviso Regional Hospital, from October to December 2021 and candidate to the haemorrhoidal artery embolization were included in the study.

Brief summary: To evaluate the usefulness of endoanal ultrasound in the evaluation of emorrhoidal artery embolization outcomes

Detailed description: Haemorrhoidal artery embolization (Emborrhoid) is a novel method for the treatment of haemorrhoids. Through the catheterization of the femoral artery and a selective angiogram of the inferior mesenteric artery, embolic agents are delivered to occlude the SRA. Despite the technical success rate has been reported to reach 93%-100%, clinical success ranges between 63% and 94% with rebleeding occurring in 13.6% of cases due to the presence of a significant MRA in 24% of cases \[BIBLIO} . There is no data in the literature on how the arterial flow changes after the treatment.

The primary aim of the present study was to assess the reduction in the blood supply by comparing the hemorrhoidal arterial systolic peak before and after Hemborrhoid by using endoanal ultrasound (EAUS) combined with doppler. The secondary aim was to evaluate if a relation exists between the reduction and the efficacy of this treatment by the Hemorrhoidal Bleeding Score.

Eligibility criteria: Inclusion Criteria:

* symptomatic hemorrhoidal disease (French bleeding score \[FBS\] \> 4), Goligher's classification score II or III, age \>18 years, failure of non-operative management (change life style, dietary modification, supplemental fibers for constipation, over-the-counter treatments).

Exclusion Criteria:

* age \< 18 years, Goligher prolapse score IV, pregnancy, previous haemorrhoidal surgery, inflammatory bowel disease.

Primary outcomes:
measure: the reduction in the blood supply
timeFrame: one month
Secondary outcomes:
measure: correlate the systolic peak reduction at the doppler analysis with the patients' symptoms improvement.
timeFrame: one month
Other outcomes:
Locations:
city: Treviso
country: Italy
facility: Ospedale Ca Foncello
Study officials:
References:
Clinical trial NCT04593199: Physical Activity Promotion in Children Using a Novel Smartphone Game: A Pilot Randomized Controlled Trial
Official title: Physical Activity Promotion in Children Using a Novel Smartphone Game: A Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Physical Activity
Keywords: Children
Mobile health
Gamification
Physical Activity
Lead sponsor: University of Victoria
Sponsor class: OTHER
First posted: 2020-10-19
Enrollment: 160
Sex: ALL
Minimum age (years): 8
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Increasing physical activity is critical for children's overall health. Smartphone apps using gamification has shown promise to increasing physical activity using game techniques. This study is a 4-week randomized controlled trial using a gamified smartphone app to determine acceptability and preliminary effectiveness to increase physical activity in children.


Eligibility criteria: Inclusion Criteria:

* Children aged 8-14 years old
* Not meeting the recommended Canadian physical activity guidelines of 60min per day of moderate-to-vigorous physical activity
* English-literate
* Normal to corrected vision

Exclusion Criteria:

* Diagnosis or injury that prevents physical activity participation
* No access to a smartphone or tablet

Primary outcomes:
measure: User satisfaction with gamified smartphone app
timeFrame: 4 weeks
measure: Acceptability with gamified smartphone app
timeFrame: 4 weeks
Secondary outcomes:
measure: Steps
timeFrame: 4 weeks
measure: Physical activity minutes
timeFrame: 4 weeks
measure: Motivation for physical activity
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Victoria
country: Canada
facility: University of Victoria
state: British Columbia
Study officials:
References:
Clinical trial NCT04990999: Vestibular Extraction Technique (VET): a Novel Atraumatic Extraction Technique
Official title: Vestibular Extraction Technique (VET): a Novel Atraumatic Extraction Technique (Randomized Clinical Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tooth Extraction
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2021-08-05
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: study proposes an alternative atraumatic tooth extraction procedure; Apically achieved exodontia, which might offer an alternative to the conventional incisal exodontia, whilst providing minimum tissue trauma and subsequently maximum marginal tissue preservation.

Detailed description: A sample of 26 patients that received the extraction therapy For Group (A) patients, Atraumatic extractions using periotomes followed by conventional forceps were performed.

For Group (B) patients, the novel technique of Vestibular Root Extraction was performed to the sample group's hopeless teeth.

Eligibility criteria: Inclusion Criteria:

* Single non-adjacent hopeless maxillary anterior teeth
* Type II socket)
* Intact overlying soft tissues.
* Adequate palatal and at least 3 mm apical bone

Exclusion Criteria:

* Smokers
* Pregnant females
* Patients with systemic diseases

Primary outcomes:
measure: Changes in post restorative soft tissue height
timeFrame: at baseline and 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Private Practice Clinic
Study officials:
References:
Clinical trial NCT04114799: Haemodynamical Optimization During Brain Surgery
Official title: A Comparison of Perioperative Fluid Management Using Invasive Haemodynamical Measurement of Fluid Responsiveness (Aisys GE) and Non-invasive Measurement of Haemodynamics (ClearSight System, Edwards) During Brain Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Brain Edema
Keywords: fluid responsiveness
haemodynamical monitoring
ClearSight
Lead sponsor: University Hospital Hradec Kralove
Sponsor class: OTHER
First posted: 2019-10-03
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The decision to give fluids perioperatively could be based on methods used to identify preload responsiveness, either invasive or noninvasive estimates of stroke volume variation during mechanical ventilation. This study compares fluid management using invasive measurement SPV/PPV (Aisys GE) and noninvasive haemodynamic measurement (ClarSight, Edwards).

Detailed description: The aim of the study is to optimise fluid management and to reduce perioperative risks during brain surgery. Adequate perioperative management guided by hemodynamic monitoring can help to reduce the risk of complications and thus potentially improve outcomes.

This study compares fluid management algorithms based either on invasive detection of fluid responsiveness using pulse pressure variation (PPV) and systolic pressure variation (SPV) values (Aisys GE monitoring system) in group A, or on noninvasive measurement of haemodynamics (stroke volume variation (SVV), cardiac index (CI) and systemic vascular resistance (SVR) values) (ClearSight, Edwards) in group B.

Eligibility criteria: Inclusion Criteria:

* Glasgow Coma scale 15
* ASA Physical Status Classification System I-III
* planed surgery for brain tumor to 5 hours
* postoperative awakening
* sinus rhythm

Exclusion Criteria:

* NYHA III, IV
* BMI over 40 in females and over 35 in men
* awake operation
* postoperative artificial ventilation

Primary outcomes:
measure: fluid balance difference
timeFrame: up to 5 hours after start of operation
Secondary outcomes:
measure: mean dose of norepinephrine
timeFrame: up to 5 hours after start of operation
measure: level of creatinin
timeFrame: 24 hours
measure: postoperative lung dysfunction
timeFrame: 1 day
measure: length of postoperative stay
timeFrame: up to 2 month after surgery
Other outcomes:
Locations:
city: Hradec Kralove
country: Czechia
facility: University Hospital Hradec Kralove
Study officials:
affiliation: University Hospital Hradec Kralove
name: Pavel Dostal, MD, Ph.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT05092906: Contribution of Hypnosis During a Lumbar Puncture.
Official title: Randomized Controlled Study Evaluating The Contribution of a Hypnosis Intervention During a Lumbar Puncture in the Neurology Department.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Keywords: lumbar puncture
anxiety
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2021-10-26
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to assess the effect of hypnosis, as add on therapy, on patients requiring a lumbar puncture (LP) as part of their medical management.

Detailed description: This study will follow the zelen's methodology randomization. It is an add-on study design.

1. The study will be presented to patients as an assessment of their comfort during the LP. The intervention group is not presented to the patient.
2. Patients are asked to sign the consent of the standard of care group.
3. Randomization into two equally sized groups:

   * Intervention arm : LP with complementary hypnoanalgesia
   * Control arm : LP without complementary hypnoanalgesia
4. Patients who have been randomized into the control group, will have LP according to the standard of care.

Patients who have been randomized into the hypnoanalgesic group will be informed about the hypnoanalgesia intervention and then asked to sign the consent of the hypnosis group.

* if the patient accepts, he will benefit from hypnosis during LP.
* if the patient refuses, he will re-join the control group without hypnosis.

The physicians performing LP will be the same in both groups. A phone call follow-up is scheduled on day 3 and 7 after intervention.

Eligibility criteria: Inclusion Criteria:

* Required a lumbar puncture for diagnosis
* Affiliated with social security system
* Patient's written consent

Exclusion Criteria:

* LP contraindication
* History of previous LP
* Psychiatric disorder making the realization of a hypnosis irrelevant
* Cognitive-behavioural abilities that do not allow the completion of the study
* Persons who are protected under the act. Person deprived of liberty by judicial decision
* Pregnant or Breastfeeding woman

Primary outcomes:
measure: Maximum pain felt during LP
timeFrame: Immediately at the end of LP procedure
Secondary outcomes:
measure: Comfort felt during LP
timeFrame: Immediately at the end of LP procedure
measure: Ratio of patients with a Numeric Pain Rating Scale (NPRS) score >= 4.
timeFrame: Immediately at the end of LP procedure
measure: Acceptation of hypnosis
timeFrame: Day1
measure: State and Trait anxiety before LP
timeFrame: Before randomization
measure: Assess pain at Day 3 and Day 7
timeFrame: Three days and then seven days after the LP.
measure: Timeframe for resumption of usual activities.
timeFrame: Seven days after the LP.
Other outcomes:
Locations:
city: Grenoble
country: France
facility: Neurology department of Grenoble University Hospital
state: Isere
Study officials:
References:
Clinical trial NCT02006706: A Study of MabThera/Rituxan (Rituximab) in Combination With Methotrexate in Patients With Rheumatoid Arthritis and Inadequate Response to DMARD Therapy
Official title: An Open-label Study to Evaluate the Effect of MabThera in Combination With Methotrexate on Disease Activity in Patients With Active Rheumatoid Arthritis After DMARD Treatment Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rheumatoid Arthritis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2013-12-10
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will evaluate the efficacy and safety of MabThera/Rituxan plus methotrexate in patients with active rheumatoid arthritis who have had an inadequate response to at least 1 DMARD treatment. All patients will receive MabThera (1000mg iv infusion) on days 1 and 15, and methotrexate (10-25mg po) weekly. The anticipated time on study treatment is 3-12 months.


Eligibility criteria: Inclusion Criteria:

* adult patients, 18-80 years of age;
* rheumatoid arthritis after inadequate response to \>=1 DMARD treatment;
* active disease;
* DMARDs other than methotrexate withdrawn for at least 4 weeks prior to start of study treatment.

Exclusion Criteria:

* autoimmune disease other than rheumatoid arthritis;
* bone/joint surgery within 8 weeks prior to screening, or joint surgery planned within 24 weeks of MabThera infusion;
* concurrent treatment with any DMARD or antiTNF-alfa;
* intra-articular or parenteral corticosteroids within 4 weeks prior to screening.

Primary outcomes:
measure: Change From Baseline Disease Activity Score Based on 28-Joint Count (DAS28) at Week 24
timeFrame: Baseline, Week 24
Secondary outcomes:
measure: Health Assessment Questionnaire-Disability Index (HAQ-DI)
timeFrame: Baseline, Week 24
Other outcomes:
Locations:
city: Belgrade
country: Serbia
city: Niska Banja
country: Serbia
city: Nova Sad
country: Serbia
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT05017506: The Coronavirus Impact Scale Validity and Reliability Study
Official title: Turkish Validity and Reliability Study of The Coronavirus Impact Scale
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: TURKISH VALIDITY AND RELIABILITY STUDY OF THE CORONAVIRUS IMPACT SCALE
Keywords: Coronovirus, Impact, Reliability, Validity, Measuring tool, Nursing.
Lead sponsor: T.C. ORDU ÜNİVERSİTESİ
Sponsor class: OTHER
First posted: 2021-08-24
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adults presenting to outpatient clinics in the hospital.

Brief summary: This research; The Turkish validity and reliability study of the "Coronavirus Impact Scale" developed by Stoddard and Kaufman (2020) will be conducted in order to bring a new measurement tool to our country.

Detailed description: This research; The Turkish validity and reliability study of the "Coronavirus Impact Scale" developed by Stoddard and Kaufman (2020) will be conducted in order to bring a new measurement tool to our country.

Method: This research was planned as a methodological study. Research Question: Is the "Coronavirus Impact Scale" a valid and reliable measurement tool for Turkish society?

Eligibility criteria: Inclusion Criteria:

* At least 18 years old,
* At least primary school graduate,
* Able to communicate verbally and
* Persons who agree to participate in the research will be included in the research.

Exclusion Criteria:

* Psychiatric illness and unable to communicate,
* Having a language problem
* Persons who do not have the skills to read and understand the questionnaire will be excluded from the research.

Primary outcomes:
measure: Coronavirus Impact Scale
timeFrame: 8 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ordu
country: Turkey
facility: Ordu Univercity
state: Cumhurıyet Campus
Study officials:
References: