louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06719349: Lumbar Discopathy Decompression with Lateral Interbody Fusion: Radiological and Clinical Outcomes
Official title: Single-Level Lateral Lumbar Interbody Fusion in Author's Modification: Clinical and Radiographic Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spine Degeneration
Fusion of Spine (Disease)
Keywords: Spine
Decompression
Interbody Fusion
Diskectomy
Lead sponsor: Podkarpackie Oncological Center
Sponsor class: OTHER
First posted: 2024-12-05
Enrollment: 38
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We retrospectively reviewed the medical data of patients who underwent single-level LIF from January to December 2021 at the Orthopaedic Oncology Department in Brzozów and the Trauma and Orthopaedic Department in Stalowa Wola.

Brief summary: The aim of the study was to introduce a single-segment lumbar spine decompression and fusion with intervertebral implants through modified by the authors lateral lumbar approach. Functional, surgical and radiographic outcomes was evaluated.


Eligibility criteria: Inclusion Criteria:

Single-segment L1-L4 spine discopathy.

Exclusion Criteria:

Any other spinal diseases. More than one level of discopathy.

Primary outcomes:
measure: the quality of life
timeFrame: 3 months after the surgery
measure: the functional status - Karnofsky scale
timeFrame: 3 months after the surgery
measure: the functional status Oswestry Disability Index
timeFrame: 3 months after the surgery
measure: the intensity of pain
timeFrame: 3 months after the surgery
Secondary outcomes:
measure: Radiographic Outcomes: The Cross-Sectional Area of the Spinal Canal
timeFrame: 3 months after the surgery
measure: Radiographic Outcomes: The Height and Width of the Intervertebral Foramina
timeFrame: 3 months after the surgery
measure: Radiographic Outcomes: lumbar segmental angle.
timeFrame: 3 months after the surgery
Other outcomes:
Locations:
city: Brzozów
country: Poland
facility: Subcarpatian Oncology Centre
state: Podkarpackie
Study officials:
References:
citation: Schizas C, Theumann N, Burn A, Tansey R, Wardlaw D, Smith FW, Kulik G. Qualitative grading of severity of lumbar spinal stenosis based on the morphology of the dural sac on magnetic resonance images. Spine (Phila Pa 1976). 2010 Oct 1;35(21):1919-24. doi: 10.1097/BRS.0b013e3181d359bd.
citation: Lin GX, Akbary K, Kotheeranurak V, Quillo-Olvera J, Jo HJ, Yang XW, Mahatthanatrakul A, Kim JS. Clinical and Radiologic Outcomes of Direct Versus Indirect Decompression with Lumbar Interbody Fusion: A Matched-Pair Comparison Analysis. World Neurosurg. 2018 Nov;119:e898-e909. doi: 10.1016/j.wneu.2018.08.003. Epub 2018 Aug 10.
citation: Ozgur BM, Aryan HE, Pimenta L, Taylor WR. Extreme Lateral Interbody Fusion (XLIF): a novel surgical technique for anterior lumbar interbody fusion. Spine J. 2006 Jul-Aug;6(4):435-43. doi: 10.1016/j.spinee.2005.08.012.
Clinical trial NCT01108549: Treatment of Chronic Fatigue Syndrome and Fibromyalgia With D-ribose- a Multicenter Study
Official title: Treatment of Chronic Fatigue Syndrome and Fibromyalgia With D-ribose- a Multicenter Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Chronic Fatigue Syndrome
Keywords: Fibromyalgia
Chronic Fatigue Syndrome
D-ribose
fatigue
Lead sponsor: Kona Research Center
Sponsor class: OTHER
Collaborators: name: Bioenergy Life Science, Inc.
name: Integrative Therapeutics, Inc.
First posted: 2010-04-22
Enrollment: 257
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To determine whether adding Ribose 5 grams 3 x day would improve quality of life, energy, sleep and cognitive function and decrease pain in patients with CFS and/or fibromyalgia (CFS/FMS).

Detailed description: Chronic Fatigue Syndrome and Fibromyalgia (CFS/FMS) are debilitating syndromes affecting \~ 2-4% of the population. Although they are heterogeneous conditions associated with many triggers, including infections, autoimmune illnesses, hormonal dysfunctions and other processes, they appear to have the common pathology of being associated with impaired energy metabolism.

As D-ribose has been shown to increase cellular energy synthesis in heart and skeletal muscle, and was shown to significantly improve clinical outcomes in CFS/FMS in an earlier pilot study, we conducted a larger, community based, multicenter trial to see if these findings could be generalized to a broader patient population. We hypothesized that giving D-ribose would improve function in CFS/FMS patients.

Eligibility criteria: Inclusion Criteria:

* diagnosed with Fibromyalgia (FMS) (by American College of Rheumatology \[ACR\] criteria) and/or Chronic Fatigue Syndrome (CFS- by Centers for Disease Control \[CDC\] criteria) by a health practitioner.

Exclusion Criteria:

* pregnant or nursing women, or
* any participants with known severe medication or nutrient sensitivities, or
* previous ribose use.

Primary outcomes:
measure: total score of hedonic scale of 5 symptoms
timeFrame: Change in total score of 5 symptoms after 3 weeks of treatment
Secondary outcomes:
measure: Total of change in hedonic scale
timeFrame: at 1 week of treatment
measure: total change in hedonic scale
timeFrame: after 2 weeks of treatment
measure: Side effects
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Green Bay
country: United States
facility: Enzymatic Therapy
state: Wisconsin
Study officials:
affiliation: Kona Research Center
name: Jacob E Teitelbaum, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02572349: Trial of IW-1701 (A Stimulator of Soluble Guanylate Cyclase (sGC)) in Healthy Volunteers
Official title: A Randomized, Double-blind, Placebo-controlled, Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IW-1701 Administered Orally as Single Doses to Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Healthy Subjects
Lead sponsor: Cyclerion Therapeutics
Sponsor class: INDUSTRY
First posted: 2015-10-08
Enrollment: 24
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 objectives of the study are to assess the safety and tolerability of a range of single doses of IW-1701 when administered as oral capsules to healthy subjects, to determine the pharmacokinetic profile and pharmacodynamics effects of a range of single doses of IW-1701 when administered as oral capsules to healthy subjects.


Eligibility criteria: Inclusion:

* Between 18 and 60 years old at the Screening Visit;
* Women of childbearing potential must have a negative pregnancy test and must agree to use double-barrier contraception;
* BMI \> 18.5 and \< 32.0 kg/m2 at the Screening Visit;
* In overall good health with no clinically significant laboratory, ECG, or physical exam findings;
* Other inclusion criteria per protocol.

Exclusion:

* History of any clinically-significant medical condition;
* Other exclusion criteria per protocol.

Primary outcomes:
measure: Assessment of the safety and tolerability of IW-1701 in healthy subjects via adverse events
timeFrame: From baseline up to 8 days
Secondary outcomes:
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Ironwood Investigational Site
state: Texas
Study officials:
References:
Clinical trial NCT02099149: Antibody Levels Associated With Reduced Risk of Invasive Group B Streptococcus Disease in Infants Aged Less Than 90 Days
Official title: Establishing a Sero-correlate of Protection Against Invasive Group B Streptococcus Disease in Newborns and Young Infants Aged Less Than 90 Days.
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Invasive Group B Streptococcus Disease
Keywords: Group B Streptococcus
early onset disease
late onset disease
anticapsular antibodies
serotype specific
Lead sponsor: Novartis
Sponsor class: INDUSTRY
Collaborators: name: Novartis Vaccines
First posted: 2014-03-28
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women aged 18 years or older attending for antenatal care or delivery at 3 academic hospital centers in the Johannesburg area and the antenatal clinics serving those hospital centers.

Brief summary: Compare anticapsular antibody levels against Group B Streptococcus at delivery in mothers and their infants who develop disease versus those who do not. Use this comparison to establish antibody levels associated with reductions in risk of GBS disease in infants aged less than 90 days.


Eligibility criteria: Inclusion Criteria:

* Pregnant women attending participating community/hospital antenatal clinics and/or delivering at participating delivery centers.
* Subjects aged ≥18 years.
* Able to understand and comply with planned study procedures.
* Provides written informed consent.

Exclusion Criteria:

* Refuses to consent to study participation.

Primary outcomes:
measure: Early onset Group B Streptococcus Disease due to serotypes Ia or III
timeFrame: 0-6 days
Secondary outcomes:
measure: Late onset Group B Streptococcus Disease due to serotype III
timeFrame: 7-90 days
Other outcomes:
Locations:
city: Soweto
country: South Africa
facility: Respiratory and Meningeal Pathogen Research Unit
state: Gauteng
Study officials:
affiliation: Novartis Vaccines
name: Novartis Vaccines
role: STUDY_CHAIR
References:
Clinical trial NCT03950206: Intraoperative Assessment of Ureteral Perfusion in Women With Endometriosis
Official title: Intraoperative Assessment of Ureteral Perfusion Using Indocyanine Green Angiography in Women Submitted to Laparoscopic Surgery for Endometriosis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Endometriosis
Keywords: Endometriosis
Ureters
Indocyanine green angiography
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2019-05-15
Enrollment: 23
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Deep infiltrating endometriosis (DIE) is a severe form of endometriosis in which lesions affect retroperitoneal tissue and pelvic organs wall. It is often characterized by pain (dysmenorrhea, dysuria, dyspnea, dyspareunia, and chronic pelvic pain) and infertility, drastically impacting on women' quality of life. It is typically multifocal, involving uterosacral ligaments, the upper third of posterior vaginal wall, bowel, bladder, and ureters.

Indocyanine green (ICG) is an anionic tricarbocyanine molecule able to bind to plasma proteins into the vascular system and to become fluorescent if excited by near-infrared light (NIR). NIR-ICG imaging is used in gynecology for the intraoperative diagnosis of occult peritoneal and deep endometriosis at white light and to assess tissue perfusion and guide surgical strategy.

Detailed description: Patients with clinical and trans-vaginal / abdominal ultrasound diagnosis of deep endometriosis, undergoing surgery for the removal of endometriotic lesions are included in the study.

Ureter perfusion will be intraoperatively assessed using indocyanine green angiography.

After surgery, patients will be included in the post-operative follow-up, as usual in our clinical practice.

Eligibility criteria: Inclusion Criteria:

* patients undergoing laparoscopic surgery for endometriosis
* informed consent to participate in the study

Exclusion Criteria:

* known or suspected allergy to iodide
* history of active pelvic infection
* presence of intra-abdominal or pelvic malignancy
* pelvic radiation therapy
* hyperthyroidism
* liver dysfunction
* serum creatinine \> 2.0 mg/dL

Primary outcomes:
measure: Feasibility and safety: Clavien-Dindo Classification (from Grade I to V)
timeFrame: From the surgery time, assessed up to 7 days after surgery
Secondary outcomes:
measure: Ureteral vascularization
timeFrame: Intraoperative
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Diego Raimondo
state: BO
Study officials:
References:
citation: Raimondo D, Borghese G, Mabrouk M, Arena A, Ambrosio M, Del Forno S, Degli Esposti E, Casadio P, Mattioli G, Mastronardi M, Seracchioli R. Use of Indocyanine Green for Intraoperative Perfusion Assessment in Women with Ureteral Endometriosis: A Preliminary Study. J Minim Invasive Gynecol. 2021 Jan;28(1):42-49. doi: 10.1016/j.jmig.2020.04.004. Epub 2020 Apr 10.
Clinical trial NCT06624306: Comparing Efficacy and Complication Between Prone Versus Prone-Flexed Position for Percutaneous Nephrolithotomy (PCNL)
Official title: Comparing Efficacy and Complication Between Prone Versus Prone-Flexed Position for Percutaneous Nephrolithotomy (PCNL)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Urolithiasis
Kidney Stone
Complication
Lead sponsor: Fayoum University Hospital
Sponsor class: OTHER
First posted: 2024-10-02
Enrollment: 85
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: Comparing Efficacy and Complication Between Prone Versus Prone-Flexed Position For Percutaneous Nephrolithotomy (PCNL)


Eligibility criteria: Inclusion Criteria:

1. Staghorn calculi
2. Renal pelvis stones \&gt;2 cm
3. Lower pole stones \&gt;1.5 cm
4. SWL-resistant stones

Exclusion Criteria:

1. Age \&lt;18 years or Pregnancy
2. Bilateral simultaneous PCNL
3. Need for 3 percutaneous tracts intraoperative
4. Morbid obesity (BMI \&gt;40)
5. Non opaque renal stones.
6. Refuse to complete study requirements
7. Atypical bowel interposition need CT guided puncture
8. Tumour in the presumptive access tract area or Potential malignant kidney tumour

Primary outcomes:
measure: Comparing the prone with the prone-flexed position for PCNL reporting complications
timeFrame: 1 year
Secondary outcomes:
measure: Assessment of stone free rate of the two groups
timeFrame: 1 year
Other outcomes:
Locations:
city: Fayoum
country: Egypt
facility: Fayoum faculty of Medicine
Study officials:
References:
Clinical trial NCT01897506: Assessing Risk of Food Insecurity Within Households of Children With Food Allergy
Official title: Assessing Risk of Food Insecurity Within Households of Children With Food Allergy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Food Allergy
Asthma
Allergic Rhinitis
Atopic Dermatitis
Eosinophilic Esophagitis
Keywords: Food insecurity
Health literacy
Quality of life
Lead sponsor: Arkansas Children's Hospital Research Institute
Sponsor class: OTHER
First posted: 2013-07-12
Enrollment: 650
Sex: ALL
Minimum age (years): 1
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Families with children who have allergy appointments at Arkansas Children's Hospital between 1-17 years of age. We will recruit 325 families with patients in the food allergy group and 325 families with patients in the without food allergy group.

Brief summary: Our central hypothesis is that dietary limitations introduced by food allergy will contribute to increased food insecurity in households with food allergic children when compared to food insecure households without food allergic children.

Detailed description: Specific Aim 1 To describe food insecurity in families of the pediatric allergy population, specifically comparing the prevalence of food insecurity rates between households of food allergic patients and households of allergic patients without food allergy.

Specific Aim 2 To examine health literacy in parents of patients in the pediatric allergy population, comparing food insecure patients with and without food allergy to food secure patients with food allergy.

Specific Aim 3 To examine quality of life in food allergic patients' households using the food allergy impact scale, comparing food allergic patients' households with food insecurity to food allergic patients' households without food insecurity.

Eligibility criteria: Inclusion Criteria:

* Parents whose child has an allergy appointment with the Allergy and Immunology Department at Arkansas Children's Hospital between 1-17 years of age with allergic disease

Exclusion Criteria:

* Parents whose child has an allergy appointment with the Allergy and Immunology Department at Arkansas Children's Hospital less than 1 years of age or 18 years of age and older will not be eligible to participate in this study. Children with immunodeficiency disease will be excluded.

Primary outcomes:
measure: Presence of food insecurity within an atopic population
timeFrame: 1.25 years
Secondary outcomes:
measure: Health Literacy Rate
timeFrame: 1.25 years
Other outcomes:
measure: Quality of life of families with food allergic members
timeFrame: 1.25 years
Locations:
city: Little Rock
country: United States
facility: Arkansas Children's Hospital
state: Arkansas
Study officials:
affiliation: University of Arkansas for Medical Sciences / Arkansas Children's Hospital
name: Stacie M Jones, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04662606: Neurofunctional Correlates of Intentional Actions Towards Food Stimuli
Official title: Neurofunctional Correlates of Intentional Actions Towards Food Stimuli
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Food Preferences
Lead sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Sponsor class: OTHER
First posted: 2020-12-10
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: In this project, the investigators will explore the cognitive neuroscience of intentional action in relation to food behaviour. To unravel how the brain systems involved in intentional control of actions and how these interact with the reward system in different physiological conditions and in relation to lean-weight or obesity, the investigators will manipulate the degree of intentionality of the behaviours under examination and the level of satiety of the participants.


Eligibility criteria: Inclusion Criteria:

* Normal weight (normal BMI)
* No MRI controindications
* No neurological or cognitive problems

Exclusion Criteria:

* Underweight or overweight
* MRI controindications
* Neurological or cognitive problems

Primary outcomes:
measure: BOLD (Blood Oxygen Level Dependent) signal
timeFrame: This outcome will be measured on the recruitment day
Secondary outcomes:
Other outcomes:
Locations:
city: Milano
country: Italy
facility: IRCCS Galeazzi
state: Italia
city: Milan
country: Italy
facility: IRCCS Istituto Ortopedico Galeazzi
state: Milano
Study officials:
References:
Clinical trial NCT00299806: SPP100 (Aliskiren) Regimen in Patients With Severe Hypertension
Official title: A Multi-center, Open-label Study Assessing the Safety and Efficacy of 8 Week's Treatment of SPP100 (Aliskiren) Regimen in Patients With Severe Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Keywords: Hypertension, aliskiren, blood pressure, rennin
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2006-03-07
Enrollment: 39
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Assessing the safety and efficacy of SPP100 (Aliskiren) regimen in patients with severe hypertension


Eligibility criteria: Inclusion Criteria:

* Age: 20 - 80 years old
* Gender: Male or female
* Status: Outpatients
* severe hypertension

Exclusion Criteria:

* Patients with a clinically significant allergy
* Patients who have received other investigational drug
* Alcoholic patients

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Incidence of adverse events after 8 weeks
Secondary outcomes:
measure: Change from baseline in mean sitting systolic and diastolic blood pressure after 8 weeks
measure: Average sitting systolic blood pressure/mean sitting diastolic blood is < 160/100 mmHg or blood pressure reduction from baseline is > 20/10 mmHg after 8 weeks
measure: Average sitting diastolic blood pressure < 90 mmHg or a reduction from baseline of > 10 mmHg after 8 weeks.
Other outcomes:
Locations:
city: Japan
country: Japan
facility: Novartis Pharmaceuticals
Study officials:
affiliation: Novartis Pharmaceuticals, Japan
name: Novartis Pharmaceuticals
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06871306: Investigation Of Transcutaneous Auricular Vagus Nerve Stimulation Efficacy In Female Fibromyalgia Patients
Official title: Investigation Of Transcutaneous Auricular Vagus Nerve Stimulation Efficacy In Female Fibromyalgia Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia Syndrome
Lead sponsor: Fenerbahce University
Sponsor class: OTHER
First posted: 2025-03-11
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: This study aimed to examine the effects of transcutaneous auricular vagus nerve stimulation (taVNS) on pain, depression, anxiety, functionality, and autonomic function in fibromyalgia syndrome (FMS).

primary hypothesis: TAVSS application is not an effective treatment for depression, physical limitation, functional disability, anxiety, pain and autonomic nerve system in female FMS patients.

secondary hypothesis: TAVSS application is an effective treatment for depression, physical limitation, functional disability, anxiety, pain and autonomic nerve system in female FMS patients.


Eligibility criteria: Inclusion Criteria:

* Female volunteer participants
* Aged 18-45 with regular menstrual cycles
* Diagnosed with FMS (Widespread Pain Index≥ 17
* Symptom Severity Scale≥ 21) according to the 2013 ACR diagnostic criteria by a specialist physician.

Exclusion Criteria:

* Neurological deficits,
* Diabetes
* Neuropathic disorders
* Chronic inflammation
* Immune deficiencies
* Cardiac diseases
* Pregnancy
* Being in the perimenopausal or postmenopausal stages,
* Menstrual cycles of less than 28 days,
* Started new medication within the last 3 months,
* Modifications to their existing treatment apart from taVNS.

Primary outcomes:
measure: Fibromyalgia Impact Questionnaire
timeFrame: From enrollment to the 28th day of control
measure: Visual Analog Scale
timeFrame: From enrollment to the 28th day of control
measure: PNS Index Activity
timeFrame: From enrollment to the 28th day of control
measure: SNS Index Activity
timeFrame: From enrollment to the 28th day of control
measure: Assessment of Autonomic Nervous System Activity (SNS and PNS Index)
timeFrame: From enrollment to the 28th day of control
Secondary outcomes:
measure: Beck Depression Index
timeFrame: From enrollment to the 28th day of control
measure: Beck Anxiety Inventory
timeFrame: From enrollment to the 28th day of control
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Sancak Tıp Merkezi
Study officials:
References: