louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05500040: Changes in Faecal Calprotectin Levels and Participation-related Scores Following Three Weeks of Inpatient Rehabilitation
Official title: Veränderungen Des Faecalen Calprotectinwertes Und Teilhabebezogener Scores in Folge Einer Dreiwöchigen Phase II Rehabilitation [Changes in Faecal Calprotectin Levels and Participation-related Scores Following Three Weeks of Inpatient Rehabilitation]
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Crohn Disease
Ulcerative Colitis
Lead sponsor: Pensionsversicherungsanstalt
Sponsor class: OTHER
First posted: 2022-08-12
Enrollment: 226
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: Rehabilitation patients with IBD in inpatient rehabilitation

Brief summary: For many people affected by inflammatory bowel disease (IBD), their quality of life and their ability to participate in their professional and social lives are severely restricted. Rehabilitation measures based on the biopsychosocial ICF model aim to support the restoration of these abilities. Physiological parameters (e.g. biomarkers) as well as patient-reported outcomes (PROs) can be used to assess the success of ICF-based rehabilitation measures and to optimize them. A suitable biomarker to monitor inflammation in IBD patients is faecal calprotectin. In addition, PROs that support patients in providing information, for example on their health-related quality of life or on their subjective ability to work, can provide information on the individual social and occupational participation ability of the patients. The aim of this project is to investigate changes in a biomarker (calprotectin) as well as in selected PROs after a three-week inpatient phase II rehabilitation.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of Crohn's Disease or Ulcerative Colitis
* Participation in an inpatient phase II rehabilitation

Exclusion Criteria:

-

Primary outcomes:
measure: Faecal Calprotectin
timeFrame: 3 weeks of inpatient rehabilitation
measure: Ced Disk
timeFrame: 3 weeks of inpatient rehabilitation
measure: European Quality of Life 5 Dimensions 5 Level (EQ-5D-5L)
timeFrame: 3 weeks of inpatient rehabilitation
measure: Patient Health Questionnaire-4 (PHQ-4)
timeFrame: 3 weeks of inpatient rehabilitation
measure: Work ability index (WAI)
timeFrame: 3 weeks of inpatient rehabilitation
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Rehabilitationszentrum Bad Aussee
state: Styria
Study officials:
affiliation: Pensionsversicherungsanstalt
name: Doreen Stöhr, Mag.
role: STUDY_CHAIR
References:
Clinical trial NCT06387940: Acute Metabolic Effects of Carbohydrate Restriction at Varying Energy Levels
Official title: Investigation Into the Postprandial Effects of Varying Calorie Content of Low-Carbohydrate Diets on Human Metabolic Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: University of Surrey
Sponsor class: OTHER
First posted: 2024-04-29
Enrollment: 12
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study investigates how different low-carbohydrate diets affect metabolism and hunger in overweight adults. We will measure metabolic rates and blood metabolites.

Detailed description: Participants will engage in three distinct eating plans: a standard diet with usual carbohydrate and calorie levels, a low-carb diet with typical calories, and a low-carb diet with reduced calories. Each diet is followed for a single day, with subsequent monitoring to assess how the body processes food and manages hunger after a meal. The goal is to understand the potential metabolic benefits of reducing carbohydrate intake, either alone or in combination with calorie reduction. This research aims to identify simpler dietary strategies that could improve heart health and assist in weight management without the need for severe calorie restriction or fasting, offering valuable insights for enhancing health outcomes in overweight individuals.

Eligibility criteria: Inclusion Criteria:

* stable weight within ±3 kg over the past three months
* no significant medical history.

Exclusion Criteria:

* pregnancy
* breastfeeding,
* using medications that could affect the study's outcomes
* high intake of caffeine and alcohol
* existing eating or psychiatric disorders
* adherence to strict dietary regimens like veganism
* high BMI resulting from significant muscle mass

Primary outcomes:
measure: Biomarkers in blood Measured
timeFrame: 8 hours (fasting and post-meal)
measure: Resting metabolic rate
timeFrame: 8 hours (fasting and post-meal)
Secondary outcomes:
measure: Perceived Appetite Scores
timeFrame: 8 hours (fasting and post-meal)
measure: Food intake
timeFrame: baseline and after each diet arm for 1 day
Other outcomes:
Locations:
city: Guildford
country: United Kingdom
facility: University of Surrey
Study officials:
affiliation: University of Surrey
name: Hayriye Biyikoglu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05292040: A Study of LY3857210 in Healthy Participants
Official title: An Adaptive Design, Phase 1, Open-label Study to Investigate Receptor Occupancy in Brain After Single Oral Doses of LY3857210 as Measured by Positron Emission Tomography (PET) With the Radioligand [18F]-LY3818850 in Healthy Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2022-03-23
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The main purpose of this study is to evaluate the presence of study drug LY3857210 in the brain measured by positron emission tomography (PET) with the radioligand \[18F\]-LY3818850 in healthy participants. The safety and tolerability of LY3857210 will also be evaluated. The study will last up to approximately 6 weeks for each participant and may include up to four visits to the study center.


Eligibility criteria: Inclusion Criteria:

* Overtly healthy male or female participants as determined by medical evaluation
* Have body weight ≥ 45 kilograms (kg) and body mass index (BMI) within the range 18.5 to 32.0 kilograms per square meter (kg/m²) (inclusive)
* Are males and in agreement to follow contraceptive requirements, or women of non-child-bearing potential

Exclusion Criteria:

* Have contraindications to undergoing magnetic resonance imaging (MRI) examination including but not limited to implants such as implanted cardiac pacemakers or defibrillators, insulin pumps, cochlear implants, metallic ocular foreign body, implanted neural stimulators, CNS aneurysm clips, and other medical implants that have not been certified for head MRI
* Have clinically significant findings on the screening MRI scan, as judged by the investigator
* Suffer from claustrophobia and would be unable to tolerate the confined spaces of MRI or PET camera

Primary outcomes:
measure: Change from baseline in brain receptor occupancy (RO) of LY3857210 measured by [18F]-LY3818850 PET scan
timeFrame: Baseline through study completion, up to approximately 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Invicro, Institute for Neurodegenerative Disorders
state: Connecticut
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
Clinical trial NCT00004340: Phase II Randomized Study of the Effects of Growth Hormone on Children and Adolescents on Maintenance Dialysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Renal Osteodystrophy
End Stage Renal Disease
Keywords: end stage renal disease
rare disease
renal and genitourinary disorders
renal osteodystrophy
Lead sponsor: National Center for Research Resources (NCRR)
Sponsor class: NIH
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: University of California, Los Angeles
First posted: 1999-10-19
Enrollment: 109
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: OBJECTIVES: I. Evaluate the separate and combined skeletal effects of recombinant human growth hormone (GH) and calcitriol in patients with adynamic renal osteodystrophy.

II. Assess whether calcium-regulated changes in parathyroid hormone secretion predict changes in bone formation.

III. Characterize the response to GH in cancellous bone and in growth plate cartilage in patients with secondary hyperparathyroidism during calcitriol therapy.

Detailed description: PROTOCOL OUTLINE: This is a randomized study. Patients are stratified by bone lesion turnover and secondary hyperparathyroidism.

Patients in the first group are treated with recombinant human growth hormone subcutaneously every day for 8 months.

Patients in the second group are treated with calcitriol for 8 months, administered as a daily oral dose or an intraperitoneal dose three times a week.

Patients in the third group are treated with growth hormone and calcitriol (same dosages as above).

A control group does not receive any hormonal therapy.

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

* End-stage renal disease undergoing continuous cycling peritoneal dialysis at the University of California at Los Angeles

--Prior/Concurrent Therapy--

* No concurrent prednisone
* No concurrent cytotoxic agents
* At least 12 months since parathyroidectomy

--Patient Characteristics--

* Other: No documented history of poor compliance with medical treatment regimens

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California Los Angeles School of Medicine
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Isidro B. Salusky
role: STUDY_CHAIR
References:
Clinical trial NCT02681640: uPAR PET/CT for Preoperative Staging of Breast Cancer Patients
Official title: Phase II Trial: uPAR PET/CT for Preoperative Staging of Breast Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: Curasight ApS
First posted: 2016-02-12
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The sensitivity and specificity of uPAR PET/CT for preoperative detection of lymph node metastases in breast cancer.

Detailed description: The sensitivity and specificity of uPAR PET/CT for detection of lymph node metastases will be tested by observer-blinded readings (two separate teams) and compared to diagnostic performance of conventional preoperative diagnostic workup procedures. The reference test will be histopathology of lymph nodes obtained by operative lymph node dissection (SN/ALND). Primary end point dichotomized: +/- lymph node metastases in ipsilateral axilla.

Eligibility criteria: Inclusion Criteria:

* Biopsy-verified breast cancer
* Primary tumor more than 2 cm (ultrasound or clinically)
* The participants must be capable of understanding and giving full informed written consent

Exclusion Criteria:

* Pregnancy
* Lactation/breast feeding
* Weight above 140 kg
* Treatment with neoadjuvant chemotherapy
* Known allergy towards the IMP

Primary outcomes:
measure: Sensitivity and specificity of uPAR PET/CT in identifying axillary lymph node metastases from breast cancer
timeFrame: 1 hour
Secondary outcomes:
measure: Number of axillary lymph node metastasis
timeFrame: 1 hour
measure: Number of distant metastases
timeFrame: 1 hour
Other outcomes:
measure: Optimal time point for performing PET/CT following injection of 68Ga-NOTA-AE105
timeFrame: 0-60 minutes
Locations:
city: Copenhagen
country: Denmark
facility: Department of Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet
Study officials:
affiliation: Rigshospitalet, Denmark
name: Dorthe Skovgaard, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05593640: Thromboxane A2 and Osteoarthritis
Official title: Throboxane Effect on Chondrocytes; Role in Osteoarthritis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Osteoarthritis
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
Collaborators: name: French Society of Rheumatology
First posted: 2022-10-25
Enrollment: 20
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with osteoarthritis and knee effusion

Brief summary: TXA2 inhibits the expression of the primary marker of thermogenesis (UCP1) while prostacyclin (PGI2), another metabolite derived from arachidonic acid, enhances its expression. Given the close relationship between the adipocyte and the chondrocyte, the study team hypothesises that thromboxane A2 controls chondrocyte formation and function and thus cartilage homeostasis. The study objectives are: i) to analyse the role of TXA2 on chondrocyte differentiation in vitro, ii) to determine the association between circulating and tissue TXA2 levels in a rat model of osteoarthritis, and iii) to correlate circulating and synovial fluid levels of TXA2 with the development of osteoarthritis in a small human cohort. The proposed research aims to better understand the mechanisms underlying the role of lipid metabolites in chondrocyte formation and function, paving the way for the development of nutritional and pharmacological therapies to combat OA and associated metabolic disorders.


Eligibility criteria: Inclusion Criteria:

* presence of knee osteoarthritis with effusion, , no inflammatory disease

Exclusion Criteria:

* anticoagulant treatment
* inflammatory disease

Primary outcomes:
measure: to look for correlation between the rate of throboxane and the grade of osteoarthritis
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: NICE Cedex 1
country: France
facility: CHU de NICE
Study officials:
References:
Clinical trial NCT06937840: Comparison of Optimal Endotracheal Tube Depth Using Four Different Formulas in Children Aged 1-4 Years and Verification With Fiberoptic Bronchoscopy
Official title: Comparison of Optimal Endotracheal Tube Depth Using Four Different Formulas (Based on Age, Height, Weight, and Third Finger Length) in Children Aged 1-4 Years and Verification With Fiberoptic Bronchoscopy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pediatric Surgical Procedures Requiring Endotracheal Intubation Under General Anesthesia
Keywords: Pediatric airway, endotracheal tube, intubation depth
Lead sponsor: Ankara University
Sponsor class: OTHER
First posted: 2025-04-22
Enrollment: 120
Sex: ALL
Minimum age (years): 1
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Between 1 and 4years of ages pediatric patients scheduled for elective surgery under general anesthesia

Brief summary: . The optimal position of the endotracheal tube (ETT) within the trachea is the middle third portion, distal to the vocal cords. In addition to clinical assessments, methods such as posteroanterior chest radiography (PA-CXR) and fiberoptic bronchoscopy (FOB) can be used to verify ETT placement.

In our study, we aim to explain the relationship between the most accurate endotracheal tube depth and various formulas by using fiberoptic bronchoscopy, with the help of four different formulas based on age, height, weight, and third finger length.The study further seeks to:

1. To identify the most accurate formula for estimating ETT placement depth in the pediatric population living in Turkey.
2. To reduce the potential complications that may arise from incorrect ETT depth.
3. To determine which formula, when verified by fiberoptic bronchoscopy, is also consistent with auscultation findings-especially in situations where chest radiography or fiberoptic bronchoscopy may not be readily available.


Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists (ASA) physical status 1 , 2 or 3
* Patients scheduled for elective surgical procedures
* Informed consent must be obtained from both the patient and, if applicable, their parent or guardian.

Exclusion Criteria:

* Patients under 1 year old or over 4 years old
* Patients with tracheobronchial anomalies
* Patients with vertebral column anomalies
* Patients with a history of tracheostomy and difficult intubation
* Patients who do not want to be included in the study
* Children with finger anomalies and syndromic associations
* Cases requiring nasal intubation

Primary outcomes:
measure: To determine the correct depth of endotracheal tube insertion
timeFrame: only once
measure: A comparative analysis of four formulas used to determine endotracheal tube positioning
timeFrame: only once
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara University School Of Medicine
Study officials:
References:
Clinical trial NCT04463940: Xanthine Oxidase and Uric Acid Origin in Preeclamptic Women
Official title: The Origin of Xanthine Oxidase and Its Metabolite, Uric Acid, in Preeclamptic Pregnant Women - A Pilot Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pre-Eclampsia
Hyperuricemia
Keywords: Xanthine oxidase
Uric acid
Lead sponsor: Barzilai Medical Center
Sponsor class: OTHER
First posted: 2020-07-09
Enrollment: 100
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women with and without diagnosis of Pre-Eclampsia and serum Uric Acid greater than 6 mg/dL

Brief summary: Findings regarding the presence of xanthine oxidase and uric acid in different blood locations is important in preeclamptic women. We aim to detecting Xanthine oxidase and uric acid levels in both umbilical cord artery and vein as well as maternal blood (3 "locations") in pregnant women with and without diagnosis of preeclampsia. The study population will be divided into groups matching the three "locations" in order to describe and compare outcome levels.

Detailed description: Significance - findings regarding the presence of xanthine oxidase and uric acid in different blood locations may provide a scientific basis for understanding the source of them in preeclamptic women. Aim - detecting Xanthine oxidase and uric acid levels in both umbilical cord artery and vein as well as maternal blood (3 "locations"). Methods - samples will be collected from pregnant women with and without diagnosis of preeclampsia with blood uric acid \> 6 mg/dL. Than the study population will be divided into groups matching the three "locations". The investigators will describe and compare outcome levels (including Xanthine oxidase, uric acid).

Eligibility criteria: Inclusion Criteria:

* preeclampsia and none-preeclampsia diagnosed pregnant women.

Exclusion Criteria:

* Known or reported kidney disease.

Primary outcomes:
measure: Uric Acid
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Ashkelon
country: Israel
facility: Barzilai Medical Center
Study officials:
affiliation: Barzilai University Medical Center
name: Simon Shenhav, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01788540: Intralipid for Recurrent Miscarriage
Official title: The Role of Intralipid in Natural Killer Cell Positive Cases With Recurrent Miscarriages Undergoing IVF/ICSI Cycles: a Double Blind Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Abortion, Spontaneous
Abortion, Habitual
Keywords: Recurrent miscarriage
Implantation failure
Intralipid
ICSI / IVF failure
Lead sponsor: Woman's Health University Hospital, Egypt
Sponsor class: OTHER
First posted: 2013-02-11
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Intralipid infusion can improve the outcome in NK cells positive females with history of recurrent miscarriages undergoing IVF/ICSI cycles.


Eligibility criteria: Inclusion Criteria:

* Couples with unexplained secondary infertility
* Three or more prior consecutive clinical miscarriages after either spontaneous pregnancy or after IVF/ICSI.
* Elevated natural killer (NK) cells CD16, CD56 and cells with both CD16/CD56 \>12%.

Exclusion Criteria:

* Age above forty years old.
* Antiphospholipid syndrome (lupus anticoagulant and/or anticardiolipin antibodies \[IgG or IgM\]); other recognised thrombophilic conditions (testing according to usual clinic practice).
* Intrauterine abnormalities (as assessed by ultrasound, hysterosonography, hysterosalpingogram, or hysteroscopy).
* Abnormal parental karyotype.
* Other identifiable causes of recurrent miscarriages (tests initiated only if clinically indicated) e.g., diabetes, thyroid disease and systemic lupus erythematosus (SLE).
* Disturbances of normal fat metabolism such as pathologic hyperlipemia
* Allergic to it; or to eggs, soybean oil, or safflower oil.
* Severe liver disease, kidney disease, lung disease, anemia, blood clotting disorder.

Primary outcomes:
measure: chemical pregnancy rate
timeFrame: 10 months
Secondary outcomes:
measure: clinical pregnancy rate,
timeFrame: 10 months
Other outcomes:
measure: ongoing pregnancy rate
timeFrame: 10 months
measure: abortion rate
timeFrame: 12 months
Locations:
city: Cairo
country: Egypt
facility: Kasr el ainy hospital
Study officials:
affiliation: Cairo University
name: Dina M Dakhly, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dakhly DM, Bayoumi YA, Sharkawy M, Gad Allah SH, Hassan MA, Gouda HM, Hashem AT, Hatem DL, Ahmed MF, El-Khayat W. Intralipid supplementation in women with recurrent spontaneous abortion and elevated levels of natural killer cells. Int J Gynaecol Obstet. 2016 Dec;135(3):324-327. doi: 10.1016/j.ijgo.2016.06.026. Epub 2016 Aug 30.