louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05670613: Does a Clinical Support System for Parenteral Nutrition (PN) Facilitate the Judgement on Choosing the Most Effective Commercial Solution Per Patient (and Modify it, if Necessary)?
Official title: Does a Clinical Support System for Parenteral Nutrition (PN) Facilitate the Judgement on Choosing the Most Effective Commercial Solution Per Patient (and Modify it, if Necessary)? Is This Solution an Appropriate Alternative to Customized PN for Optimum Nutrition Outcome?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Clinical Decision Support System
Lead sponsor: Iaso Maternity Hospital, Athens, Greece
Sponsor class: OTHER
First posted: 2023-01-04
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: Standard formulas of PN have been developed and provided to patients. Only few randomized controlled studies compared standardized vs individualized PN. Individually tailored PN, only if standard PN solutions do not meet patient's nutritional needs. ASPEN society recommends the use computerized prescribing. Technology has enabled the incorporation of medical guidelines in CDSSs. New approach: Comparison of patient's calculated nutritional needs with commercial available solutions.


Eligibility criteria: Inclusion Criteria:

* Hospitalize Patients unable to be fed via gastrointestinal tract.
* Hemodynamically stable patients.
* PN regimen should remain the same for the first 3 days.

Exclusion Criteria:

* Hemodynamically unstable.
* Anticipated need for parenteral nutrition less than 5 days.

Primary outcomes:
measure: Estimate of Macro and Micro Nutrient Needs for PN.
timeFrame: 0 months - 12 months
measure: Estimate the difference between actual PN energy needs (kcal per day) and energy provided in the PN solutions available in the market (kcal per 100ml).
timeFrame: 0 months - 12 months
measure: Estimate the difference between actual PN needs and nutrient content of Ready to use Solution for PN available in the market.
timeFrame: 0 months - 12 months
measure: Estimate the difference between actual PN needs and nutrient content of Ready to use Solution for PN available in the market.
timeFrame: 0 months - 12 months
measure: Estimate the difference between actual PN needs and nutrient content of Ready to use Solution for PN available in the market.
timeFrame: 0 months - 12 months
measure: Difference of time spent on estimation of PN needs when conducted by hand and CDSS.
timeFrame: 0 months - 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Iaso General Hospital
Study officials:
References:
Clinical trial NCT04793113: A Study to Assess the Effects of Freshly Fit Meals on Body Weight and Wellness in Overweight and Obese Adults
Official title: A Study to Assess the Effects of Freshly Fit Meals on Body Weight and Wellness in Overweight and Obese Adults
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Weight Loss
Lead sponsor: Freshly, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Biofortis Clinical Research, Inc.
First posted: 2021-03-11
Enrollment: 50
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The primary objective of this trial is to examine the weight-loss efficacy of Freshly Fit meals, as well as body composition, waist/hip circumference, metabolic markers, and quality of life in overweight and obese adults.


Eligibility criteria: Inclusion Criteria:

* Male or female, 21-55 years of age, inclusive, at Visit 1 (Day -10).
* BMI of 25.00 to 34.99 kg/m2, inclusive, at Visits 1 and 2 (Day -10 and -3).
* Non-smoker and has no plans to change smoking habits during the study period.
* Willing to follow study instructions.
* Willing and able to comply with the visit schedule (e.g., subjects with travel plans and cannot fully comply with study instructions will be excluded).

Exclusion Criteria:

* Abnormal laboratory test result of clinical significance at Visit 1 (Day -10), at the discretion of the Investigator. One re-test will be allowed on a separate day prior to Visit 2 (Day -3) for subjects with abnormal laboratory test results.
* History or presence of clinically important cardiac, renal, hepatic, endocrine, pulmonary, biliary, pancreatic, or neurological disorders that may affect the subject's ability to adhere to the study protocol and/or affect study outcomes, in the judgment of the Investigator.
* History of gastrointestinal surgery for weight reducing purposes.
* Participation in a weight loss trial within 12 mo of Visit 1 (Day -10).
* Weight loss or gain ≥10 lb (4.5 kg) within the 6 mo prior to Visit 1 (Day -10). Participation in a program/service intended to alter body weight (e.g., Nutrisystem, Weight Watchers, Noom) within 6 mo of Visit 1 (Day -10).

Primary outcomes:
measure: Weight Change
timeFrame: 16 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Addison
country: United States
facility: Biofortis Clinical Research
state: Illinois
Study officials:
References:
Clinical trial NCT06146413: Triggering Oocyte Maturation in Normoresponders Using Double Trigger or HCG Trigger
Official title: Triggering Oocyte Maturation in Normoresponders Using Double Trigger or HCG Trigger . A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Infertility
Keywords: Infertility
IVF-ET
HCG trigger
Double trigger
Lead sponsor: Bedaya Hospital
Sponsor class: OTHER
First posted: 2023-11-24
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to compare the efficacy double trigger \[ co-administration of GnRH agonist with HCG 40 and 34 h prior to ovum pick-up, respectively\] with HCG trigger in inducing oocyte maturation.

Detailed description: Several studies revealed that the double trigger regimen was effective in the treatment of patients with a history of immature oocytes retrieved or with suboptimal oocytes yield.

The investigators designed this randomized controlled trial to compare the efficacy double trigger with HCG trigger in inducing oocyte maturation.in normoreponders undergoing IVF-ET

Eligibility criteria: Inclusion Criteria:

* Normoresponders
* GnRH antagonist cycles

Exclusion Criteria:

* BMI more than 35
* Endometriosis
* AMH less than 1.1 ng
* AMH more than 4
* PCOS
* Poor responders

Primary outcomes:
measure: Metaphase-II oocytes rate
timeFrame: Ten to fifteen days after starting ovarian stimulation
Secondary outcomes:
measure: Clinical pregnancy rate
timeFrame: 5 weeks after embryo transfer
measure: Ongoing Pregnancy Rate
timeFrame: 18 weeks after embryo transfer
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Bedaya Hospital
Study officials:
affiliation: Cairo University
name: Ismail Aboul Foutouh, Prof.
role: STUDY_CHAIR
References:
citation: Haas J, Zilberberg E, Dar S, Kedem A, Machtinger R, Orvieto R. Co-administration of GnRH-agonist and hCG for final oocyte maturation (double trigger) in patients with low number of oocytes retrieved per number of preovulatory follicles--a preliminary report. J Ovarian Res. 2014 Aug 2;7:77. doi: 10.1186/1757-2215-7-77.
Clinical trial NCT01652313: Pharmacokinetic Properties of Rasagiline (Lu 00-773) in Healthy Young Chinese Men and Women
Official title: A Single Centre, Open-label, Multiple-dose Interventional Study Investigating the Pharmacokinetic Properties of Rasagiline (Lu 00-773) in Healthy Young Chinese Men and Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Parkinson's Disease
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
First posted: 2012-07-30
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to fulfil regulatory requirements for registration of a new chemical entity in China. Rasagiline is approved for the treatment of Parkinson's Disease (PD) in Europe and the US. Rasagiline is safe and well tolerated in healthy subjects, and the efficacy and safety has been demonstrated in placebo- and active comparator-controlled phase III studies.


Eligibility criteria: Inclusion Criteria:

* The subject is a Chinese man or woman
* The subject is, in the opinion of the investigator, generally healthy
* If female, the subject must have a negative pregnancy test at screening and baseline, and agree not to try to become pregnant from Screening until after the Follow-up Visit

Exclusion Criteria:

* The subject is, in the opinion of the investigator, unlikely to comply with the clinical study protocol or is unsuitable for any other reason.

Other inclusion and exclusion criteria may apply.

Primary outcomes:
measure: Pharmacokinetic (PK) AUC determination of rasagiline and its metabolite 1-aminoindan (1-AI)
timeFrame: 7 days
measure: PK Cmax determination of rasagiline and its metabolite 1-aminoindan (1-AI)
timeFrame: 7 days
Secondary outcomes:
measure: Number of patients with adverse events as a measure of safety and tolerability
timeFrame: 7 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: CN001
Study officials:
affiliation: LundbeckClinicalTrials@lundbeck.com
name: Email contact via H. Lundbeck A/S
role: STUDY_DIRECTOR
References:
Clinical trial NCT01641913: Intestinal Permeability in Response to Treatment in Eosinophilic Esophagitis Patients
Official title: Determination of Intestinal Permeability and Response to Treatment in Patients With Eosinophilic Esophagitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Eosinophilic Esophagitis
Keywords: Eosinophilic Esophagitis
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2012-07-17
Enrollment: 20
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: Do patient's with eosinophilic esophagitis have increased small intestinal permeability and if this changes in response to topically administered esophageal steroids?

Detailed description: Eosinophilic esophagitis is an allergy mediated disease in which antigens exposed to the gastrointestinal tract trigger a combined immediate hypersensitivity.

The investigators anticipate that patients with active eosinophilic esophagitis will have increased intestinal permeability on urine collection of sugars. The investigators are not sure whether these findings will be found in patients who have been successfully treated with topical esophageal steroids. Improvement in intestinal permeability would be perceived as indicating that esophageal disease drives the intestinal permeability. Lack of improvement would indicate that eosinophilic esophagitis is a more systemic disease in which increased small bowel permeability is a marker or perhaps important driver of the disease.

Eligibility criteria: Inclusion Criteria:

* Subjects between the ages of 18 and 80 with Eosinophilic Esophagitis diagnosed by compatible symptoms, endoscopic findings, histology and lack of response to proton pump inhibitors or negative pH study.

Exclusion:

* Vulnerable populations, such as those with diminished mental acuity, will be excluded.
* Patients allergic to Lactulose
* Women who are pregnant or lactating.

Primary outcomes:
measure: To assess patients gastrointestinal symptoms in patients with EoE by means of standard validated questionnaires
timeFrame: 30 days
Secondary outcomes:
measure: To determine if patients with eosinophilic esophagitis have increased small intestinal permeability and if this changes in response to topically administered esophageal steroids.
timeFrame: 2 hours
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic, Rochester, MN
name: David Katzka, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00600613: Assess the Feasibility of Cone Beam CT to Localize Liver Metastases Immediately Prior to Radiotherapy
Official title: A Pilot Study to Assess the Feasibility of Cone Beam CT to Localize Liver Metastases Immediately Prior to Radiotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Localize Liver Metastases
Keywords: Radiation Therapy
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2008-01-25
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to test a new and possibly more accurate method of positioning patients with liver tumors in preparation for radiation treatment.

The positioning of patients with liver cancer is important because the tumor moves a bit when you breathe and makes it hard to determine the right position of the tumor at the time of treatment. Also, depending upon what is in your stomach at the time of treatment, it may change the shape of the liver and make it difficult to plan the radiation treatment. As part of this study, we will take a new type of image of your liver in addition to the standard portal images. This new type of image is called a cone-beam image. It shows a much more detailed picture of the liver tumors than the standard portal images. Normally, marker seeds need to be placed near the liver metastasis for radiation treatment. If the results of this study show that the tumor can be positioned as accurately with the new images as with the old images, then future patients with liver tumors would not have to have marker seeds placed into their liver. The use of cone beam imaging for the setup of patients with liver tumors is new.


Eligibility criteria: Inclusion Criteria:

* Age \> than or equal to 18 years
* KPS \> than or equal to 80
* Able to tolerate immobilization cradle positioning
* Able to give informed consent
* Histologically confirmed diagnosis of solid tumor malignancy
* Liver metastases visualized on CT imaging

Exclusion Criteria:

* Lymphoid primary histology (lymphoma/leukemia)
* Allergic reaction to intravenous CT contrast
* Liver function tests (AST, ALT, Bilirubin) \> 2.0 x normal
* Abnormal kidney function (serum creatinine \> 1.5)
* INR \> 2.0, Platelet count \<70.000.
* Marker seed placement not possible
* \> 5mm excursion after abdominal compression

Primary outcomes:
measure: Number of Participants Eligible for Cone Beam Tumor Localization"
timeFrame: Up to 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Yoshiya Yamada, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03363113: Outcome of Botulinum Toxin Treatment for Oromandibular Dystonia
Official title: Outcome of Botulinum Toxin Treatment for Oromandibular Dystonia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dystonia; Orofacial
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2017-12-06
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated by botulinum toxin injection for oromandibular dystonia in the Fondation Rothschild (Paris)

Brief summary: Symptoms of oromandibular dystonia can be alleviated by injections of botulinum toxin. The scope of this study is to describe the efficacy of this procedure, by a retrospective systematic review of patients medical charts


Eligibility criteria: Inclusion Criteria:

* Patient suffering from oromandibular dystonia
* Medical follow up in the Fondation Ophtalmologique Rothschild (Paris)
* Treatment by at least one session of botulinum toxin injection

Exclusion Criteria:

* Patient cannot assess symptoms improvement using a Likert scale

Primary outcomes:
measure: Clinical improvement score
timeFrame: Two months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00240513: Study Comparing Acne in Patients Taking Oral Minocycline to Patients Taking Minocycline Plus Topical Tretinoin
Official title: A Randomized Study to Compare the Acne Relapse Rate After a 3-mo Course of Oral Minocycline, to a 3-mo Course of Oral Minocycline in Combination With a Daily Dose of Topical Tretinoin 0.01% Followed by 3 mo of Topical Tretinoin Alone
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Acne Vulgaris
Keywords: Acne
Lead sponsor: Derm Research @ 888 Inc.
Sponsor class: INDUSTRY
Collaborators: name: Stiefel, a GSK Company
First posted: 2005-10-18
Enrollment: 38
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The use of oral antibiotics alone to treat inflammatory acne provides little to no long term therapeutic benefit.

Acne relapse rates can be reduced by using topical tretinoin 0.01% in conjunction with minocycline, thereby increasing the therapeutic effect of the oral antibiotic.

Detailed description: Although oral antibiotics have been the mainstay of treatment of inflammatory acne for 30 years, studies comparing their efficacy have little scientific value.

Evidence-based dermatology proves minocycline to be an effective treatment for acne vulgaris while the patient remains on the medication; however, the relapse rate of acne after a course of antibiotics has never been established.

The relapse rate would appear to be significant, as repeated courses and long-term antibiotic use are commonly prescribed in practice. The increasing problem of drug resistance has raised issues of the suitability of such long term antibiotic treatment and this overuse is probably a contributing factor of multiple drug resistance in our society.

Eligibility criteria: Inclusion Criteria:

* Provision of written consent
* Either sex
* Any age
* Diagnosis of acne vulgaris with a minimum of 20 inflammatory acne lesions on the face.

Exclusion Criteria:

* Known hypersensitivity to tetracyclines
* Use of any oral antibiotics in the previous 3 months
* Pregnancy, breast-feeding or lactating
* Inability or unwillingness to comply with the requirements of the protocol, or agree to the use of their data as determined by the investigator.
* Concomitant medical condition which, in the investigator's opinion, may confound the study results or interfere with study assessments or outcomes.
* Patients with severe acne on the chest, back or trunk.

Primary outcomes:
measure: Long-term efficacy
timeFrame: 4 years
Secondary outcomes:
measure: Relapse rate
timeFrame: 4 years
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Derm Research @ 888 Inc
state: British Columbia
Study officials:
affiliation: DermResearch @ 888 Inc.
name: Richard Thomas, MD, FRCP(C)
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06861413: A Phase 1 Study to Evaluate the Relative Bioavailability of a VX-828 Tablet Formulation
Official title: A Phase 1, Open-label, Randomized, Parallel Study to Evaluate the Relative Bioavailability of a Tablet Formulation of VX-828 in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cystic Fibrosis
Lead sponsor: Vertex Pharmaceuticals Incorporated
Sponsor class: INDUSTRY
First posted: 2025-03-06
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the relative bioavailability of a VX-828 tablet formulation compared to a suspension and evaluate its safety and tolerability.

Detailed description: This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.).

Eligibility criteria: Key Inclusion Criteria:

* Body mass index (BMI) of 18.0 to 32.0 kilogram per square meter (kg/m\^2)
* A total body weight of more than (\>) 50 Kg
* Nonsmoker or ex-smoker for at least 3 months before screening
* Participants of non-childbearing potential

Key Exclusion Criteria:

* History of febrile illness or other acute illness that has not fully resolved within 14 days before the first dose of study drug
* Any condition possibly affecting drug absorption

Other protocol defined Inclusion/Exclusion criteria may apply.

Primary outcomes:
measure: Area Under the Concentration Versus Time Curve from the Time of dosing to the Last Measurable Concentration (AUC0-tlast) of VX-828 in Plasma
timeFrame: From Day 1 up to Day 24
measure: Maximum Observed Concentration (Cmax) of VX-828 in Plasma
timeFrame: From Day 1 up to Day 24
Secondary outcomes:
measure: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: From Signing of Informed Consent Form (ICF) up to Safety Follow Up (Up to Day 36)
Other outcomes:
Locations:
city: Tempe
country: United States
facility: Celerion - Tempe
state: Arizona
Study officials:
References: