louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04334538: Effect of an Alternative RUTF on Intestinal Permeability in Children With Severe Acute Malnutrition
Official title: Effect of an Alternative RUTF on Intestinal Permeability in Children With Severe Acute Malnutrition
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malnutrition, Child
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: Project Peanut Butter, Sierra Leone
name: Ministry of Health and Sanitation, Sierra Leone
First posted: 2020-04-06
Enrollment: 129
Sex: ALL
Minimum age (years): 6
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Ready-to-use therapeutic food (RUTF) is the standard of care for the treatment of SAM. UNICEF requires that there be no oil separation in these products necessitating the use of emulsifiers. The effect of emulsifiers on gut health and integrity in children receiving an exclusive diet of RUTF is unknown. The PIs have recently completed a randomized, triple-blind, controlled, clinical equivalency trial in Sierra Leone comparing the alternative oat RUTF (oat-RUTF) to standard RUTF on recovery rates in children with SAM. This study demonstrated higher rates of recovery among children receiving the oat-RUTF. The investigators hypothesize that this benefit may be due to the lack of emulsifier in the oat-RUTF resulting in improved intestinal health.This research project is a double-blind, randomized, controlled clinical effectiveness trial comparing a novel RUTF containing oats and no emulsifier and standard RUTF on recovery from severe acute malnutrition (SAM) and effects on intestinal health. The trial will be conducted in up to 40 PHUs in Western Rural and Pujehun Districts where supplementary feeding programs (SFP) are not currently available.


Eligibility criteria: Inclusion Criteria:

* mid-upper arm circumference (MUAC) \<11.5 cm

Exclusion Criteria:

* Children currently involved in another research trial or feeding program
* Children developmentally delayed
* have a chronic debilitating illness
* history of peanut or milk allergy

Primary outcomes:
measure: Change of % of lactose excreted between enrollment and 4 weeks after enrollment
timeFrame: at week 4 after enrollment
Secondary outcomes:
measure: fecal 16S rRNA configuration after 4 weeks of feeding
timeFrame: after 4 weeks of feeding
Other outcomes:
Locations:
city: Pujehun
country: Sierra Leone
facility: Project Peanut Butter
Study officials:
References:
citation: Hendrixson DT, Naskidashvili N, Stephenson KB, Laury ML, Koroma AS, Manary MJ. An Alternative Oat-Containing, Ready-To-Use, Therapeutic Food Does Not Alter Intestinal Permeability or the 16S Ribosomal RNA Fecal Microbiome Configuration Among Children With Severe Malnutrition in Sierra Leone: A Randomized Controlled Trial. J Nutr. 2023 Jan 14;152(12):2744-2753. doi: 10.1093/jn/nxac207.
Clinical trial NCT02491138: An Evaluation of Appearance-based Interventions for the Promotion of Sleep
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Habits
Healthy
Keywords: participants
Lead sponsor: Yale-NUS College
Sponsor class: OTHER
Collaborators: name: Duke-NUS College
name: University of St Andrews
First posted: 2015-07-07
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study evaluates the efficacy of appearance-based interventions in promoting healthy sleep. One group of participants will receive standard information about sleep (control group), while the other group will receive information about how sleep affects their physical appearance (intervention group).


Eligibility criteria: Inclusion Criteria:

* 18-24 years
* \<7 hours of sleep routinely

Exclusion Criteria:

* per-existing medical, sleep, or psychiatric conditions;
* history of substance abuse.

Primary outcomes:
measure: Objective sleep duration
timeFrame: Up to 1 month after the intervention
measure: Self-reported sleep hygiene
timeFrame: Up to 1 month after the intervention
Secondary outcomes:
measure: Subjective sleep quality
timeFrame: Up to 1 month
measure: Insomnia-related cognition
timeFrame: Up to 1 month
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Yale-NUS College
Study officials:
References:
citation: Perucho I, Vijayakumar KM, Talamas SN, Chee MW, Perrett DI, Liu JCJ. A Web-Based Photo-Alteration Intervention to Promote Sleep: Randomized Controlled Trial. J Med Internet Res. 2019 Sep 26;21(9):e12500. doi: 10.2196/12500.
Clinical trial NCT05079438: Dendrobium Huoshanense Suppository in Rectal Cancer
Official title: A Multicenter Randomized Controlled Stage III Clinical Study of Dendrobium Huoshanense Suppository in Locally Advanced Rectal Cancer Patients Treated by Neoadjuvant Chemoradiotherapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Locally Advanced Rectal Cancer
Keywords: Neoadjuvant Chemoradiotherapy
Dendrobium Huoshanense
irinotecan
capecitabine
Lead sponsor: Zhejiang Cancer Hospital
Sponsor class: OTHER
First posted: 2021-10-15
Enrollment: 168
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To evaluates the role of Dendrobium Huoshanense Suppository for radiation proctitis in locally advanced rectal cancer treated by capecitabine and irinotecan based neoadjuvant chemoradiation.


Eligibility criteria: Inclusion Criteria:

1. pathological confirmed rectum adenocarcinoma
2. clinical stage T3-4 and/or N+
3. the distance from anal verge less than 10 cm
4. without distance metastases
5. performance status score: 0\~1
6. without previous anti-cancer therapy
7. able to follow the protocol during the study period
8. sign the inform consen

Exclusion Criteria:

1. Pregnant or breastfeeding women
2. Those with other history of malignant disease in the past 5 years, except for cured skin cancer and cervical carcinoma in situ
3. If there is an uncontrolled history of epilepsy, central nervous system disease or mental disorder, the investigator may determine that the clinical severity may hinder the signing of informed consent or affect the patient's oral medication compliance.
4. Clinically severe (ie, active) heart disease, such as symptomatic coronary heart disease, New York Heart Association (NYHA) class II or more severe congestive heart failure or severe arrhythmia requiring medication intervention (see appendix 12), or a history of myocardial infarction in the last 12 months
5. Organ transplantation requires immunosuppressive therapy Severe uncontrolled recurrent infections, or other serious uncontrolled concomitant diseases
6. Subject blood routine and biochemical indicators do not meet the following criteria: hemoglobin ≥ 90g / L; absolute neutrophil count (ANC) ≥ 1.5 × 109 / L; Alanine transaminase (ALT), aspartate aminotransferase (AST) ≤ 2.5 times the upper limit of normal; alkaline phosphatase (ALP) ≤2.5 times the normal upper limit; serum total bilirubin \<1.5 times the normal upper limit; serum creatinine \<1 times the normal upper limit; serum albumin ≥ 30g / L
7. Anyone who is allergic to any research medication
8. DPD deficiency

Primary outcomes:
measure: ≥Grade 2 proctitis
timeFrame: During chemoradiotherapy
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Ji Zhu
state: Zhejiang
Study officials:
References:
Clinical trial NCT01750138: SNE1725: Can Oral Glutamine Facilitate Early Return of Gut Function
Official title: Can Preoperative Oral Glutamine Facilitate Earlier Return of Gut Function in Patients Undergoing Colorectal Surgery. A Prospective Randomized Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gut Function
Lead sponsor: Scarborough General Hospital
Sponsor class: OTHER
First posted: 2012-12-17
Enrollment: 206
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The gastrointestinal tract has many functions; it provides nutrition, produces hormones, performs a barrier function, maintains a stable gastrointestinal micro flora and plays an important role in the inflammatory process as it is the largest producer of cytokines (proteins associated with inflammation). This gut function is impaired after colorectal (bowel) surgery. There is evidence to suggest that impaired gut function is associated with increased complications. Hence if gut function is preserved, it should equate with better outcomes. As a result, there has been increasing interest in treatments called Gut Specific Nutrients (GSN), which specifically target gut function. Most notable of them is Glutamine, a conditionally essential amino acid and preferred fuel source for intestinal cells. Research has shown that glutamine promotes cell growth, increases clearance of harmful organisms from the blood, and reduces the surgical stress response. In other words, glutamine has a favourable influence on gut function.

Recent studies from our unit using intravenous glutamine in critically ill patients have shown an early return of gut function, which in turn is associated with attenuation of the inflammatory response and improved outcomes. It is not known whether oral glutamine is associated with a similar outcome. A recent pilot study at our unit suggests an association between oral glutamine and early return of gut function. The aim of this research is to determine if giving oral glutamine results in an early return of gut function and whether this is associated with an attenuation of the systemic inflammatory response.


Eligibility criteria: Inclusion Criteria:

* All adult patients undergoing elective colorectal surgery (both open or keyhole) will be eligible for the study.

Exclusion Criteria:

* Allergy to glutamine/placebo
* Failure to obtain informed consent.
* Patients with existing infections.
* Pregnant women and children under the age of 18 years will be excluded from the study.
* Patients on antibiotics in the previous 2 weeks.

Primary outcomes:
measure: Gut function
timeFrame: post op
Secondary outcomes:
Other outcomes:
Locations:
city: Scarborough
country: United Kingdom
facility: Scarborough District Hospital
state: North Yorkshire
Study officials:
affiliation: Scarborough General Hospital
name: syed irfan kabir, MBBS, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02882438: Glucosamine Sulphate and Ginkgo Biloba as Antifungal Activity for Treating Tinea Pedis
Official title: Glucosamine Sulphate and Ginkgo Biloba for Treating Tinea Pedis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Foot Infection Tinea Pedis
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2016-08-29
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Tinea Pedis infected the feet of about 20-25% of the world population. Tinea Pedis is a fungal infection of the feet and it is easily spread. Oral therapy is usually used for chronic conditions or when topical treatment has failed. The aim of this study is to prove the antifungal and antibacterial activity of Ginko Biloba (GKB) \& Glucosamine (GL) as separate material or both in combination.

Detailed description: Ginko Biloba (GKB) \& Glucosamine (GL) were formulated in different dosage forms such as capsules, hydrogel and spray. GKB\&GL were in filled in hard gelatin capsules as three formulae (GKB caps, GL caps and both as mixture in caps). Also, GKB\&GL were formulated in hydrogel using 2% carbopol 934 as three formulae (GKB only, GL only and both as mixture). The same also were formulated as spray using alcohol, water and glycerol in concentration of 60%, 20% and 20% respectively. The study included 5 trials, involving 35 participants. The oral formulae were tried on 30 participants having Tenia Pedis. Fluconazole was as standard antifungal drug.The antifungal activity of all gel formulae was determined by Agar well-diffusion method. It is also important to follow up and collect data, preferably for six months for local and systemic activity, to establish whether or not the infection recurred or not. In future clinical trials, research should consider the costs of the different treatment approaches.

Eligibility criteria: Inclusion Criteria:

* It is important to follow up and collect data, preferably for six months for local and systemic activity of Ginkgo Biloba and Glucosamine, to establish whether the infection recurrent or not.

Exclusion Criteria:

* Larger numbers of participants having different kind of fungal infection are needed to test efficiency drug in order to produce more reliable data.

Primary outcomes:
measure: Assessment the antifungal activity of Ginkgo Biloba & Glucosamine
timeFrame: six months
Secondary outcomes:
measure: Stability test for different dosage forms
timeFrame: three months
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut Clinic
Study officials:
References:
citation: Tauber A, Muller-Goymann CC. In vitro model of infected stratum corneum for the efficacy evaluation of poloxamer 407-based formulations of ciclopirox olamine against Trichophyton rubrum as well as differential scanning calorimetry and stability studies. Int J Pharm. 2015 Oct 15;494(1):304-11. doi: 10.1016/j.ijpharm.2015.08.023. Epub 2015 Aug 11.
Clinical trial NCT06877338: Inspiratory and Trunk Muscle Activity During IMT on Stable and Unstable Surfaces in Stroke Patients
Official title: Inspiratory and Trunk Muscle Activity During Inspiratory Muscle Training on Stable and Unstable Surfaces in People After Stroke
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Stroke
Inspiratory Muscle Training
Diaphragm
Sternocleidomastoid Muscles
Trunk Muscle Activity
Lead sponsor: Hong Kong Metropolitan University
Sponsor class: OTHER
First posted: 2025-03-14
Enrollment: 24
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: People diagnosed with stroke who meet the criteria will be invited to participate in the study

Brief summary: This study aims to investigate the differences in muscle recruitment of the diaphragm (assessed using ultrasound), the sternocleidomastoid (SCM) and trunk muscles (both measured via surface electromyography (sEMG)), during loaded breathing training performed on both stable and unstable surfaces. The goal is to understand the interaction between the inspiratory and trunk muscles during Inspiratory muscle training (IMT) across these two surface conditions.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 40 years and \< 80 years
* Breathing spontaneously
* Clinically diagnosed with ischemic and/or hemorrhagic stroke
* Stroke duration from onset between 1 and 12 months
* No thoracic or abdominal surgery in the past 6 months
* No cognitive impairment (Montreal Cognitive Assessment (MoCA) score ≥ 26)
* Able to understand and follow verbal instructions
* No facial palsy or only mild facial palsy without limitation of labial occlusion
* Able to complete all loaded breathing tests on both stable and unstable surfaces included in this study

Exclusion Criteria:

* Acute myocardial infarction or acute heart failure
* Acute pain in any part of the body
* History of chronic respiratory illness or positive clinical signs of impaired respiratory function (such as shortness of breath, hypoxemia, chronic cough, and sputum retention)
* Presence of a nasal feeding tube, tracheal tube, or any condition that prevents the measurement or implementation of the study procedures

Primary outcomes:
measure: Diaphragmatic thickening fraction
timeFrame: Day 1
Secondary outcomes:
measure: Muscle activation of the sternocleidomastoid muscle
timeFrame: Day 1
measure: Muscle activation of the trunk muscles
timeFrame: Day 1
measure: Perceived Exertion Borg scale
timeFrame: Day 1
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04952038: Sleep Disorders and the Onset and Progression of ALS
Official title: Effect of Sleep Disorder on Onset and Progression of Amyotrophic Lateral Sclerosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Amyotrophic Lateral Sclerosis
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2021-07-07
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients diagnosed as probable, or definite ALS

Brief summary: 200 cases of ALS patients were collected to explore whether sleep disorders are related to earlier onset age, and whether sleep disorders accelerate the progress of ALS and shorten the survival time of ALS patients.

Detailed description: 200 patients with ALS were collected. 1) sleep disorders were assessed by Pittsburgh sleep quality index (PSQI) and Epworth Sleepiness Scale (epworth) at baseline Sleeping Scale，ESS）； 2) Name, age, gender and onset site were collected to explore whether sleep disorders were associated with earlier onset age; 3) The patients' function (ALSFRS-R) at baseline and every 3 months within 2 years were collected, and the end-point time (death and invasive breathing) was recorded to evaluate whether sleep disturbance accelerated the decline of patients' function and shortened their short-term survival.

Eligibility criteria: Inclusion Criteria:

* Patients who have been diagnosed in the Department of Neurology of the Third Hospital of Beijing Medical University since August 2020. The clinical diagnosis of patients with amyotrophic lateral sclerosis includes: probable and define;
* Informed consent has been signed.

Exclusion Criteria:

* Those who can not cooperate to complete the scale and receive follow-up.

Primary outcomes:
measure: ALSFERS-R
timeFrame: 2 years
measure: end point event
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
Study officials:
affiliation: Peking University Third Hospital
name: Dongsheng Fan
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01332838: A Comparison of Specialized Versus Standard Compression After Saphenous Ablation
Official title: A Comparison of Specialized Versus Standard Compression After Saphenous Ablation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Varicose Veins
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: Lake Washington Vascular
name: Sigvaris, Inc
First posted: 2011-04-11
Enrollment: 20
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 determine if the use of specialized compression garments, in comparison to standard compression, improves early patient outcomes after endovenous ablation.


Eligibility criteria: Inclusion Criteria:

* Age 18 years and above
* CEAP Class C2 or C3 disease
* Incompetence of the great saphenous vein defined a reflux persisting\>0.5 seconds in the upright position
* Planned endovenous ablation of the great saphenous vein

Exclusion Criteria:

* Inability of patient or legal guardian to provide informed consent
* Previous history of DVT
* Clinical evidence of significant chronic venous disease (CEAP classes C4, C5, C6)
* Planned concomitant phlebectomy or sclerotherapy within 4 weeks of endovenous ablation
* Documented allergy or intolerance to compression stockings
* Arterial insufficiency as documented by an ankle-brachial index \<0.5
* Known prothrombotic condition
* Life expectancy less than 1 year
* Inability to return for follow-up due to geographic inaccessibility, concurrent medical conditions or substance abuse
* Weight greater than 220 pounds or height \> 6'4"

Primary outcomes:
measure: Behavioral Recovery After Varicose Veins (BRAVV) score.
timeFrame: 7 days
Secondary outcomes:
measure: Additional scoring and venous duplex ultrasonography
timeFrame: 7 and 28 days
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
References:
Clinical trial NCT04714138: Remote Video Consultation for Quality of Life Assessment in Patients Hospitalised After COVID-19 Infection
Official title: Remote Evaluation of Quality of Life and Functional Capacities in Patients Hospitalised for COVID-19: a Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Lead sponsor: Groupe Hospitalier du Havre
Sponsor class: OTHER
First posted: 2021-01-19
Enrollment: 157
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: COVID-19 adults patients hospitalised at Le Havre hospital between March 1st and May 11th

Brief summary: Around 90.000 patients have been hospitalised due to COVID-19 infection in France between March 1st and June 15th; 19% of those requiring intensive care. Approximately 80% of these patients have been discharged home by September 30th. Nonetheless, COVID-19 infection along with intensive care consequences are very likely to impede those patients quality of life and functional capacities.

This study aims to describe the quality of life outcomes and functional capacities of COVID-19 survivors, at least 6 months after primary care hospital discharge.


Eligibility criteria: Inclusion Criteria:

* Adult patient
* COVID-19 hospitalisation at Le Havre hospital between March 1st and May 11th
* Non-opposition during first phone contact

Exclusion Criteria:

* Guardianship
* Juvenile patients
* Pregnancy
* Inability to communicate
* Cognitive disorders
* Deceased patient

Primary outcomes:
measure: Health-related quality of life
timeFrame: 10 to 12 months after hospital discharge during remote video consultation
Secondary outcomes:
measure: Functional capacity
timeFrame: 10 to 12 months after hospital discharge during remote video consultation
measure: Independency
timeFrame: 10 to 12 months after hospital discharge during remote video consultation
Other outcomes:
Locations:
city: Montivilliers
country: France
facility: Groupe Hospitalier Du Havre
state: Normandie
Study officials:
References: