louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04745221: Efficacy and Safety of Auto-FMT in Preventing aGVHD
Official title: Efficacy and Safety of Autologous Fecal Bacteria Transplantation in Preventing Acute Graft Versus Host Disease After Haploidentical Hematopoietic Stem Cell Transplantation: a Multicenter, Open, Randomized Controlled Clinical Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Graft Versus Host Disease, Acute
Lead sponsor: The First Affiliated Hospital of Soochow University
Sponsor class: OTHER
First posted: 2021-02-09
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: To evaluation the efficacy and safety of autologous fecal bacteria transplantation in preventing acute graft versus host disease after haploidentical hematopoietic stem cell transplantation. Bone marrow transplant patients were recruited.


Eligibility criteria: Inclusion Criteria:

* Haplo-HSCT patients; Bacteroidetes \>0.1%; inverse Simpson diversity ≥2

Exclusion Criteria:

* Gastrointestinal diseases；Age\>60; or Age\<10；Probiotics or prebiotics were taken before enrollment

Primary outcomes:
measure: Acute Graft-Versus-Host Disease
timeFrame: 90 days after haploidentical hematopoietic stem cell transplantation
Secondary outcomes:
measure: overall survival
timeFrame: 90 days after haploidentical hematopoietic stem cell transplantation
measure: Event free survival
timeFrame: 90 days after haploidentical hematopoietic stem cell transplantation
Other outcomes:
Locations:
city: Suzhou
country: China
facility: Ye Zhao
state: Jiangsu
Study officials:
References:
Clinical trial NCT03619421: Zinc Supplement Before or With Food in Generally Healthy Men
Official title: Evaluation of Zinc Supplementation Taken Prior or With Food
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Zinc Deficiency
Dyslipidemias
Zinc Excess
Inflammation
Keywords: zinc
nutrition
supplement
food
Lead sponsor: UCSF Benioff Children's Hospital Oakland
Sponsor class: OTHER
First posted: 2018-08-07
Enrollment: 35
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to determine the influence of food consumption timing on the body's response to a zinc supplement

Detailed description: This research is a dietary intervention study designed to evaluate the effect of the food consumption timing on the absorption of zinc supplement.

The main objective is to measure plasma zinc in generally healthy male subjects, who will consume zinc supplement with food or 30-min before food for 2-weeks.

In addition to the primary objectives, correlations in enzyme activity with changes in fat metabolism, namely circulating triglyceride and cholesterol, will be determined. This will enable the determination of the effect of a low Zn intake on various aspects of dyslipidemia.

Eligibility criteria: Inclusion Criteria:

* willing to stop supplementation 4 weeks prior to start of the study
* has an operative understanding of English
* no plans to move from the area during the study period
* regularly eat breakfast

Exclusion Criteria:

* Chronic or acute metabolic disease
* smoker or user of nicotine products
* history of alcohol abuse, or use of illicit drugs (incl marijuana)
* Is underweight or overweight, body mass index (BMI) \< 18 or \> 30 kg/m2

Primary outcomes:
measure: Plasma Zinc changes
timeFrame: Day 0, Day 15
Secondary outcomes:
measure: Body weight changes
timeFrame: Day 0, Day 15
measure: Essential Fatty acid changes
timeFrame: Day 0, Day 15
measure: Blood glucose changes
timeFrame: Day 0, Day 15
Other outcomes:
Locations:
city: Oakland
country: United States
facility: UCSF Benioff Children's Hospital Oakland Research Institute
state: California
Study officials:
affiliation: UCSF Benioff Children's Hospital Oakland Research Institute
name: Jung Suh, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Massih YN, Hall AG, Suh J, King JC. Zinc Supplements Taken with Food Increase Essential Fatty Acid Desaturation Indices in Adult Men Compared with Zinc Taken in the Fasted State. J Nutr. 2021 Sep 4;151(9):2583-2589. doi: 10.1093/jn/nxab149.
Clinical trial NCT00719121: Study on Anti-inflammatory Effects of Topical R115866 Gel
Official title: Placebo-Controlled, Investigator Blinded, Explorative Trial to Evaluate the Anti-inflammatory Effect of Multiple Topical Applications of R115866 Gel (0.35%) in Two Models of Cutaneous Inflammation in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cutaneous Inflammation
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2008-07-21
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: The purpose of this exploratory trial is to assess the anti-inflammatory effect(s) of topical R115866 in a model of UVB-induced inflammation and in a model of cutaneous irritation.


Eligibility criteria: Inclusion Criteria:

* Body Mass Index should be between 18 and 28 kg/m2
* Subjects are healthy as determined by medical history, physical examination and clinical laboratory tests carried out at screening
* Subjects with a phototype III or IV (according to Fitzpatrick classification)

Exclusion Criteria:

* Subjects with history of or active alcohol or substance abuse problems.
* Known hypersensitivity to azoles, adapalene, retinoids or any other ingredient of the gels
* Subjects who have a laboratory value which, in the opinion of the investigator, is clinically-relevant out of the normal range
* Subjects with clinically relevant abnormal ECG-intervals or morphology of the ECG, QTc interval \>450 ms
* Use of vitamin A (\>1000 µg/day) or the use of concomitant medication, except paracetamol; All other medication must have been stopped at least 14 days before the first administration of gel)
* Subjects who have received an investigational product which is not a biological within the month preceding the screening visit; If the investigational product is a biological, a 3-month wash-out period is required.
* Use of ultraviolet light (including artificial UVA and UVB as well as excessive natural sun exposure) unless stopped at Visit 1
* Subjects judged by the investigator to have a high probability of lack of compliance with the provisions of the protocol
* Subjects having any medical condition which, in the opinion of the investigator at the site, is a contraindication to enrollment

Primary outcomes:
measure: Primary efficacy endpoint was the mean value of TEWL (Trans-epidermal water loss)
timeFrame: Day 1 through Day 9 of treatment
Secondary outcomes:
measure: Erythema
timeFrame: Day 1 through Day 8 of treatment and Day 15 post-treatment
Other outcomes:
Locations:
city: Liege
country: Belgium
facility: Department of DermatopathologyCentre Hospitalier Universitaire du Sart Tilman
Study officials:
affiliation: Department of Dermatopathology Centre Hospitalier Universitaire du Sart-Tilman
name: Prof. Dr. G. Piérard, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01716221: An Objective Double-blind Evaluation of Bupropion and Citalopram in an Individual With Friedreich Ataxia
Official title: An Objective Double-blind Evaluation of Bupropion and Citalopram in an Individual With Friedreich Ataxia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Friedreich Ataxia
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2012-10-29
Enrollment: 1
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to document the clinical effects of bupropion and citalopram in a single subject with Friedreich Ataxia.

Detailed description: This is a double blind study with a single subject to objectively document the clinical effects of bupropion and citalopram in a single patient with Friedreich Ataxia (FA), whose disorder symptoms have improved with the use of these medications.

Eligibility criteria: Inclusion Criteria:

* Friedreich Ataxia

Exclusion Criteria:

* Unable to provide Informed Consent

Primary outcomes:
measure: International Cooperative Ataxia Rating Scale (ICARS)
timeFrame: Assessements are performed in 5 different states in a single patient: baseline (Bupropion 100mg and Citalopram 20mg - unblinded), then blinded at 5 weeks (citalopram), 10 weeks (placebo), 15 weeks (bupropion), and 20 weeks (citalopram + bupropion)
measure: Friedreich Ataxia Rating Scale (FARS)
timeFrame: Assessements are performed in 5 different states in a single patient: baseline (Bupropion 100mg and Citalopram 20mg - unblinded), then blinded at 5 weeks (citalopram), 10 weeks (placebo), 15 (bupropion), and 20 weeks (citalopram + bupropion)
Secondary outcomes:
measure: Comparison of FARS and ICARS
timeFrame: Assessements are performed in 5 different states in a single patient: baseline (Bupropion 100mg and Citalopram 20mg - unblinded), then blinded at 5 weeks (citalopram), 10 weeks (placebo), 15 (bupropion), and 20 weeks (citalopram + bupropion)
Other outcomes:
measure: Hamilton Depression Rating Scale
timeFrame: Assessements are performed in 5 different states in a single patient: baseline (Bupropion 100mg and Citalopram 20mg - unblinded), then blinded at 5 weeks (citalopram), 10 weeks (placebo), 15 (bupropion), and 20 weeks (citalopram + bupropion)
Locations:
Study officials:
affiliation: University of Colorado, Denver
name: Olga Klepitskaya, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05024721: Study to Evaluate the Efficacy and Safety of HIP2101 in Patients With Acute or Chronic Gastritis
Official title: A Multicenter, Randomized, Double-blind, Active-controlled, Phase Ⅲ Study to Evaluate the Efficacy and Safety of HIP2101 in Patients With Acute or Chronic Gastritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gastritis
Lead sponsor: Hanmi Pharmaceutical Company Limited
Sponsor class: INDUSTRY
First posted: 2021-08-27
Enrollment: 326
Sex: ALL
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the safety and clinical efficacy of HIP2101 in patients with acute or chronic gastritis.


Eligibility criteria: Inclusion Criteria:

* 19≤ age ≤ 75
* Have been diagnosed as acute or chronic gastritis with at least 1 erosion by endoscopy within 7 days before enrollment.
* Patients understood the consents and purpose of this trial and signed consent form

Exclusion Criteria:

* Patients who cannot perform endoscopy
* Active gastric or duodenal ulcer
* Reflux esophagitis, barrett's esophagus, gastric or esophageal varix
* Zollinger-Ellison syndrome, pyloric obstruction, and esophageal stricture, Inflammatory Bowel Diease, acute pancreatitis
* History of gastrointestinal surgery
* History of malignancy tumor, especially in the upper gastrointestinal tract
* Severe liver disorder(at screening day, AST or ALT level exceeds 3 times more than normal upper range)
* Severe renal disorder(at screening day, MDRD eGFP ≤ 30 mL/min/1.73m2) or chronic renal disease
* Bleeding disorder
* Patients who have taken drugs containing following list within 2 weeks before endoscopy : H2-receptor antagonists, Proton pump inhibitors, P-CABs, gastrin inhibitors, antacids, gastric mucosal protectants, anticholinergics
* Patients who have taken anticoagulants within a week before endoscopy
* Patients who have taken drugs containing following list after endoscopy : GI tract regulators, salicylates, steroids, , NSAIDs, bisphosphonates, selective serotonin reuptake inhibitors, iron supplements, oriental herbal medicines
* History of allergic reaction to the medications used in this study
* Use of other investigational drugs within 30 days prior to the study
* History of alcohol or drug abuse
* Positive to pregnancy test, nursing mother, intention on pregnancy
* Considered by investigator as not appropriate to participate in the clinical study with other reason

Primary outcomes:
measure: Improvement rate of erosion
timeFrame: week 2
Secondary outcomes:
measure: Cure rate of erosion
timeFrame: week 2
measure: Cure rate of edema
timeFrame: week 2
measure: Improvement rate of erythema
timeFrame: week 2
measure: Improvement rate of hemorrage
timeFrame: week 2
measure: Improvement rate of GI symptoms
timeFrame: week 2
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
References:
Clinical trial NCT02639221: A Phase I, Double Blind, Placebo Controlled, First in Human, Single and Multiple Ascending Oral Dose, Safety, Tolerability and Pharmacokinetic Study in Healthy Male and Female Subjects
Official title: PXT002331 A Phase I, Double Blind, Placebo Controlled, First in Human, Single and Multiple Ascending Oral Dose, Safety, Tolerability and Pharmacokinetic Study in Healthy Male and Female Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Parkinson's Disease
Lead sponsor: Prexton Therapeutics
Sponsor class: INDUSTRY
First posted: 2015-12-24
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The principal aim of this study is to obtain safety and tolerability data when PXT002331 is administered orally as single and multiple doses to healthy subjects.


Eligibility criteria: Inclusion Criteria:

1. Subjects will be; 1.1. males or females of non childbearing potential 1.2. For females, non childbearing potential is defined as follows:

   * permanently sterile following hysterectomy, bilateral salpingectomy, bilateral oophorectomy, or confirmed tubal occlusion (not tubal ligation)
   * postmenopausal, defined as at least 1 year post cessation of menses (without an alternative medical cause) 1.3. of any ethnic origin 1.4. between 18 and 60 years of age, inclusive
2. Subjects will have a 2.1. body mass index (BMI) between 18.0 kg/m2 and 32.0 kg/m2, inclusive 2.2. body weight between 50 kg and 100 kg, inclusive
3. Subjects will be in good health, as determined by; 3.1. medical history 3.2. physical examination 3.3. vital signs assessment 3.4. 12 lead ECG and 24 hour Holter Monitoring 3.5. clinical laboratory evaluations (congenital non haemolytic hyperbilirubinaemia is not acceptable)
4. Subjects will have given their written informed consent to participate in the study and to abide by the study restrictions

Primary outcomes:
measure: Number of Serious Adverse Events
timeFrame: 16 days
measure: Number of clinically relevant signs or symptoms
timeFrame: 16 days
Secondary outcomes:
Other outcomes:
Locations:
city: United Kingdom
country: United Kingdom
facility: United Kingdom
Study officials:
References:
Clinical trial NCT01535521: Sleep Positional Trainer for Positional Sleep Apnea After Mandibular Advancement Device (MAD) Therapy
Official title: Evaluation of Sleep Position Trainer for Positional Sleep Apnea Patients After Therapy With Mandibular Advancement Device (MAD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Positional Sleep Apnea
Mandibular Advancement Device
Lead sponsor: University Hospital, Antwerp
Sponsor class: OTHER
First posted: 2012-02-17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: The investigators will perform a clinical trial comparing mandibular advancement device (MAD) therapy with sleep positional trainer (SPT) and the combination of MAD and SPT in patients with positional sleep apnea using MAD. Patients are invited for 2 consecutive polysomnographies (PSGs) in randomized order: one PSG with SPT, one PSG with SPT and MAD. PSGs are performed at the Antwerp University Hospital.


Eligibility criteria: Inclusion Criteria:

* patients with supine dependent Obstructive Sleep Apnea (OSA) after Mandibular Advancement Device (MAD) Therapy: Apnea Hypopnea Index (AHI) supine ≥ 2x AHI non supine
* 5 \< AHI \< 50/h sleep on polysomnography (PSG) with MAD in situ
* ≥ 20% supine position during PSG with the MAD in situ
* AHI non-supine \< 10/h en AHI supine ≥ 10/h on PSG with MAD in situ
* Unchanged Body Mass Index (BMI)(BMI ± 1 kg/m²) at moment of inclusion compared to BMI at baseline PSG

Exclusion Criteria:

* age \< 18 years

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: Antwerp University Hospital
state: Antwerp
Study officials:
References:
citation: Dieltjens M, Vroegop AV, Verbruggen AE, Wouters K, Willemen M, De Backer WA, Verbraecken JA, Van de Heyning PH, Braem MJ, de Vries N, Vanderveken OM. A promising concept of combination therapy for positional obstructive sleep apnea. Sleep Breath. 2015 May;19(2):637-44. doi: 10.1007/s11325-014-1068-8. Epub 2014 Oct 22.
Clinical trial NCT05107921: Bromfenac Sodium Hydrate Eye Drops in Familial Exudative Vitreoretinopathy
Official title: Efficacy of Bromfenac Sodium Hydrate Eye Drops in Children With Familial Exudative Vitreoretinopathy After Diode Laser Photocoagulation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Familial Exudative Vitreoretinopathies
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2021-11-04
Enrollment: 39
Sex: ALL
Minimum age (years): 1
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study aims to investigate the efficacy and safety of bromfenac sodium hydrate eye drops in patients with familial exudative vitreoretinopathy receiving diode laser photocoagulation.

Detailed description: This study aims to evaluate the presence of macular edema as the primary measure and the presence of conjunctival injection as the secondary measure for the investigation of the efficacy of bromfenac sodium hydrate eye drops in patients with familial exudative vitreoretinopathy receiving diode laser photocoagulation.

Eligibility criteria: Inclusion Criteria:

* Newly diagnosed patients with familial exudative vitreoretinopathy
* Needing diode laser photocoagulation
* Consent to the study

Exclusion Criteria:

* History of corneal diseases
* History of hypersensitivity to bromfenac sodium
* History of hypersensitivity to non-steroidal anti-inflammatory drugs
* Progressive ocular infection
* Liver diseases
* Hypersensitivity to sulfur dioxide
* Receiving anti-coagulation drugs
* History of coagulopathies

Primary outcomes:
measure: Macular edema response rate
timeFrame: 4 weeks after the diode laser photocoagulation
Secondary outcomes:
measure: Conjunctival injection response rate
timeFrame: 4 weeks after the diode laser photocoagulation
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Jeong Hun Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01029821: Low-Molecular-Weight Heparin (LMWH) for Deep Venous Thrombosis (DVT) Prophylaxis
Official title: Low-Molecular-Weight Heparin for DVT Prophylaxis After Open Reduction and Internal Fixation of Ankle Fractures: A Randomized, Prospective Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Deep Venous Thrombosis
Keywords: Low-Molecular-Weight-Heparin
Open Reduction and Internal Fixation
Thromboprophylaxis
Lead sponsor: University of Tennessee
Sponsor class: OTHER
First posted: 2009-12-10
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 1. The use of LMWH following open reduction and internal fixation of ankle fractures will reduce the number of thrombi formed.
2. The rates of clinically significant DVT will be equivalent between two groups.

Detailed description: Routine use of thromboprophylaxis may be over treatment and definitely increases healthcare costs. While prophylaxis may reduce the number of thrombi formed the exact number and clinical significance of these is unknown. This study seeks to answer the question of whether or not DVT prophylaxis with low-molecular-weight heparin (LMWH) following ORIF of ankle fractures is warranted.

Eligibility criteria: Inclusion Criteria:

* At least 18 years old
* Surgical ankle fracture able to be definitively treated with one operation

Exclusion Criteria:

* Younger than 18 years of age
* Other significant injury
* Known hypercoagulable state
* History of bleeding disorder
* History of DVT

Primary outcomes:
measure: We will compare the rates of thrombi formation between the two groups. We will record any clinical significant thrombi or complications that arise from thrombi. We will record any complications related to administration of LMWH.
timeFrame: first post-operative office visit (usually 10-14 days)
Secondary outcomes:
measure: We may find that there is in fact significant benefit to giving prophylaxis to this subset of patients in the form of decreased rates of throb\mbus formation and the complications related to thrombi. The risk/benefit ratio should be favorable.
timeFrame: first post-operative office visit (10-14 days)
Other outcomes:
Locations:
city: Chattanooga,
country: United States
facility: Erlanger Medical Center
state: Tennessee
Study officials:
affiliation: University of Tennessee
name: Dale Ingram, M.D.
role: PRINCIPAL_INVESTIGATOR
References: