louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00392574: Safety and Efficacy of Prulifloxacin Versus Placebo in Traveler's Diarrhea
Official title: A Multicenter, Double-Blind, Randomized Study to Compare The Safety and Efficacy of Prulifloxacin Versus Placebo in the Treatment of Acute Gastroenteritis in Adult Travelers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Gastroenteritis in Adult Travelers
Keywords: Gastroenteritis
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2006-10-26
Enrollment: 282
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: The objective of this pivotal Phase III study is to investigate the safety and efficacy of prulifloxacin versus placebo in the treatment of subjects with acute bacterial gastroenteritis.

Detailed description: This double-blind trial will compare the safety and efficacy of prulifloxacin versus placebo in adult travelers with acute gastroenteritis characterized by diarrhea with one or more of the following signs or symptoms: nausea, vomiting, abdominal pain or cramping, fecal urgency, moderate to severe gas-related symptoms, or tenesmus of ≤72 hours duration.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of Acute Bacterial Gastroenteritis;
* Traveler from Industrialized Country;
* Capable of giving Informed Consent

Exclusion Criteria:

* Fever (\>100.3 degrees);
* Pregnant or Breast Feeding or Not using adequate birth control;
* Known or Suspected (co-)Infection with non-bacterial pathogen;
* Symptoms of Gastroenteritis of \>72 hours;
* Bloody Diarrhea;
* Concomitant antibacterial with activity against enteric bacterial pathogens;
* History of IBD;
* Unable/Unwilling to comply with study protocol;
* \> 2 doses of anti-diarrheal medication within 24 hours;
* Antimicrobial Treatment within 30 days

Primary outcomes:
measure: Time to last unformed stool
timeFrame: Study days 1-3
Secondary outcomes:
measure: Clinical cure based on relief of signs and symptoms
timeFrame: Study days 1-3
measure: Microbiologic eradication rates
timeFrame: Study days 1-3
Other outcomes:
Locations:
city: New Hope
country: United States
facility: INC Research
state: Pennsylvania
Study officials:
affiliation: University of Texas
name: Herbert Dupont, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03962374: The Comparison of the Success Rate of the Endotracheal Intubation Between the Stylet and the Frova With Acute Angled Videolaryngoscope
Official title: The Comparison of the Success Rate of the Endotracheal Intubation Between the Stylet and the Frova With Acute Angled Videolaryngoscope
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anesthesia, General
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2019-05-24
Enrollment: 166
Sex: ALL
Minimum age (years): 19
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 compare the effect of frova and stylet on the success rate of tracheal intubation when using a video laryngoscope.


Eligibility criteria: Inclusion Criteria:

* 1. adult patients aged over 19 years who are undergoing endotracheal intubation for elective surgery.
* 2. Patients who have one of the predictors of difficult intubation such as Mallampati classification 3 or 4, limited the movement of the neck, body mass index less than 35 kg/m2, a distance from the tip of the chin to the thyroid cartilage of less than 6.5 cm, a interincisor distance less than 3.5 cm, inability to protrude of lower incisors over the upper incisors, or a diagnosis of obstructive sleep apnea.

Exclusion Criteria:

* 1. Patients receiving emergency surgery
* 2. Pregnant women
* 3. Patients scheduled for oral surgery such as tonsillectomy, vocal cord surgery
* 4. Patients who have a history of ankylosing spondylitis or have a large tumor of 4 cm or more on the tongue and need an awake intubation
* 5. Patients who are at risk of vomiting due to not fasting time

Primary outcomes:
measure: Success rate of first attempt of endotracheal intubation
timeFrame: for 10 minutes during anesthetic induction
Secondary outcomes:
measure: time for endotracheal intubation
timeFrame: for 10 minutes during anesthetic induction
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine
Study officials:
References:
Clinical trial NCT04062474: Epidural Intervention of Spinal Nerves With Tumor Necrosis Factor-Alpha Inhibitor
Official title: Treatment of Pain in Patients With Lumbar Spinal Stenosis By Epidural Intervention of Spinal Nerves With Local Anesthetic, Steroids and Tumor Necrosis Factor-Alpha Inhibitor Respectively：a Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Stenosis
Lead sponsor: Nanjing First Hospital, Nanjing Medical University
Sponsor class: OTHER
First posted: 2019-08-20
Enrollment: 90
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is to assess the clinical efficacy of epidural injections with Tumor Necrosis Factor-Alpha(TNF-α) Inhibitor in patients with chronic radicular pain caused by lumbar spinal stenosis.

Detailed description: This study is to assess the clinical efficacy of epidural injections with Tumor Necrosis Factor-Alpha(TNF-α) Inhibitor in patients with chronic radicular pain caused by lumbar spinal stenosis.Ninety patients were diagnosed with lumbar spinal stenosis and were randomly assigned to 3 groups, for each group 30 cases. Patients in Group A received epidural injection of spinal nerve with 2.0 ml of lidocaine and 10 mg of Tumor Necrosis Factor-Alpha Inhibitor (etanercept) onto the affected spinal nerve, Group B patients received epidural injection with lidocaine 2ml mixed with 2ml of steroid(Diprospan), and group C patients received epidural injections with 4.0 ml of lidocaine only. All the 3 groups were evaluated by VAS and ODI, and received 6 months' follow-up.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of spinal stenosis with radicular pain at least 5 scores of VAS(ranging from 0 to 10).
* Failed to improve symptom significantly through conservative treatment, including physiotherapy, chiropractic therapy, exercise, medication and bed rest.

Exclusion Criteria:

* lumbar surgery history,
* spinal stenosis without radicular pain,
* uncontrollable or unstable use of opioids,
* uncontrolled mental illness,
* pregnant or lactating women,
* patients with a history of adverse reactions or possible adverse reactions to local anesthetics, etanercept or Steroids.

Primary outcomes:
measure: visual analog scale
timeFrame: 6 months
measure: Oswestry Disability Index
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Wei P, Xu Y, Yao Q, Wang L. Randomized trial of 3-drug combination for lumbar nerve root epidural injections with a TNF-alpha inhibitor in treatment of lumbar stenosis. Br J Neurosurg. 2020 Apr;34(2):168-171. doi: 10.1080/02688697.2020.1713990. Epub 2020 Jan 20.
Clinical trial NCT02542774: Sex Differences in the Risk of Cardiovascular Diseases Associated With Diabetes
Official title: Sex Differences in the Risk of Cardiovascular Diseases Associated With Diabetes: an Examination of Variation in Health Service Delivery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diabetes Mellitus
Keywords: Diabetes mellitus
Stroke
Myocardial infarction
Stable angina pectoris
Heart failure
Quality of care
Lead sponsor: University College, London
Sponsor class: OTHER
First posted: 2015-09-07
Enrollment: 80000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients in the CALIBER database who have diabetes, are included in the Clinical Practice Research Datalink (CPRD) and consented to data linkage.

Brief summary: To evaluate the risk of cardiovascular events associated with medication use for controlling blood glucose, blood pressure and cholesterol levels in men and women with diabetes treated in primary care

Detailed description: The management and treatment of adult diabetes is far from optimal. The most recent report from the National Diabetes Audit showed that only one in three people with diabetes are achieving recommended standards for controlling blood glucose, blood pressure and cholesterol levels; and only three in five received basic care processes to reduce their risk of diabetes-related complications such as blindness, amputation and kidney disease. Women did 15% worse than men, which may explain some of the reported higher excess risk of coronary heart disease and stroke, consequent to diabetes in women than men. More efficient and equitable care in people with diabetes could lead to substantial cost savings, and would improve the lives of women and men currently living with diabetes.

The objective of this research isto evaluate the risk of cardiovascular events associated with medication use for controlling blood glucose, blood pressure and cholesterol levels in men and women with diabetes treated in primary care.

Eligibility criteria: Inclusion Criteria:

* Patients with diabetes at or before study entry, and participants who develop new-onset diabetes during follow-up.
* Age ≥ 18 years
* Data collected in the period 1997-2010
* Minimum time since registration of 1 year
* Minimum of 1 year of up to standard data (CPRD quality standard)

Exclusion Criteria:

• None

Primary outcomes:
measure: First occurrence of cardiovascular disease
timeFrame: 10 years
Secondary outcomes:
measure: Cardiovascular mortality
timeFrame: 10 years
measure: All cause mortality
timeFrame: 10 years
Other outcomes:
Locations:
city: Oxford
country: United Kingdom
facility: The George Institute for Global Health, Nuffield Department for Population Health, University of Oxford
Study officials:
affiliation: The George Institute
name: Sanne Peters
role: STUDY_DIRECTOR
References:
Clinical trial NCT06675565: A Study to Evaluate ALN-AGT01 RVR in Adult Healthy Volunteers
Official title: A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of ALN-AGT01 RVR in Adult Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: RNAi therapeutic
Lead sponsor: Alnylam Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2024-11-05
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety, tolerability and PK of single ascending doses of ALN-AGT01 RVR.


Eligibility criteria: Inclusion Criteria

* Is an adult healthy volunteer
* Has a body mass index ≥18 kg/m\^2 and ≤28 kg/m\^2

Exclusion Criteria

* Has alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> upper limit of normal (ULN)
* Has known human immunodeficiency virus infection; or known current or chronic hepatitis C virus or hepatitis B virus infection
* Has an estimated glomerular filtration rate (eGFR) of \<90 mL/min/1.73m\^2 at screening

Note: other protocol defined inclusion / exclusion criteria apply

Primary outcomes:
measure: Frequency of Adverse Events (AEs)
timeFrame: Up to 3 months
Secondary outcomes:
measure: Area Under the Plasma Concentration-time Curve (AUC) of ALN-AGT01 RVR in Plasma
timeFrame: Predose and up to 3 days postdose
measure: Maximum Observed Plasma Concentration (Cmax) of ALN-AGT01 RVR in Plasma
timeFrame: Predose and up to 3 days postdose
measure: Time to Maximum Plasma Concentration (Tmax) of ALN-AGT01 RVR in Plasma
timeFrame: Predose and up to 3 days postdose
measure: Concentrations of ALN-AGT01 RVR in Urine
timeFrame: Predose and up to 1 day postdone
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Clinical Trial Site
Study officials:
References:
Clinical trial NCT01467765: The Effect of Elemental Diet on Gastric Emptying
Official title: The Comparative Study of Elemental Diet and Regular Liquid Diet on Gastric Emptying in Patients With Percutaneous Endoscopic Gastrostomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postprocedural Delayed Gastric Emptying
Lead sponsor: Showa Inan General Hospital
Sponsor class: OTHER
First posted: 2011-11-09
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: In patients with percutaneous endoscopic gastrostomy (PEG) delayed gastric emptying has been speculated as a cause of aspiration pneumonia. Elemental diet may facilitate gastric emptying in PEG patients as compared with regular liquid enteral nutrients, resulting in the prevention of aspiration pneumonia.


Eligibility criteria: Inclusion Criteria:

* percutaneous endoscopic gastrostomy patients

Exclusion Criteria:

* history of abdominal surgery

Primary outcomes:
measure: Measurement of gastric emptying
timeFrame: Four hours (from 7:30 am to 11:30 am)
Secondary outcomes:
Other outcomes:
Locations:
city: Komagane
country: Japan
facility: Showa Inan General Hospital
state: Nagano
Study officials:
References:
Clinical trial NCT03520465: Utility of a Supraaponeurotic Mesh as Prophylaxis of the Midline Eventration After an Oncological Colorrectal Resection
Official title: Utility of a Supraaponeurotic Mesh as Prophylaxis of the Midline Eventration After an Oncological Colorrectal Resection
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Eventration
Lead sponsor: Instituto de Investigacion Sanitaria La Fe
Sponsor class: OTHER
First posted: 2018-05-09
Enrollment: 154
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Randomized prospective experimental study, in which the effect of a prophylactic mesh is assessed in the eventration rate diagnosed by CT at one year after surgery in patients with CRC who underwent elective intervention for supra-infraumbilical midline laparotomy, considering as treatment the supra-aponeurotic mesh positioning (experimental group), and comparing it to the standard closing with a continuous suture using slow absorption monofilament.

Detailed description: Randomized prospective experimental study, in which we evaluate patients with CRC who underwent elective intervention for supra-infraumbilical midline laparotomy in order to:

Main objective:

- To assess the effect of the prophylactic mesh in the eventration rate diagnosed by CT at one year after surgery in patients with CRC who underwent elective intervention for supra-infraumbilical midline laparotomy.

Secondary objectives:

* To compare the appearance of complications in the control group and in the experimental group.
* Compare costs derived from short and long-term mesh placement in both groups.

We consider as treatment the supra-aponeurotic mesh positioning (experimental group), and compare it to the standard closing with slow absorption monofilament.

Eligibility criteria: Inclusion Criteria:

* Elective surgery for colorectal cancer.
* Surgery by middle laparotomy.
* Informed consent signed by the patient.
* Age \> 18 years.

Exclusion Criteria:

* Midline hernia or eventration.
* Presence of mesh in the abdominal wall because of a previous surgery.
* Palliative surgery.
* Synchronous metastases (Stage IV cancer according to TNM).

Primary outcomes:
measure: Eventration rate
timeFrame: 1 year
Secondary outcomes:
measure: Complications rate
timeFrame: 1 year
measure: Short and long term derived costs
timeFrame: 1 year
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Hospital Universitario y Politécnico La Fe
Study officials:
affiliation: Instituto de Investigación Sanitaria La Fe
name: Matteo Frasson
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00205465: Phase 2 Clinical Study in Psoriasis With Oral Investigational Drug VX-765
Official title: A Randomized, Double-Blind, Placebo-Controlled, Safety and Tolerability Study of VX-765 in Subjects With Chronic Plaque Psoriasis Requiring Systemic Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Psoriasis
Lead sponsor: Vertex Pharmaceuticals Incorporated
Sponsor class: INDUSTRY
First posted: 2005-09-20
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the safety and tolerability of VX-765 in subjects with chronic plaque psoriasis treated for 28 days.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with chronic plaque psoriasis for at least 6 months
* Prior systemic therapy

Exclusion Criteria:

* Current or prior history of illness precluding use of immunomodulatory therapy.

Primary outcomes:
measure: Incidence of adverse events
measure: Abnormal laboratory values
measure: Abnormal ECGs and vital signs
Secondary outcomes:
measure: PK/PD
measure: Target lesion score after 28 days of treatment
measure: Proportion of subjects meeting "clear" or "almost clear" criteria utilizing a static Physician's Global Assessment (sPGA)
measure: Proportion of subjects demonstrating ≥ 50% and ≥ 75% decrease from baseline in Psoriasis Area and Severity Index (PASI) to the end of 28 days of treatment
measure: Change in PASI from baseline to the end of 28 days of treatment
Other outcomes:
Locations:
Study officials:
affiliation: Vertex Pharmaceuticals Incorporated
name: Robert Kauffman, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03640065: Evaluation of The Effect of Live Probiotic Cultures Present in Fermented Dairy Product (Yogurt) Versus The Effect of Freeze-Dried Probiotic Sachets on Gingival Bleeding of Adolescents
Official title: The Effect of Freeze-Dried Probiotic Sachets Versus Fermented Dairy Product (Yogurt) on Gingival Bleeding on Brushing in Adolescents (12-15) Years Old : A Randomized Clinical Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Gingival Inflammation
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-08-21
Enrollment: 20
Sex: ALL
Minimum age (years): 12
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the effect of probiotics supplied in two different forms (dairy products containing probiotics as yogurt and freeze-dried synthetic probiotics sachets) on improving gingival condition and caries potentiality of dental plaque in adolescents


Eligibility criteria: Inclusion Criteria:

1. Children aged 12-15 years old
2. Children complaining from gingival problems
3. Medically free children
4. Children not registered in other clinical researches

Exclusion Criteria:

1. Children with systemic diseases, mental disorders, chronic debilitating diseases.
2. Children using antibiotic treatment during the study
3. Children with orthodontic treatment
4. Children using antimicrobial mouthwash
5. Children taking any probiotic supplemental therapy

Primary outcomes:
measure: Change in Gingival bleeding On Brushing
timeFrame: base line and after 4 weeks
Secondary outcomes:
measure: Change in Dental plaque pH
timeFrame: base line and after 4 weeks
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Mai M Ismaiel
Study officials:
References:
Clinical trial NCT02128165: Effect of Gastric Balloon in Morbid Obesity: Prospective Study
Official title: Effect of Gastric Balloon in Morbid Obesity: Prospective Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Morbid Obesity
Keywords: gastric balloon
morbid obesity
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2014-05-01
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to compare the efficacy of gastric balloon in weight reduction among two different categories of morbidly obese people.

Detailed description: To study to effect of gastric balloon in weight reduction among those above 35 BMI and those above 45 BMI.

Eligibility criteria: Inclusion Criteria:

* morbid obesity

Exclusion Criteria:

* patient refusal
* psychological patients
* oesophageal or gastric abnormalities

Primary outcomes:
measure: Effect of weight loss
timeFrame: 6 months
Secondary outcomes:
measure: Tolerance
timeFrame: 6 months
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University
Study officials:
References: