louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04037904: Long-term Follow-up of Interleukin-1B and H+,K+-ATPase mRNA Expression After Helicobacter Pylori Eradication
Official title: Long-term Follow-up of Interleukin-1B and H+,K+-ATPase mRNA Expression After Helicobacter Pylori Eradication
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Helicobacter Pylori Infection
Keywords: Helicobacter pylori
Interleukin-1 beta
Gastric H+, K+- APTase
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2019-07-30
Enrollment: 490
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Controls and patients with gastric dysplasia or gastric cancer who received esophagogastroduodenoscopy and underwent H. pylori tests

Brief summary: We will evaluate the long-term changes of gastric H+, K+-adenosine triphosphatase (H+, K+-ATPase) and Interleukin-1B mRNA expression according to Helicobacter pylori (H.pylori) infection and intestinal metaplasia and investigate the long-term effect of H. pylori eradication

Detailed description: H. pylori suppresses gastric acid secretion by repressing gastric acid pump, H+, K+-ATPase, and stimulating Interleukin-1B. In this study, we will evaluate the expression of H+, K+-ATPase and Interleukin-1B mRNA according to H. pylori infection and intestinal metaplasia in controls and patients with gastric cancer. In addition, we observe the changes of H+, K+-ATPase and Interleukin-1B mRNA expression over 5 years after H. pylori eradication.

Eligibility criteria: Inclusion Criteria:

* Controls who did not have any evidence of gastric cancer, gastric dysplasia, esophageal tumor, peptic ulcer and lymphoma on esophagogastroduodenoscopy
* Patients with gastric dysplasia or gastric cancer who diagnosed with gastric dysplasia or early gastric cancer in the final pathological report

Exclusion Criteria:

* Subjects with previous eradication treatment for H. pylori
* Subjects with previous gastrectomy

Primary outcomes:
measure: Interleukin-1B and H+,K+-ATPase mRNA expression
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
Study officials:
References:
Clinical trial NCT01122004: The Effect of Gabapentin (Neurentin) and Pregabalin (Lyrica) in Pain Reduction After Photorefractive Keratectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Refractive Errors
Lead sponsor: Shahid Beheshti University of Medical Sciences
Sponsor class: OTHER
First posted: 2010-05-12
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Primary purpose: TREATMENT

Brief summary: The studied patients will be given randomly one of three following drugs1:Gabapentin2: Pregabalin or placebo for 3 days after Photorefractive keratectomy surgery. The pain will be measured based on visual analog scale(VAS) on the day of operation and on the 3 rd day (morning, evening) and then compared among three groups.


Eligibility criteria: Inclusion Criteria:

* patients candidate for PRK, 17\<age\<70

Exclusion Criteria:

* use of any systemic analgesic drugs, drug intolerance, need of systemic or topical administration of NSAIDs or eye drops for allergy and glaucoma, dry eyes, pregnancy, breast feeding

Primary outcomes:
measure: pain degree based on visual analog scale(VAS)
Secondary outcomes:
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Ophthalmic Research Center
Study officials:
References:
Clinical trial NCT00127504: Clinical Trial of Rifampin and Azithromycin for the Treatment of River Blindness
Official title: Trial of Rifampin and Azithromycin for Treatment of Endosymbiotic Bacteria (Wolbachia) in Onchocerca Volvulus in Guatemala
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Onchocerciasis
Keywords: Onchocerciasis
Wolbachia
Therapy
Lead sponsor: Centers for Disease Control and Prevention
Sponsor class: FED
Collaborators: name: Universidad del Valle, Guatemala
name: University of Alabama at Birmingham
First posted: 2005-08-08
Enrollment: 80
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether rifampin and/or azithromycin are effective in the treatment of river blindness (onchocerciasis).

Detailed description: Mass treatment with ivermectin (Mectizan, Merck \& Co) is the mainstay of the current efforts to control onchocerciasis, but the drug is not lethal to adult Onchocerca volvulus parasites. Wolbachia, an endosymbiotic bacterium necessary for the fecundity of O. volvulus, can be eradicated with four-six week courses of doxycycline, but this cannot be implemented in current mass drug administration programs. The purpose of this study is to evaluate if a shorter course (five days) with antibiotics that could be used in children and potentially pregnant women would likewise be effective.

Guatemalan patients with onchocercal nodules will be enrolled in an open label trial with four treatment groups: Group A (rifampin 20 mg/kg by mouth \[po; maximum 600 mg/day\]); B (azithromycin 12 mg/kg po \[maximum 500 mg/day\]); C (combination of rifampin 20 mg/kg po \[maximum 600 mg/day\] and azithromycin 12 mg/kg po \[maximum 500 mg/day\]); D (control group, multivitamin). At the end of the five day treatment course all participants will receive a single dose of ivermectin (150 mcg/kg).

Nodulectomies will be performed 9 months after treatment and the O. volvulus will be analyzed by immunohistochemical staining specific for Wolbachia.

Eligibility criteria: Inclusion Criteria:

* Males and non-pregnant/non lactating females \>5 years of age
* One onchocercal nodule in an anatomical position where it can be easily removed surgically

Exclusion Criteria:

* Pregnancy (based on urine pregnancy test)
* Breast-feeding
* Women taking oral contraceptives
* Allergy or other adverse reaction to either medication
* Use of other medications that might interact with rifampin
* Clinical evidence of liver disease (jaundice, swollen abdomen)
* Clinical evidence of chronic disease/alcoholism

Primary outcomes:
measure: Eliminating Wolbachia endobacteria present in O. volvulus worms after 9 months
Secondary outcomes:
measure: Elimination of microfilaria in skin snips and histological examination of worms after 9 months
Other outcomes:
Locations:
city: Guatemala City
country: Guatemala
facility: Universidad del Valle/MERTU
Study officials:
affiliation: CDC/NCID/DPD
name: Josef Amann, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03813004: Kinematics and Kinetics of Gait Perturbations in Young Healthy Adults
Official title: Kinematics and Kinetics of Gait Perturbations in Young Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Balance Disorders
Keywords: motek grail
balance
gait perturbation
Lead sponsor: Józef Piłsudski University of Physical Education
Sponsor class: OTHER
First posted: 2019-01-23
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Investigators would like to examine, what are strategies for balance recovery in gait perturbations. Different perturbation types where used in the current study. The study involves the analysis of kinematic and kinetic parameters. Researchers hypothesize that research including young healthy adults would help to elaborate fall prevention program for seniors.


Eligibility criteria: Inclusion Criteria:

* age 18-35
* female or male
* good health condition

Exclusion Criteria:

* lower limb injuries (last 6 months)
* head injuries (last 6 months)
* diseases of the vestibular system
* serious eye defects
* extreme sports athletes

Primary outcomes:
measure: Motek Grail output (joint angles)
timeFrame: 40 minutes
measure: Motek Grail output (joint moments)
timeFrame: 40 minutes
measure: Motek Grail output (ground reaction forces)
timeFrame: 40 minutes
measure: Motek Grail output (centre of pressure)
timeFrame: 40 minutes
measure: Body composition
timeFrame: 10 minutes
measure: Range of movement
timeFrame: 20 minutes
measure: Height
timeFrame: 2 minutes
measure: Weight
timeFrame: 2 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Józef Piłsudski University of Physical Education in Warsaw
state: Mazowsze
Study officials:
References:
Clinical trial NCT01101204: The Effects of Hypolipemic and Antidiabetic Treatment on Cytokines
Official title: Effects of High and Low Doses of Metformin, Fenofibrate and Simvastatin, Administered Together and in Sequence With Lifestyle Intervention on Lipid Profile, Glucose Metabolism, Low-grade Inflammation and Hemostasis in Patient's Blood Plasma in Type 2 Diabetic Patients With Serious Mixed Dyslipidemia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes
Dyslipidemia
Inflammation
Cytokines
Lead sponsor: Medical University of Silesia
Sponsor class: OTHER
First posted: 2010-04-09
Enrollment: 200
Sex: ALL
Minimum age (years): 35
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The study is planned to show whether combined hypolipemic and antidiabetic therapy with various daily dosages influence the fasting plasma glucose, insulin sensitivity and proinflammatory cytokines in diabetic and dyslipidemic subjects.


Eligibility criteria: Inclusion Criteria:

* Age (35-64yr)
* Primary hyperlipidemia (Total cholesterol \>200mg/dl, Triglycerides \>150mg/dl)
* Type 2 Diabetes
* For women:
* Menopause (\>12 months)
* Post hysterectomy
* Mechanical contraception
* Obtained informed consent

Exclusion Criteria:

* Secondary hyperlipidemia
* Morbid obesity (BMI\>40kg/m2)
* Alcohol or drug abuse
* Acute or chronic inflammation
* Congestive Heart Failure (NYHA III or IV)
* Unstable Ischaemic Heart Disease
* Moderate or severe hypertension
* Cancer in less than 5 years
* Chronic kidney disease (stage III-V)
* Liver failure
* Oral contraception
* Not compliant patient
* Laboratory results:
* alanine transferase (\>3xULN)
* creatine kinase (\>5xULN)
* haemoglobin (\<10/dl)
* PLT (\<100G/l)
* WBC (\<3,5G/l or \>10G/l)

Primary outcomes:
measure: Antiinflammatory effects of combined antidiabetic and hypolipemic treatment
timeFrame: 30 days
Secondary outcomes:
measure: Insulin sensitivity
timeFrame: 30 days
measure: Coagulation parameters
timeFrame: 30 days
Other outcomes:
Locations:
city: Katowice
country: Poland
facility: Department of Clinical Pharmacology
Study officials:
References:
Clinical trial NCT00067704: Emotional Disclosure in HIV
Official title: Efficacy of an Emotional Disclosure Intervention in HIV
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Keywords: Complementary Therapies
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2003-08-27
Enrollment: 283
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The specific objective of this study are to examine whether or not a treatment aimed at emotional disclosure may have beneficial psychological, health and immune effects for HIV infected individuals. The goal of the current study is to test the efficacy of emotional disclosure through writing in patients with HIV infection. We will compare emotional disclosure through writing about traumatic experiences (experimental intervention) to a control intervention (writing about emotionally neutral topics). \[Note that HIV RNA viral load, CD4 T cells, urinary cortisol, health related dysfunction, psychological distress, and medication adherence are the 6 primary outcome variables.


Eligibility criteria: Inclusion Criteria

* 18-65 years of age inclusive
* At least 8 years of formal education
* Literate
* Fluent in English

All of the following three must apply:

* No active Category C HIV AIDS-defining symptoms
* CD4 T-lymphocyte count between 150-499
* Viral load \>1000

Exclusion Criteria

* Less than 8 years formal education
* Illiterate or non-English speaking
* Active systemic diseases that would interfere with participation
* Current alcohol or substance dependence
* Planned change in HIV medication in the next 6 months, or recent change in past 2 months
* Introduction of antidepressant medication within 30 days of study start
* Current psychological counseling, cognitive behavior therapy, support group or other psychological therapy, or plans to start any of the above
* Diagnosis of PTSD or major depression
* Unable to attend at least 4 treatment sessions

Primary outcomes:
measure: Decrease in psychological distress
timeFrame: 1 year
Secondary outcomes:
measure: Increase in CD4 T-lymphocytes
timeFrame: 1 year
measure: Decrease in the number of HIV symptoms
timeFrame: 1 year
Other outcomes:
Locations:
city: Coral Gables
country: United States
facility: University of Miami Dept. of Psychology & Behavioral Medicine
state: Florida
Study officials:
affiliation: University of Miami Dept. of Psychology & Behavioral Medicine
name: Gail Ironson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01356004: Effective Study of Live Attenuated Varicella Vaccine to Treat Severe Resistant Psoriasis
Official title: Live Attenuated Varicella Vaccine: A New Effective Adjuvant Weapon in the Battlefield Against Severe Resistant Psoriasis, a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Psoriasis
Keywords: severe resistant
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2011-05-19
Enrollment: 35
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: Immunotherapy was reported in the treatment of psoriasis. Treatment of resistant psoriasis may be difficult and cyclosporine can induce some remission.

The investigators hypothesized that the combined use of live attenuated varicella vaccine as an adjuvant therapy to low dose cyclosporine in the treatment of severe resistant psoriasis can give positive responses.


Eligibility criteria: Inclusion Criteria:

* Severe psoriasis: At least 30% of body involved) according to the rule of nine.
* Resistance to conventional therapy (PUVA, methotrexate, retinoids):

(Maximum PASI 50% improvement while on treatment for a duration not less than 6 months).

* Immunologically competent individuals with
* Seropositive for the varicella antibodies

Exclusion Criteria:

* Any contraindication to live attenuated varicella vaccine
* Any contraindication to cyclosporine

Primary outcomes:
measure: Number of Participants with PASI score improvement as a Measure of effective treatment
timeFrame: 12 weeks
Secondary outcomes:
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Cairo
country: Egypt
Study officials:
References:
Clinical trial NCT01235104: Impact of Total Nephrectomy on Patients With Kidney Stone
Official title: Impact of Total Nephrectomy on Patients With Kidney Stone
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Kidney
Urolithiasis
Nephrectomy
Treatment Outcome
Complications
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2010-11-05
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with kidney stone submitted to total nephrectomy from january 2001 to october 2010 at University of Sao Paulo General Hospital

Brief summary: The aim of this study is to investigate the outcomes of total nephrectomy on patients with kidney stone disease.

Detailed description: The aim of this study is to retrospectively investigate the effects of total nephrectomy on renal function, quality of life, early and late complications and development of the stone disease on the remnant unit on patients with kidney stone disease.

Eligibility criteria: Inclusion Criteria:

* Total nephrectomy
* Kidney stone disease

Exclusion Criteria:

* \< 18 y.o.
* Cancer
* Kidney transplant
* Solitary kidney

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Department of Urology of University of Sao Paulo General Hospital
name: Alexandre Danilovic, M.D., Ph. D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06549504: Bioequivalence Study of AG2202
Official title: An Open-label, Randomized, Fasting, Single, Oral Administration, Group 2, Stage 2, Cross-over Bioequivalence Study of AG2202 in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Bioequivalence Study
Lead sponsor: Ahn-Gook Pharmaceuticals Co.,Ltd
Sponsor class: INDUSTRY
First posted: 2024-08-12
Enrollment: 34
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate the human bioequivalence of AG2202T and AG2202R.

Detailed description: To evaluate the bioequivalence of two formulations of AG2202T and AG2202R after a single oral dose administration in healthy Korean subjects under fasting conditions.

Eligibility criteria: Inclusion Criteria:

* Subjects aged 19 years or older at the time of screening
* Subjects with a BMI of 18.0-30.0 kg/m2
* Subjects who do not have clinically significant congenital or chronic diseases and who do not have any pathological symptoms or findings as a result of general clinical examination
* Subjects who are deemed eligible based on the screening tests

Exclusion Criteria:

* Subjects who have taken drugs that induce or inhibit drug metabolizing enzymes within 30 days prior to the first dose or who have taken drugs that may interfere with the investigational product within 10 days prior to the first dose
* Subjects who have taken the investigational drug within 6 months prior to the first dose
* Subjects who donated whole blood within 8 weeks prior to the first dose, or donated blood components within 2 weeks, or received a blood transfusion within 4 weeks prior to the first dose

Primary outcomes:
measure: AUC
timeFrame: Pharmacokinetic plasma samples collected over 36 hour period
measure: Cmax
timeFrame: Pharmacokinetic plasma samples collected over 36 hour period
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05843604: Cerebral and Cognitive Markers of Treatment Resistance in Obsessive Compulsive Disorder
Official title: Cerebral and Cognitive Markers of Treatment Resistance in Obsessive-compulsive Disorder: Towards Personalization of Patient Care
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: OCD
Keywords: functional MRI
Lead sponsor: Centre Hospitalier Henri Laborit
Sponsor class: OTHER
First posted: 2023-05-06
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients will be recruited from the Clinical Research Unit of Poitiers. All volunteer patients included in this study will be included regardless of the degree of resistance to treatment or the severity of their disease. Patients will not be hospitalized for the duration of the study unless their condition requires it.

Healthy volunteers will be recruited locally by advertisement or through acquaintances, and will be matched to each patient based on age, gender, laterality, and education level. They must not have an acute pathology being treated, nor take psychotropic drugs, nor be followed in psychotherapy. In their history, we must not find hospitalization in a psychiatric environment or a psychiatric illness according to the M.I.N.I. version 5.0.0.

Brief summary: This study aims to define individual profiles of treatment resistants in order to find indicators and predictors of the therapeutic response.


Eligibility criteria: Inclusion Criteria:

* Obsessive compulsive disorder diagnosed according to Diagnostic and Statistical Manual 5 criteria (patients will be included regardless of the severity and resistance of their pathology and their levels of executive functions)
* Understand and accept the constraints of the study
* Be a beneficiary or affiliated to a Health Insurance scheme

Exclusion Criteria:

* Present one of the diagnoses according to the criteria of the DSM 5: schizophrenic disorders, substance abuse or dependence to a substance according to the criteria of the M.I.N.I. version 5.0 (Sheehan et al., 1998)
* Generalized anxiety disorder, social anxiety, nicotine dependence and history of a major depressive episode are not exclusion criteria according to the M.I.N.I. version 5.0 (Sheehan et al., 1998)
* Have a serious intercurrent pathology
* Being a pregnant woman
* Being a woman of childbearing age without effective contraception.
* Being hospitalized under duress or on an outpatient basis in a care program
* Being under judicial protection (reinforced curatorship, guardianship)

Primary outcomes:
measure: Cerebral activity modification during N-back task
timeFrame: Day 1
measure: Cerebral activity modification during Stroop task
timeFrame: Day 1
measure: Cerebral activity modification during switching task (Monsell et Mizon task )
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Poitiers
country: France
facility: Centre Hospitalier Henri Laborit
Study officials:
References: