louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00002130: A Long-Term, Follow-On Safety Study of Four Doses of OPC-8212 (Vesnarinone) in HIV-Infected Persons
Official title: A Long-Term, Follow-On Safety Study of Four Doses of OPC-8212 (Vesnarinone) in HIV-Infected Persons
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Keywords: Acquired Immunodeficiency Syndrome
Antiviral Agents
vesnarinone
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: To examine the continued safety and tolerability of four doses of vesnarinone in HIV-infected patients who have completed a short-term study (less than 12 months on continuous treatment) of the drug.

Detailed description: Patients who have completed a limited duration study (less than 12 months of continuous treatment) of vesnarinone on protocols FDA 234A or FDA 234B and who have no current signs or symptoms of AIDS-defining illnesses may roll over to this study and continue receiving their regimen of vesnarinone for 12 months beyond their original participation.

Eligibility criteria: Inclusion Criteria

Concurrent Medication:

Allowed:

* Chemoprophylaxis for Pneumocystis carinii, candida, and mycobacteria.
* Acyclovir for acute treatment of herpes.

Exclusion Criteria

Concurrent Medication:

Excluded:

* Antiretroviral agents, including ddI, ddC, AZT, and d4T.
* Immunosuppressive agents.
* Investigational HIV drugs/therapies including vaccines.
* Interferon or other immunomodulating agents.
* Corticosteroids (other than topical).
* Megestrol acetate.
* Agents known to cause neutropenia.
* Ganciclovir.
* Cytotoxic chemotherapy.

Concurrent Treatment:

Excluded:

* Radiation therapy.

Patients with the following prior conditions are excluded:

* Poor compliance (less than 80 percent of drug taken) on the Phase I protocol (FDA 234A or FDA 234B).
* Missed more than one clinic visit on the Phase I protocol.

Prior Medication:

Excluded:

* Acyclovir as prophylaxis for herpes within 48 hours prior to study entry.

Patients meet the following criteria:

Successful completion of short-term therapy with vesnarinone on FDA 234A or FDA 234B.

Active illicit drug abuse.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA School of Medicine
state: California
city: Atlanta
country: United States
facility: AIDS Research Consortium of Atlanta
state: Georgia
Study officials:
References:
Clinical trial NCT02117648: A Study of LY2835219 in Participants With Cancer
Official title: Effects of CYP3A Inhibition by Clarithromycin on the Pharmacokinetics of LY2835219 and Its Metabolites in Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Neoplasm
Neoplasm Metastasis
Keywords: advanced cancer
metastatic cancer
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2014-04-21
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to assess how the body handles Abemaciclib when it is given with another drug called clarithromycin. The study doctor will measure the amount of Abemaciclib that is absorbed into the blood stream and the time that it takes to remove Abemaciclib from the body. The safety and tolerability of these drugs will be studied.

Each participant will complete 2 study periods in fixed order. After screening, Period 1 will last approximately 8 days and Period 2 will last approximately 15 days. Participants who complete Period 2 may continue to receive Abemaciclib in 28-day cycles until discontinuation criteria are met.


Eligibility criteria: Inclusion Criteria:

* Have histological or cytological evidence of cancer (solid tumors) that is advanced and/or metastatic
* Have a performance status of 0 to 2 on the Eastern Cooperative Oncology Group (ECOG) scale

Exclusion Criteria:

* No symptomatic central nervous system (CNS) malignancy or metastasis

Primary outcomes:
measure: Pharmacokinetics (PK): Area Under the Concentration Time Curve From Zero to Infinity (AUC[0-∞]) of Abemaciclib
timeFrame: Period 1: Predose; 1, 2, 4, 6, 8, 10, 24, 48, 72, 96, 120, 144, 168hr, Period 2: 1, 2, 4, 6, 8, 10, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240hr Post dose
measure: PK: Maximum Concentration (Cmax) of Abemaciclib
timeFrame: Period 1: Predose; 1, 2, 4, 6, 8, 10, 24, 48, 72, 96,120,144,168hr, Period 2: 1, 2, 4, 6, 8, 10, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240hr Post dose
Secondary outcomes:
Other outcomes:
Locations:
city: Memphis
country: United States
facility: Accelerated Comm. Oncology Research Network (ACORN)
state: Tennessee
city: Memphis
country: United States
facility: The West Clinic
state: Tennessee
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
citation: Gelbert LM, Cai S, Lin X, Sanchez-Martinez C, Del Prado M, Lallena MJ, Torres R, Ajamie RT, Wishart GN, Flack RS, Neubauer BL, Young J, Chan EM, Iversen P, Cronier D, Kreklau E, de Dios A. Preclinical characterization of the CDK4/6 inhibitor LY2835219: in-vivo cell cycle-dependent/independent anti-tumor activities alone/in combination with gemcitabine. Invest New Drugs. 2014 Oct;32(5):825-37. doi: 10.1007/s10637-014-0120-7. Epub 2014 Jun 13.
Clinical trial NCT02649348: Effects of Prehabilitation in Gastric Cancer Patients With Metabolic Syndrome on Perioperative Outcome
Official title: Effects of Pre-operative Prehabilitation on the Clinical Outcomes of Gastric Cancer Patients With Metabolic Syndrome Who Undergo Laparoscopic Radical Gastrectomies: A Polit Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stomach Neoplasms
Metabolic Syndrome X
Keywords: gastric neoplasm
metabolic syndrome
prehabilitation
pre-operative exercise
laparoscopic radical gastrectomy
Lead sponsor: Qingdao University
Sponsor class: OTHER
First posted: 2016-01-07
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: A prospective randomised controlled trial to investigate the effects of a pre-operative prehabilitation protocol on clinical outcomes of gastric cancer patients with metabolic syndrome who undergo laparoscopic radical gastrectomies and to determine the underlying mechanisms.

Detailed description: To investigate the effects of a pre-operative prehabilitation protocol on clinical outcomes of gastric cancer patients with metabolic syndrome who undergo laparoscopic radical gastrectomies and to determine the underlying mechanisms.

Eligibility criteria: Inclusion Criteria:

* histologically-proven pre-operative stage I-III gastric cancer
* Combined with metabolic syndrome
* Age limits from 18 to 80 years old
* Classified into American Society of Anesthesiology (ASA) II or III surgical risk
* no history of abdominal surgery on organs located at the abdominal supramesocolic level

Exclusion Criteria:

* Combined with severe cardiac or pulmonary disease or other organ dysfunction
* ASA IV
* The history of abdominal surgery
* Conversion to open surgery
* The presence of gastrointestinal obstruction, perforation or necrosis;
* Declined to participate in this study

Primary outcomes:
measure: The proportion of postoperative complications
timeFrame: up to six months
Secondary outcomes:
Other outcomes:
Locations:
city: Qingdao
country: China
facility: the Affiliated Hospital of Qingdao University
state: Shandong
Study officials:
affiliation: The Affiliated Hospital of Qingdao University
name: Yan Han, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT01247948: Evaluating the Accuracy of Navigation Assisted Pedicle Screw Placement of Spine Surgery
Official title: A Multi-center Randomized Controlled Trial Evaluating the Accuracy of Navigation Assisted Pedicle Screw Placement of Spine Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pedicle Screw of Fixation
Keywords: pedicle screw of fixation operation
spine surgery
navigation assisted
Lead sponsor: Beijing Jishuitan Hospital
Sponsor class: OTHER
First posted: 2010-11-25
Enrollment: 656
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: TREATMENT

Brief summary: The purpose of this study is to investigate the difference of the accuracy and safety between traditional spine surgery and computer assisted navigation system spine surgery.

Detailed description: The object of study is the patients who are going to undergo pedicle screw fixation operation. there are two clinical trial centers.one is beijing jishuitan hospital,the other is beijing shuili hospital.the study protocol will be reviewed by the Ethics Committee of Beijing Jishuitan Hospital. after the patients sign the informed consent,they will be divided into two groups randomly.the patients' basic information and medical informations including the accuracy and safety will be collected.the data above all will be compared.

Eligibility criteria: Inclusion Criteria:

* Patients who need to undergo pedicle screw fixation surgery
* Sign informed consent
* Capacity person

Exclusion Criteria:

* refused to sign the informed consent
* the age is not between 18 and 75 years old

Primary outcomes:
measure: the accuracy of pedicle screw
timeFrame: one week after the spine surgery
Secondary outcomes:
measure: complication
timeFrame: three days after the spine surgery
Other outcomes:
Locations:
Study officials:
affiliation: Beijing Jishuitan Hospital
name: Wei Tian, doctor
role: STUDY_CHAIR
References:
Clinical trial NCT00363948: Controlled Study of MK-0431/ONO-5435 in Patients With Type 2 Diabetes Mellitus
Official title: MK-0431/ONO-5435 Phase III Clinical Study - Metformin Add-On Study for Patients With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes Mellitus
Keywords: MK-0431
ONO-5435
Type 2 diabetes mellitus
Lead sponsor: Ono Pharmaceutical Co. Ltd
Sponsor class: INDUSTRY
First posted: 2006-08-15
Enrollment: 188
Sex: ALL
Minimum age (years): 20
Maximum age (years): 74
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 determine the safety and efficacy of MK-0431/ONO-5435 in patients with Type 2 diabetes mellitus who have inadequate glycemic control on diet/exercise therapy and metformin as monotherapy


Eligibility criteria: Inclusion Criteria:

* Patients with type 2 diabetes mellitus on diet/exercise therapy and metformin as monotherapy

Exclusion Criteria:

* Patients with type 1 diabetes mellitus

Primary outcomes:
measure: HbA1c
timeFrame: 12 weeks
measure: safety
timeFrame: 52 weeks
measure: tolerability
timeFrame: 52 weeks
Secondary outcomes:
measure: Plasma glucose
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Chubu
country: Japan
facility: Chubu Region
city: Chugoku
country: Japan
facility: Chugoku Region
city: Hokkaido
country: Japan
facility: Hokkaido Region
city: Hokuriku
country: Japan
facility: Hokuriku Region
city: Kanto
country: Japan
facility: Kanto Region
city: Kinki
country: Japan
facility: Kinki Region
city: Kyushu
country: Japan
facility: Kyushu Region
city: Tohoku
country: Japan
facility: Tohoku Region
Study officials:
affiliation: Ono Pharmaceutical Co. Ltd
name: Mikio Nishii
role: STUDY_DIRECTOR
References:
citation: Kadowaki T, Tajima N, Odawara M, Nishii M, Taniguchi T, Ferreira JC. Addition of sitagliptin to ongoing metformin monotherapy improves glycemic control in Japanese patients with type 2 diabetes over 52 weeks. J Diabetes Investig. 2013 Mar 18;4(2):174-81. doi: 10.1111/jdi.12001. Epub 2012 Oct 22.
Clinical trial NCT05894148: Clinical Study of Multiple Dose Genakumab for Injection in Chinese Healthy Adults
Official title: A Randomized, Double-Blind, Placebo-Controlled, Multiple-dose Escalation Phase I Study of Genakumab for Injection in Chinese Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Interstitial Lung Disease
Keywords: Safety,
Tolerability,
Pharmacokinetics,
Genakumab
Lead sponsor: Changchun GeneScience Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Afﬁliated Hospital of North Sichuan Medical College
First posted: 2023-06-08
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the safety and tolerability of multiple-dose subcutaneous injections of Genakumab for Injection in Chinese healthy adult volunteers.

Detailed description: There are 2 dose groups with 12 participants in each group, including 10 participants in the experimental group and 2 participants in the placebo control group. Each subject receives Genakumab or placebo once every four weeks for three times.

Eligibility criteria: Inclusion Criteria:

* 18 years ≤ age ≤45 years, and in good health;
* body mass index is within the range of 19 - 26 kg/m\^2 (including 19 kg/m\^2 and 26 kg/m\^2);
* No parental scheme from the screening period to 3 months after the study period.

Exclusion Criteria:

* Participants have abnormal physical and auxiliary examination results with clinical significance;
* History of cardiovascular, liver, kidney, digestive, blood, nervous system and allergic diseases, mental and metabolic disorders,
* Participants who use any prescription drugs within 2 weeks prior dosing.
* Participants who receive (attenuated) live vaccines within 3 months prior to dosing;
* Participation in any clinical investigation within 3 months prior to dosing;
* Donation or loss of 400 mL or more of blood within 3 months prior to dosing;
* Tuberculosis symptoms, contact with patients with suspected tuberculosis symptoms
* Positive results in Hepatitis B surface antigen (HBsAg), Hepatitis C antibody, Syphilis antibody or HIV antibody;
* Current or previous drug or alcohol abuse;
* Other conditions in which the investigator preclude enrollment into the study

Primary outcomes:
measure: The frequency of adverse events (AE)
timeFrame: Up to 20 weeks
Secondary outcomes:
measure: Maximum observed serum Genakumab concentration
timeFrame: up to 20 weeks
measure: Area under the serum Genakumab concentration-time curve
timeFrame: up to 20 weeks
Other outcomes:
Locations:
city: Chengdu
country: China
facility: Chengdu Xinhua Hospital Affiliated to North Sichuan Medical College
state: Sichuan
Study officials:
affiliation: Chengdu Xinhua Hospital
name: Xiaolan Yong, bachelor
role: STUDY_CHAIR
References:
Clinical trial NCT04214548: A Pilot Study to Explore the Role of Gut Flora in Eczema
Official title: A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Eczema
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Eczema
Keywords: microbiome
Lead sponsor: ProgenaBiome
Sponsor class: OTHER
First posted: 2020-01-02
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with eczema

Brief summary: This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records regarding eczema.

Detailed description: The goal of this Research Study is to better understand how the genetic information in subject's microbiome correlates to the information provided in surveys and in medical records regarding eczema.

Eligibility criteria: Inclusion Criteria:

1. Signed informed consent by patient
2. Male or female patients age 18 and older.
3. Diagnosis of eczema

Exclusion Criteria:

1. Refusal by patient to sign informed consent form
2. Treatment with antibiotics within 2 weeks prior to screening
3. Treatment with probiotics within 6 weeks prior to screening
4. History of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy.
5. Postoperative stoma, ostomy, or ileoanal pouch
6. Participation in any experimental drug protocol within the past 12 weeks
7. Treatment with total parenteral nutrition
8. Any clinically significant evidence of disease that could interfere with the subject's ability to enter the trial
9. Inability of patient to adequately communicate with the investigator or their respective designee and/or comply with the requirements of the entire stud

Primary outcomes:
measure: Correlation of Microbiome to Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) via Relative Abundance Found in Microbiome Sequencing
timeFrame: 3 years
Secondary outcomes:
measure: Validation of Sequencing Methods
timeFrame: 3 years
Other outcomes:
Locations:
city: Ventura
country: United States
facility: ProgenaBiome
state: California
Study officials:
affiliation: ProgenaBiome
name: Sabine Hazan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06714448: A Study of the Effectiveness of Risk Minimization Measures Related to Depakine® (Sodium Valproate) in Saudi Arabia
Official title: Post Authorization Safety Study Assessing the Effectiveness of Risk Minimization Measures Related to Depakine® (Sodium Valproate) in Saudi Arabia
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Epilepsy
Seizures
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2024-12-03
Enrollment: 3500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: In this survey-based study, the data will be collected from each healthcare professional participant in Saudi Arabia once at a certain time. However, the study will take 7 months, from 30 November 2024 to 30 May 2025, to collect the required number of responses.

Brief summary: A cross-sectional, national, multicenter, survey-based study to assess the effectiveness of Risk Minimization Measures related to Depakine® (sodium valproate) in Saudi Arabia. The study duration will be 7 months from 30 November 2024 to 30 May 2025. The end of study is defined as the end of the data collection period. No intervention will be administered, and no study related visits are required.


Eligibility criteria: Inclusion Criteria:

* Healthcare professionals working only in Saudi Arabia AND
* Prescribers of Depakine® (sodium valiporate) at least once in the six months leading up to survey completion OR
* Obstetricians/Gynecologists who consulted at least one women of childbearing potential treated with Depakine® (sodium valproate) in the six months leading up to survey completion OR
* Pharmacists who have dispensed Depakine® (sodium valproate) in the six months leading up to survey completion

Exclusion Criteria:

* Healthcare professionals who may have conflicts of interest with the survey (i.e. employed by regulatory bodies or pharmaceutical companies)
* Healthcare professionals (or with a relative) involved in valproate-related lawsuits or associations for victims of valproate syndrome
* Healthcare professionals who are not prescribing Depakine® (sodium valproate), except for obstetricians/gynecologists (who do not prescribe Depakine® \[sodium valproate\])
* Healthcare professionals having started to prescribe or dispense Depakine® (sodium valproate) earlier than six months before survey completion

The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.

Primary outcomes:
measure: Percentage of healthcare professionals who received and read the educational materials
timeFrame: 7 months
measure: Healthcare professionals' knowledge score
timeFrame: 7 months
measure: Healthcare professionals' behavior score
timeFrame: 7 months
Secondary outcomes:
Other outcomes:
Locations:
city: Chilly-Mazarin
country: France
facility: Sanofi-Aventis
Study officials:
References:
Clinical trial NCT04765930: Combined Q-switched Nd:YAG Laser and Platelet Rich Plasma Versus Q- Switched Nd:YAG Laser Alone in Melasma
Official title: Combined Q-switched Nd:YAG Laser and Platelet Rich Plasma Versus Q- Switched Nd:YAG Laser Alone in the Treatment of Melasma: A Split Face Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hyperpigmentation
Melasma
PRP
Lasers
Keywords: laser toning
Hemi-MASI
Colorimeter
Erythema Index
Melanin Index
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-02-23
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Melasma is a common, acquired, esthetically disfiguring hypermelanosis of the face. Melasma is considered a disappointing challenge when treatment options are addressed. Diverse treatment modalities such as retinoic acid, hypo-pigmenting agents like hydroquinone, azelaic acid, and kojic acid, chemical peels, microdermabrasion, and lasers have been tried for the treatment of melasma. There is no universally proven therapy that induces and maintains remission of the condition. Q-switched: Nd YAG laser toning and platelet rich plasma (PRP) are promising treatments for melasma.The aim of this work is evaluate the efficacy and safety of combined PRP and Q-switched: NdYAG laser in the treatment of melasma using clinical assessment, in addition to assessment of Melanin Index and Erythema Index.


Eligibility criteria: Inclusion Criteria:

* Patients with bilateral nearly symmetric melasma on the face.

Exclusion Criteria:

* Patients receiving systemic or topical or laser treatment relevant to melasma within three months before enrollment into the study.
* Use of oral or injectable contraceptives or hormone replacement therapy during treatment or 12 months before
* Patients active skin infections and active HSV
* History of hypertrophic scars or keloids.
* Patients with hypercoagulable state or bleeding diatheses
* Pregnant and lactating females.
* History of liver diseases
* Intake of systemic chemotherapy, corticosteroids, antiplatelets or anticoagulants

Primary outcomes:
measure: Hemi-Melasma Area and Severity Index (MASI) score
timeFrame: 2 months after final treatment
Secondary outcomes:
measure: Melanin Index
timeFrame: 2 months after final treatment
measure: Erythema Index
timeFrame: 2 months after final treatment
Other outcomes:
measure: Paients' Satisfaction assessed by the VAS
timeFrame: 2 months after final treatment
Locations:
city: Cairo
country: Egypt
facility: Department of Dermatology, Cairo University
Study officials:
References: