louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00144469: A Study of Peginterferon Alfa-2a in Combination With Ribavirin in Patients With Chronic Hepatitis C
Official title: A Phase III Study of Ro25-8310 (Peginterferon Alfa-2a) in Combination With Ro20-9963 (Ribavirin) in Patients With Chronic Hepatitis C
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Hepatitis C
Lead sponsor: Chugai Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2005-09-05
Enrollment: 300
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluated the efficacy and safety of the combination of peginterferon alfa-2a plus ribavirin in treatment-naïve patients with HCV genotype 1b infection, compared with peginterferon alfa-2a monotherapy.

Additionally, the study evaluated the efficacy and safety of the combination of peginterferon alfa-2a plus ribavirin in patients with CHC who had failed to respond to previous conventional-interferon based therapy.

Detailed description: Treatment-naïve patients were randomly assigned in a 1:1 ratio to 48 weeks of double-blind treatment with subcutaneous, once-weekly injections of 180 μg of peginterferon alfa-2a (40KD) plus either twice-daily oral ribavirin (600 to 1000mg/day) or placebo.

All patients who had received previous treatment with conventional interferon but had failed to respond (no suppression of HCV-RNA below detection limits of a sensitive assay) or had relapsed (reversion to HCV-RNA positive state after suppression) received the combination of peginterferon alfa-2a (40KD) plus ribavirin for 48 weeks at the dosages stated above.

Eligibility criteria: Inclusion Criteria:

* Adult patients with quantifiable serum HCV-RNA (≥500 IU/mL))
* elevated serum alanine aminotransferase activity (≥45 IU per liter)within six months of screening
* liver biopsy findings consistent with a diagnosis of chronic hepatitis C.

Exclusion Criteria:

* Patients with neutropenia (fewer than 1,500 neutrophils per cubic millimeter)
* leukopenia (fewer than 3,000 white blood cells per cubic millimeter)
* thrombocytopenia (fewer than 90,000 platelets per cubic millimeter)
* anemia (less than 12 g hemoglobin per deciliter )
* hepatitis B co-infection
* decompensated liver disease
* organ transplant
* creatinine clearance less than 50 milliliters per minute
* poorly controlled psychiatric disease
* poorly controlled diabetes
* malignant neoplastic disease
* severe cardiac or chronic pulmonary disease
* immunologically mediated disease
* retinopathy.

Primary outcomes:
measure: Sustained virological response, defined as undetectable HCV-RNA (<50IU per milliliter) after 24 weeks of untreated follow-up (week 72).
Secondary outcomes:
measure: Biochemical response (normalization of serum alanine aminotransferase activity),
measure: Virological response (HCV-RNA <50IU per milliliter) at the end of therapy.
Other outcomes:
Locations:
Study officials:
affiliation: Chugai Pharmaceutical
name: Hirokazu Furuta
role: STUDY_DIRECTOR
References:
Clinical trial NCT03559569: Impact of Endothelial and Leukocyte Senescence in Circulatory Shock States
Official title: Impact of Endothelial and Leukocyte Senescence in Circulatory Shock States
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Shock
Cardiovascular Diseases
Infection
Keywords: Shock
Cardiovascular Diseases
Infection
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2018-06-18
Enrollment: 520
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients admitted in the intensive care unit of the "Nouvel Hôpital Civil de Strasbourg" for a circulatory shock will be included.

Healthy volunteer will be included in our Clinical Investigation Center of the "Hôpitaux Universitaires de Strasbourg"

Brief summary: Circulatory shocks (CS) are life-threatening, acute organ dysfunction. Advances in critical care medicine have decreased early hospital mortality, increasing the number of surviving patients. Regrettably, these survivors are at increased risk of new infections but also of cardiovascular disease.

The investigators hypothesize that CS with multi-organ dysfunction is associated with premature senescence of endothelial cells and immune cells and promotes endothelial thrombogenicity and immunosenescence leading to cardiovascular disease and secondary infections.

The aim of this work is therefore to evaluate the contribution of endothelial and leucocytes senescence to the occurrence of secondary events (infectious and cardiovascular) in patients with a CS. It will provide a better understanding of the pathogenesis of cardiovascular and immune diseases following a CS, likely to guide new management strategies to prevent their occurrence.


Eligibility criteria: Inclusion criteria:

* Circulatory shock
* patient with health care insurance

Exclusion criteria:

* Patients' refusal to participate in clinical research
* Pregnant woman
* Breastfeeding woman
* A patient with a protective order

Primary outcomes:
measure: The main criterion will be the acquisition of a senescent phenotype concerning leukocytes and endothelial cells.
timeFrame: 1 year
Secondary outcomes:
measure: Incidence of cardiovascular events and secondary infection in hospitalized patients in intensive care unit for circulatory shock states
timeFrame: 5 years
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Hôpitaux Universitaires de Strasbourg - Service de Réanimation médicale du NHC
Study officials:
affiliation: Hôpitaux Universitaires de Strasbourg
name: Ferhat MEZIANI
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03445169: A Food Effect Study in Healthy Volunteers With Belzutifan (PT2977, MK-6482) Tablets
Official title: A Single-Dose, Open-Label, Randomized, Food Effect Study in Healthy Volunteers With PT2977 Tablets
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Peloton Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Sponsor class: INDUSTRY
First posted: 2018-02-26
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This Phase 1, single-dose study will be conducted in adult male and female subjects (N = 16) who are in general good health and selected for participation in the study according to the selection criteria. This study will assess the effect of food on the pharmacokinetics of belzutifan Tablets. The study will consist of two periods and will be conducted in a crossover fashion.

Detailed description: Subjects will be randomized in equal numbers to two sequences of meal conditions (fasting and non-fasting). Serial blood samples will be collected after dose administration in each period. Subjects will be confined at the clinical research for a portion of each period.

Eligibility criteria: Inclusion Criteria:

* Female or vasectomized male;
* If of childbearing potential, willing to practice methods of birth control;
* If of childbearing potential, must be non-pregnant and non-lactating and have a negative serum pregnancy test result prior to enrollment into the trial;
* Has a body mass index (BMI) between 19 and 32 kg/m2; Willing and able to give written informed consent for study participation and provide consent for access to medical data;
* Willing and able to cooperate with all aspects of the protocol.

Exclusion Criteria:

* Any vaccination within 30 days before start of this study and throughout the study;
* Abnormal blood pressure or pulse rate;
* Abnormal screening electrocardiogram (ECG);
* Receipt of any investigational agent within 30 days;
* A positive history of drug abuse or a positive test result for drug(s) of abuse;
* Female subjects who are planning a pregnancy or are pregnant or lactating.

Primary outcomes:
measure: Plasma Concentrations of belzutifan assessed in both the fasting and non-fasting conditions and compared
timeFrame: 9 days in each of the fasting and non-fasting arms
Secondary outcomes:
Other outcomes:
Locations:
city: West Bend
country: United States
facility: Spaulding Clinical
state: Wisconsin
Study officials:
References:
Clinical trial NCT02047669: Implementation of Physical Exercise at the Workplace (IRMA09) - Laboratory Technicians
Official title: Implementation of Physical Exercise at the Workplace (IRMA09) - Laboratory Technicians
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Musculoskeletal Disorders
Stress
Lead sponsor: National Research Centre for the Working Environment, Denmark
Sponsor class: OTHER_GOV
Collaborators: name: University of Southern Denmark
name: University of Southampton
First posted: 2014-01-28
Enrollment: 112
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 67
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Musculoskeletal disorders and stress of employees remain a major problem in many occupations. The aim of this study is to investigate the effect of an individually tailored bio-psycho-social intervention strategy versus "usual care" ergonomics and standard physical exercises (reference group) on musculoskeletal pain, work disability, and stress in lab technicians with a history of work-related musculoskeletal pain.


Eligibility criteria: Inclusion Criteria:

* Laboratory technician
* Pain intensity \>= 3 (scale of 0-10)
* Pain duration \>= 3 months
* Pain frequency \>= 3 days per week

Exclusion Criteria:

* life threatening disease
* pregnancy

Primary outcomes:
measure: Pain intensity
timeFrame: change from baseline to week 10
Secondary outcomes:
measure: Stress
timeFrame: change from baseline to week 10
Other outcomes:
measure: WAI
timeFrame: change from baseline to week 10
measure: Fear Avoidance
timeFrame: change from baseline to week 10
measure: Muscle function
timeFrame: change from baseline to week 10
Locations:
city: Copenhagen
country: Denmark
facility: National Research Centre for the Working Environment
Study officials:
affiliation: National Research Centre for the Working Environment, Denmark
name: Lars L Andersen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jay K, Brandt M, Hansen K, Sundstrup E, Jakobsen MD, Schraefel MC, Sjogaard G, Andersen LL. Effect of Individually Tailored Biopsychosocial Workplace Interventions on Chronic Musculoskeletal Pain and Stress Among Laboratory Technicians: Randomized Controlled Trial. Pain Physician. 2015 Sep-Oct;18(5):459-71.
citation: Jay K, Brandt M, Sundstrup E, Schraefel M, Jakobsen MD, Sjogaard G, Andersen LL. Effect of individually tailored biopsychosocial workplace interventions on chronic musculoskeletal pain, stress and work ability among laboratory technicians: randomized controlled trial protocol. BMC Musculoskelet Disord. 2014 Dec 18;15:444. doi: 10.1186/1471-2474-15-444.
Clinical trial NCT05698069: Turkish Version of Pain Modulation Index
Official title: Reliability and Validity of the Turkish Version of the Pain Modulation Index
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Pain
Lead sponsor: Ege University
Sponsor class: OTHER
First posted: 2023-01-26
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who had non-cancer pain for more than 3 months duration.

Brief summary: In order to assess the validity and reliability of the Turkish version of Pain Modulation Index, 125 volunteers with chronic pain were enrolled in the study. Test and re-test method was used to assess reliability and correlation analyses with Pain Detect, visual analog scale pain and central sensitization inventory scores were used to assess validity of the questionnaire. Turkish version of the Pain Modulation Index was found to be a valid and reliable tool for evaluating chronic pain.

Detailed description: Pain Modulation Index is a questionnaire that was developed in English for the assessment of chronic pain for qualities consistent with central sensitization. The English version of the questionnaire was translated into Turkish by two physicians than back translated into English by two separate bilingual translators. Initially 10 volunteers were asked to answer this first version of the questionnaire and report any difficulties in understanding the items. Their feedback was used to give the questionnaire its final shape. For the validation stage, patients that were diagnosed as having chronic non-cancer pain with more than 3 months duration were enrolled into the study. They answered the questions twice, 15 days apart. In addition to the Turkish version of the Pain Modulation Index, on the first visit, they were also asked to answer Pain Detect and Central Sensitization Inventory. Their answers were analysed to assess the validity and reliability of the Turkish version of Pain Modulation Index.

Eligibility criteria: Inclusion Criteria:

* presence of chronic non-cancer pain of more than 3 months duration

Exclusion Criteria:

* Illiteracy
* Refusal to take part in the study

Primary outcomes:
measure: Reliability of the Turkish version of pain modulation index
timeFrame: 15 days
measure: Validity of the Turkish version of Pain Modulation Index
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Bornova
country: Turkey
facility: Ege University Hospital, Department of Physical and rehabilitation medicine
state: Izmir
Study officials:
affiliation: Ege University Hospital
name: Simin Hepguler, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Austin PD, Asghari A, Costa DSJ, Siddall PJ. The development of a novel questionnaire assessing alterations in central pain processing in people with and without chronic pain. Scand J Pain. 2020 Apr 28;20(2):407-417. doi: 10.1515/sjpain-2019-0087.
Clinical trial NCT01294969: Patient Perception Study for AL-4943A
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Allergic Conjunctivitis
Keywords: Allergic conjunctivitis
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2011-02-14
Enrollment: 47
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate patient perceptions of Al-4943 in subjects with allergic conjunctivitis previously treated with a topical ocular anti-allergy leukotriene-release inhibitor medication.


Eligibility criteria: Inclusion Criteria:

* History of allergic conjunctivitis within last 24 months
* Active signs and symptoms of ocular allergies

Exclusion Criteria:

* Severe or serious ocular condition, ocular surgical intervention, ocular infection

Primary outcomes:
measure: Overall Patient satisfaction
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Alcon Korea Ltd.
Study officials:
References:
Clinical trial NCT04282369: Evaluation Of The Efficacy Of Four Different Non-invasive Ventilation Modes Performed In The Delivery Room
Official title: Evaluation Of The Efficacy Of Four Different Non-invasive Ventilation Modes Performed In The Delivery Room In Late Preterm And Term Infants Wıth Respiratory Distress
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Respiratory Disease
Respiratory Insufficiency
Keywords: respiratory distress, newborn, noninvasive ventilation
Lead sponsor: Kanuni Sultan Suleyman Training and Research Hospital
Sponsor class: OTHER
First posted: 2020-02-24
Enrollment: 100
Sex: ALL
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Evaluation Of The Efficacy Of Four Different Non-invasive Ventilation Modes Performed In The Delivery Room In Late Preterm And Term Infants Wıth Respiratory Distress

Detailed description: In this study, it is aimed to search the efficacy and comfort of the four different non-invasive ventilation modes in the delivery room. HHFNC, NCPAP, NIPPV and NHFO modes are used for the respiratory distress of the late preterm and term babies.

Eligibility criteria: Inclusion Criteria:

* late preterm and term infants with respiratory distress

Exclusion Criteria:

* intubation for the respiratory distres.
* major abnormalities

Primary outcomes:
measure: Silverman Score
timeFrame: 6 months
Secondary outcomes:
measure: N-PASS score
timeFrame: 6 months
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Kanuni Sultan Suleyman Research and Training Hospital
city: Istanbul
country: Turkey
facility: Kanuni Sultan Suleyman Research and Training Hospital
Study officials:
References:
Clinical trial NCT01240369: Association Between VEGF-C and miRNA and Clinical Non-small Cell Lung Cancer and Esophagus Squamous Cell Carcinoma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: VEGFC Protein in Serum
VEGFC Protein in Non Small Cell Lung Cancer
VEGFC Protein in ESCC
CTTN Protein in ESCC
miR326 in ESCC and Non Small Cell Lung Cancer
Keywords: VEGFC
CTTN
miR326
ESCC
NSCLC
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
First posted: 2010-11-15
Enrollment: 250
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: ESCC and NSCLC patients

Brief summary: Lung cancer and esophageal cancer remain the leading causes of cancer death worldwide. The main problem is lack of effective tool in early detection that accounts for the poor outcome of cancer. Clinically, over 80% of patients with cancer were at late stage when they were diagnosed. Therefore, it is important for us to find the biomarker that serve as the early prediction of cancer.

The investigators have published that VEGFC over-expressed in non-small cell lung cancer. VEGFC plays a critical role in regulating motility of tumor cells, promotes proliferation of lymphatic endothelial cells and enhances migration and invasion. Investigator found that VEGFC over-expressed in the serum of esophageal cancer patients. Therefore, it is worthwhile to investigate the correlation between VEGFC, clinical lung cancer and esophageal cancer.

MicroRNAs (miRNAs) are conserved, endogenous, small, and noncoding RNA molecules of 21\~23 nucleotides that function as post-transcriptional gene regulators. Recent studies indicated that certain microRNAs reduced in cancer patients. Therefore it is important to investigate whether specific microRNA changed in certain kinds of cancer patients.


Eligibility criteria: Inclusion Criteria:

* tumor size \> 0.5 cm3

Exclusion Criteria:

* tumor size \< 0.5 cm3

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01272869: Clinical Investigation of Filter Improvement for New Filter to Ostomy Bags
Official title: Clinical Investigation of Filter Improvement for New Filter to Ostomy Bags
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ileostomy - Stoma
Lead sponsor: Coloplast A/S
Sponsor class: INDUSTRY
First posted: 2011-01-10
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of the current clinical investigation is to evaluate a new filter

Detailed description: The filter has been developed in order to significantly reduce problems with ballooning and other problems related to filter performance in people with a stoma.

Eligibility criteria: Inclusion Criteria:

* Be at least 18 years of age and have full legal capacity.
* Have given written informed consent.
* Be able to fill in the Case Report Form.
* Be ileostomy operated and have had a stoma for at least 6 months.
* Experience ballooning at least once per week.
* Be able to manage the bags themselves (application, removal).
* Be able to use a flat base plate.
* Have a stoma with a diameter less than 60 mm

Exclusion Criteria:

* Persons who irrigate
* Currently suffer from peristomal skin problems (i.e. bleeding or broken skin).
* Currently receiving or have within the past 2 months received radio- and/or chemotherapy.
* Pregnant or breastfeeding.
* Participate in other test at the same time.

Primary outcomes:
measure: Frequency of Ballooning in the Morfeus and the Sensura Filter Test Period.
timeFrame: Daily or at every change of bag in a period of a maximum of 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Humlebaek
country: Denmark
facility: Coloplast A/S
Study officials:
affiliation: Coloplast A/S
name: Daniel Carter, MSc
role: STUDY_CHAIR
References:
Clinical trial NCT00903669: Anthropometric Angular Measurement to Determine Muscle Tonus in Patients With Peripheral Facial Paralysis
Official title: Anthropometric Angular Measurement to Determine Muscle Tonus in Patients With Peripheral Facial Paralysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peripheral Facial Paralysis
Keywords: Facial paralysis
Muscle tonus
Rehabilitation
Myofunctional
Stomatognathic system
Lead sponsor: University of Campinas, Brazil
Sponsor class: OTHER
First posted: 2009-05-18
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with PFP treated in the Hospital of Unicamp

Brief summary: The current study sought to determine the reliability of the rehabilitation protocol using the labial commissure angle (LCA) as an indicator of both muscle tonus and therapeutic success. The investigators hypothesized that this measurement would provide objective data regarding the efficacy of rehabilitation for these challenging patients.

Detailed description: CONTEXT AND OBJECTIVE: In cases of peripheral facial paralysis (PFP), diminished facial movements and their resultant cosmetic sequelae may have significant emotional repercussions, in addition to producing pronounced functional deficits. Abnormal muscle proprioception and deviation of the nasal-labial filter may also interfere with articulation of the labiodental and bilabial phonemes, thus diminishing speech intelligibility. In relation to stomatognathic functions, weakened labial occlusion decreases intraoral pressure, thereby hindering liquid retention in the buccal cavity and giving rise to vestibular stasis on the paralyzed side. The aim of this study was to evaluate the reliability of the labial commissure angle (LCA) as an anthropometric marker for objectively assessing changes in facial muscle tonus.

Eligibility criteria: Inclusion Criteria:

* age range between 20 and 70 years
* incomplete PFP (Degree IV)
* integral facial nerve (FN)

Exclusion Criteria:

* systemic disease
* potentially aggravating the PFP (neurological, degenerative, endocrinological)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Campinas
country: Brazil
facility: Universidade estadual de Campinas
state: São Paulo
Study officials:
affiliation: Universidade Estadual de Campinas, Unicamp
name: Jorge R Paschoal
role: PRINCIPAL_INVESTIGATOR
References: