louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00771472: Vorinostat (MK-0683) Phase I Study in Cutaneous T-Cell Lymphoma (CTCL) Patients (MK-0683-089 EXT1)
Official title: Phase I Clinical Study of MK-0683 in Patients With Relapsed or Refractory Cutaneous T-Cell Lymphoma (CTCL)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Lymphoma
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2008-10-13
Enrollment: 10
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Part I evaluates the safety, tolerability and pharmacokinetics (PK) of vorinostat in Japanese patients with relapsed or refractory CTCL. Part II evaluates the safety of vorinostat in Japanese pts. with relapsed or refractory CTCL. Relapsed or refractory CTCL patients will be newly enrolled in Part II.


Eligibility criteria: Inclusion Criteria (Parts I \& II):

* Patients With CTCL Who Have Progressive, Persistent Or Recurrent Disease Subsequent To At Least One Prior Therapy
* Eastern Cooperative Oncology Group (ECOG) Performance Status Must Be 0-2
* Patients Have Adequate Bone Marrow, Liver Function And Renal Function

Exclusion Criteria (Parts I \& II):

* Patients Had Prior Therapy Within 3 Weeks Before Registration, Or Have Not Recovered From Toxicities Of Prior Therapy
* Patients Have Uncontrolled Intercurrent Illness
* Pregnant Or Women Have A Will To Be Pregnant And Lactating Woman

Primary outcomes:
measure: Parts I & II: Number of Participants Experiencing Clinical or Laboratory Adverse Experiences (AE)
timeFrame: Day 1 up until 30 days post study completion or early termination (up to approximately 506 days)
measure: Part I: Number of Participants Experiencing Dose Limiting Toxicity (DLT)
timeFrame: Day 1 to Day 28
Secondary outcomes:
measure: Part I: Total Drug Exposure (Area Under the Concentration Curve, AUC[0-24 Hours])
timeFrame: Days 1 & 28 of Cycle 1
measure: Part I: Maximum Drug Concentration (Cmax)
timeFrame: Days 1 & 28 of Cycle 1
measure: Part I: Time at Which Cmax Occurs (Tmax)
timeFrame: Days 1 & 28 of Cycle 1
measure: Part I: The Amount of Time it Takes for the Drug Concentration to Decrease by Half (T1/2)
timeFrame: Days 1 & 28 of Cycle 1
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Wada H, Tsuboi R, Kato Y, Sugaya M, Tobinai K, Hamada T, Shimamoto T, Noguchi K, Iwatsuki K. Phase I and pharmacokinetic study of the oral histone deacetylase inhibitor vorinostat in Japanese patients with relapsed or refractory cutaneous T-cell lymphoma. J Dermatol. 2012 Oct;39(10):823-8. doi: 10.1111/j.1346-8138.2012.01554.x. Epub 2012 Apr 16.
Clinical trial NCT04802668: Factors Influencing of Pulse Pressure Variation (PPV)
Official title: Factors Influencing the Reliability of Pulse Pressure Variation (PPV) as a Predictor of Fluid Responsiveness in Mechanically Ventilated Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Haemodynamics
Fluid Responsiveness
Pulse Pressure Variation
Keywords: haemodynamics;
Pulse pressure variation;
fluid responsiveness;
Mechanical ventilation;
Lead sponsor: Southeast University, China
Sponsor class: OTHER
First posted: 2021-03-17
Enrollment: 189
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with circulatory failure selected to enter the Department of Critical Care Medicine

Brief summary: The investigators studied the predictive value of PPV in the patients with different influencing factors;and the method to improve the predictive value,which can improve the application of PPV in ICU.

Detailed description: PPV can be used to predict fluid responsiveness in patients with circulatory shock.However, it is affected by many factors, which leads to the decrease of the applicability of PPV in ICU.Therefore, the investigators studied the predictive value of PPV in the patients with different influencing factors;and the method to improve the predictive value,which can improve the application of PPV in ICU.

Eligibility criteria: Inclusion Criteria:

* Patients requiring invasive mechanical ventilation
* Acute circulatory failure,defined as:systolic blood pressure \<90 mmHg or blood pressure in patients with previous hypertension lower than the baseline value\> 40 mmHg; vasoactive drugs are required to maintain blood pressure (mean arterial pressure\> 65 mmHg); with or without signs of hypoperfusion (oliguria\<0.5ml.kg-1.h-1 for at least 2 hours; arterial blood lactic acid\>2.5mmol.L-1; skin mottling)

Exclusion Criteria:

* The age of the patient is less than 18 years old or more than 80 years old
* Refuse to sign the informed consent to join the group
* Atrial fibrillation and other arrhythmias that seriously affect the output per beat;
* With pregnancy
* Other situations where the clinician believes that the patient is not suitable for inclusion in the study

Primary outcomes:
measure: cardiac output(CO)
timeFrame: 1 day
Secondary outcomes:
measure: measurement of Hemodynamic variables from the monitor;
timeFrame: 1 day
measure: measurement of Pulse pressure variation（PPV）from monitor;
timeFrame: Research period
measure: measurement of airway pressure variables from ventilator
timeFrame: 1 day
measure: P 0.1
timeFrame: 1 day
measure: Pocc
timeFrame: 1 day
Other outcomes:
measure: Pes
timeFrame: 1 day
measure: transpulmonary pressure
timeFrame: 1 day
measure: Outcome
timeFrame: 28 day
Locations:
city: Nanjing
country: China
facility: Ling Liu
state: Jiangsu
Study officials:
affiliation: professor
name: Haibo Qiu, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02551172: Evaluating the Efficacy and Safety of HCP1105 in Combined Hyperlipidemic Patients With High Risk for CHD
Official title: An Efficacy and Safety Study of HCP1105 Capsule in Combined Hyperlipidemic Patients With High Risk for Coronary Heart Disease (CHD): A Randomized,Double-blind, Multicenter, Phase 3 Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Hyperlipidemias
Lead sponsor: Hanmi Pharmaceutical Company Limited
Sponsor class: INDUSTRY
First posted: 2015-09-16
Enrollment: 270
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: To investigate the efficacy and safety after administration of HCP1105 in hyperlipidemic patients with high risk for CHD.

Detailed description: An efficacy and safety study of HCP1105 Capsule in combined hyperlipidemic patients with high risk for Coronary Heart Disease(CHD): A randomized,double-blind, multicenter, phase 3 study.

Eligibility criteria: Inclusion Criteria:

* age 19≤
* Subjects who have ability to comprehend the objectives, contents of study and property of study drug before participating in trial and have willingness to sign of informed consent in writing

Exclusion Criteria:

* History of clinically significant hypersensitivity reaction with HMG-CoA reductase inhibitor and Omega-3
* Subject who has active liver disease and severe liver failure(Continuous elevation of AST,ALT level with unspecified cause or AST, ALT level exceeds more than three times of maximum upper range.)

Primary outcomes:
measure: Mean rate of change of non-HDL-C (%) from baseline
timeFrame: 12 weeks
Secondary outcomes:
measure: Mean rate of change of HDL-C (%) from baseline
timeFrame: 4, 8, 12 weeks
measure: Mean rate of change of LDL-C (%) from baseline
timeFrame: 4, 8, 12 weeks
measure: Mean rate of change of Triglyceride (%) from baseline
timeFrame: 4, 8, 12 weeks
measure: Mean rate of change of Total cholesterol (%) from baseline
timeFrame: 4, 8, 12 weeks
measure: Mean rate of change of Total apo A1 (%) from baseline
timeFrame: 4, 8, 12 weeks
measure: Mean rate of change of Total apo B (%) from baseline
timeFrame: 4, 8, 12 weeks
measure: Mean rate of change of Lipoprotein(a) (%) from baseline
timeFrame: 4, 8, 12 weeks
measure: Mean rate of change of hs-CRP (%) from baseline
timeFrame: 4, 8, 12 weeks
measure: Rate of the subjects who meet the target level of treatment
timeFrame: 4, 8, 12 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Euljii General Hospital
Study officials:
affiliation: Asan Medecal Center
name: Jung-yeol Park, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03956472: Alternative Treatments in Acute Mountain Sickness
Official title: Can Osteopathy and Expiratory Resistance be Used in Prevention and/or Treatment of Acute Mountain Sickness ? a Randomized Controlled Field Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Acute Mountain Sickness
Keywords: Altitude
Acute mountain sickness
Osteopathy
End expiratory pressure
Lead sponsor: Institut de Formation et de Recherche en Médecine de Montagne
Sponsor class: OTHER
First posted: 2019-05-20
Enrollment: 50
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: PREVENTION

Brief summary: The purpose of this research is to support a hypothesis that osteopathic manual medicine (OMM) and / or a 10 cmH2O end-expiratory pressure (PEEP) could be used in the prevention of acute mountain sickness (AMS).

During altitude exposure, an exaggerated hypoxemia and the increase of intracranial pressure are both known to be major physipathological ways of AMS development.

The goal of the osteopathic protocol is to release tension on the circulatory structures directly related to cranial circulation and drainage. The main hypothesis is that it could lead to lower intracranial pressure and help reducing AMS signs. Furthermore the investigators would like to define a osteopathic score for individual AMS sensitivity, based on cranial bones mobility.

Several studies have shown that using PEEP at altitude (or hypoxia) increases SpO2. As for osteopathy protocol, the investigators would like to apply this experimental condition during real altitude exposure in a randomized controlled protocol.


Eligibility criteria: Inclusion Criteria:

* Healthy
* Experienced alpinist
* No previous acclimatization

Exclusion Criteria:

* Heart failure, respiratory failure, kidney failure
* Pregnant woman

Primary outcomes:
measure: Changes in Lake Louise Score from baseline to altitude continuous exposure.
timeFrame: mesured and reported every hour during a 10 hours altitude exposure
Secondary outcomes:
measure: Changes in numeric scale of well being from baseline to altitude continuous exposure.
timeFrame: every hour during a 10 hours altitude exposure
Other outcomes:
Locations:
city: Chamonix
country: France
facility: Ifremmont
Study officials:
References:
Clinical trial NCT06026072: Validation of the CLAD Score Ifor Renal Colic Pain
Official title: Prospective Validation of the CLAD Score in Patients Admitted to an Emergency Facility for Renal Colic Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Renal Colic
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2023-09-06
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The doctor in charge of the patient will have to examine him and take care of him according to the service protocol. He will also completed the CLAD-V score and gives his intuition on the surgical outcome of the patient
Primary purpose: PREVENTION

Brief summary: Renal colic is a frequent reason for recourse representing 1 to 2% of emergency room admissions.

This study would validate the performance of the CLAD score in predicting the need for surgical management within 7 days of patients admitted to the emergency department for renal colic pain.

Detailed description: Renal colic is a frequent reason for recourse representing 1 to 2% of emergency room admissions. It results clinically in a lumbo-abdominal pain syndrome radiating into the genitals. The origin of this pain is the tensioning of the urinary tract, most frequently by a lithiasis creating a transient obstruction

Toulouse medical team has developed the "Complicated uroLithiasis and Alternative Diagnosis" (CLAD) score, which predicts the risk of requiring surgery within 7 days of admission of patients to the emergency room for renal colic

The aim of this study is to validate this CLAD-V score by collecting the elements of the CLAD score and the clinician's intuition is made available to practitioners in the emergency department.

All patients presenting to the emergency room for renal colic pain are eligible. The doctor in charge of the patient will have to examine him and take care of him according to the service protocol. The doctor must then complete the questionnaire provided.

A reminder of the patient on D7 is carried out to collect information on the need for surgery after the emergency or not.

Each center ensures inclusions and reminders on D7 and will only transmit the database

Eligibility criteria: Inclusion Criteria:

* Adult patients admitted to the emergency room for suspected renal colic
* Patient not objecting to participation

Exclusion Criteria:

* Patients unable to express their non-objection
* Pregnant women

Primary outcomes:
measure: CLAD-V performance
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Toulouse
country: France
facility: CHU de Toulouse
state: Haute-Garonne
Study officials:
affiliation: University Hospital, Toulouse
name: Frederic BALEN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01434446: The Effect of Sound Stimulation on Hearing Ability
Official title: The Effect of Sound Stimulation on Hearing Ability
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sensorineural Hearing Loss
Lead sponsor: Earlogic Korea, Inc.
Sponsor class: INDUSTRY
First posted: 2011-09-15
Enrollment: 21
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: In the late 1990s, researchers discovered that acoustic stimuli slow progressive sensorineural hearing loss and exposure to a moderately augmented acoustic environment can delay the loss of auditory function. In addition, prolonged exposure to an augmented acoustic environment could improve age-related auditory changes. These ameliorative effects were shown in several types of mouse strains, as long as the acoustic environment was provided prior to the occurrence of severe hearing loss.

In addition to delaying progressive hearing loss, acoustic stimuli could also protect hearing ability against damage by traumatic noise. In particular, a method called forward sound conditioning (i.e., prior exposure to moderate levels of sound) has been shown to reduce noise-induced hearing impairment in a number of mammalian species, including humans.

Interestingly, recent report has suggested that low-level sound conditioning also reduces free radical-induced damage to hair cells, increases antioxidant enzyme activity, and reduces Cox-2 expression in cochlea, and can enhance cochlear sensitivity. Specifically, increased cochlear sensitivity was observed when distortion product otoacoustic emissions (DPOAEs) and compound action potentials (CAPs) were measured.

In addition to forward sound conditioning, backward sound conditioning (i.e., the use of acoustic stimuli after exposure to a traumatic noise) has been shown to protect hearing ability against acoustic trauma and to prevent the cortical map reorganization induced by traumatic noise.

In this study, the investigators examine the effect of sound stimulation on hearing ability in human subjects.


Eligibility criteria: Inclusion Criteria:

* Male and female
* Age between 20 and 70 years
* Subjects should be able to use an mp3 player

Exclusion Criteria:

* Hearing loss more than 70 dB HL at any frequency
* More than 10 dB of air-bone gaps at more than 3 frequencies in pure-tone audiometry
* Ear infections, chronic middle ear disease or any abnormality of the ear canal or ear drum
* Temporary hearing loss
* Hearing aid user
* Pregnant females

Primary outcomes:
measure: Changes of pure-tone hearing thresholds after sound stimulation
timeFrame: 2~6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Earlogic Auditory Research Institute
Study officials:
affiliation: Earlogic Auditory Research Institute
name: Eunyee Kwak, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04308746: Evaluating Attitudes Towards Organ Donation in the United States on MTurk
Official title: Evaluating Attitudes Towards Organ Donation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Individual Difference
Keywords: Organ Donation
Culture
Lead sponsor: Yale-NUS College
Sponsor class: OTHER
First posted: 2020-03-16
Enrollment: 211
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are assigned to 1 out of 2 culture orientation priming tasks (Individualistic or Collectivistic)
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The study is conducted to investigate the effects of priming different cultural orientations on participants' decisions on whether to donate their organs, in an opt-out donation system scenario where the default is a presumed consent on the part of the individual.

Detailed description: Participants complete a survey where they respond to scales measuring their baseline cultural and power distance orientations, and answer questions on their demographics such as gender, race, employment etc.

24 hours later, participants fill in a 2nd survey where they are instructed to complete 1 out of 2 possible priming tasks. The possible tasks consist of an Individualistic priming condition and a Collectivistic priming condition; both tasks require participants to answer 3 statements each to 3 questions regarding the self or their social group. Participants then indicate their choice on whether to donate their organs (default or opt-out), rate their confidence regarding their choice and complete the same scales measuring their cultural and power distance orientations.

Eligibility criteria: Inclusion Criteria:

* Aged 21 and above
* Lives in the United States of America

Exclusion Criteria:

* Below age 21
* Does not live in the United States of America

Primary outcomes:
measure: Binary survey item - Decision to Donate Organ
timeFrame: 1 minute
measure: Line scale survey item - Confidence in Decision to Donate Organ
timeFrame: 1 minute
Secondary outcomes:
measure: Individual levels of individualism & collectivism
timeFrame: 5 minutes
measure: Individual levels of power distance
timeFrame: 3 minutes
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Yale-NUS College
Study officials:
References:
Clinical trial NCT06984146: Nivo40-AVD for Advanced Classic Hodgkin Lymphoma
Official title: Flat-dose Nivolumab (40 mg) in Combination With Doxorubicin, Vinblastine, and Dacarbazine (AVD) for Newly Diagnosed Advanced Classic Hodgkin Lymphoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Hodgkin Lymphoma, Adult
Lead sponsor: National Medical Research Radiological Centre of the Ministry of Health of Russia
Sponsor class: OTHER
First posted: 2025-05-22
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of the current trial is to evaluate the efficacy and safety of flat-dose nivolumab (40 mg) in combination with AVD in the management of patients with newly diagnosed advanced classic Hodgkin Lymphoma

Detailed description: Patients will receive 6 cycles of Nivo40-AVD with interim and EOT PET/CT scan. Interim PET/CT will not affect clinical decisions and is done as part of the study on response predictors after first line PD-1 inhibitor therapy. In patients achieving only partial metabolic response after 6 cycles (Deauville score ≥ 4) radiation therapy is allowed.

Eligibility criteria: Inclusion Criteria:

1. Newly-diagnosed histologically verified advanced stage (IIB-IV as per GHSG) classic Hodgkin lymphoma
2. No past history of autoimmune disease
3. Age \> 18 years
4. Ejection fraction \> 50%
5. ECOG 0-4

Exclusion Criteria:

1. Organ failure (e.g. creatinine \> 2x ULN; ALT or AST \> 5x ULN; bilirubin \> 2x ULN; hemodynamic instability; respiratory failure \> Grade 1)
2. Uncontrolled infection
3. Pregnancy
4. Inability to sign informed consent

Primary outcomes:
measure: Progression-free survival
timeFrame: 2 years
Secondary outcomes:
measure: Overall survival
timeFrame: 2 years
measure: Complete remission and complete metabolic response
timeFrame: 2 years
measure: Adverse events
timeFrame: 2 years
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: P. Hertsen Moscow Oncology Research Institute (MORI) for administrative and economic work - the branch of the FSBI "National Medical Research Radiological Centre" (NMRRC) of the Ministry of Health of the Russian Federation
Study officials:
affiliation: FSBI "National Medical Research Radiological Centre" (NMRRC) of the Ministry of Health of the Russian Federation
name: Andrey Kaprin
role: STUDY_CHAIR
References: