louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03739788: An Investigational Study to Evaluate Experimental Medication BMS-986165 Given as a Tablet and Solution in Healthy Male Participants
Official title: Study to Evaluate the Absolute Bioavailability of BMS-986165 Tablet in Healthy Male Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Participants
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2018-11-14
Enrollment: 8
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate BMS-986165 given as a tablet in healthy male participants.


Eligibility criteria: For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Healthy male participant, as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations
* Body mass index (BMI) of 18.0 to 32.0 kg/m2, inclusive, and total body weight ≥ 50 kg (110 lb). BMI = weight (kg)/(height \[m\])2 at screening
* Normal renal function at screening as evidenced by an estimated glomerular filtration rate (eGFR) ≥ 80 mL/min/1.732

Exclusion Criteria:

* Any medical condition that presents a potential risk to the participant and/or may compromise the objectives of the study, including a history of or active liver disease
* Current or recent (within 3 months of study drug administration) gastrointestinal disease that could impact upon the absorption of study drug
* History or presence of clinically significant acute or chronic bacterial, fungal, or viral infection (eg, pneumonia, septicemia) within the 3 months prior to screening

Other protocol defined inclusion/exclusion criteria could apply

Primary outcomes:
measure: Absolute oral bioavailability (F) of BMS-986165 derived from plasma concentration versus time data
timeFrame: 4 days
Secondary outcomes:
measure: Incidence of nonserious adverse events (AE)
timeFrame: Up to 34 days
measure: Incidence of serious adverse events (SAE)
timeFrame: Up to 34 days
measure: Number of clinically significant changes in ECG, vital signs, physical examination findings, or clinical laboratory tests
timeFrame: Up to 34 days
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: Quotient Sciences
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT00563888: Change of Neural Network Indicators Through Narrative Treatment of PTSD in Torture Victims
Official title: Change of Neural Network Indicators Through Narrative Treatment of PTSD in Torture Victims
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: PTSD
Keywords: PTSD
torture survivors
Narrative Exposure Therapy
trauma-related memory processes
steady state visual evoked fields
Lead sponsor: University of Konstanz
Sponsor class: OTHER
Collaborators: name: German Research Foundation
First posted: 2007-11-26
Enrollment: 30
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: TREATMENT

Brief summary: Effective Treatment of PTSD involves talking about the traumatic event in detail.It is unclear how this process influences the sensory-specific trauma network (fear structure)in the traumatized person. The goal of the project is to test the hypothesis that treatment-facilitated recovery does not change the original fear structure but establishes an inhibitory mechanism that depends on verbal activity. An affective visual steady-state paradigm in magnetencephalography (MEG) using positive, aversive and neutral picture stimuli will be used to examine the spatial and temporal pattern of the processing of emotional stimuli. To examine the effects of treatment this paradigm will be used as outcome measure within a randomized controlled trial of Narrative Exposure Therapy and a waiting-list control condition for severely traumatized torture victims.


Eligibility criteria: Inclusion Criteria:

* experiences of organized violence/torture
* PTSD diagnosis

Exclusion Criteria:

* psychotic disorder
* neurological disease or seizures
* current drug/alcohol abuse

Primary outcomes:
measure: PTSD diagnosis and severity score according to the Clinicians Administered PTSD Scale (CAPS)
timeFrame: 4 & 9 months after completion of treatment
Secondary outcomes:
measure: steady state visual evoked magnetic fields in response to affective stimuli
timeFrame: 4 & 9 months after completion of treatment
Other outcomes:
Locations:
city: Konstanz
country: Germany
facility: University of Konstanz, Department of Psychology
Study officials:
affiliation: University of Konstanz
name: Claudia Catani, Dr.
role: STUDY_DIRECTOR
affiliation: University of Konstanz
name: Frank Neuner, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Adenauer H, Catani C, Gola H, Keil J, Ruf M, Schauer M, Neuner F. Narrative exposure therapy for PTSD increases top-down processing of aversive stimuli--evidence from a randomized controlled treatment trial. BMC Neurosci. 2011 Dec 19;12:127. doi: 10.1186/1471-2202-12-127.
citation: Adenauer H, Pinosch S, Catani C, Gola H, Keil J, Kissler J, Neuner F. Early processing of threat cues in posttraumatic stress disorder-evidence for a cortical vigilance-avoidance reaction. Biol Psychiatry. 2010 Sep 1;68(5):451-8. doi: 10.1016/j.biopsych.2010.05.015.
Clinical trial NCT05182788: The Efficacy Evaluation of CHOLESWISE Pressed Candy on Cardiovascular Health
Official title: The Efficacy Evaluation of CHOLESWISE Pressed Candy on Cardiovascular Health, a Single Center, Randomized, Doubld-Blind, Placebo Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Lead sponsor: TCI Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-01-10
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: To assess the efficacy evaluation of CHOLESWISE Pressed Candy on cardiovascular disease risk factors

Detailed description: This is a single center, randomized, double-blind and placebo controlled study. Subjects are informed to consume the samples every day for 8 weeks.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 30 years old, no gender limit;
* Patients with high blood pressure (systolic blood pressure\> 120 mmHg or diastolic blood pressure\> 80 mmHg) or high blood lipids (TC ≥ 5.18 mmol/L or TG ≥ 1.7 mmol/L), and no medication is used;
* Fully understand the purpose, benefits, potential risks and side effects of this research, and can objectively cooperate with doctors to complete the examination and assessment of diseases and physical conditions;
* People who voluntarily agree and sign an informed consent form.

Exclusion Criteria:

* People with a history of dyspepsia would affect the absorption of the test product;
* Any situation that may affect trial process, including difficult-to-control organic disease or infection, unstable angina pectoris, congestive heart failure and other severe disease;
* People with symptomatic and difficult-to-control neurological, mental diseases or mental disorders;
* Pregnant or breast-feeding women or women who have a positive result on a pregnancy test;
* Allergic to the components of the test product;
* Take supplementary foods and health supplements with the same efficacy two weeks before and during the test.

Primary outcomes:
measure: Change from baseline in blood pressure (systolic blood pressure, diastolic blood pressure)
timeFrame: Days 1, 28, and 56
measure: Change from baseline in blood lipid (total-Cholesterol, triglyceride, HDL-C, LDL-C)
timeFrame: Days 1, 28, and 56
measure: Change from baseline in blood coagulation factor (factor VII, fibrinogen)
timeFrame: Days 1, 28, and 56
measure: Change from baseline in arteriosclerosis
timeFrame: Days 1 and 56
Secondary outcomes:
measure: Change from baseline in blood glucose
timeFrame: Days 1, 28, and 56
measure: Change from baseline in blood hs-CRP
timeFrame: Days 1 and 56
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Fengxian District Central Hospital
Study officials:
References:
Clinical trial NCT04566588: Early Apical Release vs Classic Holmium Laser Enucleation of the Prostate: Randomized Controlled Trial Comparing Post-Operative Incontinence Rates and Surgical Outcomes
Official title: Early Apical Release vs Classic Holmium Laser Enucleation of the Prostate: Randomized Controlled Trial Comparing Post-Operative Incontinence Rates and Surgical Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Benign Prostatic Hyperplasia
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2020-09-28
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To determine if early apical release holmium enucleation of the prostate (EAR HoLEP), as a surgical treatment for benign prostatic hyperplasia, reduces post-operative urinary incontinence compared to classic HoLEP.


Eligibility criteria: Inclusion Criteria:

* Patients must be 18 years of age or older
* Patients must present to clinic with a diagnosis of benign prostatic hyperplasia
* Patients must be scheduled to undergo a holmium laser enucleation of the prostate

Exclusion Criteria:

* Patients with previous surgical management of BPH
* Patients with prostate biopsy revealing high risk prostate cancer
* Patients with a concomitant neurogenic bladder diagnosis (SCI, Parkinson, MS, cerebral palsy)

Primary outcomes:
measure: Post-operative Urinary Incontinence
timeFrame: Twelve Months Post-operative
Secondary outcomes:
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Health System
state: Kansas
Study officials:
References:
Clinical trial NCT00309088: FK506 Phase 3 Study: a Study for Steroid Non-resistant Myasthenia Gravis (MG) Patients
Official title: FK506 Phase 3 Study: a Double Blind Placebo Controlled Study for Steroid Non-Resistant Myasthenia Gravis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Myasthenia Gravis
Keywords: Tacrolimus
Myasthenia Gravis
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2006-03-31
Enrollment: 80
Sex: ALL
Minimum age (years): 16
Maximum age (years): 64
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to investigate the efficacy and safety for steroid non-resistant MG patients in a double blind, placebo controlled study.


Eligibility criteria: Inclusion Criteria:

* Clinically diagnosed as myasthenia gravis
* Those whose MG symptoms are well-controlled by the treatment with prednisone
* Steroid non-refractory Myasthenia Gravis: ≧20mg and ≦40mg / alternate day of steroid dose required to maintain

Exclusion Criteria:

* Those who have thymoma or the history of thymoma (Masaoka stage III or IV)
* Patients who received steroid pulse therapy, plasma exchange therapy, globulin therapy or radiation therapy within 12 weeks prior to the initiation of test drug
* Patients who started the immunosuppressant therapy or increased the dose of immunosuppressant within 12 weeks prior to the initiation of test drug.
* Patients who had undergone thymectomy within 24 weeks prior to the initiation of test drug.
* Pancreatitis or diabetes
* Serum creatinine≦1.5mg/dL

Primary outcomes:
measure: Mean dose of steroid to maintain minimal manifestation(MM)[The dose of steroid should be decreased by the rate of 5mg/alternate day/ 4 weeks after the initiation of tacrolimus or placebo treatment as far as the MM state should be maintained.]
timeFrame: 6 Months
Secondary outcomes:
measure: Total amount of steroid therapy (mg)
timeFrame: 6 Months
measure: QMG score;MG-ADL
timeFrame: 6 Months
measure: Success rate of achievement to the targeted steroid dose
timeFrame: 6 Months
Other outcomes:
Locations:
city: Chubu region
country: Japan
city: Chugoku region
country: Japan
city: Hokkaido region
country: Japan
city: Hokuriku region
country: Japan
city: Kansai region
country: Japan
city: Kanto region
country: Japan
city: Kyushu region
country: Japan
city: Shikoku region
country: Japan
city: Tohoku region
country: Japan
Study officials:
affiliation: Astellas Pharma Inc
name: Central Contact
role: STUDY_CHAIR
References:
citation: Yoshikawa H, Kiuchi T, Saida T, Takamori M. Randomised, double-blind, placebo-controlled study of tacrolimus in myasthenia gravis. J Neurol Neurosurg Psychiatry. 2011 Sep;82(9):970-7. doi: 10.1136/jnnp-2011-300148. Epub 2011 Jul 22.
Clinical trial NCT01748188: The Effectiveness of Dexketoprofen on Shoulder Pain Using Different Physiotherapy Treatments
Official title: Valuation of the Dexketoprofen Effectiveness on Subacromial Syndrome With Different Physiotherapy Treatments.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Shoulder Pain
Keywords: Subacromial syndrome
Dexketoprofen
Phonophoresis
Iontophoresis
Ultrasounds
VAS
DASH score
Constant score
Lead sponsor: University Rovira i Virgili
Sponsor class: OTHER
Collaborators: name: Hospital Universitari Sant Joan de Reus
First posted: 2012-12-12
Enrollment: 99
Sex: ALL
Minimum age (years): 36
Maximum age (years): 70
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 whether dexketoprofen administered by phonophoresis or iontophoresis is more effective in the treatment of subacromial syndrome that the conventional therapy with ultrasounds.

Detailed description: It is a question of valuing the decrease of the pain (by means of the visual analogic scale pain score) and the increase of the functionality of the joint (by means of Dash and Constant scores) of three different treatments from physical therapy to establish the most effective protocol for the treatment of the subacromial syndrome.

Determine the best physiotherapy treatment for subacromial syndrome with 20 sessions of different treatments.

A group will receive the conventional treatment with ultrasounds without drugs, another group will receive dexketoprofen by phonophoresis and the third group will receive dexketoprofen by iontophoresis.

Eligibility criteria: Inclusion Criteria:

* Subacromial syndrome diagnosed by ultrasound scanning with Rotator cuff tendinitis or partial break of the rotator cuff and / or of the brachial biceps.
* Informed consent.

Exclusion Criteria:

* To suffer shoulder arthritis or any shoulder pathology with mobility limitation.
* Fibromyalgia
* Psychologic or psychiatric pathologies
* Hypersensibility to the drug
* Back or shoulder traumatism
* To have received an analgesic infiltration on the affected shoulder in the last month
* Lack of adherence to the treatment upper to 15 % of the sessions

Primary outcomes:
measure: Pain measure by the visual analogic scale pain score.
timeFrame: 1 month
Secondary outcomes:
measure: Functionality of the joint by Dash and Constant scores
timeFrame: 1 month
Other outcomes:
Locations:
city: Reus
country: Spain
facility: Hospital Universitari Sant Joan
state: Tarragona
Study officials:
affiliation: Hospital Universitari Sant Joan de Reus
name: Carme Casajuana, PT
role: STUDY_DIRECTOR
References:
citation: Perez-Merino L, Casajuana MC, Bernal G, Faba J, Astilleros AE, Gonzalez R, Giralt M, Romeu M, Nogues MR. Evaluation of the effectiveness of three physiotherapeutic treatments for subacromial impingement syndrome: a randomised clinical trial. Physiotherapy. 2016 Mar;102(1):57-63. doi: 10.1016/j.physio.2015.01.010. Epub 2015 Mar 25.
Clinical trial NCT01713088: A Trial of Multisystemic Therapy in UK a Statutory Therapeutic Intervention for Young Offenders
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Participants Are Male and Female Adolescents 13-16 Years at Risk for Continuing to Commit Criminal Offences.
Keywords: multisystemic therapy, RCT, young offenders, U.K.
Lead sponsor: The Brandon Centre, London
Sponsor class: OTHER
First posted: 2012-10-24
Enrollment: 108
Sex: ALL
Minimum age (years): 13
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To evaluate whether Multisystemic Therapy (MST) is more effective in reducing youth offending and out-of-home placement in a large, ethnically diverse, urban U.K. sample than an equally comprehensive management protocol; to determine whether MST leads to broader improvements in youth sociality and in mediators believed to be responsible for change in MST.


Eligibility criteria: Inclusion Criteria:

* age between 13 and 16 years;
* living in the home of and being brought up by a parent or principal caretaker;
* on a court referral order for treatment or a supervision order of at least 3 months' duration, or, following imprisonment, on license in the community for at least 6 months.

Exclusion Criteria:

* being a sex offender;
* presented only with substance misuse;
* diagnosed with a psychotic illness or posed a risk to trial personnel;
* incompatible agency involvement (e.g., ongoing care proceedings).

Primary outcomes:
measure: Change in offending behavior based on police records of criminal offenses committed
timeFrame: baseline and 6, 12, 18, 24, 30 and 36 months post randomization
Secondary outcomes:
measure: self- and parent-rated symptoms of antisocial behavior, delinquency-linked cognitions, personality functioning, and parenting variables
timeFrame: baseline and 6 months after randomization
Other outcomes:
measure: Antisocial Beliefs and Attitudes Scale (ABAS)
timeFrame: Baseline and 6 months after randomization
measure: Antisocial Process Screening Device (APSD)
timeFrame: Baseline and 6 months after randomization
measure: Measure of youth's involvement with delinquent peers (IDP)
timeFrame: Baseline and 6 months after randomization
measure: Measure of Positive Parenting and Disciplinary Practices, Parent Monitoring and Supervision
timeFrame: Baseline and 6 months after randomization
Locations:
city: London
country: United Kingdom
facility: The Brandon Centre
Study officials:
References:
citation: Butler S, Baruch G, Hickey N, Fonagy P. A randomized controlled trial of multisystemic therapy and a statutory therapeutic intervention for young offenders. J Am Acad Child Adolesc Psychiatry. 2011 Dec;50(12):1220-35.e2. doi: 10.1016/j.jaac.2011.09.017. Epub 2011 Nov 6.
Clinical trial NCT01020188: Study of Global Coagulation Tests in Patients With Paroxysmal Nocturnal Haemoglobinuria
Official title: A Pilot Study Investigating the Role of Thrombin Generation and Rotational Thromboelastometry in Assessing the Prothrombotic Phenotype of Paroxysmal Nocturnal Haemaglobinuria
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Paroxysmal Nocturnal Haemoglobinuria
Lead sponsor: King's College Hospital NHS Trust
Sponsor class: OTHER
First posted: 2009-11-25
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with paroxysmal nocturnal haemoglobinuria

Brief summary: Paroxysmal nocturnal haemaoglobinuria (PNH) is a rare disease which results in breakdown of the red blood cells and bone marrow failure. It is associated with an increased risk of blood clots. Until recently, treatment has been with blood transfusions and in patients with a blood clot, blood thinners. A new treatment called eculizumab is now standard for patients who require regular blood transfusions. It works in the majority of patients by preventing the breakdown of red blood cells. This can eliminate the need for blood transfusion and reduce the risk of blood clots. It is not well understood why patients with PNH are at high risk of blood clots. The investigators plan to use specialised blood tests to assess the stickiness of the blood before starting eculizumab treatment and monthly after starting treatment. The investigators will compare these tests with standard tests of clotting.


Eligibility criteria: Inclusion Criteria:

* Presence of a PNH clone

Exclusion Criteria:

* Longterm anticoagulation for previous venous thrombosis

Primary outcomes:
measure: To establish the role of thrombin generation in assessing the prothrombotic phenotype of PNH
timeFrame: After sample is obtained
Secondary outcomes:
measure: To establish the role of thromboelastometry in evaluating the prothrombotic phenotype of PNH
timeFrame: After sample is obtained
measure: To establish effects of eculizumab treatment on thrombin generation and thromboelastometry
timeFrame: 3-6 months
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: King's College Hospital NHS Trust
Study officials:
affiliation: King's College Hospital NHS Trust
name: Raj K Patel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02963688: BRCA 1/2 Mutation in Korean Patients With Epithelial Ovarian Cancer
Official title: Prevalence Study of Germline and/or Somatic BRCA1/2 Mutation in Korean Patients With High-Grade Serous and/or Endometrioid Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: To Investigate the Prevalence of BRCA 1/2 Mutation Among Ovarian Cancer
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
Collaborators: name: AstraZeneca
First posted: 2016-11-15
Enrollment: 298
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: women 18 years of age and older with previously untreated, HG serous and/or endometrioid EOC, fallopian tube or primary peritoneal carcinoma who consented to genetic testing between 2010 and 2015

Brief summary: PURPOSE: To investigate the prevalence and clinical correlation of the germline BRCA 1/2 mutation in Korean patients with high grade(HG) serous and/or endometrioid epithelial ovarian cancer (EOC).

PATIENTS AND METHODS: In a nationwide case-control study on EOC conducted in Korea between 2010 and 2015, 298 Korean women with HG serous and/or endometrioid EOC were tested for gBRCA 1/2 mutation, regardless of the family history. Mutation screening was performed using the Ion AmpliSeq BRCA 1/2 Panel (Life Technologies, Carlsbad, CA, USA) and Ion PGM platform according to the manufacturer's instructions. Clinical characteristics including survival outcome was assessed in gBRCAm carriers.


Eligibility criteria: Inclusion Criteria:

* women 18 years of age and older with previously untreated, HG serous and/or endometrioid EOC, fallopian tube or primary peritoneal carcinoma who consented to genetic testing between 2010 and 2015

Exclusion Criteria:

* women with mucinous , clear cell, low-grade serous or endometrioid, mixed epithelial adenocarcinoma, undiffereniated carcinoma or malignant brenner's tumor

Primary outcomes:
measure: Frequency of positive mutation among ovarian cancer patients
timeFrame: 5 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: