louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02189733: Bioequivalence of Liquid and Reconstituted Lyophilized Subcutaneous Formulations of Caplacizumab.
Official title: A Phase I, Single Center, Open-Label, Randomized, Single Dose Cross-Over Study in Healthy Male Subjects to Investigate the Bioequivalence and Tolerability of Liquid and Reconstituted Lyophilized Subcutaneous Formulations of Caplacizumab.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Ablynx, a Sanofi company
Sponsor class: INDUSTRY
First posted: 2014-07-15
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The primary objective of the study is to evaluate the pharmacokinetic characteristics and demonstrate bioequivalence of a reconstituted new lyophilized formulation of caplacizumab for subcutaneous (s.c.) injection as compared to an equal nominal s.c. dose of the reference liquid formulation of caplacizumab.

The secondary objective of the study is to compare the safety and tolerability, and the pharmacodynamic parameters of the new formulation with those of the reference formulation.


Eligibility criteria: Inclusion Criteria:

* Male Caucasians aged 18 to 55 years, inclusive.
* Body weight 55 - 100 kg and body mass index (BMI) between 18.5 and 30.0, extremes included.
* Coagulation and bleeding diathesis variables (as defined in the protocol) within the normal range at screening and on Day -1.
* Others as defined in the protocol.

Exclusion Criteria:

* History or presence of diseases in the kidneys and/or heart, lungs, liver, skin, endocrine organs or other condition known to interfere with the absorption, distribution, metabolism or excretion of drugs.
* History of and/or any sign or symptom indicating current abnormal hemostasis or blood dyscrasia.
* Others as defined in the protocol

Primary outcomes:
measure: Pharmacokinetics: concentration of caplacizumab in plasma
timeFrame: Day 1 (pre-dose) until Day 7
Secondary outcomes:
measure: Pharmacodynamics as measured by Ristocetin cofactor activity in plasma
timeFrame: During screening until day 29 +/-1
measure: Safety and Tolerability: safety markers
timeFrame: From signing of informed consent form until day 43 +/- 2
measure: Pharmacodynamics as measured by von Willebrand factor antigen in plasma
timeFrame: During screening until Day 29 +/- 1
measure: Pharmacodynamics as measured by Factor VIII clotting activity in plasma
timeFrame: During screening until day 29 +/- 1
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: Quotient Clinical
Study officials:
affiliation: Ablynx, a Sanofi company
name: Jean-Michel Paillarse, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02011633: Comparison of PK After Administration of HCP1201 and Co-administration of Metformin SR 500mg and Rosuvastatin 10mg
Official title: An Open-label, Randomized, Single-dose Crossover Study to Compare the Pharmacokinetics After the Administration of HCP1201 Tablet 500/10 mg and Coadministration of Metformin SR 500 mg and Rosuvastatin 10 mg in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes Mellitus
Lead sponsor: Hanmi Pharmaceutical Company Limited
Sponsor class: INDUSTRY
First posted: 2013-12-13
Enrollment: 72
Sex: MALE
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To compare the pharmacokinetic characteristics between HCP1201 tablet 500/10 mg and co-administration of metformin 500 mg plus rosuvastatin 10 mg under fasted and fed state, respectively.

Detailed description: An Open-label, Randomized, Single-dose Crossover Study to Compare the Pharmacokinetics After the Administration of HCP1201 Tablet 500/10 mg and Coadministration of Metformin SR 500 mg and Rosuvastatin 10 mg in Healthy Volunteers

Eligibility criteria: Inclusion Criteria:

* Healthy male volunteer, age 20\~55 years
* The result of Body Mass Index(BMI) is not less than 19 kg/m2 , no more than 27 kg/m2
* Subject who has the ability to comprehend the study objectives, contents and the property of the study drug before participating in the trial.

Exclusion Criteria:

* Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study
* History of relevant drug allergies or clinically significant hypersensitivity reaction.

Primary outcomes:
measure: metformin, rosuvastatin Cmax
timeFrame: pre-dose, post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24, 48 h
measure: metformin, rosuvastatin AUClast
timeFrame: pre-dose, post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24, 48 h
Secondary outcomes:
measure: Metformin, rosuvastatin Tmax
timeFrame: pre-dose, post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24, 48 h
measure: Metformin, rosuvastatin T1/2
timeFrame: pre-dose, post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24, 48 h
measure: Metformin, rosuvastatin AUCinf
timeFrame: pre-dose, post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24, 48 h
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Wooseong Huh, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02019433: Post Market Clinical Follow-Up of Acetabular Titan-Augment Structan®
Official title: Post Market Clinical Follow-Up of Acetabular Titan-Augment Structan®
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Total Hip Arthroplasty Revision
Keywords: THA, augment, revision, pelvis
Lead sponsor: Aesculap AG
Sponsor class: INDUSTRY
First posted: 2013-12-24
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: specialist clinical centre

Brief summary: Implant Survival as well as clinical and radiological Follow-Up of acetabular Titan-Augment Structan®


Eligibility criteria: Inclusion Criteria:

* Minimum age 18 years
* Indication for cementless hip arthroplasty with acetabular defects that need Allograft or titanium augment
* Patient consent for study participation
* Physical and mental willingness to participate in the follow-ups

Exclusion Criteria:

* Patient not available for follow-up
* Increased anesthetics risks for the patient according to the "American Society of Anesthesiology": ASA IV
* Tumor
* Alcohol- or Drug abuse
* Permanent cortisone therapy
* Clinically relevant infection
* (Planned) pregnancy

Primary outcomes:
measure: Implant Survival Rates
timeFrame: 12 months
Secondary outcomes:
measure: Clinical Outcome
timeFrame: 3 and 12 months
measure: Pain
timeFrame: 3 and 12 months
measure: Osteolysis
timeFrame: 3 and 12 months
measure: Ossifications
timeFrame: 3 and 12 months
measure: Implant Position
timeFrame: 3 and 12 months
measure: Migration of Structan®
timeFrame: 3 and 12 months
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charite Campus Berlin Mitte
city: Göppingen
country: Germany
facility: Klinik am Eichert
city: Leverkusen
country: Germany
facility: St. Remigius Krankenhaus Opladen
Study officials:
References:
Clinical trial NCT05945433: Anovo™ Surgical System - Registry Study
Official title: Anovo™ Surgical System - Registry Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: GYN Disorders
Lead sponsor: Momentis Surgical
Sponsor class: INDUSTRY
First posted: 2023-07-14
Enrollment: 300
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients receiving gynecological surgical procedure with the anovo Surgical System by their surgeon will be offered to participate in the registry. To be eligible to participate in the registry, patients must understand and sign the informed consent form, including data privacy authorization, indicating their consent to participate in the registry study.

Brief summary: To collect Real-World Data (RWD) on the ongoing safety and effectiveness of the anovo Surgical system in transvaginal gynecological laparoscopic surgical procedures and to obtain information on the impact of the anovo Skills Development Pathway on user behavior and performance (where performance is measured by the learning curve of the surgeons and procedure outcomes).

Detailed description: Specific Aims:

1. To collect RWD from surgeons with varying experience and expertise on their learning curve and time to achieve competency, and as such assess the success of the Skills Development Pathway.
2. Collect safety information and analyze the causality between type and frequency of adverse events to surgeons' experience.
3. Evaluate the effectiveness of the device while minimizing bias by enrolling "all comers", which will represent the general patient population.

Eligibility criteria: All patients receiving gynecological surgical procedure with the anovo Surgical System by their surgeon will be offered to participate in the registry.

Inclusion Criteria:

* patients must understand and sign the informed consent form, including data privacy authorization, indicating their consent to participate in the registry study.
* willing to complete post-operative questionnaire

Exclusion Criteria:

-none

Primary outcomes:
measure: Conversion rate to open or laparoscopic approach
timeFrame: Procedure
measure: Rate of Unanticipated Adverse Device Effect
timeFrame: 8 Weeks Follow Up
Secondary outcomes:
measure: Surgery time (minutes)
timeFrame: Procedure
Other outcomes:
measure: Surgeon Learning Curve (surgery time against number of operations performed, considering frequency of cases and surgery difficulty)
timeFrame: Procedure
measure: Surgeon Safety Curve (cumulative UADEs against number of operations performed)
timeFrame: Procedure
measure: User Skills Development Survey
timeFrame: Procedure
Locations:
city: Celebration
country: United States
facility: AdventHealth
state: Florida
Study officials:
References:
Clinical trial NCT01525433: Cervical Cancer Screening Among Hispanic Women
Official title: Cervical Cancer Screening and Adherence to Follow-up Among Hispanic Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Cancer
Lead sponsor: Fred Hutchinson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2012-02-03
Enrollment: 451
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: In this study, 400 Hispanic women will be recruited and randomized to one of three interventions:

1. Control (no change);
2. A low-intensity information program, consisting of a video approach educating women on the importance of cervical cancer screening;
3. A higher intensity program consisting of the video plus a 'promotora' or lay-community health educator led intervention at the participant's home to encourage cervical cancer screening.

The investigators will compare which intervention is most effective in encouraging Hispanic women to undergo cervical cancer screening (Pap test)


Eligibility criteria: Inclusion Criteria:

* Female
* 21 - 64 years of age
* Hispanic or Latina
* Resident of the Yakima Valley, WA, USA
* No hysterectomy
* Last PAP test (cervical screening) more than 3 years ago
* Last seen at the local clinic less than 5 years ago

Exclusion Criteria:

* Less than 21 or greater than 64 years of age
* PAP test less 3 years ago
* Prior hysterectomy

Primary outcomes:
measure: Participant attends cervical cancer screening
timeFrame: Within 7 months of the intervention
Secondary outcomes:
measure: Patient Navigator
timeFrame: Elapsed time from diagnosis to clinic visit
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Research Center
state: Washington
Study officials:
affiliation: Fred Hutchinson Cancer Center
name: Beti Thompson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Duggan C, Coronado G, Martinez J, Byrd TL, Carosso E, Lopez C, Benavides M, Thompson B. Cervical cancer screening and adherence to follow-up among Hispanic women study protocol: a randomized controlled trial to increase the uptake of cervical cancer screening in Hispanic women. BMC Cancer. 2012 May 6;12:170. doi: 10.1186/1471-2407-12-170.
Clinical trial NCT02244333: Efficacy, Tolerability and Safety of ALNA® in Patients With Benign Prostatic Syndrome (BPS)
Official title: ALNA® - AWB in Pre-treated Patients With BPS
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostatic Hyperplasia
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-09-19
Enrollment: 4575
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with symptomatic BPS, who switched for ALNA® after preceding Terazosin therapy recruited at urologists

Brief summary: Study to assess efficacy, tolerability and safety parameters of a one month ALNA® - treatment after switch from Terazosin-treatment


Eligibility criteria: Inclusion Criteria:

* Suffering from BPS symptoms
* Preceding treating with Terazosin for at least one month
* IPSS sum score \>= 8 points prior to treatment start with ALNA® or complaints due to BP reduction by Terazosin
* Indication for a switch to treatment with ALNA® according to its Summary of Product Characteristics (SPC) for a minimum period of one month

Exclusion Criteria:

* Patients fulfilling one of the general or specific contraindications listed in the ALNA® SPC, particularly patients with known hypersensitivities against tamsulosin hydrochloride or any other ingredients of the product, orthostatic dysregulation or severe liver insufficiency could not be included in the Post Marketing Surveillance (PMS) study

Primary outcomes:
measure: Change from baseline in International Prostatic Symptom Score (IPSS) by means on patient questionnaire
timeFrame: Baseline, after 1 month
measure: Change of Quality of Life (QoL) Index by means on patient questionnaire
timeFrame: Baseline, after 1 month
measure: Global comparative assessment of Terazosin and ALNA® treatment by investigator on a 3 point-scale
timeFrame: after 1 month
Secondary outcomes:
measure: Change from Baseline in maximum urinary flow rate (Qmax)
timeFrame: Baseline, after 1 month
measure: Change from Baseline in residual urinary volume
timeFrame: Baseline, after 1 month
measure: Change from Baseline in blood pressure
timeFrame: Baseline, after 1 month
measure: Change from Baseline in Pulse rate (bpm)
timeFrame: Baseline, after 1 month
measure: Change in complications due to low blood pressure
timeFrame: Baseline, after 1 month
measure: Global assessment of efficacy by investigator on 4-point scale
timeFrame: after 1 month
measure: Global assessment of tolerability by investigator on 4-point scale
timeFrame: after 1 month
measure: Global assessment with BPS- treatment by investigator on a 4-point scale
timeFrame: Baseline, after 1 month
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01242033: Effect of Acute Red Raspberry Consumption on Post-prandial Oxidative Stress
Official title: An Acute Intervention Study Investigating the Effect of Red Raspberry Consumption on Post-prandial Oxidative Stress
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oxidative Stress
Antioxidants
Keywords: red raspberries
post-prandial
oxidative stress
antioxidants
polyphenols
vitamin C
acute dietary intervention
Lead sponsor: University of Toronto
Sponsor class: OTHER
Collaborators: name: Unity Health Toronto
First posted: 2010-11-16
Enrollment: 8
Sex: ALL
Minimum age (years): 20
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Eight healthy adult subjects will be given a meal of one, two or four cups red raspberries, or two slices white bread with or without 200 mg vitamin C, after an overnight fast and consumption of a low polyphenol diet for two days. Blood samples will be taken at various time points over an eight hour period to measure oxidative stress and antioxidant levels in the blood. Each subject will attend 5 study visits with one week intervals and be given each meal in a random order. It is hypothesized that raspberry consumption at higher doses will greater protect against meal-induced oxidative stress compared to bread controls.


Eligibility criteria: Inclusion Criteria:

* healthy adults

Exclusion Criteria:

* blood pressure greater than 120/80 mm Hg
* body mass index greater than 24.9 kg/m\^2
* history of any chronic disease
* currently taking medications
* allergy to fruit

Primary outcomes:
measure: change in antioxidant capacity from baseline (-0.25 h)
timeFrame: -0.25, 0.25, 0.5, 1, 2, 4 hours post-intake
Secondary outcomes:
measure: change in lipid peroxidation from baseline (-0.25 h)
timeFrame: -0.25, 0.25, 0.5, 1, 2, 4 hours post-intake
measure: change in thiols compared to baseline (-0.25 h)
timeFrame: -025, 0.25, 0.5, 1, 2, 4 hours post-intake
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Clinical Nutrition and Risk Factor Modification Centre; St. Michael's Hospital
state: Ontario
Study officials:
affiliation: University of Toronto
name: A V Rao, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00826033: Fluorine-18-α-Methyltyrosine Positron Emission Tomography (18F-FMT PET) for Therapy Response in Lung Cancer
Official title: Fluorine-18-α-Methyltyrosine Positron Emission Tomography to Measure Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-Small Cell Lung Cancer
Keywords: Fluorine-18-α-methyltyrosine
Positron emission tomography
Lung cancer
chemotherapy
monitoring
Lead sponsor: Gunma University
Sponsor class: OTHER
Collaborators: name: J~pharma
First posted: 2009-01-21
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study was conducted at the Gunma University Hospital.

Brief summary: L-\[3-18F\]-α-methyltyrosine (18F-FMT) is an amino-acid tracer for positron emission tomography (PET). The investigators evaluated the value of 18F-FMT PET for the assessment of therapy response in patients with lung cancer as compared with that of 2-\[18F\]-fluoro-2-deoxy-D-glucose (18F-FDG) PET.

The patients with lung cancer underwent PET studies with 18F-FDG and 18F-FMT before and after radio-/chemotherapy. The investigators used the ratio of the SUVmax of the mediastinal (N2) lymph node to the SUVmax of the primary tumor (N/P ratio ). All patients were divided into two groups of N/P ratio\<1 and N/P ratio≥1, and the survival time was estimated by Kaplan-Meier method.


Eligibility criteria: Inclusion Criteria:

* primary lung cancer All patients received first-line chemotherapy

Exclusion Criteria:

* Patients with diabetus mellitus

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Gunma
country: Japan
facility: Gunma University Graduate School of Medicine
Study officials:
References:
Clinical trial NCT00200733: The Use of Narrative in Public Health Research and Practice: Patient Experience of Wellness Acupuncture
Official title: The Use of Narrative in Public Health Research and Practice: Patient Experience of Wellness Acupuncture
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Pain
Depression
Fatigue
Keywords: acupuncture
patient narratives
qualitative methods
Lead sponsor: National Center for Complementary and Integrative Health (NCCIH)
Sponsor class: NIH
First posted: 2005-09-20
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE

Brief summary: This study examined the experiences of individuals undergoing acupuncture to gather information on patient-provider communication and on the therapeutic effects of acupuncture.

Detailed description: Authentic voice is a approach involving the use of first-hand narratives from members of a target population in order to accomplish public health goals. In the first paper, a discussion of the potential of using narratives from the target population as 1) a direct intervention; 2) a form of persuasive communications; and 3) a source of information for research into various topics. The main premise is that traditional narrative methods can be adapted to the public health context by providing the narrator with the topic of the narrative. The second paper examines the patient experience of acupuncture using narrative drawn from interviews with and letters from acupuncture patients using a content oriented approach. The third paper examines the importance of meaning shift over the course of acupuncture treatment and demonstrates the usefulness of patient narratives as a data source for examining meaning. Findings include the need for intervention studies comparing authentic voice approaches to existing health communication tools for effectiveness in creating attitude and behavior change efficiently. Authentic voice approaches also need to be researched to understand and systematize concepts such as validity in relation to target-group derived narratives. Effectiveness of authentic voice for advocacy and research should also be further tested. Concerning acupuncture, the second and third papers show that acupuncture patients report a variety of benefits far wider than previously reported in the literature. Study designs should consider this wide range of benefits when assessing acupuncture outcome. Meaning shift is also reported by acupuncture patients and may play an important (but non-specific) role in the healing associated with acupuncture.

Eligibility criteria: Inclusion Criteria:

* individuals seeking acupuncture from private practice in Baltimore/Washington metro area.

Exclusion Criteria:

* prior patients

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Johns Hokins School of Public Health
name: Mark A Stibich, PhD
role: PRINCIPAL_INVESTIGATOR
References: