louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05112029: Metabolic Profile and Adipokine Levels in Young Hyperandrogenemic Females
Official title: Metabolic Profile and Adipokine Levels in Young Hyperandrogenemic Females
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hyperandrogenism
Obesity
Metabolic Disease
Metabolic Syndrome
Lead sponsor: Medical University of Gdansk
Sponsor class: OTHER
First posted: 2021-11-08
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Hyperandrogenemic females admitted for additional assessment due to medical reasons.

Brief summary: Assessement of basic metabolic profile and adipokine levels in young hyperandrogenemic females.


Eligibility criteria: Inclusion Criteria:

* hyperandrogenemia
* informed consent to participate
* female sex
* age 18-40 years old

Exclusion Criteria:

* male sex
* no consent given

Primary outcomes:
measure: Basic metabolic profile.
timeFrame: Day of blood testing - no further assessment planned (observational study).
measure: Adipokines.
timeFrame: Day of blood testing - no further assessment planned (observational study).
Secondary outcomes:
Other outcomes:
Locations:
city: Gdańsk
country: Poland
facility: Department of Endocrinology and Internal Medicine, Medical University of Gdansk
Study officials:
affiliation: Medical University of Gdansk
name: Renata Świątkowska-Stodulska, MD PhD
role: STUDY_DIRECTOR
affiliation: Medical University of Gdansk
name: Agata Berlińska, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01351129: Single Dose Study To Compare Pharmacokinietics Of 3 Different Formulations Of PF-04991532 In Healthy Volunteers
Official title: A Phase 1, Single-Dose, Open-Label, Crossover Study To Estimate The Relative Bioavailability Of Two Controlled-Release Formulations Vs. An Immediate Release Formulation Of PF-04991532 In Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: formulation comparison
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2011-05-10
Enrollment: 12
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The primary purpose of this study is to evaluate the pharmacokinetics, safety and tolerability three different formulations of PF-04991532 in healthy adult subjects.


Eligibility criteria: Inclusion Criteria:

* Healthy male and/or female (non-childbearing potential) subjects between the ages of 21 and 55 years, inclusive.
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs).
* An informed consent document signed and dated by the subject.

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) disease or clinical findings at Screening.
* Any condition possibly affecting drug absorption (eg, gastrectomy).
* A positive urine drug screen.

Primary outcomes:
measure: Area under the plasma concentration versus time profile (AUC)
timeFrame: predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12,24,36,48 hrs postdose
Secondary outcomes:
measure: Max observed plasma concentration (Cmax)
timeFrame: predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12,24,36,48 hrs postdose
measure: Time of Cmax (Tmax)
timeFrame: predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12,24,36,48 hrs postdose
measure: Concentration at 24 hours postdose (C24hr)
timeFrame: 24 hrs postdose
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT02916329: In Vivo EGFR-ECD Molecular Imaging Using [68Ga]- Labelling Anti-EGFR Affibody Molecule
Official title: Targeted Molecular Imaging of [68Ga]- Labelling Anti-EGFR Affibody Molecule in EGFR ECD in Lung Cancer Patients and Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Molecular Imaging
Lead sponsor: Harbin Medical University
Sponsor class: OTHER
First posted: 2016-09-27
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The investigators developed \[68Ga\]-labelling Anti-EGFR Affibody Molecule as a targeted molecular imaging agent for noninvasive and repeatable detecting EGFR-ECD expression status.

Detailed description: The goals of investigators are to evaluate the use of \[68Ga\]-labelling Anti-EGFR Affibody Molecule as a novel PET/CT radiotracer to monitor EGFR-ECD expression status and classify EGFR-ECD benefit NSCLC patients. The investigators want to evaluated the use of \[68Ga\]-labelling Anti-EGFR Affibody Molecule in lung cancer imaging in adult NSCLC patients with different EGFR-ECD expression status of primary and metastatic cancers.

Eligibility criteria: Inclusion Criteria:

* Advanced NSCLC
* 18 years or older
* A life expectancy of at least 12 weeks
* Presence of a malignant lesion within the chest of at least 0.5 cm diameter as measured by computed tomography (CT)
* Written informed consent

Exclusion Criteria:

* Claustrophobia
* Pregnancy
* Metal implants in the thorax

Primary outcomes:
measure: tumor SUVmax value of 68Ga-NODAGA-ZEGFR:1907 PET/CT Imaging
timeFrame: at time of imaging
Secondary outcomes:
Other outcomes:
Locations:
city: Harbin
country: China
facility: TOF-PET/CT/MR center of the Fourth Hospital of Harbin Medical University
state: Heilongjiang
Study officials:
affiliation: The Fourth Hospital of Harbin Medical University
name: Shen Baozhong, M.D.
role: STUDY_CHAIR
References:
Clinical trial NCT01443429: A Pharmacokinetic Study of TRK-100STP in Japanese Patients With Renal Impairment
Official title: A Pharmacokinetic Study of TRK-100STP -A Single Oral Administration Study in Japanese Patients With Renal Impairment as Compared to Subjects With Normal Renal Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Renal Impairment
Keywords: TRK-100STP
PK
beraprost sodium
Japanese males and females
Subjects with mild/moderate/severe patients
renal impairment
Lead sponsor: Toray Industries, Inc
Sponsor class: INDUSTRY
First posted: 2011-09-29
Enrollment: 24
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: The PK and safety profiles to be examined following a single oral administration of TRK-100STP (120 μg) under fasting conditions to patients with renal impairment and to subjects with normal renal function.


Eligibility criteria: Inclusion Criteria:

* The eGFR 1 day before study drug administration are stipulated as follows.
* Subjects with normal renal function : ≥90
* Patients with mild renal impairment : ≥60 to \<90
* Patients with moderate renal impairment : ≥30 to \<60
* Patients with severe renal impairment : ≥15 to \<30

Exclusion Criteria:

* Patients on dialysis
* Patients who have a history of undergoing renal transplantation
* Patients with diabetes mellitus

Primary outcomes:
measure: Composite of pharmacokinetic parameters of TRK-100STP such as maximum observed concentration (Cmax,pg/mL), area under the plasma concentration-time curve (AUC,pg·hr/mL), time at maximum concentration (Tmax,hr) and mean residence time (MRT,hr)
timeFrame: Up to 48hr
Secondary outcomes:
Other outcomes:
Locations:
city: Japan
country: Japan
facility: Japan
Study officials:
References:
Clinical trial NCT04293029: Pharmacokinetics and Safety of SHR0302 in Patients With Hepatic Impairment
Official title: Pharmacokinetics and Safety of SHR0302 in Patients With Mild, Moderate Hepatic Impairment and Normal Liver Function in Phase I Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hepatic Impairment
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-03-03
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Study to Evaluate Pharmacokinetics and Safety of SHR0302 in Patients With Mild, Moderate Hepatic Impairment and Normal Liver Function in Phase I Clinical Study


Eligibility criteria: Inclusion Criteria:

All subjects:：

* Signing the informed consent forms；
* 18 years to 65 years (inclusive)；
* Body mass index should be between 18 and 30 kg/m2 (inclusive)；
* No medication was used before screening，or stable medication for 4 weeks.

Normal liver function：

* Clinical laboratory tests during the screening period were normal，or the abnormality has no clinical significance.

Hepatic impaired subjects:

* Child-Pugh Classification score clinically determined as mild or moderate hepatic impairment.
* Liver damage due to primary liver disease.

Exclusion Criteria:

All subjects:

* Subject known or suspected of being sensitive to the study drugs or its ingredient；

Normal liver function：

* Previous history of liver function impairment, or physical examination and laboratory examination at screening indicated the presence or possibility of liver function impairment.
* Hepatitis B surface antigen (HBsAg) positive or Anti-hepatitis C virus (HCV) antibody or hepatitis C core antigen positive within 3 months prior to administration.

Hepatic impaired subjects:

* Suspected or diagnosed as liver cancer or with other malignant tumors;
* Drug induced liver injury，acute liver injury，liver transplantation history.
* Subjects with hepatic failure,or severe complications caused by Hepatocirrhosis.

Primary outcomes:
measure: Peak Plasma Concentration (Cmax)
timeFrame: 72 hours after dosing
measure: Area under the plasma concentration versus time curve from single dosing time extrapolated to infinity（AUC0-∞）
timeFrame: 72 hours after dosing
measure: Area under the plasma concentration versus time curve from the last time of dosing to the last measurable concentration （AUC0-t）
timeFrame: 72 hours after dosing
Secondary outcomes:
measure: Adverse events
timeFrame: 72 hours after dosing
Other outcomes:
Locations:
city: Changchun
country: China
facility: The First Affiliated Hospital of Jilin University
state: Jilin
Study officials:
References:
Clinical trial NCT05396729: Acupoint Stimulation Improves Sleep on the Plateau
Official title: Effect of Transcutaneous Electrical Acupoint Stimulation on Sleep Quality in Healthy Volunteers on the Plateau
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sleep Disorder
Keywords: transcutaneous electrical acupoint stimulation
plateau
sleep disorder
healthy volunteer
Lead sponsor: Air Force Military Medical University, China
Sponsor class: OTHER
First posted: 2022-05-31
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Sleep disorder is common in people going to plateau. Acupuncture and related techniques could be used for treatment of sleep disorder. In this trial the effect of transcutaneous electrical acupoint stimulation on sleep disorder in people going to plateau will be investigated.


Eligibility criteria: Inclusion Criteria:

* Age from 18 to 40 years
* first time to the plateau (altitude ≥3000 meters)

Exclusion Criteria:

* those who live in area with altitude ≥2000 meters, or travel to plateau in the last half year
* history of insomnia
* patients with contraindication to transcutaneous electrical stimulation, including skin damage, infection or implantable electrical device
* difficulty in verbal communication
* history of taking medicine to improve sleep during the last 3 months
* regular daily intake of large dose of tea or coffee (\>400 mg of caffeine)
* suspected or existed abuse of drug or alcohol
* disease that influence sleep such as chronic pain

Primary outcomes:
measure: total sleep time in 5 days
timeFrame: from arrived at plateau to 5 days after arrival, in a total of 5 days
Secondary outcomes:
measure: sleep latency on the fifth day
timeFrame: from arrived at plateau to 5 days after arrival, in a total of 5 days
measure: sleep efficiency on the fifth day
timeFrame: from arrived at plateau to 5 days after arrival, in a total of 5 days
measure: number of awake on the fifth day
timeFrame: from arrived at plateau to 5 days after arrival, in a total of 5 days
measure: Pittsburgh sleep quality index on the fifth day
timeFrame: from arrived at plateau to 5 days after arrival, in a total of 5 days
measure: Score of Cognition Assessment on the third day
timeFrame: from arrived at plateau to 5 days after arrival, in a total of 5 days
measure: lowest saturation of pulse oxygenation on the fifth day
timeFrame: from arrived at plateau to 5 days after arrival, in a total of 5 days
measure: highest systolic blood pressure on the fifth day
timeFrame: from arrived at plateau to 5 days after arrival, in a total of 5 days
measure: highest heart rate on the fifth day
timeFrame: from arrived at plateau to 5 days after arrival, in a total of 5 days
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xijing hospital
state: Shaanxi
Study officials:
References:
Clinical trial NCT01348529: Internet Cognitive Behavior Therapy (CBT) for Obsessive Compulsive Disorder (OCD)
Official title: Internet-based Cognitive Behavior Therapy for Obsessive Compulsive Disorder: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obsessive Compulsive Disorder
Keywords: OCD
CBT
Reducing OCD symptoms
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2011-05-05
Enrollment: 23
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 main aim of this study is to test whether cognitive behavior therapy could be effective in treating obsessive compulsive disorder. Here, the investigators test the in group effects of a 15 week long treatment delivered via the Internet for residents in Stockholm County.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with Obsessive compulsive disorder according to the DSM criteria
* Be at least 18 years old
* YBOCS \>7

Exclusion Criteria:

* other primary diagnosis
* substance abuse,
* psychosis,
* bipolar disorder,
* suicidal ideation,
* adjusted pharmacological treatment the last two months
* current psychological treatment for OCD,
* been treated with CBT the last two years,
* serious somatic disease,
* Y---BOCS\>31
* hoarding as primary OCD subtype

Primary outcomes:
measure: Change from Baseline of obsessions and compulsions after 15 weeks and 6 months after treatment.
timeFrame: Psychiatrist visit at baseline, after 15 weeks of treatment and 6 months after treatment.
Secondary outcomes:
measure: Change from Baseline of cost data after 15 weeks and 6 months after treatment.
timeFrame: Self-ratings at baseline, after 15 weeks of treatment and 6 months after treatment.
measure: Change from Baseline of depressive symptoms after 15 weeks and 6 months after treatment.
timeFrame: Sel-ratings at baseline, after 15 weeks of treatment and 6 months after treatment.
measure: Change from Baseline of obsessions and compulsions after 15 weeks and 6 months after treatment.
timeFrame: Self-ratings at baseline, after 15 weeks of treatment and at 6 months after treatment.
measure: Change from Baseline of quality of life after 15 weeks and 6 months after treatment
timeFrame: Self-ratings at baseline, after 15 weeks of treatment and at 6 months after treatment.
measure: Change from Baseline of quality of life after 15 weeks and 6 months after treatment
timeFrame: Self-ratings at baseline, after 15 weeks of treatment and at 6 months after treatment.
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Internetpsykatrienheten, M46, Psykiatri sydväst
Study officials:
References:
citation: Andersson E, Ljotsson B, Hedman E, Kaldo V, Paxling B, Andersson G, Lindefors N, Ruck C. Internet-based cognitive behavior therapy for obsessive compulsive disorder: a pilot study. BMC Psychiatry. 2011 Aug 3;11:125. doi: 10.1186/1471-244X-11-125.
Clinical trial NCT06774729: Development of a Radiomics Model With MR to Predict the Occurence of a Infiltration of Muscoskeletal Tumor
Official title: Development of a Radiomics Model With 3T Multiparametric MR to Predict the Occurence of a Perilesional Infiltration of Muscoskeletal Tumor During the Pre- Surgery Planning
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Soft Tissue Sarcoma (STS)
Bone Cancer Tumor
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2025-01-14
Enrollment: 122
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: The study population consists in participants with a suspect of soft tissue sarcoma or bone cancer that are followed at Radiology Department of IRCCS Azienda Ospedaliero-Universitaria hospital in the city of Bologna.

Brief summary: The goal of this observational study is to evaluate the feasibility and clinical utility of radiomics to diagnose peri-lesion tumour infiltration of tumours in participants with a suspect of Bone Cancer Tumor or Soft Tissue Sarcoma (STS).

The main questions it aims to answer are:

* is radiomics able to identify the ratio of participants truly diagnosed as positive to all those who had positive test results?
* is radiomics able to identify the likelihood that a participant who has a negative test result indeed does not have the disease?

Participants eligible for this study will get a MRI as part of their regular medical care. The only difference is that their data will be recorded and anonymously analyzed.


Eligibility criteria: Inclusion Criteria:

* Age over 18
* suspect of soft tissue sarcoma with a indication for surgical treatment
* suspect of bone cancer tumor with a indication for surgical treatment
* To give informed consent

Exclusion Criteria:

* simultaneous cancer or history of cancer in the last 5 years
* acute or chronic serious conditions that could
* contraindication to conduct a Contrast-enhanced magnetic resonance imaging (MRI) such as:

  * renal failure without dialysis
  * history of allergy to a paramagnetic contrast agent
  * claustrophobia
  * symptomatic epilepsy or history of epilepsy
  * cardiac pacemaker
  * infusion pump, prosthesis or any implant not compatible with MRI
  * pregnancy

Primary outcomes:
measure: Positive Predictive Value (PPV)
timeFrame: From enrollment to the end of treatment at 2 years
measure: Negative Predictive Value (NPV)
timeFrame: From enrollment to the end of treatment at 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Study officials:
References:
Clinical trial NCT06089629: Frenuloplasty for Speech and Myofunctional Outcomes
Official title: Frenuloplasty for Speech and Myofunctional Outcomes: a Randomized, Controlled Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Ankyloglossia
Speech Delay
Dentofacial Abnormalities
Keywords: ankyloglossia
speech delay
myofunctional therapy
dentofacial abnormalities
Lead sponsor: The Oregon Clinic
Sponsor class: OTHER
First posted: 2023-10-18
Enrollment: 50
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Children with ankyloglossia (tongue tie) can have abnormal tongue function, putting them at a disadvantage when it comes to speech and articulation. Furthermore, abnormal tongue posture within the oral cavity increases the likelihood of myofunctional disorders.

Detailed description: The current body of literature surrounding ankyloglossia and speed delay is mixed. The literature base is riddled with retrospective reviews, poor descriptions of surgical intervention, and the lack of standardized grading schemes with respect to articulation. Furthermore, the candidacy for intervention in these instances only involves children with anterior tongue tie. There is a complete lack of investigation surrounding the impact of posterior tongue tie on articulation.

The other area that has inadequately been studied is the impact ankyloglossia has on myofunctional outcomes. There are data now that demonstrate how ankyloglossia is correlated with a vaulted palate and has long term orthodontic consequences. This study aims to demonstrate how release of posterior tongue tie improves lingual strength and posture.

Eligibility criteria: Inclusion Criteria:

* Children ages 5-12 with posterior tongue tie who are undergoing treatment just for ankyloglossia
* Children must already be working with an SLP who has done a speech and myofunctional evaluation

Exclusion Criteria:

* Children undergoing other procedures at the same time as the frenuloplasty (tonsillectomy, adenoidectomy, etc)
* Significant medical comorbidities (cardiovascular, neurological, etc)
* Anterior tongue tie or lip tie
* Previous lingual surgery

Primary outcomes:
measure: Speech/Articulation
timeFrame: Baseline (timepoint 0) and 2 months post-intervention (surgical group) or 2 months post-therapy alone (control group)
measure: Tongue mobility
timeFrame: Baseline (timepoint 0) and 2 months post-intervention (surgical group) or 2 months post-therapy alone (control group)
measure: Tongue strength
timeFrame: Baseline (timepoint 0) and 2 months post-intervention (surgical group) or 2 months post-therapy alone (control group)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: