louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02554565: Innovation for Standard Identification of Insertional HPV Mutations and of Target Therapeutic Genes in Cervical Cancer: Towards Development of Personalized Biomarkers in Clinical Oncology
Official title: Innovation for Standard Identification for Insertional HPV Mutations and of Target Therapeutic Genes in Cervical Cance: Towards Development of Personalized Biomarkers in Clinical Oncology (PAIR HPV : Human PapillomaVirus)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cervical Cancer
Keywords: Patients with cervical cancer
Lead sponsor: Institut Curie
Sponsor class: OTHER
First posted: 2015-09-18
Enrollment: 26
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Quantification and follow-up of circulating tumoral DNA in serum and/or plasma of patients with cervical cancer compared to the early detection of minimal metastatic disease.

Detailed description: Quantification and follow-up of circulating tumoral DNA in serum and/or plasma of patients with cervical cancer compared to the early detection of minimal metastatic disease.

Eligibility criteria: Inclusion Criteria:

1. Patient with cervical cancer, at any stage, before any anti-tumoral treatment.
2. Age ≥ 18 years.
3. Patient information and signature of the informed consent or her/his legal representative.
4. Patient having given her/his agreement for a second biopsy at diagnosis if the first one was performed outside of the center and was not cryopreserved.

Exclusion Criteria:

1. Person deprived of liberty or under supervision.
2. Inability to attend scheduled follow-up visits for any psychological, sociological or geographical reasons.

Primary outcomes:
measure: Quantification and follow-up of circulating tumoral DNA in serum and/or plasma of patients with cervical cancer compared to the early detection of minimal metastatic disease.
timeFrame: Until 2 years after treatment
Secondary outcomes:
measure: Validation of NGS methodology for the molecular characterization of genetic alterations related to the integration of viral DNA sequences.
timeFrame: Until 2 years after treatment
measure: Detailed molecular characterization of genes alterations implicated in cervical oncogenesis.
timeFrame: Until 2 years after treatment
Other outcomes:
Locations:
city: Besancon
country: France
facility: CHU Besançon
city: Caen
country: France
facility: Centre François Baclesse
city: Clermont Ferrand
country: France
facility: Centre Jean Perrin
city: Paris
country: France
facility: Institut Curie
Study officials:
References:
Clinical trial NCT04695665: Therapy of Pain Syndromes According to McGill's Method in Physiotherapy
Official title: The Effectiveness of McGill's Method in the Treatment of Vertebrogenic Algic Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vertebrogenic Pain Syndrome
Keywords: pain syndrome
efficiency
stabilization
McGill method
Lead sponsor: Charles University, Czech Republic
Sponsor class: OTHER
First posted: 2021-01-05
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this study is to determine the applicability of McGill ́s method to patients with diagnoses, collectively referred to as Vertebrogenic Algic syndrome, by comparing the measured data of proband with different diagnosis locations Vertebrogenic Algic syndrome in the Czech Republic.

Detailed description: This is a pilot experimental research involving 10 probands diagnosed with Vertebrogenic Algic syndrome in the cervical spine, 10 probands diagnosed with Vertebrogenic Algic syndrome in the thoracic spine and 10 probands diagnosed with Vertebrogenic Algic syndrome in the lumbar spine. Each participant undergo a kinesiological examination according to the McGill ́s principles together with an SF-36 questionnaire. Measured values are compared and provided a basis for testing the hypotheses. The study uses methods of research, observation, querying and comparison of collected data.

Eligibility criteria: Inclusion Criteria:

* cervical pain syndrome
* thoracic pain syndrome
* lumbar pain syndrome

Exclusion Criteria:

* red falgs

Primary outcomes:
measure: Pain relief
timeFrame: 4 weeks, 2 times a week exercising for 60 minutes
measure: multi-segmental efficiency
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Praha
country: Czechia
facility: Charles University, Faculty of physical education and sport
Study officials:
affiliation: Charles University, Faculty of physical education and sport
name: Jitka Malá, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06548165: Physiological Reaction After Food Intake
Official title: Physiological Reaction After Food Intake
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Physiological Reactivity to Cues
Keywords: wearables
food intake
physiologic reaction
Lead sponsor: University of Ulm
Sponsor class: OTHER
First posted: 2024-08-12
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The goal of this clinical trial is to clarify the normal response of the body after food intake.

Therefore, participants will wear three wearables for two weeks and document their food intake via an app- and picture-based protocol.

Detailed description: The aim of this study is to investigate physiologically measurable reactions of the body to food intake. We want to find out which of the parameters collected can provide information about food intake and which techniques for data collection are expedient in this context. Ultimately, the aim is to develop a way of determining food intake from physiological data from physiological data without the user indicating this to the device.

The following data is collected continuously over a period of 2 weeks: Electrocardiogram (ECG), pulse rate from photoplethysmogram, body temperature, movement, skin conductance, and a continuous glucose measurement in the interstitium (CGM). The test subjects will also be asked to document each of their meals and snacks via an app using a photo. As an optional additional examination, female study participants will be offered an intravaginal temperature measurement. This independently performed measurement enables the core body temperature to be recorded.

Eligibility criteria: Inclusion Criteria:

* BMI 18.5 - 25 kg/m2

Exclusion Criteria:

* vegan diet
* any kind of special diet, e.g. to lose weight
* use of medication, except for thyroid hormones and contraceptives

Primary outcomes:
measure: Electrocardiogram
timeFrame: 2 weeks
measure: Body temperature
timeFrame: 2 weeks
measure: Skin conductance
timeFrame: 2 weeks
measure: Glucose level
timeFrame: 2 weeks
Secondary outcomes:
measure: Physical Activity
timeFrame: 2 weeks
measure: Food intake
timeFrame: 2 weeks
Other outcomes:
measure: Correlation of physiological measures (electrocardiogram, pulserate, body temperature, skin conductance, glucose level)
timeFrame: 2 weeks
measure: Sex differences
timeFrame: 2 weeks
measure: Correlation with glycemic and insulin sensitivity
timeFrame: 2 weeks
Locations:
city: Ulm
country: Germany
facility: Universityhospital Ulm
Study officials:
affiliation: University of Ulm
name: Martin Heni, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04375865: Evaluating the Pharmacokinetic Interactions and Safety Between AD-2111 and AD-2112
Official title: A Phase I Clinical Trial to Evaluate the Pharmacokinetic Interactions and Safety Between AD-2111 and AD-2112 in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pain
Lead sponsor: Addpharma Inc.
Sponsor class: INDUSTRY
First posted: 2020-05-06
Enrollment: 30
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A phase I clinical trial to evaluate the pharmacokinetic interactions and safety between AD-2111 and AD-2112

Detailed description: Purpose: pharmacokinetic interactions and safety of AD-2111 and AD-2112 in healthy adult volunteers Condition or disease : Pain Intervention/treatment Drug : AD-2111(Celecoxib 200mg), AD-2112(Tramadol 150mg) Phase : Phase 1

Eligibility criteria: Inclusion Criteria:

* Healthy Adult aged 19 and more at the time of screening visit
* Body mass index (BMI) between 18.5 kg/m2 and 27.0 kg/m2 at the time of screening visit

Exclusion Criteria:

* As a result of laboratory tests, the following figures: ALT or AST or total bilirubin \> 1.5 times upper limit of normal range
* As a result of laboratory tests, the following figures: Creatinine clearance \< 80mL/min

Primary outcomes:
measure: Area under the curve in time plot (AUCt)
timeFrame: pre-dose to 72 hours
measure: Peak Plasma Concentration (Cmax)
timeFrame: pre-dose to 72 hours
Secondary outcomes:
measure: Area under the curve in time plot (AUCinf)
timeFrame: pre-dose to 72 hours
measure: Time to reach Cmax(Tmax)
timeFrame: pre-dose to 72 hours
measure: Effective half-life(t1/2)
timeFrame: pre-dose to 72 hours
measure: Clearance(CL/F)
timeFrame: pre-dose to 72 hours
measure: Volume of distribution(Vd/F)
timeFrame: pre-dose to 72 hours
measure: Area under the curve in time plot (AUCt) of O-desmethyltramadol
timeFrame: pre-dose to 72 hours
measure: Peak Plasma Concentration (Cmax) of O-desmethyltramadol
timeFrame: pre-dose to 72 hours
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Hospital
Study officials:
affiliation: Kyungpook National University Hospital
name: Young-Ran Yoon, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05878665: Low-dose Contrast Media for Low-kVp Abdomen CT
Official title: Optimizing Low-dose Contrast Media Protocol for Low-kVp Abdominopelvic CT in Suspected Acute Appendicitis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Appendicitis Acute
Keywords: acute appendicitis
acute abdomen
CT
Lead sponsor: Seoul St. Mary's Hospital
Sponsor class: OTHER
Collaborators: name: GE Healthcare
First posted: 2023-05-26
Enrollment: 292
Sex: ALL
Minimum age (years): 19
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this clinical study is to test the performance of low radiation dose abdominal CT combined with low dose contrast media for the diagnosis of acute appendicitis in young patients. The main questions to be answered are:

1, Can low-dose contrast media paired with low-dose radiation CT of the abdomen provide acceptable diagnostic accuracy in acute appendicitis? 2. How much radiation dose can be saved by using low radiation dose abdominal CT in combination with low dose contrast media?


Eligibility criteria: Inclusion criteria:

* Patients in the emergency department with suspected acute appendicitis based on clinical examination
* Patients scheduled for contrast-enhanced CT of the abdomen and pelvis for diagnosis of suspected acute appendicitis.

Exclusion criteria:

* Patients who decline to participate
* Contraindications to contrast-enhanced CT (eGFR \< 30 mL/min/173 m\^2 or pregnant)
* BMI \>= 30.

Primary outcomes:
measure: Diagnostic accuracy for acute appendicitis
timeFrame: For operated patients, postop. period (up to 1 month); If non-operated, at 6 months-FU
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul St. Mary's Hospital
Study officials:
affiliation: Seoul St. Mary's Hospital
name: Bohyun Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01575665: Normalizing CO2 in Chronic Hyperventilation by a Novel Breathing Mask: A Pilot Study
Official title: CO2 Rebreathing by a Partial Rebreathing Mask as a Treatment of Chronic Idiopathic Hyperventilation - a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyperventilation
Chronic Idiopathic Hyperventilation
Dysfunctional Breathing
Respiratory Alkalosis
Keywords: Hyperventilation
Chronic Idiopathic Hyperventilation
Dysfunctional Breathing
Respiratory Alkalosis
Respiratory Acidosis
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Rehaler
First posted: 2012-04-11
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Background: Chronic Idiopathic Hyperventilation (CIH) is a form of dysfunctional breathing which has proven hard to treat effectively. The investigators hypothesised that by periodically inducing normocapnia over several weeks, it would be possible to raise the normal resting level/set point of CO2 and achieve a reduction of symptoms.

Methods: Six CIH patients were treated two hours a day for four weeks with a novel breathing mask. The mask was used to induce normocapnia in these chronically hypocapnic patients.

Capillary blood gases (PcCO2, pH, Standard Base Excess (SBE) etc.) were measured at baseline and once each week at least three hours after mask use, as well as spirometric values, breath holding tolerance and hyperventilation symptoms as per the Nijmegen Questionnaire (NQ),.


Eligibility criteria: Inclusion Criteria:

Chronic idiopathic hyperventilation, i.e.:

* PCO2 level below 4.7 kPa AND
* SBE value more negative than -1.0

Exclusion Criteria:

* Oxygen saturation of 95% or lower at rest

Primary outcomes:
measure: Blood gas and acid/base status
timeFrame: Once every week in the treatment period of four weeks
Secondary outcomes:
measure: Hyperventilation symptoms
timeFrame: once a week
measure: Breath Hold Tolerance
timeFrame: once a week
measure: Spirometric values
timeFrame: once a week
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
Study officials:
affiliation: Aarhus University Hospital
name: Ronald Dahl
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06084065: Feasibility and Effectiveness of a Ring-type Blood Pressure Measurement Device
Official title: Feasibility and Effectiveness of a Ring-type Blood Pressure Measurement Device Compared With 24-hour Ambulatory Blood Pressure Monitoring Device: Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hypertension
Blood Pressure
Systolic Hypertension
Diastolic Hypertension
Essential Hypertension
Obstructive Sleep Apnea
Prehypertension
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2023-10-16
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The goal of this clinical trial is to evaluate the feasibility and effectiveness of a ring-type blood pressure measurement device compared to a 24-hour ambulatory blood pressure monitoring device in patients with hypertension or suspected hypertension. The main question it aims to answer is whether the 24-hour blood pressure measurement accuracy of the ring-type blood pressure monitor is similar to that of the 24-hour ambulatory blood pressure monitor. To participate, subjects must wear a ring blood pressure monitor and an ambulatory blood pressure monitor simultaneously for 24 hours.


Eligibility criteria: Inclusion Criteria:

1. Patients scheduled for 24-hour ambulatory blood pressure monitoring for diagnostic purposes among those suspected of having hypertension
2. Confirmed hypertensive patients scheduled for 24-hour ambulatory blood pressure monitoring for treatment purposes

   * Either criterion 1 or 2 are planned to be selected as study participants.

Exclusion Criteria:

* Participants who do not consent to the study
* Individuals with a Body Mass Index of 30 or above (there's a concern of measurement errors as the standard 24-hour ambulatory blood pressure cuffs may not fit well)
* Pregnancy
* Baseline heart disease patients: individuals with a history of hospitalization due to heart failure, valvular disease, or myocardial infarction
* Patients diagnosed with atrial fibrillation on a 12 lead EKG within the past 6 months
* End-stage renal disease (patients undergoing dialysis)
* Users of mobile phones that are not compatible with the test device (CART-I plus) used in the study

Primary outcomes:
measure: The average agreement between blood pressure measured with a 24-hour ambulatory BP measurement device and blood pressure measured with a ring-type BP measurement device during a subject's activity time.
timeFrame: Compare the blood pressure measured over 24 hours using a ring-type blood pressure monitor and 24-hour ambulatory blood pressure monitoring.
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National Univesity Hospital
Study officials:
References:
Clinical trial NCT01872065: Safety and Tolerability Study of ARC-520 in Healthy Volunteers
Official title: A Phase I, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalating Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ARC-520 in Normal Adult Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Arrowhead Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2013-06-07
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of ARC-520 in normal, adult volunteers.


Eligibility criteria: Key Inclusion Criteria:

* Healthy male or female subjects, 18-55 years of age
* Be a non-smoker

Key Exclusion Criteria:

* History of clinically relevant medical illnesses that in the Investigator opinion may jeopardize subject safety or interfere with participation in the study, including but not limited to hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease
* Acute signs of hepatitis/other infection (e.g., moderate fever, jaundice, nausea, vomiting, abdominal pain) evident within 4 weeks of screening and/or at the screening examination.
* Use of any drugs known to induce or inhibit hepatic drug metabolism within 30 days prior to administration of study treatment.
* Is sero-positive for HIV, HBV, HCV, and/or a history of delta virus hepatitis.
* Currently uses and/or has a history of alcohol and/or drug abuse \< 12 months from screening.
* Use of investigational agents or devices within 30 days prior to planned study dosing or current participation in an investigational study.

Primary outcomes:
measure: To determine the incidence and frequency of adverse events as a measure of safety and tolerability of ARC-520
timeFrame: One month
Secondary outcomes:
measure: To evaluate the pharmacokinetics of ARC-520 at different dose concentrations
timeFrame: 2 days
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Nucleus Network Ltd.
state: Victoria
Study officials:
affiliation: Nucleus Network Ltd
name: Jason Lickliter, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00773565: Identification of Novel Targets for Regulation of Adipose Tissue Mass
Official title: Identification of Novel Targets for Regulation of Adipose Tissue Mass
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: patients with obesity (BMI > 30 kg/m2)
Lead sponsor: Heidelberg University
Sponsor class: OTHER
Collaborators: name: Swiss Federal Institute of Technology
First posted: 2008-10-16
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of this study is to understand the metabolic changes occurring in fat tissue both during controlled weight loss that lead to the improvement of type 2 diabetes and other obesity associated metabolic disorders. The novelty of the study is the analysis of preadipocytes, a poorly characterized subfraction of the adipose tissue, which provides adipocyte precursors and thereby strongly influences adipose tissue mass changes. Knowledge of pathways involved in controlling adipose tissue composition will help to design novel intervention strategies for the treatment of obesity associated metabolic disorders such as type 2 diabetes.


Eligibility criteria: Inclusion Criteria:

* Participants of the OPTIFAST52 program
* BMI \> 30 kg/m2

Exclusion Criteria:

* Rejection of informed consent by the participant

Primary outcomes:
measure: number of adipocytes and preadipocytes under weight loss
timeFrame: three years
Secondary outcomes:
measure: metabolic function of adipocytes and preadipocytes under weight loss
timeFrame: three years
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: University Hospital Heidelberg
Study officials:
affiliation: ETH Zürich
name: Christian Wolfrum, PhD
role: STUDY_CHAIR
References: