louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04217668: Headache Provocation of People Who Are Unable to Have Headache
Official title: Pain Perception, Headache Provocation and Multiomics of People Who Are Unable to Have Headache
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Headache
Healthy
Lead sponsor: Danish Headache Center
Sponsor class: OTHER
First posted: 2020-01-03
Enrollment: 58
Sex: MALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Blinded case-control study
Primary purpose: OTHER

Brief summary: Headaches are extremely common illnesses with a combined lifetime prevalence of 90-99% in Europe. Despite this high prevalence, there are persons who have never, in their whole life, encountered a headache.

The aim of the study is to identify factors that protect against headache by studying headache after provocation in people who never have had a headache (headache resistant) versus non-resistant controls.

The investigators will use isosorbide mononitrate as a pharmacological trigger of headache. The provocation is performed by investigators who are blinded to the grouping of the participants.

The investigators hope to contribute with novelty to the current understanding of headache pathophysiology and development of more efficient treatment of headache.


Eligibility criteria: Inclusion Criteria:

* Headache resistant and non-resistant male participants from the Danish Blood Donor Study.
* Weight: 45 kg to 95 kg

Exclusion Criteria:

* Daily consumption of any medication.
* Consumption of any medication less than 12 hours prior to the study day.
* Headache on the study day or 48 hours prior to the study day.
* Amnestic or clinical signs of hypertension (systolic blood pressure \>150 mmHg and/or diastolic blood pressure \>100 mmHg) or hypotension (systolic blood pressure \<90 mmHg and/or diastolic blood pressure \<50 mmHg).
* Any severe cardiovascular disease, including cerebrovascular illness.
* Amnestic or clinical signs of current mental illness.
* Amnestic or clinical signs of current substance or drug abuse.
* Amnestic or clinical signs of any illness the responsible doctor considers relevant for participation in the study.

Primary outcomes:
measure: Area under the curve of headache intensity
timeFrame: 5 hours
Secondary outcomes:
measure: Area under the curve of headache intensity
timeFrame: 12 hours
Other outcomes:
Locations:
city: Glostrup
country: Denmark
facility: Danish Headache Center
state: Region H
Study officials:
affiliation: Danish Headache Center
name: Jes Olesen, Professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT06937268: DOTATATE PET for Meningioma Radiation Planning
Official title: Exploratory Analysis of DOTATATE PET for Meningioma Radiation Planning
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Meningioma
Lead sponsor: British Columbia Cancer Agency
Sponsor class: OTHER
First posted: 2025-04-22
Enrollment: 36
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: 68Ga-DOTATATE-based radionuclides are a novel modality in the diagnosis and treatment of central nervous system meningioma. DOTATATE is a ligand for the SSTR (somatostatin receptor), which is expressed in meningioma but not in normal brain or bone. It is also more effective than MRI in delineating tumor, which is the current imaging standard for assessing meningioma. For radiation planning, it can help to reduce the risk of geometrical miss, identify area that require dose-escalation, and reduce dose to normal tissue. The purpose of the study is to compare the radiation therapy (RT) contouring and planning for meningioma with and without the use of 68Ga-DOTATATE-PET


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years old
* Able and willing to comply with the study procedures
* Intact meningioma requiring definitive radiation
* Post-operative meningioma requiring adjuvant radiation
* No prior radiation therapy or medical therapy directed at the tumour

Exclusion Criteria:

* Breastfeeding or pregnancy
* Claustrophobia or inability to lie still in a supine position
* Unwillingness or inability to provide informed consent

Primary outcomes:
measure: Target radiation volume
timeFrame: 2 years
Secondary outcomes:
measure: Local control
timeFrame: 2 years
measure: Progression-free survival
timeFrame: 2 years
measure: Perceived usefulness by radiation oncologist
timeFrame: 2 years
measure: Adverse event
timeFrame: 2 years
measure: Rate of DOTATATE-scan completion
timeFrame: 2 years
measure: Extent of post-operative disease volume compared to MRI
timeFrame: 2 years
measure: Overall survival
timeFrame: 2 years
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: BC Cancer - Vancouver
state: British Columbia
Study officials:
References:
Clinical trial NCT01533168: Genetic Test To Identify Previously Undetectable Minimal Residual Disease in Cell Samples From Younger Patients With Acute Lymphoblastic Leukemia
Official title: Next-Generation Sequencing of Immunoglobulin Heavy Chain Variable Region to Identify Previously Undetectable Minimal Residual Disease in Children With Acute Lymphoblastic Leukemia With Prognostic Significance
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Leukemia
Keywords: childhood acute lymphoblastic leukemia in remission
recurrent childhood acute lymphoblastic leukemia
B-cell childhood acute lymphoblastic leukemia
Lead sponsor: Children's Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2012-02-15
Enrollment: 12
Sex: ALL
Minimum age (years): 1
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients With Acute Lymphoblastic Leukemia

Brief summary: RATIONALE: Testing for minimal residual disease in cell samples from patients with acute lymphoblastic leukemia may help doctors plan better treatment.

PURPOSE: This research trial studies a genetic test in identifying previously undetectable minimal residual disease in cell samples from younger patients with acute lymphoblastic leukemia.

Detailed description: OBJECTIVES:

* To identify and characterize changes in clonal populations of B cells in children with acute lymphoblastic leukemia (ALL) at diagnosis and Day 29 of induction.
* To define the ability of this technology to reclassify patients as minimal residual disease (MRD) positive at Day 29 of induction.
* To determine whether more sensitive detection of MRD at Day 29 would have clinical prognostic value in children with ALL.

OUTLINE: DNA extracted from diagnostic cells are analyzed for immunoglobulin heavy chain variable region by next-generation sequencing.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Samples from patients enrolled on COG-AALL0232 with standard-risk (SR) or high-risk (HR) acute lymphoblastic leukemia (ALL) with varying levels of MRD and relapse
* Diagnostic cells and Day 29 cells from patients that have not relapsed and are 5 years from diagnosis on protocol COG-AALL0232
* Diagnostic cells and Day 29 cells from patients that are matched for age, sex, initial white blood cell (WBC) count, and cytogenetics that have relapsed

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified

Primary outcomes:
measure: Identification and characterization of changes in clonal populations of B cells in children with ALL
measure: Reclassification of patients as MRD positive at day 29
measure: Higher sensitivity detection that allow the stratification of the MRD population into 2 groups with lower and higher likelihood of relapse
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Stanford University
name: Norman J. Lacayo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06690268: Multimodal Model Predicts Recurrence
Official title: Multimodal Clinical-imaging-pathology-driven Artificial Intelligence Model for Predicting Postoperative Recurrence of Locally Advanced Gastric Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastric Adenocarcinoma
Lead sponsor: Hebei Medical University
Sponsor class: OTHER
First posted: 2024-11-15
Enrollment: 93
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
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 includes adult patients (aged 18 and older) diagnosed with locally advanced gastric cancer (Stage II or III) who have undergone surgical resection. This population is selected based on the availability of complete clinical, imaging, and pathology data necessary for analysis by the multimodal AI-driven predictive model. The study focuses on assessing the postoperative recurrence risk in this specific group to improve personalized follow-up and treatment planning.

Brief summary: This study focuses on developing an advanced model that combines clinical information, imaging, and pathology data to predict the likelihood of cancer returning after surgery in patients with locally advanced gastric cancer. By using artificial intelligence (AI), this model analyzes various data sources to create a more accurate prediction of recurrence risk, which can help doctors, patients, and families better understand the chances of recurrence. This AI-driven approach allows healthcare providers to make more informed decisions about personalized follow-up care and potential additional treatments to improve patient outcomes.


Eligibility criteria: \*\*Inclusion Criteria:\*\*

* Patients diagnosed with locally advanced gastric cancer (Stage II or III).
* Patients who have undergone surgical resection for gastric cancer.
* Patients with complete clinical, imaging, and pathology data available for analysis.
* Age 18 years or older.
* Patients who provide informed consent to participate in the study.

\*\*Exclusion Criteria:\*\*

* Patients with distant metastasis (Stage IV) at the time of diagnosis.
* Patients with incomplete or missing clinical, imaging, or pathology data.
* Patients who have received prior treatment for gastric cancer other than surgical resection.
* Patients with other concurrent malignancies.
* Patients who are unable or unwilling to comply with the study follow-up requirements.

Primary outcomes:
measure: Prediction accuracy of postoperative recurrence in locally advanced gastric cancer
timeFrame: 24 months postoperative follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Shijiazhuang
country: China
facility: the Fourth Hospital of Hebei Medical University
state: Hebei
Study officials:
References:
Clinical trial NCT02908568: Stimulation of the Proprioceptive Trigeminocardiac Reflex
Official title: Effect of Stimulation of the Proprioceptive Trigeminocardiac Reflex Through Medical Device for the Pain of Patients With Temporomandibular Disorders
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Temporomandibular Joint Disorders
Keywords: mandibular stretching, trigeminocardiac reflex
Lead sponsor: Azienda USL 12 Versilia
Sponsor class: OTHER
First posted: 2016-09-21
Enrollment: 36
Sex: ALL
Minimum age (years): 8
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Study over muscular stretching to reduce pain the oral cavity.

Detailed description: It is a current opinion that muscular stretching is able to reduce pain and to allow increase of the opening excursion at the joints. To investigate this possibility in the face, the investigators developed a method of stretching associated with large dynamic jaws during chewing using a special device (Spring Device ®) for ten minutes, allowing the muscles of the oral cavity to relax. The height of the bite was set as two-thirds of the maximum opening (max. 2 cm.) of the mouth at rest (without forcing) thus avoiding maintaining the head of the condyle at maximum aperture for a long time. The subjects were then analyzed by means of kinesiography to determine the changes in the vertical dimension. Increasing stretching produces neuromuscular relaxation and a reduction of pain. This study showed that this therapy induces oral and extraoral pain reduction and increases neck mobility and mouth opening. The stimulation of trigeminal receptors is an important drive for therapy in the trigeminocardiac reflex (TCR).

Eligibility criteria: Inclusion Criteria:

* All the subjets up to seventy years

Exclusion Criteria:

* Subjects under eight years

Primary outcomes:
measure: Mandibular stretching influences the temporomandibular disorders
timeFrame: up to 24 weeks
Secondary outcomes:
measure: mandibular stretching induces a reduction of facial contraction and decrease of heart rate
timeFrame: up to 24 weeks
Other outcomes:
Locations:
Study officials:
References:
citation: Tonlorenzi D, Brunelli M, Conti M, Covani U, Traina G. An observational study of the effects of using an high oral splint on pain control. Arch Ital Biol. 2019 Sep 30;157(2-3):66-75. doi: 10.12871/00039829201923.
Clinical trial NCT01469468: A Study To Estimate The Effect Of Repeated Dosing of PF-05175157 On The Pharmacokinetics Of A Single Dose Of Simvastatin In Healthy Adult Subjects
Official title: A Phase 1, Open-Label, Fixed-Sequence Study To Estimate The Effect Of Repeated Dosing Of PF-05175157 On The Pharmacokinetics Of A Single Dose Of Simvastatin In Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2011-11-10
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The study is designed to investigate the effect of repeated dosing of PF-05175157 on the pharmacokinetics of a single dose of Simvastatin in healthy adult subjects.


Eligibility criteria: Inclusion Criteria:

* Healthy subjects with normal results in all screening examinations.
* Body Mass Index of 17.5 to 35.5 kg/m2

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, ocular, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
* Known history of intolerance to simvastatin or other statins.

Primary outcomes:
measure: Area under the plasma concentration curve of simvastatin and simvastatin acid
timeFrame: 10 days
measure: Maximum observed plasma concentration of simvastatin and simvastatin acid
timeFrame: 10 days
measure: Time at which maximum plasma concentration of simvastatin and simvastatin acid is observed
timeFrame: 10 days
measure: If the data permit, area under the plasma concentration curve of simvastatin and simvastatin acid extrapolated to infinite time
timeFrame: 10 days
measure: If the data permit, terminal elimination half-life of simvastatin and simvastatin acid
timeFrame: 10 days
Secondary outcomes:
Other outcomes:
Locations:
city: South Miami
country: United States
facility: Pfizer Investigational Site
state: Florida
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT00190268: Efficacy of 3,4-DAP in Fatigue Associated With Multiple Sclerosis
Official title: Multicentric Study, Comparative, Randomized, in Double Knowledge of the Effectiveness (Versus Placebo) of a Salt Of 3,4 - Diaminopyridine in the Treatment of Tiredness During the Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Multiple Sclerosis
Keywords: multiple sclerosis
fatigue
3,4-diaminopyridine
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2005-09-19
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Rational of study : 3,4-diaminopyridine is suspected to improved the fatigue associated in patient's multiple sclerosis.

In order to confirm this hypothesis, a randomized, controlled versus placebo, double blinded study is performed.

Detailed description: We proposed a randomized controlled trial between 3,4-diaminopyridine and placebo .

The main objective : improvement of fatigue by diminution of EMIF-SEP score between the arm treatment and placebo arm. The hypothesis tested is that the 3,4-DAP is efficacy in the fatigue of multiple sclerosis.

Eligibility criteria: Inclusion Criteria:

* Age \>= 18 years and = \<60 years
* Patients with multiple sclerosis clinically defined and with MIFS-SEP score \> 44, without deficit sleep and without depression.
* Patients without treatment by 3,4-DAP since 3 months
* EDSS score \< 6

Exclusion Criteria:

* ASAT/ALAT \> 2 x ULN
* MADRS \>= 20
* Abnormality cardiac rhythm
* Pregnancy
* Asthma
* Evolutive affection
* Renal failure

Primary outcomes:
measure: improvement of fatigue measured by a decrease of EMIF-SEP score compared to placebo group.
timeFrame: 43 months
Secondary outcomes:
measure: evaluation of safety
timeFrame: 43 months
measure: quality of life impact
timeFrame: 43 months
Other outcomes:
Locations:
city: Creteil
country: France
facility: Henri Mondor Hospital
city: Paris
country: France
facility: Pitié Salpetriere Hospital
city: Paris
country: France
facility: Tenon Hospital
city: Rennes
country: France
facility: Pontchaillou Hospital
Study officials:
affiliation: Hopital Henri Mondor-France
name: Pierre Cesaro, MD
role: STUDY_CHAIR
References:
Clinical trial NCT02307968: Comparative Study of Insulin Therapy Between Inner and Outer Upper Thigh
Official title: Comparison of Patient's Preference, Pain Perception, and Usability Between Inner and Outer Upper Thigh for Insulin Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus
Lead sponsor: First Affiliated Hospital of Zhejiang University
Sponsor class: OTHER
First posted: 2014-12-04
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: diabetes population

Brief summary: To observe the patient's preference, pain perception, and usability between inner and outer upper thigh for insulin therapy. To add another injection site for insulin therapy.

Detailed description: The most common injection site is the abdomen (or stomach). The back of the upper arms, the upper buttocks or hips, and the outer side of the thighs are also used. These sites are the best to inject into for two reasons: They have a layer of fat just below the skin to absorb the insulin, but not many nerves - which means that injecting there will be more comfortable than injecting in other parts of your body. But while the needle for insulin therapy is becoming shorter, it is possible to inject insulin at the inner thigh site.

Eligibility criteria: Inclusion Criteria:

* All adult patients more than 18 years age old with diabetes that need insulin therapy

Exclusion Criteria:

* Those diabetes with psychologic diseases and those patients won't be injected at thigh

Primary outcomes:
measure: pain
timeFrame: immediately after injection, 1-5minutes
measure: bleeding
timeFrame: immediately after injection, 1-5minutes
measure: leaking
timeFrame: immediately after injection, 1-5minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Department of Endocrinology, the First Affiliated Hospital to Zhejiang University School of Medicine
state: Zhejiang
Study officials:
affiliation: Department of Endocrinology, the First Affiliated Hospital to Zhejiang University School of Medicine
name: Jingyun Yuan, BS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yuan J, Chen Y, Xuan Y, Cao L, Zhu J, Wang F, Zhou X, Ye Q, Liao L, Zheng Y, Zhou Q, Chen X, Chen M, Zhou W. Can the upper inner side of the thigh become a new option for insulin injection? Curr Med Res Opin. 2016 Jul;32(7):1319-24. doi: 10.1185/03007995.2016.1174107. Epub 2016 May 17.
Clinical trial NCT02304172: The Efficacy and Safety of Thunderbeat in Thyroid Surgery
Official title: The Efficacy and Safety of Thunderbeat in Thyroid Surgery: a Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thyroid
Keywords: Thyroidectomy
Thunderbeat
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Olympus Korea Co., Ltd.
First posted: 2014-12-01
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to compare the results of total thyroidectomy using the Thunderbeat device to that with the harmonic scalpel.

Detailed description: Thunderbeat instrument combines an advanced bipolar clamp to the existing ultrasonic cutter. In the animal study with pig, the result of Thunderbeat shows fast abalation rate and same thermal conductivity. There has been reported a significant reduction in operative time and same complications with Thunderbeat in gynecology patient who underwent laparoscopic hysterectomy with lymph node dissection. Comparison of the utilization of this new device, however, with the Harmonic scalpel in thyroidectomy has not been performed in any study. The objective of this study is to compare the results of thyroidectomy using the Thunderbeat to that with the Harmonic scalpel device in respect to hemostasis, operative time and perioperative complications. All patients undergoing a thyroidectomy in our endocrine surgery department are randomized into those operated with Thunderbeat (Group A) and those with Harmonic scalpel (Group B).

Eligibility criteria: Inclusion Criteria:

* thyroidectomy
* normal vocal cord

Exclusion Criteria:

* additional surgical procedures together with the total thyroidectomy (i.e., parathyroidectomy or cervical lymph node dissection)
* Thyroid cancer patients with lymph node metastasis
* pregnant women
* uncontrolled hypertension, DM, chronic kidney failure, coagulation disorders
* aspirin or anti-platelet agent in 7 days
* Graves' disease or Hashimoto thyroiditis
* history of radiation treatment in head and neck area

Primary outcomes:
measure: Postoperative complications including laryngeal nerve palsy, hypocalcemia, hemorrhage, hematoma, wound infection and skin burn
timeFrame: postoperatively (from the day of surgery until 3 months postoperatively)
Secondary outcomes:
measure: Hemostasis
timeFrame: intraoperatively (from skin incision to skin closure) & postoperatively (from skin closure until 2 day postoperatively)
measure: Operative time
timeFrame: from skin incision to skin closure
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Su-jin Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: