louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00986700: The Effect of Late Night Meals on Fasting Glucose in Type 2 Diabetes Patients
Official title: The Effect of Late Night Meals on Fasting Glucose in Type 2 Diabetes Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fasting Hyperglycemia
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2009-09-30
Enrollment: 19
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: High fasting glucose is a very common problem in type 2 diabetic patients. The cause is probably glucose production by the liver, known as the "dawn phenomenon". The investigators hypothesize that a late night meal can lower the fasting glucose level by early morning insulin secretion stimulated by the food. In this study the investigators intend to test the effect of different kinds of late night meals on fasting glucose in type 2 diabetic patients.


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes mellitus with HbA1c 6.5-9%, fasting glucose of 126-200 mg/dl and BMI of 27-40.

Exclusion Criteria:

* Patient treated with insulin, GLP-1 analog or weight reduction medications.
* Type 1 diabetes
* Pregnancy
* Renal failure (creatinin \>1.4 for male and 1.3 for female
* Uncontrolled hypertension (\>160/100)
* Abnormal thyroid function test
* Patient treated with steroids or psychiatric medications.

Primary outcomes:
measure: fasting glucose level
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06605300: The Effects of Oxytocin and Vasopressin on Delta-beta Cross-frequency Coupling
Official title: The Modulatory Effects of Oxytocin and Vasopressin on Delta-beta Cross-frequency Coupling
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Healthy
Keywords: oxytocin
vasopressin
delta-beta coupling
Lead sponsor: University of Electronic Science and Technology of China
Sponsor class: OTHER
First posted: 2024-09-20
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The main aim of the study is to investigate whether intranasal oxytocin and vasopressin have effects on delta-beta cross-frequency coupling under resting-state and task conditions.

Detailed description: A double-blinded, placebo-controlled, between-subject design is employed in this study. In a randomized order, a total of 120 healthy males and females are instructed to self-administer intranasal spray of oxytocin, vasopressin, or placebo. (1) 15-minute resting-state EEG data are collected 35 minutes after treatment. (2) Participants complete tasks including Stroop, GO/NOGO, and anxiety induction with behavioral (response time, accuracy, or rating) and EEG data being collected. Personality traits of subjects are assessed using validated Chinese version questionnaires including the Beck Depression Inventory (BDI-II), State-Trait Anxiety Inventory (STAI), Autism Spectrum Quotient (ASQ), and Adult ADHD Self-Report Scale (ASRS-v1.1). Participants are asked to complete Positive and Negative Affect Schedule (PANAS) when they just arrive, before resting state and after the tasks. Three blood samples (5 ml) are collected into 6 ml ETDA tubes when participants just arrive, before resting state recording and after all of the tasks.

Eligibility criteria: Inclusion Criteria:

* Healthy subjects without past or current psychiatric or neurological disorders.

Exclusion Criteria:

* History of head injury.
* Pregnant,menstruating,taking oral contraceptives.
* Medical or psychiatric illness.

Primary outcomes:
measure: Resting-state EEG
timeFrame: 35-50 minutes after treatment administration.
measure: Behavioral indices in the tasks
timeFrame: 50-90 minutes after treatment administration.
measure: Task-based EEG
timeFrame: 50-90 minutes after treatment administration.
Secondary outcomes:
measure: SCR in anxiety induction
timeFrame: 70-90 minutes after treatment administration.
Other outcomes:
Locations:
city: Chengdu
country: China
facility: University of Electronic Science and Technology of China (UESTC)
state: Sichuan
Study officials:
affiliation: University of Electronic Science and Technology of China
name: Shuxia Yao, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05619900: Registry of Patients Diagnosed With Lysosomal Storage Diseases
Official title: Registry of Patients Diagnosed With Lysosomal Storage Diseases
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Mucopolysaccharidosis I
Mucopolysaccharidosis II
Mucopolysaccharidosis IV A
Mucopolysaccharidosis VI
Mucopolysaccharidosis VII
Pompe Disease Infantile-Onset
Neuronopathic Gaucher Disease
Wolman Disease
Keywords: Lysosomal Storage Disease
LSDs
Inborn Error of Metabolism
Hurler Syndrome
Sly Syndrome
Hunter Syndrome
Mucopolysaccharidosis I
Mucopolysaccharidosis II
Mucopolysaccharidosis IVa
Mucopolysaccharidosis VI
Mucopolysaccharidosis VII
Pompe Disease Infantile-Onset
Neuronopathic Gaucher Disease
Wolman Disease
MPS
Mucopolysaccharidosis
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2022-11-17
Enrollment: 250
Sex: ALL
Maximum age (years): 64
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Prenatal or postnatal patients diagnosed with a Lysosomal Storage Disease.

Brief summary: This is an international prospective and retrospective registry of patients with Lysosomal Storage Diseases (LSDs) to understand the natural history of the disease and the outcomes of fetal therapies, with the overall goal of improving the prenatal management of patients with LSDs.

Detailed description: The need for methods to track patient outcomes, clinical management, medical decision making, and quality of care are all part of current national mandates in patient safety and quality of care delivery.

The aim of this registry is to prospectively and retrospectively collect data on patients who are diagnosed with Lysosomal Storage Disease and other LSD mutations. Data collected will be used to:

1. Identify patient outcomes of therapies.
2. Improve clinical management of patients with LSDs.
3. Improve medical decision making.
4. Improve quality of care.

Eligibility criteria: Inclusion Criteria:

* Patients aged 0-64 with a diagnosis of a lysosomal storage disease
* Pregnant patients whose fetus has a diagnosis of a lysosomal storage disease

Exclusion Criteria:

* There are no current exclusion criteria

Primary outcomes:
measure: Number of patients with and types of prenatal features of Lysosomal Storage Diseases
timeFrame: 15 years
measure: Number of participants with the presence and levels of glycosaminoglycans (GAGs) in urine.
timeFrame: 15 years
measure: Number of participants that show measured levels of antibodies against the enzyme.
timeFrame: 15 years
measure: Number of participants that show functional cardiac, growth, mobility, and neurocognitive function.
timeFrame: 15 years
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Tippi C MacKenzie, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02109900: Prognostic Value of Progesterone on Oocyte Retrieval Day for In Vitro Fertilization Outcome
Official title: Prognostic Value of Progesterone Levels on Oocyte Retrieval Day for Outcome of Intracytoplasmic Sperm Injection
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Infertility
Assisted Reproductive Technology
Lead sponsor: Acibadem University
Sponsor class: OTHER
First posted: 2014-04-10
Enrollment: 180
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who are referred to Acibadem Kayseri Hospital IVF Unit

Brief summary: This observational study aims the potential role of serum progesterone levels on the day of oocyte pick-up on the probability of pregnancy, in patients undergoing antagonist IVF cycles.

There has been evidence, that increased serum levels of progesterone on triggering day are associated with a decreased probability of pregnancy after IVF.

There is no study that investigate assocation between serum progesterone levels on the day of oocyte pick-up and IVF outcomes. This study will be the first in this case.


Eligibility criteria: Inclusion Criteria:

* Age \< 40 years
* Basal FSH \< 12 IU/L
* Basal P \< 1.6 ng/mL

Exclusion Criteria:

* Women with polycystic ovaries syndrome (PCOS)
* Women with Stage III-IV Endometriosis
* Women with a pathological condition of the adrenal glands

Primary outcomes:
measure: Clinical pregnancy
timeFrame: At 6-8 weeks of gestation
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Acıbadem Kayseri Hospital
name: Turgut Aydin
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06428500: QTX3046 in Patients With KRAS G12D Mutations
Official title: A Phase 1 Trial Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of QTX3046 in Patients With Advanced Solid Tumors With KRAS G12D Mutations
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Advanced Solid Tumor
Lead sponsor: Quanta Therapeutics
Sponsor class: INDUSTRY
First posted: 2024-05-24
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: Phase 1 study to determine the safety and tolerability of QTX3046 as a single agent or in combination with cetuximab.


Eligibility criteria: Inclusion Criteria:

* Pathologically documented, locally advanced or metastatic malignancy with KRAS G12D mutations identified through molecular testing (NGS- or PCR-based) with a Clinical Laboratory Improvement Amendments-certified (or equivalent) diagnostic.
* Part 1: Advanced solid tumors with at least one prior systemic therapy.
* Evaluable and measurable disease per RECIST v1.1.
* Part 2 and 3: Measurable disease per RECIST v1.1

Exclusion Criteria:

* Active brain metastasis or carcinomatous meningitis
* Significant cardiovascular disease
* Active infection requiring intravenous (IV) antibiotics
* Prior treatment with a KRAS inhibitor

Other protocol-defined Inclusion/Exclusion Criteria may apply

Primary outcomes:
measure: Number of participants with Treatment-emergent Adverse Events (TEAEs)
timeFrame: up to 2 years
measure: Number of participants with Dose Limiting Toxicities (DLTs)
timeFrame: up to 21 days
Secondary outcomes:
measure: Area under the plasma concentration-time curve (AUC) of QTX3046
timeFrame: up to 2 years
measure: Peak plasma concentration of QTX3046 (Cmax)
timeFrame: up to 2 years
measure: Objective response rate (ORR)
timeFrame: up to 2 years
measure: Duration of response (DoR)
timeFrame: up to 2 years
Other outcomes:
Locations:
city: Grand Rapids
country: United States
facility: South Texas Accelerated Research Therapeutics, LLC Midwest
state: Michigan
city: Durham
country: United States
facility: Duke Cancer Center
state: North Carolina
city: Houston
country: United States
facility: The University of Texas MD Anderson Cancer Center
state: Texas
city: San Antonio
country: United States
facility: South Texas Accelerated Research Therapeutics, LLC San Antonio
state: Texas
city: Salt Lake City
country: United States
facility: Huntsman Cancer Institute, University of Utah
state: Utah
Study officials:
References:
Clinical trial NCT02810600: Study to Measure the Safety of 68Ga-DOTA-TATE PET/CT in the Diagnosis of Tumors Expressing Somatostatin Receptors
Official title: Phase II Study to Measure the Safety of 68Ga-DOTA-TATE PET/CT in the Diagnosis of Tumors Expressing Somatostatin Receptors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neuroendocrine Tumors
Lead sponsor: Centre de recherche du Centre hospitalier universitaire de Sherbrooke
Sponsor class: OTHER
First posted: 2016-06-23
Enrollment: 2120
Sex: ALL
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 suspected or diagnosed with tumors expressing somatostatin receptors

Brief summary: Phase-II, prospective, open label, no control group to assess the safety of 68Ga-DOTA-TATE injection in patients with suspected or diagnosed with tumors expressing somatostatin receptors. Each included patient will receive an administered dose of 50 mcg or less of the peptide (DOTA-TATE) and a range of activity between 100 - 200 MBq of 68Ga-DOTA-TATE.

The efficacy of 68Ga-DOTA-TATE in assessing this kind of tumors has been proved by numerous studies.


Eligibility criteria: Inclusion Criteria:

1. Patients with suspected or proven tumors expressing Somatostatin receptors
2. Informed consent by patient (or parents if patient is less than 18 years of age)

Exclusion Criteria:

1. Pregnancy (confirmed). In the case of a diagnostic procedure in a patient who is or may be pregnant, a clinical decision is necessary considering the benefits against the possible harm of carrying out any procedure.
2. Patient refusal to participate.
3. Impossibility to tolerate a decubitus position for 25 minutes
4. Prior allergic reaction to DOTA-TATE or somatostatin analogs

Primary outcomes:
measure: Record all adverse events
timeFrame: June 2016-June 2018
Secondary outcomes:
Other outcomes:
Locations:
city: Sherbrooke
country: Canada
facility: Centre hospitalier universitaire de Sherbrooke
state: Quebec
Study officials:
References:
Clinical trial NCT02044900: Polysomnography and Heart Rate Indexes in Obstructive Sleep Apnea
Official title: Polysomnography and Heart Rate Indexes in Obstructive Sleep Apnea
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obstructive Sleep Apnea
Keywords: obstructive sleep apnea
polysomnography
heart rate variability
mathematical biomarker
Lead sponsor: Universidade Camilo Castelo Branco
Sponsor class: OTHER
First posted: 2014-01-24
Enrollment: 50
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: primary care clinic

Brief summary: The purpose of this study is to evaluate the diagnostic accuracy of polysomnography indexes for diagnosis of sleep apnea in human subjects obstructive sleep apnea (OSA). This includes evaluation of polysomnography indexes (AHI; AI, arousal index; ODI, oxygen desaturation index) and heart rate variability (HRV) indexes.

Detailed description: This is a cross-sectional study collecting data from patients from the Sleep Institute of Itaperuna, Rio de Janeiro, Brazil. Polysomnography (PSG) monitoring and diagnosis was in accordance with American Society of Sleep Medicine (ASSM) standards. Standard baseline polysomnography is performed using a computerised system. The following extracted signals are measured: 2 electroencephalogram channels (O1-A2, O2-A1, C3-A2, C4-A1), 2 electrooculogram channels, electromyography (EMG, bilateral anterior tibialis), pulse oximetry (arterial oxygen saturation), nasal-oral airflow (thermistors), and electrocardiogram (ECG derivation DII). The polysomnograms are scored according to the criteria of Rechtschaffen and Kales.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of obstructive sleep apnea with an apnea-hypopnea index (AHI) \> 5.

Exclusion Criteria:

* Subjects with a history or clinical examination suggestive of neuromuscular disease, hypertension or any surgical treatment were not considered in the study.

Primary outcomes:
measure: Polysomnography indexes
timeFrame: one night
Secondary outcomes:
Other outcomes:
Locations:
city: Itaperuna
country: Brazil
facility: Sleep Institute of Itaperuna
state: Rio de Janeiro
Study officials:
affiliation: Camilo Castelo Branco University (UNICASTELO)
name: Ovidiu C Baltatu, MD PhD
role: STUDY_CHAIR
References:
Clinical trial NCT04903600: Efficacy Assessment of Probiotics Product on Intestinal Health and Immune System Improvement
Official title: Efficacy Assessment of Probiotics Fruit Vegetable Fiber Powder on Intestinal Health and Immune System Improvement in Human Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy
Lead sponsor: Chung Shan Medical University
Sponsor class: OTHER
Collaborators: name: TCI Co., Ltd.
First posted: 2021-05-26
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study is to investigate the effects of probiotics product (probiotics fruit vegetable fiber powder) on intestinal health and immune system improvement in adults

Detailed description: This 12 weeks randomized, single-blind and placebo-controlled study will be conduct in fifty adults. Subjects will be recruited and assigned into two groups in a 1:1 ratio (placebo, n = 25; probiotics, n=25). During the 12 weeks intervention, the subjects should take 32 g powder of placebo or probiotics product (eat 16 g for once, and twice a day). The two powder supplied in an aluminum sachet, and all products were identical in taste. Subjects also should complete the assessment of anthropometric measurement, health conditions, food record, and sample collection (feces and blood) at week 0, 4, 8 and week 12.

Eligibility criteria: Inclusion Criteria:

* Inclusion criteria include male or female participants to be aged 20-60 years old, who had colds more than four times in the past year or had gastric Infection by Helicobacter pylori or peptic ulcer, body mass index within a healthy range (18.5-27 kg/m2) and willing to commit throughout the experiment.

Exclusion Criteria:

* Exclusion criteria included cancer, chronic heart disease, use drugs which pharmacological effects may affect immunity, have systemic infections, use probiotics, prebiotics, fruit vegetable fiber supplementation, and lactose Intolerance or cow's milk allergic. Individuals who, in opinion of the investigator, seemed unlikely to complete the trial were also excluded.

Primary outcomes:
measure: Change from baseline serum TNF-α at week 12
timeFrame: Week0, Week12
measure: Change from baseline serum IL-6 at week 12
timeFrame: Week0, Week12
measure: Change from baseline serum IL-10 at week 12
timeFrame: Week0, Week12
Secondary outcomes:
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Chung Shan Medical University
state: South
Study officials:
affiliation: Chung Shan Medical University
name: Yu-Jou Chien, PhD Student
role: PRINCIPAL_INVESTIGATOR
affiliation: Chung Shan Medical University
name: Ying-Chi Chen, MS Student
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06858800: Pinch Grip and Functional Outcomes Between Hematoma Distraction Arthroplasty Versus Ligament Reconstruction Tendon Interposition Arthroplasty in Trapeziometacarpal Osteoarthritis.
Official title: Pinch Grip and Functional Outcomes betweenHematoma Distraction Arthroplasty Versus Ligament Reconstruction Tendon Interposition Arthroplasty in Trapeziometacarpal Osteoarthritis: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis Thumbs
Rhizarthrosis
Trapeziometacarpal (TMC) Arthrosis
Keywords: Osteoarthritis
Thumb
Rhizarthrosis
Trapezectomy
Arthroplasty
Lead sponsor: Hospital de la Santa creu i Sant Pau - Barcelona
Sponsor class: OTHER
Collaborators: name: Universitat Autonoma de Barcelona
name: Hospital de Mollet
First posted: 2025-03-05
Enrollment: 96
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To date, there is no gold standard for the treatment of severe trapeziometacarpal joint osteoarthritis. Despite the fact that new procedures have been described, techniques such hematoma distraction or ligament reconstruction tendon interposition are still valid non-implant options. The main hypothesis was that patients treated with LTRI technique would show superior clinical outcomes at one-year follow-up in terms of tip and key pinch and DASH scores in comparison with HDA technique. As secondary objectives, complication rates and surgical times were recorded.


Eligibility criteria: Inclusion Criteria:

Patients who attended the hand unit's outpatient clinic at a regional trauma center with a diagnosis of grade III-IV TMC OA according to the Eaton-Littler radiological scale, who had previously failed conservative treatments (NSAIDs, splints, RHB, and corticosteroid injections) and desired surgical intervention with sufficient comprehension to participate in this study.

Exclusion Criteria:

Previous procedures on the same extremity distal to the elbow, central or peripheral neurological disease, and patient withdrawal.

Primary outcomes:
measure: Functional results between HDA and LTRI using the QuickDASH test
timeFrame: From enrollment to end of follow-up at 1 year
measure: Clinical results between HDA and LTRI with the quantification of grip and tip pinch strenght with JAMAR dynanometer.
timeFrame: From enrollment to end of follow-up at 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Sant Creu i Sant Pau
Study officials:
References:
Clinical trial NCT02814500: DP-R212 Pharmacokinetic Study Phase I
Official title: DP-R212 Pharmacokinetic Study Pharmacokinetic Characteristics of DP-R212 in Comparison to Each Component Coadministered in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Alvogen Korea
Sponsor class: INDUSTRY
First posted: 2016-06-27
Enrollment: 36
Sex: ALL
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: An open label, randomized, 2-sequence, 2-period, single-dose cross-over study to evaluate the pharmacokinetics characteristics of DP-R212

Detailed description: An open label, randomized, 2-sequence, 2-period, single-dose cross-over study to evaluate the pharmacokinetics characteristics of DP-R212, a fixed dose combination compared with coadministration of separate constituents in healthy adult volunteers

Eligibility criteria: Inclusion Criteria:

* BMI 17.5\~30.5
* signed the informed consent form prior to the study participation

Exclusion Criteria:

* Clinically significant disease
* Previously donate whole blood within 60 days or component blood within 30 days
* Clinically significant allergic disease
* Taken IP in other trial within 90 days
* An impossible one who participates in clinical trial by investigator's decision including laboratory test result

Primary outcomes:
measure: AUClast
timeFrame: 0,0.5,1, 2, 3, 4, 5, 6, 8, 10, 12, 24,48,72 hr
measure: Cmax
timeFrame: 0,0.5,1, 2, 3, 4, 5, 6, 8, 10, 12, 24,48,72 hr
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: