louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03871582: Number of Meals With Adequate Protein Intake and Functionality in Middle to Older Aged Mexican Adults
Official title: Number of Meals With Adequate Protein Intake and Functionality in Middle to Older Aged Mexican Adults
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aging
Keywords: Protein intake
Older adults
Mexican adults
Functionality
Lead sponsor: Centro Universitario de Ciencias de la Salud, Mexico
Sponsor class: OTHER
Collaborators: name: Hospital General de Occidente
First posted: 2019-03-12
Enrollment: 190
Sex: ALL
Minimum age (years): 50
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Middle to older aged Mexican adults attending to the Geriatrics Department at the Western General Hospital (Hospital General de Occidente) for their usual medical screening or first time assessment.

Brief summary: The objective of this study was to analyze if the number of meals with adequate protein intake is associated with functionality in middle to older aged mexican adults.

Detailed description: Dietary protein intake per meal was assessed with 24-h dietary recalls to determine the number of meals with adequate protein intake (\>30 g, \>0.4 g/kg). Functionality was assessed with self-reported questionnaires about daily living activities (Barthel), and instrumental activities of daily living (Lawton). Subjects were categorized according the number of meals with adequate protein intake (zero meals, one meal, two or three meals), and their functionality score for both questionnaires (high, middle, and low scores).

With multinomial logistic regression, the investigators assessed if consuming zero or one meal with adequate protein intake could be associated with lower functionality in comparison with consuming two or three meals with enough protein. The logistic regression was adjusted for covariables (age, sex, BMI categories for the elderly, number of diagnosed diseases, inadequate protein intake per day \[\<1.2 g/kg/d\]).

Eligibility criteria: Inclusion Criteria:

* Subjects able to stand up and walk independently or with walking sticks only.
* Subjects able to answer questionnaires independently or with minimum caregivers' assistance

Exclusion Criteria:

* Subjects reporting any kind of hospitalization within the last year.

Primary outcomes:
measure: Functionality on Instrumental Activities of Daily Living - Lawton questionnaire
timeFrame: One day
measure: Functionality on Activities of Daily Living - Barthel questionnaire
timeFrame: One day
Secondary outcomes:
Other outcomes:
Locations:
city: Guadalajara
country: Mexico
facility: Instituto de Ciencias Aplicadas a la Actividad Física y al Deporte
state: Jalisco
Study officials:
affiliation: University of Guadalajara
name: Alejandro Gaytán-González
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02081482: Cerebral Metabolism in Patients With Refractory Chronic Cluster Headache Treated by Occipital Nerve Stimulation
Official title: Study of the Cerebral Metabolism in Patients With Refractory Chronic Cluster Headache Treated by Occipital Nerve Stimulation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Refractory Chronic Cluster Headache
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2014-03-07
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The occipital nerve stimulation (ONS) is used to treat patients with refractory primary chronic headache but its mechanism of action (MoA) remains unknown. Different hypothesis have been suggested in particular a specific action on cerebral generators involved in different types of primary headaches or a non specific action on pain modulatory network.

The aim of this study, using the chronic cluster headache as a model, is to determine the changes in cerebral metabolism induced by ONS to precise its MoA in the treatment of primary chronic headache.


Eligibility criteria: Inclusion Criteria:

* age \> 18 years
* chronic cluster headache (according to the IHS)
* refractory in who a treatment by ONS have been indicated
* patient affiliated at social security,
* informed consent signed

Exclusion Criteria:

* contraindication to MRI
* contraindication to 18F-FDG PET
* women without contraception/pregnant/breast-feeding
* patient non-compliant
* patient on legal guardianship

Primary outcomes:
measure: Comparison of cerebral metabolism
timeFrame: Baseline (before ONS), 1 week after ONS , 3 month after ONS
Secondary outcomes:
Other outcomes:
Locations:
city: Clermont Ferrand
country: France
facility: CHU -Hôpital Gabriel Montpied
city: Marseille
country: France
facility: Institut des Neurosciences
city: Nice
country: France
facility: Département d'Evaluation et Traitement de la Douleur - Pôle Neurosciences Cliniques - Centre Hospitalo-Universitaire de Nice
city: Paris
country: France
facility: Centre d'Urgence Céphalées
Study officials:
References:
Clinical trial NCT03666182: Genetics and Fat Taste Sensitivity
Official title: The Relationship Between Genetics, Body Mass Index, Fat Intake, Fat Taste Sensitivity and Food Preference
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Obesity
Taste Sensitivity
Lead sponsor: St Mary's University College
Sponsor class: OTHER
First posted: 2018-09-11
Enrollment: 96
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: European Citizen, Caucasian, Aged between 18-65 years, Female

Brief summary: A cross-sectional quantitative study will be carried out; recruiting female, Caucasian participants aged 18-65 years. The relevance of candidate gene studies is disputed. Research has shown associations between genotype and total fat intake. However, food preference is often described as a result of exposure to food types during upbringing. Many single nucleotide polymorphisms (SNP) have been associated with fat taste sensitivity, the majority of research shows that with a reduced sensitivity comes a higher total fat consumption.

This study aims to assess the relationship between rs1761667 genotype, body mass index, fat intake, fat taste sensitivity and fat taste preference.


Eligibility criteria: Inclusion Criteria:

* European Citizen.
* Caucasian
* Aged between 18-65 years.
* Female

Exclusion Criteria:

* Currently following a diet or weight loss plan or have not been for over 6 months of the previous year.
* Suffering from diabetes (type I or II).
* Have cancer, or have not had cancer in the past.
* Smoker.
* Pregnant.
* Lactose intolerant .

Primary outcomes:
measure: Body Mass Index
timeFrame: September - November 2018
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: St Mary's University
Study officials:
References:
Clinical trial NCT05737082: A Study to Evaluate the Pharmacokinetics and Safety Between HCP2201 and Co-administration of Each Component in Healty Male Volunteers
Official title: A Randomized, Open Label, Single Dose, 4-period Replicate Crossover Clinical Trial to Evaluate the Pharmacokinetic Characteristics and Safety After Administration of a Fixed-dose Combination Drug of HCP2201 and Co-administration of RLD2205 and RLD2206 in Healthy Male Volunteers Under Fasting Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Hanmi Pharmaceutical Company Limited
Sponsor class: INDUSTRY
First posted: 2023-02-21
Enrollment: 44
Sex: MALE
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the pharmacokinetic characteristics and safety between HCP2201 and co-administration of each component in fasting condition in healthy male volunteers.


Eligibility criteria: Inclusion Criteria:

* Age 19\~55 years in healthy male volunteers
* 19 kg/m\^2 ≤ BMI \< 28 kg/m\^2, weight ≥55kg
* 90 mmHg ≤ SBP \<140 mmHg, 50 mmHg ≤ DBP \<90 mmHg
* Agrees that the person, spouse, or partner uses appropriate medically recognized contraception and does not provide sperm from the date of administration of the first investigational drug to 7 days after the administration of the last investigational drug.
* Subjects who voluntarily decides to participate in this clinical trial and agree in writing to ensure compliance with the clinical trial

Exclusion Criteria:

* Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in digestive system, neuropsychiatric system, endocrine system, liver, cardiovascular system
* Subjects who judged ineligible by the investigator

Primary outcomes:
measure: Abiraterone acetate AUCt
timeFrame: 0~72 hours
measure: Abiraterone acetate Cmax
timeFrame: 0~72 hours
measure: Prednisolone AUCt
timeFrame: 0~24 hours
measure: Prednisolone Cmax
timeFrame: 0~24 hours
Secondary outcomes:
measure: AUCinf
timeFrame: 0~72 hours
measure: Tmax
timeFrame: 0~72 hours
measure: t1/2
timeFrame: 0~72 hours
measure: CL/F
timeFrame: 0~72 hours
measure: Vd/F
timeFrame: 0~72 hours
Other outcomes:
Locations:
city: Jeonju
country: Korea, Republic of
facility: Chonbuk National University Hospital
state: Jeollabuk-do
Study officials:
affiliation: Jeonbuk National University Hospital
name: Min-gul Kim, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05143320: Cognitive, Emotional and Behavioural Impairments in Patients After Sars-Cov2 Infection
Official title: Cognitive and Neuropsychiatric Features of COVID-19 Patients After Hospital Dismission: an Italian Sample.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Sars-CoV-2 Infection
Keywords: Covid-19
Cognition
Teleneuropsychology
Memory
Executive Functions
Lead sponsor: Ospedale Generale Di Zona Moriggia-Pelascini
Sponsor class: OTHER
First posted: 2021-12-03
Enrollment: 29
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who were hospitalized in the Covid ward and recovered from the acute phase of Covid-19 with no need of ICU admission. All patients had SARS-Cov-2 infection confirmed by positive PCR from nasopharyngeal swab. Neuropsychological study was performed on average 20 days after hospital discharge to have the most recent possible cognitive profile related to the infection. We enrolled 29 healthy controls (Covid-) who did not have SARS COV 2 infections with a 1:1 match by age, education and gender.

Brief summary: Recent studies suggest cognitive, emotional and behavioural impairments occur in patients after SARS-CoV-2 infection. Problems with memory, attention, information processing and executive functions are particularly prevalent in these patients, probably due to hypothesised sensitivity of the hippocampus to the virus. Cognitive impairment is also present in patients with no neurological, neuropsychological and neuropsychiatric history. Therefore, the aim of the present study is to describe neuropsychological and neuropsychiatric features in patients recovered from moderate to severe forms of Covid-19 some weeks after hospital dismission.


Eligibility criteria: Inclusion Criteria:

* Positive PCR from nasopharyngeal swab
* No ICU admission

Exclusion Criteria:

* Diagnosis of neurologic or psychiatric disorders;
* Previous cognitive impairment;
* Other medical conditions negatively affecting the cognitive status.

Primary outcomes:
measure: Cognitive and neuropsychiatirc symptoms in Covid-19 patients
timeFrame: About 20 days after hospital dismission
Secondary outcomes:
Other outcomes:
Locations:
city: Gravedona
country: Italy
facility: "Moriggia Pelascini" Hospital
state: Como
Study officials:
References:
citation: Cian V, De Laurenzis A, Siri C, Gusmeroli A, Canesi M. Cognitive and Neuropsychiatric Features of COVID-19 Patients After Hospital Dismission: An Italian Sample. Front Psychol. 2022 May 24;13:908363. doi: 10.3389/fpsyg.2022.908363. eCollection 2022.
Clinical trial NCT06132620: Clinical Efficacy of Qingxin Zishen Decoction in Treating Menopausal Syndrome and Neuroendocrine Mechanism of Regulating KNDy Neurons
Official title: Clinical Efficacy of Qingxin Zishen Decoction in Treating Menopausal Syndrome and Neuroendocrine Mechanism of Regulating KNDy Neurons
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Menopause
Lead sponsor: Jiangsu Province Hospital of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2023-11-15
Enrollment: 60
Sex: FEMALE
Minimum age (years): 41
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to determine the effects of estrogen (Fenmotong) and Qingxin Zishen Decoction on the levels of kisspeptin, NKB, and dynorphin expressed in human KNDy neurons Between patients with menopausal syndrome. The aims of the study are as follows:

* Find a new neuroendocrine mechanism of Qingxin Zishen Decoction in the treatment of menopausal syndrome.
* Evaluate the changes of new neuroendocrine indicators in the clinical treatment of menopausal syndrome.
* Develop non-hormonal drugs with definite efficacy in the treatment of menopausal syndrome.

Participants will randomly divided into the experimental group and the control group, the experimental group will be oral fenmotong, and the control group will be oral Qingxin Zi Kidney Decoction, and the efficacy, sex hormone levels and neuroendocrine index changes of the two groups will be compared.


Eligibility criteria: Inclusion Criteria:

* Women aged 41\~55;
* KIM score≥ 15 points;
* The number of hot flashes and sweating≥ 3 times/day;
* Menopause time≥ 6 months;
* FSH\>30mIU/ml,E2\<30ng/L;
* Informed consent, voluntary testing.

Exclusion Criteria:

* Unexplained vaginal bleeding;
* Sex hormone-related malignant tumors cannot be excluded;
* premature ovarian failure, or endometriosis, or hysterectomy, or bilateral adnexectomy;
* Combined with primary liver and kidney dysfunction, cardiovascular and cerebrovascular diseases, blood system diseases and other serious diseases that affect their survival;
* Exposure to sex hormone-related drugs within 3 months;
* Patients with mental abnormalities, or those with a history of alcohol or drug abuse;
* Those who have allergic reactions to the study drug;
* Those who are participating in other drug clinical researchers.

Primary outcomes:
measure: Modified Kupperman Menopausal Index
timeFrame: Baseline, at the 4th, 8th and 12th weeks of treatment
measure: Hot flashes and sweats on a five-level scale
timeFrame: Baseline, at the 4th, 8th and 12th weeks of treatment
measure: sex hormone
timeFrame: Baseline and 12th weeks of treatment
measure: Neuroendocrine indicators
timeFrame: Baseline and 12th weeks of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Yuxin Zhou
state: 南京
Study officials:
References:
Clinical trial NCT03550820: Energy Metabolism for the Patients With Pulmonary Mycobacterium Avium Complex
Official title: Energy Metabolism for the Patients With Pulmonary Mycobacterium Avium Complex
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary MAC
Energy Metabolism
Emaciation
Keywords: pulmonary MAC
energy metabolism
Lead sponsor: National Hospital Organization Minami Kyoto Hospital
Sponsor class: OTHER
First posted: 2018-06-08
Enrollment: 105
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Petients with pulmonary MAC

Brief summary: We aim to examine energy metabolism in patients with pulmonary MAC and clarify the causes of emaciation. We will also investigate the following: the relation between energy metabolism and degree of pulmonary MAC progression; relations among hospitalization, mortality rate, and time-course of changes in energy metabolism; and factors that affect energy metabolism.

Detailed description: Patients with pulmonary MAC with a lower BMI than healthy individuals also have a significantly poorer prognosis than those of normal weight. Emaciation in such patients is thought to be caused by destruction of lung structure from disease progression and an increased resting metabolic rate caused by the increased load from breathing; however, causes of emaciation and details of energy metabolism in these patients have not been studied.

Elucidating details of energy metabolism and causes of emaciation in patients with pulmonary MAC could provide the basis for improvement in nutritional status and activities of daily living through early nutrition therapy and rehabilitation. We propose to clarify the following:

Energy metabolism in patients with pulmonary MAC, including resting metabolic rate, calorie intake and consumption, and hormonal secretions.

Relation between energy metabolism and degree of pulmonary MAC progression.

Eligibility criteria: Inclusion Criteria:

* Subjects with pulmonary MAC.

Exclusion Criteria:

* Subjects with severe cardiovascular disease, diabetes, neurological disease, renal failure, endocrine disease and malignant neoplasm.

Primary outcomes:
measure: Relation between energy balance and pulmonary MAC severity
timeFrame: Three years
Secondary outcomes:
measure: Relation between inflammation (CRP et.) and pulmonary MAC severity
timeFrame: Three years
measure: Relation between bone mineral density and pulmonary MAC severity
timeFrame: Three years
measure: Relation between hormone secretion and pulmonary MAC severity
timeFrame: Three years
measure: Relation between pulmonary function and pulmonary MAC severity
timeFrame: Three years
Other outcomes:
Locations:
city: Joyo
country: Japan
facility: National Hospital Organization Minami Kyoto Hospital
state: Kyoto
Study officials:
References:
Clinical trial NCT02512120: Volume Controlled Ventilation vs Autoflow-volume Controlled Ventilation
Official title: Comparison of Volume Controlled Ventilation(VCV) vs Autoflow-volume Controlled Ventilation(Autoflow-VCV) During Robot-assisted Laparoscopic Radical Prostatectomy
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Prostate Cancer
Lead sponsor: Korea University Anam Hospital
Sponsor class: OTHER
First posted: 2015-07-30
Enrollment: 0
Sex: MALE
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Volume controlled ventilation(VCV) is a most common used ventilation mode during general anesthesia. But VCV can cause high airway peak pressure when patient under steep Trendelenberg position with pneumoperitoneum. Autoflow-VCV can reduce airway peak pressure and improve dynamic compliance. We will compare parameters(arterial blood gas analysis, airway compliance, etc) when each group applied VCV and autoflow-VCV during RALP.

Detailed description: Robot assisted laparoscopic radical prostatectomy(RALP) has been used to treatment of prostate cancer since 2001. RALP offers some advantage such as reduced blood loss, sparing nerves, less postoperative pain. However, RALP require steep Trendelenberg position with pneumoperitoneum. It can cause increased airway peak pressure and unwanted hemodynamic effect under conventional volume controlled ventilation(VCV). Autoflow-VCV use decelerating flow, can reduce airway peak pressure and improve dynamic compliance.

We will compare parameters(arterial blood gas analysis, airway compliance, etc) when each group applied VCV and autoflow-VCV during RALP.

Eligibility criteria: Inclusion Criteria:

* Adult (age 19-65)
* American Society of Anesthesiology Classification I-III

Exclusion Criteria:

* cardiovascular disease, cerebrovascular disease, pulmonary disease
* over BMI 30

Primary outcomes:
measure: Airway pressure
timeFrame: 4hours
Secondary outcomes:
measure: Vital sign
timeFrame: 4hours
Other outcomes:
measure: Arterial blood gas analysis
timeFrame: 4hours
Locations:
Study officials:
affiliation: Department of anesthesiology and pain medicine, Korea University Anam Hospital
name: Hye-Won Shin, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02665520: Penile Intracavernosal Stem Cells Therapy for Erectile Dysfunction
Official title: Phase 1 Study of the Use of Autologous Penile Stem Cells in Men With Erectile Dysfunction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Erectile Dysfunction
Keywords: stem cells injections
erectile dysfunction
Lead sponsor: Elaj medical centers
Sponsor class: OTHER
Collaborators: name: King Saud University
First posted: 2016-01-27
Enrollment: 30
Sex: MALE
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Autologous Fat Derived Stem Cell treatment of ED.

To assess safety and primary efficacy of stem cell infusion in refractory ED.

To investigate the success rate and durability of success of using this new therapy in management of moderate and sever cases of erectile dysfunction.


Eligibility criteria: Inclusion Criteria:

* Male 40 years old and older suffering from moderate to sever erectile dysfunction -

Exclusion Criteria:

* Inability to give informed consent or attend follow up
* Severe diabetic neuropathy (to be defined ? Charcot joints, diabetic ulcers?) or other neuropathic disease
* Viral disease from infectivity viewpoint
* Major penile fibrosis or severe Peyronie's disease
* Severe primary large vessel ED (defined as PSV less than 15cm/s after ICI)
* Severe primary venous leakage ED (defined as EDV more than 10cm/s after ICI)
* Prior systemic chemotherapy, or radiotherapy to donor or recipient area
* Not in potentially active sexual relationship
* Age less than 40 or over 70

Primary outcomes:
measure: Adverse Events that occur during or after the procedure to measure safety and tolerability
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Jedda
country: Saudi Arabia
facility: Elaj medical group
state: Outside U.S./Canada
city: Riyadh
country: Saudi Arabia
facility: kING SAUD UNIVERSITY
Study officials:
affiliation: King Saud University
name: Saleh Binsaleh, MD
role: STUDY_DIRECTOR
References: