louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03048747: A Multicenter Trial to Investigate the Efficacy and Safety of Tolvaptan in Patients With Hyponatremia in SIADH
Official title: A Multicenter, Uncontrolled, Open-label, Dose-titration Trial to Investigate the Efficacy and Safety of Tolvaptan Tablets in Patients With Hyponatremia in Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Syndrome of Inappropriate Antidiuretic Hormone Secretion
Lead sponsor: Otsuka Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2017-02-09
Enrollment: 16
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of this study is to investigate the efficacy and safety of tolvaptan based on the change in serum sodium concentration following administration of tolvaptan oral tablets at 7.5 to 60 mg/day for up to 30 days in patients with hyponatremia in the SIADH.


Eligibility criteria: Inclusion Criteria:

* Subjects with a definite diagnosis of SIADH in reference to "Diagnostic and Treatment Manual of the Hypersecretion of Vasopressin (SIADH), Revised in 2011"
* Subjects who have been on fluid restriction for at least 7 consecutive days at the time of informed consent and who are showing no improvement of hyponatremia at the time of the screening examination

Exclusion Criteria:

* Subjects who have transient hyponatremia induced by drug administration
* Subjects who are unable to sense thirst or who have difficulty with fluid intake
* Subjects with urinary tract obstruction
* Subjects who have participated in any other clinical trial within 30 days prior to informed consent
* Subjects with serum sodium concentration of \<120 mEq/L associated with neurologic impairment, including apathy, confusion, or seizures

Primary outcomes:
measure: Percentage of Subjects With Normalized Serum Sodium Concentration on the Day After Final IMP Administration
timeFrame: Baseline, Day2, Day3, Day4, Day5, Day7, Day14, Day21, Day after final study medication
Secondary outcomes:
measure: Change in Serum Sodium Concentration
timeFrame: Day2, Day3, Day4, Day5, Day7, Day14, Day21 and the day after final IMP administration
Other outcomes:
Locations:
city: Chubu Region
country: Japan
city: Chugoku Region
country: Japan
city: Kanto Region
country: Japan
city: Kinki Region
country: Japan
city: Kyushu Region
country: Japan
city: Sikoku Region
country: Japan
Study officials:
References:
Clinical trial NCT06150547: A Study of Metabolic Agents Following Brain Radiation
Official title: Pilot Imaging Study for CNS Metabolism
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: CNS Malignancy
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2023-11-29
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects identified as having a central nervous system malignant tumor undergoing routine care in the neuro-oncology practice at Mayo Clinic Rochester.

Brief summary: This study is being done to determine if CEST magnetic resonance imaging (MRI) and FDG PET are feasible techniques to detect metabolic differences between tumor and brain in patients with a brain tumor.


Eligibility criteria: Inclusion Criteria:

* Radiographic evidence or histopathologic confirmation of CNS malignancy, with or without prior resection.
* Provide written informed consent for the current study.
* Willing to undergo at least one MRI (and possibly more at PI discretion) with proton and/or phosphorus magnetic resonance spectroscopy analysis.

Exclusion Criteria:

* Vulnerable populations: pregnant or nursing women (Arm B exempt), prisoners, mentally handicapped.
* Cardiac pacemaker or artificial heart valve
* Metal plate, pin, or other metallic implant
* Intrauterine device, such as Copper-7 IUD
* Insulin or other drug pump
* Non-titanium aneurysm clips
* Previous gunshot wound
* Cochlear implant or other hearing device
* Employment history as a metalworker (had metal in eye)
* Permanent (tattoo) eye-liner
* For FDG-PET specifically: Fasting blood sugar level greater than 200mg/dl

Primary outcomes:
measure: Number of subjects in whom glutamate metabolite is detected and measurable.
timeFrame: Baseline
measure: Number of subjects in whom n-acetylaspartate (NAA) metabolite is detected and measurable.
timeFrame: Baseline
Secondary outcomes:
measure: Time required to perform the CEST MRI study and measure metabolites of interest
timeFrame: Duration of CEST MRI scan, approximately one to two hours.
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Terry C Burns, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00564447: Study of AzaSite (Azithromycin) Versus Vigamox in the Conjunctiva of Healthy Volunteers
Official title: A Single-Center, Open-Label, Randomized Study of the Pharmacokinetics of AzaSite Ophthalmic Solution Versus Vigamox in the Conjunctiva of Healthy Volunteers Following a Single Ocular Administration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Bacterial Infections
Eye Infections
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2007-11-28
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to evaluate the drug concentrations of AzaSite™ compared to Vigamox at various time points in conjunctiva tissue of healthy volunteers


Eligibility criteria: Inclusion Criteria:

* Have best corrected visual acuity of 0.60 logMAR or better in each eye as measured using Early Treatment of Diabetic Retinopathy Study chart

Exclusion Criteria:

* Have a known allergy and/or sensitivity to the test article(s) or its components or any therapies associated with the trial
* Have active signs or symptoms of any clinically significant ocular disorder (other than refractive disorders)
* Have a known bleeding disorder or history of bleeding complications after surgical or dental procedures
* Take aspirin, or take any other blood thinners or anti-coagulants (e.g. warfarin) including prescription, over the counter, or homeopathic therapies
* Have undergone any ocular surgical intervention within 3 months prior to Visit 1 or anticipate having ocular surgery during the study

Primary outcomes:
measure: Assessment of Pharmacokinetic Parameters
timeFrame: Up to 24 hours
measure: Assessment of Pharmacokinetic Parameters
timeFrame: Over 24 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Reza Haque
role: STUDY_DIRECTOR
References:
citation: Torkildsen G, O'Brien TP. Conjunctival tissue pharmacokinetic properties of topical azithromycin 1% and moxifloxacin 0.5% ophthalmic solutions: a single-dose, randomized, open-label, active-controlled trial in healthy adult volunteers. Clin Ther. 2008 Nov;30(11):2005-14. doi: 10.1016/j.clinthera.2008.10.020.
Clinical trial NCT05295147: Physiological Parameters and Crying Time in the Newborn Bath
Official title: The Effect of Palmar Grasp Reflex Stimulation on Physiological Parameters and Crying Time in the Newborn Bath
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infant, Newborn
Lead sponsor: Ataturk University
Sponsor class: OTHER
Collaborators: name: MSc Elif Simay KOÇ
First posted: 2022-03-24
Enrollment: 82
Sex: ALL
Minimum age (years): 2
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Bathing is essential for maintaining and improving the health of the newborn. It has numerous beneficial effects, such as cleaning and protecting the skin, preventing infections, cleaning unwanted substances, regulating blood circulation and the respiratory system, regulating body temperature, relieving pain, providing comfort, and supporting the parent-infant bond. Although bathing has many benefits, it is a stressful experience for newborn babies. Research on the effects of bathing on babies has shown that babies experience behavioral difficulties during bathing, such as crying, restlessness, hiccups, yawning, tremors, body looseness, looseness of the extremities, facial looseness, opening of fingers, and grimacing. Bathing may also lead to some physiological responses, such as hypothermia, hypoxia, dyspnea, cyanosis, desaturation, and tachycardia.Therefore, this study aimed to determine the effect of palmar grasp reflex stimulation during neonatal bath on the physiological parameters and crying time of the newborn.


Eligibility criteria: Inclusion Criteria:

* At least 24 hours after birth
* have a gestational age over 36
* not be asphyxiated
* Feeding at least 1-3 hours before bathing
* Not receiving analgesic sedation before bathing
* Stable vital signs

Exclusion Criteria:

• Ineligible for immersion tub bathing

Primary outcomes:
measure: Body temperature in Celsius
timeFrame: 12 week
measure: Respiratory rate per minute
timeFrame: 12 week
measure: Pulse per minute
timeFrame: 12 week
measure: Oxygen saturation levels in %
timeFrame: 12 week
measure: Crying time in seconds
timeFrame: 12 week
Secondary outcomes:
Other outcomes:
Locations:
city: Yakuti̇ye
country: Turkey
facility: AtaturkU
state: Erzurum
Study officials:
References:
Clinical trial NCT01503047: Conjugated Linoleic Acid (1:1 Isomer Mixture) Intake in Overweight People
Official title: Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Tonalin(R)Intake in Overweight People
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Overweight
Obesity
Lead sponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz
Sponsor class: OTHER
First posted: 2012-01-02
Enrollment: 50
Sex: ALL
Minimum age (years): 30
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of the study was to examine the effects and safety of 3 g of a 1:1 mix of c9-t11 and t10-c12 (Tonalin®) on weight control and body composition in healthy overweight individuals who maintained their normal dietary and exercise patterns.


Eligibility criteria: Inclusion Criteria:

* aged 30-55 years
* grade II overweight (BMI≥27 but \<30 kg/m2)
* not to be adhered to any calorie restriction diet
* not to be taking any weight control medication or have lost more than 5 kg in the three months prior to the study

Exclusion Criteria:

* suffering of serious concomitant disease such as diabetes mellitus type II, metabolic syndrome (according to the criteria of the Adult Treatment Panel III), cancer, kidney disease, HIV, tuberculosis, cardiovascular disease, chronic obstructive pulmonary disease, eating disorders.
* having undergone bariatric surgery and/or intestinal resection
* breastfeeding and pregnancy.
* not to give their signed, informed consent to be included in the study.

Primary outcomes:
measure: body composition(DXA)
timeFrame: 0, 3, 6 months
Secondary outcomes:
measure: anthropometric parameters
timeFrame: 0,1, 2, 3, 4, 5 and 6 month
measure: Biochemical parameters
timeFrame: 0, 3 and 6 month
measure: HOMA-Index
timeFrame: 0, 3, 6 month
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
Study officials:
References:
citation: Lopez-Plaza B, Bermejo LM, Koester Weber T, Parra P, Serra F, Hernandez M, Palma Milla S, Gomez-Candela C. Effects of milk supplementation with conjugated linoleic acid on weight control and body composition in healthy overweight people. Nutr Hosp. 2013 Nov 1;28(6):2090-8.
Clinical trial NCT00781547: Growth Hormone Treatment in Men With High Risk of Developing Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Abdominal Obesity
Metabolic Syndrome
Obesity
Keywords: growth hormone
obesity
abdominal obesity
Lead sponsor: Göteborg University
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2008-10-29
Enrollment: 40
Sex: MALE
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The overall aim of this study is to investigate the effects of GH treatment in men with the Metabolic Syndrome and a high risk of developing type 2 DM.

Forty men with abdominal obesity and impaired glucose tolerance will be randomized to two parallel treatment groups with GH and placebo for 12 months.

The subjects will receive treatment with recombinant human GH (Genotropin®) or placebo administered by a daily s.c. injection before bedtime. The initial dose of GH will be 0.4 IU per day increased to 0.8 IU after 2 weeks and to 1.2 IU after 4 weeks of treatment. Thus, the target dose is 1.2 IU per day which resembles approximately 0.015 IU/kg/day. The GH dose will be reduced by half in the event of side-effects. Oral and written instructions in terms of administration and dosage will be given.

The treatment can be discontinued by the patient. The treatment should be discontinued if malignancy is discovered, DM developes, if the subject experience a cerebrovascular disease and in the event of any other side-effects that is considered as serious.

The treatment code for each subject included in the trial will be kept at the Sahlgrenska University Hospital Pharmacy. This code can be broken on the request of the investigator.

Compliance will be assessed by collecting empty vials from the study subjects. The treatment is discontinued at the end of the study.


Eligibility criteria: Inclusion Criteria:

* Fasting plasma glucose level ≥ 6.1 and ≤ 7.8 mmol/L (IFG) and/or a plasma glucose 2 hours after a 75g oral glucose load between 6.9-11.0 mmol/L (IGT).
* BMI \> 25 kg/m2.
* Waist/hip ratio \> 0.95

Exclusion Criteria:

* Proliferative diabetic retinopathy.
* Macro-albuminuri and/or serum creatinine \>150mmol/L
* Known ischemic heart disease, previous stroke or claudicatio intermittence.
* Known malignancy.
* Other hormonal therapy.

Primary outcomes:
measure: Glucose tolerance
timeFrame: Baseline, 3, 6 and 12 months
Secondary outcomes:
measure: Fasting plasma glucose, serum insulin, HbA1c
timeFrame: Basline, 1,2,3,6,9 and 12 months
measure: Sleep architecture
timeFrame: Baseline and 12 months
measure: Visceral adipose tissue
timeFrame: Baseline and 12 months
measure: Progress of atherosclerosis (IMT)
timeFrame: Baseline and 12 months
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Centrum for Endocrinology and Metabolism, Sahlgenska University Hospital
Study officials:
References:
Clinical trial NCT02956447: Administration of Kisspeptin in Patients With Hyperprolactinemia
Official title: Administration of Kisspeptin in Patients With Hyperprolactinemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hyperprolactinemia
Hypogonadism
Keywords: Kisspeptin
Hyperprolactinemia
GnRH
Hypogonadism
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2016-11-06
Enrollment: 36
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The goal of this study is to learn more about how kisspeptin, a naturally occurring hormone, affects women with high levels of prolactin (also called hyperprolactinemia). Subjects in one group will undergo blood sampling every 10 minutes over two 12-hour periods (one 12-hour period without any intervention and one 12-hour period with intravenous (IV) kisspeptin administration). Subjects in the second group will receive subcutaneous (SC) kisspeptin every 90 minutes for eight days.


Eligibility criteria: Inclusion/Exclusion Criteria:

* confirmed diagnosis of elevated levels of prolactin measured via blood test,
* no pituitary adenoma OR a microprolactinoma (\<10 mm). Patients with a macroprolactinoma confirmed on MRI imaging will be excluded,
* no history of a medication reaction requiring emergency medical care,
* no illicit drug use or excessive alcohol consumption (\>10 drinks/week),
* not currently seeking fertility, breastfeeding or pregnant,
* no history of bilateral oophorectomy,
* willing to complete a dopamine agonist washout and/or oral contraceptive washout,
* normal physical exam and laboratory studies within protocol reference range.

Primary outcomes:
measure: Average Change in Number of Luteinizing Hormone (LH) Pulses Over 10 Hours
timeFrame: Up to 14 days
measure: Number of Participants With Evidence of Follicle Growth From Subcutaneous Kisspeptin
timeFrame: Evaluated over eight days
Secondary outcomes:
measure: Average Change in LH Pulse Amplitude
timeFrame: Up to 14 days
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Stephanie Seminara, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04148547: Transcranial Direct Current Stimulation (tDCS) in the Primary Motor Cortex in Healthy Individuals
Official title: Transcranial Direct Current Stimulation (tDCS) in the Primary Motor Cortex and Its Effects on Sensitivity, Pressure Pain Threshold, and Electromyographic Activity in Healthy Individuals: A Quasi-experimental Single-blind Sham-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Basic Physiology
Brain Stimulation
Keywords: Transcranial direct current stimulation
Lead sponsor: Universidad Autonoma de Madrid
Sponsor class: OTHER
Collaborators: name: Centro Universitario La Salle
First posted: 2019-11-01
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The main aim of this study is to assess the short-term effects of active-tDCS (a-tDCS) on the M1 regarding sensorimotor variables such as discriminative sensation, pressure pain threshold and electromyographic activity compared with a sham-tDCS (s-tDCS) in healthy individuals. The main objective was to determine whether there were clinically relevant changes generated by tDCS and if they were superior to a sham intervention.


Eligibility criteria: Inclusion Criteria:

* asymptomatic participants
* men and women aged 18 to 65 years

Exclusion Criteria:

* insomnia
* nausea
* headache
* pregnancy
* use of painkillers in the last 24 hours
* presence of metal inside the head
* pacemaker
* wound on the area of electrodes' application
* drug consumption; (j) recent application of tDCS
* psychiatric disease impeding understanding of the study.

Primary outcomes:
measure: Pressure pain threshold through an algometer
timeFrame: Change in pressure pain threshold immediately at the end of the intervention
measure: Tactile acuity threshold
timeFrame: Change in tactile acuity threshold immediately at the end of the intervention
measure: Muscle recruitment through electromyographic activity
timeFrame: Change in electromyographic activity immediately at the end of the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: CSEU La Salle
Study officials:
References:
Clinical trial NCT01913847: Safety and Efficacy Study of HGP1207 in Patients With Pulmonary Hypertension
Official title: Phase III Study to Evaluate Efficacy and Safety of HGP1207 in Patients With Pulmonary Hypertension Associated With Systolic Heart Failure
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Pulmonary Hypertension
Systolic Dysfunction
Lead sponsor: Hanmi Pharmaceutical Company Limited
Sponsor class: INDUSTRY
First posted: 2013-08-01
Enrollment: 144
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the safety and clinical efficacy of HGP1207 (Sildenafil) in subjects with pulmonary hypertension associated with systolic heart failure.


Eligibility criteria: Inclusion Criteria:

* Patients with a diagnosis of chronic heart failure (NYHA Class II and III)
* LVEF ≤ 40%
* Elevated systolic PAP: ≥ 40 mmHg
* Patients must be treated with an ACE inhibitor, ARB, beta-blocker, aldosterone antagonist at a stable dose for at least 4 weeks prior to visit 1

Exclusion Criteria:

* Patients with pulmonary hypertension associated with chronic obstructive pulmonary disease, interstitial lung disease, chronic thromboembolism or unclear/multifactorial mechanisms
* Patients who have received Nitrates/NO donor or Cytochrome P450 3A4 inhibitors within 30 days prior to visit 1
* Patients who have received calcium channel blocker, endothelin receptor antagonist, prostacyclin analogues, phosphodiesterase 5 inhibitors within 90 days prior to visit 1
* History of hypersensitivity or allergy to sildenafil or any excipients of its formulation
* Patients with hypertension (sitSBP \>170 mmHg or sitDBP\>100 mmHg) or hypotension (sitSBP\<90 mmHg or sitDBP\<50 mmHg)
* Patients with other medical condition (i.e.,alcoholism, drug abuse) that may cause the patient to be non-compliant with the protocol, confound the data interpretation
* Pregnant females or those of child bearing potential who have not had a negative pregnancy test

Primary outcomes:
measure: Change from baseline in 6-min-walk test distance
timeFrame: at 12 weeks
Secondary outcomes:
measure: Change from baseline in 6-min-walk test distance
timeFrame: at 6 weeks
measure: Change from baseline in systolic pulmonary arterial pressure (PAP)
timeFrame: at 6 weeks and 12 weeks
measure: Change from baseline in [NT pro-BNP]
timeFrame: at 6 weeks and 12 weeks
measure: Improvement in NYHA functional class
timeFrame: at 6 weeks and 12 weeks
measure: Quality of life (QoL) assessed by EuroQoL(EQ-5D-3L) and EQ visual analogue scales (VAS)
timeFrame: at 6 weeks and 12 weeks
measure: Delaying time to first occurrence of either cardiovascular events
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: 11 institutions including Hallym University Dongtan Sacred Heart Hospital
Study officials:
affiliation: Hallym University Dongtan Sacred Heart Hospital
name: Kyu Hyung Ryu, M.D. Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: