louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00806715: Iron Overload in Stem Cell Transplant Recipients
Official title: Impact of Iron Overload in Pediatric Patients Undergoing Stem Cell Transplantation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Iron Overload
Keywords: hemochromatosis
Iron overload
Stem cell transplant
Pediatrics
Pediatric Stem cell transplant
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
Collaborators: name: Dana-Farber Cancer Institute
name: Lance Armstrong Foundation
First posted: 2008-12-11
Enrollment: 38
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children undergoing allogeneic stem cell transplantation.

Brief summary: The goal of this study is to examine the impact of iron overload in patients undergoing a bone marrow transplant. We believe that the iron status in these patients is associated with complications for transplant survivors. We will examine the iron status in these patients by MRI and by screening for mutations in genes known to cause iron overload. We will also determine the levels of hepcidin (a hormone produced in the liver that appears to regulate iron homeostasis) from blood and urine.


Eligibility criteria: 1. Undergoing allogeneic HSCT for malignant or non-malignant conditions
2. Age greater than or equal to 5 years
3. Able to undergo MRI without a need for general anesthesia
4. No metal implants
5. Signed informed consent (by parent if patient is less than 18 years old, or by patient, if he or she is greater than 18 years old).

Primary outcomes:
measure: Hepatic iron content as measured by R2 MRI.
timeFrame: Pre-HSCT and Day 100
Secondary outcomes:
measure: Genetic determinants of iron overload- HFE status.
timeFrame: Pre-HSCT
Other outcomes:
Locations:
city: Boston
country: United States
facility: Children's Hospital Boston
state: Massachusetts
Study officials:
References:
Clinical trial NCT05147415: Study of Tesomet With Open-label Extension in Subjects With Hypothalamic Obesity (HO)
Official title: A Phase 2b, Double-blind, Randomized, Placebo-controlled, Dose-finding, Multi-center, 36-week Safety and Efficacy Study With Open-label Extension (OLE) Period of Tesomet in Subjects With Hypothalamic Obesity
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Hypothalamic Obesity
Lead sponsor: Saniona
Sponsor class: INDUSTRY
First posted: 2021-12-07
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the safety and efficacy of Tesomet (tesofensine + metoprolol) in subjects 18 years of age or older, with HO


Eligibility criteria: Key Inclusion Criteria:

* Subject and, if applicable, their parent or legal guardian must be willing to provide informed consent
* Diagnosis of HO secondary to damage to the hypothalamus
* Female subjects must be of non-childbearing potential
* At least 6 months since completion of therapy (chemotherapy, surgery, or radiation with resulting injury to the hypothalamus and/or the pituitary) with stable disease and lack of recurrence
* BMI 30.0 to 60.0 kg/m², inclusive
* Documented stable body weight (gain/loss \<10%) for at least 90 days prior to Screening
* Stable and well-managed pituitary replacement (eg, glucocorticoid, thyroid hormone, estrogen/progestin or testosterone, desmopressin, or growth hormone) for \>2 months prior to Screening
* Male subjects who are sexually active must be surgically sterile

Key Exclusion Criteria:

* Females who are pregnant, breastfeeding, or actively intending to become pregnant during the study
* Sitting BP that meets the following criteria after 5 minutes of rest at Screening:

  1. Systolic BP \>145 mmHg or \<100 mmHg; or
  2. Diastolic BP \>95 mmHg or \<70 mmHg
* Type 1 diabetes mellitus
* History of major depressive disorder within 2 years prior to Screening, or any history of other severe psychiatric disorder (eg, schizophrenia, bipolar disorder)
* Uncontrolled endocrine disorders (eg, Cushing syndrome, Addison's, hypothyroidism, hyperthyroidism)
* History of bulimia or anorexia nervosa
* Use of prohibited medications, including current use of selective serotonin reuptake inhibitors / serotonin-norepinephrine reuptake inhibitors (SSRIs/SNRIs)

Primary outcomes:
measure: Body weight (%)
timeFrame: Baseline to Week 36
Secondary outcomes:
measure: Body weight loss
timeFrame: Week 36
measure: Body weight (kg)
timeFrame: Baseline to Week 36
measure: Waist circumference (cm)
timeFrame: Baseline to Week 36
measure: Body Mass Index (BMI)
timeFrame: Baseline to Week 36
Other outcomes:
Locations:
city: Lansing
country: United States
facility: Sparrow Clinical Research Institute
state: Michigan
Study officials:
affiliation: Saniona
name: Sophie Guillaume, MS
role: STUDY_DIRECTOR
References:
Clinical trial NCT01198015: Creatine Metabolism in Rett Syndrome
Official title: Metabolic Evaluation of Nutrition in Rett Syndrome: Creatine Metabolism
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rett Syndrome
Keywords: Rett syndrome
Nutritional status
Creatine metabolism
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2010-09-09
Enrollment: 13
Sex: FEMALE
Minimum age (years): 3
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population (identical to the population in the preliminary research project) consists of a well-defined group of thirteen Dutch RTT girls with complete clinical, molecular, neurophysiological and metabolic work-up.

Brief summary: Rett syndrome (RTT) is an X-linked severe neurodevelopmental disorder. Despite their good appetite, many females with RTT meet the criteria for moderate to severe malnutrition. The pathological mechanism is barely understood. Although feeding difficulties may play a role in this, other constitutional factors as altered metabolic processes are suspected. Preliminary research showed elevated plasma creatine concentrations and increased urinary creatine/creatinine ratios in half of the RTT girls.

The aim of this study is to confirm previous findings and examine the functionality of the creatine transporter in RTT girls.

The investigators assume that previous findings will be confirmed, and are due to an altered functionality of the creatine transporter.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of RTT (meeting consensus diagnostic criteria (Hagberg et al, 2002));
* MECP2-mutation;
* Complete neurophysiological work-up;
* Participant preliminary research (research protocol NL25356.068.08).

Exclusion Criteria:

* Male gender

Primary outcomes:
measure: Confirm previous findings and examine the functionality of the creatine transporter in RTT girls
timeFrame: One hour
Secondary outcomes:
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
state: Limburg
Study officials:
affiliation: Maastricht University Medical Center
name: Leopold MG Curfs, Professor
role: STUDY_DIRECTOR
affiliation: Maastricht University Medical Center
name: Eric EJ Smeets, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00314015: Evaluation of the Success Rate of Immediately Loaded Implants
Official title: Evaluation of the Success Rate of Immediately Loaded Implants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Implants
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2006-04-12
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Evaluation of the success rate of immediately loaded implants based on:

* condition of the gingiva
* stability of the implants
* evaluation of the RXs
* questionnaires


Eligibility criteria: Inclusion Criteria:

* Patients with immediately loaded implants

Primary outcomes:
measure: Success of implants
timeFrame: Continuous follow-up
measure: Prothetic complications
timeFrame: Continuous follow-up
measure: Opinion of the patient
timeFrame: Continuous follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital Ghent
Study officials:
affiliation: University Hospital, Ghent
name: Hugo De Bruyn, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06045715: Follow-up Strategy for Esophageal Cancer Patients
Official title: An Optimized Post-surgery Follow-up Strategy for Patients With Esophageal Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Esophagus Cancer
Keywords: follow-up
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2023-09-21
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Chinese patients with historically proven esophageal squamous cell carcinoma and adenocarcinoma

Brief summary: The recurrence risk of patients with esophageal cancer was stratified by integrating different stages and pathological factors. The risk of recurrence was dynamically estimated for each group of patients, and the optimal follow-up strategy was developed based on the recurrence risk.

Detailed description: Patients with histologically proven, esophageal cancer (EC) patients diagnosed between 2008 and 2018 were recruited. Recursive partition analysis was applied to develop recurrence risk stratification for patients. The follow-up strategies of each stratification were developed based on monthly recurrence probability and validated by bootstrap validation and an external dataset. Markov decision-analytic models were constructed to evaluate the cost-effectiveness of the follow-up strategies.

Eligibility criteria: Inclusion Criteria:

(1) Patients aged between 18 and 80 years old; (2) Pathological diagnosis as esophageal squamous cell carcinoma or adenocarcinoma; (3) Patients underwent esophagectomy and received R0 resection.

Exclusion Criteria:

(1) Patients with secondary primary tumor; (2) Patients who died within 30 days after surgery or died of post-operation complications; (3) Patients missing essential clinical information, such as operation record, pathological diagnosis, and follow-up data; (4) Patients with radiologically or histologically confirmed distant metastasis; (5) Patients previously underwent endoscopic mucosal resection or definitive radiochemotherapy as initial treatment.

Primary outcomes:
measure: disease-free survival
timeFrame: 2008-2020
Secondary outcomes:
measure: local relapse-free survival
timeFrame: 2008-2020
measure: distant metastasis-free survival
timeFrame: 2008-2020
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Jianhua Fu
state: Guangdong
Study officials:
References:
Clinical trial NCT01764815: Evaluation of Directional Stimulation During the Implantation of Deep Brain Stimulation (DBS) Leads
Official title: Evaluation of Directional Stimulation During the Implantation of Deep Brain Stimulation Leads for the Treatment of Movement Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson's Disease
Essential Tremor
Lead sponsor: Aleva Neurotherapeutics SA
Sponsor class: INDUSTRY
First posted: 2013-01-10
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to provide proof-of-concept that directional stimulation, in an intraoperative setting, is perceivable in a subject and is different from omnidirectional stimulation. The tests will be performed using a dedicated DBS lead connected to external neurostimulator.


Eligibility criteria: Inclusion Criteria:

* Subject is indicated to undergo DBS for Parkinson's disease or Essential Tremor according to criteria of the Study site
* For Parkinson Disease:

  * Person is between 18 and 75 years of age
  * Established diagnosis of idiopathic Parkinson's disease with progression of symptoms for a minimum of 2 years.
  * Person has a history of at least 30% improvement on the Unified Parkinson's Disease Rating Scale with therapy in L-dopa (levodopa)
  * Weak control of symptoms by dopaminergic therapy (off phenomenon, fluctuations on / off, dyskinesia on)
* For Essential Tremor:

  * Person is between 18 and 80 years of age
  * Established diagnosis of Essential Tremor for a minimum of 2 years
  * Functional disability due to tremor was not adequately controlled by medication for at least 3 months prior to implant.
* Person has given his/her written consent

Exclusion Criteria:

* Person suffering from an active major psychiatric disorder
* Mattis Dementia Rating Scale score \<130 or otherwise not capable of discernment
* Presence of major co-morbidity or medical condition that may affect participation to the study
* Presence of an electrical or electromagnetic implant (e.g., cochlear implant, pacemaker)
* Person with a previous surgery for the treatment of Parkinson's disease or Essential Tremor
* Person with a previous brain ablation procedure
* Person who suffers from epilepsy
* Person who is pregnant: a pregnancy test will be performed in women of childbearing age
* Person with coagulopathies
* Abuse of drugs or alcohol

Primary outcomes:
measure: Measurement of the therapeutic window's boundaries when stimulating in specific angular directions, and comparison to those obtained when stimulating in all directions.
timeFrame: up to one hour during surgery
Secondary outcomes:
measure: Electrical functionality of the study device during the test phase
timeFrame: 1 day
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Inselspital University Hospital
Study officials:
affiliation: Inselspital, Bern University Hospital
name: Claudio Pollo, PD, Dr. med
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00671515: Pioglitazone for the Treatment of Major Depressive Disorder Comorbid With Metabolic Syndrome
Official title: Pioglitazone for the Treatment of Major Depressive Disorder Comorbid With Metabolic Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Depressive Disorder, Major
Metabolic Syndrome X
Keywords: Depressive Disorder, Major
Metabolic Syndrome X
pioglitazone
Lead sponsor: University Hospitals Cleveland Medical Center
Sponsor class: OTHER
Collaborators: name: Takeda Pharmaceuticals North America, Inc.
First posted: 2008-05-05
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of this study is to begin to test whether or not pioglitazone, an FDA approved medication used to treat high blood sugar, may be safe and effective in treating Major Depressive Disorder (MDD) in patients with comorbid Metabolic Syndrome (METSYN).


Eligibility criteria: Inclusion Criteria:

* Be male or female between the ages of 18 and 70
* DSM-IV diagnosis of major depressive disorder
* Currently depressed as confirmed by the MINI-Plus at the screening visit
* Quick Inventory of Depressive Symptomatology-Self-Report(QIDS-SR) score \> 11 at study baseline
* Meets criteria for the metabolic syndrome as defined by the NCEP ATP III criteria

Exclusion Criteria:

* Pregnancy or breast feeding
* Unstable or inadequately treated medical illness as judged by the investigator
* Severe personality disorder
* Serious suicidal risk as judged by the investigator or having a score \> 2 on item 18 of the Inventory of Depressive Symptomatology-Clinician Rated (IDS-CR) scale
* Known history of intolerance or hypersensitivity to pioglitazone
* Treatment with pioglitazone in the 3 months prior to randomization
* Currently taking an antidiabetic/glucose-lowering agent. Antidiabetic agents that are prohibited include insulin, rosiglitazone, metformin, sitagliptin, sulfonylureas (e.g. glyburide, glipizide, glimepiride), non-sulfonylurea secretagogues (e.g. repaglinide, nateglinide), incretins (e.g. exenatide), and α-glucosidase inhibitors (e.g. acarbose, miglitol).
* Diagnosed with dementia
* Diagnosed with heart failure
* Transaminase elevation \>2.5 times the upper limit of normal
* Presence of renal impairment

Primary outcomes:
measure: Change in Depression Symptom Severity From Baseline to Study Endpoint
timeFrame: Week 0 - Week 12
Secondary outcomes:
measure: Change in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) From Baseline to Study Endpoint
timeFrame: Week 0-Week 12
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center - Mood Disorders Program
state: Ohio
Study officials:
affiliation: University Hospitals Cleveland Medical Center - Mood Disorders Program
name: Joseph E Calabrese, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01125215: Capsaicin Nanoparticle in Patient With Painful Diabetic Neuropathy
Official title: Study of Topical Preparation of Capsaicin Nanoparticle in Patient With Painful Diabetic Neuropathy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Painful Diabetic Neuropathy
Keywords: Painful diabetic neuropathy
Capsaicin
Nanoparticle
Quantitative Sensory Testing
Lead sponsor: Mahidol University
Sponsor class: OTHER
Collaborators: name: Thailand Research Fund
First posted: 2010-05-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objectives of this study are to determine efficacy and safety of 0.75% topical capsaicin nanoparticle preparation versus placebo in patient with painful diabetic neuropathy.

Detailed description: Painful diabetic neuropathy is the most common cause of neuropathic pain. 0.075% topical capsaicin has been used to treat the pain. Because of high concentration, conventional capsaicin topical preparation causing burning sensation and required several time of applications per day.

The nanoparticle of capsaicin topical preparation was developed with expectation of remaining efficacy, minimizing burning sensation and improving convenience of use.

Eligibility criteria: Inclusion Criteria:

* History of type 2 Diabetes mellitus
* Peripheral neuropathy
* Stabilized on pain medication for at least one month
* No previous invasive intervention for pain relief

Exclusion Criteria:

* Local wound or any skin abnormality in the applicable area
* Allergic to capsaicin
* Refuse to participate or give consent
* Has other significant disease or receive medication that may worsen neuropathy

Primary outcomes:
measure: Pain relief from pain score reduction, using visual analog scale (VAS)
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Ramathibodi Hospital
city: Pathumthani
country: Thailand
facility: Thammasat University Hospital
Study officials:
affiliation: Faculty of Pharmacy,Mahidol University
name: Chuthamanee Suthisisang, PhD.
role: STUDY_DIRECTOR
References:
Clinical trial NCT03540615: BAY1830839: First in Man, Single Dose Escalation, Safety & Tolerability and Pharmacokinetics
Official title: Randomized, Placebo-controlled, Double-blind Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Increasing Single Oral Doses of BAY1830839 in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Arthritis, Rheumatoid
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2018-05-30
Enrollment: 64
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Dose escalation with safety assessment following each dose step.
Primary purpose: BASIC_SCIENCE

Brief summary: The primary objectives of this study are to investigate

* the safety and tolerability of increasing single oral doses of BAY 1830839 versus placebo under fasted conditions
* the pharmacokinetics after single ascending oral doses of BAY 1830839 under fasted conditions


Eligibility criteria: Inclusion Criteria:

* Body mass index (BMI) : ≥18.5 and ≤30 kg/m\*2

Exclusion Criteria:

* Relevant diseases within the last 4 weeks prior to the first study drug administration
* Febrile illness within 4 weeks before the first study drug administration
* Known hypersensitivity to the study drugs or components of the preparations
* Clinically relevant findings in the physical examination

Primary outcomes:
measure: AUC of BAY1830839 in plasma
timeFrame: Day 1, 2, 3, 4, 6 ,7, 9, and 12
measure: Cmax of BAY1830839 in plasma
timeFrame: Day 1, 2, 3, 4, 6 ,7, 9, and 12
measure: Frequency of treatment-emergent adverse events
timeFrame: From first application of study intervention up to 30 days after end of treatment
measure: Severity of treatment-emergent adverse events
timeFrame: From first application of study intervention up to 30 days after end of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: CRS Clinical Research Services Berlin GmbH
Study officials:
References: