louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00541645: Transient Osteoporosis of Pregnancy: A Possible Peptide Mediator
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Transient Osteperosis
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2007-10-10
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Time perspective: PROSPECTIVE

Brief summary: Transient osteoporosis of pregnancy (TOoP) is uncommonly encountered in orthopedic and obstetric practice, with most reports consisting of single cases.

This rare condition consists of significant osteoporosis affecting the hips and spine, causing significant morbidity, and putting young female patients at risk for vertebral and femoral neck fractures.

The pathogenesis of transient osteoporosis of pregnancy is unknown, with various theories as to its etiology.

Recently, a number of reports have described elevated levels of PTHrP in patients with transient osteoporosis in pregnancy and of the postpartum period Our goal in this study is to assess the role of PTHrP in transient osteoporosis of pregnancy


Eligibility criteria: Inclusion Criteria:

* Signed Informed consent

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Hadassah Medical Organization
name: Efrain Liebner, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hadassah Medical Organization
name: Meir Liebergall, M.D
role: STUDY_CHAIR
affiliation: The Hebrew University
name: Tzvi Bar-Shavit, Ph.D
role: STUDY_DIRECTOR
References:
Clinical trial NCT06616545: French Observatory for Patients with Type 3 Glycogenosis
Official title: French Observatory for Patients with Type 3 Glycogenosis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Glycogen Storage Disease Type III
Lead sponsor: Institut de Myologie, France
Sponsor class: OTHER
First posted: 2024-09-27
Enrollment: 150
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: GSD type 3 patients from French national reference centres

Brief summary: Glycogen storage disease type III (GSD-III) or Cori/Forbes disease, is caused by autosomal recessive mutations in the AGL gene, which codes for the glycogen debranching enzyme (GDE) involved in the release of glucose-1P from glycogen branches. Abnormal glycogen accumulation is responsible for frequent hypoglycaemia and symptoms in the liver and striated muscles (GSD-IIIa), although some patients present with liver involvement only (GSD-IIIb). In childhood, the phenotype is mainly characterised by hepatomegaly, short stature and hypoglycaemia, with minimal skeletal muscle involvement. While liver symptoms improve spontaneously around puberty, skeletal muscle weakness develops progressively in adulthood and becomes a major feature of GSD-IIIa.

Currently, there is no treatment other than dietary management tailored to the individual to limit glycogen storage and avoid hypoglycaemia.

The French GSD-III registry is a multicentre online registry dedicated to patients with type III glycogen storage disease followed in France. It has been approved by ethical and regulatory authorities. Its main inclusion criteria is the presence of a proven pathogenic AGL gene mutation and/or reduced glycogen debranching enzyme activity.

The aims of the registry are to provide a tool for recording detailed diagnostic, metabolic, neurological, cardiac and biological data on French patients with GSD-III, so as to enable i) a precise natural history of the disease, ii) identification of the outcome measures most sensitive to disease progression, iii) assessment of the frequency of the various complications of the disease and iv) identification of prognostic factors.


Eligibility criteria: Inclusion Criteria:

* Patients with molecularly characterised Glycogen Storage Disease Type III

Exclusion Criteria:

* Patients diagnosed with GSD type 3 refusing to take part in the study

Primary outcomes:
measure: Fasting period
timeFrame: Through study completion, an average of 10 years
Secondary outcomes:
measure: 6MWT distance
timeFrame: Through study completion, an average of 10 years
Other outcomes:
Locations:
city: Clamart
country: France
facility: Aphp Antoine Beclere
city: Le Kremlin-Bicêtre
country: France
facility: CHU du Kremlin-Bicêtre
city: Paris
country: France
facility: Institue of Myology
Study officials:
References:
Clinical trial NCT00232245: Use of Fish Oils to Reduce the Frequency and Duration of Episodes of Atrial Fibrillation in Patients With Paroxysmal Atrial Fibrillation.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Atrial Fibrillation
Lead sponsor: Melbourne Health
Sponsor class: OTHER
First posted: 2005-10-04
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 88
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate whether fish oil supplements may reduce the frequency and duration of paroxysmal atrial fibrillation episodes.

Atrial fibrillation is a heart condition which effects a large percentage of the population .

Atrial fibrillation is a condition frequently experienced by people who have had pacemakers inserted .

Certain Pacemakers have sophisticated monitoring features that are able to recognise episodes of atrial fibrillation.

Fish oil supplements may be of benefit to patients with heart problems.Recent evidence suggests that fish oils may be beneficial to patients with rhythm disturbances.

By interrogating pacemakers this study will investigate the effect of fish oil supplements on the frequency and duration of episodes of atrial fibrillation.


Eligibility criteria: Inclusion Criteria:

* Patients who have had at least 2 previous episodes of atrial fibrillation and an implanted pacemaker.

Exclusion Criteria:

* Patients with chronic atrial fibrillation

Primary outcomes:
measure: Atrial tachycardia and atrial fibrillation burden
timeFrame: 18 months
Secondary outcomes:
measure: Frequency and duration of atrial tachycardia/fibrillation episodes
timeFrame: 18 months
Other outcomes:
measure: Safety and tolerability of fish oil
timeFrame: 18 months
Locations:
city: Melbourne
country: Australia
facility: Royal Melbourne hospital
state: Victoria
Study officials:
affiliation: Melbourne Health
name: Paul Sparks
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kumar S, Sutherland F, Stevenson I, Lee JM, Garg ML, Sparks PB. Effects of long-term omega-3 polyunsaturated fatty acid supplementation on paroxysmal atrial tachyarrhythmia burden in patients with implanted pacemakers: results from a prospective randomised study. Int J Cardiol. 2013 Oct 9;168(4):3812-7. doi: 10.1016/j.ijcard.2013.06.030. Epub 2013 Jul 26.
Clinical trial NCT02236845: Pilot Study to Clinical Evaluate Lacrima Medical Device in Insomnia Patients
Official title: Pilot, Randomized, Cross-over Study to Evaluate Safety and Clinical Effect of Lacrima Medical Device in Patients With Chronic Insomnia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Insomnia
Keywords: Insomnia, medical device, sleep latency
Lead sponsor: Lacrima Medical LTD
Sponsor class: INDUSTRY
First posted: 2014-09-11
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The study will assess the safety, tolerability and feasibility of Lacrima investigational medical device vs. sham device in adult patients with chronic Insomnia


Eligibility criteria: Main Inclusion Criteria:

1. Adult subjects, 18 years of age and older at screening
2. Diagnosis of primary insomnia based on International Classification of Sleep Disorders, revision no 2
3. Total score of Pittsburgh Sleep Quality questionnaire is \> 5
4. Latency to persistent sleep is \> 30 minutes based on Pittsburgh questionnaire
5. Able to understand and provide written informed consent

Main Exclusion Criteria:

1. Patients using any pharmacological treatments for insomnia for 14 days
2. Patients currently using stimulants drugs 7 days
3. Patients currently using antidepressants causing sleepiness
4. Patients who are unable to commit to avoid consumption alcohol during the study
5. Patients who are unable to commit to avoid consumption caffeine after 12 pm
6. Patients who have a clinical significant or unstable medical or surgical condition

Primary outcomes:
measure: Rate of adverse events
timeFrame: Up to 37 days
Secondary outcomes:
measure: Change in sleep latency time based on sleep actigraph
timeFrame: 28 days
Other outcomes:
measure: Change in sleep latency time based on sleep diaries
timeFrame: 28 days
Locations:
city: Haifa
country: Israel
facility: Rambam Health Care Campus
Study officials:
References:
Clinical trial NCT00955045: A Long-Term, Safety Study With a Flexible Dose Range of KW-6002 in Patients With Motor Response Complications on Levodopa/Carbidopa Therapy
Official title: A Long-Term, Multicenter, Open-Label, Safety Study With a Flexible Dose Range of KW-6002 as Treatment for Parkinson's Disease in Patients With Motor Response Complications on Levodopa/Carbidopa Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Parkinson's Disease
Keywords: long-term tolerability and safety
istradefylline treatment
levodopa/carbidopa
Lead sponsor: Kyowa Kirin Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2009-08-07
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: The primary objective of this study was to establish the long-term tolerability and safety of istradefylline treatment in subjects with Parkinson's disease treated with levodopa/carbidopa. In addition, treatment response and maintenance of response were assessed.


Eligibility criteria: Inclusion Criteria:

Eligible subjects were:

* male or female
* at least 30 years of age
* had completed participation in a prior double-blind istradefylline trial
* met United Kingdom's Parkinson's Disease Society (UKPDS) brain bank criteria (Step 1 and Step 2) for Parkinson's disease and the severity of the Parkinson's disease was defined as Stages 2-4 on the Modified Hoehn and Yahr Scale while in the OFF state
* had been treated with levodopa for at least 1 year
* had been on a stable Parkinson's disease regimen within normal therapeutic ranges including levodopa for at least 4 weeks before Baseline
* were currently taking at least 4 doses of levodopa per day (3 doses per day if at least 2 doses contained slow-release formulation)
* had predictable end-of-dose wearing-off

Exclusion Criteria:

* none

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Princeton
country: United States
facility: 48 Centers in the US and 4 in Canada
state: New Jersey
Study officials:
References:
Clinical trial NCT01475045: ANASA (Patients' Satisfaction With Pulmonary Diseases' Treatment)
Official title: Multicenter, Prospective, Non Interventional Observational Study in Treatments of Asthma and Chronic Obstructive Pulmonary Disease (COPD)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Chronic Obstructive Pulmonary Disease
Keywords: COPD
Lead sponsor: Elpen Pharmaceutical Co. Inc.
Sponsor class: INDUSTRY
First posted: 2011-11-21
Enrollment: 1160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Three subgroups of patients who are already in their inhalation treatment (devices: Discus, Elpenhaler, Turbuhaler) are asked to complete the FSI-10 questionnaire valid in Greek language. The questionnaire responses indicate their satisfaction by their treatment devices.

Brief summary: The aim of the study is to compare patients' satisfaction from the use of three different inhalation devices by using the FSI-10 questionnaire

Detailed description: Patients are requested to reply to FSI-10 questionnaire regarding their satisfaction from inhalation devices. Patients are on 3 different asthma inhalation devices with combination treatment (Turbuhaler, Diskus, Elpenhaler)

Eligibility criteria: Inclusion Criteria:

* Patients \> 18 years old, both genders who are on their inhalation treatment at least two months before study enrollment,
* Who are able to be compliant to study procedures

Exclusion Criteria:

* Patients \< 18 years old,
* Patients who are on their inhalation treatment less than two months before study enrollment
* Patients who are not able to be compliant to study procedures

Primary outcomes:
measure: Patients' satisfaction
timeFrame: all study period (5 months)
Secondary outcomes:
measure: Patients devices' use
timeFrame: all study period (5 months)
Other outcomes:
Locations:
city: Athens
country: Greece
facility: 7th Pulmonary Clinic, Sotiria Hospital
city: Athens
country: Greece
facility: Sotiria Hospital
Study officials:
affiliation: 7th Pulmonary Clinic, Sotiria Hospital of Athens
name: Asimina Gaga
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03967145: Turkish Version of the Glaucoma Quality of Life-15 Questionnaire
Official title: Reliability and Validity of the Turkish Version of the Glaucoma Quality of Life-15 Questionnaire
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glaucoma
Quality of Life
Lead sponsor: Acibadem University
Sponsor class: OTHER
Collaborators: name: Haydarpasa Numune Training and Research Hospital
First posted: 2019-05-30
Enrollment: 127
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary Open-Angle Glaucoma patients

Brief summary: Glaucoma is a disease with irreversible loss of visual field and optic neuropathy and is the most important cause of irreversible vision loss after cataract in the world. Although clinical evaluations reveal the level of glaucoma quantitatively, it is necessary to evaluate the impact of this pathology on daily functions and quality of life with a holistic perspective and to provide appropriate advice to patients according to the information obtained. Glaucoma Quality of Life -15 Questionnaire (GQoL-15) was developed by Nelson et al. in 2003 to evaluate the quality of life of glaucoma patients. The aim of this study is to translate GQoL-15 into Turkish and evaluate its test-retest reliability for Turkish-speaking population.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of primary open angle glaucoma more than 6 months with visual field tests,
* Have the sufficient cognitive level to answer the scale questions.

Exclusion Criteria:

* To have retinal or optic nerve pathologies that may cause loss of visual field or decrease in visual field except glaucoma,
* To undergo eye surgery in the last 3 months.

Primary outcomes:
measure: Glaucoma Quality of Life 15 Questionnaire total score
timeFrame: 6 months
measure: 25-item National Eye Institute Visual Functioning Questionnaire (NEI-VFQ 25)
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Yücel Öztürk
Study officials:
affiliation: Acibadem University
name: Özgül Öztürk
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03269045: Study of ORL-1B in Patients With Biotinidase Deficiency
Official title: An Open-label, Single-arm, Phase 2 Study of ORL-1B in Patients With Biotinidase Deficiency
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Biotinidase Deficiency
Lead sponsor: Orpha Labs
Sponsor class: INDUSTRY
First posted: 2017-08-31
Enrollment: 20
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: An Open-label, Single-arm, Phase 2 Study of Biotin in Patients With Biotinidase Deficiency.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of biotinidase deficiency.
* Less than 18 years old.

Exclusion Criteria:

* Diagnosis of any other disease that is not a manifestation of biotinidase deficiency.

Primary outcomes:
measure: Improvement in seizure frequency
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00873145: Management of Bone Defects Around the Elbow
Official title: Modular Prosthetic Reconstruction of Major Bone Defects of the Distal Humerus.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tumor
Fracture
Cancer
Keywords: Survival
Function
Infection
Revision
Loosening
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2009-04-01
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with major bone defects around the elbow and/or distal humerus due to cancer or failed arthroplasty.

Brief summary: Background:

Bone defects of the distal humerus require complex reconstructions, for which standard prostheses may be insufficient. The researchers therefore investigated the clinical and radiological outcome of elbow reconstructions by megaprostheses.

Detailed description: Type of prosthesis:

STRYKER Humerus-HMRS

Eligibility criteria: Inclusion Criteria:

* HMRS of the elbow, distal humerus or total humerus

Exclusion Criteria:

* Unwillingness to participate

Primary outcomes:
measure: Patient Survival
timeFrame: 20 Years
Secondary outcomes:
measure: Prosthetic Survival
timeFrame: 20 Years
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna Department of Orthopaedics
Study officials:
References:
Clinical trial NCT05052645: Ear Acupuncture for Neuropathic Pain
Official title: Auricular Acupuncture in the Treatment of Neuropathic Pain: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Neuropathic Pain
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2021-09-22
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to gather information on the effectiveness of auricular acupuncture (i.e., the placement of acupuncture needles in specific points on the ear) in reducing pain and improving quality of life among patients experiencing neuropathic pain in the acute inpatient rehabilitation setting.


Eligibility criteria: Inclusion Criteria:

* Patients who have acute or chronic neuropathic pain of any etiology (traumatic, non-traumatic, central, peripheral, and mixed cases).
* Ability to provide informed consent.
* Ability to speak English and complete all aspects of this trial.
* At least 18 years of age.
* Patients will have stable neuropathic pain medication dosing for 3 days prior to enrollment to include gabapentin, pre-gabalin, TCAs, duloxetine, carbamazepine, oxcarbazepine, and venlafaxine).

Exclusion Criteria:

* Patients with platelet count \<50,000 or known bleeding disorder.
* Patients in a severe immunocompromised state.
* Pregnant women. All patients who meet the criteria will have their medical records reviewed to ensure they are not pregnant.
* Allergy to gold.
* Use of non-FDA approved herbal supplements. Their effect on enhancing or blunting effect of acupuncture is not known. Patients using medical marijuana with an approved prescription from a state issuing such prescriptions will not be excluded.
* Current infection of the skin or cartilage of the ear.
* Patients already using adjuvant modalities such as chiropractic, massage, yoga, tai chi, massage will not be excluded, but those who add in these modalities during the course of the intervention and observation period will be excluded.
* Patients not anticipated to stay for a minimum of 7 days after enrollment.
* Patient without mental capacity to participate in the consent process and the questionnaire responses.
* Fear of needles or no interest in acupuncture.

Primary outcomes:
measure: Change in self-reported neuropathic pain scores
timeFrame: Daily during inpatient stay, approximately 7-10 days
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Tony Chon, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00870545: Reintegration: The Role of Spouse Telephone BATTLEMIND Pilot Study
Official title: Reintegration: The Role of Spouse Telephone BATTLEMIND Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Military Spouses
Support Groups
Stress Disorders
Combat Disorders
Keywords: spouses
social support
reintegration
families
military
post deployment
OEF/OIF
Lead sponsor: Memphis VA Medical Center
Sponsor class: FED
Collaborators: name: United States Department of Defense
First posted: 2009-03-27
Enrollment: 86
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will expand the Department of Defense (DoD) one time, face-to-face post deployment BATTLEMIND training for spouses of Operation Enduring Freedom/Operation Iraqi Freedom (OEF/OIF) Guard/Reserve service members into year-long, telephone groups focusing on education, skills building and support. The goal is to build spouses' resilience to cope with reintegration, help them serve as a support system for returning service members, and ease the transition for families post-deployment.


Eligibility criteria: Inclusion Criteria:

1. have a spouse who participated in OEF/OIF and is at least 1 month post-deployment;
2. if not married, must have lived as married for at least one year;
3. live with the service member when not deployed;
4. have been a spouse/significant other throughout the service member's deployment period;
5. and have a telephone.

Exclusion Criteria:

1. current diagnosis of schizophrenia or other major mental illness;
2. auditory impairment that would make telephone use difficult; or
3. service member refusal of assent for spouse to participate.

Primary outcomes:
measure: Spouse Self-report of Depression
timeFrame: Baseline, 6 months, and 12 months
measure: Anxiety
timeFrame: baseline, 6 months and 12 months
measure: Quality of Marriage
timeFrame: Baseline, 6 and 12 months
Secondary outcomes:
measure: Family Coping
timeFrame: Baseline, 6 months and 12 months
measure: Spouse Social Support
timeFrame: baseline, 6 months, and 12 months
measure: Family Communication
timeFrame: baseline, 6 months, and 12 months
Other outcomes:
Locations:
city: Memphis
country: United States
facility: Memphis VA Medical Center
state: Tennessee
Study officials:
affiliation: Memphis VA Medical Center
name: Linda O Nichols, PhD
role: PRINCIPAL_INVESTIGATOR
References: