louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06346106: The Diagnostic Experience of Male Rett Syndrome
Official title: The Diagnostic Experience of Male Rett Syndrome
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Rett Syndrome
RTT
Lead sponsor: Children's Hospital Colorado
Sponsor class: OTHER
Collaborators: name: University of Colorado, Denver
name: Vanderbilt University School of Medicine
name: University of Alabama at Birmingham
name: University of Pennsylvania
name: International Rett Syndrome Foundation
name: Rocky Mountain Rett Association
First posted: 2024-04-03
Enrollment: 80
Sex: MALE
Minimum age (years): 0
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: FAMILY_BASED
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Parents/caregivers to boys with Rett syndrome

Brief summary: The Diagnostic Experience of Male Rett Syndrome collects information on the lived experiences of parents or caregivers to boys with Rett Syndrome. Key information examined includes the process of getting a male Rett syndrome diagnosis, your son's systems of care, and your priorities for his health needs.

Enrolled participants will complete an online survey with questions about having a son with Rett Syndrome. The Diagnostic Experience of Male Rett Syndrome study is available to parents or caregivers to boys (alive or passed) with Rett Syndrome. Compensation is not provided.


Eligibility criteria: Inclusion Criteria:

* English-speaking parents (over the age of 18) of male children (all ages, alive or deceased) with confirmed genetic diagnosis of male RTT

Exclusion Criteria:

* parents of male MECP2 duplication syndrome

Primary outcomes:
measure: Diagnostic experiences
timeFrame: retrospective from birth
measure: Attainment of developmental milestones and any regressions
timeFrame: retrospective from birth
measure: QI-disability
timeFrame: retrospective over prior month
measure: Parent priorities for care and counseling
timeFrame: retrospective from birth
measure: Parenting experience
timeFrame: retrospective from birth
measure: Information regarding child's death, if applicable
timeFrame: retrospective from birth
Secondary outcomes:
measure: Family demographics
timeFrame: retrospective, over last 12 months
measure: Systems of supports
timeFrame: retrospective, over last 12 months
measure: Healthcare preferences
timeFrame: retrospective, over last 12 months
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Anschutz Medical Campus
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Timothy Benke, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03997006: Is Aminophylline More Effective Than Neostigmine/Atropine Mixture in the Treatment of Post-dural Puncture Headache
Official title: Is Aminophylline More Effective Than Neostigmine/Atropine Mixture in the Treatment of Post-dural Puncture Headache: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Post-Dural Puncture Headache
Keywords: Aminophylline
Atropine
Neostigmine
Post-dural puncture headache
Spinal anesthesia
Lead sponsor: Damanhour Teaching Hospital
Sponsor class: OTHER_GOV
First posted: 2019-06-25
Enrollment: 60
Sex: ALL
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Objectives: To compare the safety and efficacy of IV aminophylline versus IV neostigmine/atropine mixture in the treatment of post-dural puncture headache (PDPH).

Background: PDPH is the most frequent complication of procedures associated with dural puncture for spinal anesthesia or following accidental dural puncture during epidural anesthesia. Since invasive treatments have known complications, pharmacologic management may be preferable.

Patients and Methods: This was a prospective, randomized, double-blind, phase four clinical trial; carried out on 60 patients presented with PDPH at our hospital. Patients were randomly allocated into two equal groups (30 patients each); group A, received IV aminophylline, and group NA, received IV neostigmine/atropine mixture.


Eligibility criteria: Inclusion Criteria:

* Patients with NPRS score of ≥ 5
* American Society of Anesthesiologists (ASA) physical status ≤ II
* Age from 21 to 50 years

Exclusion Criteria:

* Patients with NPRS score \< 5
* ASA physical status \> II
* Age \< 21 years or \> 50 years
* Pregnant women
* History of; chronic headache, Cluster headache, Migraine
* History of; Convulsions, Cerebrovascular accident, Previous neurological diseases
* Signs of meningismus
* Bronchial asthma
* Arrhythmia
* Hypertension
* Ischemic heart disease
* Hyperthyroidism

Primary outcomes:
measure: Median and Range of Numeric Pain Rating Scale (NPRS) score
timeFrame: 48 hours after initiation of treatment
Secondary outcomes:
measure: Mean and Standard deviation of PDPH duration (hours) (mean±SD)
timeFrame: 48 hours after initiation of treatment
measure: Number of participants and Rate of Treatment-related complications
timeFrame: 48 hours after initiation of treatment
Other outcomes:
Locations:
city: Damanhūr
country: Egypt
facility: Damanhour Teaching Hospital
state: El-Beheira
Study officials:
affiliation: Damanhour Teaching Hospital
name: Ahmed M Shaat, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00926406: Environmental Exposure to Lead and Its Health Effects on Patients With Maintenance Hemodialysis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anemia
Malnutrition
Inflammation
Lead Poisoning
Keywords: Environmental lead exposure, maintenance hemodialysis; blood lead levels, EDTA chelating agents, malnutrition, anemia, inflammation, mortality.
To determine whether lead chelation therapy improves the anemia, malnutrition, inflammation, morbidity or mortality in hemodialysis patients.
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2009-06-23
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: One thousand patients with LHD who have no history of exposure to lead will be observed for 18 months. Blood lead level(BLL), biochemical data, hemoglobin, albumin, Cr, high sensitivity C-reactive protein (HsCRP), and blood cell counts are assessed at baseline. The morbidity and mortality are recorded in detail. Then, one hundred subjects with high BLL (\>20μg/dl) will be randomly assigned to the study and control groups. For 3-6 months, the 50 patients in the study group will receive lead-chelation therapy with calcium disodium EDTA weekly until the BLB falls below BLL\< 5 μg/dl, and the 50 control group patients receive weekly placebo for 12 weeks. During the ensuing 18 months, the BLL, biochemical data will be regularly followed up every 3 months. BLL is measured every 6 months. If BLL of the study group patients increase \>10 μg/dl, the chelation therapy will be performed again until their BLL is \<5 μg/dl. The primary end point is morbidity or mortality during the observation and follow-up period. A secondary end point is the change in hemoglobin, albumin, Cr and Hs CRP during the follow up period.


Eligibility criteria: Inclusion Criteria:

* MHD patients have dialyzed for more than 6 months and age \>18 and \< 90 year-old

Exclusion Criteria:

* Patients with malignancies and obvious infectious diseases as well as those who are hospitalized or underwent surgery or renal transplantation within the 3 months preceding the investigation;Patients with a history of occupational exposure to heavy metals, metal intoxication, living in metal-contaminated areas were also excluded.

Primary outcomes:
measure: The primary end point is morbidity or mortality during the follow-up period.
timeFrame: 18 months follow-up period
Secondary outcomes:
measure: A secondary end point is the change in HB, albumin, Cr and Hs CRP during the follow up period.
timeFrame: 18 months follow-up period
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
References:
Clinical trial NCT00565006: A Study to Investigate the Influence of MK0859 on Blood Pressure (MK-0859-012)(COMPLETED)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Ambulatory Blood Pressure
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2007-11-29
Enrollment: 22
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes

Brief summary: This study will investigate the influence of MK0859 on ambulatory blood pressure, and how safe and tolerable MK0859 is on the subjects This is an early phase trial and some specific protocol information is in progress and not publicly available at this time. (Full information is available to trial participants).


Eligibility criteria: Inclusion Criteria:

* You are between the ages of 45-75
* You are a man or non-pregnant woman
* You agree to not eat or drink fruit or fruit juices (orange, apple or grapefruit) for 2 weeks before starting study medication

Exclusion Criteria:

* You have smoked or used other nicotine-containing products (chewing tobacco) within the last 6 months
* You have used St. John's Wort or any products that include it within the last 2 weeks
* You have used herbal, organic, dietary or nutritional remedies within the last 2 weeks
* You have a history of drug allergies (anaphylaxis, angioedema)
* You have taken an investigational drug in another clinical trial within the last 4 weeks
* You have a history of cardiovascular disease including hypertension (high blood pressure)
* You have a history of renal disease
* You have a history of gall bladder disease or have had abnormal liver function tests
* You have a history of drug or alcohol abuse
* You drink more than 6 cups of caffeinated beverages a day (coffee, tea or cola)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Krishna R, Anderson MS, Bergman AJ, Jin B, Fallon M, Cote J, Rosko K, Chavez-Eng C, Lutz R, Bloomfield DM, Gutierrez M, Doherty J, Bieberdorf F, Chodakewitz J, Gottesdiener KM, Wagner JA. Effect of the cholesteryl ester transfer protein inhibitor, anacetrapib, on lipoproteins in patients with dyslipidaemia and on 24-h ambulatory blood pressure in healthy individuals: two double-blind, randomised placebo-controlled phase I studies. Lancet. 2007 Dec 8;370(9603):1907-14. doi: 10.1016/S0140-6736(07)61813-3.
Clinical trial NCT02804906: Rehabilitation in the Home Setting for Older Adults In the Early Period After Myocardial Infarction
Official title: Rehabilitation in the Home Setting for Older Adults In the Early Period After Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Myocardial Infarction (AMI)
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2016-06-17
Enrollment: 27
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This pilot feasibility study will test whether a home-based cardiac rehabilitation intervention, using physical therapist visits combined with mobile health technology, will prevent decline in high-risk patients post acute myocardial infarction (AMI). Participants will be randomized to either an intervention arm (home-based physical therapy), or a control (usual care) arm. Prior to discharge, participants in the intervention arm will receive a 1-hour educational session by a research physical therapist that includes information on cardiac risk factor management, postoperative recovery, education on medication adherence, and a prescription for home exercise that is tailored to each patient's baseline abilities and limitations. Participants assigned to the control arm will receive a 30-minute counseling session on risk factor modification prior to discharge, in addition to usual care post-AMI.

Detailed description: All participants enrolled in this research study will receive the FDA-approved FitBit Flex, a wearable activity monitoring device which will objectively measure physical activity and sedentary behavior in the period post-hospital discharge. Daily activity monitoring will include: number of steps, distance traveled, calories burned, number of active minutes.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of acute myocardial infarction (AMI).

Exclusion Criteria:

* moderate to severe cognitive impairment; non-ambulatory
* severe heart failure (NYHA Class IV); decisional impairment as assessed by the University of California
* San Diego Brief Assessment of Capacity to Consent (UBACC) 22, if the RC questions capacity; very limited life expectancy (e.g. anticipated discharge to hospice)
* non-English/non-Spanish speaking.

Primary outcomes:
measure: Activities of Daily Living (ADL) Decline
timeFrame: 5 Weeks
Secondary outcomes:
measure: Decline in self-perceived physical health (measured by SF-12 PCS)
timeFrame: 5 Weeks
measure: Mean time spent in sedentary activity
timeFrame: 5 Weeks
measure: Mortality Rate
timeFrame: 5 Weeks
measure: Hospital readmission rate
timeFrame: 5 Weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: New York University Medical School
name: John Dodson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02941406: MP3 (Microperimeter 3) Reproducibility in Healthy Subjects and Macular Patients
Official title: Reproducibility of Microperimetry Using Nidek MP3 (Microperimeter 3) in Healthy Subjects and Patients With Macular Disease - Pilot Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Macular Degeneration
Keywords: Retina
Perimetry
Lead sponsor: Vienna Institute for Research in Ocular Surgery
Sponsor class: OTHER
First posted: 2016-10-21
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 10 healthy subjects 20 macular patients

Brief summary: The aim of the present study is to investigate the reproducibility of the MP3 and to compare the results with conventional perimetry using the Octopus 101 in healthy subjects and patients with macular disease.


Eligibility criteria: Inclusion criteria for healthy subjects

* Men and Women aged 18 and older
* Written informed consent
* Normal findings in the medical history unless the investigator considers an abnormality to be clinically irrelevant
* Normal ophthalmological findings unless the investigator considers an abnormality to be clinically irrelevant

Inclusion criteria for macular disease patients

* Men and Women aged 18 and older
* Written informed consent
* Presence of a macular disease (such as dry or exudative age-related macular degeneration, diabetic maculopathy, epiretinal membrane)

Any of the following will exclude a subject from the study:

* Any opacities (corneal scar, dense cataract) which interferes with the study relevant measurements
* Visual acuity \< 0.1 (Snellen)

Primary outcomes:
measure: Reproducibility of retinal sensitivity measurements using microperimetry
timeFrame: Two measurement within one week
Secondary outcomes:
measure: Comparison of reproducibility of retinal sensitivity measurements assessed with microperimetry and conventional perimetry
timeFrame: Two measurement within one week
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Hanusch-Krankenhaus
Study officials:
affiliation: Vienna Institute for Research in Ocular Surgery
name: Oliver Findl, MD, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02344706: Diagnostic Value of Prehospital EEG in Non-convulsive Status Epilepticus
Official title: Diagnostic Value of Prehospital EEG in Non-convulsive Status Epilepticus
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Epilepsy
Status Epilepticus
Keywords: Emergency Care, Prehospital
Coma
Electroencephalography
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
First posted: 2015-01-26
Enrollment: 30
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: Patients unconscious due to seizures in the prehospital field

Brief summary: A large proportion of patients (up to 20%) who suffer from an epileptic seizure and remain unconscious suffer from a non-convulsive epileptic seizure. The condition is difficult to diagnose, and impossible without the required instruments. Electroencephalogram is required in the diagnosis of non-convulsive status epilepticus. Presently, the diagnostic value and implementation of such a device in the prehospital field is little studied. The aim of this study is to evaluate the diagnostic value of the acquired electroencephalogram with a prototype EEG/EKG adapter connected to a Physio-Control LifePak 15 defibrillator/monitor. The EEG is registered in a otherwise normal fashion with scalp-electrodes, but only three channels are monitored, as this is deemed sufficient for the prehospital field, as well as for monitoring the epileptic seizures.


Eligibility criteria: Inclusion Criteria:

* Unconsciousness due to seizures in the prehospital field

Exclusion Criteria:

* Cardiac arrest
* Traumatic unconsciousness

Primary outcomes:
measure: Diagnostic value of EEG
timeFrame: 60min
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Helsinki University Central Hospital
name: Tom Silfvast, MD, Phd
role: STUDY_DIRECTOR
affiliation: Helsinki University Central Hospital
name: Johannes Björkman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Helsinki University Central Hospital
name: Salmi Tapani, MD, PHD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00345306: Artificial Endometrial Preparation for Frozen Thawed Embryo Transfer Applying Either Endometrin or Utrogestan
Official title: Artificial Endometrial Preparation for Frozen Thawed Embryo Transfer Applying Either Endometrin or Utrogestan - a Clinical Comparative Study
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE4
Conditions: Frozen Thawed Embryo Transfer
Keywords: endometrial preparation
Utrogestan
Endometrin
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2006-06-28
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The transfer of frozen-thawed embryos can be performed in a natural ovulatory cycle or in a hormonally manipulated cycle with a comparable pregnancy rate of 15%-20% per ET. When a hormonally modulated ET cycle is scheduled,an artificial endometrial preparation is carried out using estrogen stimulation followed by a concomitant progesterone treatment. Two progestative drugs are currently used in conventional IVF treatment, Utrogetan and Endometrin. Although Endometrin has been be efficiently used to support the luteal phase after embryo transfer in IVF cycles, currently, there is no study that assess its efficacy for clinical use in frozen-thawed ET cycles. The present study aims to compare the outcome of frozen thawed ET cycles when either Endometrin or Utrogestan are used as the progestative substitution in an artificially prepared endometrium.


Eligibility criteria: Inclusion Criteria:

1. Patients undergoing frozen thawed ET cycles
2. Patient has at least two embryos suitable for transfer after thawing
3. Age 18-35 years -

Exclusion Criteria:

1. Any known sensitivity to Endometrin or Utrogestan
2. Endometrial thickness less than 7.5 mm after estrogen priming -

Primary outcomes:
measure: Pregnancy rates
Secondary outcomes:
measure: Lutheal hormonal profile
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
city: Jerusalem
country: Israel
facility: Simon Alex
Study officials:
affiliation: Hadassah University Hospital
name: Alex Simon
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01429506: Efficacy of Laparoscopic Sleeve Gastrectomy and Intensive Medical Management in Obese Type 2 Diabetes
Official title: Effect of Laparoscopic Sleeve Gastrectomy and Intensive Medical Management in Obese Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Obesity
Keywords: Sleeve gastrectomy
Intensive medical management
Lead sponsor: PIMERIndia
Sponsor class: UNKNOWN
First posted: 2011-09-07
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this the investigators will be comparing the effects of Laparoscopic sleeve gastrectomy with intensive medical management on weight and metabolic parameters.

Detailed description: Intensive medical management will include

1. VLCD
2. Physical activity
3. Exenatide
4. Metformin
5. Insulin detemir

Eligibility criteria: Inclusion Criteria:

Type 2 Diabetics with

1. BMI ≥ 27.5 kg/m2
2. HbA1c 7-10%
3. Age 20-70 years

Exclusion Criteria:

1. Prior gastric surgery
2. Pregnancy and lactation
3. renal disease (GFR \< 60 ml/min)
4. Pancreatitis
5. Symptomatic gallstone disease
6. Active malignancy
7. Secondary causes of obesity ( Cushing's syndrome, uncontrolled Hypothyroidism)
8. Severe psychiatric illness
9. Allergic reaction to exenatide

Primary outcomes:
measure: weight loss
timeFrame: 6 months
Secondary outcomes:
measure: glycemic control
timeFrame: 6 months
Other outcomes:
Locations:
city: Chandigarh
country: India
facility: PGIMER
Study officials:
affiliation: PGIMER
name: Anil Bhansali, DM, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05733806: Study on Gynecological Rare Cancers
Official title: Prospective, Multicenter, Observational Study on Rare Gynecological Cancers
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Gynecologic Cancer
Keywords: rare cancers
gynecologic malignancies
Lead sponsor: National Cancer Institute, Naples
Sponsor class: OTHER
First posted: 2023-02-17
Enrollment: 500
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with rare gynecological malignancies

Brief summary: This is a prospective, observational, multicenter study on gynecological rare tumors.

Detailed description: This is a prospective registry aimed to better understand prognosis, clinical and pathological features, management of this rare cancer conditions for improving standard of care.

Eligibility criteria: Inclusion Criteria:

* rare gynecological malignancies
* written informed consent
* patient fit for follow-up

Exclusion criteria

-written informed consent not provided

Primary outcomes:
measure: Prevalence of gynecologic rare malignancies
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Ginecologia e Ostetricia, IRCCS Ospedale San Raffaele
city: Naples
country: Italy
facility: IRCCS Fondazione G Pascale
Study officials:
affiliation: IRCCS Fondazione G Pascale, Naples
name: Francesco Perrone, MD
role: PRINCIPAL_INVESTIGATOR
References: