louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05090917: Growth Curves in Cockayne Syndrome Type 1 and Type 2
Official title: Development of Growth Curves in Cockayne Syndrome Type 1 and Type 2
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cockayne Syndrome, Type I and II
Keywords: Cockayne Syndrome
Cockayne Syndrome, Type I and II
Growth curves
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2021-10-25
Enrollment: 85
Sex: ALL
Minimum age (years): 1
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Minor patient with cockayne syndrome with molecular confirmation, treated between 01/01/1985 and 01/03/2020

Brief summary: Despite the natural progression of Cockayne's syndrome, affected patients also present with variable neurological and gastrointestinal damage (gastroesophageal reflux, recurrent vomiting, swallowing disorders, etc.) with varying repercussions on their growth. Acute intercurrent events such as seizures, constipation, infections can also interact with their metabolism, food intake and influence their growth. The nutritional deficit potentially involved in this growth retardation can be responsible for many manifestations such as anemia, bone fractures, fatigue, coagulation disorders responsible in total for the reduction in quality and life expectancy.

Faced with growth retardation in patients with Cockayne syndrome, medical management is difficult to establish. Is this delay part of the natural course of the pathology?


Eligibility criteria: Inclusion criteria:

* Minor patient
* Cockayne syndrome with molecular confirmation, treated between 01/01/1985 and 01/03/2020
* Collection of at least one growth data (height, weight, head circumference) for a given age
* Clinic compatible with type 1 or 2 Cockayne syndrome
* Holder of parental authority not opposing, after information, the reuse of their child's medical data for the purposes of this scientific research.

Exclusion criteria:

* Refusal to participate in the study.
* Lack of molecular confirmation of Cockayne syndrome
* Lack of growth data for a given age.
* Clinic not compatible with type 1 or 2 Cockayne syndrome. Exclusion of type 3 Cockayne syndromes, trichothiodystrophy and xeroderma-pigmentosum.

Primary outcomes:
measure: Development of growth curves in Cockayne syndrome type 1 and type 2 from existing medical data
timeFrame: Files analysed retrospectively from January 01, 1985 to March 01, 2020 will be examined]
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Pédiatrie1 - Hôpitaux Universitaires de Strasbourg
Study officials:
affiliation: Service de Pédiatrie1 - Hôpitaux Universitaires de Strasbourg
name: Vincent LAUGEL, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00094341: Preference of Rheumatoid Arthritis (RA) Patients of Enbrel® (Etanercept) Auto-Injector Versus Enbrel® Pre-Filled Syringes
Official title: An Open-Label, Randomized, Crossover Study to Assess Preference of Rheumatoid Arthritis (RA) Patients of Enbrel® (Etanercept) Auto-Injector Versus Enbrel® Pre-Filled Syringes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Rheumatoid Arthritis
Keywords: Arthritis
Rheumatology
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2004-10-18
Enrollment: 215
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the preference of RA patients for the new Enbrel® (etanercept) pre-filled syringe in patients who are already taking Enbrel®.


Eligibility criteria: Inclusion Criteria:

* Have established RA diagnosis as determined by ACR criteria
* Be current user of etanercept-lyophilized preparation for at least 4 consecutive weeks of etanercept dosing on either a once weekly or twice weekly regimen
* Subject must be able to self inject
* Give written informed consent

Exclusion Criteria:

* Subject is currently enrolled in or has not yet completed at least 30 days since ending other investigational device or drug trial(s), or subject is receiving other investigational agent(s)
* Subject of childbearing potential is pregnant (e.g., positive HCG test) or is breast-feeding
* Elective surgery is planned during study period
* Subjects allergic to latex

Primary outcomes:
measure: The proportion of patients preferring the etanercept auto-injector to the etanercept pre-filled syringe.
Secondary outcomes:
measure: The proportion of patients preferring the etanercept auto-injector to the etanercept pre-filled syringe as well as to the lyophilized preparation in the following categories:
measure: Ease of use
measure: Hand discomfort during the injection
measure: Satisfaction with number of steps
measure: Time involved with the injection
measure: Nervousness with injection
measure: Confidence with the injection
measure: Convenience of use and
measure: Overall preference with the auto-injector or pre-filled syringes compared to the lyophilized preparation.
measure: To characterize the ability of patients to properly use by themselves either device independently and identify any sections of the instructions that were not clear, that may have led to loss of sterility to incomplete dosing
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00447941: Safety, PK and PD Study in Healthy Male Japanese Subjects
Official title: Randomized, Double-blind, Placebo-controlled, Ascending Multiple Dose Study of the Safety, Pharmacokinetics, and Pharmacodynamics of Sca-136 Administered Orally to Healthy Male Japanese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Schizophrenia
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2007-03-15
Enrollment: 24
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Study assessing pharmacokinetics, pharmacodynamics, safety, and tolerability of oral doses of SCA-136 in healthy male Japanese subjects


Eligibility criteria: Inclusion Criteria

* Men aged 20 to 45 years at the time of obtaining informed consent.
* Body mass index (BMI) in the range of 18.5 to 25.0 kg/m2 and body weight ≥ 50 kg.
* Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and 12-lead electrocardiogram (ECG).

Exclusion Criteria

* Presence or history of any disorder that may prevent the successful completion of the study.
* Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
* Any surgical or medical condition that may interfere with the absorption, distribution, metabolism, or excretion (ADME) of the test article (eg, resection of liver, kidney, or gastrointestinal tract).

Primary outcomes:
measure: safety and tolerability
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT02728141: Healthy Infant Development Project - Sucrose Component
Official title: Timing, Duration and Severity of Infant Iron Deficiency: Developmental Impacts - Sucrose Component
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Iron Deficiency
Lead sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Sponsor class: NIH
First posted: 2016-04-05
Enrollment: 424
Sex: ALL
Minimum age (years): 1
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL

Brief summary: Iron deficiency affects the opioid and dopamine systems in rodent models, with a higher pain threshold. The opioid system is involved in sucrose's ability to reduce pain and distress during neonatal procedures. Thus, prenatal iron deficiency might affect response to pain and sucrose analgesia. In order to compare response to pain and sucrose during heel stick in neonates with and without iron deficiency, healthy full-term Chinese infants were randomized to receive sucrose or water by syringe beforehand, in conjunction with heel stick for metabolic screening.


Eligibility criteria: Inclusion Criteria:

* Full term healthy neonates participating in the Healthy Infant Development RCT (NCT00613717) in the folic acid/early postnatal placebo group and pre- and early postnatal iron-supplemented infants.

Exclusion Criteria:

* birth weight \< 2500 g gestational age ≤ 37 wk major perinatal complications major congenital anomaly multiple birth

Primary outcomes:
measure: Infant behavior (emotion regulation)
timeFrame: up to 5 days old
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University First Hospital
Study officials:
affiliation: University of Michigan
name: Betsy Lozoff, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lumeng JC, Li X, He Y, Gearhardt A, Sturza J, Kaciroti NA, Li M, Asta K, Lozoff B. Greater analgesic effects of sucrose in the neonate predict greater weight gain to age 18 months. Appetite. 2020 Mar 1;146:104508. doi: 10.1016/j.appet.2019.104508. Epub 2019 Nov 4.
Clinical trial NCT01745341: Rates of Apnea in Patients Undergoing Vitreoretinal Surgery
Official title: Rates of Apnea in Patients Undergoing Vitreoretinal Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Apnea
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2012-12-10
Enrollment: 113
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients having vitreoretinal surgery under monitored anesthesia care

Brief summary: The purpose of this study is to determine if apnea (the stopping of breathing) occurs in patients undergoing undergoing monitored anesthesia care (MAC) for vitreoretinal surgery

Detailed description: Patients undergoing vitreoretinal surgery will be monitored during the procedure to determine if they stop breathing. This study is observational in nature and no interventions will be made.

Eligibility criteria: Inclusion Criteria:

* patients having vitreoretinal surgery under monitored anesthesia care

Exclusion Criteria:

* patients having vitreoretinal surgery without monitored anesthesia care

Primary outcomes:
measure: Apnea
timeFrame: 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford Hospital and Clinics
state: California
Study officials:
References:
Clinical trial NCT06054841: Reshaping Postpartum Follow-up
Official title: Reshaping Postpartum Follow-up in Women With High Risk Pregnancies
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hypertension in Pregnancy
Gestational Diabetes
Cervical Dysplasia
Keywords: Postpartum followup
hypertensive disorders of pregnancy
eclampsia
pre-eclampsia
pap smear
gestational diabetes
Lead sponsor: Medstar Health Research Institute
Sponsor class: OTHER
First posted: 2023-09-26
Enrollment: 240
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study is to evaluate the impact of personalized postpartum follow-up cards on completion of postpartum health related tasks. The intervention will consist of a card given to patients at time of discharge. One side of the card will list the patient's name and a list of recommended postpartum follow-up appointments based on their diagnoses at the time of discharge. Participants will be randomized to this intervention or the control group, which will consist of standard education routinely given at discharge.

The primary endpoint will be the rate of completion of a postpartum blood pressure check or two hour glucose tolerance test, or both, depending on the patient's discharge diagnosis within the first year after discharge. The secondary endpoints will include establishing care with a primary care provider within the first year after delivery, or completion of postpartum pap smear or colposcopy, as indicated.


Eligibility criteria: Inclusion Criteria:

* Subjects \>=18 years of age
* Ability to read English or Spanish
* Delivered via vaginal delivery or c-section within the past 48 hours
* Able to consent for themselves

Exclusion Criteria:

* Received antepartum care at a facility outside of the Medstar system or plans to continue care with a facility outside of the Medstar system

Primary outcomes:
measure: Blood pressure check
timeFrame: 6 months
measure: Two hour glucose tolerance test
timeFrame: 6 months
Secondary outcomes:
measure: Cervical cancer screening
timeFrame: 6 months
measure: Primary care
timeFrame: 6 months
Other outcomes:
Locations:
city: Washington
country: United States
facility: Washington Hospital Center
state: District of Columbia
Study officials:
References:
Clinical trial NCT01095341: Postoperative Hyperthyroidism
Official title: Postoperative Hyperthyroidism After Parathyroidectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hyperthyroidism
Keywords: hyperthyroidism
tertiary hyperparathyroidism
palpation thyroiditis
parathyroidectomy
thyroglobulin
rate of postoperative hyperthyroidism
Lead sponsor: Heidelberg University
Sponsor class: OTHER
First posted: 2010-03-30
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with tertiary hyperparathyroidism undergoing surgery for this reason

Brief summary: The purpose of this study is to evaluate the frequency and the clinical course of postoperative hyperthyroidism following surgery of tertiary hyperparathyroidism (THP) and to determine the diagnostic value of thyroglobulin in this setting.


Eligibility criteria: Inclusion Criteria:

* patients with tertiary hyperparathyroidism undergoing surgery for this reason
* dialysis treatment

Exclusion Criteria:

* patients wish

Primary outcomes:
measure: Hyperthyroidism
Secondary outcomes:
measure: Thyroglobulin elevation
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: University Hospital Heidelberg
Study officials:
affiliation: University Hospital Heidelberg Germany
name: Gottfried Rudofsky, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rudofsky G Jr, Grafe IA, Metzner C, Leowardi C, Fohr B. Transient post-operative thyrotoxicosis after parathyroidectomy. Med Sci Monit. 2009 Mar;15(3):CS41-3.
Clinical trial NCT03348241: Using Gum Arabic for Cancer Patients to Protect From Oral Mucositis Caused by Chemotherapy: ِِِAn Experimental Study
Official title: Randomized Controlled Trial on the Effect of Gum Arabic to Reduce Incidence of Oral Mucositis Induced by Chemotherapy for Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chemotherapy-induced Oral Mucositis
Keywords: Gum Arabic
Cancer patients
Chemotherapy
Oral mucositis
Lead sponsor: University of Science and Technology, Yemen
Sponsor class: OTHER
First posted: 2017-11-20
Enrollment: 386
Sex: ALL
Minimum age (years): 14
Maximum age (years): 83
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is an experimental study. It was a two-arm randomized, controlled, open-label trial. The patients was categorized into two groups; study group and control group. Patients of study group was received a dose of 30 grams Gum Arabic per day as oral solution (dissolved in 250 ml purified water) for six weeks along with the chemotherapy prescribed, while patients of control group was received only chemotherapy regimen.
Primary purpose: PREVENTION

Brief summary: This study was designed to investigate the effect of Gum Arabic (GA) on cancer patients to prevent chemotherapy-induced oral mucositis. Cancer patients who will receive chemotherapy were divided into two groups; study "Gum Arabic" group (which received GA with chemotherapy) and control group (chemotherapy alone); and the participants were recruited to reach 190 patients in the study group and 184 patients in control group. This clinical trial was conducted in outpatient chemotherapy sections at Radiation and Isotopes Center of Khartoum. This study was designed to test the theory that say the chemotherapy-induced oral mucositis will significantly decrease after ingestion 30 grams as daily dose of Gum Arabic in a form of solution for six weeks during therapy.


Eligibility criteria: Inclusion Criteria:

* Patients whom well diagnosed with cancer in any stage were eligible for enrolment if chemotherapy is part of their treatment plan.

Exclusion Criteria: Patients were excluded if

* they had received recent previous chemotherapy or radiotherapy,
* they had oral mucositis or periodontitis,
* there is evidence of any systemic diseases.

Primary outcomes:
measure: The effect of Gum Arabic to prevent Chemotherapy-induced Oral Mucositis was the primary outcome that assessed using World Health Organization Mucositis Scoring.
timeFrame: Six weeks for each participant from starting therapy.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Science and Technology
name: Abdulrazzaq Y. Al khazzan, MClinPharm
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04405141: Uroflowmetry Results and Vitamin D Levels
Official title: The Relationship Between Vitamin D Level and Lower Urinary Tract Symptoms in Women
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lower Urinary Tract Symptoms
Vitamin D Deficiency
Calcium Deficiency
Keywords: Lower Urinary Tract Symptoms
Vitamin D Deficiency
Calcium Deficiency
Lead sponsor: Umraniye Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2020-05-28
Enrollment: 186
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Female patients with low urinary tract symptoms.

Brief summary: The investigators aimed to evaluate the relationship between LUTS and vitamin D with uroflowmetry parameters in female patients. They found no relation between vitamin D levels and LUTS in respect to uroflowmetry. However, in low vitamin D patients, Ca is related with urologic problems. The investigators believe that there is a need for studies emphasizing serum Ca levels in addition to vitamin D levels in patients with LUTS.

Detailed description: This retrospective cohort study included 186 female patients who admitted to LUTS. Demographic characteristics, medical history, calcium (Ca) and vitamin D including laboratory studies and uroflowmetry results as maximum urine flow rate (Qmax), average urine flow rate (Qav), and voided volume (V) were recorded. Patients were divided into two groups according to age (18-50 and ≥51) and vitamin D levels (\<20 and ≥20).

Laboratory parameters, uroflowmetry results, were compared between groups.

The study was approved by the local ethics committee (approval#22/06/2018-09.29-54132726-000-14136). The study was conducted in accordance to the Helsinki Declaration and Good Clinical Practices Guidelines.

Eligibility criteria: Inclusion Criteria:

Clinical diagnosis of low urinary tract symptom

Exclusion Criteria:

Urinary tract infection, Diabetes mellitus, Neurological disorder, Pregnancy Stone disease Other urinary system disorders.

Primary outcomes:
measure: Uroflowmetry Results
timeFrame: 12 months
Secondary outcomes:
measure: Vitamin D Levels
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04376541: Fast Tracking Impact on Fentanyl Consumption and Parents Satisfaction
Official title: Fast Tracking Impact on Fentanyl Consumption and Parents Satisfaction in Non Complex Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fentanyl Adverse Reaction
Caudal Anesthesia
Keywords: fast track
congenital cardiac surgery
caudal
fentanyl
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2020-05-06
Enrollment: 70
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients diagnosed with congenital cardiac anomaly for surgical correction from 3months to 18 years of age

Brief summary: The investigators are measuring fentanyl consumption in micrograms used during anesthesia for patients on fast track congenital cardiac surgeries

Detailed description: The investigators are measuring fentanyl consumed for both fast track and conventional corrective cardiac surgeries and also parents Parental Perceptions satisfaction with early child communication in ICU and impact of caudal anesthesia on extubation time our 2ry outcomes are the hospital and ICU length of stay

Eligibility criteria: Inclusion Criteria:

* patients diagnosed with congenital cardiac anomaly for surgical correction.
* age limit: child 3months of age to 18 years

Exclusion Criteria:

patients with any o the following:

* emergency surgeries
* redo surgeries
* complex surgeries
* patients weight less than 3kg

Primary outcomes:
measure: fentanyl consumption
timeFrame: during the procedure (corrective surgery)
measure: parents satisfaction: questionnare
timeFrame: after discharge from the ICU up to 1 week
Secondary outcomes:
measure: intensive care length of stay
timeFrame: after departure from operation room until ward discharge up to 3 weeks
measure: hospital length of stay
timeFrame: from admission until home discharge up to 4 weeks
Other outcomes:
Locations:
Study officials:
References: