louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01426945: Protein Expression in Samples From Young Patients With Rhabdomyosarcoma
Official title: Evaluating Candidate Protein Expression in Human Rhabdomyosarcoma (RMS)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sarcoma
Keywords: alveolar childhood rhabdomyosarcoma
previously treated childhood rhabdomyosarcoma
previously untreated childhood rhabdomyosarcoma
recurrent childhood rhabdomyosarcoma
embryonal childhood rhabdomyosarcoma
Lead sponsor: Children's Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2011-09-01
Enrollment: 77
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children with rhabdomyosarcoma (RMS) enrolled in the Children's Oncology Group clinical trials

Brief summary: RATIONALE: Studying tissue samples from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors find better ways to treat cancer.

PURPOSE: This research trial studies protein expression in samples from young patients with rhabdomyosarcoma.

Detailed description: OBJECTIVES:

* To measure the protein expression of candidate proteins in human rhabdomyosarcoma (RMS) tumor samples.

OUTLINE: Archived tumor tissue samples are analyzed for protein expression (i.e., Notch1, Hey1, FGFR4, and Sp1) by IHC techniques and standard commercially available antibodies. Candidate proteins are then correlated with each patient age, gender, rhabdomyosarcoma (RMS) tumor stage, and RMS tumor subtype.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Tumor tissue samples from children with rhabdomyosarcoma (RMS) enrolled in the Children's Oncology Group clinical trials

  * Alveolar rhabdomyosarcoma (ARMS)
  * Embryonal rhabdomyosarcoma (ERMS)

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified

Primary outcomes:
measure: RMS protein expression profile
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Duke Cancer Institute
name: Corinne M. Linardic, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06701045: Prevalence of Malnutrition and Frailty Among the Urban Community Elderly in Bandung
Official title: Prevalence of Malnutrition and Frailty Among the Urban Community Elderly in Bandung
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Frail Elderly
Keywords: frail
elderly
malnutrition
community
Lead sponsor: Universitas Padjadjaran
Sponsor class: OTHER
First posted: 2024-11-22
Enrollment: 71
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The subject were taken form in each district there were a community health center that has an program integrated program specialized for elderly in each subdistrict. We took the subject samples from elderly that regularly visit this subdistrict program.

Brief summary: The goal of this observational study is to learn prevalence of malnutrition and frailty in elderly in Community in Bandung. The main question it aims to answer:

what is the prevalence of malnutrition and frailty in elderly in Bandung community?

Detailed description: The increase in the number and proportion of the elderly population poses various challenges, especially in the health sector. The elderly tend to be more vulnerable to health problems, such as malnutrition and frailty. Data on the prevalence of malnutrition and frailty in the elderly can be used as a basis for taking preventive and treatment measures for both conditions. This study aims to determine the prevalence of malnutrition and frailty in the elderly in the Bandung City community.

Descriptive research with a cross-sectional approach was conducted on 71 elderly participants in the Bandung City community. The sampling method used was consecutive sampling. The study used the Mini Nutritional Assessment-Short Form (MNA-SF) questionnaire to assess malnutrition and the Kihon Checklist (KCL) to assess frailty.

Eligibility criteria: Inclusion Criteria:

* age above 60 years old
* domicile in Bandung City
* able to mobilize without assistive devices
* able to see and read
* willing to participate in the study

Exclusion Criteria:

* history of hospitalization within the previous month
* Mini Mental Status Examination ( MMSE ) score \< 24

Primary outcomes:
measure: Frailty
timeFrame: On enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Bandung
country: Indonesia
facility: Community Health Center
state: West Java
Study officials:
References:
Clinical trial NCT03564145: A Long-Term Safety Study of S5G4T-1 in the Treatment of Papulopustular Rosacea
Official title: A Multi-Center, Open-Label, Long-Term Safety Study of S5G4T-1 to Evaluate the Safety of S5G4T-1 in Papulopustular Rosacea Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Papulopustular Rosacea
Lead sponsor: Sol-Gel Technologies, Ltd.
Sponsor class: INDUSTRY
First posted: 2018-06-20
Enrollment: 547
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To assess the safety of S5G4T-1 when applied once daily for up to 40 weeks in participants with papulopustular rosacea who completed either Study SGT-54-01 (NCT03448939) or Study SGT-54-02 (NCT03564119).

Detailed description: This is a long-term safety study for participants who completed either study SGT-54-01 or SGT-54-02. Participants will be admitted into the study only after a written informed consent has been obtained and not missing more than 1 visit of Visits 3, 4 or 5 in these studies. Eligible participants for enrollment will apply the study product, S5G4T-1, daily for up to an additional 40 weeks for a total of up to 52 weeks for some participants.

Eligibility criteria: Inclusion Criteria:

1. Participants must sign an Institutional Review Board (IRB) approved written informed consent for the extension study.
2. Participants must complete 12 weeks or within the Week 12 window time (± 4 days) of the double-blind treatment period of Study SGT-54-01 or Study SGT-54-02 and missed not more than 1 visit of Visits 3, 4 or 5 in Study SGT-54-01 or Study SGT-54-02.

Exclusion Criteria:

-

Primary outcomes:
measure: Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Baseline up to Week 52
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Sol-Gel
state: New York
Study officials:
References:
Clinical trial NCT02278445: Evaluation of Pulmonary Doppler Signals in Patients With Systemic Sclerosis(SSc)
Official title: Evaluation of Lung Doppler Signals (LDS) in Detecting Pulmonary Arterial Hypertension in Patients With Systemic Sclerosis (SSc)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Systemic Sclerosis
Pulmonary Hypertension
Keywords: Systemic Sclerosis
Pulmonary hypertension
Lung Doppler Signals
Lead sponsor: Echosense Ltd.
Sponsor class: INDUSTRY
First posted: 2014-10-30
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Doppler signals can be recorded from the lung parenchyma by means of a pulsed Doppler ultrasound system incorporating a special signal processing package- the Transthoracic Parametric Doppler (TPD) (Echosense Ltd., Haifa, Israel). Systemic sclerosis patients often develop pulmonary vascular disease leading to pulmonary hypertension. The TPD system may provide important insight into pulmonary blood vessels characteristics by the LDS (Lung Doppler Signals) signals that are related to pulmonary hypertension. The TPD performance in detecting PAH in SSc patients will be assessed in the study.


Eligibility criteria: Inclusion Criteria:

1. Able and willing to give signed informed consent prior to enrollment
2. Male or female, ≥ 18 years of age
3. Diagnosis of SSc according to 2013 ACR/EULAR SSc Classification Criteria (van den Hoogen 2013): Score ≥ 9.
4. Patients with RHC data available from measurement within 3 weeks prior to TPD assessment
5. No change in or initiation of PAH specific therapy between the last RHC and TPD

Exclusion Criteria:

1. People unable or unwilling to give informed consent.
2. PCWP or LVEDP \> 15 mmHg
3. Any PH etiology outside Group 1 (Dana Point, 2008)
4. Pregnant women
5. Patients having severe chest wall deformity

Primary outcomes:
measure: Number of SSc patients correctly identified with pulmonary hypertension severity in each of the 4 defined groups by RHC.
timeFrame: 12 month
Secondary outcomes:
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: Sheba Medical Center, Pulmonology department
Study officials:
affiliation: Sheba medical center, Rheumatology department
name: Merav Lidar, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03670745: Patient-centered Approaches to Provider and Adolescent Reproductive Health Communication and Shared Decision-making
Official title: Patient-centered Approaches to Provider and Adolescent Reproductive Health Communication and Shared Decision-making
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Reproductive Behavior
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2018-09-14
Enrollment: 10
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This project will utilize a sequential explanatory research design, with an embedded randomized controlled trial (RCT) intervention .
Primary purpose: SUPPORTIVE_CARE

Brief summary: Determine the effectiveness of an electronic self-administered pre-visit planning tool allowing adolescents to list areas of concern to support shared decision-making and communication during an office visit through a randomized controlled trial (RCT).

Detailed description: Aim 1: Through qualitative data collection, characterize perspectives of adolescent girls and providers regarding the feasibility and acceptability of an electronic self-administered pre-visit planning tool allowing adolescents to list areas of concern to support shared decision-making and communication during an office visit. Interviews will also explore approaches to implement and evaluate such a tool.

Aim 2: Determine the effectiveness of the tool through a randomized controlled trial (RCT).

Aim 3: Synthesize outcomes, identify opportunities for improvement and plan next steps in both research, and if the tool works well, implementation.

Eligibility criteria: Inclusion Criteria:

* Inclusion criteria for adolescent girls: between the ages of 14-18 years old, English-speaking, and a patient of a provider affiliated with the Yale New Haven Hospital.
* Inclusion criteria for healthcare providers are: a provider the Yale New Haven Hospital who regularly sees adolescent patients.

Exclusion Criteria:

* Exclusion criteria for adolescent girls: currently pregnant, or who have an impairment that would prevent them from completing the tool and survey.

Primary outcomes:
measure: Sexual and Reproductive Health Knowledge Scale
timeFrame: up to 2 weeks after appointment
measure: Contraceptive intentions
timeFrame: up to 2 weeks after appointment
measure: Communication with provider
timeFrame: up to 2 weeks after appointment
Secondary outcomes:
measure: Sources of sexual and reproductive health knowledge
timeFrame: up to 2 weeks after appointment
Other outcomes:
measure: Use and perceptions of healthcare services
timeFrame: up to 2 weeks after appointment
Locations:
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
Study officials:
affiliation: Yale University
name: Marie Brault, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06600945: Atracurium Versus Atracurium and Magnesium Sulphate As Adjuvants to Local Anesthetic
Official title: Atracurium Versus Atracurium and Magnesium Sulphate As Adjuvants to Local Anesthetic for Peribulbar Anesthesia in Cataract Surgery
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Peribulbar Anesthesia
Lead sponsor: Minia University
Sponsor class: OTHER
Collaborators: name: Minia University
First posted: 2024-09-19
Enrollment: 180
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Both sexes and from 20 to 80 years

Brief summary: To evaluate the effects of adding magnesium sulfate to atracurium with local anesthetic mixture on akinesia of globe and eyelid regarding onset and duration in cataract surgery using peribulbar technique

Detailed description: Regional anesthesia is a preferred technique for ophthalmic surgery. It's safe, inexpensive and provides efficient ocular anesthesia for ophthalmic surgery.

Among regional blocks, peribulbar block is safe to retrobulbar block due to lesser incidence of series complications such as brain-stem anesthesia globe perfusion and retrobulbar hemorrhage .

The effect of non-depolarizing neuromuscular blockers on peribulbar anesthesia has been described in many studies. According to these studies the use of atracurium as adjuvant to peribulbar anesthesia provides early onset of akinesia and improves the quality of anesthesia in absence of any adverse effect.

Magnesium sulphate is non-competitive N-Methyl-D- Aspartate (NMDA) antagonism and calcium channel blocker. Magnesium has endothelium derived Nitric Oxide induced vasodilation. It enhanced the activity of local anesthetic agent and improves the quality of anesthesia .

Eligibility criteria: Inclusion Criteria:

* Patients undergoing elective cataract surgery (phacoemulsification and intraocular lens implantation).

Patients aged 20-80 years. Both sexes. ASA physical status I\&II.

Exclusion Criteria:

- Refusal of the patient to participate in the study. Any disorder of neuromuscular system known from history or clinical examination e.g., Guillarian barre syndrome, Myasthenia gravies and Myopathies.

Patients are known to have a history of fits. Patients on medication known to interact with neuromuscular blocking drugs as antipyretics (aminoglycosides and tetracyclines), antiarrhythmic (quinidine).

Local sepsis. Coagulation abnormalities (INR\>1.4). High myopia with axial length more than 30 mm or less than 21. Mentally retarded patients and failure of proper communication as in deafness. Morbidly obese patients (BMI\>40). Patients with glaucoma (increased IOP\>20mmgh). Patients with history of hypersensitivity to study drugs. Very dense or very soft cataract .

Primary outcomes:
measure: Block quality
timeFrame: Baseline
Secondary outcomes:
measure: Block Success
timeFrame: Baseline
Other outcomes:
Locations:
city: Minya
country: Egypt
facility: Dalia yousry mohamed
Study officials:
References:
Clinical trial NCT03217045: Nutrition Protocol and Premature Infants' Growth
Official title: Impact of Introducing a Standardized Nutrition Protocol on Very Premature Infants' Growth and Morbidity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Premature Infants
Nutrition Deficiency Due to Insufficient Food
Growth Retardation
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2017-07-13
Enrollment: 158
Sex: ALL
Minimum age (years): 1
Maximum age (years): 77
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All infants born between 26 to 32 weeks gestation and admitted to our level III NICU were eligible and included in the study

Brief summary: Nutrition is a major issue for premature infants. Inappropriate nutritional intake during the first weeks of life is responsible for postnatal growth restriction and adverse long-term outcomes.

This study aimed at evaluating the impact of the introduction of an updated, standardized, nutrition protocol on very premature infants' growth and morbidity, and the care givers' compliance to the new protocol.


Eligibility criteria: Inclusion Criteria:

* All surviving infants born between 26 and 32 weeks gestation in our Level III NICU

Exclusion Criteria:

* Death
* Any congenital malformation

Primary outcomes:
measure: weight
timeFrame: weekly recording from Day 0 up to Day 77
Secondary outcomes:
measure: Necrotizing enterocolitis
timeFrame: Day 77 postnatal age
measure: late onset sepsis
timeFrame: Day 77 postnatal age
measure: patent ductus arteriosus
timeFrame: Day 77 postnatal age
measure: Bronchopulmonary dysplasia
timeFrame: Day 77 postnatal age
measure: Central venous catheters.
timeFrame: Day 77 postnatal age
measure: Compliance to the protocol
timeFrame: weekly recording from Day 0 up to Day 77
Other outcomes:
Locations:
Study officials:
References:
citation: Wittwer A, Hascoet JM. Impact of introducing a standardized nutrition protocol on very premature infants' growth and morbidity. PLoS One. 2020 May 21;15(5):e0232659. doi: 10.1371/journal.pone.0232659. eCollection 2020.
Clinical trial NCT03813745: Timing of COC Denudation and Embryo Quality
Official title: Timing of COC Denudation and Embryo Quality: A Prospective Randomised Sibling-Oocyte Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Infertility, Female
Keywords: embryo quality
denudation
IVF
ICSI
Lead sponsor: Acıbadem Atunizade Hospital
Sponsor class: OTHER
First posted: 2019-01-23
Enrollment: 100
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Those infertile patients eligible for the study design who are planned to be treated with microinjection and has given written informed consent

Brief summary: The relation between the timing of COC denudation and oocyte /embryo quality is controversial. The aim of this study is to examine whether timing of denudation of sibling oocytes has any effect on embryo quality.

Detailed description: Retrieved sibling cumulus-oocyte complexes (COCs) will be randomly divided into two groups, in the first group denudation will be in 30 minutes after oocyte retrieval, in second group denudation will take place after 2 hours of incubation.

Eligibility criteria: Inclusion Criteria:

* COH with GnRH antagonist cycle
* 5 or more oocytes collected

Exclusion Criteria:

* Fewer than 4 oocytes after retrieval
* Previous history of total fertilization failure or oocyte maturation arrest
* Male partner requiring surgical sperm retrieval (MESA or TESA).

Primary outcomes:
measure: Number of good quality cleavage embryos
timeFrame: 3 days after microinjection
measure: Embryo utilization rate
timeFrame: 1 week after microinjection
Secondary outcomes:
measure: Fertilization rate
timeFrame: 16-18 hour after microinjection
measure: Cleavage rate
timeFrame: 2 days after microinjection
measure: Blastulation rate
timeFrame: 1 week after microinjection
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Acibadem Altunizade Hospitai
Study officials:
References:
Clinical trial NCT00147745: Effects of Colesevelam on How the Body Responds to Insulin in Patients With Type 2 Diabetes
Official title: Effects of Colesevelam on Insulin Sensitivity in Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type 2 Diabetes
Keywords: Mechanism of action insulin sensitivity
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
First posted: 2005-09-07
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is designed to assess the potential mechanism of action by which WelChol® (colesevelam) may improve blood glucose control in patients with type 2 diabetes


Eligibility criteria: Inclusion Criteria:

* Patients between the ages of 18 - 75, inclusive
* Diagnosed with type 2 diabetes
* Hemoglobin A1c value greater than or equal to 8.0%
* Antidiabetic treatments may include sulfonylurea agents (non-sulfonylurea agents must be withdrawn)
* Overweight, obese (body mass index 25-45 kg/m2)

Exclusion Criteria:

* Change of dose of lipid or blood pressure lowering therapy within past three months
* Previous treatment with colesevelam for hyperlipidemia
* Serum triglyceride greater than 500 mg/dL
* Serum low density lipoprotein-cholesterol less than 60 mg/dL

Primary outcomes:
measure: Difference in Endogenous (Hepatic) Glucose Output During a High-dose Insulin Infusion From Baseline to After 12 Weeks of Treatment.
timeFrame: Baseline to 12 weeks
measure: Difference in Endogenous (Hepatic) Glucose Output During a Low-dose Insulin Infusion From Baseline to Week 12.
timeFrame: Baseline to 12 weeks
measure: Acute Effect of a Single Dose of Colesevelam on Oral Glucose Absorption From Baseline to First Dose
timeFrame: Baseline (Day -4) to first dose (Day 1)
Secondary outcomes:
measure: The Acute Effect of Colesevelam (Multiple Doses) on Oral Glucose Absorption From Baseline to 12 Weeks
timeFrame: Baseline to 12 weeks
measure: Change in Hemoglobin A1C Due to Effect of Colesevelam From Baseline to 12 Weeks
timeFrame: Baseline to 12 weeks
Other outcomes:
Locations:
city: San Diego
country: United States
facility: San Diego VMC
state: California
Study officials:
References: