louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02312076: GnRHa for Luteal Phase Support in Long GnRHa Protocol Cycles
Official title: Gonadotropin Releasing Hormone Agonist for Luteal Phase Support in Long Gonadotropin Releasing Hormone Agonist Protocol Cycles
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Infertility
Keywords: Luteal phase support, ICSI, GnRHa
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2014-12-09
Enrollment: 200
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evaluation of the effect of adding a single dose of gonadotropin releasing hormone agonist (GnRHa) as a luteal phase support on the outcomes of intracytoplasmic sperm injection (ICSI) following long GnRHa protocol

Detailed description: Endometrial preparation for embryo transfer (ET) will be started after oocyte retrieval by giving 800 mg/day natural progesterone vaginal supplement + 4 mg/day estradiol oral supplement. The patients will be randomly divided into 2 groups for luteal phase support: (i) Group A (GnRHa group) in which the luteal phase support will be continued by the same regimen started on the day of oocytes retrieval until 2 weeks after embryo transfer (ET) with subcutaneous administration of a single dose (0.2 mg) of GnRHa (Triptorelin) 6 days after oocyte retrieval, and (ii) Group B (control group) in which the luteal phase support will be continued only by the same regimen started on the day of oocytes retrieval until 2 weeks after ET

Eligibility criteria: Inclusion Criteria:

* Women subjected to ICSI through controlled ovarian hyperstimulation (COH) with pituitary downregulation by GnRHa.

Exclusion Criteria:

* Moderate or severe endometriosis.
* Hydrosalpinx.
* Uterine abnormalities.
* Myoma.
* Previous uterine surgery.

Primary outcomes:
measure: Clinical pregnancy rate
timeFrame: 6 weeks after embryo transfer
Secondary outcomes:
measure: Implantation rate
timeFrame: 6 weeks after embryo transfer
measure: Miscarriage rate
timeFrame: 12 weeks gestational age
Other outcomes:
Locations:
city: Mansourah
country: Egypt
facility: Fertility Care Unit (FCU) in Mansoura University Hospital
state: Dakahlia
city: Mansourah
country: Egypt
facility: Private fertility care centers
state: Dakahlia
Study officials:
affiliation: Mansoura University
name: Mohamed S Abdelhafez, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00281476: The Effect of High Dose Simvastatine on Multiple Myeloma
Official title: The Effect of High Dose Simvastatine on Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Multiple Myeloma
Keywords: multiple myeloma
statins
bone
Lead sponsor: Vejle Hospital
Sponsor class: OTHER
First posted: 2006-01-24
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate the effect of high doses of Simvastatine on bone metabolisme and biochemical markers of disease in Multiple Myeloma


Eligibility criteria: Inclusion Criteria:

* multiple myeloma-patients in need of treatment
* stable og progressive disease
* age = or \> 18 years
* performance status \< 3
* life expectancy \> 3 months

Exclusion Criteria:

* pregnancy
* patients incapable of giving personally concent
* renal insufficiens with creatinine clearance below 25 ml/min
* alanin aminotransferasis \> 2,5 x upper reference limit
* thyroxine below lower reference limit
* known familiar muscle-disease ar previous myopati
* creatinine kinase \> 10 x upper reference limit
* medication with drugs with known interactions wiht simvastatine

Primary outcomes:
measure: Response estimated by internationally approved criteria after 8 weeks of intermittend treatment with simvastatine
timeFrame: 8 weeks after treatment start
Secondary outcomes:
measure: Changes in markers of bone metabolisme after 8 weeks of intermittend treatment with simvastatine
timeFrame: 8 weeks after start of treatment
measure: Toxicity according to CTC after 8 weeks of intermittend treatment with simvastatine
timeFrame: 8 weeks after start of treatment
Other outcomes:
Locations:
Study officials:
name: Torben Plesner, DMSc.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03933176: Absence of Liner Following the Selective Caries Removal (ALFSCaRe)
Official title: Is the Use of a Glass Ionomer Liner Necessary After Selective Carious Tissue Removal?
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Caries; Dentin
Dental Restoration Failure of Marginal Integrity
Keywords: Glass ionomer
Bulk-Fill Composite
Lead sponsor: Universidade Federal de Sergipe
Sponsor class: OTHER
Collaborators: name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
name: Federal University of Pelotas
name: University of Brasilia
name: Universidade Federal do Ceara
name: Federal University of Uberlandia
name: Universidade Veiga de Almeida
First posted: 2019-05-01
Enrollment: 0
Sex: ALL
Minimum age (years): 6
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized, multi-centric, controlled clinical trial will assess the effectiveness of a simplified restorative protocol used after the selective carious tissue removal in posterior teeth presenting deep carious lesions. Only a regular bulk-fill composite will be used in the simplified restorative protocol following the application of universal adhesive. A liner with resin-modified glass ionomer will be used over the pulpal floor before the composite placement in the control group. The longevity of restorative procedures and post-operative sensitivity were defined as the main and secondary outcomes.


Eligibility criteria: Inclusion Criteria:

* Molar presenting deep carious lesion;

Exclusion Criteria:

* Non-vital teeth or teeth presenting pulpitis;
* Cavity margins in dentin;
* Presence of non-carious cervical lesions;
* The necessity of restoration involving any cusp replacement.

Primary outcomes:
measure: Longevity of restoration
timeFrame: Annual evaluation during 5 years
Secondary outcomes:
measure: Tooth sensitivity
timeFrame: 15 days after the restorative procedure
Other outcomes:
Locations:
city: Aracaju
country: Brazil
facility: Department of Dentistry/ Federal University of Sergipe
state: SE
Study officials:
References:
Clinical trial NCT05590676: Metformin Treatment in Infants After Perinatal Brain Injury
Official title: A Phase I Safety and Feasibility of Metformin Treatment in Infants After Perinatal Brain Injury
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Hypoxic Ischemic Encephalopathy of Newborn
Premature Birth
Keywords: Hypoxic Ischemic Encephalopathy
Newborn
Metformin
Prematurity
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
Collaborators: name: University of Waterloo
name: University of Alberta
First posted: 2022-10-21
Enrollment: 1
Sex: ALL
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A phase I study to test the feasibility and safety of treatment with metformin in infants affected by hypoxic ischemic encephalopathy (HIE) or prematurity-related brain injury


Eligibility criteria: Inclusion Criteria:

HIE Patients:

1. \> 35 weeks gestation at time of birth
2. ≤3 months at time of consent
3. Clinical diagnosis of HIE
4. Infant received therapeutic hypothermia for the treatment of HIE
5. Family lives within one hour distance of the Hospital for Sick Children (in order to facilitate home visits)

Preterm Infants:

1. \<32 weeks gestation at time of birth
2. 36-44 weeks corrected (postmenstrual) gestational age at time of metformin administration
3. Clinical team anticipates hospitalization at SickKids for at least 1 week after study enrollment

Exclusion Criteria:

1. Have a known genetic or chromosomal disorder.
2. Congenital or acquired liver or kidney disease that might, in the opinion of the Principal Investigator or delegate, affect drug metabolism.
3. History of hypoglycemia in the newborn period requiring glucose infusion rate \> 10 mg/kg/min or treatment with glucagon or diazoxide.
4. Any condition or diagnosis, that could in the opinion of the Principal Investigator or delegate, interfere with the participant's ability to comply with study instructions, might confound the interpretation of the study results, or put the participant at risk
5. \>3 months of age at the time of enrollment (term HIE patients only)
6. Weight \<10%ile based on WHO growth charts at time of initiation of study drug (term HIE patients only).
7. Maternal use of metformin while actively breastfeeding.

Primary outcomes:
measure: Number of patients with hypoglycemia (serum glucose <3.3mmol/L)
timeFrame: 2 weeks
Secondary outcomes:
measure: Plasma metformin levels
timeFrame: 2 weeks
measure: Number of patients who complete study
timeFrame: 2 weeks
measure: Number of patients who complete all study procedures
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontartio
Study officials:
affiliation: The Hospital for Sick Children
name: Brian T Kalish, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01994876: Investigation of Newly Developed 1-piece Convex Baseplates in Subjects With Ileostomy
Official title: Investigation of Newly Developed 1-piece Convex Baseplates in Subjects With Ileostomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ileostomy - Stoma
Lead sponsor: Coloplast A/S
Sponsor class: INDUSTRY
First posted: 2013-11-26
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: To investigate the performance and safety of two newly developed convex 1-piece ostomy appliances


Eligibility criteria: Inclusion Criteria:

Subjects must comply with the following criteria in order to participate in the investigation:

1. Are at least 18 years of age and have full legal capacity
2. Have had an ileostomy for at least 3 months
3. Have used a convex ostomy appliance for the last month
4. Have given written informed consent
5. Have an ileostomy with a diameter of 33 mm or less
6. Have experience leakage (seeping) under the baseplate at least two times over the last two weeks

Exclusion Criteria:

Subjects complying with the following criteria must be excluded from participation in the clinical investigation:

1. Have a loop ostomy (also called double-barrel or ostomy with two outlets)
2. Are pregnant or breastfeeding
3. Currently receiving, or have received within the last 2 months, chemotherapy or radiation therapy.
4. Currently receiving or have received, within the last month, systemic or local steroid treatment (adreno-cortical hormone) in the peristomal area
5. Currently suffering from peristomal skin problems (i.e. bleeding or broken skin (weeping skin))
6. Are currently participating in another clinical investigation or has previously participated in this investigation

Primary outcomes:
measure: Degree of Leakage
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: QPS
Study officials:
affiliation: QPS Holdings LLC
name: Kalid S Abd-Elaziz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01444976: The Effect of Sedation During Transesophageal Echocardiography on Heart Rate Variability
Official title: The Effect of Sedation During Transesophageal Echocardiography on Heart Rate Variability:A Comparison of Hypnotic Sedation With Medical Sedation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Transesophageal Echocardiography
Keywords: age range of 18-83
Lead sponsor: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Sponsor class: OTHER_GOV
First posted: 2011-10-03
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Maximum age (years): 83
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: There is no ideal sedation technique that can be used during Transesophageal Echocardiography (TEE), and the data concerning the effects of available sedation techniques on Heart Rate Variability (HRV) are limited. In this study the investigators aimed at comparing the effects of sedation through hypnotherapy with medical sedation achieved by midazolam on HRV.

Detailed description: Seventy-six patients with an indication of TEE will be recruited, the age range will be 18-83 years. In Group Topical (T) there are 26 patients who had the procedure under topical pharyngeal anesthesia, in Group Midazolam (D) there are 25 patients who will receive midazolam and in Group H there are 27 patients receiving hypnosis. All patients will have an IV access; throughout the procedure heart rate, rhythm ECG, peripheric O2 saturation will be monitored with a non-invasive monitor, blood pressure measurements were taken every 3 minutes. Rhythm Holter recordings will be obtained from all patients and TEE will be performed.

Eligibility criteria: Inclusion Criteria:

* Patients with a need of transesophageal echocardiography

Exclusion Criteria:

* Heart failure
* Bad overall condition
* Arrhythmia

Primary outcomes:
measure: Hypnotic sedation
timeFrame: two months
Secondary outcomes:
Other outcomes:
Locations:
city: Bakirkoy
country: Turkey
facility: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
state: Istanbul
Study officials:
References:
Clinical trial NCT05217576: NBM-200 Clinical Study in Blood Donation Setting
Official title: NBM-200 Clinical Study in Blood Donation Setting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemoglobin H
Lead sponsor: OneBlood, Inc.
Sponsor class: OTHER
Collaborators: name: OrSense, Ltd.
First posted: 2022-02-01
Enrollment: 387
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The NBM-200 is a portable Hemoglobin and oximetry monitor, based on occlusion spectroscopy technology, for non-invasive spot checking of hemoglobin (Hb), estimated Hematocrit (Hct), SpO2 and pulse rate.

The NBM-200 includes a reusable ring-shaped sensor probe that fits on the patient's finger, and a portable desktop monitor that calculates and displays the measurement result.

The sensor probe consists of a multi-wavelength optical measuring system and inflatable cuff employing pneumatic tissue manipulation. Blood flow in the finger can be briefly occluded and the resulting changes in its optical behavior are analyzed to provide accurate measurements of Hb.

Detailed description: The proposed study plan will support a 510(k) submission for the non-invasive NBM-200 system with a blood bank indication. In accordance with the agency's suggestion, OrSense plans to use as a predicate an FDA-cleared blood analyzer with a hemoglobin test method that is traceable to the cyanmethemoglobin method or that was standardized and calibrated using the International Council for Standardization in Hematology (ICSH) hemoglobin standard, e.g., the HemoCue-301 or EKF's Hemo Control Hemoglobin Measurement System. OrSense further plans to use the cleared NBM-200 (K142209) as a reference device. Clinical data will be collected in a blood donor population using 3 methods to check hemoglobin (Hb): (1) the non-invasive NBM-200 system; (2) a point-of-care device based on finger sticks that is FDA-cleared for use in blood banks, such as the HemoCue or EKF device; and (3) a laboratory analyzer based on venous blood samples.

Participants will be recruited via email and during their visit to the designated donor rooms.

Eligibility criteria: Inclusion Criteria:

* Regular donors and volunteers

Exclusion Criteria:

* Pregnancy

Primary outcomes:
measure: Bias
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Palm Harbor
country: United States
facility: Palm Harbor Donor Center
state: Florida
city: Saint Petersburg
country: United States
facility: OneBlood St. Pete Main Donor Center
state: Florida
city: Tampa
country: United States
facility: Tampa- Dale Mabry OneBlood Donor Center
state: Florida
Study officials:
References:
Clinical trial NCT00852176: Retrospective Long-term Safety and Efficacy Study of the Beta-Cath(TM) 3.5F System
Official title: Best Vascular P000018 Post-approval Study: Retrospective Long-term Safety and Efficacy Study of the Beta-Cath(TM) 3.5F System
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary In-stent Restenosis
Keywords: Coronary brachytherapy
Coronary restenosis
Coronary in stent restenosis
Lead sponsor: Best Vascular, Inc.
Sponsor class: INDUSTRY
First posted: 2009-02-26
Enrollment: 200
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 treated on-label with the Beta-Cath™ 3.5F System at Washington Hospital Center

Brief summary: The study will evaluate the long-term safety and efficacy of intravascular beta radiation therapy to treat coronary in-stent restenosis using the Beta-Cath(TM) 3.5F System; data will be collected retrospectively on patients treated with the Beta-Cath™ 3.5F System in routine clinical practice following FDA pre-market approval of the System. Outcomes will be reported up to 5 years following treatment.


Eligibility criteria: Inclusion Criteria:

* Patients who underwent on-label treatment (as defined below) with the Beta-Cath™ 3.5F System (30, 40 or 60mm) for in-stent restenosis (ISR) after coronary stenting.

  1. On-label treatment for the 30 and 40mm Beta-Cath™ 3.5F System is defined as: treatment of ISR in native coronary arteries with discrete lesions (treatable with a 20mm balloon) in reference vessel diameters (RVD) ranging from 2.7mm to 4.0mm
  2. On-label treatment for the 60mm Beta-Cath™ 3.5F System is defined as: treatment of ISR in native coronary arteries with lesions \<40mm in length in RVD ranging from 2.7mm to 4.0mm
* Patients must have undergone brachytherapy treatment at least 6-8 months prior to enrollment in this retrospective study and the date of their treatment must be:

  1. On or after February 8, 2002 for the 30/40mm 3.5F System
  2. On or after June 25, 2003 for the 60mm 3.5F System

Exclusion Criteria:

* Patients who do not give informed consent
* Patients who do not meet the inclusion criteria

Primary outcomes:
measure: Major Adverse Cardiac Events (MACE)
timeFrame: In-hospital and at 30 days, 6 months, 1, 2, 3, 4 and 5 years post-treatment
Secondary outcomes:
measure: Incidence of device-related procedural events
timeFrame: At time of intervention
measure: Device success, including successful delivery of the Beta-Cath(TM) 3.5F System radiation source train, return of the radiation source train, and delivery of the intended dose
timeFrame: At time of intervention
measure: Target Vessel Revascularization (TVR)
timeFrame: 6 months; 1, 2, 3, 4, and 5 years post-treatment
Other outcomes:
Locations:
city: Washington
country: United States
facility: Washington Hospital Center / Cardiovascular Research Institute (CRI)
state: District of Columbia
Study officials:
affiliation: Medstar Health Research Institute
name: Ron Waksman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01944176: The Effects of Simvastatin on Th17 Cytokines and Th17 Polarizing Cytokine in COPD Patients
Official title: The Effects of Simvastatin on Th17 Cytokines and Th17 Polarizing Cytokines in COPD Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: COPD
Keywords: COPD
Statins
Cytokines
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2013-09-17
Enrollment: 24
Sex: ALL
Minimum age (years): 35
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Airway inflammation is partly driven by Th17 and Th17-polarizing cytokines that is steroid-resistant. Statins could suppress IL-17 cytokines in other diseases such as atherosclerosis and multiple sclerosis in mouse model. The investigators hypothesize that statins might provide anti-inflammatory benefit of suppressing IL-17 cytokines in COPD patients.


Eligibility criteria: Inclusion Criteria:

* Stable COPD without an exacerbation within 3 months prior to study entry
* mild, moderate and severe COPD with or without treatments, regardless of COPD medications

Exclusion Criteria:

* Concomitant other chronic lung diseases including with TB and malignancy
* HIV
* Being on immunosuppressive drugs and systemic corticosteroids
* Dyslipidemic patients with recent cardiovascular or cerebrovascular disease within 6 month prior to study entry
* Cognitive impairment
* Currently on macrolides, azole anti-fungal agents, amiodarone and amlodipine

Primary outcomes:
measure: Sputum cytokines
timeFrame: Up to 4 weeks
Secondary outcomes:
measure: FEV1
timeFrame: Up to 4 weeks
measure: Sputum neutrophils
timeFrame: Up to 4 weeks
Other outcomes:
Locations:
city: Bangkok-noi
country: Thailand
facility: Faculty of Medicine Siriraj Hospital, Mahidol University
state: BKK
Study officials:
affiliation: Siriraj Hospital
name: Kittipong Maneechotesuwan, MD., PhD.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Maneechotesuwan K, Wongkajornsilp A, Adcock IM, Barnes PJ. Simvastatin Suppresses Airway IL-17 and Upregulates IL-10 in Patients With Stable COPD. Chest. 2015 Nov;148(5):1164-76. doi: 10.1378/chest.14-3138.