louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00002425: The Safety and Effectiveness of Saquinavir Soft Gelatin Capsules Combined With Other Anti-HIV Drugs
Official title: A Multicenter, Open-Label Study of the Safety and Activity of Saquinavir Soft Gelatin Capsule Formulation (Saquinavir SGC) in Combination With Other Antiretroviral Drugs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: HIV Infections
Keywords: Drug Therapy, Combination
Saquinavir
HIV Protease Inhibitors
Dosage Forms
Anti-HIV Agents
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Enrollment: 400
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: To evaluate the safety and antiretroviral activity of saquinavir soft gelatin capsule formulation (SQV-SGC) in combination with other antiretroviral drugs.

Detailed description: All patients receive SQV as monotherapy or in combination with other antiretroviral drugs chosen by the investigator and patient. (This study provides only SQV.) Patients may not choose another protease inhibitor (PI) as part of their combination therapy; furthermore, patients taking PIs other than SQV must undergo a 5-day washout period before study-drug administration. Patients are monitored for adverse events and changes in routine laboratory tests, plasma viral load, and CD4+ T cell levels. Outcomes are analyzed by stratifying patients according to CD4+ T cell levels and prior history with protease inhibitors.

Eligibility criteria: Inclusion Criteria

Concurrent Medication:

Allowed:

Antiretroviral treatments other than PIs.

Patients must have:

* HIV infection.
* No prior experience with PIs. (Note:
* At least 75 percent of patients must be naive to PIs.)

Exclusion Criteria

Concurrent Medication:

Excluded:

PIs other than SQV.

Prior Medication:

Excluded:

Any PIs (see note in General Criteria--Inclusion).

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Nutley
country: United States
facility: Consumer Contact
state: New Jersey
Study officials:
References:
Clinical trial NCT00034125: Phase 3 Study of LY353381 Vs Tamoxifen in Women With Locally Advanced or Metastatic Breast Cancer.
Official title: a Phase 3 Randomized Double Blind Evaluation of LY353381 Compared With Tamoxifen in Women With Locally Advanced or Metastatic Breast Cancer.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breast Neoplasms
Keywords: cancer
metastatic breast cancer
hormonal therapy
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2002-04-24
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To determine the safety and efficacy of LY353381 when compared to tamoxifen in women with advanced or metastatic breast cancer.


Eligibility criteria: Inclusion Criteria

1. Locally advanced or metastatic breast cancer
2. Bi-dimensionally measurable disease

Exclusion Criteria

1. Prior hormonal therapy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
state: Florida
city: Shreveport
country: United States
state: Louisiana
city: Boston
country: United States
state: Massachusetts
city: Nashville
country: United States
state: Tennessee
city: Capital Federal
country: Argentina
state: Buenos Aires
city: Ciudad De Buenos Aires
country: Argentina
city: Las Condes
country: Chile
state: Santiago
city: Providencia
country: Chile
state: Santiago
city: Ahmedabab
country: India
state: Gujarat
city: Mexico City
country: Mexico
state: Benito Juarez
city: Colima
country: Mexico
Study officials:
References:
Clinical trial NCT00389025: Mast-Cell Stabilizing Effects of Olopatadine
Official title: Mast-Cell Stabilizing Effects of Olopatadine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Allergic Conjunctivitis
Keywords: Subject with clinical history of seasonal allergic conjunctivitis
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2006-10-17
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: To assess the effects of olopatadine of the release of mast cell histamine


Eligibility criteria: Inclusion Criteria:

* Asymptomatic and not using any topical or systemic medication

Exclusion Criteria:

* Age

Primary outcomes:
measure: Tear histamine
Secondary outcomes:
measure: Tear cytology, subject evaluation of ocular itching, investigators evaluation of ocular redness
Other outcomes:
Locations:
city: Padova
country: Italy
facility: Padova Site
Study officials:
affiliation: Alcon Research
name: Terry Wiernas
role: STUDY_DIRECTOR
References:
Clinical trial NCT05873725: Retrospective Study of High Dose Follitropin Delta in a Mixed Protocol With Human Chorionic Gonadotropin
Official title: Retrospective Study of High Dose Follitropin Delta in a Mixed Protocol With Human Chorionic Gonadotropin
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: IVF
Infertility
Lead sponsor: Clinique Ovo
Sponsor class: INDUSTRY
First posted: 2023-05-24
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 42
Standard ages: ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women consulting the clinic for fertility issues that require in vitro fertilization

Brief summary: Follitropin delta is a rFSH, uniquely expressed in a human fetal retinal cell line, which owing to differences in glycosylation profile has a lower clearance and induces a higher ovarian response in humans than existing rFSH preparations when administered at equal doses of biological activity. A noninferiority clinical trial (ESTHER-1) in which individualized dosage of follitropin delta according to each patient's profile (AMH and weight) was compared to conventional follitropin alfa dosing for IVF have demonstrated that an individualized follitropin delta dosing is noninferior to conventional follitropin alfa with respect to ongoing pregnancy rate, ongoing implantation rate, and also live births, with a concomitant reduction in iatrogenic complications, including OHSS


Eligibility criteria: Inclusion Criteria:

* Women 18 to 42 years of age undergoing IVF/ICSI cycle
* IVF antagonist protocol
* Regular menstrual cycles of 24-35 days
* Presence of both ovaries

Exclusion Criteria:

* Endometriosis stage III/IV
* History of recurrent miscarriages, defined as ≥ 3 consecutive losses
* Women undergoing ovarian stimulation for oncologic or elective fertility preservation
* Women participating in any other research project
* Hypersensitivity to follitropin delta and/or human chorionic gonadotropin
* Use of Growth Hormone (GH) during the stimulation cycle

Primary outcomes:
measure: Number of good quality blastocysts
timeFrame: Up to 6 day
Secondary outcomes:
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Clinique Ovo
state: Quebec
Study officials:
affiliation: Clinique Ovo
name: Jacques Kadoch, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02702622: Vitamin A Equivalence of the Provitamin A in Biofortified Bananas
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vitamin A Deficiency
Keywords: bananas
biofortified
carotenoids
vitamin A
Lead sponsor: Iowa State University
Sponsor class: OTHER
First posted: 2016-03-08
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes

Brief summary: The objective will be to quantify the vitamin A equivalence of the provitamin A in transgenic biofortified bananas.


Eligibility criteria: Inclusion Criteria:

* General good health as determined by interview, blood biochemistry profile, and complete blood count
* Antecubital veins amenable to blood collection

Exclusion Criteria:

* Adverse reactions to blood sample collection
* History of anemia or excessive bleeding
* Cigarette smoking, frequent alcohol consumption
* Use of vitamin/mineral supplements
* Food allergies
* Lactose intolerance
* Abnormal thyroid status
* Chronic disease, lipid malabsorption or gastrointestinal disorders
* Hyper- or hypolipidemia
* Body mass index (BMI) \> 28
* History of eating disorder or restrained eating
* Current or planned pregnancy; menstrual cycle irregularities or abnormalities
* Use of hormonal contraceptives (affects chylomicron clearance); use of medications that may affect lipid absorption or transport

Primary outcomes:
measure: Area under the curve for retinyl ester in the plasma triacylglycerol-rich lipoprotein fraction
timeFrame: 0 - 9.5 hours postprandially
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00274222: The Role of Nebulized Budesonide in the Treatment of Acute Exacerbations of COPD
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: COPD Acute Exacerbation
Keywords: COPD, nebulized budesonide, systemic corticosteroids
Lead sponsor: Inonu University
Sponsor class: OTHER
First posted: 2006-01-10
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: This study was designed to evaluate the hypothesis that nebulized budesonide) might be an alternative to systemic corticosteroids (SC) in the treatment of patients with acute exacerbations of COPD (AECOPD).

Detailed description: Patients, hospitalized with AECOPD, were randomized into three groups. Group I received only bronchodilator treatment (BDT), Group II received SC (40 mg prednisolon) plus BDT, and Group III received nebulized budesonide (NB)(1500 mcg qid) plus BDT. Improvement rates in multiple parameters during 10-day hospitalization, and acute exacerbation and re-hospitalization rates within one-month after discharge were compared between the groups.

Eligibility criteria: Inclusion Criteria:

* COPD patients who were admitted to our pulmonary department for an acute exacerbation were prospectively enrolled in the study

Exclusion Criteria:

* COPD patients hospitalized with specific reasons like pneumonia, pulmonary emboli, congestive heart failure, pneumothorax etc. as the cause of acute exacerbation, or patients with risk of imminent respiratory failure requiring mechanical ventilation or direct admission to the ICU were excluded.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: INONU UNIVERSITY PULMONARY MEDICINE
name: HAKAN GUNEN, MD
role: STUDY_CHAIR
References:
Clinical trial NCT06275022: A Prospective Study on the Treatment of cLM Based on ICG Imaging
Official title: A Prospective Randomized Controlled Study on the Treatment of Cystic Lymphatic Malformation Based on Indocyanine Green-fluorescence Imaging
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lymphatic Malformation
Keywords: indocyanine green
children
inflow
lymphography
Lead sponsor: Nanjing Children's Hospital
Sponsor class: OTHER
First posted: 2024-02-23
Enrollment: 110
Sex: ALL
Minimum age (years): 30
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this prospective randomized controlled study is to explore the role of indocyanine green-fluorescence imaging in management of cystic lymphatic malformation.. To clarify the application value of indocyanine green-fluorescence imaging in both diagnosis and treatment of cystic lymphatic malformation (cLM) in children, is helpful for exploring pathogenesis of cLM, and providing a clearer scientific basis for subsequent surgical intervention. It also provides alternative for the future diagnosis and treatment of cLM.

Participants will receive indocyanine green-fluorescence imaging before operation, while the patients in control group will receive traditional operation.

Researchers will compare difference in curative effect between two groups.


Eligibility criteria: Inclusion Criteria:

(1) no previous intervention; (2) cLM diagnosed by pretreatment magnetic resonance imaging (MRI); (3)3 to 6 months post-treatment follow-up; (4) Superfacial cLM

Exclusion Criteria:

(1) history of iodine allergy; (2) syndromic cLM ; (3) severe liver and kidney dysfunction; (4) intralesional hemorrhage; (5) intralesional infection

Primary outcomes:
measure: Cure rate
timeFrame: 1month, 3 months
measure: Effective rate
timeFrame: 1 month, 3 months
measure: Treatment frequency
timeFrame: 3 months, 6 months
Secondary outcomes:
measure: Likert score
timeFrame: 6 months
measure: Wound infection
timeFrame: 1 month
measure: Delayed healing
timeFrame: 1 month
measure: Pigmentation
timeFrame: 1 month
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Children's hospital of Nanjing medical university
state: Jiangsu
Study officials:
affiliation: Children's Hospital of Nanjing Medical University
name: Weimin Shen, Dr.
role: STUDY_DIRECTOR
References:
Clinical trial NCT01682122: Frequency and Persistence of Wide Pulse Pressure in the Neonatal Population
Official title: Evaluation of the Frequency and Persistence of Wide Pulse Pressure in the Neonatal Population
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Blood Pressure
Pediatrics
Infant, Newborn
Cardiology
Keywords: Blood Pressure
Pediatrics
Infant, Newborn
Cardiology
Lead sponsor: Staten Island University Hospital
Sponsor class: OTHER
First posted: 2012-09-10
Enrollment: 196
Sex: ALL
Maximum age (years): 72
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy newborns in Regular and Observation nurseries who are between 0-72 hrs of age.

Brief summary: Wide Pulse Pressure is frequently present in the normal, full-term neonatal population. This study will evaluate the frequency and persistence of wide pulse pressure in the neonatal population. Using a prospective study design in the Regular newborn and Observation nurseries of SIUH, North site. Healthy newborns that are between 0-72 hrs of age will have their blood pressures measured using the oscillometric method. This data will offer insight into whether the presence of wide pulse pressure in otherwise healthy newborn infants warrants further cardiovascular evaluation


Eligibility criteria: Inclusion Criteria:

* Infants with gestational age \> or = 35weeks and birth weight \> 2500g, who are hemodynamically stable, have no cardiorespiratory abnormalities and have no evidence of sepsis. If a blood culture was drawn due to the presence of maternal risk factors (e.g. maternal fever, prolonged rupture of membranes), patients will be included only if the blood culture result is negative and in case of intrapartum antibiotic treatment, ancillary blood tests (CBC with differential, CRP) are also within the normal range

Exclusion Criteria:

* Infants with gestational age \< 35weeks or birth weight \< 2500g and with evidence of neonatal sepsis either culture proven or clinically suspected.

Primary outcomes:
measure: incidence of wide pulse pressures in healthy newborn
timeFrame: 15 mins a day
Secondary outcomes:
Other outcomes:
Locations:
city: Staten Island
country: United States
facility: Staten Island University Hospital
state: New York
Study officials:
References:
Clinical trial NCT04206722: Efficiency of Shock-wave Therapy in Symptomatic Hip Osteoarthritis
Official title: Efficiency of Shock-wave Therapy in Symptomatic Hip Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hip Osteoarthritis
Lead sponsor: Iuliu Hatieganu University of Medicine and Pharmacy
Sponsor class: OTHER
First posted: 2019-12-20
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objectives of treatment in hip osteoarthritis are pain relief, improve joint range of motion and muscle force, gait rehabilitation, patient education and socio-professional reintegration.The non-pharmacological and non-surgical methods include certain types of physical therapy: massage, heat, ultrasound, laser, shockwave therapy. Few studies have been conducted so far for outcome measurement in symptomatic hip osteoarthritis.

Detailed description: The objectives of treatment in hip osteoarthritis are pain relief, improve joint range of motion and muscle force, gait rehabilitation, patient education and socio-professional reintegration.The non-pharmacological and non-surgical methods include certain types of physical therapy: massage, heat, ultrasound, laser, shockwave therapy. Among them, shockwave therapy is not a new treatment method, and seems to be effective in rotator cuff pathology, tennis elbow, and also on knee osteoarthritis, but few studies have been conducted so far for outcome measurement in symptomatic hip osteoarthritis.

Eligibility criteria: Inclusion Criteria:

* unilateral or bilateral hip osteoarthritis

Exclusion Criteria:

* other disorders that are contraindications for shockwave or ultrasound application

Primary outcomes:
measure: change from baseline Visual Analogue Scale (VAS) score at 10 days and 30 days
timeFrame: at baseline, after 10 days, after 30 days
Secondary outcomes:
measure: change from baseline Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score at 10 days and 30 days
timeFrame: at baseline, after 10 days, after 30 days
Other outcomes:
Locations:
Study officials:
affiliation: University of Medicine and Pharmacy Iuliu Hatieganu
name: Irsay Laszlo, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01002222: Open-Label Extension Study of MCS-2 in the Treatment of Lower Urinary Tract Symptoms (MCS-2-US-c)
Official title: Open-Label, Six-Month Extension of Protocol MCS-2-TWN-a to Further Evaluate the Efficacy and Safety of MCS-2 for the Treatment of Lower Urinary Tract Symptoms Suggestive of Benign Prostatic Hyperplasia in Treatment Naïve Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Lower Urinary Tract Symptoms
Benign Prostatic Hyperplasia
Keywords: Benign Prostatic Hyperplasia
MCS-2
Multi-Carotenoids
Lower Urinary Tract Symptoms
International prostate symptom score
Lead sponsor: Health Ever Bio-Tech Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2009-10-27
Enrollment: 200
Sex: MALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is an open-label extension study of another study protocol, MCS-2-US-a. Subjects who have completed the 12-week treatment and procedures under the protocol MCS-2-US-a will be eligible for this study.

Detailed description: This open-label extension study is designed to further assess the long-term safety and efficacy of MCS-2. Subjects who have completed the 12-week treatment and procedures under the protocol MCS-2-TWN-a will be eligible for another 40 weeks of MCS-2 treatment at the optimal dose selected after the phase 2b part of MCS-2-US-a. Subjects are limited to those who are currently not being treated medically for BPH or LUTS.

Eligibility criteria: Inclusion Criteria:

* Subject has completed 12 weeks of treatment under the protocol MCS-2-US-a.
* Subject is able to understand and willing to conform to the study procedures and has signed the informed consent form for participation in this extension study.

Exclusion Criteria:

* Subject has severe LUTS at the last visit under the protocol MCS-2-US-a.
* Subject is considered ineligible for the study by the investigator(s).

Primary outcomes:
measure: Incidence of treatment-emergent adverse events (TEAE)
timeFrame: 36 weeks
Secondary outcomes:
measure: Changes from baseline in International Prostate Symptom Score (I-PSS)
timeFrame: 36 weeks
measure: Changes from baseline in urine flow rate
timeFrame: 36 weeks
measure: Changes from baseline in serum lycopene levels
timeFrame: 36 weeks
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: David Geffen School of Medicine at UCLA
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Allan J Pantuck, MD, MS, FACS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05556122: Efficacy of Compound Betamethasone Injection Combined With Ropivacaine in Ultrasound-guided Intercostal Nerve Block for Chronic Post-thoracotomy Pain
Official title: Efficacy of Compound Betamethasone Injection Combined With Ropivacaine in Ultrasound-guided Slit Intercostals Nerve Block for Chronic Post-thoracotomy Pain:A Single Blind Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Nerve Block
Lead sponsor: Affiliated Hospital of Nantong University
Sponsor class: OTHER
First posted: 2022-09-27
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The patients were divided into two groups by random number method: GroupRD1 group and GroupRD2 group were given general anesthesia and intercostal nerve block.The drug for intercostal nerve block was 0.33% ropivacaine +2.333mg compound betamethasone (1.667mg betamethasone dipropionate + 0.667mg betamethasone sodium phosphate) to 15ml.

Detailed description: The RD1 group received ultrasound-guided intercostal nerve block at the incision before anesthesia induction, and the RD2 group received ultrasound-guided intercostal nerve block at the lateral costal Angle before anesthesia induction.

Eligibility criteria: Inclusion Criteria:

1. 18-70 years old
2. ASA grade I-III
3. BMI: 18.5-28kg/m2
4. Type of surgery: elective thoracoscopic lung mass resection
5. Informed consent has been signed by the patient and/or family members

Exclusion Criteria:

1. game anesthesia or sugar cortical hormone drugs allergic
2. preoperative use of opioid medicines
3. serious blood coagulation dysfunction
4. serious heart, lung, liver and renal insufficiency
5. put, chemotherapy, and glucocorticoid immunosuppressive therapy history or diseases of the immune system
6. peptic ulcer
7. newly gastrointestinal surgery
8. has a history of thoracic surgery
9. is the central nervous system disease
10. Other glucocorticoids should be used with caution in patients such as fractures, wound repair, corneal ulcers, hyperadrenocortical disease, diabetes mellitus, pregnant women, etc.

Primary outcomes:
measure: Acute and chronic postoperative pain
timeFrame: 6 hours after surgery
measure: Acute and chronic postoperative pain
timeFrame: 24 hours after surgery
measure: Acute and chronic postoperative pain
timeFrame: 48 hours after surgery
measure: Acute and chronic postoperative pain
timeFrame: 1 months after surgery
measure: Acute and chronic postoperative pain
timeFrame: 3 months after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Nantong
country: China
facility: YiBinQin
state: Jiangsu
Study officials:
affiliation: Affiliated Hospital of Nantong University
name: DingYing Ge
role: STUDY_DIRECTOR
References: