louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00223964: Study of the Efficacy of Two Doses of Ferrlecit in the Treatment of Iron Deficiency in Pediatric Hemodialysis Patients
Official title: Randomized Double-Blind Parallel Group MultiCenter Study of the Efficacy of Two Doses of Ferrlecit® in Treatment of Iron Deficiency in Pediatric Hemodialysis Patients Receiving Epoetin.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anemia
Keywords: Iron Deficiency
Anemia in Pediatric Hemodialysis
Lead sponsor: Watson Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2005-09-22
Enrollment: 59
Sex: ALL
Minimum age (years): 2
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This was a multi-center study in iron-deficient pediatric hemodialysis patients, whose legal guardian had provided signed informed consent and satisfied the inclusion and exclusion criteria.


Eligibility criteria: Inclusion Criteria:

* Male or female pediatric end-stage renal disease (ESRD) patients.
* Predetermined TSAT and serum ferritin levels
* Receiving chronic hemodialysis therapy with an identified need for repletion iron therapy.
* Receiving a stable epoetin (EPO) dosing regimen.

Exclusion Criteria:

* Receipt of any form of iron supplements during the 4 weeks prior to the first Ferrlecit® dosing.
* Blood transfusion.
* Hypersensitivity to Ferrlecit®.
* Significant inflammatory conditions.

Primary outcomes:
measure: Demonstrate and compare effectiveness of two Ferrlecit® doses in increasing hemoglobin in iron-deficient pediatric hemodialysis patients requiring repletion iron therapy.
timeFrame: 2 weeks
Secondary outcomes:
measure: Evaluate single-dose pharmacokinetics of Ferrlecit® in iron deficient pediatric hemodialysis patients and to access the safety profile of Ferrlecit® in pediatric hemodialysis patients.
timeFrame: 48 hours
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Los Angeles
country: United States
state: California
city: San Diego
country: United States
state: California
city: Stanford
country: United States
state: California
city: Boston
country: United States
state: Massachusetts
city: Kansas City
country: United States
state: Missouri
city: Bronx
country: United States
state: New York
city: Seattle
country: United States
state: Washington
city: Aruascalientes
country: Mexico
city: Mexico City
country: Mexico
city: Bialystok
country: Poland
city: Gdansk
country: Poland
city: Krakow
country: Poland
city: Lodz
country: Poland
city: Lublin
country: Poland
city: Szczecin
country: Poland
city: Torum
country: Poland
city: Wroclaw
country: Poland
city: Zabrze
country: Poland
city: Bashkortostan
country: Russian Federation
city: Moscow
country: Russian Federation
city: Saint Petersburg
country: Russian Federation
city: Tartarstan
country: Russian Federation
city: Belgrade
country: Serbia
Study officials:
affiliation: WATSON LPHARMACEUTICAL
name: GARY HOEL, RPh, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05752864: The Effects of Sacroiliac Joint Manual Therapy on Autonomic Nervous System and Lower Abdominal Pain in Women in Their 20s With Primary Dysmenorrhea
Official title: The Effects of Sacroiliac Joint Manual Therapy on Autonomic Nervous System and Lower Abdominal Pain in Women in Their 20s With Primary Dysmenorrhea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Dysmenorrhea
Lead sponsor: Sahmyook University
Sponsor class: OTHER
First posted: 2023-03-03
Enrollment: 40
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Disorders of the autonomic nervous system are considered another possible cause of dysmenorrhea. spinal manual threapty is acting on the parasympathetic and sympathetic nerves.

The sacrum affects all vertebrae, which affects the position of this bone, is thought to have a lot to do with dysmenorrhea.

In this study, by applying spinal manual threapty threapty to the sacroiliac joint in women in their 20s with primary dysmenorrhea, we tried to present an effective treatment method by evaluating the function of the autonomic nervous system and confirming the occurrence of pain in the lower abdomen.


Eligibility criteria: Inclusion Criteria:

* Women between the ages of 20-29
* Regular menstrual cycle (24-32 days)
* Those who have had symptoms of primary dysmenorrhea for at least 1 year
* Those who have lower back pain symptoms related to menstrual pain of 5 or higher on the Visual Analysis Scale (VAS)
* The body mass index is between 20-30
* Positive reaction to Gillet test

Exclusion Criteria:

* pelvic inflammatory disease
* uterine fibroids, polycystic ovary syndrome. Those with gynecological findings such as endometriosis
* Those who have used an intrauterine contraceptive device
* Those who took birth control pills or nonsteroidal anti-inflammatory drugs at the time of the experiment

Primary outcomes:
measure: Heart Rate Variability
timeFrame: Change from baseline after intervention at 4 weeks, follow-up at 4 weeks
Secondary outcomes:
measure: Visual analog scale
timeFrame: Change from baseline after intervention at 4 weeks, follow-up at 4 weeks
measure: Pressure pain threshold
timeFrame: Change from baseline after intervention at 4 weeks, follow-up at 4 weeks
measure: Menstrual distress questionnaire
timeFrame: Change from baseline after intervention at 4 weeks, follow-up at 4 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: The wells neuropain clinic
Study officials:
affiliation: The wells neuropain clinic
name: Sungeon Park, Ph.D candidate
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00743964: Phase II Study of Epirubicin, Cisplatin and Capecitabine (ECX) Versus Cisplatin and Capecitabine (CX) for Advanced Gastric Cancer (AGC)
Official title: A Randomized Phase II Study of Combination Chemotherapy With Epirubicin , Cisplatin and Capecitabine (ECX) or Cisplatin and Capecitabine (CX) in Advanced Gastric Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Advanced Gastric Cancer
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2008-08-29
Enrollment: 91
Sex: ALL
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Recently, 3-drug (ECX) and 2-drug (CX) combination chemotherapy involving capecitabine showed promising results in randomized clinical trials for advanced gastric cancer (AGC). The objective of the study is to evaluate the safety and activity of ECX and CX combination chemotherapy given as first-line therapy for AGC.


Eligibility criteria: Inclusion Criteria:

* Aged 75 years or less
* Adenocarcinoma of stomach
* Advanced, metastatic, or recurrent
* No prio chemotherapy for advanced disease
* Adequate performance status
* Adequate major organ functions

Exclusion Criteria:

* Severe comorbid illness or active infections
* Pregnancy or lactating women
* GI obstruction or malabsorption syndrome

Primary outcomes:
measure: Failure-free survival
timeFrame: six months
Secondary outcomes:
measure: progression-free survival
timeFrame: six months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
References:
citation: Yun J, Lee J, Park SH, Park JO, Park YS, Lim HY, Kang WK. A randomised phase II study of combination chemotherapy with epirubicin, cisplatin and capecitabine (ECX) or cisplatin and capecitabine (CX) in advanced gastric cancer. Eur J Cancer. 2010 Mar;46(5):885-91. doi: 10.1016/j.ejca.2009.12.015. Epub 2010 Jan 7.
Clinical trial NCT01109264: Bendamustine Hydrochloride Injection for Initial Treatment of Chronic Lymphocytic Leukemia
Official title: Study of Bendamustine Hydrochloride Injection in Previously Untreated Chronic Lymphocytic Leukemia Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Lymphocytic Leukemia
Keywords: Chronic Lymphocytic Leukemia
Bendamustine Hydrochloride
Chlorambucil
Lead sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2010-04-23
Enrollment: 147
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: To compare the clinical efficacy and safety of bendamustine hydrochloride versus chlorambucil for initial treatment of chronic lymphocytic leukemia

Detailed description: Patients will be assessed for response after three cycles of treatment. Two additional cycles are recommended for CR, PR or SD patients, up to a maximum limit of six cycles in total. Patients will be followed up every three months until disease progression or death.

Eligibility criteria: Inclusion Criteria:

* Patients must have a diagnosis of CLL according to National Cancer Institute (NCI) Working Group criteria
* No prior treatment for CLL
* Binet stage B or C
* ECOG performance status ≤ 2
* Life expectancy ≥3 months
* AST and ALT ≤ 3 x ULN; Total bilirubin ≤ 2 x ULN; Creatinine clearance ≥ 40 mL/min
* Written informed consent

Exclusion Criteria:

* Patients were diagnosed with or treated for malignant tumors other than CLL (including central nervous system lymphoma) within one year prior to entering the study
* Transformation to Richter's syndrome, or prolymphocytic leukemia (PLL)
* Autoimmune hemolytic anemia requiring glucocorticoid therapy
* Autoimmune thrombocytopenia requiring glucocorticoid therapy
* Participation in any other clinical trials within 4 weeks prior to study entry
* Any of the following conditions: severe heart failure; cardiomyopathy; myocardial infarction within 6 months; severe, uncontrolled diabetes; severe, uncontrolled hypertension; active, uncontrolled infection; central nervous system dysfunction
* Patients received major surgery within 30 days prior to study entry
* Pregnant or lactating women
* Allergic to study drug or mannitol

Primary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: after 3 cycles and 6 cycles
Secondary outcomes:
measure: Progression-free Survival (PFS)
timeFrame: December 2013
measure: Duration of Remission (DR)
timeFrame: December 2013
measure: Overall Survival (OS)
timeFrame: December 2013
measure: The incidence and severity of adverse events
timeFrame: Up to 2 years after enrollment
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital Affiliated to Shanghai JiaoTong University School of Medicine
Study officials:
affiliation: Ruijin Hospital
name: Zhixiang Shen, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03750864: Innovative Approach to Reduce Lung Cancer Stigma
Official title: An Innovative Approach to Reduce Lung Cancer Stigma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer Stigma
Lung Cancer
Stigma, Social
Stigmatization
Acceptance Processes
Keywords: Lung cancer
Stigma
Lung cancer stigma
Acceptance and commitment therapy
Lead sponsor: University of Arizona
Sponsor class: OTHER
First posted: 2018-11-23
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This is a feasibility study examining the feasibility and acceptability of a novel psychotherapy intervention on lung cancer patients who are experiencing stigma.

Detailed description: Experiences of stigma (perception and internalization of negative appraisal and devaluation from others) are pervasive for lung cancer patients. Previous work has shown associations between lung cancer stigma and detriments in clinically relevant outcomes such as depression, lower quality of life, and reduced engagement in cancer care.

The investigators previously developed Acceptance and Commitment Therapy for Lung Cancer Stigma (ACT-LCS) as a patient-focused intervention to reduce the self-blame, guilt and inhibited disclosure associated with lung cancer stigma. ACT-LCS is based in Acceptance and Commitment Therapy (ACT), a cognitive-behavioral treatment that promotes psychological flexibility through acceptance and valued direction.

This is a feasibility study examining the feasibility and acceptability of ACT-LCS.

Eligibility criteria: Inclusion Criteria:

* Proficiency in English
* Diagnosed with or treated for Non-Small Cell Lung Cancer (NSCLC) or Small Cell Lung Cancer (SCLC) within the prior 12 months.
* Scores of 37.5 on the Lung Cancer Stigma Inventory (LCSI) screening measure

Exclusion Criteria:

* Not proficient in English

Primary outcomes:
measure: Number of individuals who consent to the intervention
timeFrame: 10 months
measure: Number of sessions that each consented patient attended
timeFrame: 10 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Arizona Cancer Center
state: Arizona
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: University of Arizona
name: Heidi Hamann, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Arizona
name: Linda Garland, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02344264: Effect of Nervus Cutaneous Femoris Lateralis-Blockade on Moderate Pain Responders After Total Hip Arthroplasty
Official title: Effect of Nervus Cutaneous Femoris Lateralis-Blockade on Moderate Pain Responders After Total Hip Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain, Postoperative
Ropivacaine
Therapeutic Use
Arthroplasty, Replacement, Hip
Keywords: US guided nerve block
Total hip Arthroplasty
NCFL
nervus cutaneous femoralis lateralis
Lead sponsor: Naestved Hospital
Sponsor class: OTHER
First posted: 2015-01-22
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The patients will be included the 1. or 2. day after surgery. All THA patients will be screened. Those reporting VAS \> 40 during active 30 degrees hip flexion will be asked to participate.

Included patients will receive 2xNCFL (singleshot) first placebo (8 ml saline) and then ropivacaine (8 ml ropivacaine 7,5mg/ml) or the other way around (randomized). There will be 45 minutes between the two blockades. The blockades will be ultrasound guided.


Eligibility criteria: Inclusion Criteria:

* THA within 48 hours and VAS\>40 during active 30 degrees hip flexion despite conventional pain medication.
* informed consent
* ASA 1-3
* BMI 18-40

Exclusion Criteria:

* Unable to communicate in danish
* Allergic reactions toward drugs used
* Abuse of alcohol/drugs
* Unable to cooperate
* Pregnant women

Primary outcomes:
measure: Difference in VAS between NCFL and placebo during active 30 degrees hip flexion
timeFrame: 45 min
Secondary outcomes:
measure: Difference in mean VAS between the groups during active hip flexion
timeFrame: 15, 30, 45, 60, 75, 90 min
measure: Difference in mean VAS between the groups at rest
timeFrame: 15, 30, 45, 60, 75, 90 min
Other outcomes:
Locations:
city: Næstved
country: Denmark
facility: Department of Anaesthesiology
state: Danmark
Study officials:
affiliation: Naestved Hospital, Department of Anaesthesiology
name: Daniel Hägi-Pedersen, Ph.D.
role: STUDY_CHAIR
References:
Clinical trial NCT00842764: Minimally Invasive Holmium:YAG Laser Blepharoplasty
Official title: Minimally Invasive Holmium:YAG Laser Blepharoplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lower Eyelid Entropion
Keywords: eyelid fat pads
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
Collaborators: name: Beckman Laser Institute University of California Irvine
First posted: 2009-02-12
Enrollment: 7
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this research study is to is to evaluate the safety and effectiveness of the FDA approved Holmium:YAG laser for reducing lower eyelid bags.

Detailed description: The researchers are interested in learning if the more precise Holmium:YAG laser can effectively tighten the orbital septum, a barrier of the orbit which holds fat in the bony orbit, while resulting in less unintentional surrounding damage and side effects.

Eligibility criteria: Inclusion Criteria:

* male/female 30 years and older
* have pronounced lower eyelid fat pads.

Exclusion Criteria:

* based on medical problems.
* Previous surgery or trauma to lower eyelid or orbit.
* pregnant or lactating.

Primary outcomes:
measure: Change in Lower Eyelid Bags.
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Orange
country: United States
facility: UCIMC
state: California
Study officials:
affiliation: Otolaryngology, UCIMC
name: Brian J Wong, M.D,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04766164: Health Beliefs, Behaviors, and Healthcare Experiences Among United States Young and Mid-Age Adults
Official title: Health Beliefs, Behaviors, and Healthcare Experiences Among a National Sample of United States Young and Mid-Age Adults
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HPV Vaccine Knowledge
Keywords: HPV
HPV Vaccine
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
First posted: 2021-02-23
Enrollment: 4000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants living throughout the United States

Brief summary: The study will provide important insight into current HPV vaccine knowledge/awareness, health beliefs, affect, vaccine discussions, decision preparedness, and vaccine intentions and behaviors among those ages 18-45, while examining potential differences in responses between those ages 18-26 and those ages 27-45 and vaccinated and unvaccinated individuals.

Detailed description: The study will provide important insight into current HPV vaccine knowledge/awareness, health beliefs, affect, vaccine discussions, decision preparedness, and vaccine intentions and behaviors among those ages 18-45, while examining potential differences in responses between those ages 18-26 and those ages 27-45 and vaccinated and unvaccinated individuals. In addition, the study will illuminate gaps in knowledge and awareness as well as the education intervention preferences (e.g., intervention platform, source of information, timing of intervention) of individuals ages 18-45. Among those ages 27-45, shared clinical decision-making is recommended. Compared to individuals ages 18-26, individuals ages 27-45 may need to be supported uniquely so that they are prepared to engage in shared clinical decision-making about HPV vaccination with their healthcare provider. Thus, among unvaccinated individuals ages 27-45, for whom shared clinical decision-making is recommended, preparedness for engagement in shared clinical decision-making will be assessed and explored. The study also will allow investigators to identify how best to target information to young adults and mid-adults both for themselves, and among those with children, for their children.

Eligibility criteria: Inclusion Criteria:

* Age 18-45
* Living in the United States
* a KnowledgePanel panelist directly or via verified partners
* Have internet access
* Able to read, write and understand English
* Individuals can participant regardless of their HPV vaccination status

Exclusion Criteria:

* Individuals who do not meet inclusion criteria

Primary outcomes:
measure: HPV Vaccine Knowledge
timeFrame: Day 1
measure: HPV-Related Educational Intervention Preferences
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
Study officials:
affiliation: Moffitt Cancer Center
name: Shannon M Christy, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01084564: Economic Evaluation of Heart Failure Management in Colombian Clinics
Official title: Economic Evaluation of Heart Failure Management in Colombian Clinics
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Asthma
Keywords: Cost-effectiveness analysis
Colombia
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2010-03-10
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Moderate to severe uncontrolled asthma.

Brief summary: Cost effectiveness analysis of local management of patients diagnosed with heart failure disease compared with an ideal guideline-based management.


Eligibility criteria: Inclusion Criteria:

* Asthma moderate to severe.

Primary outcomes:
measure: To determine cost-effectiveness of Heart Failure management in 3 Heart-specialized clinics in Bogotá Colombia
timeFrame: 12 months
measure: Incremental cost-effectiveness ratio from using Symbicort as symbicort as Maintenance and Reliever Therapy (SMART) when compared with its competitive alternatives
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Pontificia Universidad Javeriana
name: Rodolfo Dennis, M.D.
role: STUDY_DIRECTOR
affiliation: Pontificia Universidad Javeriana
name: MARÍA XIMENA ROJAS, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04958564: Comparison of Interlock Nailing Versus Dynamic Compression Plating in Transverse Fractures of Tibia
Official title: Comparison of Interlock Nailing Versus Dynamic Compression Plating in Transverse Fractures of Tibia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Transverse Fracture of Shaft of Tibia
Lead sponsor: District Headquarters Teaching Hospital Sahiwal
Sponsor class: OTHER
First posted: 2021-07-12
Enrollment: 70
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Study aims to compare two treatment modalities for treatment of transverse fractures of tibia. One is Intramedullary interlocking nail and the other is dynamic compression plate.

Detailed description: This study is a comparison of two devices used to teat transverse fractures of tibia and these include intra medullary rod popularly known as intra medullary nail and the second is a weight bearing device know as dynamic compression plate which is fixed with screws to diaphyseal segment of bone.

Eligibility criteria: Inclusion Criteria:

- Patients with closed transverse tibial fractures

Exclusion Criteria:

- Patients unsuitable for surgical intervention

Primary outcomes:
measure: weight bearing
timeFrame: 12 weeks
Secondary outcomes:
measure: time of union
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Sahiwal
country: Pakistan
facility: Orthopaedics Department ,DHQ Teaching Hospital Hospital Sahiwal
state: Punjab
Study officials:
affiliation: District Headquarters Teaching Hospital Sahiwal
name: Humayun Israr, MBBS
role: PRINCIPAL_INVESTIGATOR
References: