louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01891110: Prevention of Orthostatic Hypotension With Electric Stimulation in Persons With Acute SCI
Official title: Prevention of Orthostatic Hypotension With Electric Stimulation in Persons With Acute SCI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injury
Orthostatic Hypotension
Keywords: electric stimulation
tilt-table
Lead sponsor: Swiss Paraplegic Research, Nottwil
Sponsor class: NETWORK
First posted: 2013-07-02
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Background:

The presence of orthostatic hypotension (OH) as a consequence of blood volume redistribution during verticalisation in persons with spinal cord injury (SCI) is a common condition.

Aims:

To investigate the impact of three different types of electric stimulation (ES) (ES of the abdominal muscles versus ES of lower limb muscles versus simultaneously ES of abdominal and lower limb muscles versus control) on blood pressure stabilization and verticalisation-degrees between 0° and 70°. The hypothesis is, that the ES-induced contractions of the muscles cause a stabilisation respectively an increase of the blood pressure during the tilt-table test.

Subjects:

20 Women and men, at least 18 years of age, following an acute and traumatic SCI, with a lesion level above T6, an American Spinal Injury Association (AIS) Impairment Scale A,B or C and a diagnosis of OH (by tilt table test) were eligible for the study.

Methods:

Each patient underwent randomly three different types of ES sessions while being positioned on a tilt-table. The following sessions were planned:

A) ES of the abdominal muscles B) ES of the lower limb muscles C) Combination of A and B D) Control session (=diagnostic session)

Study type: Intervention Design: Prospective interventional study


Eligibility criteria: Inclusion Criteria:

* inpatients
* positive diagnosis of OH
* acute traumatic SCI
* lesion level above T6
* AIS A, B or C

Exclusion Criteria:

* fractures of the lower limbs
* decubitus (NPUAP \>2)
* massive psychiatric dysfunction
* suicide intention

Primary outcomes:
measure: blood pressure [mmHg]
timeFrame: 1 day (single measurement at each arm )
Secondary outcomes:
measure: Heart rate
timeFrame: 1 day (single measurement at each arm )
Other outcomes:
Locations:
city: Nottwil
country: Switzerland
facility: Swiss Paraplegic Center
state: Luzern
Study officials:
affiliation: Swiss paraplegic center
name: Aurelio Tobon, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01919710: Safety and Efficacy Studies of rHSA/GCSF Fusion Protein For Injection to Treat Neutropenia
Official title: Phase 1 Study of rHSA/GCSF in Neutropenia After Chemotherapy of Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Underdose (Unintentional)
Cancer
Tumor
Keywords: Neutropenia
chemotherapy
rHSA/GCSF
Lead sponsor: Tianjin SinoBiotech Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Peking University Cancer Hospital & Institute
First posted: 2013-08-09
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Safety and efficacy studies of rHSA/GCSF fusion protein for injection in treatment of neutropenia induced by chemotherapy of cancer patients.

Detailed description: A dosage climbing for the safety and efficacy studies for the neutropenia induced by chemotherapy cancer patients Repeat-dose studies for the safety and efficacy studied for the neutropenia.

Eligibility criteria: Inclusion Criteria:

- chemotherapy induced neutropenia

Exclusion Criteria:

- treated with other biological drugs or other neutropenia therapy drugs

Primary outcomes:
measure: Number of adverse events
timeFrame: 14 days
Secondary outcomes:
measure: AUC
timeFrame: 14 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Cancer Hospital
Study officials:
affiliation: Peking University Cancer Hospital & Institute
name: Jun ZHU, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01921010: Benefit of Elevation of HDL-C in Women
Official title: Benefit of Elevation of HDL-cholesterol/Triglyceride Lowering on Cardiovascular Outcomes in Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cardiovascular Outcomes
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
First posted: 2013-08-13
Enrollment: 43
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The combination of HDL-C elevation, lowering of triglycerides and further LDL-C reduction accomplished by the addition of niacin to statin medication would improve endothelial function as compared to LDL-C reduction alone in patients with and without coronary artery disease and the combination of low HDL-C/high triglycerides.

The combination of lipid lowering therapy would have beneficial effects on markers of inflammation. These benefits would be particularly evident in women.


Eligibility criteria: Inclusion Criteria:

* Stable CAD(coronary artery disease) patients on statin therapy with LDL-C between 90-135mg/dl and triglycerides \> 150mg/dl
* Well-controlled diabetes with HbA1C \< 7.5 currently on statin therapy, able to tolerate Niacin without unstable blood glucose levels with LDL-C between 90-135mg/dl and triglycerides \> 150mg/dl
* Stable patients on statin therapy with LDL-C between 90-135mg/dl and triglycerides \> 150mg/dl

Exclusion Criteria:

* History of MI(myocardial infarction), PTCA(percutaneous transluminal coronary angiography) or surgery within previous 3 months
* Currently on Niaspan and unwilling to withdraw Niaspan therapy or known intolerance to niacin
* Active or known gall bladder disease
* Pregnant or nursing women
* Significant comorbidity that precludes participation
* Significant liver disease, active alcoholism, or LFT(liver function test) \>1.5x's ULN( upper limit of normal) at screening
* Diabetes with Hg A1C(hemoglobin A1c) \< 7.5
* PI perceived inability to comply with protocol

Primary outcomes:
measure: endothelial function
timeFrame: 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
Study officials:
affiliation: Cedars-Sinai Medical Center
name: C. Noel Bairey Merz, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00005110: A Multi-Centered Study of the Long-Term Effect of Salmeterol and Albuterol in Cystic Fibrosis
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Cystic Fibrosis
Lead sponsor: National Center for Research Resources (NCRR)
Sponsor class: NIH
First posted: 2000-04-14
Sex: ALL
Minimum age (years): 5
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Long term use of bronchodilators in CF is beneficial to the improvement of pulmonary function and symptoms. This study is investigating the long-term benefit of administration of the drug Salmeterol, a bronchodilator. Salmeterol will be compared to albuterol or placebo. The medication will be inhaled twice a day for 6 months.

Detailed description: Patients that have been diagnosed with cystic fibrosis and are above 5 years and below 45 years of age are eligible. Subjects will be randomized into 1 of 3 groups. One group will get Salmeterol by multi-dose inhaler (MDI) 2 puffs 2 times a day, one group will get albuterol by MDI 2 puffs 2 times a day and the other will get placebo by MDI 2 puffs 2 times a day. Height and weight along with pulmonary function testing and vital signs will be monitored at the beginning of the study and at Visits 2, 3, and 4. Peak flow monitoring will be done each morning before study medication at home. A daily diary will be kept of this measurement. Subjects will be seen in the research center at visits 1,2,3, and 4. Telephone contact will be done at Day 15, 60, 120, and 150. Individual outcomes include a potential increase in pulmonary function testing and a decrease in frequency of pulmonary exacerbations, hospitalizations, and usage of antibiotics.

Eligibility criteria: Inclusion Criteria:

* Ability to perform reproducible spirometry
* FEVI \> 50% and \< 90% (Knudsen)
* A CF pulmonary exacerbation within the last year or an FEVI\<80%
* At least one delta f508 allele on CF mutation analysis
* Ability to demonstrate use of inhaled medicine and FEVI and PEFR monitor
* Written informed consent
* Negative serum pregnancy test on enrollment

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: St. Louis
country: United States
facility: Division of Allergy and Pulmonary Medicine
state: Missouri
Study officials:
References:
Clinical trial NCT00544310: Pilot Study Evaluating the Safety and Potential Trends in Efficacy of Adhexil
Official title: A Prospective, Controlled, Randomized, Multi-Center, Exploratory Pilot Study Evaluating the Safety and Potential Trends in Efficacy of Adhexil
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Bilateral Ovarian Disease
Lead sponsor: OMRIX Biopharmaceuticals
Sponsor class: INDUSTRY
First posted: 2007-10-16
Enrollment: 25
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The objective is to evaluate the safety and initial efficacy of the Omrix Anti-Adhesion (AA) kit, Adhexil™ in preventing and/or reducing post-operative adhesions in patients undergoing surgery involving the ovaries.

Detailed description: Adhexil™ contains the components that form the anti-adhesive barrier, BAC and Thrombin. Thrombin is a sterile solution, containing highly purified human thrombin. BAC is a sterile, solution whose principal component is a concentrate of human fibrinogen. Adhexil™ is supplied in two vials and an application device.

Eligibility criteria: Inclusion Criteria:

* Female patients aged 18-45 years at screening
* Patients undergoing elective laparoscopic surgery due to known or suspected bilateral ovarian disease

Exclusion Criteria:

* Pregnant (including ectopic pregnancy) or breastfeeding patient
* Patients with a documented diagnosis of cancer
* Patients with a lymphatic, hematologic or coagulation disorder
* Patients with a known or suspected hypersensitivity to blood, blood products or any constituent of Adhexil™
* Patients who are immunocompromised, possess autoimmune disorders, or who are routinely taking anticoagulants.
* Patients who have participated in another clinical study within 30 days of enrolment.
* Investigator's opinion that the patient is medically unfit or would be at major risk if enrolled into the study.

Primary outcomes:
measure: Preventing and/or reducing post-operative adhesions in patients undergoing surgery involving the ovaries
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
state: New York
city: Duisburg
country: Germany
city: Valencia
country: Spain
city: Oxford
country: United Kingdom
Study officials:
References:
Clinical trial NCT04255810: Systemic Symptoms: Biospecimen Analysis Study
Official title: Systemic Symptoms: Biospecimen Analysis Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Women With Breast Implants With and Without Self-reported Systemic Symptoms
Women Undergoing an Elective Mastopexy (Breast Lift) or Small Reduction
Lead sponsor: Glicksman, Caroline, M.D.
Sponsor class: INDIV
Collaborators: name: The Aesthetic Surgery Education & Research Foundation
First posted: 2020-02-05
Enrollment: 150
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Genetic females between the ages of 30 and 65 who fall into one of the three cohorts.

Brief summary: An increasing number of women are reporting a collection of non-specific systemic symptoms thought to be caused by their breast implants. There is no current pathophysiologic explanation or diagnostic test for BII; it is not a recognized medical disease at this time. This study aims to address the questions asked by patients, physicians, and the FDA with regard to the scientific validity of BII.

Detailed description: An increasing number of women are reporting a collection of non-specific systemic symptoms thought to be caused by their breast implants. The term Breast Implant Illness or "BII" originated with several social media groups. There is no current pathophysiologic explanation or diagnostic test for BII; it is not a recognized medical disease at this time. Recently several studies have been designed and funded to study the role of psychological and social behavioral factors. This study has been designed to scientifically analyze biospecimens from three cohorts of age matched women in the United States. This study aims to address the questions asked by patients, physicians, and the FDA with regard to the scientific validity of BII.

Eligibility criteria: Inclusion Criteria:

Consecutive patients who present to investigator surgeon for:

1. Self-reported BII requesting explantation;
2. Patient who presents for breast implant exchange or explantation without self-reported symptoms of BII;
3. Patient who presents for a mastopexy or small reduction less than 200grams (without implants or soft tissue support);
4. Willingness to follow study requirements including 3-6 week and 6 month follow-up exams; and
5. Genetic Female.

Exclusion Criteria:

1. Subject lives more than three hours away from the investigator surgeon;
2. Previous breast reconstruction for cancer;
3. Active malignancy anywhere else in the body;
4. Has been implanted with any silicone implant other than a breast implant anywhere else in the body;
5. History of radiation to the breast;
6. Currently on anti-estrogen therapy; or
7. HIV positive.

Primary outcomes:
measure: Change in self-reported systemic symptoms
timeFrame: 3-6 weeks and 6 months and 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Sea Girt
country: United States
facility: Glicksman Plastic Surgery
state: New Jersey
Study officials:
References:
Clinical trial NCT00812110: Influenza Vaccination for Parents and Other Caregivers in the Pediatric Medical Home
Official title: Influenza Vaccination for Parents and Other Caregivers in the Pediatric Medical Home
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Influenza
Keywords: Influenza prevention
Lead sponsor: Akron Children's Hospital
Sponsor class: OTHER
First posted: 2008-12-19
Enrollment: 336
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: We hypothesize that when offered influenza vaccine at little or no cost, in a setting where the value of the vaccine is connected to one's high risk child, vaccination rates for parents will approach 90-95%, similar to rates obtained in the Neonatal Intensive Care Unit environment.


Eligibility criteria: Inclusion Criteria:

* Parents or caregiver adults who accompany at-risk children to a Pediatric Care outpatient clinic appointment. High risk children are defined as those 0 to 5 years of age, or who have any of the following diagnoses:

  * Sickle cell disease
  * Asthma
  * Cystic fibrosis
  * Chronic renal disease
  * Congenital heart disease
  * Cancer
  * Any immunodeficiency

Exclusion Criteria:

* Caregivers of children residing in group homes
* Persons whose children do not meet the Center for Disease Control (CDC) definition of high-risk
* Persons who have had allergic reactions to influenza vaccination or any other vaccination in the past
* Persons who are allergic to eggs or egg products
* Persons who are allergic to thimerosol
* Previous diagnosis of Guillain-Barré syndrome (GBS)
* Persons who are moderately to severely ill at the time the vaccination is to be given

Primary outcomes:
measure: Number of Participants Who Received Influenza Vaccine.
timeFrame: 1 hour
Secondary outcomes:
measure: Background Rate of Influenza Vaccination in the Parents/Caregivers of High Risk Pediatric Patients in a Low Income Population?
timeFrame: 16 months
Other outcomes:
Locations:
city: Akron
country: United States
facility: Akron Children's Hospital
state: Ohio
Study officials:
affiliation: Akron Children's Hospital
name: Peter C White, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05939310: Fluorescence Guided Surgery in Breast Cancer - The MARGIN-2 Study
Official title: Improving Radical Resection Rates in Patients With Breast Cancer by Intraoperative Imaging Using Bevacizumab-IRDye800CW - the MARGIN-2 Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Breast Cancer Invasive
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
Collaborators: name: Martini Hospital Groningen
First posted: 2023-07-11
Enrollment: 70
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The goal of this clinical trial is to intraoperatively visualize tumour tissue in breast cancer patients using fluorescence imaging with the tracer bevacizumab-IRDye800CW and thereby enhance real-time clinical decision making, preventing postoperative tumour-positive margins.


Eligibility criteria: Inclusion Criteria:

* Patients are females with histologically proven carcinoma of the breast
* The carcinoma of the breast is a local disease with limited size (but tumor size ≥ 0.5cm) and in the multidisciplinary tumor board meeting breast conserving therapy is advised.
* Age ≥ 18 years
* Written informed consent has been obtained
* Women of childbearing potential (premenopausal women with intact reproductive organs and women less than two years after menopause) require use of effective contraception at least 3 months before administration of the tracer (if not, a negative serum pregnancy test has to be submitted), and they need to be willing to ensure that she or her partner uses effective contraception during the trial and for 3 months thereafter.

Exclusion Criteria:

* Medical or psychiatric conditions that compromise the patient's ability to give informed consent
* Non palpable breast tumor or prior surgery of this breast
* Received an investigational drug within 30 days prior to bevacizumab-IRDye800CW
* History of myocardial infarction, cerebrovascular accident, uncontrolled cardiac heart failure or unstable angina within 6 months prior to enrollment
* Inadequately controlled hypertension with or without current antihypertensive medication
* Significant renal or hepatic impairment (grade II or higher deviations by CTCAE)
* History of allergy or infusion reactions bevacizumab or other monoclonal antibodies
* Pregnant or lactating women
* Patients receiving Class IA (quinidine, procainamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents
* Life expectancy \< 12 weeks
* Preoperatively undetectable lymph nodes using SPECT-scan, requiring the use of patent blue

Primary outcomes:
measure: Detection
timeFrame: 1 year
Secondary outcomes:
measure: Detection ex-vivo imaging
timeFrame: 1 year
measure: Detection in-vivo imaging
timeFrame: 1 year
measure: Radical resection rate
timeFrame: 1 year
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
city: Groningen
country: Netherlands
facility: Martini Ziekenhuis
Study officials:
References:
Clinical trial NCT01005810: A Trial of N-Acetylcysteine (an Over-the-Counter Medicine) in Adolescents Who Smoke Marijuana
Official title: A Controlled Trial of N-Acetylcysteine (NAC) in Cannabis Dependent Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cannabis Dependence
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2009-11-01
Enrollment: 116
Sex: ALL
Minimum age (years): 13
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is investigating how N-Acetylcysteine (NAC), an over-the-counter medication, will reduce marijuana use when combined with Contingency Management, a behavioral treatment. It is hypothesized that marijuana dependent adolescents who are treated with NAC will use less marijuana during treatment when compared to adolescents who receive a placebo.

Detailed description: This protocol involves investigation of N-Acetylcysteine (NAC) as a pharmacological treatment for cannabis dependence in adolescents. While recent advances have been made in psychosocial treatments for cannabis dependent adolescents, minimal work has been done to investigate the potential adjunctive role for pharmacotherapy in treatment. NAC is an inexpensive, over-the-counter agent with a favorable tolerability profile in adults and children, in common use since FDA approval in 1963. Preclinical and preliminary clinical research in adults suggests a role for NAC in addiction treatment via glutamate modulation.

Eligibility criteria: Inclusion Criteria:

* Age 13-21 years
* Regular Marijuana smoker meeting DSM-IV criteria for cannabis dependence and seeking marijuana cessation treatment

Exclusion Criteria:

* Allergy or intolerance to NAC
* Pregnancy or lactation
* Use of carbamazepine or nitroglycerine (or any other drug deemed to be hazardous if taken with NAC) within 14 days of study participation
* Current enrollment in treatment for cannabis dependence
* Current substance dependence, other than cannabis or nicotine
* Significant medical or psychiatric illness that may place the participant at increased risk in the judgement of the study physician

Primary outcomes:
measure: Percentage of Negative Urine Cannabinoid Tests During Treatment
timeFrame: weekly during treatment, for 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Kevin M Gray, MD
role: PRINCIPAL_INVESTIGATOR
References: