louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00610519: Treatment of Acute Pharyngo-Tonsillitis With Essential Oils of Aromatic Plants
Official title: Treatment of Acute Pharyngo-Tonsillitis With Essential Oils of Some Aromatic Medical Plants.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Viral Pharyngitis
Viral Tonsillitis
Keywords: Viral pharyngo-tonsillitis;
Herbal medicine;
Traditional medicine;
Aromatic essential oils;
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
First posted: 2008-02-08
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized, double blind, parallel group study, compared the efficacy of spray containing aromatic essential oils of some herbal plants, against placebo in the treatment of patients with acute viral Pharyngo-tonsillitis.

Study objectives: Primary to demonstrate a throat pain relief within 20 minutes after first administration of treatment with the spray.

Secondary to demonstrate a reduction of a defined symptoms sum score based on symptoms and signs comparing baseline therapy from the beginning to the end of 3 days treatment

Detailed description: This study compared the efficacy of spray containing aromatic essential oils of Eucalyptus citriodora, Eucalyptus globulus, Mentha piperita, Origanum syriacum, and Rosmarinus Officinalis, against placebo in the treatment of patients with acute viral Pharyngo-tonsillitis.

In- vitro and clinical studies suggest therapeutic potential of aromatic herbs and trees oils in the treatment of Pharyngo-Tonsillitis. The pharmacological and clinical activity of Eucalyptus citriodora, Eucalyptus globulus, Mentha piperita, Origanum syriacum, and Rosmarinus Officinalis, include anti-inflammatory, anti-bacterial and anti-viral activities. Some of these herbs and trees oils have direct activity on the respiratory tract, the coughing reflex and the airflow in the nasal tract.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of acute viral pharyngo-tonsillitis.
* Active disease less than 48 hours
* Patients agree to sign informed consent according to GCP and Israel national regulations.

Exclusion Criteria:

* Acute follicular tonsillitis.
* Peritonsillar abscess.
* Under any antibiotically treatment.
* Asthma disease.
* Under coumadine therapy.
* Hyper sensitivity to Aromatic essential oils.
* Any immuno-suppressive disease

Primary outcomes:
measure: To demonstrate a throat pain relief within the first 20 minutes after first administration of treatment with the spray.
timeFrame: 20 minutes
Secondary outcomes:
measure: To demonstrate a reduction of a defined symptoms sum score based on symptoms and signs comparing baseline therapy from the beginning to the end of 3 days treatment.
timeFrame: 3 days
Other outcomes:
Locations:
city: Afula
country: Israel
facility: Otorhinolaryngology department
Study officials:
affiliation: haemek medical center
name: Yoseph Rakover, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00154219: Efficacy and Safety Study of Lumiracoxib in Patients With Primary Hip Osteoarthritis
Official title: A 13-week, Multicenter, Randomized, Double-blind, Double-dummy, Placebo-controlled, Parallel Group Trial of Lumiracoxib (COX189) 100 mg o.d. in Patients With Primary Hip Osteoarthritis Using Celecoxib (200 mg o.d.) as a Positive Control
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoarthritis, Hip
Keywords: Osteoarthritis, Hip, Lumiracoxib, Efficacy, Safety
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-09-12
Enrollment: 1200
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy, tolerability, and safety of the investigational drug, lumiracoxib as compared to celecoxib and placebo in subjects with hip osteoarthritis. Both lumiracoxib and celecoxib belong to the same class of drug (COX-2 selective nonsteroidal anti-inflammatory drugs \[NSAIDs\]).


Eligibility criteria: Inclusion Criteria:

* Diagnosis of primary hip osteoarthritis
* Qualifying pain intensity in the hip joint
* Requiring NSAID therapy

Exclusion Criteria:

* Rheumatoid arthritis or other inflammatory joint disease
* Disease or disorder that may interfere with pain assessment of the hip
* Open knee/hip surgery within the last year
* Past history of heart attack, stroke or angina (chest pain)
* Liver disorder
* History of severe adverse reactions of any kind under lumiracoxib or celecoxib treatment

Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: WOMAC 3.1 LK questionnaire after 13 weeks of treatment
measure: Patient's global assessment of disease activity (VAS) after 13 weeks of treatment
Secondary outcomes:
measure: Overall OA pain intensity (VAS)by visit
measure: Physician's global assessment of disease activity (VAS) by visit
measure: Response to treatment according to OARSI criteria by visit
measure: Actual OA pain intensity at 12 hours post-dose by visit
measure: Number of rescue tablets taken during the study
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: For US Site Information, contact Novartis Pharmaceuticals
state: New Jersey
city: Multiple Cities
country: Canada
facility: Various Sites
city: Multiple Cities
country: Germany
facility: Various Sites
city: Multiple Cities
country: Italy
facility: Various Sites
city: Multiple Cities
country: United Kingdom
facility: Various Sites
Study officials:
References:
citation: Schnitzer TJ, Dattani ID, Seriolo B, Schneider H, Moore A, Tseng L, Sallstig P, Rebuli R, Maxwell T. A 13-week, multicenter, randomized, double-blind study of lumiracoxib in hip osteoarthritis. Clin Rheumatol. 2011 Nov;30(11):1433-46. doi: 10.1007/s10067-011-1776-4. Epub 2011 May 24.
Clinical trial NCT05889819: Orange Almond Potato Cookies Supplementation
Official title: Orange Almond Potato Cookies Supplementation Effect on the Height-for-Age Z-score Among Stunted Preschool-aged Children During COVID-19 Pandemic
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nutritional Stunting
Keywords: COVID19
stunted under-five children
weight
HAZ score
orange almond potato cookies
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2023-06-05
Enrollment: 42
Sex: ALL
Minimum age (years): 12
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: One treatment group received almond orange potato cookies during 4 weeks. One control group received almond potato cookies during 4 weeks.
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to assess the effect of potato almond orange cookie supplementation on the nutritional status of stunted under-five children.

The main questions aimed to answer are:

* Can cookie supplementation improve the weight of stunted under-five children?
* Can cookie supplementation improve the weight for age z score of stunted under-five children?

Participants divided in the two groups i.e.:

* Treatment group received 50 g potato almond orange cookie each day during 4 weeks.
* Control group received 50 g potato orange cookie each day during 4 weeks.
* Mothers of both groups given balanced nutrition education for stunted under-five children twice at the second and third week of study.

Detailed description: Treatment group received 50 g potato almond orange cookie each day during 4 weeks.

Control group received 50 g potato orange cookie each day during 4 weeks.

Eligibility criteria: Inclusion Criteria:

* Age in the range of 12-59 months
* Male and female
* Lived in Sawangan Lama, Depok, and Depok Jaya neighborhoods of Depok City (three urban villages with a large stunting prevalence)
* Had a Height-for-Age Z-score (HAZ) index of \< -2 SD
* Were not suffering from chronic or infectious diseases.

Exclusion Criteria:

* Suffered from chronic or infectious diseases

Primary outcomes:
measure: Mean change of weight
timeFrame: 4 weeks
measure: Mean change of height
timeFrame: 4 weeks
measure: Mean change of Height for Age - Z score
timeFrame: 4 weeks
Secondary outcomes:
measure: Balanced nutrition of stunted under-five children knowledge
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Depok
country: Indonesia
facility: Depok, Depok Jaya, Sawangan Sub-districts
state: West Java
Study officials:
affiliation: Indonesia University
name: Fatmah Fatmah, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00662519: Neulasta in Type 1 Diabetes
Official title: Short Course of Pegylated GCSF (Neulasta®) as Immunomodulatory Therapy for Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 1 Diabetes
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: Juvenile Diabetes Research Foundation
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2008-04-21
Enrollment: 21
Sex: ALL
Minimum age (years): 12
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary purpose of this study is to find out if giving a 12 week course of Neulasta (Pegylated granulocyte colony stimulating factor (GCSF)) to people with type 1 diabetes (T1D) is safe. The secondary purpose of this research study is to determin if giving GCSF to patients with T1D changes the immune system or preserves insulin production.

Detailed description: As a participant in this study the following will happen:

Blood test, Mixed meal Tolerance Test (MMT) to find out how much C-peptide is being produced, Human Leukocyte Antigen (HLA) test, Hemoglobin A1C (HbA1c) test for overall blood sugar control, and randomized to either receive the 12 week course of Neulasta (Pegylated granulocyte colony stimulating factor (GCSF)) or a placebo (no medication).

Eligibility criteria: Inclusion Criteria:

* Must be \> 12 years old and have a confirmed diagnosis of "recent onset T1D" as defined by:
* T1D for \< 6 months,
* Stimulated C-peptide ≥ 0.2 pmol/ml
* Presence of at least one diabetes-related autoantibody (e.g., GAD, IA-2, IAA, ICA)
* Normal screening values for CBC
* Willing to comply with intensive diabetes management
* No history of allergy to GCSF
* Females having reproductive potential must be willing to avoid pregnancy and have a negative pregnancy test

Exclusion Criteria:

* Known hypersensitivity to E.Coli-derived proteins, pegfilgrastim, Filgrastim, or any other component of the product
* Chronic use of steroids or other immunosuppressive agents
* Active infection
* Inability to maintain intensive diabetes management
* Pregnancy
* History of malignancy
* Currently participating in another type 1 diabetes treatment study.
* Use of non-insulin pharmaceuticals that affect glycemic control

Primary outcomes:
measure: Area Under the Curve C-peptide Changed Time 0, 12 weeks, 24 weeks, 48 weeks and 96 weeks.
timeFrame: Changed Time 0, 12 weeks, 24 weeks, 48 weeks and 96 weeks.
measure: Number of participants with adverse events
timeFrame: 96 Weeks
Secondary outcomes:
measure: Hemoglobin A1c (HbA1c) levels have the same target distribution for treatment and placebo
timeFrame: 96 weeks
measure: Increase T regulatory cells (Treg) from the bone marrow
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Michael J Haller, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01190319: Study: Effects of Strawberries on Blood Pressure
Official title: Effect of Strawberry Powder on Blood Pressure in Individuals With Pre-Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pre-hypertension
Keywords: blood pressure
strawberry
fruit phenolics
LDL oxidation
Flow mediated dilation (FMD)
Lead sponsor: University of California, Davis
Sponsor class: OTHER
Collaborators: name: California Strawberry Commission
First posted: 2010-08-27
Enrollment: 50
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The specific aim of the study is to determine whether a freeze dried powder provided by the California Strawberries Commission, can reduce blood pressure in patients with pre-hypertension. The powder is prepared by the California Strawberry Commission (CSC).

Detailed description: Primarily, we would like to find out whether freeze dried strawberry powder lowers blood pressure. In addition we would like to know if the strawberry alters the subject's blood cholesterol and the ability of the subject's blood vessels to relax.

Eligibility criteria: Inclusion Criteria:

* Pre-hypertensive men and women (JNC 7 \[The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure\] criteria) between the ages of 25 and 65 years who have no clinical evidence/history of cardiovascular, respiratory, renal, gastrointestinal or hepatic disease.

Exclusion Criteria:

* Subjects who:

  1. are taking over the counter anti-oxidant supplements,
  2. are taking prescription medications that may interfere with study procedures or endpoints,
  3. have unusual dietary habits (eg., pica),
  4. are actively losing weight or trying to lose weight,
  5. are addicted to drugs or alcohol,
  6. present with significant psychiatric or neurological disturbances,
  7. have known allergies to strawberry, will be excluded from participating in this study.
  8. Patients known to have glaucoma
  9. Pregnant and/or lactating females

Primary outcomes:
measure: Change in blood pressure
timeFrame: 8 weeks
Secondary outcomes:
measure: Change in low density lipoprotein (LDL) oxidation
timeFrame: 8 weeks
measure: Change in flow mediated dilation (FMD)
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Davis
country: United States
facility: University of California Davis (Ragle Hall)
state: California
Study officials:
affiliation: University of California, Davis
name: Chulani T Kappagoda, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, Davis
name: Britt Burton-Freeman, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00489619: Safe Pregnancy by Infectious Disease Control
Official title: Safe Pregnancy by Infectious Disease Control in the Democratic Republic of Congo - Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy
Malaria
Keywords: Infectious diseases
Democratic Republic of Congo
Malaria
International
Maternal and child health
Women's Health
Global Network
Sexually transmitted infections (STIs)
Lead sponsor: NICHD Global Network for Women's and Children's Health
Sponsor class: NETWORK
Collaborators: name: Global Network for Women's and Children's Health Research
name: Bill and Melinda Gates Foundation
name: Fogarty International Center of the National Institute of Health
name: National Center for Complementary and Integrative Health (NCCIH)
name: National Institute of Dental and Craniofacial Research (NIDCR)
name: National Cancer Institute (NCI)
name: RTI International
name: University of North Carolina
name: Kinshasa School of Public Health
First posted: 2007-06-21
Enrollment: 2008
Sex: FEMALE
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE

Brief summary: Malaria and sexually transmitted infections (STIs) are common in pregnant women in Africa and are important preventable causes of poor birth outcomes and maternal and infant mortality. This study investigated baseline characteristics of the population including: rates of STIs including HIV, prevalence of malaria and tuberculosis (TB) and resistance to common antimalarial drugs.

Detailed description: A cross-sectional observational study was conducted with 2008 pregnant women attending either Binza or Kingasani Maternity clinics in Kinshasa, DRC to determine baseline rates of STIs, TB and malaria. Data was collected for sample size calculation in a larger STI/Malaria and TB randomized controlled trial.

Eligibility criteria: Inclusion Criteria:

* older than or equal to 15 years of age
* pregnant
* presenting for antenatal care at one of the two target maternities for the first time during the current pregnancy
* willing to provide informed consent

Exclusion Criteria:

* refusal to participate in the HIV voluntary and counseling program at the maternity center or refusal to share HIV results with the study staff.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Kinshasa
country: Congo, The Democratic Republic of the
facility: Binza Maternity
city: Kinshasa
country: Congo, The Democratic Republic of the
facility: Kingasani Maternity
Study officials:
affiliation: University of North Carolina
name: Robin Ryder, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01467219: Pilot Study Using a PET Gamma Probe to Evaluate Lymph Nodes in Endometrial Cancer
Official title: Intra-operative Lymph Node Evaluation Using a Hand Held PET Gamma Probe in Endometrial Cancer Surgery - A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endometrial Cancer
Keywords: early
high risk
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2011-11-08
Enrollment: 12
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The surgical management of high-risk endometrial cancer often involves an extensive operation to remove lymph nodes as sites of possible cancer spread.

18F-FDG PET/CT imaging is increasingly being used to identify sites of cancer spread and recently groups have used an intra-operative gamma probe to better localize metastatic disease. In this pilot study, patients with newly diagnosed early stage, high-risk endometrial cancer undergoing primary surgery will have a pre-operative PET scan and intra-operative localization of metastatic lymph nodes with the use of a gamma probe. A complete lymphadenectomy will follow and ability to detect positive lymph nodes of both PET scan and the intra-operative probe will be calculated.

This study addresses the feasibility of an FDG detection gamma probe in addition to a pre-operative PET/CT for lymphatic mapping in women with clinical early stage high risk endometrial cancer. The study will also evaluate the role of identifying metastatic lymph nodes intraoperatively that would otherwise be clinically negative.


Eligibility criteria: Inclusion Criteria:

* Women with adenocarcinoma of the endometrium with one of the following subtypes:

  * Serous
  * Clear Cell
  * Carcinosarcoma (MMMT)
  * High grade endometrioid
* Clinical stage 1 or 2
* Patients who have signed an approved informed consent.
* Patients who will undergo surgery that includes a hysterectomy and/or hysterectomy, bilateral salpingo-oophorectomy, bilateral pelvic and para-aortic lymph node

Exclusion Criteria:

* Patients with previous retroperitoneal surgery
* Patients with previous history of pelvic/abdominal radiation
* Any patient treated with neoadjuvant chemotherapy and/or radiation

Primary outcomes:
measure: Identification of metastatic disease in endometrial cancer through pre-operative PET assessment in combination with an FDG intra-operative gamma probe.
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University Health Network - Princess Margaret Cancer Center
state: Ontario
Study officials:
affiliation: Princess Margaret Hospital, University Health Network
name: Marcus Bernardini, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02253719: Cervical Cancer Screening in HIV Positive and Negative Women in Cambodia
Official title: Screening for Prevention of Cervical Cancer in HIV-positive and HIV-negative Cambodian Women Using Direct Visualization With Acetic Acid
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cervical Neoplasia
Cervical Cancer
Keywords: cervical neoplasia
cervical cancer'
visual inspection acetic acid
cryotherapy
Lead sponsor: Sihanouk Hospital Center of HOPE
Sponsor class: OTHER
First posted: 2014-10-01
Enrollment: 1000
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The 1000 women will be recruited from the current patient base of Sihanouk hospital and the surrounding community.

Brief summary: The prevalence of cervical neoplasia in Cambodia is not known. There are no screening programs in place. The investigators plan on introducing a screening program based on WHO criteria and utilizing visualization with acetic acid. Patients who are positive will be offered same-day cryotherapy if indicated or will be referred for biopsy, LEEP and hysterectomy as indicated. The planned patient pool for this study is 1000 women, half of whom will be HIV positive (and thus have a presumed higher incidence of cervical neoplasia).


Eligibility criteria: Inclusion Criteria:

* female, age 30-49, able to give informed consent

Exclusion Criteria:

* pregnancy, gross cervical mass, prior cervical cancer, unable to give informed consent, prior complete hysterectomy, allergic to acetic acid

Primary outcomes:
measure: Prevalence of cervical neoplasia in HIV positive women
timeFrame: up to 12 months
measure: Prevalence of cervical neoplasia in HIV negative women
timeFrame: up to 12 months
Secondary outcomes:
measure: Treatment of HIV positive women who screen as positive
timeFrame: up to 12 months
measure: Treatment of HIV negative women who screen as positive
timeFrame: up to 12 months
Other outcomes:
Locations:
city: Phnom Pehn
country: Cambodia
facility: Sihanouk Hospital, St. 134, Sangkat Vealvong, Khan 7 Makara
Study officials:
affiliation: Sihanouk Hospital
name: Thay Sovanarra, MD
role: PRINCIPAL_INVESTIGATOR
References: