louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05949437: Effect of Yoga Breathing Exercises Versus Aerobic Exercise on Hematological Parameters
Official title: The Effect of Yoga Breathing Exercises Versus Aerobic Exercise on Hematological Parameters in Iron Deficiency Anemic Females
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Iron Deficiency Anemia
Lead sponsor: October 6 University
Sponsor class: OTHER
First posted: 2023-07-18
Enrollment: 60
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Is there effect of yoga breathing exercises versus aerobic exercise on hematological parameters in iron deficiency anemic females?

The purpose of the study is to investigate the effect of yoga breathing exercises versus aerobic exercise on hematological parameters in iron deficiency anemic females

Detailed description: 60 patients with iron deficiency anemia and will receive medical treatment of anemia and Dietary advice for 12 weeks . thirty patient from the 60 patients will receive yoga therapy and 50 minutes yoga therapy 6 days a week for 12 weeks while the other 30 patients will receive aerobic exercise for 12 weeks

Eligibility criteria: Inclusion Criteria:

1. Sixty female patients referred with iron deficiency anemia
2. Their age will be ranged from 30-40 years old.
3. All patients have a history of anemia.
4. All patients should be medically stable.
5. The body mass index (BMI) ranged from 25:29.9 Kg/m2
6. Number of parity not exceed 3 times.
7. Period of menses from 3-5 days

Exclusion Criteria:

1. Patients with cognitive impairments.
2. All types of anemia except iron deficiency anemia
3. patients with hearing problems.
4. patients with Diabetes, Hypertension.
5. Patients with Musculoskeletal, Neurological, Cardiovascular and Respiratory problems
6. patients with mental problems.

Primary outcomes:
measure: serum iron level
timeFrame: it will be measured after 12 weeks
measure: ferritin level
timeFrame: it will be measured after 12 weeks
measure: iron binding capacity level
timeFrame: it will be measured after 12 weeks
measure: count of red blood cells
timeFrame: it will be measured after 12 weeks
measure: Hemoglobin level
timeFrame: it will be measured after 12 weeks
measure: hematocrite level
timeFrame: it will be measured after 12 weeks
measure: lymphocytes level
timeFrame: it will be measured after 12 weeks
Secondary outcomes:
measure: six minute walking distance
timeFrame: it will be measured after 12 weeks
measure: The fatigue severity scale(FSS)
timeFrame: it will be measured after 12 weeks
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: October 6 university
Study officials:
affiliation: 6 october University
name: shoukry MA youssef, ass lecturer
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03271437: Flash Open Trial With Therapists In Training
Official title: Flash Open Trial With Therapists In Training
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Trauma, Psychological
Lead sponsor: Trauma Institute & Child Trauma Institute
Sponsor class: OTHER
First posted: 2017-09-05
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will test the eye movement desensitization and reprocessing (EMDR) based Flash technique and a progressive counting (PC) based variant. EMDR-trained therapists will be trained in the standard Flash, and PC-trained therapists will be trained in PC Flash. In each group they will try it with a minor upsetting memory, and then with two more significant upsetting memories. Participants will use the subjective units of distress scale (SUDS) to rate distress pre- and post-treatment.


Eligibility criteria: Inclusion Criteria:

* Therapist trained by Trauma Institute \& Child Trauma Institute in EMDR or PC

Primary outcomes:
measure: Change in SUDS following treatment
timeFrame: Pre-treatment, immediately post-treatment, one week post-treatment, and one month post-treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Northampton
country: United States
facility: Trauma Institute & Child Trauma Institute
state: Massachusetts
Study officials:
affiliation: Trauma Institute & Child Trauma Institute
name: Ricky Greenwald, PsyD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01916837: Genomic Grade Index (GGI): Feasibility in Routine Practice and Impact on Treatment Decisions in Early Breast Cancer
Official title: Genomic Grade Index (GGI): Feasibility in Routine Practice and Impact on Treatment Decisions in Early Breast Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Invasive Breast Cancer
Keywords: Breast cancer
Feasibility
Genomic grade index
Lead sponsor: Jules Bordet Institute
Sponsor class: OTHER
First posted: 2013-08-06
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study includes patients diagnosed with early-stage invasive breast cancer and operable disease.

Brief summary: In this prospective study the investigators sought to evaluate the feasibility of using the genomic signature - Genomic Grade Index (GGI) - in routine clinical practice and its impact on treatment recommendations.

Detailed description: The primary objective of this study was to evaluate the feasibility of implementing Genomic Grade Index (GGI) in community hospitals in Belgium for breast cancer patients with node negative and 1-3 node positive early breast cancer. GGI would be considered a feasible genomic test if results were obtained in \> 70% of evaluated patients.

Eligibility criteria: Inclusion Criteria:

Histologically confirmed invasive breast cancer meeting the following criteria:

* T1, T2, or operable T3 disease
* Zero to three positive lymph nodes and no distant metastases
* Operable disease - Must have undergone breast-conserving surgery or mastectomy with either a sentinel node procedure or full axillary clearance

Exclusion Criteria:

* No other invasive cancer within the past 5 years except for adequately treated carcinoma in situ of the cervix or non melanoma skin cancer
* No psychological, familial, sociological, or geographical condition that would preclude entering into a clinical study

Primary outcomes:
measure: The success rate in obtaining the Genomic Grade Index in clinical practice
timeFrame: 12 months
Secondary outcomes:
measure: The impact of Genomic Grade Index results on adjuvant treatment decision
timeFrame: 12 months
Other outcomes:
measure: The success rate of reporting Genomic Grade Index results
timeFrame: 12 months
Locations:
city: Brussels
country: Belgium
facility: Institut Jules Bordet
Study officials:
References:
citation: Metzger-Filho O, Catteau A, Michiels S, Buyse M, Ignatiadis M, Saini KS, de Azambuja E, Fasolo V, Naji S, Canon JL, Delree P, Coibion M, Cusumano P, Jossa V, Kains JP, Larsimont D, Richard V, Faverly D, Cornez N, Vuylsteke P, Vanderschueren B, Peyro-Saint-Paul H, Piccart M, Sotiriou C. Genomic Grade Index (GGI): feasibility in routine practice and impact on treatment decisions in early breast cancer. PLoS One. 2013 Aug 19;8(8):e66848. doi: 10.1371/journal.pone.0066848. eCollection 2013.
Clinical trial NCT06288737: Assessing Patient Engagement in Keratoconus Clinical Research
Official title: Exploring Enrollment and Engagement Trends in Individuals Managing Keratoconus: A Comprehensive Examination of Data on Keratoconus Clinical Trials
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Keratoconus
Keywords: keratoconus
Lead sponsor: Power Life Sciences Inc.
Sponsor class: INDUSTRY
First posted: 2024-03-01
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with keratoconus who are actively considering enrolling in a clinical study, but have not yet completed enrollment and randomization.

Brief summary: This study aims to investigate the influences behind patient choices regarding involvement, discontinuation, or re-engagement in keratoconus clinical trials. Uncovering these factors is essential to enhance the relevance and efficacy of future research endeavors.

In essence, this trial aims to deepen understanding of the factors influencing participation in keratoconus clinical trials. Elevating participation rates could expedite the development of innovative treatments for this challenging condition.


Eligibility criteria: Inclusion Criteria:

* Signed Written Informed Consent
* Aged ≥ 18 years old
* No prior treatment for keratoconus

Exclusion Criteria:

* Participant is actively receiving study therapy in another
* Inability to provide written informed consent
* Women of childbearing potential without a negative pregnancy test; or women who are lactating.

Primary outcomes:
measure: Rate of patients who decide to join in a keratoconus clinical trial
timeFrame: 3 months
measure: Number of keratoconus patients who remain in clinical trial until completion
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Power Life Sciences
state: California
Study officials:
affiliation: Power Life Sciences Inc.
name: Michael B Gill
role: STUDY_DIRECTOR
References:
citation: Moran S, Gomez L, Zuber K, Gatinel D. A Case-Control Study of Keratoconus Risk Factors. Cornea. 2020 Jun;39(6):697-701. doi: 10.1097/ICO.0000000000002283.
citation: Kandel H, Pesudovs K, Nguyen V, Chen JY, Poon A, Mills R, Watson SL. Patient-Reported Outcomes in Keratoconus: A Save Sight Keratoconus Registry Study. Cornea. 2023 May 1;42(5):590-597. doi: 10.1097/ICO.0000000000003119. Epub 2022 Aug 24.
citation: Aiello F, Gallo Afflitto G, Ceccarelli F, Garzione F, Pocobelli G, Pinci C, Di Lorenzo G, Siracusano A, Nucci C. Keratoconus and Personality Traits: A Case-Control Study. Cornea. 2024 Feb 1;43(2):237-244. doi: 10.1097/ICO.0000000000003284. Epub 2023 Apr 5.
Clinical trial NCT03878537: Recurrence Monitoring in NSCLC Using Circulating Tumor DNA
Official title: Recurrence Monitoring in NSCLC Using Circulating Tumor DNA
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Non Small Cell Lung Cancer
Lead sponsor: Scripps Translational Science Institute
Sponsor class: OTHER
Collaborators: name: Scripps Health
name: Lexent Bio, Inc.
First posted: 2019-03-18
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients aged 18 or older with NSCLC

Brief summary: This research study is investigating the role of cell free tumor DNA profiling in determining disease relapse and/or progression for patients with advanced NSCLC.

Detailed description: The objective of this study is to determine the ability of cell free tumor DNA genomic profiling to predict disease relapse or progression while on therapy for advanced stage NSCLC in comparison to current standard objective measures of disease relapse or progression.

This study is a prospective observational study. The investigators will assess whole genome sequencing from patient blood samples collected alongside routine blood draws with each treatment cycle to determine the tumor load score at each timepoint while on therapy. CT images will be obtained at routinely ordered timepoints throughout therapy and will be used in the assessment for standard clinical or radiographic evidence of disease progression. These methods of measuring disease progression will be compared in a lead time analysis.

Eligibility criteria: Inclusion Criteria:

* Treatment naïve biopsy confirmed not surgically resectable stage III or greater NSCLC
* Baseline CT imaging available

Exclusion Criteria:

* Patients unable to undergo biopsy for initial tissue diagnosis
* Patients who do not wish to pursue standard of care therapy
* Patients with another diagnosis of malignancy

Primary outcomes:
measure: Progression Free Survival
timeFrame: 24 months
measure: Progression Free Survival
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Scripps Health/Scripps Clinic Hillcrest/Scripps Clinic Torrey Pines
state: California
Study officials:
affiliation: Scripps Health
name: Marin Xavier
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00002037: Evaluation of the Therapeutic Benefit of r-metHuIFN- Gamma in AIDS Patients With Disseminated Mycobacterium Avium-Intracellulare (MAI) Infection: A Multi-Centered Pilot Study
Official title: Evaluation of the Therapeutic Benefit of r-metHuIFN- Gamma in AIDS Patients With Disseminated Mycobacterium Avium-Intracellulare (MAI) Infection: A Multi-Centered Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mycobacterium Avium-Intracellulare Infection
HIV Infections
Keywords: AIDS-Related Opportunistic Infections
Mycobacterium avium-intracellulare Infection
Interferon-gamma, Recombinant
Acquired Immunodeficiency Syndrome
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: To examine the effectiveness of subcutaneous gamma interferon in reducing severity of Mycobacterium avium- intracellulare (MAI) bacillemia episodes in AIDS patients in an open-label dose-randomized multi-center pilot clinical investigation. To evaluate the safety of gamma interferon given by subcutaneous injection (SC) in the AIDS patient in the presence and absence of AZT therapy.


Eligibility criteria: Inclusion Criteria

Patients must have:

* Diagnosis of AIDS and persistent Mycobacterium avium- intracellulare (MAI) bacillemia.
* Life expectancy of at least 3 months.
* Baseline chest X-ray and EKG (electrocardiogram).

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

* Known hypersensitivity to interferons or other exogenous lymphokine.
* History of cardiac abnormality or disease.
* History of hypertension.

Patients with the following are excluded:

* Known hypersensitivity to interferons or other exogenous lymphokine.
* History of cardiac abnormality or disease.
* History of hypertension.

Prior Medication:

Excluded within 4 weeks of study entry:

* Corticosteroids.
* Anti-inflammatory medication (except aspirin).
* Changes in the dose of anti-mycobacterial drugs.
* Immune agents.

Prior Treatment:

Excluded within 4 weeks of study entry:

* Radiotherapy.

Risk Behavior:

Excluded:

* Intravenous drug abuse.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York Hosp - Cornell Med Ctr
state: New York
Study officials:
References:
Clinical trial NCT00966537: The 3-Dimensional Ultrasound for Fetal Anomaly Scan
Official title: The 3-Dimensional Ultrasound for Fetal Anomaly Scan.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pregnancy
Keywords: to study the clinical application of 3D/4D ultrasound for fetal scanning
to study the clinical application of 3D/4D ultrasound for pelvic scanning;
to demonstrate how to optimally display the different organs.
to correlate our findings with other diagnostic tools like MRI, CT;
to correlate our findings with clinical outcome.
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2009-08-27
Enrollment: 600
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: pregnant woman

Brief summary: The aim of this study is 1) to study the clinical application of 3D/4D ultrasound for fetal scanning during pregnancy; 2) ) to study the clinical application of 3D/4D ultrasound for pelvic scanning; 3) to demonstrate how to optimally display the different organs. 4) to correlate our findings with other diagnostic tools like MRI, CT; 5) to correlate our findings with clinical outcome.

Detailed description: A prospective studies of patients that coming to the ultrasound (US) unit in Sheba Medical Center from November 2007 for diagnostic US examination.

Patients will receive information of the study (printed and oral) and will ask to sign informed consent to act as a research subject and permission to use personal heath information for research.

Studies is performed using commercially available ultrasound equipment (Voluson 730 Expert, General Electric Healthcare, Kretztechnik, Zipf, Austria) with volumetric abdominal RAB 4-8 MHz and volumetric transvaginal RIC 5-9 MHz transducer probes.

During the examination of the patient pictures and 3D/4D volumes will acquired either by static 3D or 4D Volume or STIC (Spacio Temporal Image Corelation), Contrast Imaging in plane C (VCI-C) with and without Doppler (Color, Power and High Definition) and with B-flow. Image quality will be assessed in various modes. For optimizing the image volumes manipulations will be performed by positioning of the

Eligibility criteria: Inclusion Criteria:

* pregnant woman who come for fetal anomaly scan.

Exclusion Criteria:

-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Ramat-gan,
country: Israel
facility: Sheba Medical Center
Study officials:
References:
Clinical trial NCT01507337: Comparison of the Effect of Liraglutide in Young Versus Elderly Healthy Volunteers
Official title: An Open Label, Single Dose Trial With Two Groups Comparing the Pharmacokinetics of Liraglutide in Young Versus Elderly Healthy Subjects of Both Sexes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Healthy
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2012-01-10
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Europe. The aim of this trial is to compare the exposure of liraglutide in young versus elderly healthy subjects.


Eligibility criteria: Inclusion Criteria:

* Good general health as judged by the investigator, based on medical history, physical examination including 12-lead ECG (electrocardiogram), vital signs, and blood and urinary laboratory assessments
* Age, young subjects: age 18-45 years (both incl.)
* Age, elderly subjects: age at least 65 years
* Body Mass Index (BMI) 18-30 kg/m\^2 (both incl.)
* Blood pressure, young: Diastolic 50-90 mmHg, systolic 90-140 mmHg
* Blood pressure, elderly: Diastolic 50-95 mmHg, systolic 92-160 mmHg

Exclusion Criteria:

* History of any clinically significant renal, hepatic, cardiovascular, pulmonary, gastrointestinal, metabolic, endocrine, haematological, neurological, psychiatric disease, or other major disorders that could interfere with the objectives of the trial, as judged by the investigator
* Impaired renal function
* Any clinically significant abnormal ECG (electrocardiogram)
* Active hepatitis B and/or active hepatitis C
* Positive HIV (human immunodeficiency virus) antibodies
* Febrile illness within 5 days prior to first administration of liraglutide
* History of alcoholism or drug abuse during the last 12 months
* Smoking of more than 10 cigarettes per day, or the equivalent for other tobacco products
* Habitual excessive consumption of methylxanthine-containing beverages and foods (coffee, tea, soft drinks such as cola, chocolate) as judged by the investigator

Primary outcomes:
measure: Area under the liraglutide plasma concentration time curve (AUC 0-t)
Secondary outcomes:
measure: Area under the liraglutide plasma concentration time curve (AUC 0-infinity)
measure: Cmax, maximum liraglutide plasma concentration
measure: tmax, time to reach Cmax
measure: t½, terminal plasma elimination half-life
measure: Adverse events
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Damholt B, Golor G, Wierich W, Pedersen P, Ekblom M, Zdravkovic M. An open-label, parallel group study investigating the effects of age and gender on the pharmacokinetics of the once-daily glucagon-like peptide-1 analogue liraglutide. J Clin Pharmacol. 2006 Jun;46(6):635-41. doi: 10.1177/0091270006288215.
Clinical trial NCT00687037: Safety Oral Mucosa Evaluation - Acceptability With Odontological Follow up - Cepacol Canela Power
Official title: Uni Centric Study, Phase III, for Safety Oral Mucosa Evaluation: Basic Acceptability With Odontological Follow up - Cepacol Canela Power
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Healthy
Keywords: oral hygiene
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2008-05-30
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: To prove the safety, in normal conditions, of the odontological use formulation of the product Cepacol Canela Power.


Eligibility criteria: Inclusion Criteria:

* Integral buccal mucous (without oral pathologies);
* Normal odontological exams;

Exclusion Criteria:

* Lactation or gestational risk or gestation;
* Use of Anti-inflammatory or immunosuppression drugs 15 days before the study;
* Being in odontological treatment;
* Pathological or mucous disease which can interfere or active gynaecological disease which may interfere wtih study results;
* Personal history of allergic disease in the area to be treated;
* Allergic or atopic history;

Primary outcomes:
measure: Patients will be evaluated according to the adverse reactions and the intensity of them. The volunteers will also answer a questionnaire about the physical attributes of the product.
timeFrame: 21 days
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Sanofi-aventis
Study officials:
affiliation: Sanofi-aventis administrative office Brazil
name: Jaderson Lima, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02104037: Liraglutide in Spinal Fluid
Official title: Liraglutide in Spinal Fluid
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Liraglutide Blood-brain Transfer
Lead sponsor: University Hospital, Gentofte, Copenhagen
Sponsor class: OTHER
First posted: 2014-04-04
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to investigate transfer of liraglutide from blood to cerebrospinal fluid.


Eligibility criteria: Inclusion Criteria:

Type 2 diabetes treated with liraglutide 1.8 mg for 1 month and 5% weight loss

Exclusion Criteria:

-

Primary outcomes:
measure: cerebrospinal fluid concentration of liraglutide
timeFrame: time 60 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Hellerup
country: Denmark
facility: Diabetes Research Division, Department of Medicine
Study officials:
References: