louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05848986: Study if the Presence of Functional FcERI/RII on the Surface of Human Blood Platelet
Official title: Study if the Presence of Functional FcERI/RII on the Surface of Human Blood Platelet
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Allergy
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2023-05-08
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients assessed in the allergy clinic of the Strasbourg University Hospital

Brief summary: Anaphylactic shock is the most severe expression of immediate hypersensitivity reactions. The mechanisms leading to these reactions are still poorly understood and may involve platelets, especially in the most severe forms.

The IgE ( ImmunoglobulineE)-mediated mechanism, involving the FcERI(the high-affinity receptor for the Fc region of immunoglobulin E (IgE) receptor present on the surface of mast cells and basophilic cells, is the most common mechanism. The receptors FcERI and FcERII are also described as being present on the surface of blood platelets, which would imply their activation along with the other cells involved. However, studies showing the presence of the FcERI/RII receptors on blood platelets suffer from many biases.

The main objective of the research is to study whether the FcERI/RII receptors are present and functional on the surface of blood platelets from allergic patients.


Eligibility criteria: Inclusion Criteria:

* Age \> 18 years-old
* With a protein/drug allergy (hymenoptera, arachide, amoxicillin)
* Confirmed by skin tests and/or challenge test
* With specific IgEs

Exclusion Criteria:

* Patients who refuse to participate to this study
* Patients unable to consent

Primary outcomes:
measure: Presence of functionnal FcERI/RII receptors on the surface of blood platelets from allergic patients
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Les Hôpitaux Universitaires
Study officials:
affiliation: University Hospital, Strasbourg, France
name: CHARLES AMBROISE TACQUARD, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03321786: Legionnaires' Effect on Smell
Official title: Legionella Pneumonia's Effect on Olfactory Function
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Legionnaires' Disease
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2017-10-26
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The subjects to be tested in this study represent two different populations. The first is a group of who have survived Legionnaires' disease. The second group will be healthy men and women over the age of 18 years.

Brief summary: The goal of this study is to determine whether survivors of Legionnaires' disease suffer smell loss. A quantitative olfactory test will be performed by the participants. Such testing will require approximately 20-30 minutes of the participant's time. The participants will take the University of Pennsylvania Smell Identification Test (UPSIT), a scratch-and-sniff test to assess their ability to identify odors in a forced- choice format. Volunteers will also complete a questionnaire asking personal history, demographic questions, and medical history.


Eligibility criteria: Inclusion Criteria:

* Persons of generally good health, as obtained from a screening questionnaire who are 18 years of age and older
* Both men and women of all ethnic backgrounds will be accepted.

Exclusion Criteria:

* Age less than 18
* Pregnant Women
* Persons who mental competence is limited, such as those with dementia

Primary outcomes:
measure: Score on the University of Pennsylvania Smell Identification Test
timeFrame: 20-30 Minutes
Secondary outcomes:
measure: Questionnaire Responses
timeFrame: 20-30 Minutes
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Richard L Doty, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05228886: The SINCERE Intervention to Address COVID-19 Health Disparities
Official title: Intensifying Community Referrals for Health: the SINCERE Intervention to Address COVID-19 Health Disparities
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: COVID-19
Vulnerable Populations
Social Determinants of Health
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2022-02-08
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The goal of this real world efficacy study is to understand the benefit of universal social needs screening, community-based service referrals, and telephonic follow-up as a scalable strategy for preventing COVID-19 transmission, and for addressing the secondary health effects of the social, behavioral, and economic changes following the COVID-19 pandemic. With statewide community service providers, existing health information technology, and piloted methods, we seek to determine the effectiveness of universal social needs screening and community service referrals - the SINCERE intervention - in improving health outcomes of COVID-19 vulnerable and socioeconomically disadvantaged populations and whether intensive follow-up and collaborative goal-setting helps overcome barriers to community service use by patients seen in the emergency department and seeking COVID testing at community-based and mobile clinic locations.


Eligibility criteria: Inclusion Criteria:

* Adult (\> 17 years)
* English or Spanish speaking
* Completed the referral process at the UHealth ED, one of the COVID-19 testing sites or the Primary Children's ED and indicated both social needs and willingness to receive service low- and no-cost referrals from the United Way 211 community referral service
* Able to be reached by phone during the intervention OR able to complete surveys sent by text or email

Exclusion Criteria:

* Those unable to communicate verbally
* Those living in nursing facilities, or those who are not otherwise responsible for self-care

Primary outcomes:
measure: Change in Global Health over 12-week time period
timeFrame: Baseline, 2-week, 4-week and 12-week surveys
measure: Change in Depression over 12-week time period
timeFrame: Baseline, 2-week, 4-week and 12-week surveys
measure: Change in Anxiety over 12-week time period
timeFrame: Baseline, 2-week, 4-week and 12-week surveys
Secondary outcomes:
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: University of Utah
name: Andrea Wallace, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05929963: Observational Study of the Interaction Between Hepatitis C Virus Infection and Pregnancy
Official title: Observational Study of the Interaction Between Hepatitis C Virus Infection and Pregnancy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hepacivirus
Pregnancy
Lead sponsor: Beijing Ditan Hospital
Sponsor class: OTHER
First posted: 2023-07-05
Enrollment: 300
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pregnant women with hepatitis C:RNA negative (anti-HCV positive and HCV RNA negative) or RNA positive (anti-HCV positive and HCV RNA positive) pregnant women

Brief summary: The goal of this observational study is to learn about he effects of hepatitis C virus on pregnancy. The main question\[s\] it aims to answer are:

Effect of hepatitis C virus on liver function in pregnant women Mother-to-child transmission rate in pregnant women with hepatitis C

Detailed description: This study aims to collect demographic data, biochemical indicators during pregnancy, pregnancy complications, and fetal outcomes through the hospital HIS and LIS systems to investigate the impact of HCV infection on pregnancy outcomes, mother-to-child transmission, and long-term child development, and to provide assistance in the clinical management of pregnant women with HCV infection.

Eligibility criteria: Inclusion Criteria:

* normal (anti-HCV negative) or RNA negative (anti-HCV positive and HCV RNA negative) or RNA positive (anti-HCV positive and HCV RNA positive) pregnant women
* pregnant women aged 20-45 years
* complete pregnancy data available

Exclusion Criteria:

* Combination of other liver diseases such as viral hepatitis (hepatitis A, B, D, E), alcoholic hepatitis, autoimmune hepatitis, metabolic hepatitis, non-alcoholic fatty liver disease
* Combination of other viral infections with potential loss of liver function
* Mental illness
* Patients with immunosuppression
* Mother with cirrhosis or liver tumour

Primary outcomes:
measure: Incidence of various adverse pregnancy outcomes
timeFrame: 2023-2025
Secondary outcomes:
measure: Mother-to-child transmission rate of HCV
timeFrame: 2023-2025
measure: Development of children born to HCV pregnant women
timeFrame: 2023-2025
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Ditan Hospital
Study officials:
affiliation: Beijing Ditan Hospital
name: Yao Xie, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01515163: Exercise and Systemic Lupus Erythematosus
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Systemic Lupus Erythematosus
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2012-01-23
Enrollment: 90
Sex: FEMALE
Minimum age (years): 7
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators hypothesize that a three-month aerobic exercise training program will positively affect the lipid profile, insulin sensitivity , cytokine profile, the cardiovascular parameters and muscle strength in SLE patients.


Eligibility criteria: Inclusion Criteria:

* Age between 7 and 40 years
* SLEDAI ≤ 4

Exclusion Criteria:

* Cardiovascular dysfunction
* Rhythm and conduction disorders
* Musculoskeletal disturbances
* Kidney and pulmonary involvements
* Peripheral neuropathy
* Use of tobacco
* Treatment with lipid-lowering or hypoglycemic drugs
* Fibromyalgia
* Use of chronotropic or antihypertensive drugs
* Physically active subjects

Primary outcomes:
measure: Lipid profile - Plasma levels of total cholesterol (mg/dl), VLDL-chol (mg/dl) HDL-chol (mg/dl), LDL-chol (mg/dl), triglycerides (mg/dl), Apolipoprotein AI and AII (mg/dl) and Apolipoprotein B (mg/dl)
timeFrame: 3 months
measure: Insulin sensitivity as measured by the Hyperinsulinemic-Euglycemic Clamp
timeFrame: 3 months
measure: Cytokine response - Plasma levels of TNF-α (pg/ml), IL-6 (pg/ml), IFN-type I (pg/ml), IL-10 (pg/ml)and IL-1ra (pg/ml)
timeFrame: 3 months
Secondary outcomes:
measure: Cardiovascular parameters
timeFrame: 3 months
measure: Muscle Strength
timeFrame: 3 months
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: University of Sao Paulo
state: SP
Study officials:
References:
citation: Benatti FB, Miyake CNH, Dantas WS, Zambelli VO, Shinjo SK, Pereira RMR, Silva MER, Sa-Pinto AL, Borba E, Bonfa E, Gualano B. Exercise Increases Insulin Sensitivity and Skeletal Muscle AMPK Expression in Systemic Lupus Erythematosus: A Randomized Controlled Trial. Front Immunol. 2018 Apr 27;9:906. doi: 10.3389/fimmu.2018.00906. eCollection 2018.
citation: Benatti FB, Miossi R, Passareli M, Nakandakare ER, Perandini L, Lima FR, Roschel H, Borba E, Bonfa E, Gualano B, de Sa Pinto AL. The effects of exercise on lipid profile in systemic lupus erythematosus and healthy individuals: a randomized trial. Rheumatol Int. 2015 Jan;35(1):61-9. doi: 10.1007/s00296-014-3081-4. Epub 2014 Jun 28.
citation: Prado DM, Benatti FB, de Sa-Pinto AL, Hayashi AP, Gualano B, Pereira RM, Sallum AM, Bonfa E, Silva CA, Roschel H. Exercise training in childhood-onset systemic lupus erythematosus: a controlled randomized trial. Arthritis Res Ther. 2013 Mar 26;15(2):R46. doi: 10.1186/ar4205.
Clinical trial NCT04354363: PRP in Intracytoplasmic Sperm Injection
Official title: Role of PRP in Intracytoplasmic Sperm Injection in Infertile Women
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Infertility
Lead sponsor: Aljazeera Hospital
Sponsor class: OTHER
First posted: 2020-04-21
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized controlled trial
Primary purpose: OTHER

Brief summary: Infertility is a major problem nowadays

Detailed description: ovarian and uterine factor of infertility are very hard to treat

Eligibility criteria: Inclusion Criteria:

* women with primary infertility

Exclusion Criteria:

* women with unexplained infertility

Primary outcomes:
measure: The number of women wo will have chemical pregnancy
timeFrame: within 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Algazeerah
Study officials:
affiliation: Algezeera hospitaland National Research Centre ,Egypt
name: Mahmoud Alalfy, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT03004963: Bioimpedance-guided Fluid Management in Chronic Peritoneal Dialysis Patients.
Official title: Bioimpedance-guided Fluid Management in Chronic Peritoneal Dialysis Patients: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: End Stage Renal Disease
Keywords: Peritoneal Dialysis
Volume Status
Body Composition Monitor
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2016-12-29
Enrollment: 213
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Peritoneal dialysis (PD) is one of established treatments in the end stage renal disease patients. Volume overload is a predictor of mortality in PD patients. In this Randomized controlled trial, the investigators use the Body Composition Monitor (BCM), a multifrequency bioimpedance device, to measure the level of overhydration in PD patients and explore its value in fluid management in peritoneal dialysis patients as well as their prognosis.

Detailed description: Optimal fluid management is one of the primary objectives of dialysis treatment, and there is significant concern that peritoneal dialysis (PD) patients can become progressively fluid-loaded with time on treatment, especially as residual kidney function declines. Body Composition Monitor (BCM) has the potential to enable better management of fluid balance. The investigators undertake a prospective, randomized, open-label, controlled trial to determine whether availability of longitudinal BCM measures help clinicians maintain stable fluid status over 24 months in 300 peritoneal dialysis patients.

Eligibility criteria: Inclusion Criteria:

* Patients 18 years or older but no older than 80 years.
* who had been on chronic peritoneal dialysis for more than 3 months.
* All of them have signed the informed consent.

Exclusion Criteria:

* were expected to stop PD treatment in 6 months;
* were amputees;
* had a cardiac pacemaker or metallic implants;
* had peritonitis one month before recruitment;
* treated together with hemodialysis;
* were during pregnancy or lactation;
* were positive with HIV;
* had serious diseases, including cancer, infection and liver cirrhosis, which were not suitable for the study.

Primary outcomes:
measure: volume status
timeFrame: 96 weeks
measure: The incidence of cardiovascular events
timeFrame: 96 weeks
measure: patient mortality
timeFrame: 96 weeks
measure: technique failure
timeFrame: 96 weeks
Secondary outcomes:
measure: blood pressure
timeFrame: 96 weeks
measure: residual renal function
timeFrame: 96 weeks
measure: peritoneal function
timeFrame: 96 weeks
measure: heart function
timeFrame: 96 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Department of nephrology , Renji Hospital, Shanghai Jiao Tong University School of Medicine
state: Shanghai
Study officials:
affiliation: Department of Nephrology, Renji Hospital, Shanghai Jiaotong University, School of Medicine, Shanghai
name: Wei Fang, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05680363: Prospective Sibling Oocyte Study of a New Method to Improve Embryo Development in IVF/ICSI Patients
Official title: Prospective Sibling Oocyte Study of a New Method to Improve Embryo Development in IVF/ICSI Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Infertility
Lead sponsor: Fecundis Lab SL
Sponsor class: OTHER
First posted: 2023-01-11
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 41
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Prospective, multi-centric, split-sample, sibling oocyte study evaluating the safety and efficacy of a new method to prepare sperm samples for IVF (in vitro fertilization) / ICSI (intracytoplasmic sperm injection) compared to standard procedures.


Eligibility criteria: Female:

Inclusion Criteria:

* With ovarian reserve of between 8 and 30 antral follicles counting both ovaries
* Treatment planned for embryo transfer at the blastocyst stage

Exclusion Criteria:

* Any diagnosed sexually transmitted infection (STI)
* Diabetes or other metabolic disorders.
* Recurrent pregnancy loss (defined as \>2 clinical pregnancies without live birth).
* Previous failures in two or more IVF cycles

Male:

Inclusion Criteria for IVF:

* Age: 20-55 years
* Fresh sample (not cryopreserved )
* Sperm motility (TOTAL) ≥ 40% in spermogram
* Normal sperm morphology (Kruger criteria) ≥ 4% in spermogram
* Sperm count after swim up ≥ 5x10\^6
* Treatment planned for embryo transfer at the blastocyst stage

Inclusion Criteria for ICSI:

* Age: 20-55 years
* Fresh sample (not cryopreserved )
* Sperm concentration ≥ 10x10\^6 /ml in spermogram
* Sperm motility (TOTAL) ≥ 20% in spermogram
* Normal sperm morphology (Kruger criteria) ≥ 3% in spermogram
* Treatment planned for embryo transfer at the blastocyst stage

Exclusion Criteria:

* Any diagnosed sexually transmitted infection (STI)
* Total failure of in vitro fertilization in previous cycles.

Primary outcomes:
measure: Development rate to blastocysts
timeFrame: Days 5-6 post insemination
Secondary outcomes:
measure: Fertilization rate
timeFrame: Day 1 post insemination
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: In Vitro Buenos Aires
state: Caba
city: Buenos Aires
country: Argentina
facility: Pregna
state: Caba
city: Buenos Aires
country: Argentina
facility: WeFIV
state: Caba
city: Rosario
country: Argentina
facility: Fertya
state: Santa Fe
Study officials:
affiliation: Fecundis Lab SL
name: Mariano Buffone, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00944463: Trial of Simvastatin and Gemcitabine in Pancreatic Cancer Patients
Official title: Randomized Double-blinded, Placebo-controlled Phase II Trial of Simvastatin and Gemcitabine in Advanced Pancreatic Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pancreatic Cancer
Keywords: advanced pancreatic cancer
gemcitabine
simvastatin
placebo
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2009-07-23
Enrollment: 106
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: The purpose of this study is to determine whether simvastatin is effective in the treatment of advanced pancreatic cancer patients.

Detailed description: Randomized double-blinded, placebo-controlled phase II trial of simvastatin and gemcitabine in advanced pancreatic cancer patients.

Eligibility criteria: Inclusion Criteria:

1. Age \> 18 years
2. Histologically or cytologically confirmed, metastatic or unresectable pancreatic adenocarcinoma (if repeated biopsy (\>3) fails or if biopsy is not feasible, the inclusion of the patient will be determined by the central PI)
3. ECOG performance status of 0\~2
4. no radiotherapy within 1 month of the study entry
5. measurable or evaluable lesion according to RECIST criteria
6. no prior history of chemotherapy for pancreatic cancer (gemcitabine-based adjuvant chemotherapy ≥ 12 months from the study entry will be allowed)
7. adequate marrow, hepatic, renal and cardiac functions (absolute neutrophil count ≥ 1.5 x 109/L; platelet count ≥ 75 x 109/L, serum creatinine ≤ 1.5 x ULN), serum aspartate aminotransferase/alanine aminotransferase ≤ 5 x ULN or ≤ 10 x ULN if liver abnormalities are due to underlying malignancy; total bilirubin ≤ 2.0 x ULN
8. written informed consent must be provided

Exclusion Criteria:

1. severe co-morbid illness and/or active infections
2. pregnant or lactating women
3. active CNS metastases not controllable with radiotherapy or corticosteroids A.patients with symptoms suggestive of CNS metastases must undergo radiologic evaluation to rule out metastases B.patients with known, asymptomatic CNS lesions are permitted
4. known history of hypersensitivity to study drugs
5. patients who are currently on statin therapy or has taken statin as lipid lowering agents within 1 year of the study entry

Primary outcomes:
measure: Time to progression
timeFrame: Every 2 cycles until progression
Secondary outcomes:
measure: Safety profiles of gemcitabine/simvastatin
timeFrame: Every cycle until progression
measure: Response rate
timeFrame: Every 2 cycles until progression
measure: Duration of response
timeFrame: Every 2 cycles until progression
measure: Overall survival
timeFrame: Every 3 months
measure: Correlative analyses
timeFrame: after completion of accrual
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center, Seoul, Korea
name: Young Suk Park, M.D.,Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: