louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00002062: Open-Label "Compassionate" Use Study of Spiramycin for the Treatment of Diarrhea Due to Chronic Cryptosporidiosis in Immunocompromised Patients
Official title: Open-Label "Compassionate" Use Study of Spiramycin for the Treatment of Diarrhea Due to Chronic Cryptosporidiosis in Immunocompromised Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cryptosporidiosis
HIV Infections
Keywords: Spiramycin
AIDS-Related Opportunistic Infections
Immune Tolerance
Cryptosporidiosis
Diarrhea
Drugs, Investigational
Acquired Immunodeficiency Syndrome
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: This protocol provides for the availability of spiramycin under compassionate-use conditions for the treatment of chronic diarrhea due to cryptosporidium in patients with a compromised immune system, thus deriving additional information regarding its safety and efficacy profile.


Eligibility criteria: Exclusion Criteria

Co-existing Condition:

Patients with known sensitivity to macrolide antibiotics are excluded. Consideration must be given to the fact that spiramycin is a macrolide antibiotic and, therefore, may have the potential to induce hepatotoxicity.

* Patients with a compromised immune system may have hepatic abnormalities or even hepatitis. If the benefit-to-risk ratio does not favor the use of spiramycin, the patients must be excluded from the study.

Concurrent Medication:

Excluded:

* Other investigational drugs.

Patients with known sensitivity to macrolide antibiotics are excluded. Consideration must be given to the fact that spiramycin is a macrolide antibiotic and, therefore, may have the potential to induce hepatotoxicity.

* Patients with a compromised immune system may have hepatic abnormalities or even hepatitis. If the benefit-to-risk ratio does not favor the use of spiramycin, the patients must be excluded from the study.

Prior Medication:

Excluded within 7 days of study entry:

* Other investigational drugs.

Diagnosis of chronic diarrhea due to cryptosporidiosis and a compromised immune system but not limited to patients with AIDS.

* Patients receiving chemotherapy for a malignancy.
* Patients who are iatrogenically immune-suppressed following organ transplantation.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Horsham
country: United States
facility: Rhone - Poulenc Rorer Pharmaceuticals
state: Pennsylvania
Study officials:
References:
Clinical trial NCT06109662: Multimorbidity and Sarcopenia Feasibility Study in Chronic Kidney Disease
Official title: Multimorbidity and Sarcopenia Feasibility Study in Chronic Kidney Disease
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Chronic Kidney Diseases
Sarcopenia
Lead sponsor: University Hospitals of Derby and Burton NHS Foundation Trust
Sponsor class: OTHER
First posted: 2023-10-31
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 80 participants with different levels of renal function (normal renal function, CKD3,4 and 5) to be recruited from secondary care renal department.

Brief summary: The aim of this research study is to look at the body composition (such as muscle and fat) in people with chronic kidney disease (CKD) and comparing it with body composition is people without CKD. The investigators currently understand loss of muscle function and mass (sarcopenia) affect the general health of people as they age, but this process seems to be more common, accelerated, and occurs earlier in people with CKD. There is limited evidence in this area, and we believe that if we understand when and how sarcopenia affects people with CKD, investigators can guide future trials and treatments to help treat sarcopenia, and in turn improve quality of life and health outcomes in people with CKD.

Detailed description: In this study, the investigators will follow up people with CKD in two visits a year apart. In both visits, the investigators will measure the participants body composition and estimated kidney function using 2 different testing methods - Cystatin C eGFR and Creatinine eGFR. Using both the results in a formula, the creatinine muscle index can be calculated. If this index correlated with sarcopenia, it will be helpful tool in the care of people with CKD as will be a easy to use screening tool for sarcopenia in this population.

Eligibility criteria: Inclusion Criteria:

Subjects capable of giving informed consent

≥18 years of age Chronic kidney disease stages 3-5 looked after in secondary care nephrology Healthy volunteers with normal kidney function (Control)

Exclusion Criteria:

* Pregnancy
* Subjects with known neuromuscular diseases, e.g. myopathy, muscular dystrophy, muscular atrophy
* Renal transplant recipients
* Patients with pacemakers

Primary outcomes:
measure: Creatinine Muscle Index (mg/day per 1.73m2)
timeFrame: Day 1 (day recruited) and at 1 year
Secondary outcomes:
measure: Skeletal muscle mass (kg)
timeFrame: At Day 1 (day recruited) and 1 year
measure: Multimorbidity Score
timeFrame: Day 1 (day recruited) and 1 year
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00366262: Study Evaluating the Gastrointestinal Safety of PLA-695 Compared to Placebo and Naproxen
Official title: A Randomized, Double-Blind, Parallel Group Study To Compare The 7-Day Gastrointestinal Safety of 2 Doses of PLA-695 To That Of Placebo And Naproxen
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Health
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2006-08-21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to provide an initial assessment of the gastrointestinal safety of a 7-day regimen of PLA-695 compared to placebo or naproxen.


Eligibility criteria: Inclusion Criteria:

* Healthy men or women of nonchildbearing potential, aged 18 to 60 years.

Exclusion Criteria:

* Abnormal baseline endoscopy.
* Positive Helicobacter pylori serology.

Primary outcomes:
measure: The rate of erosions and ulcers present after 7 days of treatment for PLA-65 will be compared to placebo and naproxen.
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
state: Texas
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT06772662: One Up, One Down: Analyzing Patient Preference on Cryotherapy Machine Tubing Placement
Official title: One Up, One Down: Analyzing Patient Preference on Cryotherapy Machine Tubing Placement
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cryotherapy Tubing Placement
Lead sponsor: Children's Hospital of Orange County
Sponsor class: OTHER
First posted: 2025-01-13
Enrollment: 100
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this research study is to better understand patient preference and their satisfaction rates with cryotherapy machines based on the direction of the tubing. This study will evaluate both satisfaction and pain of patients who use the cryotherapy machines in the two groups: tubing facing towards the head, and the other with tubing facing toward the feet.


Eligibility criteria: Inclusion Criteria:

* Patients scheduled for an arthroscopic ACL reconstruction (CPT 29888) or MPFL reconstruction/augmentation with internal brace (CPT 27422 or 27429)
* Ages 10-18 years old at the time of surgery
* Patients who have access to a cryotherapy unit at the time of surgery

Exclusion Criteria:

* No ACL reconstruction (CPT 29888) nor MPFL reconstruction/augmentation with internal brace (CPT 27422 or 27429) performed during knee arthroscopy (i.e., isolated meniscus repair, synovectomy/debridement, etc.)
* Patients do not have access to a cryotherapy unit
* Patients less than 10 or older than 18 at the time of surgery

Primary outcomes:
measure: Patients will prefer one direction of tubing placement over the other (up or down) by the end of 7 days post-op
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Orange
country: United States
facility: Children's Hospital of Orange County
state: California
Study officials:
affiliation: Children's Hospital of Orange County
name: John Schlechter, DO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02173262: REaCT Integrated Consent Model to Compare Two Standard of Care Regimens
Official title: Feasibility of Using an Integrated Consent Model to Compare Two Standard of Care Regimens for Primary Prophylaxis of Taxotere/Cyclophosphamide-Induces Febrile Neutropenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Breast Cancer
Keywords: Breast
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
First posted: 2014-06-24
Enrollment: 142
Sex: FEMALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The Integrated Consent Model is being increasingly used internationally to improve patient care. In this feasibility study we will explore whether the model is feasible in practice; and whether it can be used to increase the number of physicians and patients who take part in clinical trials, and address the critical issue around the optimal febrile neutropenia prevention by randomizing eligible patients to either G-CSF or ciprofloxacin.


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed primary breast cancer
* Planned TC chemotherapy
* ≥19 years of age
* Able to provide verbal consent
* Willing to complete a survey

Exclusion Criteria:

• Contraindication to either Ciprofloxacin or G-CSF

Primary outcomes:
measure: The percentage of randomized patients in each physician's practice
timeFrame: every 4 weeks up to 2 years
Secondary outcomes:
measure: rates of febrile neutropenia
timeFrame: Once when the last participant completes chemotherapy up to year 2
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: The Ottawa Hospital
state: Ontario
Study officials:
affiliation: The Ottawa Hospital Cancer Centre
name: Mark Clemons, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Clemons M, Mazzarello S, Hilton J, Joy A, Price-Hiller J, Zhu X, Verma S, Kehoe A, Ibrahim MF, Sienkiewicz M, Stober C, Vandermeer L, Hutton B, Mallick R, Fergusson D. Feasibility of using a pragmatic trials model to compare two primary febrile neutropenia prophylaxis regimens (ciprofloxacin versus G-CSF) in patients receiving docetaxel-cyclophosphamide chemotherapy for breast cancer (REaCT-TC). Support Care Cancer. 2019 Apr;27(4):1345-1354. doi: 10.1007/s00520-018-4408-6. Epub 2018 Aug 11.
Clinical trial NCT03232762: Effects of Diet on Pregnancy Outcome and Child Obesity
Official title: Effects of Diet on Pregnancy Outcome and Child Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy Related
Diet Modification
Obesity
Hypertension
Pre-Eclampsia
Blood Pressure
Breast Feeding
Birth Weight
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2017-07-28
Enrollment: 303
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of the study is to compare 3 different diets in pregnancy, equal in calories, and fats, different in refined grains compared to whole grains as a source of carbohydrates, and in calories from carbohydrate, compared to protein as a source of calories.The hypothesis is that there will be differences in the specified outcomes because the proportions of macronutrients are significant. The primary objective is to detect differences in weight gain.

Detailed description: There will be randomized sequential assignment of pregnant women at the initial clinic visit to Diet A, a high proportion of calories from refined grains as a carbohydrate source, and Diet B, a high proportion of calories from whole grains. Random number assignment is impractical for counseling purposes and blinding not possible. Therefore, randomization by diet assignment by day of initial visit via random number was chosen. If the random number is odd Diet A would be selected, if the random number is even Diet B will be selected for that day.

Eligibility criteria: Inclusion Criteria:

* All normal pregnant patients who will be more than three months from term

Exclusion Criteria:

* Illness making it a high risk pregnancy
* Chronic renal disease
* Malignancy
* Congestive heart failure
* Diabetes
* Hypertension

Primary outcomes:
measure: Differences in weight gain
timeFrame: 6 Months
Secondary outcomes:
measure: Pre-Term Birth Rate
timeFrame: 6 Months
measure: Neonatal Weight
timeFrame: 6 Months
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: NYU Langone Health
name: Bruce Young, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sun H, Yamada P, Paetow A, Chan M, Arslan A, Landberg R, Dominguez-Bello MG, Young BK. A randomized controlled trial of the effects of whole grains versus refined grains diets on the microbiome in pregnancy. Sci Rep. 2022 May 7;12(1):7509. doi: 10.1038/s41598-022-11571-4.
Clinical trial NCT06937762: Coblation Tonsillotomy Versus Radiofrequency and Cold Knife Dissection Tonsillectomy
Official title: Intracapsular Coblation Tonsillotomy Versus Extracapsular Radiofrequency and Cold Knife Dissection Tonsillectomy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Chronic Tonsillitis
Lead sponsor: Kafrelsheikh University
Sponsor class: OTHER
First posted: 2025-04-22
Enrollment: 72
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study aims to assess and compare the outcomes between coblation intracapsular tonsillotomy versus extracapsular Radiofrequency and cold knife dissection tonsillectomy efficacy in managing patients requiring tonsil surgery as regards (time of operation, Intraoperative blood loss, postoperative pain, postoperative bleeding, complications, tonsillar fossa healing)


Eligibility criteria: Inclusion criteria:

Recurrent Acute tonsillitis Tonsillitis resulting in febrile convulsions Enlarged tonsils that cause upper airway obstruction, dysphagia, sleep disorders Chronic tonsillitis Chronic or recurrent tonsillitis in a streptococcal carrier not responding to beta-lactamase-resistant antibiotics

Exclusion criteria:

Patients with known bleeding disorders Acute infections of tonsil Contraindications for general anesthesia Anemia Patients unwilling or unable to give informed consent were excluded from this study patients

Primary outcomes:
measure: comparision of the severity of postoperative pain between the three groups.
timeFrame: The first time on day 1, the second time on day 3 and third time on day 7
Secondary outcomes:
Other outcomes:
Locations:
city: Kafrelsheikh
country: Egypt
facility: Kafrelsheikh University Hospitals
Study officials:
References:
citation: Metcalfe C, Muzaffar J, Daultrey C, Coulson C. Coblation tonsillectomy: a systematic review and descriptive analysis. Eur Arch Otorhinolaryngol. 2017 Jun;274(6):2637-2647. doi: 10.1007/s00405-017-4529-4. Epub 2017 Mar 18.
citation: Liu Q, Zhang Y, Lyu Y. Postoperative hemorrhage following coblation tonsillectomy with and without suture: A randomized study in Chinese adults. Am J Otolaryngol. 2021 Jan-Feb;42(1):102760. doi: 10.1016/j.amjoto.2020.102760. Epub 2020 Oct 18.
Clinical trial NCT05484362: Acute Effect of Crocus Sativus on Postprandial Glycemia
Official title: Acute Effect of Two Doses of Crocus Sativus on Postprandial Glycemia: A Randomized Clinical Trial in Healthy Humans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Potential Abnormality of Glucose Tolerance
Appetitive Behavior
Blood Pressure
Keywords: Crocus sativus
Blood glucose responses
blood pressure
subjective appetite
blood glucose concentrations
Lead sponsor: Agricultural University of Athens
Sponsor class: OTHER
First posted: 2022-08-02
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Crossover, double blind, randomized clinical trial
Primary purpose: OTHER

Brief summary: This study investigated the effects of two different doses of Crocus Sativus in glucose beverages on glycemic responses.

Detailed description: This study examined the short-term effects of two different doses (15 mg and 30 mg) of Crocus Sativus in glucose beverages on postprandial glycemic responses in healthy young adults.

Eligibility criteria: Inclusion Criteria:

* Healthy
* Non-smoking
* Non-diabetic men and women
* Body Mass Index (BMI) between 18.5 and 24.9 kg/m2
* Normal blood pressure

Exclusion Criteria:

* Severe chronic disease (e.g., coronary heart disease, diabetes mellitus, kidney or liver conditions, endocrine conditions)
* Gastrointestinal disorders
* Pregnancy
* Lactation
* Competitive sports
* Alcohol abuse
* Drug dependency
* Allergy in Crocus Sativus

Primary outcomes:
measure: Capillary blood glucose responses
timeFrame: 2 hours
Secondary outcomes:
measure: Subjective appetite ratings
timeFrame: 2 hours
measure: Blood pressure
timeFrame: 2 hours
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Agricultural University of Athens
state: Attica
Study officials:
affiliation: Agricultural University of Athens
name: Aimilia Papakonstantinou, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04496791: Quality Control of CE-Certified Phonak Hearing Aids - 2020_26
Official title: Quality Control of CE-Certified Phonak Hearing Aids - 2020_26
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss
Lead sponsor: Sonova AG
Sponsor class: INDUSTRY
First posted: 2020-08-03
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: Phonak Hearing Devices pass through different development and study phases. At an early stage, feasibility studies are conducted to investigate new algorithms, features and functions in an isolated manner. If the benefit is proven, their performance is then investigated regarding interdependency between all available algorithms, features and functions running in parallel in a hearing aid (pivotal/pre-validation studies) and, resulting from the pre-validation studies, they get optimized. Prior to product launch, the Phonak Hearing Systems get reviewed by a final quality control in terms of clinical trials. This is a validation study, investigating improved algorithms, features, functions and wearing comfort. This will be a clinical investigation which will be conducted mono centric at Sonova AG Headquarters based in Stäfa (Switzerland).

Detailed description: This study will investigate the combination of the features to determine if the audiological performance and quality of the new successor of the Marvel family shows an improved benefit over Phonak Audéo Marvel before going into the System Validation. Therefore this study will be a comparative study. The study will determine if hearing impaired users wearing the successor hearing aids, have better initial acceptance with the new precalculation, better sound quality and speech intelligibility, more clarity and loudness comfort in soft and loud environments compared to Phonak Marvel RIC (Receiver in channel) hearing aids. Another objective of the study is to compare the listening effort with the two different study devices.

Eligibility criteria: Inclusion Criteria:

* Hearing Loss range: N3-N4
* experienced hearing aid user
* willingness to wear behind the ear hearing aids
* Informed Consent as documented by signature

Exclusion Criteria:

* the audiogram is not in the fitting range of the intended hearing aid
* first time user
* limited mobility and not in the position to attend weekly appointments in Stäfa (Switzerland)
* participant is not able to describe experiences and hearing impressions
* allergies against the material of the hearing aid

Primary outcomes:
measure: Rating of the sound quality for the new and the comparative HI
timeFrame: 4 weeks
Secondary outcomes:
measure: Speech intelligibility in noisy situations (only test device)
timeFrame: 4 week
measure: Speech intelligibility in quiet situations
timeFrame: 4 week
measure: Speech intelligibility in noisy situations
timeFrame: 4 weeks
measure: Rating of sound quality
timeFrame: 1 week
Other outcomes:
Locations:
city: Stäfa
country: Switzerland
facility: Sonova AG
Study officials:
References: