louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05852951: Cycle and Ovulation Study Expansion
Official title: Cycle and Ovulation Study Expansion
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Menstruation
Keywords: menstruation
ovulation
menstrual cycle
Lead sponsor: Apple Inc.
Sponsor class: INDUSTRY
Collaborators: name: Exponent
First posted: 2023-05-10
Enrollment: 698
Sex: FEMALE
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Contract research organization

Brief summary: The objective of this study was to collect menstrual cycle, health sensor data and general health information to understand correlations between menstrual cycle and health sensor data, and how those correlations may be affected by general health. Participants entered menstrual cycle information (such as start dates, end dates, symptoms, flow), basal body temperature as measured by a thermometer, and ovulation and progesterone test results via apps installed on their iPhone. Additionally, participants were provided with an Apple Watch and a wrist-worn hardware prototype wrist-worn sleep band to collect physiological sensor data. Both menstrual cycle information and physiological sensor data stored on the participants' iPhone prior to enrolling in the study (up to 18 months) was also collected. This study aimed to collect data from females aged 14 and older who are currently menstruating with irregular and regular menstrual cycles.


Eligibility criteria: * At least 14 years of age (19 for residents of Alabama and Nebraska and 21 for residents of Mississippi)
* Can communicate in written and spoken English
* Own functioning iPhone iOS 14 or later, with access to reliable data plan and Wifi
* Access to reliable Wifi in the bedroom
* Willingness to participate in remote visits and follow study procedures for the duration of the study, including use of Apple Watch and a wrist-work hardware prototype
* Able to read and understand the written consent form
* Reside in the US for the duration of the study

Primary outcomes:
measure: Retrospective ovulation day estimate
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Exponent
state: Arizona
Study officials:
affiliation: Exponent
name: Bo Qing, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06565351: S-cystatin C vs.Injection Clearance Measurements to Estimate Kidney Function in Patients With Spinal Cord Injuries
Official title: Feasibility of Replacing 99mTc-DTPA GFR Measurements With eGFR From s-Cystatin C in Individuals With Spinal Cord Injuries
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spinal Cord Injuries
Renal Failure
Keywords: spinal cord injury
renal Failure
GFR
Glomerular filtration rate
DTPA clearance
Cystatin C
eGFR
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2024-08-21
Enrollment: 248
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 248 consecutive individuals with neurogenic bladder dysfunction due to spinal cord injury coming to routine control of their kidney function every 2-3 years according to international guidelines

Brief summary: * In individuals with spinal cord injury (SCI) kidney function defined as Glomerular Filtration Rate (GFR) is monitored by injection of e.g.99mDTPA and subsequent blood sampling (DTPA-clearance)
* GFR calculated from plasma samples of the endogenous substance s-Cystatin C (eGFR cystatin C) was compared to DTPA-clearance in 248 individuals with SCI.
* It is concluded that eGFR based on plasma s-cystatin C can replace the more tedious 99mDTPA-clearance procedures in individuals with SCI


Eligibility criteria: Inclusion Criteria:

Neurogenic bladder dysfunction due to spinal cord injury

Exclusion Criteria:

None

Primary outcomes:
measure: Estimated clearance of Cystatin C (eGFR cystatin C)
timeFrame: through study period (2 years)
Secondary outcomes:
measure: Test/ retest variability of eGFR cystatin C
timeFrame: Up to three months
measure: Long term repeatability of eGFR cystatin C
timeFrame: Up to three years
Other outcomes:
Locations:
city: Glostrup
country: Denmark
facility: Dept. of Clinical Physiology and Nuclear Medicine, Copenhagen University Hospital, Rigshospitalet; Glostrup
Study officials:
affiliation: Rigshospitalet: Glostrup
name: Ulrik B. Andersen
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02890251: Visual Maturation in Premature Newborns According to Factors Influencing Its Development
Official title: Visual Maturation in Premature Newborns According to Factors Influencing Its Development
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Delayed Visual Maturation
Keywords: Infant
Premature
Diseases
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2016-09-07
Enrollment: 69
Sex: ALL
Minimum age (years): 6
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Premature babies, born before 33 weeks of amenorrhea and hospitalized at CHRU Nancy, evaluated at term equivalent age.

Brief summary: The purpose is to describe the level of visual maturation of premature newborns at term equivalent age.

The secondary purpose is to determine factors associated to an altered level of visual maturation, through an exploratory approach.


Eligibility criteria: Inclusion Criteria:

* Infants born before 33 weeks of amenorrhea and hospitalized at CHRU Nancy

Exclusion Criteria:

* Parental opposition
* Ocular malformation
* Face malformation
* Cranial stenosis
* Chromosomal abnormality

Primary outcomes:
measure: Measurement of Visual Acuity by Baby Vision Cards
timeFrame: Baseline
Secondary outcomes:
measure: Control of the Retina by Retinal Camera
timeFrame: Baseline
measure: Measurement of cycloplegic refraction by mydriaticum 0.5%
timeFrame: Baseline
measure: Presence, absence of light reflex by clinical evaluation
timeFrame: Baseline
measure: Presence, absence or abnormality of visual fixation by clinical observation
timeFrame: Baseline
measure: Analysis of visual cortex with MRI
timeFrame: Baseline
Other outcomes:
Locations:
Study officials:
affiliation: Maternité Régionale Universitaire A. Pinard CHRU Nancy
name: Jean-Michel HASCOET, Pr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wirth M, Naud A, Schmitt E, Clerc-Urmes I, Hascoet JM. Visual Maturation at Term Equivalent Age in Very Premature Infants According to Factors Influencing Its Development. Front Physiol. 2018 Nov 20;9:1649. doi: 10.3389/fphys.2018.01649. eCollection 2018.
Clinical trial NCT01419951: Launch II: A Pilot Randomized Control Trial of a Clinic and Clinic Plus Home Intervention for Preschool Obesity
Official title: LAUNCH II: Learning About Activity and Understanding Nutrition for Better Child Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Obesity
Keywords: Behavioral treatment
Preschool aged children
Obesity
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: National Center for Research Resources (NCRR)
First posted: 2011-08-18
Enrollment: 60
Sex: ALL
Minimum age (years): 2
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this project is to pilot test a behavioral intervention that includes a home visit component compared to a clinic only and standard of care for the treatment of obesity in preschool age children. The results of this study will inform the design of a larger randomized control trial.

H1: The clinic + home intervention will result in a significantly greater decrease in BMIz compared to the in clinic only intervention or pediatric standard of care at 6 months post-treatment.


Eligibility criteria: Inclusion Criteria:

* 2 years 0 months to 5 years 11 months of age
* at or above the 95th percentile BMI for age and sex
* have at least one parent with a BMI at or greater than 25
* medical clearance from pediatrician

Exclusion Criteria:

* non-English speaking
* living greater than 50 miles from medical center
* a disability or illness that would preclude engagement in moderate activity
* medical condition/medication associated with weight
* enrolled in another weight management program

Primary outcomes:
measure: Change in BMI z score
timeFrame: Change from Baseline to 6 months
Secondary outcomes:
measure: Change in Parent weight loss
timeFrame: Change from baseline to 6 months
measure: Change in Child caloric intake
timeFrame: Change from baseline to 6 months
measure: Change in Home food and activity environment
timeFrame: Change from baseline to 6 months
measure: Change in Child physical activity
timeFrame: Change from baseline to 6 months
measure: Change in Parent-child mealtime interactions
timeFrame: Change from baseline to 6 months
measure: Change in Health related quality of life
timeFrame: Change from baseline to 6 months
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Lori J Stark, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01076751: Observational Registry of Treatment Patterns in Castrate-resistant Prostate Cancer (CRPC) Patients
Official title: Observational Prospective Study of Survival, Treatment Patterns, Disease and Economic Outcomes in Patients With Metastatic Castrate-resistant Prostate Cancer (CRPC) With Progression During or After a First-line Docetaxel-based Regimen
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Prostatic Neoplasms
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2010-02-26
Enrollment: 82
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with metastatic castrate-resistant prostate cancer

Brief summary: Primary Objective:

* Describe real-life survival of CRPC patients who received first-line docetaxel and have disease progression

Secondary Objective:

* Describe treatment patterns
* Describe the characteristics and outcomes of patients who received second-line taxane-based treatment compared to others
* Describe economic and patient-reported outcomes


Eligibility criteria: Inclusion criteria:

* Patients with CRPC progressing during the course of first line docetaxel-based chemotherapy or after at least 3 cycles (equivalent to 225mg/m2) of first line docetaxel-based chemotherapy
* Patient who have given their written consent

Exclusion criteria:

* Current participation in a clinical trial for the second-line treatment of prostate cancer
* Patients having received less than 3 cycles of first line docetaxel-based chemotherapy and discontinued for a reason other than disease progression or toxicity
* Patients having already started a second line treatment

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: Overall survival
timeFrame: At Month 12 or death
Secondary outcomes:
measure: Sequence of treatment in second-line, third-line
timeFrame: At Month 6 (+/- 2 months), Month 12 or death
measure: Characteristics and outcomes of patients who receive second-line taxane-based treatment compared to others
timeFrame: At baseline, Month 6 (+/- 2 months), Month 12 or death
measure: Indicators of health care resource utilization
timeFrame: At baseline, Month 6 (+/- 2 months), Month 12 or death
measure: Quality of life
timeFrame: At baseline, Month 6 (+/- 2 months) or Month 12
Other outcomes:
Locations:
city: Bridgewater
country: United States
facility: Sanofi-Aventis Administrative Office
state: New Jersey
city: Paris
country: France
facility: Sanofi-Aventis Administrative Office
city: Frankfurt
country: Germany
facility: Sanofi-Aventis Administrative Office
city: Barcelona
country: Spain
facility: Sanofi-Aventis Administrative Office
city: Guildford Surrey
country: United Kingdom
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References:
Clinical trial NCT01334151: Pharmacokinetic and Pharmacodynamic Properties of BIOD-105 and BIOD-107 Compared to Humalog® in Subjects With Type 1 Diabetes
Official title: A Double-blind Study of the Pharmacokinetic and Pharmacodynamic Properties of BIOD-105 and BIOD-107 Compared to Humalog® in Subjects With Type 1 Diabetes Including Assessments of Safety and Injection Site Toleration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes Mellitus Type 1
Lead sponsor: Biodel
Sponsor class: INDUSTRY
First posted: 2011-04-13
Enrollment: 13
Sex: ALL
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to assess the speed of absorption and onset of action of BIOD-105 and BIOD-107 and compare them to Humalog®.

Detailed description: The secondary objectives of this study are to assess other pharmacokinetic characteristics of BIOD-105 and BIOD-107 and compare those to Humalog®, to assess other pharmacodynamic characteristics of BIOD-105 and BIOD-107 and compare those to Humalog®, and to evaluate the safety and tolerability of BIOD-105 and BIOD-107 compared to Humalog®.

Eligibility criteria: Inclusion Criteria:

Subjects must present with the following:

1. Body Mass Index: ≥ 18 - ≤ 28 kg/m2
2. Diagnosed with type 1 diabetes mellitus for at least 1 year
3. Insulin antibody less than or equal to 10 μU/mL at screening

Exclusion Criteria:

Subjects presenting with any of the following will not be included in the study:

1. Type 2 diabetes mellitus
2. Serum C-peptide \> 1.0 ng/mL
3. HbA1c \> 10.0%
4. History of hypersensitivity to any of the components in the study medication
5. Treatment with any other investigational drug in the last 30 days before screening visit
6. Regular smoking as assessed clinically by the Investigator.

Primary outcomes:
measure: Speed of absorption
timeFrame: 480 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Chula Vista
country: United States
facility: Profil Institute for Clinical Research, Inc. (PICR)
state: California
Study officials:
affiliation: Profil Institute for Clinical Research, Inc. (PICR)
name: Linda Morrow, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06114251: Hepatitis B Virus Reactivation: a Cautionary Event After Liver Transplantation for Patients With Hepatocellular Carcinoma
Official title: Hepatitis B Virus Reactivation: a Cautionary Event After Liver Transplantation for Patients With Hepatocellular Carcinoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Liver Transplant; Complications
Lead sponsor: Zhejiang University
Sponsor class: OTHER
First posted: 2023-11-02
Enrollment: 920
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: From January 2015 to December 2020, the electronic medical records of liver cancer patients who underwent liver transplantation at the First Affiliated Hospital, Zhejiang University School of Medicine and Shulan (Hangzhou) Hospital were retrospectively reviewed.Recipients were followed up after liver transplantation until Dec 31, 2022. During the follow-up period, the recipients were managed according to a standard protocol. All recipients received a nucleoside analog after liver transplantation. HBV serological markers, such as hepatitis B surface antigen (HBsAg), hepatitis B e antigen (HBeAg) and HBV DNA were monitored regularly. The alpha-fetoprotein (AFP) level was determined every 1-2 months. The ultrasound or computed tomography or magnetic resonance imaging was performed every 3-6 months in HCC patients who underwent liver transplantation.

Brief summary: Highly active hepatitis B virus (HBV) is known to be associated with poor outcomes in patients with hepatocellular carcinoma (HCC). This study aims to investigate the relationship between HBV status and HCC recurrence after liver transplantation. The study retrospectively analyzed HCC patients undergoing liver transplantation in 2 centers between January 2015 and December 2020. We reviewed post-transplant HBV status and its association with outcomes.


Eligibility criteria: Inclusion Criteria:

* (1) preoperative diagnosis of HBV-related HCC and (2) pathologically confirmed HCC.

Exclusion criteria

* (1) non-HBV-related HCC; (2) simultaneous presence of other tumors; (3) re-transplantation; (4) presence of portal vein tumor thrombus; and (5) a survival time of less than 90 days.

Primary outcomes:
measure: Postoperative recurrence of liver cancer
timeFrame: 2015.1.1-2020.12.31
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05010551: Translation and Validation of MPCOSQ in Urdu Language
Official title: Translation and Validation of Modified Polycystic Ovary Syndrome Questionnaire in Urdu Language
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: PCOS- Polycystic Ovary Syndrome
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2021-08-18
Enrollment: 180
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients diagnosed with PCOS

Brief summary: To translate and validate modifies polycystic ovary syndrome quality of life (MPCOQ) questionnaire into Urdu. To evaluate the reliability, validity and of Urdu version of modified polycystic ovary syndrome quality of life questionnaire (MPCOQ).

Detailed description: * All statistical analyses will be conducted using the Statistical Product and Service Solution version 21 software.
* Continuous variables will be shown by mean and standard deviation and the categories will be demonstrated in frequency and percentage.
* In this study, factor structure of the (MPCOQ) will be analyzed using the principal component factor analysis with varimax rotation.
* Intraclass Correlation Coefficient (ICC) (95% confidence interval) will be used for test-retest value and Cronbach's Alpha will be used for internal consistency analysis.
* Measurement error will be determined by calculating the standard error of measurement (SEM) and the Smallest Detectable Change (SDC). Independent t-test will be used to determine the differences between groups

Eligibility criteria: Inclusion Criteria:

* • Age 18 - 30

  * Married
  * Female patients diagnosed with PCOS, having 2 of the following Rotterdam diagnostic criteria:

I. Polycystic ovaries visualized on ultrasound scan (presence of 12 follicles or more in one or both ovaries and/or increased ovarian volume \>10ml II. Clinical signs of hyperandrogenism (the hirsutism score based on the Ferriman-Gallwey score \>7 or obvious acne) III. Having an interval between menstrual periods \>35 days and/or amenorrhea as the absence of vaginal bleeding for at least 6 months, i.e. 199 days Patients who are willing to participate

Exclusion Criteria:

* • Non-adrenal hyperplasia, thyroid dysfunction, and hyperprolactinemia

  * Female undergoing Hormone Replacement Therapy
  * Female with malignancies
  * Any recent fractures, surgeries
  * Patient with nephrological and neurological conditions
  * Dementia or cognitive impairments

Primary outcomes:
measure: Modified polycystic ovary syndrome quality of life questionnaire
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: Abeer Fatima
state: Punjab
city: Rawalpindi
country: Pakistan
facility: Zohra Institute of Health Sciences
Study officials:
affiliation: Riphah International University
name: Sarah Ehsan
role: PRINCIPAL_INVESTIGATOR
affiliation: Riphah International University
name: Abeer Fatima, MS(cppt)
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06144151: A Pilot Study for Pupillary Assessment to Predict CAR-T Related Neurotoxicity
Official title: A Pilot Study for Pupillary Assessment to Predict CAR-T Related Neurotoxicity
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Neurotoxicity
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2023-11-22
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: MD Anderson Cancer Center

Brief summary: To learn about the relationship between changes in pupil size and reactivity and the start of neurological side effects in patients after receiving CAR-T cell therapy.

Detailed description: Primary Objective:

To assess the association between the status of NPi drop from baseline (prior to CAR T-cell infusion) to the lowest NPi post Axi-cel (CD19 CAR-T cell) infusion and the status of immune effector cell-associated neurotoxicity onset within 10 days post CD19 CAR-T cell infusion.

Secondary Objective:

To evaluate the largest absolute difference in NPi between two eyes (∆ NPi) and assess its association with severity of clinical symptoms as measured by Immune Effector Cell Encephalopathy (ICE) and or radiographic / EEG findings

Exploratory Objective:

To assess the feasibility and safety of a pupillometer use in patient treated with Axi-cel therapy.

Eligibility criteria: Inclusion Criteria:

To be considered eligible for study participation, patient will satisfy all relevant inclusion criteria and none of the exclusion criteria.

Inclusion Criteria:

1. Ages Eligible for Study: 18 Years and above (Adult, Older Adult)
2. Sexes Eligible for Study: All
3. Patient with histologically proven DLBCL, PMBCL or tFL, or follicular Lymphoma receiving axi-cel CAR-T cell therapy in the inpatient setting at MD Anderson Cancer Center
4. Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

1. Patients who have already been administered CAR-T cell therapy.
2. The patient who is unwilling or unable to comply with the requirements of the study including being able to be assessed with pupillometer
3. Patient has a condition which places him at an unacceptable risk as determined by the investigator

Primary outcomes:
measure: Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
timeFrame: Through study completion; an average of 1 year.
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Ranjit Nair, MD
role: PRINCIPAL_INVESTIGATOR
References: