louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06889727: Pregnancy and Childbirth in Women with Thalassemia Yesterday and Today
Official title: Pregnancy and Childbirth in Women with Thalassemia Yesterday and Today: a Multicentre Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thalassemia
Lead sponsor: Fondazione per la Ricerca sulle Anemie ed Emoglobinopatie in Italia
Sponsor class: OTHER
First posted: 2025-03-21
Enrollment: 75
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: FEMALE THALASSEMIE DEPEND TRANSFUSION

Brief summary: Recent advances in the management of thalassemia have significantly improved life expectancy and quality of life of patients with this hemoglobinopathy, with a consequent increase in their reproductive potential and desire to have children.Since an initial report of a successful pregnancy in a woman with thalassemia major by Walker in 1969, hundreds of pregnancies have been reported so far, highlighting that women carefully managed in the preconception phase usually carry out a successful gestation and labor, both in case of spontaneous conception and assisted reproductive techniques.


Eligibility criteria: Inclusion Criteria:

* Transfusion dependent and nontransfusion- dependent thalassemia
* Pregnancy ended with the birth of a live or dead foetus
* Pregnancy ended in miscarriage or voluntary abortion
* Pregnancy in progress

Exclusion Criteria:

* Other types of anemia
* Pregnancy not initiated despite assisted fertilization practices
* Subjects unwilling to sign informed consent

Primary outcomes:
measure: number of pregnancies in women with beta thalassemia followed in Italian centres
timeFrame: 15 YEARS
measure: number of pregnancies spontaneously
timeFrame: 15 YEARS
measure: number of pregnancies after hormonal stimulation
timeFrame: 15 YEARS
measure: likelihood of miscarriage
timeFrame: 15 YEARS
measure: foetal death
timeFrame: 15 YEARS
Secondary outcomes:
Other outcomes:
Locations:
city: Cagliari
country: Italy
facility: UniversityCagliari, OspPed Microcitemico, Cagliari
Study officials:
References:
Clinical trial NCT02902627: Pain in Oncolgy: Evaluation of a Non Invasive Monitoring Device (ANI). A Monocentric Prospective Study
Official title: Pain in Oncolgy: Evaluation of a Non Invasive Monitoring Device (ANI). A Monocentric Prospective Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Cancer
Lead sponsor: Hopital Foch
Sponsor class: OTHER
First posted: 2016-09-16
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: l'ANI (Analgesia Nociception Index

The main objective of the research is to estimate the Analgesia Nociception Index (ANI) as a parameter giving the possibility of measuring the pain in painful metastatic cancer. The parameter ANI is compared with visual analogical scale (VAS) score.


Eligibility criteria: Inclusion Criteria:

* more than 18 years, -no legal protection, -
* life expectancy is considered over 3-months
* not receiving of béta-blocking,
* Having a rhythm sinusal without extrasystole
* benefiting from a coverage by a social security system

Exclusion Criteria:

* Pace-Maker
* Diabetes mellitus

Primary outcomes:
measure: Comparison of the ANI parameter with the VAS
timeFrame: 4 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Suresnes
country: France
facility: Hopital Foch
Study officials:
affiliation: Hopital Foch
name: Marc Fischler
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06558227: Study of ZG005 Combined With Bevacizumab Versus Sintilimab Combined With Bevacizumab in Advanced Hepatocellular Carcinoma
Official title: A Multicenter, Randomized, Open-label Phase II Study of ZG005 Combined With Bevacizumab Versus Sintilimab Combined With Bevacizumab for First-line Treatment of Advanced Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Hepatocellular Carcinoma
Lead sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Sponsor class: INDUSTRY
First posted: 2024-08-16
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is a randomized, open-label, positive-controlled, multicenter phase II clinical trial. It evaluates the efficacy and safety of ZG005 combined with Bevacizumab compared to Sintilimab combined with Bevacizumab in first-line treatment for patients with advanced hepatocellular carcinoma.


Eligibility criteria: Inclusion Criteria:

* Fully understand the study and voluntarily sign the informed consent form.
* 18-75 years of age;
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1；
* Life expectancy ≥ 12 weeks.

Exclusion Criteria:

* Patients were deemed unsuitable for participating in the study by the investigator for any reasons.

Primary outcomes:
measure: progression free survival，PFS
timeFrame: through study completion, up to 2 year
Secondary outcomes:
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
state: Sichuan
Study officials:
affiliation: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
name: Jason Wu
role: STUDY_CHAIR
References:
Clinical trial NCT06907927: Using Artificial Intelligence to Improve Radiologists' Performance in Radiology Report Writing: a Randomised Controlled Trial
Official title: Using Artificial Intelligence to Improve Radiologists' Performance in Radiology Report Writing: a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Healthy
Lead sponsor: Wuhan Union Hospital, China
Sponsor class: OTHER
First posted: 2025-04-02
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This is a randomised controlled trial to assess whether artificial intelligence software can improve radiologists' performance in radiology report writing and improve the quality of radiology reports.


Eligibility criteria: Inclusion Criteria:

1. Radiologists who submit reports;
2. Clinical experience of less than 10 years and more than six months;
3. An average of more than 10 radiology reports are submitted per day;
4. Participants provided signed informed consent.

Exclusion criteria：

1. Radiologists who review reports;
2. Clinical experience of less than 6 months or more than 10 years;
3. An average of less than 10 radiology reports are submitted per day.）

Primary outcomes:
measure: Error rates in radiology reports
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Union Hospital，Tongji Medical College，Huazhong University of Science and Technology
state: Hubei
Study officials:
References:
Clinical trial NCT01620827: Hospital vs. Cell Phone Number Follow-Up Randomization Study
Official title: Study Subject Responsiveness to Follow-Up Phone Calls From a Hospital Landline as Compared With From a Private Cellular Phone Number
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Subject Follow-up
Keywords: follow up
cell phone
hospital landline
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2012-06-15
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: This study is being conducted to evaluate the hypothesis that study subjects will be more responsive to follow-up phone calls made from personal cell phone numbers than from hospital landline numbers. To evaluate this, study subjects previously enrolled in a cardiac biomarker study (the Early Identification of Acute Coronary Syndrome study) were randomized to receive their follow-up phone calls (the calls associated with the Early ID study occur at 30 days and 1 year after initial enrollment) from either a hospital office landline or from the personal cell phones of the research assistants making these calls. This was done as a 1:1 randomization. The number of call attempts required to reach the study subjects were recorded as the calls were made and the date of successful follow-up was recorded once contact was made.


Eligibility criteria: Inclusion Criteria:

* Enrollment in the Early Identification of Acute Coronary Syndrome study
* Working telephone numbers

Exclusion Criteria:

* None

Primary outcomes:
measure: Successful phone call contact at 30 days
timeFrame: 90 days
Secondary outcomes:
measure: The number of call attempts required to obtain successful follow-up
timeFrame: 90 days
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Judd Hollander, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05728827: A Study to Compare Two Rehabilitation Protocols for Knee Osteoarthritis
Official title: Rehabilitation With Blood Flow Restriction Training to Enhance Anti-gravity Treadmill Effects in the Treatment of Patients With Knee Osteoarthritis: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Knee Osteoarthritis
Lead sponsor: Ente Ospedaliero Cantonale, Bellinzona
Sponsor class: OTHER
First posted: 2023-02-15
Enrollment: 70
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this randomized controlled study is to investigate whether the implementation of Blood Flow Restriction, in which the de-loading factor is delivered by the combined progressive de-loaded walking to running activity on an antigravity treadmill (treatment group), is more effective than the same antigravity protocol alone (control group).

Participants will be divided as follows:

Intervention group: anti-gravity treadmill combined with blood flow restriction Control group: anti-gravity treadmill Both groups will also undergo a standardized knee Osteoarthritis management through an aerobic and strength program.


Eligibility criteria: Inclusion Criteria:

* Age included between 45 and 80 years old
* Patients with knee OA diagnosed by a medical doctor with a radiological confirmation
* Patients able to provide informed consent and follow all the study procedures as indicated by the protocol
* Informed Consent as documented by signature

Exclusion Criteria:

* Younger than 44 years old or older than 81 years old included
* Known drug or alcohol abuse
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc.
* Participation in another study with an investigational drug within the 30 days preceding and during the present study
* Treatment with an injective approach in the previous 3 month
* Surgical treatment in the previous 12 months.

Primary outcomes:
measure: Post-operative knee outcome on Western Ontario and McMaster Universities Arthritis Index
timeFrame: Change from Baseline to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Lugano
country: Switzerland
facility: Christian Candrian
Study officials:
affiliation: EOC
name: Christian Candrian, MD
role: STUDY_CHAIR
References:
Clinical trial NCT03139227: Apigenin in Increasing Health Benefits in High Risk Breast Clinic Patients
Official title: Celery-Based Dietary Intervention: A Feasibility Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Health Status Unknown
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2017-05-03
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This pilot clinical trial studies the side effects and best dose of apigenin in increasing health benefits in high risk breast clinic patients. Celery is high in apigenin, a compound that may have anti-cancer activities. Eating a celery-based diet may help in prevention and treatment of inflammatory diseases including cancer.

Detailed description: PRIMARY OBJECTIVES; I. To determine the feasibility of apigenin oral supplementation using a specially formulated celery-banana bread.

II. To determine the safety and tolerability of apigenin supplementation.

OUTLINE: This is a dose-escalation study.

Patients consume one serving of lower dose apigenin celery-banana bread daily on days 1-7, and then consume one serving of higher dose apigenin celery-banana bread on days 8-14. Patients undergo blood sample collection on day 1 prior to and 6 hours after bread ingestion, on day 8 prior to and 6 hours after ingestion of bread, and on day 15 (or endpoint). Patients also provide a baseline urine sample and then 24-hour urine samples on days 1, 7, 8, and 14.

Eligibility criteria: Inclusion Criteria:

* Patients should be followed in Stefanie Spielman Comprehensive Breast Center (SSCBC) High Risk Breast Clinic
* No known allergy to ingredients of banana bread preparation (eggs, almonds and other nuts since the celery also has almond powder)
* Must be \> 1 year from pregnancy, lactation or chemotherapy
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
* Ability to give informed consent
* Participate in the specified study visits and laboratory testing including three (20 mL) blood draws and three 24 hour urine collections

Exclusion Criteria:

* Concurrent malignancy or metastatic malignancy of any kind
* Ongoing chemotherapy, radiation therapy, or other cancer-related treatment
* Current and past history of hypertension
* Chronic use of any herbal or dietary supplement containing apigenin within the 3 months prior to entry on the study
* Pregnant or nursing women
* Concurrent use of tamoxifen, raloxifene, or any of the aromatase inhibitors

Primary outcomes:
measure: Apigenin levels in blood and urine
timeFrame: Up to 14 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Ohio State University Comprehensive Cancer Center
name: Sagar Sardesai, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01749527: Does Patient Activity Level Affect 24-Hour Pad Test Results in Stress-Incontinent Women
Official title: Does Patient Activity Level Affect 24-Hour Pad Test Results in Stress-Incontinent Women?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: 24-hour Pad Test Weight Gain With and Without Activity
Keywords: 24-hour pad test
Activity
Stress urinary incontinence
Lead sponsor: St George Hospital, Australia
Sponsor class: OTHER
First posted: 2012-12-13
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: We hypothesised that in women with stress urinary incontinence, the severity of leakage on a 24 hour pad test was affected by activity.

Detailed description: We asked women to perform two separate pad tests, one with normal activity, and another with decreased activity.

Eligibility criteria: Inclusion Criteria:

* Stress urinary incontinence

Exclusion Criteria:

* language other than english

Primary outcomes:
measure: 24-hour pad test weight gain (mls)
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06387927: Effect of Home-exercise Programs Versus Supervised Core Stability Exercises on Hypertensive Patient With Low Back Pain
Official title: The Effectiveness of Home-based Exercise Programs Versus Supervised Conventional Core Stability Exercises in Treatment of Chronic Mechanical, Non-specific Low Back Pain Patients With Controlled Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Low Back Pain
Lead sponsor: Ahram Canadian University
Sponsor class: OTHER
First posted: 2024-04-29
Enrollment: 30
Sex: ALL
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Thirty male and female hypertension patients with chronic mechanical non-specific low back pain were included in this randomized controlled study conducted at the Ababa Private Physical Therapy Center in Beni-Seuf, Egypt. They were randomly assigned into two equal groups; the study group A control (n = 15) had a supervised conventional core stability, while the study group B (n = 15) received a home exercise program. In both groups' patients had evaluations before and after their six-week course of therapy. Modified-modified Schober test was used to assess the active back range of motion (ROM), Arabic version of Oswestry disability index (ODI) was utilized to evaluate functional disability, and visual analog scale (VAS) was used to measure pain.


Eligibility criteria: Inclusion Criteria:

* hypertensive patient
* patient with chronic back pain
* The patients aged 30 to 50 years

Exclusion Criteria:

* Patients with vertebral fractures
* patient with surgical spinal fixation
* patient with rheumatic disorders
* patient with systemic diseases
* patient with multiple sclerosis.

Primary outcomes:
measure: Assessment of pain
timeFrame: up to 4 weeks
measure: Assessment of lumbar flexion range of motion
timeFrame: up to 4 weeks
measure: Assessment of functional disability
timeFrame: up to 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Faculty of physical therapy
Study officials:
References:
Clinical trial NCT00474227: Proper Nutrition, Physical Exercise and Appropriate Weight in Individuals With Long Term Mental Illness
Official title: Proper Nutrition, Physical Exercise and Appropriate Weight in Individuals With Long Term Mental Illness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: obesity
weight gain
schizophrenia
schizoaffective disorder
antipsychotic induced weight gain
Lead sponsor: Lev-Hasharon Mental Healtlh Center
Sponsor class: OTHER_GOV
First posted: 2007-05-16
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Based on previous findings that mentally ill inpatients are interested in losing treatment associate weight gain and are capable of adhering to a weight reduction program, this study will investigate the effects of participation in nutrition intervention, physical exercise and will monitor measurement of metabolic profiles (cholesterol, triglycerides and glucose). Hypothesis: participants will reduce weight, maintain weight loss and experience reduction in metabolic values and will experience improved quality of life.

Detailed description: Study sample: 50 chronic psychiatric inpatients with DSM_IV diagnosis of schizophrenia or schizoaffective disorder, aged 18 or older. Exclusion criteria - pregnancy, severe physical illness, refusal to participate.

Study instruments: Q-LES-Q-18 (quality of life): Positive and Negative Syndrome Scale; Laboratory test- glucose levels, metabolic profiles (cholesterol, triglycerides). Measurements: Weight, BMI, pulse Intervention: Weekly group therapy, lectures on nutrition, physical exercise Duration of study: 3 months

Eligibility criteria: Inclusion Criteria:

* Ages 18 and older
* Men or women
* Schizophrenia or schizoaffective disorder
* BMI greater than 26
* Agreement to participate and capacity to provide written informed consent

Exclusion Criteria:

* Pregnancy
* Severe physical illness
* Refusal to participate

Primary outcomes:
measure: weight reduction
timeFrame: three months
Secondary outcomes:
measure: improved metabolic profile
timeFrame: 3 months
Other outcomes:
Locations:
city: Netanya
country: Israel
facility: Lev Hasharon Mental Health Center
Study officials:
affiliation: Lev HaSharon Mental Health Center
name: Gloria Ilievici, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Lev HaSharon Mental Health Center
name: Yuval Melamed, MD, MHA
role: STUDY_DIRECTOR
References:
Clinical trial NCT02148627: Safety Study of LY3041658 in Healthy Participants
Official title: A Single-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3041658 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: antibody
autoimmune
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2014-05-28
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The main purpose of this study is to evaluate the safety of LY3041658 in healthy participants, including first generation Japanese. The study will also investigate how the drug is processed and affects key immune cells. Study participation will last 4 months.

Protocol amended in January, 2016 to include first generation Japanese participants.


Eligibility criteria: Inclusion Criteria:

* All:

  * Body mass index (BMI) between 18.0 to 32.0 kilogram per square meter (kg/m²).
  * Absolute neutrophil count at screening should be ≥1.8 and ≤7.2 x 10\^3/microliter (uL), inclusive.
* First-generation Japanese:

  * Participant, biological parents, and biological grandparents must be of exclusive Japanese descent and born in Japan.
  * Are 20 to 65 years of age, inclusive, at the time of initial screening.

Exclusion Criteria:

- Have received antibody-based biologic agents (marketed or investigational) within 3 months or 5 half lives (t1/2) of the drug (whichever is longer) prior to screening.

Primary outcomes:
measure: The Number of Participants with One or More Drug-Related Adverse Events
timeFrame: Baseline to study completion (Day 85)
Secondary outcomes:
measure: Pharmacokinetics: Maximum Plasma Concentration (Cmax) of LY3041658
timeFrame: Predose through Day 85, at specified timepoints
measure: Pharmacokinetics: Area Under the Plasma Concentration-time Curve (AUC) from Time 0 to Time of Last Measurable Concentration (tlast)
timeFrame: Predose through Day 85, at specified timepoints
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Parexel Early Phase Unit at Glendale
state: California
city: Baltimore
country: United States
facility: PAREXEL-Phase 1 Baltimore Harbor Hospital Center
state: Maryland
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: