louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04216485: Lifestyle Intervention in Pregnant Women With PCOS
Official title: Intensive Lifestyle Intervention on Gestational Weight Gain and Development of Gestational Diabetes Mellitus in Overweight/Obese Pregnant Women With a History of Polycystic Ovarian Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Polycystic Ovary Syndrome
Overweight and Obesity
Gestational Diabetes
Lead sponsor: Capital Medical University
Sponsor class: OTHER
First posted: 2020-01-02
Enrollment: 296
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Polycystic ovarian syndrome (PCOS) is the most common reproductive disorder in women of childbearing age and is also associated with metabolic abnormalities including obesity, type 2 diabetes, dyslipidemia, etc. Importantly, a number of adverse outcome are seen in pregnancies complicated by PCOS, including gestational diabetes mellitus (GDM), preeclampsia and miscarriage. However, optimal management of PCOS complicated pregnancy is not known. This study seeks to explore whether healthy lifestyle intervention in overweight/obese pregnant women with PCOS could reduce gestational weight gain (GWG) and incidence of GDM.

Detailed description: A randomized controlled trial in PCOS pregnant women will be initiated at 8-12 weeks of gestation util delivery. Participants will be randomly assigned to the control group (standard care) or the intervention group (intensive lifestyle intervention). The intervention will focus on restricting energy intake combined with behavioral lifestyle modification through participation in group sessions and individual counseling. The primary outcome will be GWG and secondary outcome will be the incidence of GDM.

Our hypothesis is that intensive lifestyle intervention in overweight/obese pregnant women with PCOS will decrease GWG and reduce the incidence of GDM.

Eligibility criteria: Inclusion Criteria:

* gestational age between 8 and 12 weeks of gestation, pre-pregnancy BMI≥25 (kg/m2)
* age ≥18 years, and a singleton pregnancy.

Exclusion Criteria:

* patients with prediabetes and diabetes, hypertension, chronic renal disease, thyroid disorder
* gestational weeks ≥ 13
* age \<18 years
* multiple pregnancy
* uterine malformation
* or physical restriction that prevents exercise.

Primary outcomes:
measure: Gestational weight gain
timeFrame: From date of randomization until the date of delivery, assessed up to 9 months
Secondary outcomes:
measure: Incidence of Gestational Diabetes Mellitus
timeFrame: From enrollment to 24-28 weeks of gestation
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Obstetrics and Gynecology Hospital,Capital Medical University
Study officials:
affiliation: Beijing Obstetrics and Gynecology Hospital
name: Guanghui Li, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06925685: Follow-Up for Study Participants Treated With an Allogeneic CAR T-Cell Product
Official title: Long Term Follow up Study for Participants Treated With an Allogeneic CAR T-Cell Product in a Prior Clinical Study
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Hematologic Malignancies
Solid Tumors
Keywords: CAR T
Allogeneic CAR T
long term follow up
Lead sponsor: Allogene Therapeutics
Sponsor class: INDUSTRY
First posted: 2025-04-13
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants who have received an allogeneic CAR T-cell product.

Brief summary: An observational, long-term follow up (LTFU) study of participants who received an allogeneic CAR T product in a prior clinical study. Participants will be followed for 15 years after their last infusion of an allogenic CAR T cell product.


Eligibility criteria: Inclusion Criteria:

* Received an allogenic CAR T-cell product infusion to treat an oncologic condition in a previous Allogene or Servier sponsored clinical study

Exclusion Criteria:

* Less than 12 months of follow up after the last allogeneic CAR T-cell product, unless approved by the Allogene Medical Monitor

Primary outcomes:
measure: Incidence of delayed adverse events potentially related to allogeneic CAR T-cell product and allogeneic CAR T-cell product-related SAEs
timeFrame: Up to 15 years post treatment with allogeneic CAR T-cell product
measure: Overall survival (OS)
timeFrame: Up to 15 years post treatment with allogeneic CAR T cell product
measure: Presence of replication competent lentivirus (RCL) in blood
timeFrame: Up to 15 years post treatment with allogeneic CAR T cell product
Secondary outcomes:
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Circuit Clinical
state: New York
Study officials:
affiliation: Allogene Therapeutics, Inc.
name: Allogene Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT03897985: Measurement of Anaesthesia-depth Trough Narcotrend TM in Patients Undergoing Electro-Convulsion-Therapy (ECT)- Influence of Anasthesia Depth on Quality of Convulsion
Official title: Measurement of Anaesthesia-depth Trough Narcotrend TM in Patients Undergoing Electro-Convulsion-Therapy (ECT)- Influence of Anaesthesia Depth on Quality of Convulsion - A Non-Intervention Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anesthesia
Lead sponsor: Medical University Innsbruck
Sponsor class: OTHER
First posted: 2019-04-01
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient sceduled for elective ECT for the Treatment of severe deppression

Brief summary: The Electro-Convulsion-Therapy (ECT) is a well accepted treatment option in severe depression. The quality of ECT is evaluated basing on minimal seizure duration (\>15sec), the sympathic response and the postictal EEG-suppression.

For the treatment general anaesthesia is needed. On the other hand anaesthesia strongly influences the quality of the seizure. The goal is to find an anaesthesia-depth that is needed for the well-being of the patient and allows a good ECT.

In daily routine the dose of anesthetic agents and the assesment of anesthesia-depth is based on the subjective estimation of the anesthetist and also on ealier interventions.

The aim of the study is to assess any correlation between measured anesthesia-depth using the Narcotrend TM and the Quality of the ECT.


Eligibility criteria: Inclusion Criteria:

* ASA (American Society of Anesthesiologists) Physical Satus I-3
* \>18 years \< 90 years
* Signed informed consent

Exclusion Criteria:

* Refusal of the patient

Primary outcomes:
measure: Correlation of anesthesia depth measured by Narcotrend TM and quality of ECT treatment
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: Medical University Innsbruck
Study officials:
References:
citation: Gasteiger L, Heil M, Horner E, Andexer J, Kemmler G, Hausmann A, Lederer W. Relationship Between Anesthesia Depth and Quality of Seizures in Patients Undergoing Electroconvulsive Therapy: A Prospective Observational Study. J ECT. 2022 Mar 1;38(1):62-67. doi: 10.1097/YCT.0000000000000792.
Clinical trial NCT06250985: New Treatment of Cardiac Device Infections; Immediate Reimplantation After Removal of Infected System
Official title: New Treatment of Cardiovascular Implantable Electronic Device (CIED) Infections; Immediate Reimplantation After Removal of Infected System
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Endocarditis, Bacterial
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2024-02-09
Enrollment: 176
Sex: ALL
Minimum age (years): 18
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this randomized clinical trials is to ascertain the safety and efficacy of immediate reimplantation of cardiac electronic implantable devices in patients with endocarditis and device-infections, compared to standard care, i.e. reimplantation at a later procedure date.

The primary outcome is the occurence of the composite primary endpoint within 6 months of randomization consisting of

* Death
* Symptomatic embolism (systemic arterial embolism or pulmonary embolism)
* Bacteremia og pocket-infection
* Removal of a CIED due to new infection


Eligibility criteria: Inclusion Criteria:

* Culture positive or negative infection of a CIED acording to PI
* Indication for removal of device
* Indictation for reimplantation of new device
* A minimum of 3 days of sufficient antibiotic treatment (intravenous or oral) has been administered
* stabilization criteria fulfilled i.e. I) negativ blood cultures, II) WBC \< 15 mia/L or reduction of min. 25% and III) CRP \<50 or min. 25% reduction.

Exclusion Criteria:

* Immunoincompetence (active chemotherapy or prednisone treatment \> 20mg/day
* Device-infection within last 6 months (relaps)
* Septic shock
* Stabilization criteria not fulfilled after 10 days of suficient antibiotic treatment

Primary outcomes:
measure: Composite primary outcome
timeFrame: within 6 months of randomization
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
Study officials:
affiliation: Rigshospitalet, Denmark
name: Henning Henning
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00014885: Bone Lead Levels and College Achievement Scores
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lead Poisoning
Keywords: Lead exposure
Bone lead
Cognitive function
Academic achievement
Neurobehavior
Lead sponsor: National Institute of Environmental Health Sciences (NIEHS)
Sponsor class: NIH
First posted: 2001-04-13
Enrollment: 750
Sex: ALL
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: yes
Time perspective: RETROSPECTIVE

Brief summary: This project studies the relationship between lead exposure and academic achievement in college students. Most studies of the neurobehavioral effects of lead have focused on performances at the low end of the distribution. There is evidence that lead affects outcome across the entire distribution. This is a retrospective cohort study of subjects whose cognitive function is adequate to gain admission to college. We will use x-ray fluorescence to measure bone lead concentrations in undergraduate college students and test the hypothesis that achievement scores are related to early lead exposure. Early lead exposure has been shown to have measurable effects on academic performance and neurobehavioral outcomes at 18 years of age. Should an effect be found in this study, the spectrum of lead toxicity would be expanded to include subjects with above average function.


Eligibility criteria: Current undergraduate student at the University of Pittsburgh who have taken the Scholastic Aptitude Test (SAT).

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02500485: The Drug-drug Interaction of SHR3824 and SP2086
Official title: Drug Interaction Study of Henagliflozin and Retagliptin in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Type 2 Diabetes
Keywords: SHR3824 SP2086 drug-drug interaction
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2015-07-16
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to investigate the potential interaction between multiple oral doses of SHR3824 and multiple oral doses of SP2086 in healthy adult volunteers.

Detailed description: This is an open-label (volunteers will know the names of treatments they are assigned) single-center study of SHR3824 and SP2086 in healthy adult volunteers. SHR3824(a Sodium-Glucose Cotransporter 2 inhibitor) is currently under development to lower blood sugar levels in patients with type 2 diabetes mellitus (T2DM) ,and SP2086(a Dipeptidyl peptidase IV inhibitor) is also currently under development to lower blood sugar levels in patients with type 2 diabetes mellitus (T2DM).SP2086 will be administered orally (by mouth) as 100mg on Days 1, 2, 3, 4, 15, 16, 17 and 18, SHR3824 will be administered orally (by mouth) as 20mg on Days 11, 12, 13, 14, 15, 16, 17 and 18. Both SHR3824 and SP2086 tablets will be taken with 8 ounces (240 mL) of water.

Eligibility criteria: Inclusion Criteria:

* Healthy volunteers with a body mass index (BMI, a measure of a person's weight in relation to height) between 19 and 24 kg/m2.

Exclusion Criteria:

* History of diabetes
* History of heart failure or renal insufficiency,Urinary tract infections, or vulvovaginal mycotic infections
* History of or current clinically significant medical illness as determined by the Investigator
* History of clinically significant allergies, especially known hypersensitivity or intolerance to lactose
* Known allergy to SHR3824 or SP2086 or any of the excipients of the formulation of SHR3824 or SP2086

Primary outcomes:
measure: The maximum plasma concentration (Cmax) of SHR3824.
timeFrame: At protocol-specified times up to Day 14 and Day 18.
measure: The area under the plasma concentration-time curve (AUC) of SHR3824.
timeFrame: At protocol-specified times up to Day 14 and Day 18.
measure: The maximum plasma concentration (Cmax) of SP2086.
timeFrame: At protocol-specified times up to Day 4 and Day 18.
measure: The area under the plasma concentration-time curve (AUC) of SP2086.
timeFrame: At protocol-specified times up to Day 4 and Day 18.
measure: The number of volunteers with adverse events as a measure of safety and tolerability.
timeFrame: Up tp day 18.
Secondary outcomes:
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Phase I Unit of Tongji Hospital affilated Tongji Medical School of Huangzhong Science and Thechnology
state: Hubei
Study officials:
References:
Clinical trial NCT01483885: Comparison of the Analgesic Effects of Acupuncture and Modulated Electroanalgesia in Cold Induced Pain
Official title: Comparison of the Analgesic Effects of Acupuncture and Modulated Electroanalgesia in Cold Induced Pain.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Cold Exposure
Lead sponsor: Universidade Federal do Piauí
Sponsor class: OTHER
First posted: 2011-12-02
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Physiotherapy offers a range of therapeutic modalities for pain management including Transcutaneous Electrical Nerve Stimulation (TENS), Interferential current (IC) and Acupuncture. The objective of this study was to investigate the hypoalgesic effect of TENS, CI and Acupuncture in a cold-induced pain model.


Eligibility criteria: Inclusion Criteria:

* Healthy subjects

Exclusion Criteria:

* Subjects with no history of any kind of disease

Primary outcomes:
measure: Cold Pain threshold
timeFrame: 24 hours
Secondary outcomes:
measure: Pain Tolerance threshold
timeFrame: 24 hours
Other outcomes:
Locations:
city: Parnaíba
country: Brazil
facility: Fuad Ahmad Hazime
state: Piauí
Study officials:
References:
Clinical trial NCT06096285: Heterogeneity and Development of Early COPD
Official title: Heterogeneity and Disease Development of Early Chronic Obstructive Pulmonary Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Chronic obstructive pulmonary disease
Early COPD
Heterogeneity
Disease development
Lead sponsor: China-Japan Friendship Hospital
Sponsor class: OTHER
First posted: 2023-10-23
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study plans to involve the individuals with different early COPD status, as well as comparable controls.

Brief summary: This study aims to investigate the clinical characteristics and heterogeneities of early chronic obstructive pulmonary disease (COPD), to determine the disease development of early COPD, and to establish a multidimensional model for predicting the outcomes of early COPD.


Eligibility criteria: Inclusion Criteria:

* The individuals who meet the defining criteria of PRISm, COPD Stage 0, Pre-COPD, Early COPD, Young COPD, and Mild COPD, according to the latest GOLD documents and publications.

Exclusion Criteria:

* Age \< 18 years or \> 80 years;
* Pregnant or maternal women;
* Having malignant and active tumor(s), and receiving treatment;
* Undergoing a surgical operation;
* Having problems with mental awareness;
* Having difficulties in daily activities;
* Participating in other interventional clinical trials.

Primary outcomes:
measure: Number of participants with COPD exacerbation
timeFrame: One year
Secondary outcomes:
measure: FEV1
timeFrame: One year
measure: FVC
timeFrame: One year
measure: FEV1/FVC ratio
timeFrame: One year
measure: FEV1% predicted value
timeFrame: One year
measure: FVC% predicted value
timeFrame: One year
measure: The COPD Assessment Test scale
timeFrame: One year
measure: The modified Medical Research Council dyspnea scale
timeFrame: One year
Other outcomes:
Locations:
city: Beijing
country: China
facility: China-Japan Friendship Hospital
state: Beijing
Study officials:
affiliation: China-Japan Friendship Hospital
name: Jieping Lei, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05701085: Patient Navigator PRE-ACT Educational Intervention to Promote Decision Making Among Minorities
Official title: Prospective Cohort Study of a Patient Navigator PRE-ACT Educational Intervention to Promote Decision Making About Clinical Trials Among Racial and Ethnic Minorities
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Educational Intervention
Minorities
Keywords: PRE-ACT
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2023-01-27
Enrollment: 240
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 study focuses on psychosocial barriers at the patient level with the goal of promoting high quality decision making around clinical trials participation. The proposed study adapts the PRE-ACT model to racial and ethnic minority patients who were underrepresented in the original PRE-ACT study and will be combined with a patient navigator model.

Detailed description: The primary objective of the proposed research is to employ a non-directive method to improve preparedness for consideration of clinical trials among racial minority patients by providing tailored information to address knowledge and attitudes towards clinical trials. This model has been previously studied in a primarily white, well-educated population. It is unknown how well this model adapts to meet the needs of diverse patient populations.

Eligibility criteria: Inclusion Criteria:

* Participants must have a diagnosis of either advanced (metastatic) cancer or early stage disease for which they are undergoing oncological work-up, treatment or surveillance
* Participants must be at least 18 years of age
* Participants have a non-white race or Hispanic ethnicity recorded in their patient demographics in the electronic medical record
* Participant must have a life expectancy greater than three months based on the primary oncology team's clinical assessment.
* Participants must be able to read and verbally communicate in English.
* Participants must provide written informed consent.

Exclusion Criteria:

-

Primary outcomes:
measure: Change in knowledge regarding cancer clinical trials after the intervention
timeFrame: Up to 4 months
measure: Change in attitudes regarding cancer clinical trials after the intervention
timeFrame: Up to 4 months
Secondary outcomes:
Other outcomes:
measure: Rate of racial/ethnic minority participation in cancer clinical trials before and after the intervention (exploratory outcome)
timeFrame: Up tp 28 months
Locations:
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
name: Lauren Chiec, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00415285: Docetaxel Followed by Capecitabine Versus Concomitant Docetaxel/Capecitabine for Early Stage Breast Cancer
Official title: Randomized Phase II Trial of Sequential Docetaxel Followed by Capecitabine Versus Concomitant Docetaxel/Capecitabine as in Induction Therapy for Early Stage Breast Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Breast Neoplasms
Keywords: Breast
Cancer
Early-Stage
Chemotherapy
Lead sponsor: Georgia Center for Oncology Research & Education
Sponsor class: OTHER
Collaborators: name: Sanofi
First posted: 2006-12-22
Enrollment: 100
Sex: FEMALE
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 identify new chemotherapy treatment regimens with better response rates and to find out if the combination of docetaxel and capecitabine can shrink the size of breast tumors and preserve the breast.

Detailed description: The purpose of this study is to identify new chemotherapy treatment regimens with better response rates and to find out if the combination of docetaxel and capecitabine can shrink the size of breast tumors and preserve the breast.

Induction chemotherapy offers the possibility of less surgery and determines tumor sensitivity in vivo. Previous trials have demonstrated that complete pathologic response in the breast at surgery corresponds with improved outcome. Additionally, we will correlate specific molecular markers in the breast tumors before and after chemotherapy, with response to treatment.

Expression of these molecular markets may be used in the future to predict the likelihood of response to chemotherapy given post-operatively.

Approximately 100 patients will participate at Emory Winship Cancer Institute and Emory Crawford W. Long Hospital and Grady Health System in Atlanta, Georgia.

Eligibility criteria: Inclusion Criteria:

* Histologically or cytologically confirmed breast carcinoma.
* Early stage breast cancer (stage 1, 2, 3).
* No evidence of disease outside the breast or chest wall, except ipsilateral axillary lymph nodes.
* 18 years of age or older.
* Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Exclusion Criteria:

* Prior chemotherapy, hormonal therapy, biologic therapy or radiation therapy for breast cancer.
* Major surgery within 28 days of study entry.
* Evidence of CNS metastases.
* Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Grady Memorial Hospital
state: Georgia
city: Atlanta
country: United States
facility: Emory Crawford Long Hospital
state: Georgia
city: Atlanta
country: United States
facility: Winship Cancer Institute of Emory University
state: Georgia
Study officials:
affiliation: Emory University
name: Ruth O'Regan, MD
role: PRINCIPAL_INVESTIGATOR
References: