louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01414283: Prostate-specific Membrane Antigen Antibody-Drug Conjugate in Subjects With Prostate Cancer
Official title: A Phase 1 Dose-escalation Study of PSMA ADC in Subjects With Progressive, Castration-resistant, Metastatic Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Prostate Cancer
Lead sponsor: Progenics Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2011-08-11
Enrollment: 52
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Prostate-specific Membrane Antigen Antibody-Drug Conjugate (PSMA ADC) 1301 is an open-label, dose-escalation phase 1 study of PSMA ADC administered IV in subjects with progressive, castration-resistant, metastatic prostate cancer that has progressed after prior taxane therapy. For all subjects, PSMA ADC will be administered in four repeating cycles.


Eligibility criteria: Inclusion Criteria:

1. A diagnosis of progressive, castration-resistant, metastatic prostate cancer.
2. Prior chemotherapy regimens, one of which contains taxane.
3. Eastern Cooperative Oncology Group status of 0 or 1

Exclusion Criteria:

1. Clinically significant cardiac disease or severe debilitation pulmonary disease
2. Evidence of an active infection requiring ongoing antibiotic therapy
3. Any prior treatment with any other therapy targeting PSMA
4. History of drug and/or alcohol abuse

Primary outcomes:
measure: Determine the maximum tolerated dose of PSMA ADC
timeFrame: 13 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Tarrytown
country: United States
facility: Progenics Pharmaceuticals, Inc.
state: New York
Study officials:
affiliation: Progenics Pharmaceuticals, Inc.
name: Robert J Israel, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04790383: Clinical Performance of Advanced Self- Adhesivee Resin Composite Hybrid Restorations.
Official title: Clinical Performance of Advanced Self-Adhesive Resin Composite Hybrid Restorations Versus Conventional Resin Composite Restorations in Posterior Teeth (1y Randomized Clinical Trial).
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Caries Class II
Caries,Dental
Keywords: self-Adhesive resin composite hybrid restorations
Posterior resin composite
Surefil One
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-03-10
Enrollment: 63
Sex: ALL
Minimum age (years): 17
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Clinical performance according to modified USPHS criteria of advanced self-Adhesive resin composite hybrid restorations is evaluated for 1 year versus conventional resin composite restorations in posterior teeth.


Eligibility criteria: Inclusion Criteria:

* Patients with carious proximal cavities in molars
* Good oral hygiene.
* Presence of favorable occlusion and teeth are in normal contact with the adjacent teeth.

Exclusion Criteria:

* Teeth with signs and symptoms of irreversible pulpitis or pulp necrosis.
* Severe periodontal problems.

Primary outcomes:
measure: Clinical performance
timeFrame: Change from baseline at 6, 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
References:
Clinical trial NCT02755883: Strides for Life I: Increasing Physical Activity in Stage 1 Lung Cancer Patients
Official title: Strides For Life I: A Randomized Controlled Trial of Induction of Positive Affect to Increase Physical Activity in Early Stage Lung Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer
Keywords: Physical activity
non-small lung cancer
positive affect
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: Lung Cancer Research Foundation
First posted: 2016-04-29
Enrollment: 29
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: PREVENTION

Brief summary: This randomized controlled trial will evaluate, among 54 stage early stage lung cancer patients, whether a behavioral intervention versus an educational Control group results in improved function at 6-months.

Detailed description: This is a two arm randomized controlled trial that will evaluate, among 54 stage 1 non-small cell lung cancer patients, whether induction of positive affect vs. an educational Control group, results in improved function as assessed by the 6-minute Walk Test. Our primary outcome will be a within-patient change in the 6-Minute Walk Test at 6 months.

Eligibility criteria: Inclusion Criteria:

* Non-small cell lung cancer (Stage 1)

Exclusion Criteria:

1. Cognitive impairment
2. Inability to walk
3. \< 12 month anticipated survival
4. enrollment in other behavioral programs
5. lack of medical approval to participate
6. substance/alcohol dependence or participation in a substance abuse treatment program within 12 months
7. major psychiatric illness.

Primary outcomes:
measure: Kilocalories/week assessed by 6-minute walk test
timeFrame: 1 month to 6 months
Secondary outcomes:
measure: Forced expiratory volume (FEV1)
timeFrame: 1 month to 6 months
measure: Functional Assessment of Cancer Therapy- Lung (FACT-L14)
timeFrame: 1 month to 6 months
measure: Activity expenditure (assessed by the Fit Bit Zip accelerometer)
timeFrame: 1 month to 6 months
measure: Maximal Oxygen Consumption (VO2 max)
timeFrame: 1 month to 6 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Janey Peterson, EdD, MS, RN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06403683: Physical Activity Level and Insomnia
Official title: Relationship Between Physical Activity Levels and Insomnia in Females With Primary Dysmenorrhea
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Primary Dysmenorrhea
Keywords: Physical Activity Level
Insomnia
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-05-08
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: This study will be conducted on 150 females recruited from El_ Nassr hospital in Helwan, Cairo, Egypt and from social media. Patients will be divided into two equal groups:

Brief summary: This study aims to investigate the relationship between physical activity levels and insomnia in females with primary dysmenorrhea.

Detailed description: This study will be designed as a case-control study, conducted on 150 females recruited from El_Nassr hospital in Helwan, Cairo, Egypt and from social media. Patients will be divided into two equal groups: group A(75 patients complain from PD according to WaLIDD score)\& group B(75 patients don't complain from PD according to WaLIDD score). All data and information of each female in this study, including name, age, address, weight, height, and menstrual history, will be recorded in a recording data sheet. WaLIDD score will be used to assess PD symptoms, Insomnia Severity Index will be used to assess insomnia, International Physical Activity Questionnaire (Short-form)\& Six-Minute Walk Test will be used to assess physical activity levels. Inclusion criteria: 1)Patient ages will be ranged between 18-25 years old, 2)They do not receive any drugs, 3)Being a virgin. Participants will be excluded if they 1) Using hormonal contraception (such as oral contraceptives and injections), 2)Taking any medications, 3)History of chronic disease, 4)Having any psychiatric or gynecological problems (such as PCO, amenorrhea, women who suffered from menopause). The subject, who missed for any of assessment session, would be withdraw form the research.

Eligibility criteria: Inclusion Criteria:

1. Patient ages will be ranged between 18-25 years old.
2. They do not receive any drugs.
3. Being a virgin .

Exclusion Criteria:

1. Using hormonal contraception (such as oral contraceptives and injections).
2. Taking any medications.
3. History of chronic disease.
4. Having any psychiatric or gynecological problems (such as PCO, amenorrhea, women who suffered from menopause).

Primary outcomes:
measure: Insomnia
timeFrame: Through study completion, an average of 6 months
measure: Physical activity level
timeFrame: Through study completion, an average of 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Cairo University
Study officials:
affiliation: Department of Woman's Health, Faculty of Physical Therapy, Cairo University, Giza, Egypt
name: Dalia Mohamed Kamel, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT05299983: MyMenoPlan: Online Resource for Improving Women's Menopause Knowledge and Informed Decision-making
Official title: MsFLASH: Living a Healthy Menopause, Aim 2 Randomized Controlled Trial of MyMenoPlan
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Menopause
Premenopause
Postmenopause
Keywords: Computer-Assisted Decision Making
Internet-Based Intervention
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2022-03-29
Enrollment: 410
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: As part of a National Institute on Aging -funded R01, the investigators developed an evidence-based, multi-media digital resource entitled MyMenoPlan to help women learn about the menopause transition, and the symptoms and treatments of perimenopause/menopause. MyMenoPlan is also designed to help women learn about the effectiveness of treatments for a comprehensive list of midlife symptoms and compare treatments that may help with the specific symptoms women are experiencing.

Detailed description: The purpose of this research study is to:

1. Investigate how women randomly assigned to visit MyMenoPlan use the website (time spent on website, treatment and symptom page views, use of interactive tools, and use of the MyMenoPlan tool).
2. Compare the ratings of women randomly assigned to MyMenoPlan to those randomly assigned to other menopause websites for perceived quality of information, readability, self-efficacy, and credibility of these online menopause resources.

Eligibility criteria: Inclusion Criteria:

* As stated above

Exclusion Criteria:

* N/A

Primary outcomes:
measure: Perceived Quality of Information
timeFrame: Each survey question is answered after spending at least 20 minutes on the assigned website(s)
measure: Readability
timeFrame: Each survey question is answered after spending at least 20 minutes on the assigned website(s)
measure: Self-Efficacy for Managing Menopause Symptoms
timeFrame: Each survey question is answered after spending at least 20 minutes on the assigned website(s)
measure: Credibility
timeFrame: Each survey question is answered after spending at least 20 minutes on the assigned website(s)
Secondary outcomes:
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: UC San Diego
state: California
Study officials:
affiliation: University of California, San Diego
name: Andrea Z. LaCroix, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02740283: The Early Diagnosis of Gestational Diabetes Mellitus Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gestational Diabetes Mellitus
Keywords: Gestational Diabetes Mellitus
Oral Glucose Tolerance Test
Lead sponsor: First Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2016-04-15
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The main purpose of the study is to evaluate an OGTT at 18 to 20 gestational weeks as an early diagnosis method of GDM in low risk pregnant women. By investigating maternal and neonatal outcomes that are associated with the early OGTT and regular OGTT results, the study will provide a evidence for the most appropriate time to perform an OGTT in pregnant women.


Eligibility criteria: Inclusion Criteria:

* Singleton pregnant women will be invited to participate in this study if they are between 18 and 40 years of age, and have had their first prenatal visit in our center before 18 weeks 0 days of gestation.

Exclusion Criteria:

* Previous history of GDM or preexisting DM
* Family history of diabetes mellitus (first degree relative with diabetes or a sister with GDM)
* Body mass index\>30 kg/m2
* Previous macrosomia (baby with birth weight \>4,000 g) or a history of stillbirth
* Polycystic ovary syndrome
* Medications: corticosteroids, antipsychotics
* Participant not willing to take OGTT twice (at 18-20 gestational weeks and 24-28 gestational weeks), or not willing to have a series of prenatal care visits and deliver in our center.

Primary outcomes:
measure: Rate of GDM diagnosed in 18-20 gestational week.
timeFrame: up to 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Liu B, Cai J, Xu Y, Long Y, Deng L, Lin S, Zhang J, Yang J, Zhong L, Luo Y, Zhou Y, Zhang Y, Li Z, Chen H, Wang Z. Early Diagnosed Gestational Diabetes Mellitus Is Associated With Adverse Pregnancy Outcomes: A Prospective Cohort Study. J Clin Endocrinol Metab. 2020 Dec 1;105(12):dgaa633. doi: 10.1210/clinem/dgaa633.
citation: Liu B, Xu Y, Zhang Y, Cai J, Deng L, Yang J, Zhou Y, Long Y, Zhang J, Wang Z. Early Diagnosis of Gestational Diabetes Mellitus (EDoGDM) study: a protocol for a prospective, longitudinal cohort study. BMJ Open. 2016 Nov 21;6(11):e012315. doi: 10.1136/bmjopen-2016-012315.
Clinical trial NCT02231983: Clinical Characteristics and Genetic Profiles of Severe Combined Immunodeficiency in China
Official title: Clinical Characteristics and Genetic Profiles of Severe Combined Immunodeficiency in China
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Severe Combined Immunodeficiency
Keywords: Clinical Characteristics
Genetic Profiles
Lead sponsor: Shanghai Children's Medical Center
Sponsor class: OTHER
First posted: 2014-09-04
Enrollment: 50
Sex: ALL
Minimum age (years): 2
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: SCID patients

Brief summary: Severe combined immunodeficiency (SCID), a rare primary immunodeficiency dieases (PID), is poorly characterized in mainland China. We meant to explore the patients with SCID refered to our hospital and summarize their clinical manifestations and genetic features.

Detailed description: Diagnostic criteria were based on recommendations by the Pan-American Group for Immunodeficiency and the European Society for Immunodeficiencies, which included failure to thrive, persistent diarrhea, respiratory symptoms, and oral candidiasis, or Pneumocystis pneumonia, severe bacterial infections, and disseminated Bacillus Calmette-Guérin (BCG) infection during the first 2 to 7 months of life. In addition, patients included in the study were \<2 years of age, with either transplacentally acquired maternal T cells or \<20 % CD3+ T cells, the absolute lymphocyte count (ALC) \<3000/mm3. Exclusion criteria include HIV infection, congenital rubella, DiGeorge syndrome, Zap70 deficiency, Cartilage hair hypoplasia, PNP deficiency and MHC class II deficiency.

Eligibility criteria: Inclusion Criteria:

Diagnostic criteria were based on recommendations by the Pan-American Group for Immunodeficiency and the European Society for Immunodeficiencies, which included failure to thrive, persistent diarrhea, respiratory symptoms, and oral candidiasis, or Pneumocystis pneumonia, severe bacterial infections, and disseminated Bacillus Calmette-Guérin (BCG) infection during the first 2 to 7 months of life.

Exclusion Criteria: HIV infection, congenital rubella, DiGeorge syndrome, Zap70 deficiency, Cartilage hair hypoplasia, PNP deficiency and MHC class II deficiency.

Primary outcomes:
measure: times of infections
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai children's medical center
state: Shanghai
Study officials:
References:
Clinical trial NCT03778983: Cognitive Development After Pediatric Liver Transplantation
Official title: Cognitive Development After Pediatric Liver Transplantation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cognitive Development After Pediatric Live Transplantation
Keywords: Cognitive Development
Pediatric Live Transplantation
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2018-12-19
Enrollment: 130
Sex: ALL
Minimum age (years): 2
Maximum age (years): 7
Standard ages: CHILD
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study chooses children who underwent pediatric Ltx before 12 month at RenJi Hospital , Chinese, now age before 2 and 7 years . Inclusion criteria were as follows: (1) age between2 and7 years, (2) residency in China, (3) sufficient Chinese language skills, (4) at least 1 year post-Ltx, (5) no acute diseases and (6) no mental handicap.

Brief summary: The purpose of this study is to investigate the cognitive performance after pediatric live transplantation.

Detailed description: During the last 20 years, survival rates after pediatric liver transplantation (Ltx) have increased steadily. Today, pediatric Ltx is a well-established treatment for a variety of liver diseases in their final stage. Even in relative indications (i.e. certain metabolic diseases), liver transplantation is a promising treatment option that actually is becoming increasingly important in clinical practice .

Importantly, childhood cognitive ability is highly predictive for educational achievement and later occupational outcomes as well as health behavior . Current research indicates that liver transplanted children are at higher risk for developing cognitive deficits compared to the age-matched normal population .

The aim of present study is to evaluate the cognitive development after pediatric liver transplantation. The investigators expect to understand of the association between cognitive deficits and certain disease-related variables, which may be contribute to optimizing clinical care of these patients.

Eligibility criteria: Inclusion Criteria:

1. Pediatric patients accepted Live Transplantation before 12 month, and now age between 2 and 7 years;
2. residency in China;
3. sufficient Chinese language skills;
4. at least 1 year post-Ltx;
5. no acute diseases;
6. no mental handicap.

Exclusion Criteria:

1. Re-transplantation
2. Patients with localized or systemic infection
3. Patients cor-morbid with auto-immune disease
4. Combined liver and kidney transplantation
5. Lack of informed consent

Primary outcomes:
measure: Intelligence function evaluated by Wechsler Intelligence Scale IV
timeFrame: at least 1 year after pediatric live transplantation
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Renji Hospital, School of Medicine, Shanghai Jiaotong University
state: Shanghai
Study officials:
affiliation: Anesthesiology Department Renji Hospital, Shanghai
name: Diansan Su, MD
role: STUDY_CHAIR
References:
Clinical trial NCT05797883: FOLFOX/FOLFIRI Containing Levofolinic Acid (Zuoyu ®) in the Treatment of Unresectable or Metastatic Colorectal Cancer
Official title: Clinical Study on the Efficacy and Safety of FOLFOX/FOLFIRI± Targeted Drug Regimen Containing Levofolinic Acid (Zuoyu ®) in the Treatment of Unresectable or Metastatic Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Unresectable or Metastatic Colorectal Cancer
Lead sponsor: China Medical University, China
Sponsor class: OTHER
First posted: 2023-04-04
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To observe and evaluate the efficacy and safety of FOLFOX/FOLFIRI± target-directed regimen containing Levofolinic Acid (Zuoyu ®) in first-line treatment of unresectable or metastatic colorectal cancer


Eligibility criteria: Inclusion Criteria:

* Male or female, ≥18 years old;
* Patients with histopathologically confirmed unresectable or metastatic colorectal cancer who have not previously received chemotherapy or targeted therapy for unresectable or metastatic lesions;
* Have at least one measurable lesion according to RECIST 1.1 standards;
* ECOG PS score: 0-2;
* Expected survival greater than 3 months;
* Routine blood routine, liver and kidney function, electrocardiogram and other routine tests were basically normal, no contraindications of chemotherapy;
* The subjects voluntarily joined the study, signed the informed consent, had good compliance, and cooperated with follow-up visits;
* Researchers believe treatment can benefit.

Exclusion Criteria:

* A proven allergy to the test drug and/or its excipients;
* Pregnant or lactating women;
* Patients judged by the investigator to be unsuitable for inclusion in this study;

Primary outcomes:
measure: Objective response rate (ORR)
timeFrame: 2 years
Secondary outcomes:
measure: Progression-free survival (PFS)
timeFrame: 2years
measure: Disease control rate (DCR)
timeFrame: 2years
Other outcomes:
Locations:
city: Shenyang
country: China
facility: Liaoning Cancer Hospital & Institute
state: Liaoning
Study officials:
References: