louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05827328: Explore the Optimal Surgical Timing for Lung Surgery and Mediastinal Surgery After COVID-19 Infection
Official title: A Prospective Observational Study to Explore the Optimal Surgical Timing for Lung Surgery and Mediastinal Surgery After COVID-19 Infection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thoracic Diseases
Thoracic Surgery
Lead sponsor: Shanghai Pulmonary Hospital, Shanghai, China
Sponsor class: OTHER
First posted: 2023-04-25
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who undergo thoracic surgery for the clinical diagnosis of lung cancer or mediastinal tumors with or without SARS-CoV-2 infection.

Brief summary: Exploring the optimal interval time in patients with the clinical diagnosis of lung cancer or mediastinal tumors indicated for thoracic surgeries after SARS-CoV-2 infection by comparing 30-day mortality and 30-day morbidity.


Eligibility criteria: Inclusion Criteria:

1. The patient has fully understood the nature of this study and voluntarily agreed to participate by signing an informed consent form.
2. Participants of any gender between the ages of 18 and 85 are eligible.
3. Preoperative imaging evaluation +/- biopsies indicates that the patient has resectable lung cancer or mediastinal tumors without distant metastasis.

Exclusion Criteria:

1. Patients who have previously undergone lung surgery;
2. Patients previously infected with SARS-CoV-2 more than 6 months before thoracic surgery;
3. Patients who did not receive Chest computed tomography (CT) at admission or within 7 days before surgery, or whose Chest CT at admission suggests pneumonia or current infection with SARS-CoV-2 (confirmed by routine laboratory tests as positive nucleic acid in admission or on the day of surgery);
4. The elapsed time from SARS-CoV-2 diagnosis to surgery is within 4 weeks;
5. Local unresectable lesions or distant metastases are found intraoperatively.

Primary outcomes:
measure: The incidence of perioperative mortality
timeFrame: 30 days after surgery
Secondary outcomes:
measure: The incidence of perioperative complications
timeFrame: 30 days after surgery
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Pulmonary Hospital
city: Shanghai
country: China
facility: Anhui Chest Hospital
city: Shanghai
country: China
facility: Anqing Municipal Hospital
city: Shanghai
country: China
facility: Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
city: Shanghai
country: China
facility: The First Affiliated Hospital of Anhui Medical University
city: Shanghai
country: China
facility: Wuhan University Renmin Hospital
Study officials:
affiliation: Shanghai Pulmonary Hospital, Shanghai, China
name: Peng Zhang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06895928: A Trial of SHR-A2102 With Other Antitumor Therapies in Advanced Solid Tumors
Official title: A Phase II, Multicenter, Open-Label Study of Safety, Tolerability and Efficacy of SHR-A2102 for Injection in Combination With Other Antitumor Therapies in Patients With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Advanced Solid Tumors
Lead sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-03-26
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study is being conducted to evaluate the safety, tolerability and efficacy of SHR-A2102 with other antitumor therapies in advanced solid tumors to explore the reasonable dosage, safety and efficacy of SHR-A2102 for advanced solid tumors.


Eligibility criteria: Inclusion Criteria:

1. The age of signing the informed consent is 18 -70 years, regardless of gender.
2. At least one measurable lesion according to RECIST v1.1 criteria.
3. The ECOG score is 0 or 1.
4. Expected survival ≥12 weeks.
5. Good level of organ function.
6. Have the ability to give informed consent and to comply with the treatment plan.
7. Male subjects whose partners are women of childbearing age and female subjects who are fertile are required to use highly effective contraceptive methods.

Exclusion Criteria:

1. Inadequately treated central nervous system metastases or the presence of uncontrolled or symptomatic active central nervous system metastases.
2. Spinal cord compression not cured by surgery and/or radiotherapy.
3. Subjects with uncontrolled tumor-related pain.
4. Received antitumor therapy within 4 weeks before the start of the study.
5. Subjects with severe cardiovascular and cerebrovascular disease.
6. History of immunodeficiency, including a positive HIV test.

Primary outcomes:
measure: Adverse events (AEs)
timeFrame: From day 1 to 90 days after the last dose.
measure: Serious adverse events (SAEs)
timeFrame: From day 1 to 90 days after the last dose.
measure: Objective response rate (ORR)
timeFrame: About 2 years.
Secondary outcomes:
measure: Disease control rate (DCR)
timeFrame: About 2 years.
measure: Duration of response (DOR)
timeFrame: About 2 years.
measure: Progression free survival (PFS)
timeFrame: About 2 years.
measure: Overall survival (OS)
timeFrame: About 2 years.
Other outcomes:
Locations:
city: Taiyuan
country: China
facility: Shanxi Cancer hospital
state: Shanxi
Study officials:
References:
Clinical trial NCT02249728: Absorption, Metabolism and Excretion Study of [14C]PBT2 and Absolute Bioavailability of PBT2
Official title: A Phase I , Open-Label Study to Evaluate the Absorption, Metabolism and Excretion of [14C]-PBT2 and to Estimate the Absolute Bioavailability of PBT2 in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Pranabio
Sponsor class: UNKNOWN
First posted: 2014-09-26
Enrollment: 6
Sex: MALE
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of the study is to investigate how the test drug, PBT2, is taken up, broken down and removed from the body when given as an oral capsule, a radiolabelled oral suspension and a radiolabelled intravenous injection.


Eligibility criteria: Inclusion Criteria:

* Healthy males
* Body mass index of 18.0 to 35.0 kg/m2

Exclusion Criteria:

* History of any drug or alcohol abuse in the past 2 years
* Regular alcohol consumption \>21 units per week (1 unit = ½ pint beer, 25 mL of 40% spirit or a 125 mL glass of wine)
* Current smokers and those who have smoked within the last 12 months
* Radiation exposure, including that from the present study, excluding background radiation but including diagnostic x-rays and other medical exposures, exceeding 5 mSv in the last 12 months or 10 mSv in the last 5 years.
* Clinically significant abnormal biochemistry, haematology or urinalysis as judged by the investigator
* Positive drugs of abuse test result
* Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results
* History of cardiovascular, renal, hepatic, chronic respiratory or GI disease as judged by the investigator

Primary outcomes:
measure: Absolute Bioavailability of PBT2 (F%)
timeFrame: 0 to 72 hours post oral dose
measure: Mass Balance
timeFrame: 168 h (7 days) post dose
Secondary outcomes:
measure: IV PK Profile of [14C]-PBT2 and Total Radioactivity as Assessed by AUC(0 Last)
timeFrame: 0 to 72 h post oral dose
measure: Oral PK Profile of PBT2 as Assessed by AUC(0-last)
timeFrame: 72 h post oral dose
measure: Safety and Tolerability of PBT2
timeFrame: 72 h post oral dose
measure: Ratio of Whole Blood, Plasma [14C] PBT2 at 24 Hours
timeFrame: 0 to 24 hours
measure: Oral PK Profile of [14C]-PBT2 as Assessed by AUC(0-last)
timeFrame: 0 to 72 hours
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: Quotient Clinical
state: Nottinghamshire
Study officials:
affiliation: Prana Biotechnology Ltd
name: Caroline Herd, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02561728: Hanger Helmet Study
Official title: Prospective Study to Evaluate Effectiveness of the Hanger Helmet vs the P Pod Helmet in Improving the Head and Face Symmetry
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Plagiocephaly
Craniosynostosis
Keywords: Helmet
Hangar
P-Pod
Plagiocephaly
Surgery
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
First posted: 2015-09-28
Enrollment: 0
Sex: ALL
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine a group of patients requiring helmet therapy (either patients with plagiocephaly or post-surgical patients) to compare outcomes of infants treated with the Hanger helmet (Hanger, Inc.) to outcomes of infants treated with the P Pod Helmet (Lorica Scientific, LLC). Currently both helmets are prescribed at CCHMC. The investigators' goal is to determine which helmet is more effective in skull remodeling and to standardize the investigators' care for these patient types.

Detailed description: The use of helmet therapy to correct abnormal head shape due to either positional plagiocephaly secondary to pressure on the posterior skull with infant position and furniture use or after minimally invasive surgery for craniosynostosis is currently the treatment of choice at Cincinnati Children's Hospital (CCHMC). Helmet treatment in children with positional plagiocephaly is initiated for infants between 4 and 9 months of age (at CCHMC). Helmet treatment for children undergoing surgery for craniosynostosis is initiated following endoscopic cranial vault and stip craniectomy surgery after swelling from the surgery has subsided (generally within two weeks of surgery). Treatment with helmet therapy has been shown to improve head shape in both patient diagnoses. There are two types of helmets available to the investigators' patients (Hanger Helmet and P Pod Helmet) and to date, no research has evaluated whether one helmet type is more efficient in reshaping the skull than the other type. The current study seeks to fill this gap in the literature by comparing the outcomes for infants treated with a Hanger Helmet to the outcomes for infants treated with a P Pod Helmet. The investigators will measure skull symmetry with a 3dMD camera and take routine cross lateral measurements with a caliper designed for this use. Infants participating in the study will be randomized using a computerized program, Minim.

Eligibility criteria: Inclusion Criteria:

* Diagnosis which requires helmet therapy treatment
* Under 10 months of age

Exclusion Criteria:

* Children who do not need helmet therapy

Primary outcomes:
measure: Root Mean Square (RMS)
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: John van Aalst, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00343928: Amino Acids, Serotonin, and Body Weight Regulation
Official title: Amino Acids, Serotonin, and Body Weight Regulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Anorexia Nervosa
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2006-06-23
Enrollment: 21
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study will assess the behavioral effects of an amino acid mixture thought to influence serotonin function in individuals who have recovered from anorexia nervosa.

Detailed description: Anorexia nervosa is a serious psychiatric disorder resulting in psychosocial distress for patients and their families, potentially severe medical consequences, and substantial long-term mortality. A major emphasis in current therapeutic research in anorexia nervosa is exploration of new interventions to stabilize recovery and prevent relapse. Although the etiology of anorexia nervosa is unknown, altered regulation of the neurotransmitter serotonin in the central nervous system is thought to contribute to preoccupation with body shape and weight, dysregulated eating patterns, persistent anxiety, and frequent mood fluctuations. The goal of this exploratory project is to assess the behavioral effects of an amino acid mixture thought to influence serotonin function in individuals who have recovered from anorexia nervosa. It is hypothesized that this brief intervention will help diminish residual eating disorder symptoms.

All participants in this crossover study will attend eight sessions over a 9-week period. Participants will spend approximately 2 weeks in each phase, during which they will receive an amino acid mixture and the control condition.

Eligibility criteria: Inclusion Criteria:

* History of anorexia nervosa
* In normal weight range with resumed menses
* No recent bulimic episodes
* Persistent symptoms of anxiety

Exclusion Criteria:

* Currently treated with psychotropic medication
* Diagnosed with major depression
* Current or recent substance dependence
* Serious medical illness
* Pregnant or breastfeeding

Primary outcomes:
measure: Anxiety and preoccupation with body image
timeFrame: Measured at Week 9
Secondary outcomes:
measure: Eating patterns
timeFrame: Measured at Week 9
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: David C. Jimerson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04678128: Dance4Healing: Explore the Benefits of Tele-Dance in Individuals with an Implantable Cardioverter-defibrillator (ICD)
Official title: Dance4Healing: a Pilot Study to Explore the Benefits of Tele-Dance in Individuals with an Implantable Cardioverter Defibrillator
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: ICD
Anxiety
Patient Engagement
Keywords: ICD
Anxiety
QOL
Engagement
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2020-12-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study is to determine if it is feasible to using a Telehealth Dance Platform with patients that have an implantable Cardioverter Defibrillator, and will compare the activity engagement, anxiety, and Quality of Life


Eligibility criteria: Inclusion Criteria:

1. Patients that have had an ICD implanted for at least 1 month
2. Patients have access to web-based on-line programs
3. Patient can provide cardiac clearance for exercise from their treating physician OR they have written stress test results from within the last 6 months indicating no ischemia.
4. Patient is 18 years old or greater.

Exclusion Criteria:

1. Patient is non-English speaking.
2. Patient is assessed as having NYHA Class IV heart failure.
3. Patient had ventricular tachycardia (VT), ventricular fibrillation (VF) or has received "tachy" therapy from their ICD within last 4 weeks.
4. Patient has had a change in medical arrhythmia management or ablation procedure within the last 4 weeks.
5. Any medical issues that compromise walking or dancing, including cardiac, neurological or orthopedic .

Primary outcomes:
measure: Activity in hours/day from ICD interrogation as a measure of activity engagement over time
timeFrame: 36 weeks
measure: Change in calculated score from Patient Activation as a measure of Patient Activity Engagement over time
timeFrame: Baseline, Week 8(pre-intervention), Week 16 (post-intervention), Week 28 (long term)
measure: Total Amount of Time spent accessing the dance platform in minutes as a measure of Activity Engagement during the study intervention
timeFrame: Total time in minutes over the 8 week intervention period
Secondary outcomes:
measure: Change in Anxiety Score over time
timeFrame: Baseline, Week 8(pre-intervention), Week 16 (post-intervention), Week 28 (long term)
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford Arrhythmia Clinic
state: California
Study officials:
affiliation: Stanford Healthcare
name: Linda K Ottoboni, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05364528: Pregnancy Rate in Direct Versus Afterload Technique of Embryo Transfer
Official title: Pregnancy Rate in Single Step Versus After Load Technique of Embryo Transfer: a Retrospective Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fertility Issues
IVF
Embryo Transfer
Lead sponsor: Istituto Clinico Humanitas
Sponsor class: OTHER
First posted: 2022-05-06
Enrollment: 8127
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 43
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study database includes all the single fresh and frozen (G5-G6) blastocyst transfers performed at Humanitas Fertility Centre between 1st January 2016 and 31th December 2021 by using the direct and afterload protocols.

Brief summary: The primary outcome of the study is to determine if a difference in terms of pregnancy rate exists between direct and afterload embryo transfer (ET) techniques.

The secondary end points include the evaluation of the difficult transfer rates.

Detailed description: The study database includes all the single fresh and frozen (G5-G6) blastocyst transfers performed at Humanitas Fertility Centre between 1st January 2016 and 31th December 2021 by using the direct and afterload protocols.

Any blastocysts that underwent preimplantation genetic testing will be excluded from the analysis, as well as embryos derived from gamete donation or those imported from other centers.

Data are gathered using a specific internal web-based database, which allows to organize, store and readily retrieve information about patients and IVF cycle.

Eligibility criteria: Inclusion Criteria:

* IVF procedure
* Fresh and frozen single blastocyst transfer

Exclusion Criteria:

* Any blastocysts that underwent PGS testing
* Embryos derived from gamete donation
* Embryos imported from other centers

Primary outcomes:
measure: clinical pregnancy rate
timeFrame: 6 years
Secondary outcomes:
measure: difficult transfer rate
timeFrame: 6 years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06271928: A Multicenter Clinical Study of Yijing Keli in the Treatment of Ovarian Aging
Official title: The Efficacy and Safety of Chinese Herbal Compound Yijing Keli in the Treatment of Ovarian Aging: A Multicenter and Prospective Study.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Ovarian Aging
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2024-02-22
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Ovarian aging (OA) seriously affects the physical and mental health of women. Nowadays, Chinese herbs have huge appeal and potential in treating OA. We have created a new Chinese herbal combination Yijing Keli, whereas its safety and efficacy still need to be validated. Hence, we will perform a population-based, multicenter study to confirm the safety and efficacy of Yijing Keli in therapy of OA. We aim to provide a solid evidence for TCM in therapy of OA.


Eligibility criteria: Inclusion Criteria:

1. The age range of patient is 18-55 years old.
2. The diagnostic criteria for ovarian aging.
3. Sign the informed consent form.

Exclusion Criteria:

1. Patient is known to be allergic or unsuitable for the Chinese herbal compound.
2. Women who are pregnant and lactating.
3. Abnormal uterine bleeding, except ovulation disorders.
4. Women is taking hormone drugs and has stopped taking them within 3 months;
5. Women with endometriosis, myadenosis, submucosal fibroids or the size of non- submucosal fibroids is more than 4 cm.
6. The nature of pelvic mass is unknown.
7. Women with polycystic ovary syndrome, hyperprolactinemia, hyperandrogenemia, diabetes, thyroid and adrenal dysfunction and other endocrine diseases affecting ovulation.
8. Patients with serious primary diseases such as cardiovascular, liver, kidney, lung, biliary, hematopoietic system (Hb\<90g/L) and malignant tumor, and psychiatric patients.
9. Patients are participating in other clinical trials or have participated in other clinical trials within the last month.
10. Unsuitable for the study evaluated by the investigator.

Primary outcomes:
measure: the recovery rate of ovarian function
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Study officials:
affiliation: Tongji Hospital
name: jinjin zhang, professor
role: STUDY_CHAIR
References:
Clinical trial NCT04210128: Glucose Monitoring to Predict and Treat High Glucose Levels After Steroid Treatment
Official title: Continuous Glucose Monitoring For Prediction and Treatment of Steroid-Induced Hyperglycemia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Pancreatic Cancer
Diabetes
Pre Diabetes
Keywords: Glucose Monitoring
19-315
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2019-12-24
Enrollment: 3
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be recruited through the breast and gastrointestinal (GI) medicine oncology clinics at MSKCC.

Brief summary: The purpose of this study is to see if continuous glucose monitoring can identify how often people who have pre-diabetes or medical obesity or well-controlled diabetes experience very high glucose values while receiving chemotherapy for breast cancer or pancreatic.


Eligibility criteria: Inclusion Criteria:

* Patient aged 18 or older undergoing neoadjuvant chemotherapy regimens including taxane and/or anthracycline for breast cancer.
* Patient aged 18 or older undergoing any chemotherapy regimen for pancreatic cancer
* Have 'high metabolic risk(either pre-diabetes, obesity, or well-controlled diabetes) defined as either:

  * Pre-diabetes and/or obesity group: one or more of known HbA1c 5.7-6.5%, fasting glucose \> 100 mg/dL, or BMI \> 30
  * Well-controlled diabetes: Known HbA1c \< 7.5 on lifestyle alone or up to one oral antidiabetic agent
  * Any patient undergoing treatment for pancreatic adenocarcinoma on either no antidiabetic agent or up to one oral antidiabetic agent

Exclusion Criteria:

* Patients with type 1 diabetes, a history of hospitalization for either hyperglycemia or ketoacidosis, a history of hypoglycemia requiring hospitalization, rashes or other skin reactions that would preclude placement of the CGM
* Use of anticoagulants or antiplatelet agents other than aspirin
* Platelet count \< 50 K/μL within 60 days prior to enrollment.

Primary outcomes:
measure: severe hyperglycemia
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: James Flory, MD
role: PRINCIPAL_INVESTIGATOR
References: