louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03057743: Imaging of in Vivo Sigma-2 Receptor Expression With 18F-ISO-1 Positron Emission Tomography in Metastatic Breast Cancer
Official title: Imaging of in Vivo Sigma-2 Receptor Expression With 18F-ISO-1 Positron Emission Tomography in Metastatic Breast Cancer
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: METASTATIC BREAST CANCER
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
First posted: 2017-02-20
Enrollment: 4
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Metastatic Breast Cancer

Brief summary: Pilot study using \[18F\]ISO-1 PET/CT to image sigma-2 receptor binding in metastatic breast cancer. Correlate baseline uptake and change in uptake after therapy with time to progression and standard and experimental pathology assays of biopsy or surgical tissue. The target population is up to 30 adult patients at least 18 years, with at least one site of disease outside the liver by at least one type of standard imaging.


Eligibility criteria: Inclusion Criteria:

* At least 18 years of age
* Biopsy proven or clinically documented metastatic breast cancer with at least one lesion outside the liver by standard imaging (e.g. CT, MRI, Bone Scan, Ultrasound, FDG PET/CT)
* Plan to start new systemic therapy for metastatic disease.
* Participants must be informed of the investigational nature of this study and be willing to provide written informed consent and participate in this study in accordance with institutional and federal guidelines prior to study-specific procedures.

Exclusion Criteria:

* Females who are pregnant at the time of screening will not be eligible for this study, urine or serum pregnancy test will be performed in women of child-bearing potential at the time of screening.
* Inability to tolerate imaging procedure in the opinion of an investigator or treating physician.
* Serious or unstable medical or psychological conditions that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study.

Primary outcomes:
measure: Progression free survival
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Abramson Cancer Center of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Abramson Cancer Center at Penn Medicine
name: Elizabeth MdDonald, MD, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03855943: Evaluating the Effects of a Computerized Training Program Coupled With Cognitive Behavioral Therapy (CBT) for OCD.
Official title: Personalized Computerized Inhibitory Control Training for OCD
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obsessive-Compulsive Disorder
Lead sponsor: Hebrew University of Jerusalem
Sponsor class: OTHER
First posted: 2019-02-27
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will evaluate the effects of a computerized training program coupled with cognitive behavioral therapy (CBT) for OCD.

Detailed description: This study will evaluate the effectiveness of a computerized training program (called Personalized Computerized Inhibitory Training, or PCIT) coupled with cognitive behavioral therapies (CBT) consisting of Exposures and Response Prevention in treating obsessive compulsive disorder (OCD) in patients who previously underwent CBT, but still have residual symptoms.

Eligibility criteria: Inclusion Criteria:

* Principal diagnosis of OCD (assessed by SCID).
* Clinically significant OCD symptoms (Y-BOCS score of at least 14).
* Allowed to be on medications if they have been on a stable dose for at least 12 weeks prior to the study and will remain on a stable dose during this study.
* Have access to a computer or laptop.

Exclusion Criteria:

* Individuals with the following disorders will excluded: bipolar, psychosis, current major depressive disorder (assessed by SCID).
* Patients with head injury and loss of consciousness of more than five minutes or a neurological condition affecting the central nervous system.
* Patients taking a psychiatric medication will be asked to maintain a stable dose for 6 weeks prior to study entry.
* Patients with a history of more than 8 hours of therapist-assisted ERP for OCD in the past 6 months,
* Vision or hearing loss (although individuals with vision corrected by glasses or contacts will not be excluded).
* Active suicidality warranting immediate clinical care.

Primary outcomes:
measure: Obsessive-compulsive symptoms measured after 3 weeks of treatment
timeFrame: 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hebrew University of Jerusalem
Study officials:
affiliation: Hebrew University of Jerusalem
name: Noa Tauber, MA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01575743: Effects of Aerobic Exercise on Occupational Burnout
Official title: Effects of Aerobic Exercise on Occupational Burnout
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Burnout Syndrome
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2012-04-11
Enrollment: 24
Sex: MALE
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of the present study is to investigate the impact of regular aerobic exercise on psychopathology, cortisol secretion, BDNF, sleep, cognitive performance, and psychological functioning in people suffering from professional burnout. Pre- and postassessments after 12 weeks of training will be performed.


Eligibility criteria: Inclusion Criteria:

* burnout
* male participants
* non-smokers

Exclusion Criteria:

* psychiatric disorders
* smokers
* physical diseases

Primary outcomes:
measure: Change of burnout severity by aerobic exercise training
timeFrame: Change from baseline to follow-up after 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: UPK Basel
Study officials:
affiliation: UPK Basel, Basel Switzerland
name: Johannes Beck, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gerber M, Brand S, Elliot C, Holsboer-Trachsler E, Puhse U, Beck J. Aerobic exercise training and burnout: a pilot study with male participants suffering from burnout. BMC Res Notes. 2013 Mar 4;6:78. doi: 10.1186/1756-0500-6-78.
Clinical trial NCT05703243: Discovering Novel Cancer Treatment Options Using a Comprehensive NGS-based Liquid Molecular Testing Panel in the Community Setting ("DINOSAur II")
Official title: Discovering Novel Cancer Treatment Options Using a Comprehensive NGS-based Liquid Molecular Testing Panel in the Community Setting. ("DINOSAur II")
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stage III Solid Tumors
Stage IV Solid Tumors
Lead sponsor: Glendale Adventist Medical Center d/b/a Adventist Health Glendale
Sponsor class: OTHER
Collaborators: name: Guardant Health, Inc.
First posted: 2023-01-27
Enrollment: 572
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Newly diagnosed cancer patients at the pathology level

Brief summary: To prospectively identify cancer patients whose tumors express specific molecular markers targeted by therapeutic agents from a comprehensive l i q u i d molecular test, for the purpose of selecting the most clinically appropriate treatment in a pragmatic two arm trial.


Eligibility criteria: Inclusion Criteria:

* Patients who have given informed consent in accordance with the methods and procedures of this study
* Diagnosis of cancer (stage 3 and stage 4; solid tumors only) requiring medical care
* Patients who have not received treatment related to his/her cancer
* Patients who are willing to sign a release of medical records to the research team
* Male and female patients ≥18 years of age
* Patients under oncology care
* Sufficient clinical status for collection of blood sample within usual care

Exclusion Criteria:

* Patients considered minors in the jurisdiction where the protocol is conducted
* Patients who are prisoners and pregnant women
* Patients who cannot provide consent and did not sign a power of attorney

Primary outcomes:
measure: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (QLQ-C30)
timeFrame: 2 years
Secondary outcomes:
measure: Compare the proportion of enrolling in clinical trials
timeFrame: 2 years
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Adventist Health Glendale
state: California
Study officials:
affiliation: Glendale Adventist Medical Center dba Adventist Health Glendale
name: Mihran H Shirinian, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05644743: Clinical Transformation of Organoid Model to Predict the Efficacy of GC in the Treatment of Intrahepatic Cholangiocarcinoma
Official title: Clinical Transformation of Organoid Model to Predict the Efficacy of GC in the Treatment of Intrahepatic Cholangiocarcinoma
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Organoids
Intrahepatic Cholangiocarcinoma
Keywords: Organoid
Lead sponsor: Eastern Hepatobiliary Surgery Hospital
Sponsor class: OTHER
First posted: 2022-12-09
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients were histologically or cytologically diagnosed with locally advanced inoperable radical resectable or metastatic intrahepatic cholangiocarcinoma.

Brief summary: The clinical incidence of intrahepatic cholangiocarcinoma (ICC) is high and insidious, and the prognosis of advanced patients is poor. The clinical manifestations of traditional chemotherapy GC and emerging targeted therapy are different in most patients, and there is still no effective scheme to evaluate the differences in individual patient reactivity. Patient-derived tumor organoids (PDO) are 3D-cultured tissues based on tumor cell dryness that reproduce a variety of biological characteristics of parental tumors in vitro and have similar drug responsiveness to tumors in vivo. This project plans to use clinical cases and optimized organoid culture system to first construct relevant organoids from unresectable ICC patient puncture samples. Secondly, based on the organoid model of intrahepatic cholangiocarcinoma, the clinical efficacy of GC regimen was predicted, and in vitro and in vivo drug screening was conducted to explore the guidance of patient-derived tumor organoids for clinical treatment. Then, multi-omics data of organoids and in vitro and in vivo drug efficacy evaluation model were used to explore the drug resistance genes of intrahepatic cholangiocarcinoma, providing the basis for personalized drug screening and efficacy evaluation of intrahepatic cholangiocarcinoma.


Eligibility criteria: Inclusion Criteria:

- Histologically confirmed intrahepatic cholangiocarcinoma They are between 18 and 80 years old Written informed and signed consent form Biopsy sample of the intrahepatic bile duct

Exclusion Criteria:

- Under 18, over 80 Informed consent cannot be given Biopsy samples were not available

Primary outcomes:
measure: Consistency of organoids and clinical patient responses to drugs
timeFrame: 3 years
measure: Construction of drug resistance prediction model
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Deputy director
name: chengjun sui, dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01675843: Ovarian Stimulation and Intrauterine Insemination in Women With Polycystic Ovarian Syndrome
Official title: Ovarian Stimulation and Intrauterine Insemination in Women With Polycystic Ovarian Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Infertility
Polycystic Ovarian Syndrome
Intrauterine Insemination
Keywords: Infertility
PCOS
IUI
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2012-08-30
Enrollment: 140
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study null hypothethesis is: intrauterine insemination (IUI) does not improve pregnancy rates in women with polycystic ovary syndrome. Infertile women with pcos will receive gonadotropins for ovarian stimulation and then randomize to either IUI or timed intercourse (TI)


Eligibility criteria: Inclusion Criteria:

- women who failed to get pregnant after 6 ovulation induction cycles with clomiphene citrate (cc) alone, despite of being ovulating with cc, having patent Fallopian tubes as confirmed by hysterosalpingography and their partners had fertile semen parameters according to criteria of World Health Organization (WHO 2010)

Exclusion Criteria:

male factor infertility

Primary outcomes:
measure: Live Birth Rate
timeFrame: 20 months
Secondary outcomes:
measure: Clinical pregnancy rate
timeFrame: 16 months
Other outcomes:
measure: multiple pregnancy rate
timeFrame: 20 months
Locations:
city: Mansoura
country: Egypt
facility: Fertility Care Unit
state: Eldakahlia
Study officials:
affiliation: Mansoura University
name: Ahmed Gibreel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00000343: Brain Changes in Stimulant Dependent Subjects - 8
Official title: Brain Changes in Stimulant Dependent Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Substance-Related Disorders
Keywords: stimulant dependence
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
First posted: 1999-09-21
Enrollment: 90
Sex: ALL
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to identify the neurophysiologic indicators of cocaine or methamphetamine use and withdrawal, to examine the relationship between subjects' reports of depression, craving, and stimulant use, and neurophysiologic measures, and to identify neurophysiologic measures which can be used to identify new treatments for stimulant dependence.

Detailed description: By Incorporating QEEG into clinical trails, the plan is to develop physiologic markers of treatment efficacy, and to aid in the identification of effective treatments.

Eligibility criteria: Inclusion Criteria:

M/F ages 21-50. Meet DSM-IV criteria for cocaine dependence. Agree to conditions of the study and sign informed consent.

Exclusion Criteria:

Psychiatric disorder that requires medication therapy. History of seizures. Pregnant and/or nursing women. Dependence on ETOH or benzodiazepines or other sedative/hypnotics. Acute hepatitis. Other medical conditions that deem participation to be unsafe.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Friends Research Institute
state: California
Study officials:
affiliation: Friends Research Institute, Inc.
name: Walter Ling, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06140043: Augmented Reality for Orthognatic Surgery Patient Education
Official title: Augmented Reality for Orthognatic Surgery Patient Education
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Malocclusion
Dentofacial Deformities
Patient Satisfaction
Informed Consent
Patient Education
Keywords: Orthognatic Surgery
Augmented Reality
Patient Satisfaction
Informed Consent
Patient Education
3D
BSSO
BIMAX
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
Collaborators: name: UMC Utrecht
name: Uniklinik RTWH Aachen
First posted: 2023-11-18
Enrollment: 60
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: patients are randomised to one of two groups, either consultation with models on a computer screen or with models shown in augmented reality
Primary purpose: OTHER

Brief summary: To evaluate whether the use of augmented reality (AR) for visualizing 3D models can be a valuable addition to patient education regarding orthognathic procedures compared to using only 2D visualization (on a computer screen).


Eligibility criteria: Inclusion Criteria:

* Patients planned for an orthognathic intake consult in the period of July to april 2024 at the UMCU or UMCG or Uniklinik RTWH Aachen;
* Patients with dentofacial deformity (dysgnathia) including: class II malocclusion, class III malocclusion, or open bite;
* Patients undergoing treatment using BSSO (Bilateral Sagittal Split Osteotomy), Le Fort I, or BIMAX;
* The planned treatment is either with or without a genioplasty procedures.
* Patients 16 years of age or older.

Exclusion Criteria:

* Patients with craniofacial syndromes, such as cleft lip and palate
* Patient which require an osteotomy involving two or more segments

Primary outcomes:
measure: Patient satisfaction
timeFrame: Immediately after the regular first intake consult
measure: Objective knowledge
timeFrame: Immediately after the regular first intake consult
Secondary outcomes:
Other outcomes:
measure: Diagnosis
timeFrame: During the first intake consult
measure: Occlusion Class
timeFrame: During the first intake consult
Locations:
city: Aachen
country: Germany
facility: UniKlinik RWTH Aachen
city: Groningen
country: Netherlands
facility: UMC Groningen
city: Utrecht
country: Netherlands
facility: UMC Utrecht
Study officials:
affiliation: UMC Groningen
name: J Kraeima, dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05470543: Effect of Nurse-led Supportive Care on Caregiver Burden and Well-being
Official title: Effect of Nurse-led Supportive Care on Caregiver Burden and Well-being Among Primary Caregivers of Women With Breast Cancer: A Pragmatic Parallel Group Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nurse-led Supportive Care
Keywords: Breast cancer
Caregiver burden
Well-being
Nurse-led care
Lead sponsor: Izmir Bakircay University
Sponsor class: OTHER
First posted: 2022-07-22
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Breast cancer is the most common type of cancer in women with a high mortality rate in the world. Women may experience many different physiological and psychological symptoms (such as pain, nausea-vomiting, fatigue, stress, anger, and isolation) during diagnosis and treatment process. Family members often become caregivers at the time of diagnosis, and treatment of breast cancer patients. Therefore, family caregivers experience burden and poor health-related quality of life.

Detailed description: This a pragmatic, parallel group randomized controlled trial aimed that investigating the effect of nurse-led supportive care on caregiver burden and well-being among primary caregivers of women with breast cancer. This trial was conducted in the chemotherapy outpatient clinic of training and research hospital located in Turkey. All primary caregivers were family members.

Eligibility criteria: Inclusion Criteria:

* Being the primary caregiver of breast cancer patients
* Literate
* Able to understand and complete the questionnaires
* Willingness to participate in the study

Exclusion Criteria:

* Having communication problems
* Having psychological diseases
* Receiving any supportive care

Primary outcomes:
measure: Zarit Burden Interview (ZBI)
timeFrame: Change from baseline Zarit Burden Interview score at 9th weeks.
Secondary outcomes:
measure: Caregiver Well-Being Scale
timeFrame: Change from baseline Caregiver Well-Being Scale score at 9th weeks.
Other outcomes:
Locations:
city: Izmir
country: Turkey
facility: Izmir Bakircay University Faculty of Health Sciences
Study officials:
affiliation: Izmir Bakircay University Faculty of Health Sciences Izmir, Turkey, 35560
name: Pinar Zorba Bahceli, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05822843: A Phase 1 Study of ESG206 in Adult Subjects With B-cell Lymphoid Malignancies
Official title: A Phase I, Open Label, Multiple Dose, Dose Escalation Study to Investigate the Safety, Tolerability, Pharmacokinetics and Antitumor Activities of Anti-BAFFR mAb(Monoclonal Antibody), ESG206 in Subjects With B-cell Lymphoid Malignancies
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: B-cell Lymphoid Malignancies
Lead sponsor: Shanghai Escugen Biotechnology Co., Ltd
Sponsor class: INDUSTRY
First posted: 2023-04-21
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This is a phase I, multicenter, open label, sequential-cohort, dose escalation study of ESG206. The purpose is to evaluate the clinical safety, tolerability, PK (pharmacokinetics), and preliminary efficacy and to establish the MTD (maximum tolerated dose), if any, and RP2D (recommended phaseII dose) of ESG206 in adult subjects with B lymphoid malignancies.


Eligibility criteria: Inclusion Criteria:

* Willing and able to provide written informed consent for the trial.
* Male or female and at least 18 years of age.
* Subjects must have a histologically confirmed (or documented), incurable B-cell hematologic malignancy that had progressed despite standard of care therapy and for which there was no alternative therapy of proven benefit or no effective standard therapy is available or tolerable.
* Measurable or evaluable Disease.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Subject must have adequate organ function.

Exclusion Criteria:

* Has had prior chemotherapy, targeted therapy, immunotherapy or any other agents used as systemic treatment for cancer, within 14 days before first dosing.
* Had major surgery within 4 weeks before first dosing.
* Had undergone an autologous stem cell transplant within 100 days before first dosing.
* Evidence of severe or uncontrolled systemic diseases (e.g., unstable or uncompensated respiratory, hepatic, or renal disease).
* Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to the investigational product or excipients.
* Pregnant or breastfeeding women.
* Unwillingness or inability to follow the procedures outlined in the protocol.

Primary outcomes:
measure: Percentage of Participants Experiencing Any Treatment Emergent Adverse Events
timeFrame: First dose date up to last dose plus 30 days
Secondary outcomes:
measure: Cmax
timeFrame: Up to 20 months
measure: AUC0-inf
timeFrame: Up to 20 months
measure: Tmax
timeFrame: Up to 20 months
measure: T1/2
timeFrame: Up to 20 months
measure: Overall Response Rate (ORR)
timeFrame: Up to 20 months
measure: Progression-free Survival (PFS)
timeFrame: Up to 20 months
measure: ADA
timeFrame: Up to 20 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Cancer Hospital
Study officials:
References: