louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00580476: Assessing Depression in a Geriatric Cancer Population
Official title: Assessing Depression in a Geriatric Cancer Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Prostate Cancer
Keywords: Breast Cancer
Prostate Cancer
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: City of Hope National Medical Center
First posted: 2007-12-24
Enrollment: 201
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Geriatric Patients with Breast or Prostate Cancer

Brief summary: The goal of this study is to learn more about how we measure depression in elderly cancer patients (patients aged 70 and older). Depression is one of the most common causes of emotional distress in the elderly and continues to be under-recognized. This is a problem because depression can have a negative impact on quality of life. The symptoms of depression are linked to poor health outcomes and higher costs of health care. In fact, depression is one of the top five concerns facing the elderly today.

Detailed description: We have a few questionnaires that have been used to measure depression, but we do not know how these measures work with people with cancer. This study will help us answer this question. To complete this study, we need people who may or may not be feeling down or depressed.

If you choose to take part, you will be asked to do the following:

1. Fill out questionnaires that ask about:

   * Your age, eduction, race, and income
   * Your mood

   In all, these questionnaires will take about 10 minutes to complete.
2. Answer questions about your mood. This will also take about 10 minutes to complete.

Eligibility criteria: Inclusion Criteria:

1. Age 70 and older
2. Diagnosis of early or late stage prostate cancer, or diagnosis of early or late stage breast cancer
3. Actively engaged in one of the following cancer treatments: chemotherapy, radiation therapy, hormone therapy
4. Able to provide informed consent
5. Ability to converse, write and read English

Exclusion Criteria:

1.Major psychopathology or cognitive impairment likely in the judgment of the research staff to interfere with the participation or completion of the protocol.

Primary outcomes:
measure: Test the sensitivity and specificity of the Geriatric Depression Scale-Short Form and two other widely used assessments of depression to detect major and minor depression in a geriatric breast and prostate cancer population.
timeFrame: 2 years
Secondary outcomes:
measure: To develop a cut-off score for the GDS that is specific to a cancer population.
timeFrame: 2 years
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: Christian Nelson, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01283776: Cyclophosphamide as Sole Graft-Versus-Host-Prophylaxis After Allogeneic Stem Cell Transplantation
Official title: A Phase II Study to Investigate the Efficacy of Cyclophosphamide as Sole Graft-Versus-Host-Prophylaxis After Allogeneic Stem Cell Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Multiple Myeloma
Non-Hodgkin-Lymphoma
Hodgkin's Disease
Lead sponsor: University of Cologne
Sponsor class: OTHER
First posted: 2011-01-26
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: A phase II clinical study to assess the efficacy of post-transplantation cyclophosphamide as single-agent GvHD prophylaxis after allogeneic hematopoietic stem cell transplantation in patients with multiple myeloma or lymphoma and to describe the influence of the modified immunosuppression concept on relapse rates, minimal residual disease, immune reconstitution and chimerism.


Eligibility criteria: Inclusion Criteria:

* Patients with multiple myeloma, Non-Hodgkin's lymphoma or Hodgkin's disease after allogeneic stem cell transplantation with reduced intensity conditioning

  * Written informed consent
  * No uncontrolled infections

Exclusion Criteria:

* Severe organ dysfunction defined as:
* Cardiac left ventricular ejection fraction (LVEF) of less than 35%
* diffusing lung capacity (DLCO) of less than 40%
* total lung capacity (TLC) of less than 40%
* forced expiratory volume (FEV1) of less than 40%
* total bilirubin \>3mg/dl
* creatinine-clearance of less than 40 ml/min
* pregnancy or breast feeding
* participation in other experimental drug trials

Primary outcomes:
measure: Number of patients not requiring additional immunosuppression
timeFrame: day 100 after transplant
Secondary outcomes:
measure: Overall Survival
timeFrame: day 100 after transplant
measure: engraftment
timeFrame: day 100 after transplant
measure: chimerism
timeFrame: day 100 after transplant
measure: relapse incidence
timeFrame: day 100 after transplant
measure: acute GvHD
timeFrame: day 100 after transplant
measure: non-relapse mortality
timeFrame: day 100 after transplant
measure: immune reconstitution
timeFrame: day 100 after transplant
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: University of Cologne
Study officials:
affiliation: University of Cologne
name: Christoph Scheid, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06527976: Dexamethasone Versus Demedetomidine Addition for Adductor Canal Block
Official title: Dexmedetomedine Versus Dexamethasone in Ultrasound Guided Adductor Canal Block for Patients Undergoing Knee Arthroscope
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-07-30
Enrollment: 90
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Single-injection peripheral nerve block (PNB) is commonly used for perioperative analgesia and anesthesia. Three approaches for extending the duration of PNB include continuous PNB with catheter-based techniques, novel local anesthetics delivery systems and addition of novel adjuvants to local anesthetics.


Eligibility criteria: Inclusion Criteria:

* elective operation
* ASA STATUS I and II

Exclusion Criteria:

* patient refusal
* ASA status III and IV
* contraindications to local anesthesia

Primary outcomes:
measure: visual analogue scale score
timeFrame: 24 hours postoperative
Secondary outcomes:
measure: analgesia duration
timeFrame: 24 hours postoperative
measure: opioid consumption
timeFrame: 24 hours postoperative
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut university
Study officials:
References:
Clinical trial NCT05172076: COVID-19-associated Anxiety of Pregnant Women for Anomalies, Stillbirth and Preterm Labor-2
Official title: COVID-19-associated Anxiety of Pregnant Women for Anomalies, Stillbirth and Preterm Labor-2
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anxiety State
Lead sponsor: Martin-Luther-Universität Halle-Wittenberg
Sponsor class: OTHER
First posted: 2021-12-29
Enrollment: 276
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: pregnant women between 33 until 37 weeks of gestations with planned labor in University Hospital of Halle or St.Elisabeth and St.Barbara Hospital Halle, Germany

Brief summary: Capture of anxiety for anomalies, stillbirth and preterm labor of pregnant women during COVID-19 pandemia


Eligibility criteria: Inclusion Criteria:

* consenting ability

Exclusion Criteria:

* language barrier
* uncompleted questionary

Primary outcomes:
measure: anxiety for anomalies during COVID-19-pandemic and before (percentage difference in agreement to the items of the questionnaire)
timeFrame: 6 months
measure: anxiety for stillbirths during COVID-19-pandemic and before (percentage difference in agreement to the items of the questionnaire)
timeFrame: 6 months
measure: anxiety for preterm labour during COVID-19-pandemic and before (percentage difference in agreement to the items of the questionnaire)
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Halle
country: Germany
facility: KH St.Elisabeth und St.Barbara
state: Sachsen Anhalt
city: Halle
country: Germany
facility: University Hospital of Halle
state: Saxony Anhalt
Study officials:
References:
Clinical trial NCT06971276: Assessing the Utility of Plasma ctHPVDNA for Anal Cancer Screening
Official title: Assessing the Utility of Plasma ctHPVDNA for Anal Cancer Screening
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Anal Dysplasia
Keywords: HPV
Liquid biopsy
Anal cancer
Anal intraepithelial neoplasia
Early cancer detection
HPV-DeepSeek
NGS
Lead sponsor: Massachusetts Eye and Ear Infirmary
Sponsor class: OTHER
First posted: 2025-05-14
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergone screening for anal dysplasia and control patients from the general population.

Brief summary: The study is to test a liquid biopsy assay for screening and classifying anal dysplasia from blood.

Detailed description: Anal squamous cell carcinoma, despite being considered as a rare cancer, has seen a steady rise in incidence over the past three decades. Recent evidence from the Anal Cancer-HSIL Outcomes Research (ANCHOR) study demonstrated benefits of treating anal high-grade squamous intraepithelial lesion (HSIL), highlighting the importance of screening anal cancers and high-grade precancers. Current anal cancer screening starts with HPV testing and/or cytology for primary screening, followed by high-resolution anoscopy (HRA) with biopsy for confirmatory diagnosis. However, the poor specificity of HPV testing and the extremely limited capacity of HRA urges the development of new screening approaches for identifying anal high-grade precancers and cancers. Blood circulating tumor HPV DNA (ctHPVDNA) is an emerging non-invasive biomarker for screening and treatment monitoring of HPV-associated cancers, but its significance in anal cases remains underexplored. Here the investigators use an ultrasensitive HPV whole genome sequencing assay to test the hypothesis that anal precancers are detectable in the blood.

Eligibility criteria: Inclusion Criteria:

* Past or current anal HPV-positive population undergone anal dysplasia screening.
* Control patients from the general population.

Exclusion Criteria:

* Not meeting inclusion criteria.

Primary outcomes:
measure: Cancer Developmental Stage
timeFrame: Periprocedural
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Department of Infectious Diseases, Mass General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Daniel L. Faden, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04943276: A Novel Noninvasive Thermoregulatory Device for Postural Tachycardia Syndrome
Official title: A Novel Noninvasive Thermoregulatory Device for Postural Tachycardia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postural Tachycardia Syndrome
Keywords: Thermoregulation
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Embr Labs, Inc.
First posted: 2021-06-29
Enrollment: 23
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: The investigators hope to learn the feasibility and preliminary efficacy of the Embr device for improving thermal comfort in individuals with POTS and impaired thermoregulation. Feasibility will be assessed via usage of the Embr device and participant feedback. Preliminary efficacy measures will include temperature-related symptoms and temperature- related quality of life in individuals with POTS and impaired thermoregulation.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of POTS
* Participant self-report of heat or cold intolerance
* Willingness to wear the Embr device for 3 weeks, charging the device daily, and
* Have a working smartphone (iPhone 6 or greater; or Android 8.0 or greater
* Comfortable downloading and using the companion app on their phone
* Able to provide informed written consent
* Able to complete written questionnaires

Exclusion Criteria:

* Prior or current use of the study device
* Hypohidrosis, hyperhidrosis, or anhidrosis, as determined by sudomotor testing; peripheral neuropathy; perimenopausal, menopausal, postmenopausal state; temperature intolerance due to other medical disorders (i.e. malignancy, systemic autoimmune disease)
* Medications known to affect sweat function
* Non-English speaking

Primary outcomes:
measure: Change from baseline in Compass-31 survey at study endpoint
timeFrame: Baseline and end of study ( 4 weeks)
measure: Change from baseline in Pittsburg Sleep Quality Index (PSQI) at study endpoint
timeFrame: Baseline and end of study ( 4 weeks)
measure: Change from baseline in Insomnia Severity Scale Index (ISI) at study endpoint
timeFrame: Baseline and end of study ( 4 weeks)
measure: Temperature Quality of life Questionnaire
timeFrame: Week 1,2,3,4
measure: Temperature related daily interference scale
timeFrame: Week 1,2,3,4
measure: OCEAN Temperature Related Psychogenic Questionnaire
timeFrame: Week 1,2,3,4
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford Neuroscience Health Center
state: California
Study officials:
affiliation: Stanford University
name: Mitchell Miglis
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03847376: Pre-Approval Access to Rilpivirine Long Acting (RPV LA) Injectable Suspension for the Treatment of a Participant With Human Immunodeficiency Virus (HIV)-1 Infection
Official title: Rilpivirine Long Acting Single Patient Requests
Study type: EXPANDED_ACCESS
Overall status: APPROVED_FOR_MARKETING
Conditions: HIV
Keywords: Rilpivirine
Long Acting Rilpivirine Injection
HIV
Rilpivirine Expanded Access
Rilpivirine Single Patient Request
Lead sponsor: Janssen Sciences Ireland UC
Sponsor class: INDUSTRY
Collaborators: name: ViiV Healthcare
First posted: 2019-02-20
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: The main purpose of this pre-approval access program (PAAP) is to provide rilpivirine Long Acting (RPV LA) injectable suspension for the treatment of human immunodeficiency virus (HIV)-1 infection as single patient request to individuals who have no available treatment alternatives and/or limited treatment options (for example, who are unable to participate in the Phase III clinical studies or do not qualify). RPV LA can only be provided if participants are also eligible for cabotegravir Long Acting injections.



Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Janssen Sciences Ireland UC
name: Janssen Sciences Ireland UC Clinical Trial
role: STUDY_DIRECTOR
References:
Clinical trial NCT02917876: Predictors of De-novo Development of Obstructive Sleep Apnea in Pregnancy
Official title: Predictors of De-novo Development of Obstructive Sleep Apnea in Pregnancy
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Obstructive Sleep Apnea
Pregnancy
Obesity
Sleep
Keywords: Obstructive Sleep Apnea
Pregnancy
Obesity
Fluid shifts
Body composition
Sleep
Lead sponsor: The Miriam Hospital
Sponsor class: OTHER
Collaborators: name: Brown University
name: Rhode Island Hospital
name: Women and Infants Hospital of Rhode Island
First posted: 2016-09-28
Enrollment: 450
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: Pregnant women, 18 years or older, at less than 13 completed weeks of gestation and who have a BMI that is greater than 30 kg/m2 at recruitment.

Brief summary: This study seeks to understand the physical, physiologic and biologic features that predispose a woman to the development of obstructive sleep apnea once they are exposed to the cardiopulmonary and metabolic physiological changes of pregnancy. Knowing these specific predictive factors can help identify a population at risk and guide clinicians to develop suitable targeting screening strategies.

Detailed description: Patients will be recruited from multiple community and hospital-based practices that care for pregnant women. Subjects will have:

1. measurements of body composition
2. anthropometric measures
3. sleep and mood questionnaires
4. Home sleep studies
5. blood testing for biological markers
6. salivary testing for hormonal markers
7. pulmonary function tests and upper airway patency measurements

Women without sleep apnea at enrollment will then be followed longitudinally for the development of obstructive sleep apnea during pregnancy with repeat assessment during their third trimester. Women diagnosed with sleep apnea at enrollment will have no further assessment in late pregnancy.

Monetary incentives will also be issued at data collection points. Subjects will receive small gift incentives such as baby-related items.

Eligibility criteria: Inclusion Criteria:

* \<13 completed weeks of gestation
* BMI \>30 kg/m2 at recruitment
* \>18 years of age
* Ability to give informed consent

Exclusion Criteria:

* Unable to meet inclusion criteria
* Twin pregnancies

Primary outcomes:
measure: Characteristics of participants who develop obstructive sleep apnea defined as an apnea hypopnea index >5 events per hour
timeFrame: Up to 40 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Providence
country: United States
facility: The Miriam Hospital
state: Rhode Island
Study officials:
affiliation: The Miriam Hospital
name: Ghada Bourjeily, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sanapo L, Bublitz MH, Bai A, Mehta N, Messerlian GM, Catalano P, Bourjeily G. Association between sleep disordered breathing in early pregnancy and glucose metabolism. Sleep. 2022 Apr 11;45(4):zsab281. doi: 10.1093/sleep/zsab281.
Clinical trial NCT00830076: A Study of the Effects of Co-Administration of Sitagliptin (MK-0431) and Metformin on Incretin Hormone Concentrations (MK-0431-110)
Official title: A Study to Assess the Effects of Co-Administration of Sitagliptin and Metformin on Incretin Hormone Concentrations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2009-01-27
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study will assess the effects of sitagliptin and metformin alone and after co-administration on incretin hormone concentrations in patients with Type 2 diabetes.


Eligibility criteria: Inclusion Criteria:

* Female subjects must have a negative pregnancy test
* Subject has type 2 diabetes and is not currently receiving treatment with an oral AHA agent, has not received such treatment for 3 months prior to study, and/or has not received more than 4 total weeks treatment with an oral AHA agent for 12 to 18 months prior to the study
* Subject is a nonsmoker or has not smoked and/or used nicotine for at least 6 months

Exclusion Criteria:

* Subject has a history of stroke, seizures, or major neurological disorders
* Female subject is breastfeeding
* Subject cannot refrain from use of any prescription or non-prescription drugs beginning 2 weeks prior to first dose of study drug
* Subject consumes more than 3 alcoholic beverages per day
* Subject consumes more than 6 caffeinated beverages per day
* Subject has had major surgery, or has donated or lost 1 unit of blood within 4 weeks of screening
* Subject has a history of cancer, except certain skin or cervical cancer or other cancers treated more than 10 years prior to screening
* Subject has a history of multiple and/or severe allergies or intolerance to drugs or food

Primary outcomes:
measure: Incremental Post-prandial 4-hour Weighted Mean Active Glucagon-like Peptide-1 (GLP-1) Plasma Concentrations
timeFrame: 6 hours postdose (4 hours postmeal) on Day 2
Secondary outcomes:
measure: β-cell Sensitivity
timeFrame: 6 hour post-dose (4 hour postmeal) on Day 2
measure: Incremental Post-prandial 4-hour Weighted Mean Plasma Glucose Concentrations
timeFrame: 6 hours postdose (4 hours postmeal) on Day 2
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT05420376: Comparison of Whole Mesh and Split Mesh Use in Laparoscopic Inguinal Hernia Repair
Official title: Prospective Comparison of Whole Mesh and Split Mesh Use in Patient Groups Undergoing Laparoscopic Inguinal Hernia Repair
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hernia, Inguinal
Keywords: Laparoscopic Inguinal Hernia
Laparoscopic Hernia
Whole Mesh
Split Mesh
TAP
TEPP
Inguinal hernia
Lead sponsor: Istanbul Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2022-06-15
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: At least 80 patients who will undergo laparoscopic inguinal hernia repair surgery will be randomized into 2 groups. For the patients in the first group, the whole mesh will be laid on the area without being fixed. The patients in the second group will be given a mesh of the same size, but partially divided horizontally and wrapped around the spermatic cord. Demographic data of patients in both groups, quality of life data(Carolinas Comfort Scale) at postoperative 1st, 7th, 30th, 3rd and 6th months, postoperative pain (VAS values), clinical seroma rate, recurrence and other complications will be monitored. When the desired number of patients and follow-up period are reached, the data in the 2 groups will be compared.


Eligibility criteria: Inclusion Criteria:

* Clinical or/and radiological diagnosed primary inguinal hernia
* TEP or TAPP surgical methods

Exclusion Criteria:

* Recurrent hernias
* Patients with previous groin operations on same side
* Pregnant women
* Patients who did not accept to participate in the study
* ASA score of 3 or higher,

Primary outcomes:
measure: Carolinas Comfort Scale values
timeFrame: 6 month
measure: Recurrence rates
timeFrame: 6 month
Secondary outcomes:
measure: Recurrence rates
timeFrame: 6 month
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Training and Research Hospital
Study officials:
References: