louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00193245: Oral Topotecan Versus Docetaxel in Second-Line Treatment of Non-Small Cell Lung Cancer
Official title: A Randomized Trial of Oral Topotecan Versus Docetaxel in Second-Line Treatment of Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lung Cancer
Lead sponsor: SCRI Development Innovations, LLC
Sponsor class: OTHER
Collaborators: name: AstraZeneca
name: Aventis Pharmaceuticals
name: GlaxoSmithKline
First posted: 2005-09-19
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: In this trial we will evaluate and compare the efficacy and toxicity of oral topotecan with intravenous docetaxel in the second-line treatment of patients with non-small cell lung cancer.

Detailed description: Upon determination of eligibility, patients will be randomly assigned to one of two treatment arms:

* Topotecan
* Docetaxel

For ever 2 patients treated, 1 will receive treatment A (Topotecan) and 1 will receive treatment B (Docetaxel). The study is not blinded so both the patient and the doctor will know which treatment has been assigned.

Eligibility criteria: Inclusion Criteria:

To be included in this study, you must meet the following criteria:

* Relapsed or Progressive Disease
* Stage IIIB (not candidate for combined modality) or IV
* No more than one prior chemotherapy regimen
* Able to perform activities of daily living without assistance
* Measurable disease outside of radiation port
* Adequate bone marrow, liver and kidney function
* Must understand study and sign informed consent prior to enrollment

Exclusion Criteria:

You cannot participate in this study if any of the following apply to you:

* Prior treatment with Topotecan or Docetaxel
* Uncontrolled brain metastases
* Moderate peripheral neuropathy

Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.

Primary outcomes:
measure: Overall response rate
Secondary outcomes:
measure: Time to Progression
measure: Overall survival
measure: Overall toxicity
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Tennessee Oncology, PLLC
state: Tennessee
Study officials:
affiliation: SCRI Development Innovations, LLC
name: Howard A. Burris, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jones S, Thompson D, Barton J, Patton J, Shipley D, Greco FA, Spigel D, Infante J, Burris HA 3rd. A randomized phase II trial of oral topotecan versus docetaxel in the second-line treatment of non-small-cell lung cancer. Clin Lung Cancer. 2008 May;9(3):154-9. doi: 10.3816/CLC.2008.n.023.
Clinical trial NCT04832945: SARS-CoV-2 Pre-exposure Prophylaxis With Ivermectin Retrospective Cohort Study
Official title: Multicenter Retrospective Cohort Study of Ivermectin as a SARS-CoV-2 Pre-exposure Prophylactic Method in Healthcare Workers in Dominican Republic
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Keywords: Ivermectin
SARS-CoV-2
Coronavirus
Prophylaxis
PrEP
Covid-19
Lead sponsor: Grupo Rescue S.A.S República Dominicana
Sponsor class: NETWORK
First posted: 2021-04-06
Enrollment: 713
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Workers who was part of Ivermectin prophylaxis program and signed the informed consent at CMPC and CMBO in Dominican Republic was analyzed and included in the intervention group. Those who didn't participate in the prophylaxis program but were on active duty during the 4 weeks of the study were included in the control group.

Workers excluded from Ivermectin prophylaxis program was:

* Pregnant or suspected pregnant women
* Women breastfeeding
* Patients receiving coumarin anticoagulants
* Those allergic to Ivermectin

Brief summary: This observational study, a multicenter retrospective cohort database study, carried out in two medical centers, Centro Medico Bournigal (CMBO) in Puerto Plata and Centro Medico Punta Cana (CMPC) in Punta Cana, Dominican Republic, sought to determine whether Ivermectin, at a weekly orally dose of 0.2 mg/kg, is an effective pre-exposure prophylactic method (PrEP) for the spread of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), in the healthcare workers. The study began on June 29, 2020 and ended on July 26, 2020 (4 weeks).


Eligibility criteria: Inclusion Criteria:

* Active workers from Centro Medico Bournigal (CMBO) and Centro Medico Punta Cana (CMPC) during the study.

Exclusion Criteria

* Workers with positive Covid-19 RT-PCR prior to the start of the study
* Those that did not take the first dose of Ivermectin the first week at the start of the study
* Those that did not complied with at least 2 out of 4 weekly doses
* Those that had greater than 14 days difference in days between two intakes Ivermectin

Primary outcomes:
measure: Number of participants RT-PCR positive for Covid-19
timeFrame: 4 weeks
Secondary outcomes:
measure: Number of sick participants who condition deteriorated
timeFrame: 4 weeks
measure: Number of sick participants who died
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Puerto Plata
country: Dominican Republic
facility: Centro Medico Bournigal
city: Punta Cana
country: Dominican Republic
facility: Centro Médico Punta Cana
Study officials:
affiliation: Grupo Rescue
name: Jose Morgenstern, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Grupo Rescue
name: Jose Natalio Redondo, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Grupo Rescue
name: Alvaro Olavarria, Data Analyst
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05827445: Cutaneous Sensory Block Area of the Laparoscopic Assisted Transversus Abdominis Plane Block
Official title: Cutaneous Sensory Block Area of the Laparoscopic Assisted Transversus Abdominis Plane
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cholecystolithiasis
Keywords: Transversus abdominis plane block
Lead sponsor: Nordsjaellands Hospital
Sponsor class: OTHER
First posted: 2023-04-25
Enrollment: 30
Sex: ALL
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 undergoing elective laparoscopic cholecystectomy in a day surgery setting for cholecystolithiasis

Brief summary: The goal of this observational study is to assess the size and location of cutaneous sensory block area after dual laparoscopic assisted transverse abdominis plane block (L-TAP) with ropivacaine in patients undergoing laparoscopic cholecystectomy.

L-TAP is applied as a medial subcostal infiltration between midclavicular and central sternal lines and a lateral subcostal infiltration between midclavicular and anterior axillary line bilaterally.


Eligibility criteria: Inclusion Criteria:

* undergoing elective laparoscopic cholecystectomy in a day surgery setting
* able to give oral and written consent

Exclusion Criteria:

* prior surgery to the upper abdominal wall
* known sensory deficits of the abdominal wall or thorax
* allergy to local anesthetics
* pregnancy

Primary outcomes:
measure: Cutaneous Sensory Block Area (CSBA)
timeFrame: 1.5 hours postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Hillerød
country: Denmark
facility: Copenhagen University Hospital - North Zealand
Study officials:
References:
Clinical trial NCT01594645: The Clinical Impact of Selecting Acrosome Reacted Spermatozoa for ICSI
Official title: The Impact of Selecting Acrosome Reacted Spermatozoa for ICSI- a Prospective RCT
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Infertility
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2012-05-09
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Presently spermatozoa for ICSI are selected based on morphology and motion, without determining if acrosome reaction (AR) had occurred during sperm preparation or not. Although not critical if the sperm is injected into the ooplasm, the occurrence of AR might might be an indicator of better spermatozoon quality and implantation potential, especially in severe OTA cases. It is impossible with conventional plain optic microscopy used in IVF units to determine in vivo (without fixation) if AR has occurred, and as a result spermatozoa are injected randomly. It is readily possible to distinguish AR+ from AR- spermatozoa using polarized light microscopy due to different bifriengance.

In this study the investigators seek to determine, by a prospective RCT, if selecting only acrosome reacted spermatozoa, in severe OTA cases, will improve the outcome of ICSI and the entire IVF process.

Detailed description: A prospective RCT to determine the effect of polscope based spermatozoa selection for ICSI.

Eligibility criteria: Inclusion Criteria:

* Female: normal uterine cavity and ovarian reserve. Male: TMC \< 1000000 cells.

Exclusion Criteria:

* Female: Abnormal uterine anatomy, low ovarian reserve, contributing egg factor, PGD.

Primary outcomes:
measure: fertilization rate
timeFrame: 24-72 h
Secondary outcomes:
measure: Clinical pregnancy
timeFrame: up to 6 weeks
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah University Hospital
Study officials:
affiliation: HMO
name: Yoel Shufaro, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06844045: Point of Care STI Testing
Official title: Clinical and Implementation Outcomes of a Point of Care Sexually Transmitted Infection Testing Strategy to Improve HIV Prevention Service Delivery in Adolescents
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Point of Care STI Testing
Keywords: HIV Prevention
HIV Testing
HIV Pre-Exposure Prophylaxis
Gonorrhea
Chlamydia
Sexually Transmitted Infections
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: Children's Hospital of Philadelphia
First posted: 2025-02-25
Enrollment: 5150
Sex: ALL
Minimum age (years): 16
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The proposed research hypothesizes that point-of-care testing (POCT) for sexually transmitted infections (STIs) gonorrhea and chlamydia will be a feasible, acceptable, and appropriate implementation strategy for improving HIV testing and Pre-exposure prophylaxis (PrEP) delivery in youth, by increasing opportunities for clinician-patient counseling, decreasing loss to follow up, and allowing for same-day HIV prevention service provision. This hypothesis will be tested in a pragmatic non-randomized trial comparing clinical (HIV testing and PrEP counseling and prescription) and implementation (feasibility, acceptability, and appropriateness) outcomes between adolescents receiving POCT compared to laboratory-based testing at three clinics within a large pediatric health system.


Eligibility criteria: Inclusion Criteria:

- Patients age 16-24 years receiving POCT or lab-based GC/CT testing

Exclusion Criteria:

- Patients with known HIV or active PrEP prescriptions.

Primary outcomes:
measure: Rates of HIV Test Completion
timeFrame: Day 1 - Measured on date of STI testing
Secondary outcomes:
measure: Number of participants who received PrEP counseling
timeFrame: Day 1 - Same day as STI testing encounter
measure: Time to STI treatment
timeFrame: Time from STI diagnosis to treatment, up to 9 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Mount Sinai Adolescent Health Center
name: Sarah Wood, MD, MSHP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01322945: Barrow Nasal Inventory Survey
Official title: Observational Study of Nasal Outcomes Following Endonasal Surgery for Anterior Skull Base Lesions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pituitary Tumors
Lead sponsor: St. Joseph's Hospital and Medical Center, Phoenix
Sponsor class: OTHER
First posted: 2011-03-25
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Neurosurgery and endocrinology clinic

Brief summary: The purpose of this study is to evaluate patient nasal outcome following endo-nasal surgery. This type of surgery is conducted for pituitary and skull base tumors. There is no published data on trauma to the nose during surgery and how it impacts nasal functioning. The investigators propose to develop a survey and administer it to patients before and after surgery to learn about their perception of nasal functioning.

Detailed description: A 9-item patient survey (the ASK Nasal Inventory) focusing on the most common postoperative complaints, such as crusting, sinusitis, pain, and ease of breathing, was developed by the anterior skull base team at the Barrow Neurological Institute. Content was validated in structured patient interviews by four subject-matter experts with both endonasal and control groups. Eligible patients for the control group included patients undergoing any neurosurgical procedure requiring anesthesia that did not involve the endonasal corridor, such as spinal decompression procedures, craniotomies for trigeminal neuralgia, and shunting procedures. This survey was self-administered pre- and 3 months post-surgery.

Eligibility criteria: Inclusion Criteria:

* Adults with planned endonasal surgery for pituitary tumor or skull base lesion

Exclusion Criteria:

* Children

Primary outcomes:
measure: Change in Mean Survey Response From Baseline to 90 Days Post Surgery
timeFrame: Baseline, 90 days post surgery
Secondary outcomes:
measure: Test-retest Reliability of the ASK Nasal Inventory
timeFrame: 90 days and 120 days post surgery
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Barrow Neurological Institute
state: Arizona
Study officials:
affiliation: Barrow Neurological Institute
name: Andrew Little, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Little AS, Jahnke H, Nakaji P, Milligan J, Chapple K, White WL. The anterior skull base nasal inventory (ASK nasal inventory): a clinical tool for evaluating rhinological outcomes after endonasal surgery for pituitary and cranial base lesions. Pituitary. 2012 Dec;15(4):513-7. doi: 10.1007/s11102-011-0358-4.
Clinical trial NCT04803045: Does a Brief Intervention Decrease Patient Drop Out Rates?
Official title: The Impact of a Brief Intervention on Retention Rates With Patients Who Did Not Return to Care After an Initial Physician Visit
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infertility
Keywords: Infertility
IVF
Patient retention
Lead sponsor: Boston IVF
Sponsor class: OTHER
First posted: 2021-03-17
Enrollment: 647
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Female patients attending an initial consult at Boston IVF between set dates.

Brief summary: The goal of this study is to determine a) if a follow-up email to selected patients who had an initial consult with an infertility specialist, but did not return for a second visit, would change return to care behavior and b) why patients had not returned.

Detailed description: From July 2017 to March 2018 all patients who had attended an initial visit with an infertility specialist at the clinic, but had not returned for at least three months were selected to receive a follow up email. Those selected for an email excluded patients who the Investigator's knew had achieved a pregnancy, already had a plan for treatment, had visited for an egg freeze and all LGTBQ patients. The email asked if the patient had any questions about that visit, offered support to the patient and included contact information for the patient liaison sending the email. The email also asked each participant to indicate why they had not returned and were provided 4 options and an opportunity to write in a response. From April 2018 to December 2018 no emails were sent to patients. No other change of patient contact practice was initiated during the trial period. This study will observe routine to care behavior of these patients after 11 months post initial consult date.

Eligibility criteria: Inclusion Criteria:

* Female patients attending an initial consult with a physician at Boston IVF and were recommended to continue care with the clinic

Exclusion Criteria:

* Patients who the Investigators knew had achieved a pregnancy
* Patients who already had a plan for treatment in place after their initial consult
* Patients who had visited for an egg freeze
* LGTBQ patients

Primary outcomes:
measure: Return to care behavior
timeFrame: 11 months after initial consult
Secondary outcomes:
Other outcomes:
Locations:
city: Waltham
country: United States
facility: Boston IVF
state: Massachusetts
Study officials:
affiliation: Boston IVF
name: Alice Domar, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00939445: Short Daily Hemodialysis and Online HDF: Which One is Better?
Official title: Short Daily Hemodialysis and Online HDF: Which One is Better?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: End Stage Renal Disease
Lead sponsor: Bangkok Metropolitan Administration Medical College and Vajira Hospital
Sponsor class: OTHER_GOV
First posted: 2009-07-15
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 1. To compare the efficacy of

1. Short Daily Hemodialysis
2. Online HDF in term of adequacy of dialysis.

Detailed description: The investigators intend to compare the efficacy between these modalities of treatment in terms of adequacy and also other parameters such as calcium-phosphorus balance and hematocrit

Eligibility criteria: Inclusion Criteria:

* stable ESRD
* KT/V \> 1.2 for thrice weekly or \> 1.8 for twice weekly

Exclusion Criteria:

* Inadequate vascular access flow rate
* Concurrent medical illnesses
* History of non-compliance

Primary outcomes:
measure: Adequacy
timeFrame: 3 months
Secondary outcomes:
measure: Hematocrit, calcium, phosphorus
timeFrame: 3 months
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Renal Unit, BMA Medical College and Vajira Hospital
Study officials:
References:
Clinical trial NCT06792045: Prediction of Tongue Base Obstruction During Sleep
Official title: Tongue Motor Functions Assessment As a Screening Tool for Obstructive Sleep Disordered Breathing in Children
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Obstructive Sleep Disordered Breathing
Keywords: obstructive sleep disordered breathing
pediatrics
sleep
obstructive sleep apnea
snoring
tongue
Lead sponsor: Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2025-01-24
Enrollment: 48
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be recruited during ENT consultations.

Brief summary: This study investigates the hypothesis that, in children, tongue motor functions can predict both the anatomical site and the degree of upper airway obstruction contributing to obstructive sleep-disordered breathing.

Detailed description: Patients will be enrolled during their visit to the ENT physician. Subsequently, their tongue motor functions will be assessed during their pre-surgical appointment. Finally, they will undergo a drug-induced sleep endoscopy prior to their surgery.

Eligibility criteria: Inclusion Criteria:

* Age between 6 and 17 years old
* Medical diagnosis of obstructive sleep-disordered breathing requiring surgical removal of tonsils (partial or total) and/or adenoids
* Positive Pediatric Sleep Questionnaire (8 or more positive responses)
* Eligibility for surgical intervention

Exclusion Criteria:

* Neurological, cardiac, or respiratory comorbidity other than obstructive sleep-disordered breathing
* Previous surgery of the upper airway or oral cavity
* History of or current head or neck cancer
* Cranial, upper airway, or oral cavity malformation
* Contraindication to performing endoscopy

Primary outcomes:
measure: Extent of tongue base obstruction
timeFrame: During the planned surgery
Secondary outcomes:
measure: Breathing pattern
timeFrame: During the pre-surgical appointment
measure: Tongue mobility (MBLF score)
timeFrame: During the pre-surgical appointment
measure: Tongue pressures (kPa)
timeFrame: During the pre-surgical appointment
measure: Tongue mobility restriction due to its frenulum ratio (%)
timeFrame: During the pre-surgical appointment
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Cliniques universitaires Saint-Luc
Study officials:
References:
Clinical trial NCT02123745: ivWatch Model 400: Device Validation for Infiltrated Tissues
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infiltration of Peripheral IV Therapy
Keywords: infiltration
extravasation
peripheral intravenous therapy
Lead sponsor: ivWatch, LLC
Sponsor class: INDUSTRY
First posted: 2014-04-28
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: A single arm trial consisting of 70 adult volunteers to assess the safety and efficacy of the ivWatch Model 400 when observing infiltrated tissues at common sites for peripheral IV therapy.


Eligibility criteria: Inclusion Criteria:

* Informed consent
* Pass health screen by clinician
* 18 years or older

Exclusion Criteria:

* Fail health screen

Primary outcomes:
measure: Red Notification Sensitivity to Infiltrated Tissues
timeFrame: After each participant has been infiltrated, an expected average of 1 hour
Secondary outcomes:
measure: Yellow Notification Sensitivity to Infiltrated Tissues
timeFrame: After each participant has been infiltrated, an expected average of 1 hour
measure: Infiltrated Volume When Red Notification Issued
timeFrame: After each participant has been infiltrated, an expected average of 1 hour
measure: Infiltrated Volume When Yellow Notification Issued
timeFrame: After each participant has been infiltrated, an expected average of 1 hour
measure: Significant Skin Irritation or Disruption to Skin Integrity
timeFrame: After each participant has been infiltrated, an expected average of 1 hour
Other outcomes:
Locations:
city: Williamsburg
country: United States
facility: ivWatch, LLC
state: Virginia
Study officials:
References: