louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03768258: Testosterone Implants and the Incidence of Breast Cancer
Official title: Testosterone Implants and the Incidence of Breast Cancer RETROSPECTIVE CHART REVIEW
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Lead sponsor: Millennium Wellness LLC
Sponsor class: OTHER
First posted: 2018-12-07
Enrollment: 1268
Sex: FEMALE
Minimum age (years): 24
Maximum age (years): 92
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women who presented to the office of Dr. Rebecca Glaser between March 2008- March of 2103 with symptoms of hormone deficiency and received testosterone implant therapy were asked to participate in the study. This current chart review study will examine the 10-year incidence of breast cancer in women accrued to the study.

Brief summary: This current chart review study was designed to investigate the incidence of breast cancer in women treated with subcutaneous testosterone therapy for symptoms of hormone deficiency.

Detailed description: A prior ten-year prospective, observational, study was initially approved in March of 2008 by the IRB board through the Atrium Medical Center, Premier Health Partners in Middletown, Ohio 45005 and registered through the Office for Human Research Protections (OHRP). Expedited approval continued annually through 2013 at which time the IRB board was closed. All participants signed a study consent and HIPPA consent. Recruitment closed in 2013. The original protocol was designed to investigate the incidence of breast cancer in women presenting with symptoms of hormone deficiency treated with subcutaneous testosterone implants or, testosterone combined with the aromatase inhibitor anastrozole implants. A computer program was specifically designed to track and follow patients prospectively and all patients continued to be followed through 2018.

Eligibility criteria: Inclusion Criteria:

* Female patients treated between March 2008 - March 2013
* Women who received at least two testosterone pellet insertion procedures
* Women previously accrued to the prospective cohort study

Exclusion Criteria:

* Pre-existing breast cancer
* Women who received a single testosterone pellet insertion

Primary outcomes:
measure: Incidence of invasive breast cancer
timeFrame: 10-year results
Secondary outcomes:
measure: Incidence of ductal carcinoma in situ
timeFrame: 10-year results
Other outcomes:
Locations:
Study officials:
References:
citation: Glaser RL, York AE, Dimitrakakis C. Incidence of invasive breast cancer in women treated with testosterone implants: a prospective 10-year cohort study. BMC Cancer. 2019 Dec 30;19(1):1271. doi: 10.1186/s12885-019-6457-8.
Clinical trial NCT02238158: Postmarketing Surveillance of Atrovent® in Chronic Obstructive Pulmonary Disease
Official title: Postmarketing Surveillance (as Per §67(6)AMG [German Drug Law]) of Atrovent® in Chronic Obstructive Pulmonary Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-09-12
Enrollment: 595
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with chronic obstructive airways disease recruited at general practitioners

Brief summary: To obtain further information on the tolerability and efficacy of Atrovent® inhalets in long term treatment of Chronic Obstructive Pulmonary Disease under conditions of daily practice


Eligibility criteria: Inclusion Criteria:

* Primarily patients of both gender, older than 40 years, who suffer from Chronic Obstructive Pulmonary Disease
* Only patients who had not been treated with Atrovent® within the last year were to be considered for inclusion

Exclusion Criteria:

• Contraindications listed in the Instructions for Use/Summary of Product Characteristics for Atrovent® Inhalets

Primary outcomes:
measure: Investigator assessment of improvement of the clinical picture rated on a 6-point symptom profile
timeFrame: Up to 12 months after first study drug administration
Secondary outcomes:
measure: Assessment of efficacy by investigator on a 4-point scale
timeFrame: Up to 12 months after first study drug administration
measure: Assessment of efficacy by patient on a 4-point scale
timeFrame: Up to 12 months after first study drug administration
measure: Assessment of tolerability by investigator on a 4-point scale
timeFrame: Up to 12 months after first study drug administration
measure: Assessment of tolerability by patient on a 4-point scale
timeFrame: Up to 12 months after first study drug administration
measure: Number of patients with adverse drug reactions
timeFrame: Up to 12 months after first study drug administration
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00004658: Phase II Study of Ribose, Uridine, and Thymidine for a Complex Syndrome Involving Excessive 5'-Nucleotidase Activity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: 5'-Nucleotidase Syndrome
Keywords: 5'-nucleotidase syndrome
inborn errors of metabolism
rare disease
Lead sponsor: Office of Rare Diseases (ORD)
Sponsor class: NIH
Collaborators: name: University of California, San Diego
First posted: 2000-02-25
Sex: ALL
Minimum age (years): 0
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: OBJECTIVES: I. Evaluate the efficacy of oral ribose in patients with a complex 5'-nucleotidase syndrome who have not received uridine (UR) and thymidine (TDR).

II. Evaluate the efficacy of UR/oral ribose and UR/TDR. III. Evaluate the efficacy of oral ribose given in combination with UR/TDR.

Detailed description: PROTOCOL OUTLINE: Newly identified patients receive ribose daily for 8 weeks. Patients who improve continue therapy. If improvement then reaches a plateau, uridine (UR) and thymidine (TDR) are added to the regimen.

Patients who receive no benefit after 8 weeks of ribose are treated with UR/TDR. Patients who improve after 8 weeks of this combination continue therapy.

Ribose is added to the treatment regimen for patients on UR/TDR at entry. At maximal improvement, TDR and UR are sequentially tapered.

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- Complex syndrome with excessive skin fibroblast 5'-nucleotidase activity characterized by: Recurrent infection Seizure disorder Speech impairment Attention deficit and behavior problems --Prior/Concurrent Therapy-- Concurrent uridine and thymidine therapy allowed --Patient Characteristics-- Other: No pregnant women

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of California, San Diego
name: Alice L. Yu
role: STUDY_CHAIR
References:
Clinical trial NCT06647758: Association Between Post-operative Anemia and Mortality After Valvular Heart Surgery
Official title: Association Between Remote Post-operative Anemia and Mortality in Patients Undergoing Valvular Heart Surgery
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Patients Undergoing Valvular Heart Surgery
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2024-10-18
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: tertiary care hospital

Brief summary: The investigators aimed to evaluate whether postoperative anemia can predict 1-year mortality after valvular heart surgery independent of preoperative anemia. Patients who underwent valvular heart surgery were divided into four groups according to whether or not they had preoperative and postoperative anemia. Postoperative one-year mortality, as well as overall mortality and a composite of death and heart failure requiring hospitalization, was investigated according to the groups, adjusted by confounders.


Eligibility criteria: Inclusion Criteria:

* Patients who underwent valvular heart surgery between January 2016 and July 2023 at Severance Cardiovascular Hospital of Yonsei University Health System.

Exclusion Criteria:

* patients who underwent only pulmonary valve surgery
* those with missing hemoglobin values at 2months after the surgery, due to loss of follow up or death.

Primary outcomes:
measure: postoperative 1-year mortality
timeFrame: One year after valvular heart surgery
Secondary outcomes:
measure: overall mortality
timeFrame: postopeartive one-year
measure: composite of death and congestive heart failure (CHF) requiring rehospitalization
timeFrame: postopeartive one-year
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine and Anesthesia
Study officials:
References:
Clinical trial NCT05666258: Gene Expression Profiling to Help Define the Need for Neo-Adjuvant Chemotherapy in HR+, HER- Breast Cancer Patients
Official title: Gene Expression Profiling to Help Define the Need for Neo-Adjuvant Chemotherapy in HR+, HER- Breast Cancer Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Cancer
Keywords: Neoadjuvant chemotherapy
GEP
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2022-12-27
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients of the Breast Clinic

Brief summary: The goal of the experiment is surgical de-escalation. Patients with newly diagnosed cT1-3, cN1, cM0 and HR+, HER2- breast cancer and low clinical risk usually first receive breast cancer surgery, after which chemotherapy can be added based on the final anatomopathological results or additional Gene Expression Profiling (GEP) testing.

Chemotherapy helps reduce the cancer recurrence or metastasis risk. Adjuvant chemotherapy (AC) can be given for large tumours, aggressive tumours with high grade tumour cells, or if axillary lymph node invasion is discovered during surgery. If the investigators were able to identify patients requiring chemotherapy prior to surgery, they could treat them with Neo-Adjuvant Chemotherapy (NAC) instead. By using MammaPrint® GEP, the investigators would be able to stratify patients into either a low- or high-risk category. Since the high-risk group is known to benefit from chemotherapy to improve overall survival, they would be treated with NAC, which could also potentially lead to surgical de-escalation. Breast conserving procedures, such as a lumpectomy instead of a mastectomy, could allow more aesthetically pleasing results and increase patient quality of life. Using NAC for patients with axillary lymph node invasion could lead to nodal complete pathological response (cN1 -\> ypN0), allowing patients that are willing to enter the TADANAC trial a lymph node sparing procedure instead of a full axillary lymph node dissection.


Eligibility criteria: Inclusion Criteria:

* Tumour characteristics: HR+, HER-
* Histopathological tumour characteristics: cT1-3, cN1, cM0, all histological types included
* Age: 18-85 years

Exclusion Criteria:

* Tumour characteristics: cT4, cN2-3, cM1
* Age: \<18 or \>85 years old
* Received chemotherapy in the last 5 years
* Pregnancy

Primary outcomes:
measure: De-escalation of breast cancer surgery
timeFrame: 8 months after inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Jette
country: Belgium
facility: Universitair Ziekenhuis Brussel
state: Brussel
Study officials:
References:
Clinical trial NCT00142558: A Study Evaluating the Effect of Etoricoxib and Indomethacin in the Treatment of Acute Gout (0663-081)(COMPLETED)
Official title: A Randomized, Double-Blind, Active-Comparator-Controlled 5-Day Trial of the Effect of Etoricoxib 120 mg Versus Indomethacin 150 mg in the Treatment of Acute Gout
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Gout
Keywords: Arcoxia
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2005-09-02
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A study to evaluate the effects of etoricoxib and indomethacin in the treatment of acute gout.


Eligibility criteria: Inclusion Criteria:

* Males or females at least 18 years of age who have acute gout.

Primary outcomes:
measure: Patient assessment of pain (0- to 4- Likert scale)
Secondary outcomes:
measure: Patient Global Assessment of Response to Therapy (0- to 4- point scale)
measure: Investigator Global Assessment of Response to Therapy (0- to 4- point scale)
measure: Tenderness of the study joint (0- to 3-point scale)
measure: Swelling of the study joint (0- to 3-point scale)
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Navarra S, Rubin BR, Yu Q, Smugar SS, Tershakovec AM. Association of baseline disease and patient characteristics with response to etoricoxib and indomethacin for acute gout. Curr Med Res Opin. 2007 Jul;23(7):1685-91. doi: 10.1185/030079907x210750.
Clinical trial NCT06901258: Genius PillBox Study
Official title: Genius PillBox: Pilot and Feasibility Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Older Adults (65 Years and Older)
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2025-03-28
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to pilot test the how acceptable older adults find a commercially available pillbox organizer with embedded sensors and automated reminders to support medication adherence.

Detailed description: The purpose of this study is to pilot test how acceptable older adults find a commercially available pillbox organizer with embedded sensors and automated reminders to support medication adherence. Individuals who agree to participate in the study will be provided with the pillbox organizer and asked to use the pillbox for 1 month. The pillbox contains 7 compartments with embedded sensors that detects if there is a pill present. Blinking lights and a flashing letter specifying the day of the week, are used to alert users to take their medicines. After taking the first dose, a 24-hour count down timer will begin. If the medication specified for that day is not taken within the target time the device will beep to alert the user. Participants will complete a structured interview at baseline and 1 month follow-up to assess demographic and health related information, medication adherence and how they found using the pillbox organizer. Additionally, if individuals have a family member who supports their medication use, they will be asked to complete an interview at the 1 month follow-up to understand how they found using the pillbox organizer.

Eligibility criteria: Primary Inclusion Criteria are for older adults who manage multi-drug regimens. Inclusion Criteria:

1. Age 60 or older
2. Taking 3 or more medications
3. Takes medications twice per day or less
4. Adequate cognitive capacity (defined as less than 2 errors on 6 item cognitive screener).

Additionally, a family member that assists with a participant's medicines can also be invited to participate. The family member eligibility criteria is:

1. Age 18 or older
2. Support family member taking 3 or medications, twice a day or less
3. Adequate cognitive capacity (defined as less than 2 errors on 6 item cognitive screener)

Primary outcomes:
measure: Acceptability of Pillbox
timeFrame: 1 Month
measure: Fidelity of Pillbox Use
timeFrame: 1 Month
Secondary outcomes:
measure: Medication Adherence
timeFrame: Baseline, 1 Month
measure: Medication Adherence
timeFrame: Baseline, 1 Month
Other outcomes:
Locations:
Study officials:
affiliation: Northwestern University
name: Rachel O'Conor, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05492058: Tactile Stimulus, Music Play and Virtual Reality Video Watching During Non-Stress Test on Maternal Anxiety and Fetal Parameters
Official title: Effects of Tactile Stimulus, Music Play and Virtual Reality Video Watching During Non-Stress Test on Maternal Anxiety and Fetal Parameters: A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fetal Heart Failure
Fetal Movement Disorder
Keywords: nursing
fetal health
women
women health
Lead sponsor: Adiyaman University Research Hospital
Sponsor class: OTHER
First posted: 2022-08-08
Enrollment: 120
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The research was carried out to determine the effects of tactile stimulation, music listening and virtual reality video watched during the non-stress test on maternal anxiety level and fetal parameters.


Eligibility criteria: Inclusion Criteria:

* - Not having any risk factors (pre-eclampsia, IUGG, premature rupture of membranes, getational diabetes, etc.) during pregnancy
* Absence of uterine contraction as a result of NST,
* No cardiovascular disease diagnosed in the fetus,
* Being in the 18-49 age group

Exclusion Criteria:

* Any complications in pregnancy and fetus
* Refusal to accept the final test

Primary outcomes:
measure: Fetal heart rate, fetal movement
timeFrame: 20 minutes
measure: Maternal anxiety
timeFrame: 20 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Çankaya
country: Turkey
facility: Lokman hekim University
state: Ankara
Study officials:
References:
Clinical trial NCT01212458: Effect of Oral Rufinamide and Oxcarbazepine on Nerve Excitability, Hyperalgesia, Allodynia and Flare Reaction Compared to Placebo. A Monocenter, Randomized, Double-blind, Cross-over Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy Subjects
Keywords: gesunde Probanden
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2010-09-30
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: healthy volunteers

Brief summary: Untersuchungen über die Wirkmechanismen von Antiepileptika haben gezeigt, dass durch eine Blockierung von spannungsabhängigen Natrium-Kanälen im Nervensystem die Schmerzübertragung moduliert werden kann. Verschiedene Antiepileptika werden in der chronischen Schmerztherapie schon lange angewendet (z.B. Oxcarbazepinum, Trileptal ® bei Trigeminusneuralgie oder diabetischer Polyneuropathie).

In unserer Untersuchung wollen wir zwei in der Schweiz zugelassene Antiepileptika bezüglich ihrer Wirkung auf das Schmerzempfinden untersuchen. Eines dieser Medikamente, Trileptal® (Wirkstoff: Oxcarbazepinum), wird schon häufig bei chronischen Schmerzzuständen eingesetzt. Das zweite Medikament, Inovelon® (Wirkstoff: Rufinamid) ist seit mehr als einem Jahr in der Schweiz zugelassen und wird klinisch vor allem in der Behandlung von besonderen Epilepsieformen im Kindesalter eingesetzt. Wir erwarten, dass auch nach Gabe von Inovelon® die Schmerzleitung in den Nervenzellen verändert und die lokalen Schmerzreaktionen in der Haut vermindert werden.

* Trial with medicinal product


Eligibility criteria: Inclusion criteria: Male

* Age: 18-65 years
* Weight: 50 - 100 kg
* Height: 155 - 195 cm
* Signed and dated informed consent

Exclusion criteria:

* Contraindications to the class of drugs under study
* Intellectually or mental impaired subjects
* Known hypersensitivity to class of drugs or the investigational product
* Drug abuse
* Known peripheral neuropathies
* Diabetes mellitus
* Chronic alcohol consumption
* Congestive heart disease
* Participants of other studies during study period and 30 days prior to study begin
* Smoker
* Abnormal electrocardiogram
* Any regular concomitant medication

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich, Institut of Anaesthesiology
state: ZH
Study officials:
affiliation: University Hospital Zurich, Institut of Anaesthesiology
name: Konrad Maurer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03854058: Respiratory Muscle Strength in Patients With Obesity Hypoventilation Syndrome (OHS) or With a Precursor of the Disease
Official title: Multimodal Measurement of Respiratory Muscle Strength by Using Volitional and Non-volitional Tests in Patients With Obesity Hypoventilation Syndrome (OHS), Obesity-associated Hypoventilation and OHS-Risk-Patients to Evaluate Pathophysiological Determinants and Predictors for the Presence of a Sleep-related Hypoventilation Requiring Treatment in Obese Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Obesity Hypoventilation Syndrome
Lead sponsor: Wissenschaftliches Institut Bethanien e.V
Sponsor class: OTHER
First posted: 2019-02-26
Enrollment: 50
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: Patients with OHS or OHS-risk

Brief summary: Using an extensive set of both volitional and non-volitional tests of respiratory muscle function and strength it is the aim of this study to

* identify potential determinants for the development of obesity hypoventilation
* to identify predictors for the presence of a sleep-related hypoventilation requiring treatment in obese patients


Eligibility criteria: Inclusion Criteria:

* patients with BMI \> 30 and obesity-associated hypoventilation stages I - IV
* patients with BMI \> 30 and elevated OHS-risk (= obstructive sleep apnea without hypercapnia)
* age:18-80 years
* capacity to consent

Exclusion Criteria:

* any other disease, that causes ventilatory insufficiency
* pacemaker, defibrillators or device for deep brain or vagus nerve stimulation
* esophagitis, Barrett-esophagus, esophageal cancer
* acute gastritis and ulcera ventriculi
* epilepsy
* any medical, psychological or other condition impairing the patient's ability to provide informed consent

Primary outcomes:
measure: Carbon dioxide rebreathing test
timeFrame: 1 day
measure: transdiaphragmatic pressure (non-volitional)
timeFrame: 1 day
measure: peripheral nervous system (non-volitional)
timeFrame: 1 day
measure: diaphragmal ultrasound - excursion (non-volitional)
timeFrame: 1 day
measure: diaphragmal ultrasound - thickness (non-volitional)
timeFrame: 1 day
measure: P0.1 (volitional)
timeFrame: 1 day
measure: PImax (volitional)
timeFrame: 1 day
Secondary outcomes:
measure: Comparison of PImax and transdiaphragmatic pressure
timeFrame: 1 day
Other outcomes:
Locations:
city: Solingen
country: Germany
facility: Institut für Pneumologie an der Universität zu Köln / Wissenschaftliches Institut Bethanien für Pneumologie e.V.
state: Nordrhein-Westfalen
Study officials:
affiliation: Wissenschaftliches Institut Bethanien e.V
name: Winfried J Randerath, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: