louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00527709: Hold Parameters on Likely Cardiovascular Depressant Medications
Official title: Hold Parameters on Likely Cardiovascular Depressant Medications (HOLD)
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Asystole
Bradycardia
Hypotension
Lead sponsor: Hackensack Meridian Health
Sponsor class: OTHER
First posted: 2007-09-11
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: RETROSPECTIVE

Brief summary: This pilot study is being pursued to observe whether certain medications are given to patients within a timeframe where their being given could play a part in a critical event in the management of the patient.

There are general rules about when it would be appropriate for these types of medications not to be given. However, it is not current standard practice for the criteria to be put in place without the expressed wishes of the ordering physician or their agent.

Research Question:

Can the administration of cardio-depressant medications be documented as a significant risk factor for hypotensive or bradycardic events?


Eligibility criteria: Inclusion Criteria:

* Serial evaluation of the first 50 documented events of Code Blue or call to Rapid Response Team involving hypotension, bradycardia or asystole in the adult inpatient population events beginning January 1, 2006.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
Study officials:
affiliation: Hackensack Meridian Health
name: Amit Tailor, MD, MBA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03470909: SKINI - Radicality of Skin-Sparing and Nipple-Sparing Mastectomy
Official title: SKINI - Prospective Evaluation of the Radicality of Breast Tissue Removal With Skin-Sparing and Nipple-Sparing Mastectomy (SSM or NSM)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgery
Keywords: Remaining breast tissue
Skin-Sparing Mastectomy
Nipple-Sparing Mastectomy
Prophylactic
Lead sponsor: Brust-Zentrum AG
Sponsor class: OTHER
First posted: 2018-03-20
Enrollment: 160
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Prospective collection of health related personal data and biological material (tissue biopsy) in patients undergoing mastectomy.

Detailed description: In this prospective, multi-center trial patients undergoing mastectomy and fulfilling inclusion criteria receive additional biopsies from the remaining skin envelope in order to quantify the amount of residual breast tissue.

Since the investigators will assess, 142 breasts will be investigated. This means a maximum of n=142 patients will be included (corresponding to a minimum of n=71 patient).

On the specimen additional histological sections in radial direction will be performed.

The aim of the study is to evaluate the quality of Skin- Sparing and Nipple-Sparing Mastectomy. On each predefined location in the wound cavity the investigators will investigate where residual breast tissue (RBT) will be found or not. If no RBT can be detected at all predefined breast locations this breast will be classified as having no RBT (=RBT negative). If breast tissue can be detected the investigators have a RBT positive breast.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing uni- or bilateral Skin-Sparing or Nipple-Sparing mastectomy
* Female participants ≥ 18 years of age
* The subject was informed on the project and gave her written informed consent to use her data and samples for this project.

Exclusion Criteria:

- Not fulfilling inclusion criteria

Primary outcomes:
measure: Detection of residual breast tissue (RBT)
timeFrame: 20 months
Secondary outcomes:
measure: Distance between surface of the removed breast and glandular tissue
timeFrame: 20 months
measure: Detection of residual disease
timeFrame: 20 months
measure: Correlation of patient- and therapy-related factors with residual breast tissue (RBT) and with distance between surface of removed breast and glandular tissue
timeFrame: 20 months
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: Brust-Zentrum AG
Study officials:
References:
citation: Papassotiropoulos B, Guth U, Chiesa F, Rageth C, Amann E, Baege A, Elfgen C, Varga Z, Moskovszky L, Endhardt K, Masser R, Tinguely M, Farhadi J, Lardi A, Dammann F, Diebold J, Li Q, Dubsky P, Tausch C. Prospective Evaluation of Residual Breast Tissue After Skin- or Nipple-Sparing Mastectomy: Results of the SKINI-Trial. Ann Surg Oncol. 2019 May;26(5):1254-1262. doi: 10.1245/s10434-019-07259-1. Epub 2019 Mar 4.
Clinical trial NCT01455909: A Study to Evaluate ITCA 650 Compared to Sitagliptin for the Treatment of Type 2 Diabetes
Official title: A Phase 3, Randomized, Active Comparator, Double-Blind, Multi-Center Study to Compare the Efficacy, Safety and Tolerability of ITCA 650 to Sitagliptin as Add-on Therapy to Metformin in Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Type 2 Diabetes
Lead sponsor: Intarcia Therapeutics
Sponsor class: INDUSTRY
First posted: 2011-10-20
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Phase 3 study to compare treatment with ITCA 650 to sitagliptin when added to metformin monotherapy in patients with type 2 diabetes.


Eligibility criteria: Inclusion Criteria:

* HbA1c between 7.5%-10%
* on metformin monotherapy
* BMI between 25 \& 45 kg/m2

Exclusion Criteria:

* taking thiazolidinedione, sulfonylurea, DPP-4, exenatide, alpha glucosidase inhibitors, meglitinides or insulin within last 3 months
* history of pancreatitis

Primary outcomes:
measure: Change in HbA1c
timeFrame: 39 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Hayward
country: United States
facility: Intarcia Therapeutics, Inc
state: California
Study officials:
References:
Clinical trial NCT03625609: Sexaffectivity in Autistic Spectrum Disorder
Official title: Sexaffectivity in Autistic Spectrum Disorder: Observed Behaviors and Referred Needs in Adolescence
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Autistic Disorders Spectrum
Sexual Behavior
Adolescent Development
Sexual Inadequacy
Lead sponsor: Parc Taulí Hospital Universitari
Sponsor class: OTHER
First posted: 2018-08-10
Enrollment: 200
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Boys and girls with ASD who want to participate in the collection of a scale with their families. Ages between 12 years old and 18 years old.

Brief summary: The WHO defines sexual health as a state of physical, emotional, mental and social well-being, related to sexuality, not only the absence of illness, dysfunction or disability. To acquire and maintain adequate sexual health, the sexual rights of all people must be respected, protected and fully exercised.

People with Autism Spectrum Disorder (ASD) present difficulties in the development of social interaction skills, among other problems that directly affect their sexual health. The consolidated prejudices and social myths related to the sexual affectivity of people with ASD, and in general to people with intellectual diversity, have meant that they do not pay any attention to the sexual health of this group in the assessment of their needs.

Main objectives: to understand the experience lived by young people with ASD and their caregivers in relation to the affective needs during adolescence and to know the cognitive and behavioral expression of the affective dimension of adolescents with ASD.

Mixed simultaneous design: qualitative based on the phenomenological paradigm, in order to establish the perceived needs of young adults with ASD, their families and the professionals who attend them, with the realization of focus groups and in-depth interviews. The second quantitative part will be developed in adolescents (12-18 years) and their families, evaluating the habitual behaviors and difficulties of Interaction in the affective expression, by means of questionnaires and self-administered scales. It will be necessary to sign the Informed Consent by all the participants, with the specific acceptance of the project by the CEIC of the investigator's center.


Eligibility criteria: Inclusion Criteria:

* Adolescents with ASD. 12-18 years old

Exclusion Criteria:

* Non defined

Primary outcomes:
measure: Sexual Behaivor Scale
timeFrame: 12-18 years old
Secondary outcomes:
Other outcomes:
Locations:
city: Sabadell
country: Spain
facility: Jordi Torralbas Ortega
state: Barcelona
Study officials:
References:
Clinical trial NCT06759207: Assessment of Corneal Topography and Densitometry in Rheumatoid Patients
Official title: Assessment of Corneal Topography and Densitometry in Rheumatoid Patients: A Prospective Case Control Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cornea
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2025-01-06
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients have RA presented for ophthalmic clinic during the period of the study

Brief summary: Corneal transparency is a result of its unique ultrastructure with collagen fibrils regularity, integrity of connective tissue, and balanced keratocyte components. Corneal densitometry is known to be altered in cases corneal haze or scar, but recently it is assumed to be altered earlies in presence of a systemic inflammatory disease, even before clinical manifestations take place.

The aim of this study is to assess changes in corneal topography and corneal densitometry in RA patients with clinically clear corneas and to compare these results with those of healthy control subjects.


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with rheumatoid arthritis

Exclusion Criteria:

* corneal opacity; severe dry eye; glaucoma; any inflammatory ocular disorder or infection including blepharitis, conjunctivitis, meibomitis and dacryocystitis; central or peripheral thinning evident in slit-lamp examination; history of ocular surgery, trauma, or contact lens use; and patients using any topical medication other than artificial tears will be excluded from the study.

Primary outcomes:
measure: Corneal topographic changes and densitometry in patients with rheumatoid arthritis
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Amr Mounir
city: Sohag
country: Egypt
facility: Elshimaa A.Mateen
Study officials:
affiliation: Assistant Professor
name: Elshimaa A.Mateen, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04557007: Drug Concentration Monitoring of Pembrolizumab in Non-Small Cell Lung Cancer Patients
Official title: Drug Concentration Monitoring of Pembrolizumab in Treatment-naive Non-Small Cell Lung Cancer Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: NSCLC
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
First posted: 2020-09-21
Enrollment: 250
Sex: ALL
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: NSCLC patients With Advanced disease elligible for routine treatment With immunotherapy alone or in combination With chemotherapy.

Brief summary: This observational study explores associations between drug trough-levels and clinical outcomes in Non Small Cell Lung Cancer (NSCLC) patients treated with immunotherapy (pembrolizumab) either alone or combined with chemotherapy. Through-levels of pembrolizumab will be examined in blood samples collected during the first-line treatment period. In addition T-cell responses in peripheral blood and anti-drug antibodies will be monitored. Results of drug trough-levels and T-cell responses will be linked to clinical outcome. 250 patients with NSCLC will be enrolled in this trial.


Eligibility criteria: Inclusion Criteria:

* Subjects must be \> 18 years and must voluntary sign an informed consent
* Treatment-naïve patients with advanced NSCLC receiving immunotherapy alone (pembrolizumab) or combined with chemotherapy

Exclusion Criteria:

* Any anti-cancer therapy \< 6 months prior to inclusion

Primary outcomes:
measure: Objective response
timeFrame: 3 months
Secondary outcomes:
measure: Adverse events
timeFrame: 2 years
measure: PD-1 Expression on CD-8 T-cells
timeFrame: First 3 months
measure: Overall survival
timeFrame: 5 years observation
measure: Progression-Free survival
timeFrame: 1 year
Other outcomes:
measure: Pembrolizumab clearance
timeFrame: 3 months
Locations:
city: Trondheim
country: Norway
facility: St Olavs University Hospital
Study officials:
affiliation: Oslo University Hospital
name: Ragnhild Nome, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02270307: MSC and Cyclophosphamide for Acute Graft-Versus-Host Disease (aGVHD) Prophylaxis
Official title: Allogeneic Bone Marrow Transplantation (Allo-BMT) From Human Leukocyte Antigen (HLA) - Identical Related and Unrelated Donors in Patients With Hematological Malignancies With High Risk of Relapse Using Cyclophosphamide (CY) and Mesenchymal Stromal Cells (MSC) as aGVHD Prophylaxis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Leukemia
Multiple Myeloma
Lead sponsor: National Research Center for Hematology, Russia
Sponsor class: NETWORK
First posted: 2014-10-21
Enrollment: 40
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: PREVENTION

Brief summary: Evaluating the effectiveness of the new protocol which replace the standard immunosuppressive therapy with use of MSCs and CY in patients at high risk of relapse.

Detailed description: This trial try to find a new way of refractory hematological malignancies treatment. Aim of this study evaluating the effectiveness of the new protocol which replace the standard immunosuppressive therapy with use of MSCs and CY in patients at high risk of relapse.

Eligibility criteria: Inclusion Criteria:

* Refractory forms of acute leukemia, but in complete remission (CR)
* Second and third remission of acute leukemia
* 2nd and 3rd chronic phase chronic myelogenous leukemia (CML) (or Ph + ALL)
* relapsed multiple myeloma
* advanced leukemia

Exclusion Criteria:

* ICU
* Mechanical ventilation

Primary outcomes:
measure: Overall survival
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: BMT department
Study officials:
affiliation: Ministry of Health
name: Valery Savchenko, Prof.
role: STUDY_DIRECTOR
References:
Clinical trial NCT06423807: Preoperative Ondansetron Lozenge for Prevention of Post-Spinal Shivering in Caesarean Section
Official title: Preoperative Ondansetron Lozenge for Prevention of Post-Spinal Shivering in Caesarean Section: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ondansetron Lozenge
Post-Spinal Shivering
Cesarean Section
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2024-05-21
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study is to estimate the role of ondansetron lozenge on prevention of post-spinal shivering in cesarean section.

Detailed description: Spinal anesthesia (SA) is preferred for cesarean section (CS) compared with general anesthesia(GA) because of several advantages, including prevention of the potential risk of GA-related neurotoxicity.

Post-spinal shivering (PSS) could be a provocative factor for postoperative pain and its appropriate treatment prevents non-thermoregulatory tremors. Shivering also causes aggravating postoperative pain by stretching of sutures.

Ondansetron is a selective antagonist for receptor 5-hydroxytryptamine 3 and is very effective in the prevention and treatment of shivering intra- and post-operation. Ondansetron can affect the body temperature and shivering in rats since the balance of nor-epinephrine and 5-hydroxytryptamine (5-HT) in the preoptic-anterior hypothalamus controls the temperature set point.

Eligibility criteria: Inclusion Criteria:

* Age from 18 to 40 years.
* American Society of Anesthesiology (ASA) physical status II.
* Parturient women undergoing CS under spinal anesthesia.

Exclusion Criteria:

* Parturient women with any contraindication or hypersensitivity to the study drugs.
* Any history of cardiovascular diseases, psychosis, hypertension, fetal distress, cord prolapse initial.
* Temperature more than 38°C or less than 36°C.
* Body Mass Index (BMI)\> 40 kg/m2.
* Medical history of alcohol or drug abuse.
* Parkinson's disease or any extrapyramidal disease.
* Intraoperative blood transfusion.
* History of chemotherapy treatment.

Primary outcomes:
measure: Incidence of shivering
timeFrame: 24 hours postoperatively
Secondary outcomes:
measure: Incidence of postoperative nausea and vomiting (PONV)
timeFrame: 24 hours postoperatively
measure: Patients' satisfaction
timeFrame: 24 hours postoperatively
measure: Adverse effects
timeFrame: 24 hours postoperatively
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University
state: El-Gharbia
Study officials:
affiliation: Faculty of Medicine Tanta University, Egypt
name: Mohammed S Elsharkawy, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02233907: Post-marketing Surveillance of Ventilat® in Long-term Therapy in Chronic Obstructive Pulmonary Disease
Official title: Post-marketing Surveillance (as Per § 67(6) AMG [German Drug Law]) of Ventilat® in Long-term Therapy 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: 2014-09-09
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: Patient with chronic obstructive pulmonary disease at general practitioners

Brief summary: Study to obtain further information on the tolerability and efficacy of Ventilat® metered dose inhaler in long-term treatment of Chronic Obstructive Pulmonary Disease under conditions of daily practice


Eligibility criteria: Inclusion Criteria:

* Patients of both genders older than 40 years, who suffer from Chronic Obstructive Pulmonary Disease
* Only patients who have not been treated with Ventilat® within the last year are to be considered for inclusion

Exclusion Criteria:

* Contraindications listed in the Instructions for Use/Summary of Product Characteristics for Ventilat® metered dose inhaler

Primary outcomes:
measure: Change in the clinical picture
timeFrame: up to 12 months
Secondary outcomes:
measure: Assessment of efficacy by investigator on a 4-point scale
timeFrame: after 12 months
measure: Assessment of efficacy by patient on a 4-point scale
timeFrame: after 12 months
measure: Number of patients with adverse drug reactions
timeFrame: up to 12 months
measure: Assessment of tolerability by investigator on a 4-point scale
timeFrame: after 12 months
measure: Assessment of tolerability by patient on a 4-point scale
timeFrame: after 12 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02415907: Investigating the Absorption, Metabolism and Excretion (AME) of Idalopirdine
Official title: Interventional, Open-label, Two Single Dose, Fixed-sequence Study Investigating the Absorption, Metabolism and Excretion (AME) of Idalopirdine Following a Single Oral Dose of Lu AF67708 ([Ethyl-1-14C]-Idalopirdine) and Lu AF67709 ([Benzyl-7-14C]-Idalopirdine) in Healthy Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
First posted: 2015-04-14
Enrollment: 6
Sex: MALE
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigating the absorption, metabolism and excretion of radio labelled single doses of idalopirdine in healthy men.


Eligibility criteria: Inclusion Criteria:

* Healthy men
* aged between 40-60 years (inclusive)
* BMI in the range 19 and 30 kg/m2 (minimum weight 60 kg)

Exclusion Criteria:

* The subject has previously been dosed with idalopirdine.

Other protocol defined inclusion and exclusion criteria do apply

Primary outcomes:
measure: Cumulative amounts of radioactivity excreted in urine and faeces (% of dose)
timeFrame: 0 to 168 hours
measure: Pharmacokinetic (PK) of idalopirdine and radioactivity in plasma (Cmax, tmax, AUC, t1/2, oral clearance and apparant volume of distribution. (composite outcome measure)
timeFrame: 0 to 168 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: GB802
Study officials:
affiliation: LuncbeckClinicalTrials@Lundbeck.com
name: Email contact via H. Lundbeck
role: STUDY_DIRECTOR
References: