louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01364935: Comparison of DuoFertility, LadyComp/BabyComp and Clearblue Monitors
Official title: Pilot Study Comparing Fertility Monitors: DuoFertility Monitor, LadyComp/Babycomp Monitor and Clearblue Ovulation Tests in Support of FDA Application
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infertility
Lead sponsor: Cambridge University Hospitals NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: Cambridge Temperature Concepts
First posted: 2011-06-03
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Female participants trying to conceive, with regular menstrual cycles.

Brief summary: Comparative study to determine whether several fertility monitoring products - the DuoFertility monitor, the LadyComp/Babycomp monitor and Clearblue Ovulation tests - are substantially equivalent in performance, and secondarily to determine the appropriateness of labeling information for the DuoFertility monitor.

Detailed description: The investigators plan to recruit 30 women who are currently trying to conceive, and ask them to use the 3 fertility monitors for duration of 3 menstrual cycles. Additionally, during the study the women will be asked to fill in online questionnaires to assess the usability of the monitors. As the spouse is often a critical partner in the purchase decision and compliance, the investigators will also ask the spouse to complete similar online questionnaires.

Eligibility criteria: Inclusion Criteria:

* Participant is willing and able to give informed consent for participation
* Females aged 18 to 44 years
* Have a body mass index (BMI) above 19 and below 29
* Regular menstrual cycles, i.e. no greater than 7 days difference between the shortest and longest cycle in the last 6 months
* Minimum menstrual cycle 24 days
* Maximum menstrual cycle 33 days
* Female participants willing to use the 3 fertility monitors for at least 3 cycles.
* Willing to fill in regular questionnaires and study diaries

Exclusion Criteria:

* Women aged younger than 18 years, or older than 44 years
* Have a BMI less than 18 or greater than 29
* Any diagnosed systemic illnesses, including but not restricted to thyroid disease, diabetes or inflammatory diseases
* Polycystic ovary disease
* Endometriosis or other pelvic pathology (including proven tubal disease)
* Taking steroids, including oral contraceptives or anti inflammatory drugs

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Cambridge
country: United Kingdom
facility: Cambridge University Hospitals NHS Foundation Trust
state: Cambridgeshire
Study officials:
affiliation: Cambridge University Hospitals NHS Foundation Trust
name: Basil Matta
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05600335: Short-term Outcomes of ERAS Protocol in RAME for Esophageal Cancer
Official title: Short-term Outcomes of Enhanced Recovery After Surgery Protocol in Robotic-assisted McKeown Esophagectomy for Esophageal Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Esophageal Cancer Patients
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2022-10-31
Enrollment: 211
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with esophageal cancer undertaking resection by RAME were included. According to different perioperative management strategies, all eligible patients were divided into the ERAS group and conventional group.

Brief summary: This single-center, retrospective cohort study aimed to evaluate the short-term outcomes of enhanced recovery after surgery (ERAS) protocol in perioperative robotic-assisted McKeown esophagectomy (RAME) among esophageal cancer patients.


Eligibility criteria: Inclusion Criteria:

1. first detected and endoscopically confirmed esophageal cancer;
2. preoperative evaluation showed no distant metastases and suitable for RAME;
3. preoperative clinical stage of I to III;

Exclusion Criteria:

1. patients had a history of thoracic or abdominal surgery;
2. patients were IV to VI in the American Society of Anesthesiologists (ASA) physical status classification system;
3. patients had other malignancies;
4. patients had missing clinical data

Primary outcomes:
measure: time to first flatus
timeFrame: 2019-2022
measure: time to out-of-bed activity
timeFrame: 2019-2022
measure: time to liquid diet
timeFrame: 2019-2022
measure: postoperative pain score
timeFrame: 2019-2022
measure: duration of analgesic pump
timeFrame: 2019-2022
measure: postoperative hospital stay
timeFrame: 2019-2022
measure: ICU length of stay
timeFrame: 2019-2022
measure: in-hospital mortality
timeFrame: 2019-2022
measure: incidence of various postoperative complications
timeFrame: 2019-2022
Secondary outcomes:
measure: postoperative chest drainage volume
timeFrame: 2019-2022
measure: preoperative anesthesia time
timeFrame: 2019-2022
measure: operation time
timeFrame: 2019-2022
measure: blood loss
timeFrame: 2019-2022
measure: conversion rate
timeFrame: 2019-2022
measure: radicality of surgery
timeFrame: 2019-2022
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
state: Sichuan
Study officials:
affiliation: West China Hospital
name: Yidan Lin, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02371135: Metagenomic Evaluation of the Gut Microbiome in Patients With Lynch Syndrome and Other Hereditary Colonic Polyposis Syndromes
Official title: Metagenomic Evaluation of the Gut Microbiome in Patients With Lynch Syndrome and Other Hereditary Colonic Polyposis Syndromes
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Lynch Syndrome
Hereditary Colonic Polyposis Syndromes
Keywords: Gut Microbiome
15-016
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: Harvard University
name: Broad Institute of MIT and Harvard
First posted: 2015-02-25
Enrollment: 77
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: Potential research subjects will be identified prospectively within the clinics of the Clinical Genetics and Gastroenterology Services, of MSKCC.

Brief summary: The purpose of this study is to understand the role bacteria that normally live in the colon may play in colorectal cancer risk, in addition to the hereditary risk to colorectal cancer. The investigators will collect stool specimens as well as additional colon biopsy specimens during the patient's scheduled colonoscopy procedure. The investigators will also collect a questionnaire about diet and lifestyle. The samples will be used to study the impact of diet on naturally-occurring oral and gut bacteria and their influences on human health including risk of cancer.


Eligibility criteria: Inclusion Criteria:

* Male or Female age 18 or older
* Hereditary colorectal cancer syndrome with one of the following:

  * Lynch syndrome, as defined by the presence of a deleterious germline mutation in the MLH1, MSH2, MSH6, PMS2 or EPCAM genes
  * Other hereditary colonic polyposis syndromes, as defined by the presence of a deleterious germline mutation in any one of the following polyposis genes (APC, biallelic MYH, STK11, SMAD4, BMPR1A, or other CRC-risk associated genes at discretion of PI)

Exclusion Criteria:

* Unable to provide informed consent for testing
* Unable to complete English language questionnaire
* Receiving active chemotherapy
* Having completed active chemotherapy less then 12 months prior to day of scheduled lower endoscopy
* No infectious or drug induced colitis less then 12 months prior to day of scheduled lower endoscopy
* No history of inflammatory colitis (Crohn's disease or ulcerative colitis)

Primary outcomes:
measure: association of the gut microbiome and dietary factors (To validate said associations, individual questions from the Brief Diet and Lifestyle Questionnaire will be primarily used in the overall analyses)
timeFrame: 2 years
Secondary outcomes:
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: Zsofia Stadler, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01257035: Predictive Value of 18F-FAZA in Rectum Cancer
Official title: The Predictive Value of 18F-FAZA-PET/CT in Neoadjuvant Radiation for Patients With Locally Advanced Rectum Cancer
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Locally Advanced Rectum Cancer
Keywords: Rectum cancer
FAZA
18F-FAZA-PET/CT
Radiotherapy
Chemoradiotherapy
Lead sponsor: Vejle Hospital
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
First posted: 2010-12-09
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with locally advanced rectum cancer receiving preoperative radiation treatment and concomitant chemotherapy at the Dept. of Oncology, Vejle Hospital.

Brief summary: The primary purpose of the study is to investigate 18F-FAZA-PETs role as predictor of response to neoadjuvant chemoradiation of locally advanced rectum cancer.


Eligibility criteria: Inclusion Criteria:

* Histopatologically verified adenocarcinoma in the rectum
* T4 tumor eller T3 tumor \< 10 cm from the anus and \< 5 mm from the mesorectal fascie measured by MR scan. At the distal part of the rectum the distance to the mesorectal fascie is \< 5 mm and therefore all T3 tumors are included in this area
* Suitable for preoperative radiation and chemotherapy
* No distant metastases
* Age \>18 years
* Hematology ANC ≥1.5x10\^9/l. Thrombocytes ≥ 100x10\^9/l.
* Biochemistry Bilirubin ≤ 3 x UNL. ALAT ≤ 5 x UNL
* Creatinine ≤ UNL
* Contraception for fertile women
* Written and orally informed consent

Exclusion Criteria:

* Other malignant disease within 5 years, excl. non-melanotic skin cancer
* Previous radiation treatment of the pelvis
* Pregnant or breastfeeding women
* Surgery within 6 weeks prior to enrollment
* Serious concurrent medical disease
* Enrollment in study "A prospective observational study of patients with rectum cancer after concomitant radiation and chemotherapy", where the patients are potientially not operated.

Primary outcomes:
measure: Response to chemoradiotherapy measured by TRG
timeFrame: 8 weeks after chemoradiation treatment
Secondary outcomes:
measure: Recurrence free survival
timeFrame: From date of inclusion till date of verified recurrence
measure: Survival
timeFrame: From date of inclusion till date of death by any cause
Other outcomes:
Locations:
city: Vejle
country: Denmark
facility: Vejle Hospital
Study officials:
References:
Clinical trial NCT02882035: Opioid Free Anesthesia: What About Patient Comfort?
Official title: Opioid Free Anesthesia: What About Patient Comfort?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anesthesia
Keywords: pain
patient comfort
Lead sponsor: Université Libre de Bruxelles
Sponsor class: OTHER
Collaborators: name: Jules Bordet Institute
First posted: 2016-08-29
Enrollment: 66
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 66 female patients undergoing breast cancer surgery were randomized in the Jules Bordet Institute, the Belgian oncology institute. One group received an opioid anesthesia, the other group an opioid free one. The hypothesis of this study was that opioid free anesthesia improves the postoperative quality of recovery of anesthesia.

Detailed description: Opioids used as part of balanced anesthesia have known undesired side effects such as: respiratory depression, post-operative nausea and vomiting, pruritus, difficulty voiding and ileus.

The purpose of this study was to determine whether opioid free anesthesia influences the quality of recovery. A multimodal approach combining ketamine, lidocaine and clonidine was used as an alternative for an opioid based anesthesia.

The hypothesis of this study was that patient comfort and satisfaction level after an opioid free anesthesia would be higher compared to after a more traditional opioid anesthesia.

Eligibility criteria: Inclusion Criteria:

* Oncological patients undergoing a total mastectomy or lumpectomy associated with a total axillary dissection were screened.
* Patients with an ASA physical status of II were included.
* Knowledge of either French, English or Dutch was required.

Exclusion criteria were the following:

* Allergy or contraindications to one of the study drugs, renal failure, hepatic failure, hyperthyroidism, AV block 2 or 3 or severe bradycardia, left ventricular failure, unstable blood pressure, epilepsy and psychiatric disturbance.

Primary outcomes:
measure: QoR-40
timeFrame: 24 hours post-operatively
Secondary outcomes:
measure: Post-operative NRS
timeFrame: during 24 hours post-operative
measure: Post-operative piritramide consumption
timeFrame: during the first 24 hours post-operative
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Institut Jules Bordet
Study officials:
References:
Clinical trial NCT05458635: Predictors of Pulmonary Hypertension in Patients With Hypersensitivity Pneumonitis
Official title: Predictors of Pulmonary Hypertension in Patients With Hypersensitivity Pneumonitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Hypertension
Hypersensitivity Pneumonitis
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-07-14
Enrollment: 60
Sex: ALL
Minimum age (years): 29
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Hypersensitivity pneumonitis (HP) is a complex immune mediated disorders caused by repeated inhalation of and sensitization to wide range of antigens including organic particles and chemical compounds, leading to exaggerated immuneresponse. Hypersenstivity pneumonitis is a common form of diffuse parenchymal lung diseases in Egypt .Pulmonary hypertension has been found as a complication of a number of diseases affecting the lung interstitium, including hypersensitivity pneumonitis, with subsequent affection of the life expectancy Rationale of the study: to find predictors for the development of pulmonary hypertension in patients with hypersensitivity pneumonitis

Detailed description: Cross sectional study included 60 patients with established diagnosis of HP , work up includes history of exposure, clinical examination, HRCT chest, ABGs,6MWD, desaturation degree , spirometry, echocardiography and right heart catheter in patients with high echo probability of PH.

Eligibility criteria: Inclusion Criteria:

* All patients with confirmed diagnosis of Hypersensitivity pneumonitis

Exclusion Criteria:

* Other interstitial lung diseases

Primary outcomes:
measure: Percentage of pulmonary hypertension in patients with HP
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr alainy school of medicine
Study officials:
References:
Clinical trial NCT01171235: Study of Biomarker From Blood and Tissue of Head and Neck Carcinoma
Official title: Study of Previously Collected Blood and Tissue Samples From Patients With Nasopharyngeal Carcinoma,Laryngeal Carcinoma and Hypopharyngeal Carcinoma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Laryngeal Neoplasms
Pharyngeal Neoplasms
Keywords: Laryngeal Neoplasms
Pharyngeal Neoplasms
Lead sponsor: Southern Medical University, China
Sponsor class: OTHER
First posted: 2010-07-28
Enrollment: 200
Sex: ALL
Minimum age (years): 15
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all of nasopharyngeal carcinoma, hypopharyngeal carcinoma or laryngeal carcinoma visited at ENT department of NanFang hospital

Brief summary: The aim of the study is to find for one or more serum or tissue markers of molecular biology in head and neck cancer patients used for early diagnosis, predicting prognosis and being sensitive to chemotherapy and radiotherapy

Detailed description: Head and neck malignant tumors, especially nasopharyngeal carcinoma in southern China with the high incidence, its incidence, treatment, prognosis or tumor markers in serum has been a hot research with little progress.In our study, we collect NPC-based collection including the blood samples of laryngeal, hypopharyngeal cancer, separating serum and white blood cells stored in -80 degrees，while tissues are frozen in liquid nitrogen and embedded in paraffin。 Patient treatment and prognosis are combined in order to find for markers of molecular biology used for early diagnosis, predicting prognosis and being sensitive to chemotherapy and radiotherapy.

Eligibility criteria: Inclusion Criteria:

* all of nasopharyngeal carcinoma
* hypopharyngeal carcinoma or laryngeal carcinoma visited at ENT department of NanFang hospital

Exclusion Criteria:

* all of above patients whose anticipated survival duration were less than 6 months

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: E.N.T department of NanFang hospital
name: Ping Xiang Li, doctor
role: STUDY_DIRECTOR
References:
citation: Yu BL, Peng XH, Zhao FP, Liu X, Lu J, Wang L, Li G, Chen HH, Li XP. MicroRNA-378 functions as an onco-miR in nasopharyngeal carcinoma by repressing TOB2 expression. Int J Oncol. 2014 Apr;44(4):1215-22. doi: 10.3892/ijo.2014.2283. Epub 2014 Jan 28.
Clinical trial NCT03862235: Decreased T1 Times and Impaired Myocardial Contractility in Anabolic Androgenic Steroids Users
Official title: Decreased Myocardial Native T1 Times and Impaired Myocardial Contractility in Young Anabolic Androgenic Steroids Users
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Focal Fibrosis
Keywords: anabolic steroid
T1-mapping
cardiac structure
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2019-03-05
Enrollment: 50
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Anabolic androgenic steroids users and nonusers were recreational weightlifters or amateur bodybuilding athletes who were recruited from gymnasiums.

Sedentary control group was recruited from community sample.

Brief summary: Anabolic androgenic steroids (AAS) abuse may have a toxic on myocardium that could lead to cardiac alterations. Clinical cases reported myocardial fibrosis in AAS users. However, recent studies did not find myocardial fibrosis in AAS users using T1-mapping technique. The aim of this study was to evaluate cardiac structure by cardiovascular magnetic resonance (CMR) with late-gadolinium enhancement (LGE), cardiac T1-mapping and extracellular volume (ECV). We also evaluated the cardiac contractility in AAS users.

Detailed description: Twenty strength-trained AAS users (AASU) age 29±5 yr, 20 age-matched strength-trained AAS nonusers (AASNU), and 10 sedentary controls (SC) were enrolled.

Cardiac structure was assessed by LGE, T1-mapping and ECV. Cardiac contractility was evaluated as cardiac strain by CMR (feature tracking) and echocardiography (speckle tracking)

Eligibility criteria: Inclusion Criteria:

* Anabolic androgenic steroids users and Anabolic androgenic steroids nonusers groups had been involved in strength training for at least 2 years;
* Anabolic androgenic steroids users should be self-administering anabolic androgenic steroids in periodic cycles lasting from 8 to 12 weeks for at least 2 years with 2-4 cycles per year;
* All anabolic androgenic steroids users were on a cycle over the course of the study;
* Sedentary control group: sedentary men without cardiovascular disease.

Exclusion Criteria:

* Smoking;
* Alcohol consumption;
* Use of diuretics and/or antihypertensive medications;
* Liver and kidney disease

Primary outcomes:
measure: Cardiac T1-mapping
timeFrame: 1 day
Secondary outcomes:
measure: Myocardial Contractility
timeFrame: 1 day
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Instituto do Coração do Hospital da Clínicas da Universidade de Sao Paulo
state: SP
Study officials:
affiliation: Heart Institute (InCor), University of Sao Paulo Medical School
name: Maria Janieire NN Alves, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01354535: Types of Fixation of Vancouver B1 Periprosthetic Fractures
Official title: Isolated Locked Compression Plating Versus Cable Plating and Strut Allografts With Cerclage Wiring for Vancouver B1 Periprosthetic Femoral Fractures: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Femur Fractures
Keywords: periprosthetic
femur fractures
Vancouver B1
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
First posted: 2011-05-17
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare two different but standard treatments for the fixation of Vancouver B1 periprosthetic. The investigators aim to compare open reduction internal fixation using a locked plating system versus plating and strut allograft with cerclage wiring to determine which treatment results in a faster return to function as measured by the TUG test at 6 weeks post-op.


Eligibility criteria: Inclusion Criteria:

* Age: over 18, no upper limit
* Vancouver type B1 periprosthetic fracture
* Fracture is amenable to either treatment group
* Prosthesis is well fixed
* Provision of informed consent

Exclusion Criteria:

* Presence of an active infection around the fracture (soft tissue or bone)
* Loose prosthesis
* Trauma patients with an ISS \> 16 or associated major injuries of the lower extremities
* Known substance abuse
* Likely problems, in the judgment of the investigators, with maintaining follow-up (i.e., patients with no fixed address, report a plan to move out of town, or intellectually challenged patients without adequate family support)

Primary outcomes:
measure: TUG test score at 6 weeks post-op
timeFrame: 6 weeks
Secondary outcomes:
measure: Re-operation rates
timeFrame: 1 year
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: St. michael's Hospital
state: Ontario
Study officials:
affiliation: Unity Health Toronto
name: Emil Schemitsch, MD, FRCS(C)
role: PRINCIPAL_INVESTIGATOR
affiliation: Unity Health Toronto
name: Aaron Nauth, MD, FRCSC
role: PRINCIPAL_INVESTIGATOR
References: