louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03163537: Disturbing Factors in the Operating Room
Official title: Disturbing Factors and Stress Levels in Vascular Surgeons During Kidney Transplantations
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Disturbing Factors
Stress
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2017-05-23
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Vascular surgeons during kidney transplantation

Brief summary: Observation of disturbing factors in the operating room and comparison between day and night shift. The investigators have chosen to observe kidney transplantations, since this type of operation has the same priority during day and night. Stress levels of surgeons will be measured using the HealthPatch.


Eligibility criteria: Inclusion Criteria:

* All vascular surgeons who are able to perform elective as well as postmoral kidney transplantations

Exclusion Criteria:

-

Primary outcomes:
measure: Factors that are disturbing for vascular surgeons during kidney transplantations
timeFrame: 2 hours
Secondary outcomes:
measure: Stress levels
timeFrame: 2 hours
measure: State Trait Anxiety Inventory
timeFrame: 5 minutes
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01022437: Geranium Oil and Its Components for the Relief of Numbness-OB 100
Official title: Geranium Oil and Its Components for the Relief of Numbness-OB 100
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nerve Conduction
Numbness
Lead sponsor: Pennington Biomedical Research Center
Sponsor class: OTHER
First posted: 2009-12-01
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study is designed to evaluate the effectiveness of geranium oil and its components in the relief of numbness and the restoration of sensations.

Detailed description: This is a pilot study to define the time course, the incidence of sensation restoration and the improvement in nerve conduction in people with numbness by using topical geranium oil.

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* Neuropathy with the inability to feel touch in a standard nylon filament test
* Signed informed consent

Exclusion Criteria:

* Pregnant or nursing
* Known allergies to geranium oil or geranium oil fractions
* Open sore in the area of numbness
* Migraine headaches or headaches to strong smells

Primary outcomes:
measure: Response to numbness relief and restoration of sensation
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Penningto Biomedical Research Center
state: Louisiana
Study officials:
affiliation: Pennington Biomedical Research Center
name: Alok Gupta, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01433237: Studying Biomarkers in Samples From Patients With Rhabdomyosarcoma
Official title: A Retrospective Study on the Diagnostic Value of Serum miR-206 in Rhabdomyosarcoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sarcoma
Keywords: embryonal childhood rhabdomyosarcoma
adult rhabdomyosarcoma
alveolar childhood rhabdomyosarcoma
adult soft tissue sarcoma
childhood rhabdomyosarcoma
Lead sponsor: Children's Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2011-09-13
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Rhabdomyosarcoma (RMS), embryonal RMS, and non-RMS.

Brief summary: RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This research trial studies biomarkers in samples from patients with rhabdomyosarcoma.

Detailed description: OBJECTIVES:

* Determine whether circulating muscle-specific microRNAs, especially serum miR-206, are potential biomarkers for rhabdomyosarcoma (RMS).

OUTLINE: Archived serum samples are analyzed for miR-206 expression.

PROJECTED ACCRUAL: A total of 15 samples from patients with alveolar rhabdomyosarcoma (RMS), 15 from patients with embryonal RMS, and 10 from patients without RMS will be accrued for this study.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Serum specimens of rhabdomyosarcoma (RMS), embryonal RMS, and non-RMS available from the Soft Tissue Sarcoma committee of Children's Oncology Group

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified

Primary outcomes:
measure: Serum miR-206 as a biomarker for RMS
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Kyoto Prefectural University of Medicine
name: Hajime Hosoi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04343937: Retrolaminar Block for Postoperative Analgesia in Lumbar Herniectomy Surgery
Official title: Retrolaminar Block for Postoperative Analgesia in Lumbar Herniectomy Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postoperative Pain
Keywords: Retrolaminar block
Lead sponsor: Erzincan University
Sponsor class: OTHER
First posted: 2020-04-14
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients underwent retrolaminar block

Brief summary: This retrospective study included 30 patients scheduled for lumbar herniectomy under general anesthesia. The patients were randomized to receive either retrolaminar block or intravenous analgesia treatment.Numeric Pain Rating Scale (NPRS) was used to measure the pain intensity of patients in postoperative period. Postoperative analgesic requirements were recorded to asses effectiveness of regional anesthesia.Opiod and NSAİD as rescue medication were recorded postoperatively.

Detailed description: This retrospective study included 30 patients scheduled for lumbar herniectomy under general anesthesia. The patients were randomized to receive either RLB or intravenous analgesia treatment. All patients were routinely monitored and their heart rate, blood pressure and pulse oxymetry recorded during the anesthesia. Numeric Pain Rating Scale (NPRS) scores evaluated at 2, 8, 12, 24 and 48 h after the surgery. Opiod and NSAİD as rescue medication were recorded postoperatively

Eligibility criteria: Inclusion Criteria:

* patients accepted to part in the study

Exclusion Criteria:

* patients not accepted to part in the study
* allergic reaction to local anesthetics drugs
* lumbar herniectomy of more than two levels

Primary outcomes:
measure: postoperative pain: Numeric Pain Rating Scale
timeFrame: at the second hour after the surgery
measure: postoperative pain: Numeric Pain Rating Scale
timeFrame: at the eighth hour after the surgery
measure: postoperative pain: Numeric Pain Rating Scale
timeFrame: at the twelfth hour after the surgery
measure: postoperative pain: Numeric Pain Rating Scale
timeFrame: at the twenty forth hour after the surgery
measure: postoperative pain: Numeric Pain Rating Scale
timeFrame: at the forty-eighth hour after the surgery
Secondary outcomes:
measure: postoperative analgesic requirements
timeFrame: at the second hour after the surgery
measure: postoperative analgesic requirements
timeFrame: at the eighth hour after the surgery
measure: postoperative analgesic requirements
timeFrame: at the twelfth hour after the surgery
measure: postoperative analgesic requirements
timeFrame: at the twenty forth hour after the surgery
measure: postoperative analgesic requirements
timeFrame: at the forty-eighth hour after the surgery
Other outcomes:
Locations:
city: Erzincan
country: Turkey
facility: Nurcan Kutluer Karaca
Study officials:
References:
Clinical trial NCT02092415: Assessment of Limb Perfusion During Junctional Tourniquet
Official title: Assessment of Limb Perfusion During Junctional Tourniquet
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bleeding
Keywords: Tourniquet
Muscle perfusion
Contrast ultrasound
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2014-03-20
Enrollment: 10
Sex: ALL
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of this study is to use contrast enhanced ultrasound to determine the degree to which flow is reduced during application of a junctional tourniquet (JT). Contrast enhanced ultrasound is performed to quantify thigh and calf perfusion at baseline and during application of the JT


Eligibility criteria: Inclusion Criteria:

* Healthy subject
* Age 19-50

Exclusion Criteria:

* Peripheral artery disease
* Known heart failure
* Right to left shunt
* Pregnancy
* Presence of femoral artery aneurysm

Primary outcomes:
measure: Muscle Perfusion
timeFrame: baseline and 1 min post occlusion
Secondary outcomes:
Other outcomes:
Locations:
city: Portland
country: United States
facility: OHSU
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Jonathan R Lindner, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Davidson BP, Belcik JT, Mott BH, Landry G, Lindner JR. Quantification of residual limb skeletal muscle perfusion with contrast-enhanced ultrasound during application of a focal junctional tourniquet. J Vasc Surg. 2016 Jan;63(1):148-53. doi: 10.1016/j.jvs.2014.06.107. Epub 2014 Jul 24.
Clinical trial NCT03587415: Serum Preptin and Amylin Levels in Polycystic Ovary Syndrome Patients
Official title: Serum Preptin and Amylin Levels With Respect to Body Mass Index in Polycystic Ovary
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Polycystic Ovary Syndrome
Keywords: amylin; obesity; polycystic ovarian syndrome; preptin
Lead sponsor: Recep Tayyip Erdogan University Training and Research Hospital
Sponsor class: OTHER
First posted: 2018-07-16
Enrollment: 80
Sex: FEMALE
Minimum age (years): 17
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Polycystic ovary syndrome

Brief summary: Preptin and amylin are pancreatic hormones which participate in glucose homeostasis. This study aims to evaluate how serum preptin and amylin levels are altered in polycystic ovary syndrome (PCOS) patients and healthy women based on BMI groups .

Detailed description: Materials and Methods: This is a cross-sectional review of 40 PCOS patients and 40 healthy women who were matched with respect to BMI (\<25 kg/m2 and ≥25 kg/m2).

Eligibility criteria: Inclusion Criteria:

the patients with PCOS

Exclusion Criteria:

Cushing's syndrome 21-hydroxylase deficiency Congenital adrenal hyperplasia Thyroid dysfunction Hyperprolactinemia Diabetes Chronic cardiovascular Hepatic, renal, and hematologic diseases Malignancies Using oral contraceptives, anti-androgens, glucocorticoids, anti-hypertensives, anti-diabetics, calcium supplements and anti-obesity drugs and those who smoke or consume alcohol

-

Primary outcomes:
measure: Serum Preptin and Amylin Levels with Respect to Body Mass Index in Polycystic Ovary Syndrome Patients
timeFrame: six months
Secondary outcomes:
Other outcomes:
Locations:
city: Rize
country: Turkey
facility: Recep Tayyip Erdogan University
Study officials:
affiliation: Recep Tayyip Erdogan University
name: Senol sentürk, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02166515: The Study of Massively Parallel Sequencing in Early Detection for Gynecologic Malignant Tumor
Official title: The Study of Massively Parallel Sequencing in Early Detection for Gynecologic Malignant Tumor
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gynecologic Malignant Tumor
Keywords: cervical cancer
ovarian cancer
endometrial cancer
high-throughput sequencing
Lead sponsor: Third Military Medical University
Sponsor class: OTHER
Collaborators: name: Shenzhen Huada Genomics Co., Ltd.
First posted: 2014-06-18
Enrollment: 200
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The experiment group are patients with cervical cancer, ovarian cancer or endometrial cancer.While the control group are volunteers on the basis of informed consent.

Brief summary: As human aging, 50% of women will be faced with the threat of cancer, especially gynecological malignancies. Ovarian, cervical and endometrial cancer are three major gynecological malignancies. In recent years, the incidence of cervical cancer, especially in young women significantly increased; ovarian cancer, although the incidence of malignant tumors in the female reproductive system ranked second, but its mortality rate already in the first place; and the morbidity and mortality of endometrial cancer is also rising.

The key to gynecologic malignancies is how to early diagnose and treat. With the advancement of science and technology, such as molecular biology techniques widely used in the medical field, early diagnosis, proper treatment and other aspects in gynecologic malignancies is expected to achieve a breakthrough. Genome-wide scan strategy, making the whole genome for linkage analysis for gynecological malignancies possible. Therefore, the investigators intend to find specific mutations to provide a new early screening approach for gynecological malignancies, which in later result in early diagnosis and specific treatment for gynecological malignant tumors.


Eligibility criteria: Inclusion Criteria:

* Female aging from 16 to 75-year old;
* Preoperative diagnosis of gynecologic malignancies;
* Have the ability to comply with Research programs;
* Voluntarily participate in the study and signed an informed consent form

Exclusion Criteria:

* The cases do not meet the inclusion criteria should be removed from,indicating the reason for excluding.

Primary outcomes:
measure: Gene mutation from species of cervical cancer, endometrial cancers and ovary cancer
timeFrame: 4 years
Secondary outcomes:
measure: the difference between detection sensitivity
timeFrame: 4 years
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Department of Obstetrics and Gynaecology, Southwest Hospital, Third Military
state: Chongqing
Study officials:
References:
Clinical trial NCT03362515: Treatment of Post-Operative Sinonasal Polyposis With Topical Furosemide
Official title: Treatment of Post-Operative Sinonasal Polyposis With Topical Furosemide
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Nasal Polyps
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
First posted: 2017-12-05
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Prior studies have suggested that topical furosemide may reduce the recurrence of sinonasal polyposis following sinus surgery. This project aims to further investigate that claim through a blinded randomized controlled clinical trial following patients who undergo functional sinus surgery for chronic rhinosinusitis with sinonasal polyposis by randomly assigning participants to receive topical furosemide versus placebo nasal spray for 2 months post operatively. Outcomes would be compared at 6 months through endoscopic grading scores using Lund Kennedy and Meltzer scores as well as Sino-Nasal Outcome Test (SNOT-22) scores to measure the rate and degree of recurrence and impact on symptoms in the treatment group versus placebo.


Eligibility criteria: Inclusion Criteria:

* Patients with chronic rhinosinusitis and sinonasal polyposis who are candidates for functional endoscopic sinus surgery

Exclusion Criteria:

* Hypersensitivity to furosemide or sulfonamides
* pregnancy
* history of tinnitus
* history of sensorineural hearing loss
* poorly controlled diabetes
* current diuretic therapy
* known electrolyte disorder
* currently taking aminoglycosides
* BUN and creatinine levels out of the normal range
* history of renal disease
* allergy to sulfonamides

Primary outcomes:
measure: Polyp Recurrence
timeFrame: 6 months
measure: Polyp Recurrence
timeFrame: 6 months
measure: Polyp Recurrence
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Thomas Jefferson University Department of Otolaryngology
state: Pennsylvania
Study officials:
References:
Clinical trial NCT03532815: Lifestyle Intervention for Cardiovascular Disease Risk Factors Among Female Residents at the National Guard Residential City, Jeddah, Saudi Arabia
Official title: A Randomized Controlled Trial of Lifestyle Intervention for Cardiovascular Disease Risk Factors Among Female Residents at the National Guard Residential City, Jeddah, Saudi Arabia, 2015
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Keywords: Cardiovascular Diseases, Framingham risk score, Life style modification, Randomized Controlled Trial
Lead sponsor: King Abdullah International Medical Research Center
Sponsor class: OTHER
First posted: 2018-05-22
Enrollment: 85
Sex: FEMALE
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Cardiovascular disease (CVD) remains the major cause of mortality globally. Applying a comprehensive interventional program based on the individual's risk may reduce the incidence and complications of CVD; thus, helping to decrease the burden on the healthcare system. This study compared the effects of a 3-month intervention involving lifestyle modification and physical activity with standard care in women ≥30 years having a moderate-to-high risk of CVD, with respect to improving physical activity and cardiovascular disease risk factors at the National Guard Residential City in Jeddah, Saudi Arabia, in 2015. The effects of this community-based lifestyle program were assessed through a randomized controlled trial. Women in the intervention group (n=31) received health education, exercise training, and diet counselling as individuals and in groups according to the participant's risk. Women in the control group (n=28) received one health education session at the screening site. The Framingham risk score (FRS) was calculated at baseline and at 3 months for both groups. The mean participant age was 42±8 years.


Eligibility criteria: Inclusion Criteria:

1. Women aged ≥ 30 years.
2. The participants must be at moderate to high-risk of CVD according to FRS.

Exclusion Criteria:

1. Women aged \< 30 years.
2. Women aged ≥ 30 years with low risk of CVD according to FRS.
3. Pregnant women.
4. Female patients diagnosed with CVD.

Primary outcomes:
measure: Framingham Risk Scores Reduction
timeFrame: 3 months
Secondary outcomes:
measure: Framingham Risk Category Changes
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
affiliation: KAIMRC
name: Jumana Khouja, MD, SBCM
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cox JL, Vallis TM, Pfammatter A, Szpilfogel C, Carr B, O'Neill BJ. A novel approach to cardiovascular health by optimizing risk management (ANCHOR): behavioural modification in primary care effectively reduces global risk. Can J Cardiol. 2013 Nov;29(11):1400-7. doi: 10.1016/j.cjca.2013.03.007. Epub 2013 Jun 21.
Clinical trial NCT02362815: Ultrasound Assessment of Clear Liquid Intake During Labour
Official title: Fluid Intake During Labour, Ultrasound Evaluation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia
Lead sponsor: Hopital Foch
Sponsor class: OTHER
First posted: 2015-02-13
Enrollment: 156
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: We designed a two arms prospective, randomised, simple blinded trial to compare the impact of clear liquid intake on gastric content before delivery. We hypothesize that there will be no difference between the two groups, leading to safety of clear liquid intake during labour.

Detailed description: Gastric emptying is a major concern for anesthetists in obstetric. In order to prevent the risk of gastric aspiration, we are used to forbid to eat and to drink during labour.

However, this behaviour is controversial and some studies have shown that clear liquid intake can be safe during labour. Informations from a bedside ultrasound examination of the stomach content may be a useful tool to balance benefits and risks of such attitude. This technique has recently been shown very promising in pregnant women for the assessment of the gastric volume.

Eligibility criteria: Inclusion Criteria:

* Any pregnant woman at term

Exclusion Criteria:

* Pathologic pregnancy
* Twin pregnancy
* Body mass index above 35 kg/m2 before pregnancy
* Cervix dilation above 8 cm
* Refusal

Primary outcomes:
measure: Percentage of parturients with a full stomach
timeFrame: average of 6 hours
Secondary outcomes:
measure: Parturient comfort
timeFrame: average of 6 hours
measure: Evolution of the antral area
timeFrame: average of 6 hours
measure: Anxiety
timeFrame: average of 6 hours
measure: Pain intensity
timeFrame: average of 6 hours
Other outcomes:
Locations:
city: Suresnes
country: France
facility: Hopital Foch
state: Hauts-de-Seine
city: Paris
country: France
facility: Tenon
state: Ile De France
city: Montreuil
country: France
facility: CHI Andre Gregoire
Study officials:
References:
citation: Rousset J, Clariot S, Tounou F, Burey J, Hafiani EM, Feliot E, Quesnel C, Bonnet F, Fischler M. Oral fluid intake during the first stage of labour: A randomised trial. Eur J Anaesthesiol. 2020 Sep;37(9):810-817. doi: 10.1097/EJA.0000000000001278.