louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01824472: Understanding the Sleep Apnea/Insomnia Interaction
Official title: Understanding the Sleep Apnea/Insomnia Interaction: a CPAP/Sham-CPAP Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Apnea Syndromes
Sleep Initiation and Maintenance Disorders
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2013-04-04
Enrollment: 45
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: Nearly half of all patients with obstructive sleep apnea have insomnia symptoms, and in some, but not all cases, these insomnia symptoms are caused by the obstructive sleep apnea. The purpose of this study is to find out what type of insomnia symptoms are caused by obstructive sleep apnea and therefore most likely to respond to obstructive sleep apnea treatment with continuous positive airway pressure (also known as CPAP) and if additional treatment with cognitive-behavioral therapy for insomnia is beneficial.


Eligibility criteria: Inclusion Criteria:

1. Sleep Apnea
2. Insomnia
3. Age \>18

Exclusion Criteria:

1. Sedative/psychoactive drug use recently
2. Other clinically significant sleep disorders
3. Previous treatment for obstructive sleep apnea (OSA)
4. Requires oxygen or bilevel PAP therapy
5. Clinically unstable medical condition
6. Recent shift work
7. Significant alcohol use
8. Other clinically significant causes of insomnia
9. Illicit drug use
10. Prescription stimulants
11. Safety restrictions
12. Unable to treat sleep apnea with positive airway pressure therapy
13. Communication barriers
14. Cognitive impairment

Primary outcomes:
measure: Insomnia Severity Index Score
timeFrame: Between Baseline and Day 42.
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania Health System
state: Pennsylvania
Study officials:
References:
Clinical trial NCT01634672: Prevalence of Gastroesophageal Reflux Disease in Peritoneal Dialysis and Hemodialysis Patients
Official title: Prevalence of Gastroesophageal Reflux Disease in Peritoneal Dialysis and Hemodialysis Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gastroesophageal Reflux Disease
Keywords: Gastroesophageal Reflux Disease
peritoneal dialysis
hemodialysis
Lead sponsor: Konyang University Hospital
Sponsor class: OTHER
First posted: 2012-07-06
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with chronic kidney disease undergoing peritoneal dialysis and hemodialysis over 1 year were enrolled

Brief summary: The purpose of this study is to determine the prevalence of GERD among chronic kidney disease with peritoneal dialysis and hemodialysis in Korea.

Detailed description: Gastroesophageal reflux disease is a common upper gastrointestinal disorder in chronic kidney disease. But, little is known about the prevalence in dialysis patients. The aims of this study were to determine the prevalence of GERD among chronic kidney disease with peritoneal dialysis and hemodialysis in Korea.

Eligibility criteria: Inclusion Criteria:

* peritoneal dialysis and hemodialysis patients

Exclusion Criteria:

* a history of abdominal surgery or with a proton pump inhibitor before 1 month and a eradication of H. pylori were excluded

Primary outcomes:
measure: prevalence of GERD among chronic kidney disease with peritoneal dialysis and hemodialysis
timeFrame: 2 yrs
Secondary outcomes:
measure: risk factor for GERD in peritoneal dialysis and hemodialysis patients
timeFrame: 2 yrs
Other outcomes:
Locations:
city: Daejon
country: Korea, Republic of
facility: Konyang Univ.Hospital
Study officials:
affiliation: Konyang University Hospital
name: Hyun jung Song, Bechelor's
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03062072: Emergence of Chemotherapy Related Hyperglycemia in nOn-diabetic Patients
Official title: Emergence of Chemotherapy Related Hyperglycemia in nOn-diabetic Patients (ECHO)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cancer
Colon Cancer
Breast Cancer
Malignant Lymphoma
Keywords: normoglycemia
cancer
chemotherapy
Hyperglycemia Drug Induced
Lead sponsor: National Cancer Center, Korea
Sponsor class: OTHER_GOV
Collaborators: name: SMG-SNU Boramae Medical Center
First posted: 2017-02-23
Enrollment: 300
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: The patients with advanced cancers (colorectal, breast) who treated with curative intents, and ones with malignant lymphoma who are expected to achieve complete remission with chemotherapy (mainly, CHOP regimen)

Brief summary: To assess chemotherapy related hyperglycemia in non-diabetic patients, the investigators will assess the incidence of hyperglycemia and analyze co-medications and risk factors.


Eligibility criteria: Inclusion Criteria:

* Patients with cancers (colorectal, breast) who treated with curative intents and ones with malignant lymphoma who are expected to achieve complete remission with chemotherapy (mainly, CHOP regimen)
* Patients without history of diabetes mellitus
* Normal glucose tolerance, as defined in the protocol

Exclusion Criteria:

* Patients with diabetes mellitus or hyperglycemia, as defined in the protocol

Primary outcomes:
measure: Incidence of type 2 diabetes mellitus
timeFrame: during chemotherapy (about 1 year)
Secondary outcomes:
measure: Change in HbA1c
timeFrame: during chemotherapy (about 1 year)
measure: Change in glycated albumin
timeFrame: during chemotherapy (about 1 year)
measure: Recurrence free survival (RFS)
timeFrame: from the Date of enrollment to the date of disease recurrence or date of any cause assessed upto 100 months
Other outcomes:
Locations:
city: Goyang
country: Korea, Republic of
facility: National Cancer Center, Korea
city: Seoul
country: Korea, Republic of
facility: Seoul National University Boramae Medical Center
Study officials:
affiliation: National Cancer Center, Korea
name: Eun Kyung Lee
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lee EK, Koo B, Hwangbo Y, Lee YJ, Baek JY, Cha YJ, Kim SY, Sim SH, Lee KS, Park IH, Lee H, Joo J, Go S, Heo SC, Moon MK. Incidence and disease course of new-onset diabetes mellitus in breast and colorectal cancer patients undergoing chemotherapy: A prospective multicenter cohort study. Diabetes Res Clin Pract. 2021 Apr;174:108751. doi: 10.1016/j.diabres.2021.108751. Epub 2021 Mar 17.
Clinical trial NCT02930746: Sun Protection Factor Assay (SPF Assay 199/2016)
Official title: Sun Protection Factor (SPF) Assay: UVA Protection Factor Assay Minimal Persistent Pigment-Darkening Dose
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sunscreening Agents
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2016-10-12
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: To evaluate the Sun Protection Factor efficacy on human skin.


Eligibility criteria: Inclusion Criteria:

* Fitzpatrick Skin Type l, ll and/or lll for UVB testing. Fitzpatrick Skin Type ll, lll and/or lV for UVA testing.
* Male and female.
* Aged between 18-70 years old.
* Good health as determined from the HRL SHF (Subject History Form).
* Signed and dated Informed Consent Form.
* Signed and dated HIPAA (Health Insurance Portability and Accountability Act) form.
* An unambiguous MED (Minimal Erythema Dose) or MPPD (Minimal Persistent Pigment Darkening Dose)

Exclusion Criteria:

* Subjects on test at any other research laboratory or clinic.
* Known allergy or sensitivity to sunscreens, cosmetics and toiletries, topical drugs and/or ultraviolet light.
* Pre-existing dermatologic conditions which have been diagnoses by a medical professional (e.g. psoriasis, eczema, etc.)which would interfere with this study.
* Pre-existing other medical conditions (e.g. adult asthma, diabetes).
* Treatment with antihistamines or corticosteroids within one week prior to initiation of the test.
* Treatment with antibiotics within two weeks prior to initiation of the test.
* Chronic medication which could affect the results of the study.
* Known pregnant or nursing women.

Primary outcomes:
measure: Minimal Erythema Dose (MED)
timeFrame: Up to 15 minutes
measure: Minimal Persistent Pigment Darkening Dose (MPPD)
timeFrame: Up to 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Union
country: United States
state: New Jersey
Study officials:
References:
Clinical trial NCT01011946: Staging of Axillary Lymph Nodes Using the PEM Flex Solo II Pet Scanner in Patients With Breast Cancer
Official title: Staging of Axillary Lymph Nodes Using the PEM Flex Solo II Pet Scanner in Patients With Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2009-11-11
Enrollment: 36
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The purpose of this study is to determine if PEM scan can improve axillary lymph node staging by assessing if they are involved by cancer. Your doctor may refer you for a PEM scan, PEM stands for positron emission mammography, a relatively new and advanced application of positron emission tomography or PET scanning. For decades, PET has helped doctors diagnose and treat disease.

Detailed description: Subjects will receive bilateral (both sides) breast and axillary PEM scans. All recruited subjects chosen for the study will have biopsy proven breast cancer and are eligible for chemotherapy. They will undergo bilateral breast MRI for staging which is considered standard of care. Breast MRI and PEM scans will be performed at at baseline (phase 0 or pre-operative phase), 2nd MRI and PEM after 1 to 2 weeks of NAC (phase 1) and 3rd MRI and PEM after 1 to 2 weeks of phase 1 (phase 2). DCE-MRI and PEM will be performed not more than 14 days apart within each phase. Cranio-Caudal (CC) and Medial Lateral Oblique (MLO) PEM views will be performed of both the ipsilateral and contralateral breast and axillae by a Mammography Technologist trained in mammographic positioning.

Eligibility criteria: Inclusion Criteria:

* Women 18-75 years old with newly diagnosed breast cancer who are considered candidates for breast conserving surgery (i.e. lumpectomy).

Exclusion Criteria:

* Children (\<18 years old)
* Pregnant or Lactating women
* Diabetic patients (Type I or II)
* Patients who are scheduled for a sentinel node procedure using radioactive Tc-99m within 24 hours of PEM
* Patients who have NOT undergone a standard of care bilateral breast MRI at UC.

Primary outcomes:
measure: Sensitivity and Specificity of FDG Positron Emission Mammography (PEM) in Identifying Axillary Lymph Node (ALN) Metastases From Breast Cancer
timeFrame: PEM was performed prior to surgery and LN sampling immediately following surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: The University of Chicago Medical Center
state: Illinois
Study officials:
affiliation: The University of Chicago Medical Center
name: Daniel Appelbaum, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06594146: Study of CM313 (SC) Injection in Subjects With Primary Immune Thrombocytopenia (ITP)
Official title: A Randomized, Double-blind, Placebo-controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Initial Efficacy of CM313 (SC) Injection in Subjects With Primary Immune Thrombocytopenia
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Primary Immune Thrombocytopenia
Lead sponsor: Keymed Biosciences Co.Ltd
Sponsor class: INDUSTRY
First posted: 2024-09-19
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This is a randomized, double-blind, placebo-controlled study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and initial efficacy of CM313 (SC) injection in patients with primary immune thrombocytopenia.


Eligibility criteria: Inclusion Criteria:

* 18 years old ≤ 75 years old, male or female.
* Fully understand and are able to comply with the requirements of the protocol and voluntarily sign the informed consent form.

Exclusion Criteria:

* Previously received allogeneic stem cell transplantation or organ transplantation.
* Laboratory abnormalities with clinical significance at screening visit.
* Pregnant or breastfeeding women, or women planning to become pregnant or breastfeeding during the study period; Male partners who plan to become pregnant during the study period.
* With any other situations that are not suitable for participation in this study by the investigator.

Primary outcomes:
measure: Adverse event
timeFrame: Up to Week 16
Secondary outcomes:
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Institute of Hematology & Blood Diseases Hospital
Study officials:
affiliation: Chinese Academy of Medical Sciences
name: Lei Zhang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03530046: High Strong Ion Difference Fluid vs Hartmann's Solution on Acid-Base Status in Sepsis
Official title: A Double-Blind, Randomized Control Trial of Rapidly Infused High Strong Ion Difference Fluid Versus Hartmann's Solution on Acid-Base Status in Sepsis and Septic Shock Patients in the Emergency Department Hospital Pulau Pinang
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Septicemic Shock
Lead sponsor: Clinical Research Centre, Malaysia
Sponsor class: OTHER
First posted: 2018-05-21
Enrollment: 162
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: This is a research to study primarily the effect of rapidly infused high strong ion difference (SID) fluid vs Hartmann's solution in altering the pH and bicarbonate level of the patient, who is in sepsis with metabolic acidosis. Half of the study population gets high SID fluid, while the other half will get Hartmann's solution.

Detailed description: Balanced fluids are preferred in initial resuscitation of septic patients based on several recent studies.

The Stewart's concept on acid-base balance predicts that high strong ion difference (SID) fluid thus will increase the pH level.

High SID fluid are specially formulated by adding sodium bicarbonate into half saline solution, the resultant fluid contains sodium= 145mmol/L and chloride=70mmol/L (SID= 75) as compared to Hartmann's solution with the SID of 20.

Eligibility criteria: Inclusion Criteria:

* age≥18 years
* fulfills 2/3 qSOFA criteria
* presumed infection
* a blood pH at presentation ≤ 7.35
* hyperlactatemia (blood lactate level, \>2mmol/L )

Exclusion Criteria:

* existing cardiac failure, major cardiac arrhythmia, advanced chronic kidney disease or end stage failure
* known pregnancy
* suspected dengue
* primary diagnosis is related to burn, trauma, or drug overdose
* if more than 500cc of resuscitation fluid was administered before enrollment.

Primary outcomes:
measure: pH change
timeFrame: 2 hours
measure: bicarbonate level change
timeFrame: 2 hours
Secondary outcomes:
measure: Lactate level difference
timeFrame: 2 hours
measure: Development of pulmonary edema
timeFrame: 48 hours
measure: 30 days all-cause mortality
timeFrame: 30 days
measure: Length of stay
timeFrame: 90 days
Other outcomes:
Locations:
Study officials:
affiliation: Emergency Department, Hospital Pulau Pinang
name: Chunchiat Yeoh, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01019746: Controlled Propofol Administration
Official title: Comparison of Closed-oop of Propofol Versus Manual Control Using Bispectral Index (BIS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: HYPNOSIS
Keywords: Hypnosis with propofol
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
First posted: 2009-11-25
Enrollment: 40
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 the administration of the standard anesthetic agent (propofol) using this automatic system with the manual administration of propofol by the anesthesiologist.


Eligibility criteria: Inclusion Criteria:

* patients aged 18 to 90 years
* surgery lasting more than 30 min

Exclusion Criteria:

* inability to provide informed consent
* allergies to study drug

Primary outcomes:
measure: Comparison of control administration of propofol with manual administration.
timeFrame: 1 year
Secondary outcomes:
measure: Emergence from anesthesia
timeFrame: 1 year
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: MUHC - Montreal General Hospital
state: Quebec
Study officials:
References:
citation: Hemmerling TM, Charabati S, Zaouter C, Minardi C, Mathieu PA. A randomized controlled trial demonstrates that a novel closed-loop propofol system performs better hypnosis control than manual administration. Can J Anaesth. 2010 Aug;57(8):725-35. doi: 10.1007/s12630-010-9335-z. Epub 2010 Jun 9.
Clinical trial NCT02440269: The Effect of Circadian Rhythms on Norctrend Index in Anesthesia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Patients Needed Surgery and Anesthesia
Except on the Head or Facial Surgery
Lead sponsor: Southwest Hospital, China
Sponsor class: OTHER
First posted: 2015-05-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients who receive surgery and general anesthesia

Brief summary: The purpose of this study is to determine whether the Circadian Rhythms effects on the Norctrend Index in Anesthesia.

Detailed description: It has been reported that circadian rhythm has many aspects of influence on human body. But little is knew about the circadian rhythm affect on Narcotrend index (made in Germany) in total intravenous anesthesia .The investigators' study is to find the relationship between them.

Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists（ASA） Ⅰ - Ⅱ;
* ability to compliance the research plan;
* volunteered and signed for the study ;
* receive surgery and general anesthesia

Exclusion Criteria:

* ASA\>Ⅱ;
* Head or facial surgery
* can't collaborate;

Primary outcomes:
measure: narcotrend index
timeFrame: during operation time
Secondary outcomes:
Other outcomes:
Locations:
city: ChongQing
country: China
facility: Department of Anesthesiology, Southwest Hospital Third Military Medical University
state: Chongqing
Study officials:
References:
citation: Shen JH, Ye M, Chen Q, Chen Y, Zhao HL, Khan A, Yi B, Ning JL, Lu KZ, Gu JT. Effects of circadian rhythm on Narcotrend index and target-controlled infusion concentration of propofol anesthesia. BMC Anesthesiol. 2021 Sep 6;21(1):215. doi: 10.1186/s12871-021-01445-z.
Clinical trial NCT01226069: Effectiveness of Topical Glycerine Sulphate Paste, Hirudoid Cream and Nil Application on Superficial Phlebitis
Official title: To Investigate the Effectiveness of Topical Glycerine Sulphate, Hirudoid Cream and Nil Application in Treating Peripheral Cannula Related Phlebitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infection
Keywords: superficial phlebitis
cannula-related vein inflammation
Glycerine magnesium sulphate
Hirudoid cream
Nursing
Lead sponsor: Tan Tock Seng Hospital
Sponsor class: OTHER
First posted: 2010-10-21
Enrollment: 147
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the interventional study is to compare the different treatment modalities in reducing erythema size and rate of resolving phlebitis.


Eligibility criteria: Inclusion Criteria:

* Patients admitted to the study institution between Dec 2009 and Feb 2010 and observed to develop redness associated with peripheral infusion cannula.

Exclusion Criteria:

* Thrombosis, poor skin condition, and pus seen at the previous puncture.

Primary outcomes:
measure: Erythema size
timeFrame: 5 days
Secondary outcomes:
measure: Time to resolve redness
timeFrame: 5 days
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Tan Tock Seng Hospital
Study officials:
affiliation: Tan Tock Seng Hospital
name: Isabel Ng, MSc Epidemiology
role: PRINCIPAL_INVESTIGATOR
References:
citation: dos Reis PE, Silveira RC, Vasques CI, de Carvalho EC. Pharmacological interventions to treat phlebitis: systematic review. J Infus Nurs. 2009 Mar-Apr;32(2):74-9. doi: 10.1097/NAN.0b013e318198d497.
citation: Almenar L, Hernandez M, Gimeno JV, Palencia M, Algarra F. [Heparinoids versus nitroglycerin in the treatment of superficial phlebitis]. Rev Clin Esp. 1993 Oct;193(5):229-31. Spanish.
citation: Cokmez A, Gur S, Genc H, Deniz S, Tarcan E. Effect of transdermal glyceryl trinitrate and anti-inflammatory gel in infusion phlebitis. ANZ J Surg. 2003 Oct;73(10):794-6. doi: 10.1046/j.1445-2197.2003.02791.x.
citation: Gouping Z, Wan-Er T, Xue-Ling W, Min-Qian X, Kun F, Turale S, Fisher JW. Notoginseny cream in the treatment of phlebitis. J Infus Nurs. 2003 Jan-Feb;26(1):49-54. doi: 10.1097/00129804-200301000-00007.
citation: Vilardell M, Sabat D, Arnaiz JA, Bleda MJ, Castel JM, Laporte JR, Vallve C. Topical heparin for the treatment of acute superficial phlebitis secondary to indwelling intravenous catheter. A double-blind, randomized, placebo-controlled trial. Eur J Clin Pharmacol. 1999 Feb;54(12):917-21. doi: 10.1007/s002280050575.
citation: Gua H, Li Y-J, Ma H-J. Efficacy observation of glycerine magnesium sulphate emulsion on the treatment of phlebitis. Journal of Lanzhou University (Medical Sciences). 2007;33(2):67-69.