louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05906186: Study Intestinal Complaints During Chemotherapy.
Official title: Study Intestinal Complaints During Chemotherapy.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Constipation
Keywords: Kiwifruit
Chemotherapy
Lead sponsor: Spaarne Gasthuis
Sponsor class: OTHER
First posted: 2023-06-15
Enrollment: 80
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: For this study adult patients undergoing their first neo adjuvant or adjuvant chemotherapy are included.

Brief summary: Study intestinal complaints during chemotherapy. A prospective study into intestinal complaints in patients undergoing chemotherapy treatment. A pre and post implementation design is used to establish if eating two kiwi fruits per day can prevent constipation.

Detailed description: The Medical Research Involving Human Subjects Act (WMO) does not apply to this research. Nonetheless it will be conducted according to the principals of Good Clinical Practice (GCP), privacy legislation (AVG) and Medical Treatment Agreement Act (WGBO). The consumption of eating two kiwi's a day can be seen as a slight variation on standard advice with regards to a healthy diet. Maintaining a diary may take some time from the participant but at the same time is of use during follow up visits where side effects, including the occurrence of constipation are discussed. The The study is approved by the Advisory Committee on Local Feasibility (ACLU) of the Spaarne Gasthuis.

Eligibility criteria: Inclusion Criteria:

1. First chemotherapy/cytostatics treatment
2. Neo-adjuvant or adjuvant treatment
3. Performance status World Health Organization (WHO) 0-1
4. Age 18+
5. Written informed consent
6. Command of the Dutch language

Exclusion Criteria:

1. Kiwi allergy
2. Patients using standard laxatives prior to the first chemotherapy/cytostatic treatment.
3. Patients with a history of bowel resection
4. Patients with stoma

Primary outcomes:
measure: 1. How common are constipation symptoms in patients undergoing chemotherapy treatment?
timeFrame: 1 year
Secondary outcomes:
measure: 2. Does the use of laxatives decrease when consuming two kiwi's a day?
timeFrame: 1 year
measure: 3. Which interventions against constipation do patients experience as the most comfortable?
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01084486: Effect of Treatment With Insulin Sensitizer on Arterial Properties, Metabolic Parameters and Liver Function in Patients With Nonalcoholic Fatty Liver Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Nonalcoholic Fatty Liver Disease
Keywords: nonalcoholic fatty liver disease
Pulse wave velocity
augmentation index
metformin
Lead sponsor: Wolfson Medical Center
Sponsor class: OTHER_GOV
First posted: 2010-03-10
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: Abstract

Background: Insulin resistance has an important role in the development of nonalcoholic fatty liver disease (NAFLD) and is involved in both pathological processes: hepatic steatosis and atherosclerosis. Therefore, treatment of NAFLD with insulin sensitizers is likely to have a favorable effect towards hepatic steatosis and cardiovascular outcomes.

Objectives: The present study investigated the effect of metformin on arterial properties, metabolic parameters and liver function in patients with NAFLD. Methods In randomized, placebo controlled study, 63 patients with NAFLD were assigned to one of two groups: Group 1 received daily metformin; Group 2 received placebo. Pulse wave velocity (PWV) and augmentation index (AI) were performed using SphygmoCor (version 7.1, AtCor Medical, Sydney, Australia) at baseline and at the end of 4-month treatment period.. Metabolic measures and serum adiponectin levels were determined.


Eligibility criteria: Inclusion Criteria:

* In a single-center study, 63 patients (32 males and 31 females) diagnosed with nonalcoholic fatty liver disease were recruited from the outpatient clinic and evaluated for the study.

Exclusion Criteria:

* Patients with history of unstable angina, MI, CVA or major surgery within the six months preceding entrance to the study.
* Patients with unbalanced endocrine disease or any disease that might affect absorption of medications.
* Patients with plasma creatinine \> 1.5 mg/dl, and electrolyte abnormalities.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Holon
country: Israel
facility: Wolfson Medical Center
Study officials:
References:
citation: Sofer E, Shargorodsky M. Effect of metformin treatment on circulating osteoprotegerin in patients with nonalcoholic fatty liver disease. Hepatol Int. 2016 Jan;10(1):169-74. doi: 10.1007/s12072-015-9649-6. Epub 2015 Jul 22.
citation: Shargorodsky M, Omelchenko E, Matas Z, Boaz M, Gavish D. Relation between augmentation index and adiponectin during one-year metformin treatment for nonalcoholic steatohepatosis: effects beyond glucose lowering? Cardiovasc Diabetol. 2012 Jun 7;11:61. doi: 10.1186/1475-2840-11-61.
citation: Sofer E, Boaz M, Matas Z, Mashavi M, Shargorodsky M. Treatment with insulin sensitizer metformin improves arterial properties, metabolic parameters, and liver function in patients with nonalcoholic fatty liver disease: a randomized, placebo-controlled trial. Metabolism. 2011 Sep;60(9):1278-84. doi: 10.1016/j.metabol.2011.01.011. Epub 2011 Mar 15.
Clinical trial NCT00947986: Mucociliary Clearance Time in Chronic Rhinosinusitis (CRS) Patients After Sinus Surgery
Official title: Effect of Baby Shampoo Nasal Irrigation on Mucociliary Clearance Time in Patients After Sinus Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Rhinosinusitis
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2009-07-29
Enrollment: 60
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: The investigators are looking at the effects of baby shampoo nasal irrigation on the movement of mucous in the nose in patients who have undergone sinus surgery for chronic sinus problems.


Eligibility criteria: Inclusion Criteria:

* CRS
* s/p sinus surgery

Exclusion Criteria:

* nasal polyps

Primary outcomes:
measure: Change in mucociliary clearance time (MCT)
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: UT Department of Otolaryngology Clinic
state: Texas
Study officials:
References:
Clinical trial NCT03172286: Radiofrequency Technic's Impact on Perineal Postpartum Pain
Official title: Radiofrequency Technic's Impact on Perineal Postpartum Pain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Delivery; Injury
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2017-06-01
Enrollment: 62
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double blind study
Primary purpose: TREATMENT

Brief summary: A study in the postpartum period reveals that among women who delivered vaginally and having perineal lesions, between 95 and 100% of them suffer from perineal pain (episiotomy, tears from 1st to 4th degree) to 24 hours of vaginal delivery; and between 60 and 91% 7 days after delivery.

Severe pain that is not taken into account can become chronic pain. It has physical and psychological consequences. It is therefore essential to prevent these risks in young mothers.

The main objective of this study is to assess the efficacy of radiofrequency treatment on perineal pain postpartum, after a vaginal delivery, instrumented or not, in patients with perineal lesions.

A double-blind randomized prospective single-center study will be conducted on patients delivering at Marseille's north hospital.

Women who gave birth to the North hospital site, with perineal lesions (tears, episiotomy) will be invited to enroll in the study.

Patients will be then randomized into two groups, one with radiofrequency treatment, the other without treatment with radiofrequency.

The duration of inclusion is provided over 6 months. Each topic will be followed over a period of 1 month. The total study duration is 7 months.

The expected results are a significant reduction in pain scores during the first days postpartum in women with perineal alteration caused by a vaginal delivery instrumented or not. Also an improvement in the quality of life of patients during the first days.


Eligibility criteria: Inclusion Criteria:

* Patients who naturaly delivered with ou without instruments such as Suction cup, spatulas, forceps
* Patients presenting perineal lesions

Exclusion Criteria:

* Patients who delivered through cesarean section

Primary outcomes:
measure: Pain score using analogical pain scale
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique Hôpitaux de Masreille
Study officials:
affiliation: Assistance Publique Hôpitaux de Marseille
name: Urielle DESALBRES
role: STUDY_DIRECTOR
References:
citation: Bretelle F, Fabre C, Golka M, Pauly V, Roth B, Bechadergue V, Blanc J. Capacitive-resistive radiofrequency therapy to treat postpartum perineal pain: A randomized study. PLoS One. 2020 Apr 27;15(4):e0231869. doi: 10.1371/journal.pone.0231869. eCollection 2020.
Clinical trial NCT04756986: Malic Acid in Treatment of Xerostomia
Official title: Efficacy of Malic Acid Spray in Treatment of Xerostomia in Type II Diabetic Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Xerostomia
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2021-02-16
Enrollment: 52
Sex: ALL
Minimum age (years): 35
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Background: xerostomia is a subjective sensation of dry mouth resulting from quantitative and /or qualitative changes of saliva. Patients receiving drugs like antihypertensives and antidepressants or patients receiving chemotherapy or radiotherapy for treatment of head and neck cancers may suffer from xerostomia. It also can be experienced in patients with systemic diseases like diabetes mellitus, systemic lupus erythematosus, sjogren's syndrome and rheumatoid arthritis. Malic acid spray with concentration of 1% has grabbed the attention over the last few years as an effective treatment for xerostomia.

Study objective: To evaluate the effect of 1% malic acid spray in treatment of xerostomia in type 2 diabetic patients.

Detailed description: This randomized controlled clinical trial included 52 patients with type 2 diabetes mellitus suffering from xerostomia, divided equally into two groups. Group-I was managed by topical spray containing 1% malic. Group- II was managed by a placebo spray. Both groups received the treatment for 2 weeks. Dry mouth questionnaire scores (DMQ) and unstimulated salivary flow rate was collected before and after treatment.

Eligibility criteria: Inclusion Criteria:

* Patients with type 2 diabetes mellitus suffering from xerostomia.
* Patients aged between 35 and 50 years old.
* Glycated hemoglobin less than 7% (28) .
* Duration of diabetes mellitus not less than 4 years and not more than 8 years.

Exclusion Criteria:

* Patients receiving any drugs that cause hyposalivation like anti-hypertensive drugs.
* Patients with any systemic disease reported to produce hyposalivation (sjogren's syndrome, hepatitis c, rheumatoid arthritis and lupus erythematosus) (8).
* Patients receiving chemo-therapy and radio-therapy.
* Mouth breathers.

Primary outcomes:
measure: The unstimulated salivary flow rate
timeFrame: 4 weeks
Secondary outcomes:
measure: scoring of severity of xerostomia
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Dentistry, Alexandria University
Study officials:
affiliation: Alexandria University
name: Eglal M Mousa, PHD
role: STUDY_DIRECTOR
affiliation: Alexandria University
name: Yasmin Y Gaweesh., PHD
role: PRINCIPAL_INVESTIGATOR
affiliation: Alexandria University
name: Noha K. Abo Aasy, PHD
role: PRINCIPAL_INVESTIGATOR
affiliation: Alexandria University
name: Shaimaa A. Muhamed, BDS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03351686: Tranexamic Acid in Preventing Postpartum Hemorrhage in High Risk Pregnancies During Elective Cesarean Section
Official title: The Effect of Tranexamic Acid in Preventing Postpartum Hemorrhage in High Risk Pregnancies During Elective Cesarean Section, a Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Postpartum Hemorrhage
Keywords: tranexamic acid
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2017-11-24
Enrollment: 140
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: postpartum hemorrhage (PPT) represents one of the major causes of maternal mortality . Tranexamic acid is used in many studies in management of PPH in combination with ecobolics. this study aims to evaluate the possible value of the use of tranexamic acid in prevention of postpartum hemorrhage .


Eligibility criteria: Inclusion Criteria:

* Gestational age of 28 weeks or more.
* Chronic Hypertension.
* Preeclapmsia -Eclampsia.
* Multiple pregnancy.
* Uterine Liomyomas.
* Polyhydraminos.
* Fetal macrosomia.
* Associated Thrombocytopenia
* History of postpartum hemorrhage.

Exclusion Criteria:

* Patients with rheumatic heart disease.
* Patients with history Cardiac Valve Replacement.
* Current or past history of DVT.
* Women on any anticoagulant therapy.
* Sensitivity to tranexamic acid
* Pregnancies with any abnormally implanted or located placenta.

Primary outcomes:
measure: prevention of postpartum hemorrhage in high risk group
timeFrame: intraoperative
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Mansoura University
name: Hanan Nabil, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02405286: Prospective Assessment of the Rockall Risk ScoringSystem in Patients With Upper Gastrointestinal Hemorrhage
Official title: Prospective Assessment of the Rockall Risk ScoringSystem in Patients With Upper Gastrointestinal Hemorrhage
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastrointestinal Bleeding
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2015-04-01
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult Egyptian patients with acute upper gastrointestinal bleeding

Brief summary: This study aimed to Assess the validity of the Rockall score for the prediction of rebleeding and death in patients with upper gastrointestinal bleeding.

Detailed description: This present study aimed to evaluate:

Assess the validity of the Rockall score for the prediction of rebleeding and death in patients with upper gastrointestinal bleeding.

1- Technical Design: The technical design included research design, setting, subject and tools for data collection.

Research design:

A descriptive exploratory design was followed to achieve the aim of the study. Study setting: This study was conducted between Tropical department in AinShams university and Gastroenterology and Hepatology department in TheodorBilharz Research Institute.

Sample size: EPI - INFO program version 6 was used for sample size calculation guided by power of the test = 80% - confidence level =95% and accepted margin of error = 5% and risk ratio = 5.5 - total sample minimum accepted = 50 This study included 50 recipients and done Tropical department in Ain Shams university and Gastroenterology and Hepatology department in .

Theodore Bilharz Research Institute

Eligibility criteria: Inclusion Criteria:

* Adult Egyptian patients.
* Patients with acute upper G.I hemorrhage.
* Informed consent.

Exclusion Criteria:

* Refuse to participate in this study.

Primary outcomes:
measure: Clinical condition of the patients with accute upper gastrointstinal bleeding after 48 hours from endoscopy
timeFrame: 48 hours
Secondary outcomes:
measure: number of participants with variceal bleeding and other causes of upper gastrointestinal bleeding regarding the clinical condition after 48 hours
timeFrame: 48 hours
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Egypt Ain Shams center University Hospitals
Study officials:
References:
Clinical trial NCT04597463: The Combination of Endometrial Injury and Freeze All Strategy in Women With a History of RIF
Official title: The Combination of Endometrial Injury and Freeze All Strategy in Women With a History of Repeated Implantation Failure.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endometrial Injury
Hysteroscopy
Repeated Implantation Failures
Keywords: Endometrial injury
Hysteroscopy
RIF
IVF
ART
Lead sponsor: National and Kapodistrian University of Athens
Sponsor class: OTHER
First posted: 2020-10-22
Enrollment: 60
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Endometrial injury in RIF patients
Primary purpose: TREATMENT

Brief summary: The investigators checked the hypothesis whether endometrial injury performed during the cycle before a frozen embryo transfer in women with RIF can improve pregnancy rates

Detailed description: After a freeze all cycle, participants were divided in two groups: an intervention group (n=30), who underwent endometrial injury before the transfer, and a control group (n=30), who underwent no other intervention. The primary outcome was clinical pregnancy rate, while secondary clinical and laboratory parameters. Baseline and cycle characteristics were also compared between groups.

Eligibility criteria: Inclusion Criteria:

* Women with RIF under 42 years old
* BMI 20-30
* Normal endometrial cavity
* FSH \<15 IU/L
* Absence of immunological or hematological disorder

Exclusion Criteria:

* women over 42 years old
* FSH\>15 IU/L
* women with chronic immunological or hematological disorder
* stage III or IV of endometriosis
* women with pathology concerning the endometrial cavity
* women with a medical history of adnexectomy or oophorectomy

Primary outcomes:
measure: Physiological parameter - Live birth rate
timeFrame: 22 weeks
Secondary outcomes:
measure: Physiological parameter -Clinical pregnancy rate
timeFrame: 7 weeks
measure: Adverse event - Miscarriage
timeFrame: 22 weeks
Other outcomes:
Locations:
city: Athens
country: Greece
facility: National and Kapodistrian University of Athens
Study officials:
affiliation: National and Kapodistrian University of Athens
name: Charalampos Siristatidis, Prof
role: STUDY_DIRECTOR
References:
citation: Basile N, Garcia-Velasco JA. The state of "freeze-for-all" in human ARTs. J Assist Reprod Genet. 2016 Dec;33(12):1543-1550. doi: 10.1007/s10815-016-0799-9. Epub 2016 Sep 14.
citation: Barash A, Dekel N, Fieldust S, Segal I, Schechtman E, Granot I. Local injury to the endometrium doubles the incidence of successful pregnancies in patients undergoing in vitro fertilization. Fertil Steril. 2003 Jun;79(6):1317-22. doi: 10.1016/s0015-0282(03)00345-5.
citation: Wong KM, van Wely M, Mol F, Repping S, Mastenbroek S. Fresh versus frozen embryo transfers in assisted reproduction. Cochrane Database Syst Rev. 2017 Mar 28;3(3):CD011184. doi: 10.1002/14651858.CD011184.pub2.
Clinical trial NCT01303263: A Brief Intervention to Improve Cost-effective Resource Use Among Medicine Housestaff
Official title: A Brief Intervention to Improve Cost-effective Resource Use Among Medicine Housestaff
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Graduate Medical Education
Cost-Effectiveness
Keywords: efficiency
cost-awareness
hospitals
graduate medical education
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: Partners Center of Expertise in Quality and Patient Safety
First posted: 2011-02-24
Enrollment: 96
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Allocation: RANDOMIZED

Brief summary: OBJECTIVE: To test a brief intervention designed to improve the cost-effectiveness of care provided by medicine housestaff for hospitalized patients.

HYPOTHESIS: A brief intervention in which medicine residents receive itemized bills for recent patients cared for by them, followed by a discussion on approaches to reducing unnecessary inpatient costs, can result in significant cost reductions without adversely affecting patient outcomes.

Detailed description: We designed a brief educational intervention with two primary objectives: 1) to increase awareness among residents about how their decisions impact the costs of inpatient medical care; and 2) to improve the cost-effectiveness of care provided by residents without adversely affecting patient outcomes. We hypothesized that a brief intervention in which residents receive bills for patients they recently cared for, followed by a discussion on approaches to reducing unnecessary inpatient costs, would reduce costs without adversely affecting patient outcomes.

Eligibility criteria: Inclusion Criteria:

* Internal Medicine Residents on Inpatient Rotations at Brigham \& Women's Hospital

Exclusion Criteria:

* Having a team member who was in either the control group or intervention group in a prior round of this study.

Primary outcomes:
measure: Total Cost
timeFrame: 2 weeks following educational intervention
measure: Lab Cost
timeFrame: 2 weeks following educational intervention
measure: Pharmacy Cost
timeFrame: 2 weeks following educational intervention
measure: Radiology Cost
timeFrame: 2 weeks following educational intervention
Secondary outcomes:
measure: length of stay
timeFrame: 2 weeks after educational intervention
measure: admission to an intensive care unit (ICU)
timeFrame: 2 weeks after educational intervention
measure: 30-day readmission
timeFrame: within 30 days after end of study period
measure: 30-day mortality
timeFrame: within 30 days after end of study period
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham & Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: David Bates, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Brigham and Women's Hospital
name: Benjamin D Sommers, MD, PhD
role: STUDY_DIRECTOR
References: