louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06016985: Effects of Caffeinated Gum on a Basketball-specific Tests in Basketball Players
Official title: National Taiwan University of Sport
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Caffeine
Keywords: Eccentric exercise
basketball
Lead sponsor: National Taiwan Sport University
Sponsor class: OTHER
First posted: 2023-08-30
Enrollment: 14
Sex: MALE
Minimum age (years): 20
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study investigated the effects of chewing 3 mg/kg of caffeinated gum on basketball free throw accuracy and basketball -specific performance. Fifteen trained basketball players with at least a top 8 national ranking were recruited to be participants in this study. After 2 simulation tests to familiarize the experimental procedure, we employed a double blind, randomized crossover design to divide participants into caffeine trial (CAF) and placebo trial (PL). The CAF trial chewed caffeine gum containing 3 mg/kg for 10 minutes, whereas the PL trial chewed a placebo gum without caffeine. After 15 minutes rest, the stationary free throw shooting test, countermovement jump, t-test, 20-meter segmented dash test, squat in the flywheel device and running based anaerobic sprint test were conducted.


Eligibility criteria: Inclusion Criteria:

* 6 years of professional basketball training and with at least a top 8 national ranking
* 6 months of continuous training,
* 3 months of recovery from sports injuries such as strains and sprains.

Exclusion Criteria:

* Non-specialized basketball players.
* has not trained regularly for the past 6 months.
* has recovered from from a sports injury for less than 3 months, or had epilepsy, hypertension, hyperlipidemia, heart disease, arthritis, osteoporosis, brain injury, or a history of caffeine allergy.
* Subjects with previous caffeine allergy response.

Primary outcomes:
measure: stationary free throw
timeFrame: 15 min after intervention
Secondary outcomes:
measure: 20-meter segmented dash
timeFrame: 15 min after intervention
measure: fatigue index
timeFrame: 15 min after intervention
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: National Taiwan University of Sport
Study officials:
References:
Clinical trial NCT01019785: Vitamin D During In Vitro Fertilisation (IVF) - A Prospective Randomized Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Pregnancy Complication
Keywords: Pregnancy rate (pos test, live fetus at 12 weeks, baby home)
Pregnancy complication (Pregnancy hypertension, SGA, diab)
Thrombin generation
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
First posted: 2009-11-25
Enrollment: 1000
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: During IVF treatment women will be randomized into supplementation with a high or a low dose of Vitamin D Main outcome Laboratory pregnancy, live pregnancy at 12 weeks, Baby take home rate, OHSS Secondary outcome: 1. Pregnancy complications (pregnancy hypertension, SGA, Diabetes) 2.Thrombin generation


Eligibility criteria: Inclusion Criteria:

* All women initiating IVF treatment

Exclusion Criteria:

* Women that have entered the study before

Primary outcomes:
measure: Laboratory pregnancy, live pregnancy at 12 weeks, take home baby rate
timeFrame: 4 weeks to 9 month
Secondary outcomes:
measure: Pregnancy complications (pregnancy hypertension, SGA, diabetes)
timeFrame: 9 months
Other outcomes:
Locations:
city: Huddinge
country: Sweden
facility: IVF Unit Karolinska University Hospital, Huddinge
Study officials:
References:
citation: Epstein E, Lindqvist PG, Geppert B, Olsson H. A population-based cohort study on sun habits and endometrial cancer. Br J Cancer. 2009 Aug 4;101(3):537-40. doi: 10.1038/sj.bjc.6605149. Epub 2009 Jun 23.
citation: Lindqvist PG, Epstein E, Olsson H. Does an active sun exposure habit lower the risk of venous thrombotic events? A D-lightful hypothesis. J Thromb Haemost. 2009 Apr;7(4):605-10. doi: 10.1111/j.1538-7836.2009.03312.x.
citation: Showell MG, Mackenzie-Proctor R, Jordan V, Hart RJ. Antioxidants for female subfertility. Cochrane Database Syst Rev. 2020 Aug 27;8(8):CD007807. doi: 10.1002/14651858.CD007807.pub4.
Clinical trial NCT01022385: The Effect of a Very Low-residual Diet on the Preparation Before Capsule Endoscopy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gastrointestinal Complaints
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2009-12-01
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Primary purpose: DIAGNOSTIC

Brief summary: The aim of the proposed study is to compare prospectively two methods of small bowel preparation prior capsule endoscopy study, the effect on the cleanliness and the quality of visualization after two protocols of preparation: a 12 hour fast only versus 24 hour of a very low residual diet (ENSURE, Abbott Laboratories, Israel) + 12 hour fast.


Eligibility criteria: Inclusion Criteria:

* Consecutive patients who will submitted to capsule endoscopy due to following medical indications:

  * suspected Crohn's disease
  * obscure GI bleeding
  * iron deficiency anemia
  * suspected malabsorption disease
  * unexplained abdominal pain
  * unexplained chronic diarrhea

Exclusion Criteria:

* pregnancy
* patients who had previous surgery on Gastrointestinal tract
* patients with previous intestinal obstruction
* patients who will refuse to participate in the study
* diabetes mellitus
* known celiac disease

Primary outcomes:
measure: Cleanliness and better visualization of the small bowel during capsule endoscopy
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Hillel Yaffe Medical Center
Study officials:
References:
Clinical trial NCT02354885: TXA in the EMS on the Helicopter and the Ambulance
Official title: Administration of Tranexamic Acid in the Preclinical Setting and Its Effect on Coagulation Parameters and Outcome in Multiple Trauma Patients and Isolated TBI in EMS (Schutz Und Rettung Zürich) and Helicopter Rescue(REGA).
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Bleeding
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: Cantonal Hospital of St. Gallen
name: Luzerner Kantonsspital
First posted: 2015-02-03
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Coagulopathy in trauma increases mortality and morbidity. Early administration of tranexamic acid (TXA) seems to improve survival and outcome. Thus this study evaluates the administration of TXA on scene by the emergency medical services (EMS) or by the crew of a rescue helicopter in multiple trauma patients or isolated traumatic brain injury (TBI). Coagulopathy will be assessed by standard laboratory tests as well as thromboelastometry.

Detailed description: Coagulopathy in trauma increases mortality and morbidity. Early administration of tranexamic acid (TXA) seems to improve survival and outcome; this was shown partially by the CRASH2 study, where patients received TXA in the emergency room. Thus this study evaluates the administration of TXA on scene by the EMS or by the crew of a rescue helicopter in multiple trauma patients or isolated TBI. Coagulopathy will be assessed by standard laboratory tests as well as thromboelastometry in 50 patients. The results will be compared to a study published by Theusinger et al. (Changes in Coagulation in Standard Laboratory Tests and ROTEM in Trauma Patients Between On-Scene and Arrival in the Emergency Department.Theusinger OM et al. Anesth Analg. 2014 Dec 24. \[Epub ahead of print\] PMID: 25545751) where no TXA was administered on scene and only changes in coagulation between on scene and in the emergency department were assessed.

Eligibility criteria: Inclusion Criteria:

* multiple trauma
* traumatic brain injury

Exclusion Criteria:

* pregnant
* \< 18 years
* no TXA
* not speaking the german language

Primary outcomes:
measure: Tranexamic acid administered in the preclinical setting and its influence on coagulation parameters (laboratory and thromboelastometry)
timeFrame: 12 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich, Division of Anaesthesiology
state: ZH
city: Zurich
country: Switzerland
facility: USZ
Study officials:
affiliation: USZ
name: Oliver M. Theusinger, PD Dr med
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stein P, Studt JD, Albrecht R, Muller S, von Ow D, Fischer S, Seifert B, Mariotti S, Spahn DR, Theusinger OM. The Impact of Prehospital Tranexamic Acid on Blood Coagulation in Trauma Patients. Anesth Analg. 2018 Feb;126(2):522-529. doi: 10.1213/ANE.0000000000002708.
Clinical trial NCT05392985: Detection and Analysis of MBC With Heterogeneous ER Expression
Official title: Chemotherapy Versus Endocrine Therapy in Metastatic Breast Cancer Patients With Heterogeneous Estrogen Receptor Expression
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2022-05-26
Enrollment: 51
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with breast cancer (according to ICD-10) with confirmed metastasis, regardless of being de novo diagnosed or progressed from a non-metastatic stage.

Brief summary: To investigate the treatment pattern and efficacy of MBC patients with ER heterogeneity using a novel convenient way of 18F-fluoroestradiol positron emission tomography/computed tomography (18F-FES PET/CT).


Eligibility criteria: Inclusion Criteria:

* Patients received 18F-FES PET/CT in Fudan University Shanghai Cancer Center from 2017-2021.
* Patients had both FES positive (FES+) and negative (FES-) lesions in FES exam.
* Patients received further treatment.

Exclusion Criteria:

* Incomplete medical records.

Primary outcomes:
measure: PFS
timeFrame: 6 weeks
Secondary outcomes:
measure: Adverse events
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
Study officials:
affiliation: Fudan University
name: Biyun Wang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01511185: Effect of Liraglutide on the Beta-cell Responsiveness in Subjects With Type 2 Diabetes Compared to a Healthy Control Group
Official title: NNC 90-1170 Mechanism of Action: A Double-blind, Randomized, Single-center, Placebo Controlled, Crossover Study to Examine Beta-cell Responsiveness to Graded Glucose Infusion in Subjects With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2012-01-18
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This trial is conducted in the United States of America (USA). The aim of this trial is to assess the effect of NNC 90-1170 on beta-cell responsiveness to increasing blood glucose concentrations in subjects with type 2 diabetes.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with type 2 diabetes, either newly diagnosed with at least 2 months of diet or on OAD monotherapy for at least 3 months
* Body Mass Index (BMI): 24-35 kg/m\^2 inclusive

Exclusion Criteria:

* SUBJECTS WITH TYPE 2 DIABETES
* Receipt of any investigational drug within three months prior to this trial
* Recurrent severe hypoglycemia as judged by the investigator
* Cardiac disease
* Use of any drug (except an OAD (oral anti-diabetic drug)) that in the investigator's opinion could interfere with the blood glucose level
* Haemoglobin maximum 10 g/L
* HbA1c above 12%
* Loss of more than 400 mL blood during the 3 months prior to trial start
* HEALTHY SUBJECTS
* Receipt of any investigational drug within 3 months prior to this trial
* Clinically relevant cardiac disease or any clinically significant abnormal ECG (electrocardiogram)
* Use of any drug that in the investigator's opinion could interfere with the blood glucose level
* Haemoglobin max. 10 g/L
* HbA1c at least 6%

Primary outcomes:
measure: AUC (area under the curve) of Insulin Secretion Rate (ISR) over the 90-216 mg/dL glucose interval
Secondary outcomes:
measure: Slope of the mean ISR vs mean glucose
measure: AUC (area under the curve) of glucagon concentration over the 90-216 mg/dL glucose interval
measure: Insulin Clearance
measure: NNC 90-1 170 plasma concentration
measure: Adverse events
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: Novo Nordisk Investigational Site
state: Michigan
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Chang AM, Jakobsen G, Sturis J, Smith MJ, Bloem CJ, An B, Galecki A, Halter JB. The GLP-1 derivative NN2211 restores beta-cell sensitivity to glucose in type 2 diabetic patients after a single dose. Diabetes. 2003 Jul;52(7):1786-91. doi: 10.2337/diabetes.52.7.1786.
Clinical trial NCT06266585: Clinical Deterioration in Cerebral Venous Thrombosis: A Predictive Study
Official title: Risk Factor Analysis and Development of a Predictive Model for Clinical Deterioration During Hospitalization in Patients With Cerebral Venous Thrombosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebral Venous Thrombosis
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
Collaborators: name: Beijing Chao Yang Hospital
name: Beijing Friendship Hospital
First posted: 2024-02-20
Enrollment: 273
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with cerebral venous thrombosis (CVT)

Brief summary: The objective of this retrospective, prospective, multicenter cohort study is to determine the risk factors for deterioration of CVT patients after admission and establish a scoring model for risk stratification of patients. This study included two stages, the first stage was to enroll CVT patients from a single center from 2017 to 2022 for modeling, and the second stage was to enroll CVT patients from three centers in 2023 for external validation


Eligibility criteria: Inclusion Criteria:

* Age≥ 18 years old
* Patients were diagnosed with cerebral venous thrombosis (CVT) through imaging techniques such as Computed Tomography Venography (CTV), Magnetic Resonance Venography (MRV), or Digital Subtraction Angiography (DSA)
* The diagnostic algorithm for CVT conformed to the current guideline criteria

Exclusion Criteria:

* Patients who had performed endovascular treatment (EVT) or decompressive craniectomy (DC) before admission and those whose primary treatment was EVT or DC rather than conservative treatment after admission
* Patients with severe hepatic or renal insufficiency
* Patients with intracranial tumors
* Patients with other cerebrovascular diseases

Primary outcomes:
measure: Number of Participants with CVT deteriorated on radiology
timeFrame: After admission until discharge, a maximum of 30 days
measure: Number of Participants with altered neurological function
timeFrame: After admission until discharge, a maximum of 30 days
measure: Number of Participants with altered consciousness
timeFrame: After admission until discharge, a maximum of 30 days
Secondary outcomes:
measure: Neurological function at 30th day after onset (mRS)
timeFrame: 30th day after onset
measure: Emergency surgery rates
timeFrame: After admission until discharge, a maximum of 30 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Capital Medical University Affiliated Beijing Tiantan Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT01078285: Effectiveness Of A Program That Includes Counseling And Patient Support On Adherence To Treatment With Lipitor
Official title: Impact Of An Integrated Intervention Program On Adherence To Atorvastatin
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Medication Non-Adherence
Keywords: Integrated program on adherence using counseling
support services including cost-sharing where appropriate and educational materials mailed monthly.
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-03-02
Enrollment: 500
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * Male and female aged \>21 years
* Have received a new or re-fil prescription for atorvastatin at first study visit to Prairie Heart Institute
* Signed informed consent

Brief summary: Despite extensive reports of the benefits of statins in reducing serious cardiovascular events such as stroke and heart disease in patients with elevated LDL-cholesterol, patients do not take their medicines regularly as prescribed. Reasons include forgetfulness, lack of understanding of the seriousness of the disease, and fear of side effects. An intervention strategy comprising 3-5 minutes of counseling, emotional support and cost-sharing may be motivational and improve adherence to treatment.


Eligibility criteria: Inclusion Criteria:

* Male and female aged \>21 years
* Have received a new or re-fil prescription for atorvastatin at first study visit to Prairie Heart Institute
* Signed informed consent

Exclusion Criteria:

* Unwilling to give written informed consent
* Failed statin treatment in the past
* Switched from another statin to atorvastatin because of co-pay program
* Participated in an earlier Market Research study on Impact of cholesterol management behaviors post in-clinic adherence intervention

Primary outcomes:
measure: Proportion of Days Covered (PDC)
timeFrame: 180 days
Secondary outcomes:
measure: Medication Possession Ratio (MPR)
timeFrame: 180 days
measure: Persistence-the number of continuous days a patient is supplied with medication using the allowable grace period or gap (30 or 60 days).
timeFrame: 180 days
measure: Percent of patients that are at least 80% adherent (PDC>0.8)
timeFrame: 180 days
measure: Percent of patients who fill at least one atorvastatin prescription during the period of study
timeFrame: 180 days
Other outcomes:
Locations:
city: Springfield
country: United States
facility: Prairie Heart Institute
state: Illinois
city: Springfield
country: United States
facility: Memorial Medical Center
state: Illinois
city: Springfield
country: United States
facility: Prairie Diagnostic Center
state: Illinois
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT02188485: Social Connections and Late Life Suicide
Official title: Social Connections and Late Life Suicide
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Suicidal Ideation
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2014-07-11
Enrollment: 62
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: With the long-term goal of improving interventions for late-life suicide, the purpose of this study is to examine whether a mechanism by which behavioral interventions reduce risk for late-life suicide is by increasing social connectedness. The investigators propose to examine whether a manualized intervention that targets connectedness--ENGAGE--increases connectedness in older adults who report clinically significant depression and disconnectedness-operationalized as feeling lonely and/or like a burden on others. The investigators propose a randomized controlled trial comparing the ENGAGE intervention with care-as-usual (CAU), using n=100 primary care patients aged ≥ 60 years who report social disconnectedness (i.e., loneliness or burdensomeness) and either Minor or Major Depression. At baseline, 3-week, 6-week and 10-week assessments, subjects will report on social connectedness, depression, and suicide risk. The investigators hypothesize that those subjects assigned to ENGAGE will report greater increases in connectedness-measured as greater belongingness and lower burdensomeness-compared to CAU; that ENGAGE will produce greater reductions in depression and suicide ideation than CAU; and that changes in depression will be accounted for changes in social connectedness.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 60 yrs;
* English speaking;
* Reside in the community;
* Endorse social disconnectedness, as measured by feeling lonely and/or like a burden on others;
* Meet criteria for Minor or Major Depression.

Exclusion Criteria:

* Imminent risk for suicide;
* Active psychosis;
* Significantly impaired cognitive functioning (i.e., MOCA \<23);
* Active substance abuse in the last year (AUDIT score of 5 or more);
* Hearing loss that precludes comfortable communication;
* Residence in a long-term care facility.

Primary outcomes:
measure: Social Connectedness
timeFrame: 10 weeks
Secondary outcomes:
measure: Suicide Ideation
timeFrame: 10 weeks
measure: Depression
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester
state: New York
Study officials:
affiliation: University of Rochester
name: Kimberly A Van Orden, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Van Orden, K. A., et al.