louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03890458: The Effect of Vitamin D on Fertility
Official title: Effects of Vitamin D Supplements on Pregnancy Outcomes in Embriyo Transfer Cycles
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Infertility
Infertility, Female
Vitamin D Deficiency
Vitamin D3 Deficiency
Keywords: vitamin D
vitamin D supplementation
infertility
D vitamin deficiency
infertile women
embryo transfer
pregnancy rate
Lead sponsor: Akdeniz University
Sponsor class: OTHER
First posted: 2019-03-26
Enrollment: 118
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Objective: To examine the effect of vitamin D supplements on the pregnancy and clinical pregnancy rate in embryo transfer cycles.

Design: Experimental study with a pre- and post-test. Setting: In Vitro Fertilization Center Patients: Its sample consisted of 118 women, 58 in the experimental group and 60 in the control group.

Intervention(s): At the beginning of the infertility treatment, the experimental group took vitamin D supplements, and the control group did not. Vitamin D supplementation for infertile women includes regulation of a diet rich in vitamin D, educational and motivational interviews about insolation, and taking vitamin D orally.

Main Outcome Measure(s): 25(OH)D and beta HCG levels


Eligibility criteria: Inclusion Criteria:

* 18-45 years old
* literate in Turkish
* voluntary participation
* primarily infertile
* had undergone controlled ovarian hyperstimulation and had a fresh ET
* vitamin D levels lower than 30ng/mL before infertility treatment

Exclusion Criteria:

* patients with uncorrected congenital or acquired uterine anomalies
* bone, parathyroid gland, kidney and liver disorders
* use of anticonvulsants/antacid drugs
* taking dietary supplements contain vitamin D
* secondary infertility

Primary outcomes:
measure: Blood Vitamin D level
timeFrame: The 25 (OH)D levels of the experimental group women were tested on the second or third day of their menstrual cycle. (Pretest)
measure: Blood Vitamin D level
timeFrame: The 25 (OH)D levels of the women were tested on the two weeks after embryo transfer. (Posttest)
Secondary outcomes:
measure: Biochemical pregnancy
timeFrame: HCG levels of the women were evaluated on the two weeks after embryo transfer (Post test)
Other outcomes:
Locations:
city: Antalya
country: Turkey
facility: Murat Özekinci
Study officials:
affiliation: Akdeniz University
name: Gamze Teskereci
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05875558: M-TACE Treatment for Unresectable Hepatocellular Carcinoma
Official title: Lipiodol Combined With Microspheres TACE for Unresectable HCC
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hepatocellular Carcinoma
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2023-05-25
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study aims to investigate the safety and efficacy of transarterial chenmoembolization（TACE） combined with microspheres for unresectable hepatocellular carcinoma(HCC).


Eligibility criteria: Inclusion Criteria:

1. 18≤Age\<80 on day of signing informed consent.
2. Have histologically confirmed diagnosis or radiological diagnosis of HCC with at least one \>3cm targeted lesion.
3. Have Barcelona Clinic Liver Cancer (BCLC) Stage C disease or BCLC Stage B disease, BCLC stage A disease but refuse a surgical or ablation therapy.
4. Have a Child-Pugh Class A/B（\<7） liver score.
5. Have a performance status of 0 or 1 using the ECOG.
6. Have a predicted life expectancy of greater than 3 months.

Exclusion Criteria:

1. The targeted lesions have received TACE or other locoregional therapy within 3 months.
2. Tumor burden over 70% of the liver volume.
3. Lesions can not be measured by mRECIST.
4. Has a diagnosed additional malignancy.
5. Patients with Hb\<9.0g/dL, WBC\<1.0×10\^9/L， TB\>3mg/dL，ALT/AST\>5 UL, ALB\<2.8g/dL， INR\>2.3, Cr \>2mg/mL or CCr\<30mL/min.
6. Severe heart, lung or cerebral disease.

Primary outcomes:
measure: ORR
timeFrame: 1 month after first mTACE
measure: ORR
timeFrame: 3 months after first mTACE
Secondary outcomes:
measure: OS
timeFrame: 1 year
measure: OS
timeFrame: 3 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Department of Interventional Radiology, Zhongshan Hospital, Fudan University.
state: Shanghai
Study officials:
References:
Clinical trial NCT01645358: Helmet Ventilation in Acute Hypercapnic Respiratory Failure
Official title: Hypercapnic Acute Respiratory Failure: Is the Helmet an Effective Interface?"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypercapnic Respiratory Failure
Chronic Obstructive Pulmonary Disease
Keywords: COPD
NIV
Acute Hypercapnic Respiratory Failure
COPD patients with hypercapnic respiratory failure
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2012-07-20
Enrollment: 80
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: Lack of tolerance to the treatment, makes the interface choice for non-invasive ventilation (NIV) one of the key factor. To date the helmet is rarely used in Acute Hypercapnic Respiratory Failure (AHRF), because of its large dead space, despite in hypoxic respiratory failure, it is largely employed as a "rotating" strategy when the facial mask is poorly tolerated.

In a multicenter randomized controlled trial, the investigators will compare the clinical efficacy of a new helmet designed to specifically improve the performance in chronic obstructive pulmonary disease (COPD) versus a full face mask during an episode of AHRF.


Eligibility criteria: Inclusion Criteria:

* pH \< 7,35 and PaCO2 \> 45 mmHg
* respiratory rate \> 20 b/min

Exclusion Criteria:

* hypoxic respiratory failure
* coma
* inability to stand NIV
* lack of informed consent

Primary outcomes:
measure: Arterial Blood gases
timeFrame: at 1 hour after the start of NIV
Secondary outcomes:
measure: Arterial Blood Gases
timeFrame: Once a day at 8 am until discharge
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Sant'Orsola malpighi Hospital
city: Bologna
country: Italy
facility: Sant'Orsola Malpighi
Study officials:
References:
citation: Pisani L, Mega C, Vaschetto R, Bellone A, Scala R, Cosentini R, Musti M, Del Forno M, Grassi M, Fasano L, Navalesi P, Nava S. Oronasal mask versus helmet in acute hypercapnic respiratory failure. Eur Respir J. 2015 Mar;45(3):691-9. doi: 10.1183/09031936.00053814. Epub 2014 Dec 10.
Clinical trial NCT00202358: Perioperative Effect of Atenolol on Cytokine Profiles
Official title: The Effect of Perioperative Atenolol on Post-Operative Cytokines
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Surgery
Keywords: perioperative
beta-blockers
inflammation
outcomes
Lead sponsor: Saini Foundation
Sponsor class: OTHER
Collaborators: name: Medtronic - MITG
First posted: 2005-09-20
Enrollment: 60
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: Studies have shown that beta-blockers such as atenolol when given in the perioperative period reduce morbidity and mortality. One study showed that atenolol given just during the surgery period, seemed to improve outcomes up to 2 years later. This is hard to explain since beta-blockers act on the body by blocking the effects of adrenalin and thereby lowering heart rate and blood pressure.

This study is designed to find out if perioperative atenolol might exert its long term effects through an anti-inflammatory mechanism rather than by lowering heart rate and blood pressure. It is known that inflammation increases after surgery as part of the healing process. However, it is also becoming clear that low-grade chronic inflammation can also lead to long term adverse effects.


Eligibility criteria: Inclusion Criteria:

* elective abdominal, orthopedic, or gynecologic surgery
* ability to give informed consent
* ability to tolerate beta-blocker therapy
* ability to comply with follow-up requirements

Exclusion Criteria:

* currently receiving beta-blocker therapy
* EKG documented 2nd or 3rd degree heart block
* EKG documented sinus bradycardia
* Serum creatinine \> 2.0
* current treatment asthma
* history of rheumatoid arthritis
* history of Crohn's disease
* history of lupus
* history of inflammatory cancer

Primary outcomes:
measure: Postoperative levels of IL-6 and C-Reactive protein
timeFrame: 6 hrs, 48 hrs, 6 weeks
Secondary outcomes:
measure: IL-10, TNF-α
timeFrame: 6 hrs, 48 hrs, 6 weeks
Other outcomes:
Locations:
city: Hyannis
country: United States
facility: Cape Cod Hospital
state: Massachusetts
Study officials:
affiliation: Dept Medicine, Cape Cod Hospital
name: Vikas Saini, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06799858: Localization of Breast Cancer with the Sirius Pintuition Magnetic Seed
Official title: Localization of Breast Cancer with the Sirius Pintuition Magnetic Seed: a Pilot Study in the Czech Republic
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Cancer Surgery
Lead sponsor: Silesian Hospital in Opava
Sponsor class: OTHER
First posted: 2025-01-29
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with non-palpable breast cancer or pathological lymph node localised by magnetic seed Sirius Pintuition.

Brief summary: A prospective pilot study in the Czech Republic examining the use of magnetic seed Sirius Pintuition for the localization of non-palpable malignant breast tumors and pathological lymph nodes.


Eligibility criteria: Inclusion Criteria:

* breast cancer confirmed by a core-cut biopsy
* localisation of non-palpable breast cancer or pathological lymph node with a magnetic seed Sirius Pintuition
* breast cancer surgery in Surgical dpt, Silesian Hospital in Opava

Exclusion Criteria:

* disagree with participation in the study

Primary outcomes:
measure: Hypotesis 1
timeFrame: 1 year
measure: Hypotesis 1_1
timeFrame: 1 year
measure: Hypotesis 1_2
timeFrame: 1 year
Secondary outcomes:
measure: Hypotesis 2
timeFrame: 1 year
measure: Hypotesis 2_1
timeFrame: 1 year
Other outcomes:
Locations:
city: Opava
country: Czech Republic
facility: Silesian Hospital in Opava
Study officials:
References:
Clinical trial NCT04947696: Circulating Epigenetics in Pancreatic Surgery
Official title: Towards Precision Medicine in Pancreatic Surgery - an Integrative Approach Combining Deep Learning, Genetics and Epigenetics
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pancreatic Neoplasms
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2021-07-01
Enrollment: 200
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: Pancreatic cancer patients

Brief summary: The overall objective of the study is to assess DNA-methylation changes in circulating blood cells and cell free DNA in plasma from patients undergoing the Whipples procedure for pancreatic caner


Eligibility criteria: Inclusion Criteria:

* Patients with pancreatic cancer scheduled for the Whipples procedure

Exclusion Criteria:

* Under 18 years of age
* Pregnancy
* Unable to provide informed consent.

Primary outcomes:
measure: Changes in DNA-methylation patterns from the pre to postoperative setting
timeFrame: Up to 30 days postoperatively
Secondary outcomes:
measure: Occurence of a postoperative complication
timeFrame: 30 days postoperatively
measure: Relapse of pancreatic cancer
timeFrame: 2 years from time of operation
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
Study officials:
References:
Clinical trial NCT01119196: The Measurement of Insulin Resistance in Peritoneal Dialysis Patients
Official title: The Measurement of Insulin Resistance in Peritoneal Dialysis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: End Stage Renal Disease
Keywords: Peritoneal Dialysis
Insulin resistance
Lead sponsor: Vanderbilt University
Sponsor class: OTHER
First posted: 2010-05-07
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this study is to examine the relevance of insulin resistance in peritoneal dialysis (PD) patients as well as the means to improve this metabolic derangement. We will do so through a prospective randomized study using Icodextrin as an alternate dialysate solution to routine glucose-based dialysate. We hypothesize that (1) the glucose loading associated with PD leads to impairment in insulin sensitivity, (2) the degree of insulin resistance is dependent on the basal metabolic state (fasting versus stimulated), and (3) the replacement of conventional dialysate with glucose-sparing dialysate preparations will improve insulin resistance and associated metabolic disturbances in PD patients.


Eligibility criteria: Inclusion Criteria:

* Medically stable and receiving stable PD for ≥ 3 months;
* BMI ≤ 45;
* Most recent Kt/V ≥1.7 or Tccr ≥ 50l/week/1.73m2;
* On Glucose lactate-buffered PD solutions with consistent glucose exposure.

Exclusion Criteria:

* Pregnancy or breast-feeding;
* Intolerance to the study protocols;
* Severe, unstable, active, or chronic inflammation disease (active infection, active connective tissue disorder, active cancer, HIV, liver disease);
* Chronic use of anti-inflammatory medication except low dose (\< 10mg/d) prednisone;
* Severe hypokalemia (K+ level \< 3.0 mEq/L);
* Hypercalcemia (Ca++ level \> 11.0 mg/dL);
* Have a glycogen storage disease;
* Intolerant to maltose or isomaltose;
* Allergic to cornstarch or icodextrin;
* Recent abdominal surgery in the past 30 days;
* Chronic Obstructive Lung Disease (COPD) or Interstitial lung disease;
* Insulin-Dependent Diabetes Mellitus (IDDM).

Primary outcomes:
measure: improvement in glucose disposal rate
timeFrame: 12 weeks
Secondary outcomes:
measure: the Pearson or Spearman correlation coefficient values between insulin resistance (IR) measured by insulin clamp study and other methods (e.g., HOMA, QUICKI, OGTT)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Alp Ikizler, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00826696: A Retrospective Review of the Seasonality of Pre-Eclampsia
Official title: A Retrospective Review of the Seasonality of Pre-Eclampsia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Preeclampsia
Keywords: preeclampsia
Lead sponsor: Oklahoma State University Center for Health Sciences
Sponsor class: OTHER
First posted: 2009-01-22
Enrollment: 500
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women of all races who were admitted to OSUMC for delivery of a baby (both cesarean and vaginal deliveries) between 1/1/05 and 12/31/07, with or without a diagnosis of pre-eclampsia.

Brief summary: This retrospective review will will attempt to determine whether our data show a significant difference in number of deliveries of women with pre-eclampsia compared to deliveries without pre-eclampsia during certain months of the year.

Detailed description: This study is a retrospective review of obstetrics charts of women who gave birth at OSU Medical Center between January 01, 2005 and December 31, 2007.

Included will be patient charts of women \> 18 years old who were admitted to OSUMC for delivery (both cesarean and vaginal deliveries) between 1/1/05 and 12/31/07, with and without a diagnosis of pre-eclampsia. The data collected will be recorded in a spreadsheet by month/day of delivery, and whether pre-eclampsia was a diagnosis. Also included will be total number of deliveries per month and total number of pre-eclampsia diagnoses per month. The rate of pre-eclampsia will be calculated.

A contingency table with corresponding chi square test will be performed to determine whether there is a significant relationship of the diagnosis of pre-eclampsia with seasonality, defined primarily by month. Certain data occurring during transition periods between seasons may be excluded from analyses.

Eligibility criteria: Inclusion Criteria:

* Women who gave birth at OSU Medical Center between January 01, 2005 and December 31, 2007 and were \> 18 years old who were admitted to OSUMC for delivery (both cesarean and vaginal deliveries) between 1/1/05 and 12/31/07, with and without a diagnosis of pre-eclampsia.

Exclusion Criteria:

* Females under age 18

Primary outcomes:
measure: Number of women per month who had a diagnosis of pre-eclampsia at OSU Medical Center when they delivered a baby.
timeFrame: Data assessed from patient charts retrospectively
Secondary outcomes:
Other outcomes:
Locations:
city: Tulsa
country: United States
facility: Oklahoma State University Medical Center
state: Oklahoma
Study officials:
affiliation: OSU Center for Health Sciences
name: Nicole Bullock, DO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00530296: CBT to Treat Depression in Renal Patients
Official title: Effectiveness of Cognitive Behavioral Therapy in Patients With End-Stage Renal Disease in Hemodialysis and With Depression
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Depression
End Stage Renal Disease
Keywords: Depression
End stage renal disease
Quality of Life
Cognitive Behavioral Therapy
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2007-09-17
Enrollment: 80
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 purpose of this study is to determine whether Cognitive Behavioral Therapy is effective in the treatment of depression in patients with end-stage renal disease in hemodialysis therapy

Detailed description: Depression is a persistent problem among patients with end-stage renal disease and it does not tend to improve over time. The implementation of effective interventions to treat and prevent recurrence of depressive episodes is needed. The objectives of this study are: 1)the detection of Major Depression in hemodialysis patients; 2)to allocate patients with depression in two groups: structured program of treatment with CBT (group therapy)and control group (conventional psychotherapy at the dialysis unit); and 3)to verify whether after 3 months of CBT there was a remission of depressive symptoms and a improvement of the quality of life in the CBT group.

Eligibility criteria: Inclusion Criteria:

* Patients with a diagnosis of Chronic renal disease (end stage) in hemodialysis for at least 3 months
* Diagnosis of Major depression disorder (4 or more clinical criteria in MINI and a BDI score of 10 or more)

Exclusion Criteria:

* Patients in process of renal transplant with (living donor)
* Psychiatric comorbidity
* Cognitive impairment or mental retardation
* Current substance abuse
* Heart failure, angina pectoris, arrhythmias

Primary outcomes:
measure: Mini International Neuropsychiatric Interview (MINI-DSM-IV) Beck Depression Inventory (BDI)
timeFrame: Baseline; 3 months (end of intervention); follow-up (6 months after the end of the intervention)
Secondary outcomes:
measure: Kidney Disease and Quality of Life Short-form (KDQOL-SF)
timeFrame: Baseline; 3 months (end of intervention); follow-up (6 months after the end of the intervention)
Other outcomes:
Locations:
city: Sao Jose do Rio Preto
country: Brazil
facility: Priscila Silveira Duarte
state: Sao Paulo
Study officials:
affiliation: Federal University of Sao Paulo (UNIFESP)
name: Priscila S. Duarte, MA
role: PRINCIPAL_INVESTIGATOR
affiliation: Federal University of Sao Paulo (UNIFESP)
name: Ricardo CS Sesso, PhD
role: STUDY_CHAIR
affiliation: FAMERP Medical School
name: Maria Cristina OS Miyazaki, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT03200496: Pharmacokinetics and Safety/Tolerability Profiles of DA-5206 Versus Talion® Under Fasting and Fed States in Healthy Male Subjects
Official title: Comparisons of Pharmacokinetics and Safety/Tolerability Profiles Between DA-5206 and Talion® Under Fasting and Fed States in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Dong-A ST Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2017-06-27
Enrollment: 30
Sex: MALE
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is Open-label, Randomized, 3-sequence study to compare of pharmacokinetics and safety/tolerability profiles betweens DA-5206, a SR formulation of bepotastine besilate and Talion®, a IR formulation of bepotastine besilate under fasting and fed states in healthy male subjects


Eligibility criteria: Inclusion Criteria:

* Healthy male volunteer 19 years to 45 years
* Body mass index in the range of 18 to 29 kg/m2 and body weight greater than 50 kg
* The subjects personally signed and dated informed consent document after informed of all pertinent aspects of the study, fully understanding and determided spontaneously to participate

Exclusion Criteria:

* Subject with serious active cardiovascular, respiratory, hepatologic, renal, hematologic, endocrine, urologic, immunologic, dermal, neurologic, or psychological disease or history of such disease
* Subject with acute disease within 28 days before the first dose of Investigational product
* Subject with known for history of disease which affect on the absorption, distribution, metabolism, excretion of drug
* Subjects who are unwilling or unable to use highly effective methods of contraception as outlined in this protocol for the duration of the study

Primary outcomes:
measure: Area under the plasma concentration versus time curve (AUC)
timeFrame: 0~24hr
measure: Peak Plasma Concentration (Cmax)
timeFrame: 0~24hr
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
Study officials:
References: