louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02844153: Metformin Use in Chronic Kidney Disease: The CKD-Met Study
Official title: Metformin Use in Chronic Kidney Disease: The CKD-Met Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Type 2 Diabetes
Chronic Kidney Disease
Keywords: Metformin
type 2 diabetes
chronic kidney disease
antidiabetic medications
lactic acidosis
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2016-07-26
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with type 2 diabetes seen by a nephrologist at the University hospital of Lyon Sud, between March 2014 and March 2020

Brief summary: Metformin is the most widely prescribed oral treatment for diabetes, and the only one that showed a survival benefit.

Yet, there is no consensus on the optimal dose and withdrawal of metformin in chronic kidney disease (CKD) patients.

The aim of the study is to describe the use and side-effects of metformin in CKD patients in routine practice.


Eligibility criteria: Inclusion Criteria:

* 18 years old or more
* Type 2 diabetes
* Seen by a nephrologist (consultation or hospitalization) between March 2014 and March 2020 in the Department of Nephrology, Lyon Sud university hospital, France

Exclusion Criteria:

* On-going treatment by dialysis
* Kidney transplantation
* Type 1 diabetes
* Missing data (metformin treatment)

Primary outcomes:
measure: Percentage of patients receiving metformin
timeFrame: every January 1st up to 2020
Secondary outcomes:
measure: Dose of metformin
timeFrame: every January 1st up to 2020
measure: Occurence of reasons for non-prescription of metformin
timeFrame: every January 1st up to 2020
measure: CKD stages
timeFrame: every January 1st up to 2020
measure: Doses of oral antidiabetes medications
timeFrame: every January 1st up to 2020
measure: starting time of insulin
timeFrame: every January 1st up to 2020
measure: occurrence of lactic acidosis
timeFrame: every January 1st up to 2020
Other outcomes:
Locations:
city: Pierre-Bénite
country: France
facility: Claude Bernard University, Lyon, France, Lyon Sud university hospital
Study officials:
affiliation: Claude Bernard University, Lyon, France, Lyon Sud university hospital
name: Denis FOUQUE, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Coliche V, Koppe L, Laville M, Nouvier M, Pelletier S, Trolliet P, Fouque D. Metformin misuse in chronic kidney disease. Diabetes Metab. 2020 Sep;46(4):337-339. doi: 10.1016/j.diabet.2018.07.005. Epub 2018 Jul 24. No abstract available.
Clinical trial NCT00843453: Long-term Use of Proton Pump Inhibitors May Cause Vitamin B12 Deficiency in the Institutionalized Elderly
Official title: Long-term Use of Proton Pump Inhibitors May Cause Vitamin B12 Deficiency in the Institutionalized Elderly
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vitamin B12 Deficiency
Keywords: vitamin B12 deficiency
cyanocobalamin deficiency
proton pump inhibitors
omeprazole
Lead sponsor: University of Delaware
Sponsor class: OTHER
First posted: 2009-02-13
Enrollment: 36
Sex: ALL
Minimum age (years): 60
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This study was designed to determine whether elderly residents of long term care facilitated who had been taking proton pump inhibitors (PPI) for more than 12 months were more likely to have vitamin B12 deficiency than residents not taking PPI, and whether cyanocobalamin nasal spray improved these subjects' vitamin B12 status.

Detailed description: Subjects had serum creatinine \<1.8 mg/dL, no diagnosis of severe megaloblastic or pernicious anemia, and had not been taking vitamin B12 supplements. At baseline, serum vitamin B12 and methylmalonic acid (MMA) concentrations of 34 subjects from the PPI group were compared with those of the non-PPI group. The PPI group (n=13) was treated with cyanocobalamin nasal spray for eight weeks, and post-treatment vitamin B12 and MMA concentrations were compared with baseline concentrations.

Eligibility criteria: Inclusion Criteria:

* age 60-89 years
* PPI use for \>12 months (PPI group)
* no PPI use for 30 days prior to arm 1
* long term care resident

Exclusion Criteria:

* pernicious anemia
* severe megaloblastic anemia
* free-living
* serum creatinine \> 1.8 mg/dL

Primary outcomes:
measure: serum vitamin B12
timeFrame: baseline and after 8 weeks of treatment
measure: serum methylmalonic acid (MMA)
timeFrame: at baseline and after eight weeks of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Manchester
country: United States
facility: Long View Nursing Home
state: Maryland
city: Timonium
country: United States
facility: Stella Maris Nursing Home
state: Maryland
Study officials:
affiliation: University of Delaware
name: Nancy R Rozgony, RD< LD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Delaware
name: Chengshun R Fang, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00812253: Intensive Glycemic Control for Congestive Heart Failure Exacerbation
Official title: Intensive Glycemic Control for Congestive Heart Failure Exacerbation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Congestive Heart Failure
Diabetes Mellitus
Keywords: Heart failure
Hyperglycemia
Hospital
Diabetes Mellitus
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2008-12-22
Enrollment: 74
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: Patients with heart failure often have high blood sugar (glucose).

Detailed description: Patients with heart failure often have high blood sugar. High glucose contributes to severe hospital complications and even death. Studies suggest that heart failure patients who have high glucose or diabetes do not live as long as patients with normal glucose. In this study, we will determine whether normalizing blood sugars using intravenous insulin short-term will improve outcomes in patients hospitalized for congestive heart failure. We enrolled patients with severe heart failure and randomly assigned them into 2 groups. We used intravenous (given through the vein) insulin to lower blood sugar levels in group 1, and insulin injections in group 2. We determined whether intravenous insulin improved hospital length of stay, rates of readmission, inflammatory markers, and cardiovascular tests that predict mortality in patients with heart failure.

Eligibility criteria: Inclusion Criteria:

* Age 18 and above
* Admitted (less than 48 hours) to the OSU Ross Heart Hospital with worsening heart failure
* Hyperglycemia or diabetes. Hyperglycemia is defined as blood glucose greater than 150 mg/dL on at least 2 occasions separated by at least 4 hours apart, insulin use, or HbA1c \>6.5%.

Exclusion Criteria:

* Type 1 diabetes
* Receiving comfort care measures only
* Hospital stay expected to be less than 2 days
* Pregnancy
* Prisoners
* Participation in the study on prior hospitalizations
* Acute myocardial infarction within 3 months
* End stage renal or liver disease

Primary outcomes:
measure: Hospital Length of Stay
timeFrame: Days
Secondary outcomes:
measure: Hospital Readmission
timeFrame: 30 days
measure: Heart Rate Variability
timeFrame: 72 hours
measure: Change in Quality of Life
timeFrame: 30 day
measure: Brain Natriuretic Peptide (BNP)
timeFrame: 72 hours
measure: Cardiac Output
timeFrame: 72 hours
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
Study officials:
affiliation: Ohio State University
name: Kathleen M Dungan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05891353: Pain Modulatory Profiles in Stretching
Official title: Pain Modulatory Profiles in Stretching in Healthy Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: University of Central Florida
Sponsor class: OTHER
First posted: 2023-06-06
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to characterize immediate changes in pain sensitivity during stretching to the point of pain, stretching in a pain free range, and a cold water immersion task. Participants will attend three sessions during which they will undergo pain sensitivity assessment and complete the assigned intervention.


Eligibility criteria: Inclusion Criteria:

* Pain Free

Exclusion Criteria:

* Non-English speaking
* Regular use of prescription pain medications
* Current or history of chronic pain condition
* Currently taking blood-thinning medication
* Any blood clotting disorder, such as hemophilia
* Systemic medical condition known to affect sensation, such as uncontrolled diabetes or neurological conditions
* Any contraindication to the application of ice, such as: uncontrolled hypertension, cold urticaria, cryoglobulinemia, paroxysmal cold hemoglobinuria, circulatory compromise
* Not physically ready to exercise without a medical exam as indicated by the Physical Activity Readiness Questionnaire Plus (PAR-Q+)
* Surgery, injury, or fracture to the neck or upper extremity within the past 6 months
* Unable to perform the stretch
* Unable to attend all three sessions

Primary outcomes:
measure: Change in Pressure Pain Threshold
timeFrame: Change in PPT is applied between minutes 1 and 4
Secondary outcomes:
Other outcomes:
Locations:
city: Orlando
country: United States
facility: University of Central Florida
state: Florida
Study officials:
References:
Clinical trial NCT06005753: Surgical Treatment of Injuries and Consequences of the Acetabulum
Official title: Improving the Surgical Treatment of Injuries and Consequences of Injuries of the Acetabulum
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acetabular Fracture
Keywords: acetabulum
osteosynthesis
Stoppa approach
fracture
Lead sponsor: National Scientific Center of Traumatology and Orthopedics named after academician N.D. Batpenov
Sponsor class: OTHER_GOV
First posted: 2023-08-22
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of the program is to develop technologies for the diagnosis and treatment of injuries and consequences of the pelvis.

Purpose: to improve the technique of surgical treatment of acetabular fractures.

Detailed description: Tasks: Implementation of low-traumatic access to the acetabulum; introduction of a new implant for osteosynthesis of complex acetabular fractures into clinical practice; мathematical modeling of fixation of the acetabulum with a new implant; рublication of the results of the work carried out The relevance of the use of new implants in orthopedics is due to the problem of adaptation of implants in the body, especially with poor quality of bone tissue. Currently, work is underway to improve the materials and shapes of implants, new alloys are being studied, polymer implants are being introduced, but the problem of their integration into bones remains. A promising direction in orthopedics is the creation of implants as close as possible in their morphological shape and elasto-strength properties to human bone. But the creation of an absolute copy of the bone structure from a metal alloy leads to a weakening of its strength and loss of fixation stability, and subsequent lysis of the adjacent bone tissue.

All this indicates the need for further search for new, perhaps more promising and effective ways to solve this problem.

Eligibility criteria: Inclusion Criteria:

* patients over 18 years of age
* patients with acetabular fractures undergoing surgery
* acetabular fractures according to the classification of Judet and Letournel

Exclusion Criteria:

* patients under 18 years of age
* posterior wall fracture according to the classification of Judet and Letournel

Primary outcomes:
measure: consolidation of fracture
timeFrame: 1 year follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Astana
country: Kazakhstan
facility: Center of National Scientific center Of Traumatology and Orthopedics named after academician N.D. Batpenov
Study officials:
References:
Clinical trial NCT05752253: Counseling Intervention in Hereditary Hemorrhagic Telangiectasia in the COVID Era.
Official title: Counseling Intervention in Hereditary Hemorrhagic Telangiectasia in the COVID Era.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hereditary Hemorrhagic Telangiectasia
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2023-03-02
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: SCREENING

Brief summary: The goal of this interventional study is to determine the incidence of depression, anxiety, sleep disturbances and resilience in a sample of subjects affected by Hereditary Hemorrhagic Telangiectasia. The study is declined through the evaluation of some outcome parameters at the time of enrollment (T0), during the counseling intervention (T1 and T2) and at the end (T3) of the subjects who will have carried out an individual counseling intervention.


Eligibility criteria: Inclusion Criteria:

Recruited subjects have a diagnosis of Hereditary Hemorrhagic Telangiectasia and are 18 years of age or older.

Exclusion Criteria:

Previous or current intellectual disability and a diagnosis of psychiatric disorders in accordance with the Diagnostic and Statistical Manual of Mental Disorders, DSM-5.

Primary outcomes:
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: 12 months
measure: Connor-Davidson Resilience Scale (CD-RISC)
timeFrame: 12 months
measure: Pittsburgh Sleep Quality Index (PSQI);
timeFrame: 12 months
Secondary outcomes:
measure: Impact of counseling on clients affected by rare diseases
timeFrame: 12 months
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Fondazione Policlinico Gemelli IRCCS
Study officials:
References:
Clinical trial NCT00696553: Nutrition and Resistance Training in Head and Neck Cancer
Official title: Randomized Trial of Specialized Nutrition Therapy (SNT) Versus SNT Plus Resistance Training (RT) in Head and Neck Cancer Patients Undergoing Concurrent Chemo-Radiation Therapy (CCR)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Head and Neck Cancer
Lead sponsor: Vanderbilt University
Sponsor class: OTHER
Collaborators: name: Lance Armstrong Foundation
name: Société des Produits Nestlé (SPN)
First posted: 2008-06-12
Enrollment: 60
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: To test the effects of nutrition versus nutrition with resistance exercise on muscle mass loss, fatigue and outcomes of concurrent chemo radiation.


Eligibility criteria: Inclusion Criteria:

* Stage 3 or 4 HNC

Exclusion Criteria:

* Previous Cancer

Primary outcomes:
measure: muscle mass loss
timeFrame: 6 months
Secondary outcomes:
measure: fatigue
timeFrame: 6 months
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
Study officials:
affiliation: Vanderbilt University
name: Heidi J Silver, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00524953: Phase I Clinical Trial to Assess Safety of UV Phototherapy for the Prevention of GVHD Post Allogeneic SCT
Official title: Phase I - Clinical Trial to Assess Safety of Ultraviolet (UV) Phototherapy for the Prevention of Graft Versus Host Disease After Allogeneic Stem Cell Transplantation
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Allogeneic Transplantation (Non T-cell Depleted)
Keywords: allogeneic bone marrow transplantation
non-T-cell depleted
UV-c
GVHD
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2007-09-05
Enrollment: 0
Sex: ALL
Minimum age (years): 14
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The primary goal of thos study is to assess safety of Ultraviolet (UV) Phototherapy for the Prevention of Graft versus Host Disease after allogeneic stem cell transplantation (Phase I - Clinical trial). Following allogeneic BMT, patients will be placed on standard GVHD preventive therapy (cyclosporine).

Secondary goals -

* monitoring immune system recovery
* the influence of stem cells origin on therapy and/orGVHD prevention
* the influence of UV-c treatment on survival

clinical data and samples will be collected, during UV-c therapy, 100 days after discharge \& 6 months after discharge - to examine the long-term effect of UV-c treatment on the patient's GVHD status.

Detailed description: Treatment will be given with a portable, easy to operate device named "EUMATRON". this device contains a UV- lamp. 250 cc of blood from a peripheric vein is going through the device into a bottle with Low dose Heparin and returning to patient's body. procedure takes \~20 minutes.

Eligibility criteria: Inclusion Criteria:

* patients post non T cell depleted allogeneic stem cell transplantation

Exclusion Criteria:

* morbidity unrelated to GVHD
* patients in an hemodynamic unstable condition
* acute uncontrolled bleeding
* patients undergoing dialysis

Primary outcomes:
measure: safety and tolerability of UV-c phototherapy for the Prevention of Graft versus Host Disease after allogeneic stem cell transplantation
timeFrame: 6 months
Secondary outcomes:
measure: monitoring immune system recovery, influence on survival rates, influence of stem cells origin on treatment & prevention of GVHD
timeFrame: 100 days, 6 months
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
Study officials:
affiliation: Bone Marrow transplantation, cancer immunotherapy & immunobiology research center, Hadassah University Hospital, Ein - Kerem, Jerusalem, Israel
name: Reuven Or, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03130153: Topical Analgesic Versus Saline Mouth Rinses in Post Extraction Healing
Official title: Comparison of Topical Analgesic With Saline Rinses in Post Extraction Healing Among Hypertensive and Non-Hypertensive Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Tooth Extraction Site Healing
Lead sponsor: Aga Khan University
Sponsor class: OTHER
First posted: 2017-04-26
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: There is no evidence based guidelines on using saline rinses for post extraction oral care among hypertensives. Similarly, benefit of orally dissolved topical analgesics in addition to orally administered analgesic is questionable.

Detailed description: Objective: To compare the post dental extraction healing among subjects who took simple analgesic tablets dissolved in water versus those who used saline rinses post operatively.

Methods: A study will be done among patients who underwent dental extractions at AKHSP dental clinic, Karachi, Pakistan. Carious, periodontally mobile, traumatized or broken down teeth among 20-70 years old in either gender will be included.

In addition to the routine prescription of antibiotics and oral analgesics, the hypertensive subjects (n=20) will be advised to take dissolved Aspirin tablet as an oral care while non-hypertensive will be divided into two sub groups (n=20 each), advised saline mouth rinses or dissolved Aspirin for 5 days, respectively.

The outcome (healing of the extraction socket) will be evaluated 7 days from the day of extraction on an ordinal scale.

Eligibility criteria: Inclusion Criteria:

* Carious, periodontally mobile, traumatized or broken down teeth needing extraction
* Age 20-70 years, both genders

Exclusion Criteria:

* Diabetes
* Osteoporosis, metabolic bone disease etc.
* Radiation therapy or chemotherapy.

Primary outcomes:
measure: Healing of the extraction socket
timeFrame: Seven days from the day of extraction
Secondary outcomes:
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Aga Khan University
state: Sind
Study officials:
affiliation: AKU
name: Farhan R Khan, BDS MS FCPS
role: STUDY_DIRECTOR
References:
Clinical trial NCT06307353: Trends of Contraception Methods in Urban Medical Center in el_Balyana
Official title: Trends of Contraception Methods in Urban Medical Center in El_Balyana
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Contraception
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2024-03-12
Enrollment: 385
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 49
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: currently married woman in the child bearing period (15_49) years old attending El_Balyana urban medical Center

Exclusion Criteria:

women who are divorced or widowed or beyond age of fertility will be excluded -

Brief summary: family planning is avital primary Health care intervention that saves lives of mothers and infants empowers women and support their choices regarding their health public life and additional education .In addition family planning is considered as a short term intervention to limit population growth and manage overpopulation problems.Globally the contraception prevalance rate an indicator for family planning programs continue to face challenges in developing countries.


Eligibility criteria: Inclusion Criteria:

- currently married woman in the child bearing period (15_49) years old attending El_Balyana urban medical Center

Exclusion Criteria:

women who are divorced or widowed or beyond age of fertility will be excluded -

Primary outcomes:
measure: number of married women in child bearing period attending the El_Balyana Medical Center using contraception methods .
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Ntoimo L. Contraception in Africa: Is the global 2030 milestone attainable? Afr J Reprod Health. 2021 Jun;25(3):9-13. doi: 10.29063/ajrh2021/v25i3.1. No abstract available.
citation: Harris ML, Coombe J, Forder PM, Lucke JC, Bateson D, Loxton D. Young Women's Complex Patterns of Contraceptive Use: Findings from an Australian Cohort Study. Perspect Sex Reprod Health. 2020 Sep;52(3):181-190. doi: 10.1363/psrh.12158.
citation: Pimentel J, Ansari U, Omer K, Gidado Y, Baba MC, Andersson N, Cockcroft A. Factors associated with short birth interval in low- and middle-income countries: a systematic review. BMC Pregnancy Childbirth. 2020 Mar 12;20(1):156. doi: 10.1186/s12884-020-2852-z.
citation: Mohamed NA, Abdel-Razik MS, Salem MR. Adjustment of family planning service statistics reports to support decision-making at central and governorate level, Egypt. J Egypt Public Health Assoc. 2022 Jan 20;97(1):4. doi: 10.1186/s42506-021-00098-7.