louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01170494: Effect of Vitamin D Oral Supplements on 25 OH Vitamin D Levels
Official title: Effect of Vitamin D Oral Supplements on 25 OH Vitamin D Levels: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vitamin D Deficiency
Keywords: vitamin D2, vitamin D3, 25 Oh vitamin D2, 25 Oh vitamin D3
Lead sponsor: King Faisal Specialist Hospital & Research Center
Sponsor class: OTHER
First posted: 2010-07-27
Enrollment: 279
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Vitamin D deficiency is common world wide. 25 OH vitamin D level is the best indicator of vitamin D status. Vitamin D supplements are available as vitamin D2 or D3, in small daily or large weekly/monthly doses. Controversy continues on the relative potency of vitamin D2 compared to D3 and of daily compared to weekly or monthly doses, in increasing/maintaining total 25 OH vitamin D level.

The investigators plan to conduct a controlled trial to compare the effect of various vitamin D supplements on 25 OH vitamin D levels in healthy adults with starting 25 OH vitamin D level between 20 to 50 nmol/L.


Eligibility criteria: Inclusion Criteria:

* Healthy adults living in Riyadh area who consume no more than one serving of milk/day, do not take vitamin supplement, habitually have less than 10 hr of sun exposure per week, don't suffer from granulomatous conditions, liver disease, or kidney disease, and don't take anticonvulsants, barbiturates, or steroids.
* 25 OH vitamin D level between 20 to 50 nmol/L.

Primary outcomes:
measure: area under the curve of 25 OH vitamin D level
timeFrame: 140 days
Secondary outcomes:
measure: Cmax of 25 OH vitamin D
timeFrame: 140 days
measure: Tmax of 25 OH vitamin D level
timeFrame: 140 days
measure: area under the curve of vitamin D level
timeFrame: 140 days
measure: incidence of hypercalcemia
timeFrame: 140 days
measure: incidence of hypercalciuria
timeFrame: 140 days
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: King Faisal Specialist Hospital & research Center
Study officials:
affiliation: King Faisal Specialist Hospital & Research Center
name: Muhammad M Hammami, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hammami MM, Yusuf A. Differential effects of vitamin D2 and D3 supplements on 25-hydroxyvitamin D level are dose, sex, and time dependent: a randomized controlled trial. BMC Endocr Disord. 2017 Feb 24;17(1):12. doi: 10.1186/s12902-017-0163-9.
Clinical trial NCT01093794: Bioequivalence Study of Sitagliptin/Metformin Combination Tablet (MK0431A-122)
Official title: A Bioequivalence Study With Two Tablet Strengths of the Final Market Image (FMI) Sitagliptin/Metformin Fixed Dose Combination (FDC) Tablet
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 2 Diabetes
Keywords: Type 2 Diabetes
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2010-03-26
Enrollment: 28
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study will test the hypothesis that the Final Market Image (FMI) sitagliptin/metformin 50 mg/500 mg and 50 mg/850 mg (Fixed Dose Combination) FDC tablet and co-administration of corresponding doses of sitagliptin and China-sourced metformin as individual tablets will be bioequivalent based on assessment of the AUC(0-t) and Cmax, for both sitagliptin and metformin.


Eligibility criteria: Inclusion Criteria:

* Subject is of Chinese descent
* Subject is in good health
* Subject is a non-smoker

Exclusion Criteria:

* Subject has a history of stroke or chronic seizures
* Subject has a history of cancer
* Subject has had major surgery, donated blood or participated in another investigational study within the past 4 weeks

Primary outcomes:
measure: Area Under the Curve (AUC(0-t)) for Sitagliptin
timeFrame: baseline through 72 hours postdose
measure: Cmax for Sitagliptin and Metformin
timeFrame: baseline through 72 hours postdose
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT04253860: Effect of Transcutaneous Electrical Nerve Stimulation in Diabetic Neuropathy
Official title: Effect of Transcutaneous Electrical Nerve Stimulation on Pain percepción and Serum Inflammatory Markers in Patients With Peripheral Diabetic Neuropathy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Diabetic Neuropathy Peripheral
Keywords: Diabetic neuropathy peripheral
diabetic complications
TENS
Neuropathic treatments
Lead sponsor: Centro Universitario de Tonalá
Sponsor class: OTHER
Collaborators: name: University of Guadalajara
name: Diabetes sin Complicaciones S.A de C.V, Mexico
First posted: 2020-02-05
Enrollment: 20
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, double-blind, clinical trial
Primary purpose: TREATMENT

Brief summary: Double-blind, randomized, placebo-controlled, clinical trial. Patients with diabetic neuropathy will be randomly assigned to treatment with either TENS or TENS sham three times a week during 90 days. Clinical determinations are: pain, levesls of TNF-alpha, IL-6 and RPC-us


Eligibility criteria: Inclusion Criteria:

* Diagnostic of type 2 diabetes \> 10 years
* Diagnostic of peripheral diabetic neuropathy less than 5 years
* HbA1C \> 6.5 and \< 9%
* Plasmatic glucose \>140 mg/dL and lees than 350 mg/dL
* Informed consent signed

Exclusion Criteria:

* Use of implanted pacemaker or heart defibrillator
* Implanted brain stimulator
* History of alcohol abuse
* Use of NSAID, stereoids
* Subjects with wounds, ulcers in legs
* Subjects with hepatic, renal o neurologic diseases

Primary outcomes:
measure: Pain perception
timeFrame: Change from Baseline Pain perception at 90 days
Secondary outcomes:
measure: Tumoral Necrosis Factor Alpha
timeFrame: Change from Baseline serum levels of TNF-alpha at 90 days
measure: Interleukin-6
timeFrame: Change from Baseline serum levels of IL-6 at 90 days
measure: C Reactive Protein ultra-sensible
timeFrame: Change from Baseline serum levels of CRP-us at 90 days
Other outcomes:
Locations:
city: Guadalajara
country: Mexico
facility: University of Guadalajara
state: Jalisco
Study officials:
affiliation: Salud Enfermedad como proceso individual, CUTonalá, Universidad de Guadalajara
name: Arieh R Mercado Sesma, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06218160: The Addition of Hydromorphone to Local Anesthetics for the Repair of Inguinal Hernias in Elderly Patients
Official title: A Randomized Controlled Study of Ropivacaine Combined With Hydromorphone to Block Lumbar Muscle in Elderly Inguinal Hernia Repair.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inguinal Hernia
Keywords: hydromorphone
Quadratus lumbois block
old people
Lead sponsor: Second Hospital of Jilin University
Sponsor class: OTHER
First posted: 2024-01-23
Enrollment: 63
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: To compare the clinical and postoperative analgesic effects of hydromorphone combined with ropivacaine and ropivacaine alone in quadrangular muscle block for open inguinal hernia in elderly patients.

Detailed description: Elderly patients selected for Lichtenstein hernia repair in our hospital who met the inclusion and exclusion criteria and obtained informed consent were included in this trial, and were randomly divided into experimental group by random number table method: 0.375% ropivacaine combined with hydromorphone block group, and control group: 0.375% ropivacaine block group alone.

Eligibility criteria: Inclusion Criteria:

* Age 60 and above.
* Admission to hospital for open inguinal hernia surgery is consistent with the -indications of this surgical modality, ASA grades 1 to 3.
* No recent use of sedatives, opioids, or other analgesics.
* Good compliance, signed informed consent.
* Complete clinical data.

Exclusion Criteria:

* There are serious cardiovascular and cerebrovascular diseases.
* Abdominal infection.
* Coagulation dysfunction or receiving anticoagulation therapy.
* Local anesthesia drug allergy.
* Can not cooperate with the corresponding operation, suffering from mental illness.
* Previous surgical history of the corresponding position in the abdomen that may interfere with the surgical process of this study.

Primary outcomes:
measure: Related indexes of anesthesia effect: pain after surgery, 6, 12, 18,24, 48h after surgery.
timeFrame: From the end of surgery until two days after surgery.
measure: Related indexes of anesthesia effect: time of onset of anesthesia, duration of anesthesia maintenance.
timeFrame: From the start of anesthesia until two days after surgery.
Secondary outcomes:
measure: The occurrence of postoperative adverse reactions.
timeFrame: The operation ended two days after surgery.
Other outcomes:
Locations:
city: Changchun
country: China
facility: Second Hospital of Jilin University
state: Jilin
Study officials:
affiliation: Second Hospital of Jilin University
name: Dan Tian
role: STUDY_DIRECTOR
References:
Clinical trial NCT05349760: A Phase 2 Study to Evaluate Safety and Efficacy of AMB-05X in Subjects With Idiopathic Pulmonary Fibrosis
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of AMB-05X in Subjects With Idiopathic Pulmonary Fibrosis
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: IPF
Keywords: Idiopathic Pulmonary Fibrosis
IPF
Lead sponsor: AmMax Bio, Inc.
Sponsor class: INDUSTRY
First posted: 2022-04-27
Enrollment: 0
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2:1 randomization of active to placebo
Primary purpose: TREATMENT

Brief summary: AMB-053-01 is a randomized, placebo controlled, multicenter study which will enroll approximately 36 subjects ages 40 and older with IPF for 6 doses over a 24-week dosing period.


Eligibility criteria: Inclusion Criteria:

1. Subjects ≥40 years old.
2. History of confirmed diagnosis of IPF
3. Chest HRCT at Screening
4. Subjects who are either:

   * Not being treated with approved IPF therapies (i.e., nintedanib or pirfenidone) or
   * Being treated with approved IPF therapies (i.e., nintedanib or pirfenidone)
5. Has FVC ≥45% predicted of normal AND DLCO ≥25% and ≤90% predicted
6. Has a FEV1/FVC ratio (Tiffeneau-Pinelli Index) ≥ 0.70
7. Has adequate hematologic, hepatic, and renal function

Exclusion Criteria:

1. Prior investigational drug use within 30 days or 5 half-lives
2. Presence of emphysema exceeding the extent of fibrosis
3. Active or anticipated need for lung transplant
4. Treatment with prednisone
5. Active cancer
6. Active or chronic infection with HCV, HBV, or HIV
7. Known active tuberculosis
8. History of or current immunosuppressive condition
9. IPF exacerbation within 12 weeks
10. Lower respiratory-tract infection requiring antibiotic therapy
11. Smoking
12. Other forms of interstitial lung disease
13. History of lung volume reduction surgery or lung transplant
14. Contraindications for forced expiratory maneuvers during spirometry
15. Unstable cardiac or pulmonary disease (other than IPF)
16. Fridericia-corrected QT interval (QTcF) ≥ 450 ms (men) or ≥ 470 ms (women)
17. History of drug or alcohol abuse -

Primary outcomes:
measure: Treatment-emergent adverse events
timeFrame: Week 24
Secondary outcomes:
measure: Pulmonary Function
timeFrame: Week 28
measure: Pharmacodynamics via CSF1
timeFrame: Week 28
measure: ST GEORGE'S RESPIRATORY QUESTIONNAIRE IDIOPATHIC PULMONARY FIBROSIS (SGRQ-I)
timeFrame: Week 28
measure: Cmax
timeFrame: Week 24
measure: AUC
timeFrame: Week 24
Other outcomes:
Locations:
Study officials:
affiliation: AmMax Bio, Inc.
name: Dorothy Nguyen, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06059560: Nutritional Intervention for Patients With Multiple Cancer Types
Official title: An Open, Real-world Study of the Effects of Perioperative Intensive Nutritional Management on Short-term Quality of Life and Long-term Life Outcomes in Patients With Multiple Cancers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer
Keywords: nutrition
prognosis
Lead sponsor: First Hospital of China Medical University
Sponsor class: OTHER
First posted: 2023-09-28
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: To evaluate the nutritional status of patients with different types of tumors by continuous nutritional intervention and follow-up intervention in the perioperative period,and the impact on progression-free survival/survival and quality of life.


Eligibility criteria: Inclusion Criteria:

* ① Age ≥18 years old, \<80 years old, male or female; ② The patient signed the informed consent and volunteered to participate in the study; ③ Patients with malignant tumors (laryngeal cancer, esophageal cancer, lung cancer, gastric cancer, colorectal cancer, liver cancer, pancreatic cancer) evaluated by clinical stage II to IV; ④ Patients undergoing tumor surgery; ⑤ Patients with NRS 2002 score ≥ 3 after management risk screening; ⑥ Basic reading and communication skills; ⑦ Have the ability to act; Patients with a life expectancy greater than 6 months;

Exclusion Criteria:

* ① Acute onset of chronic disease; ② Pregnant or lactating women; ③ Patients with contraindications and no tumor surgery; (4) Patients with malignant tumors (laryngeal cancer, esophageal cancer, lung cancer, stomach cancer, colorectal cancer, liver cancer, pancreatic cancer) were confirmed by pathology and/or cytology after surgery; ⑤ Combined with cognitive dysfunction, mental disorder, consciousness disorder or unwillingness to cooperate; ⑥ Patients with severe gastrointestinal symptoms, liver and renal insufficiency (alanine aminotransferase ALT≥2 times the upper limit of normal value; Total bilirubin Tbil≥2 times the upper limit of normal value; Creatinine Cr≥2 times the upper limit of normal value); (7) Patients with two or more types of tumors; Long-term bed rest, hemiplegia or coma; ⑨ Severe dysfunction of liver, kidney and other organs; ⑩ Allergy or intolerance to nutrients or their main components (such as lactose or galactose, etc.).

Primary outcomes:
measure: Survival index
timeFrame: 3 years
Secondary outcomes:
measure: Quality of life index
timeFrame: 3years
Other outcomes:
Locations:
city: Shenyang
country: China
facility: The First Affiliated Hospital of China Medical University
state: Liaoning
Study officials:
affiliation: First Hospital of China Medical University
name: Kai Li, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00268060: Infant Medical Records: Case Report Proposal
Official title: Baby R. Case Report Proposal
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Congenital Disorders
Keywords: pediatric
cardiac
Long QT Syndrome
Pacemaker
Herg mutation
Lead sponsor: Children's Healthcare of Atlanta
Sponsor class: OTHER
First posted: 2005-12-22
Enrollment: 1
Sex: MALE
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: RETROSPECTIVE

Brief summary: Infants with congenital long QT syndrome (LQTS) and 2:1 atrioventricular block (AVB) have been recognized as a clinical subset of children with LQTS.

The purpose of this study is to describe the clinical course and outcome of a patient with congenital long QT syndrome (LQTS).

Detailed description: It has been previously reported that 2:1 AVB in neonatal LQTS seems preferentially associated with HERG mutations . It has also been reported in association with the SCN5A gene. We report on a neonate with congenital LQTS and congenital complete heart block who experienced frequent episodes of torades des pointe and ventricular tachycardia, which, over the first 2 days of life, was recalcitrant to traditional therapy of beta-blockers and other antiarrhythmics. Eventually hypotension necessitated the use of an epinephrine infusion, which halted the ventricular tachyarrhythmias. A pacemaker was implanted once the infant was stable and, currently, he is thriving. Genetic analysis revealed a HERG mutation.

For this study, we will need access to the infant's inpatient and outpatient medical records at Children's Healthcare of Atlanta at Egleston Children's Hospital and Sibley Heart Center Cardiology to include his age, date of birth, medical record number, inpatient labs, inpatient echo reports, outpatient echo reports, inpatient and outpatient EKG's, inpatient pharmacy records, the results of his genetic analysis, his history and physical, transfer notes, daily progress notes, consultation reports and operative reports from his admission beginning 9/30/04.

Eligibility criteria: Inclusion Criteria:

* Congenital long QT Syndrome single case report

Exclusion Criteria:

* Single case report

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Chldren's Healthcare of Atlanta
state: Georgia
Study officials:
affiliation: Children's Healthcare of Atlanta
name: Tracy Froehlich, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02901860: Shift Work and Risk of Cardio-vascular Disease
Official title: Impact of Shift Work on Risk of Cardiovascular Disease and Diabetes: A Cross-sectional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Shift-Work Sleep Disorder
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2016-09-15
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy adult volunteers.

Brief summary: The purpose of this research is to test the hypothesis that those with non-traditional work schedules (e.g. shift workers) have a higher cardio-metabolic risk than those with traditional work schedules (e.g. day workers), and that both accumulated sleep debt and the degree of circadian disruption predict the elevated cardio-metabolic risk. The findings of this research are expected to increase our understanding of physiologic tolerance to non-traditional work schedules and provide the basis for the development of methods for the early detection of adverse health effects and determine coping strategies for the millions of workers with non-traditional work schedules.


Eligibility criteria: Inclusion Criteria:

Age 18 and older Full-time workers- working between 7:00 a.m. and 7:00 p.m. employed full time at a medical center.

Non-traditional full-time workers- working between 7:00 a.m. and 7:00 p.m and between 7:00 p.m. and 7:00 a.m., employed full time at a medical center.

Exclusion criteria include:

Acute illness or recent change in medication. Persons employed for less than 3 months at their current job

-

Primary outcomes:
measure: cardio-metabolic risk
timeFrame: Once
Secondary outcomes:
measure: Obesity
timeFrame: Once
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01609660: Impact of Probiotics on the Intestinal Microbiota
Official title: Impact of Probiotics on the Intestinal Microbiota and Its Association With Postoperative Outcome After Colorectal Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Colorectal Cancer
Keywords: probiotics
cytokine
short chain fatty acids
complications
colorectal surgery
Lead sponsor: Federal University of Minas Gerais
Sponsor class: OTHER
First posted: 2012-06-01
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to assess the impact of probiotic administration (Saccharomyces boulardii) on patients undergoing colorectal resections comparing to the routine protocol by assessing: (1)intestinal microbiota modulation using RT-PCR to measure cytokine in the mucosa; (2) assess postoperative complications, mainly infectious and mortality, as well as length of hospital stay

Detailed description: The intestinal microbiota, a complex and dynamic population of different bacterial species, under normal circumstances, represents an important contribution to the health of the host. This plays a key role by maintaining the integrity of the epithelial barrier and helping the development of mucosal immunity. However, under some stressful situations, such as after gastrointestinal surgery, infectious complications may be originated from the patient's own intestinal microbiota. This leads to the so called "gut origin of sepsis" hypothesis. On the other hand, under similar conditions, the supply of probiotics, the good bacteria, has been shown to be beneficial, despite few controversial results. Therefore, it is important to carefully assess the efficacy of probiotics in the prevention and treatment of complications in surgical patients, as well as to evaluate the safety of its use.

Eligibility criteria: Inclusion Criteria:

* older than 18 years old
* intend to undergo elective colon resection at the UFMG Hospital

Exclusion Criteria:

* Patients in use of steroids
* Patients unable to receive the probiotics for, at least, 7 days before the operation
* Changes to the operation strategy
* Patients that discontinued probiotic use
* Patients who had previously taken any probiotic or prebiotic

Primary outcomes:
measure: Mucosal cytokine
timeFrame: April 2013
Secondary outcomes:
measure: Short chain fatty acids
timeFrame: April 2013
Other outcomes:
Locations:
Study officials:
affiliation: UFMG
name: Maria Isabel Correia, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: