louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05818657: Association of Apical Periodontitis With Chronic Kidney Disease
Official title: Prevalence of of Apical Periodontal in Patients Chronic Kidney Disease & Its Association With Markers of Kidney Disease.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Kidney Diseases
Periapical Lesions
Keywords: Apical Periodontitis
Root Canal Treatment
Lead sponsor: Postgraduate Institute of Dental Sciences Rohtak
Sponsor class: OTHER
First posted: 2023-04-19
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: CKD patients of different levels (Stage 1 to Stage 5) with age and gender matched controls will be enrolled in the study.

Brief summary: This investigation is aimed to assess the prevalence and severity of apical periodontitis (AP) in different stages of CKD patients and its impact on the systemic (nutritional and inflammatory) markers was compared to healthy individuals.

Detailed description: 105 CKD patients (35 early (EG), 35pre-dialysis (PDG) and 35 hemodialysis (HDG)groups and 105 age and gender matched healthy controls were assessed for prevalence and severity of apical periodontitis and oral disease burden . Inflammatory (hsCRP and ferritin) and nutritional (urea and creatinine) markers were estimated and eGFR was calculated for the study population. Logistic regression was used to determine the possible association between CKD and AP in study population and Linear regression was performed to evaluate the possible association between systemic markers and endodontic burden (EB) in experimental group.

Eligibility criteria: Inclusion Criteria:

* Known patient of CKD Stages 1,2,3,4 \& 5 with estimated glomerular filtration rate \[eGFR; MDRD\] with mature permanent teeth.
* \> 18 years
* \> 8 natural teeth.
* Complete medical \& dental history including panoramic radiographs of maxilla \& mandible

Exclusion Criteria:

* Patients having systemic disorders other than CKD (eg HIV, Diabetes mellitus, Coronary heart disease, history of secondary hyperparathyroidism).
* Pregnancy, lactation \& contraceptives.
* Systemic conditions that contra indicates dental treatment.
* Use of antibiotics \& anti-inflammatory in last 3 months
* Need for antibiotic prophylaxis.
* Hepatitis C and B virus.
* Patients on steroids.

Primary outcomes:
measure: Periapical Index(PAI)
timeFrame: 1 year
measure: eGFR
timeFrame: 1 year
measure: serum creatinine
timeFrame: 1 year
measure: hs-CRP
timeFrame: 1 year
measure: Blood urea
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Rohtak
country: India
facility: PGIDS
state: Haryana
Study officials:
affiliation: Post Graduate Institute Of Dental Sciences, Rohtak.
name: Dr. Shweta Mittal, MDS
role: STUDY_DIRECTOR
References:
Clinical trial NCT04553757: Seizure Control as a New Metric in Assessing Efficacy of Tumor Treatment in Patients With Low Grade Glioma
Official title: Seizure Control as a New Metric in Assessing Efficacy of Tumor Treatment in Patients With Low Grade Glioma
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Brain Neoplasm
Low Grade Glioma
Seizure Disorder
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2020-09-17
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with primary brain tumors with a history of seizures secondary to brain tumor.

Brief summary: This study investigates how seizures can vary over time with changes in low grade gliomas and its treatments. This study may help doctors find symptoms or triggers of seizures earlier than normal, and ultimately earlier care or treatment for seizures.

Detailed description: PRIMARY OBJECTIVE:

I. To evaluate the rate of change of seizure frequency and the status of the tumor at each data collection point.

SECONDARY OBJECTIVES:

I. To obtain sufficient number of patients' data in order to power the analysis to determine whether a change in seizure frequency correlates with tumor control.

II. Evaluate progression free survival and overall survival when compared with seizure control.

OUTLINE:

Patients complete a seizure assessment survey over 5 minutes at each clinic visit.

Eligibility criteria: Inclusion Criteria:

* Adult patients
* Primary brain tumors (separated by World Health Organization \[WHO\] grade I-IV)
* History of seizures secondary to brain tumor
* On tumor directed treatment
* Magnetic resonance imaging (MRI) within 2 weeks of clinic visit where seizure assessment takes place

Exclusion Criteria:

* Patients without seizures
* Patients with intracranial lesions other than primary brain tumor
* Patients not undergoing tumor directed treatment
* Absence of recent (within 2 weeks) MRI

Primary outcomes:
measure: Rate of change of seizure frequency
timeFrame: Baseline to 2 years
measure: Status of tumor
timeFrame: Up to 2 years
Secondary outcomes:
measure: Patient data collection
timeFrame: Up to 2 years
measure: Progression-free survival (PFS)
timeFrame: Up to 2 years
measure: Overall survival (OS)
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Ashley Aaroe, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04345757: After Cesarean Time Interval for Exercise (ACTIVE) Trial
Official title: After Cesarean Time Interval for Exercise (ACTIVE) Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Postoperative Complications
Keywords: Postpartum wellness
Postoperative activity
Postoperative complication
Postpartum complication
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: Hospital for Special Surgery, New York
First posted: 2020-04-14
Enrollment: 200
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: The purpose of this study is to test whether or not activity restrictions after a cesarean section are warranted and if exercise can improve postpartum wellness. This research study is being done because there is no science-based evidence to support postpartum activity restrictions after cesarean sections.

Participants will be randomly placed into one of the following study groups:

* Standard postpartum and post-operative instructions group: activity restrictions, including no strenuous exercise, sexual intercourse, or lifting objects greater than 25 pounds for 6 weeks or until evaluation at the 6 week postpartum visit
* Study group: Structured 10 week exercise protocol consisting of core strengthening exercises (concentrating on the abdominal, gluteal, and pelvic areas), breathing exercises, and diaphragm exercises.


Eligibility criteria: Inclusion Criteria:

* pregnant woman at least 18 years of age
* carrying only one baby at time of delivery
* delivery planned by scheduled cesarean section
* baby of gestational age of \> 37 weeks
* no known restrictions to exercise.

Exclusion Criteria:

* woman with pre-existing post operative complications
* medical history with exercise limitations/disabilities
* carrying more than one baby at time of delivery
* delivery (planned by scheduled or emergent) cesarean section with fetal concerns (anomaly, growth restriction, NICU admission, etc)

Primary outcomes:
measure: Change in wellness
timeFrame: 2, 6, and 10 weeks
Secondary outcomes:
measure: Change in incidence of post operative complications
timeFrame: 2, 6, and 10 weeks
measure: Change in incidence of depression, anxiety, and decreased physical functioning
timeFrame: 2, 6, and 10 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: New York Presbyterian Hospital Weill Cornell
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Robin Kalish, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01433757: Ampicillin for DYT-1 Dystonia Motor Symptoms
Official title: A Pilot, Randomized, Double-Blind, Placebo-Controlled Phase I Study to Determine the Safety and Efficacy of Ampicillin in Treating Primary Dystonia Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: DYT-1
Dystonia
Keywords: dystonia
DYT-1
AMPICILLIN
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: Tyler's Hope for a Dystonia Cure, Inc
First posted: 2011-09-14
Enrollment: 2
Sex: ALL
Minimum age (years): 7
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate if the antibiotic Ampicillin is safe and tolerated in patients that have generalized dystonia caused by the DYT-1 gene mutation, as compared to patients treated with a placebo. A placebo is a pill that looks and tastes the same as the real drug, but without the active ingredient. The second objective of this study is to determine if dystonia symptoms improve while on the study drug.

Detailed description: This is a double-blinded and randomized drug study: neither the patient nor the investigator know if patients are taking study drug (Ampicillin) or placebo.

Three study visits will include neurological exams, review of medical history, genetic test results and video-taped BFM-DRS motor scales. Patients will receive medication during baseline visit, consisting of either Ampicillin drug or placebo, which will be consumed twice daily for 28 days. Following a washout period (no drugs) of 7 days, patient will return to clinic for second study visit and receive second set of medication (placebo -vs- Ampicillin). Medication will be consumed twice daily for 28 days, with patient returning to clinic after a washout period of 7 days for final study visit in clinic.

Eligibility criteria: Inclusion Criteria:

* DYT-1 dystonia, confirmed by genetic testing
* Between ages of 7 and 80 years
* BFM-DRS score greater than 6

Exclusion Criteria:

* Negative DYT-1 dystonia gene test
* Allergy to penicillins or cephalosporins
* Concurrent bacterial, viral or fungal infection at time of enrollment
* Pregnancy
* Inability to follow study protocol
* Lactose intolerance (placebo contains lactose powder)

Primary outcomes:
measure: Safety and tolerability of Ampicillin in treating DYT-1 dystonia
timeFrame: 70 days
Secondary outcomes:
measure: Burke-Fahn Marsden Dystonia Rating Scale (BFM-DRS)
timeFrame: 70 days
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: UF Center for Movement Disorders and Neurorestoration
state: Florida
Study officials:
affiliation: University of Florida
name: Irene Malaty, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05517057: Radiologic Score and Failure of Conservative Management of Adhesive Small Bowel Obstruction
Official title: Assessment of a Predictive Radiologic Score to Predict the Failure of the Non-operative Management of Adhesive Small Bowel Obstruction: a Prospective Cohort Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Small Bowel Obstruction
Conservative Management
Imaging
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2022-08-26
Enrollment: 279
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This was an observational multicentric cohort study including all the consecutive patients admitted for initial non-surgical management for aSBO. The study took place over a period of 3 months (September 15 - December 15, 2021) in 15 French centers.

Brief summary: The management of acute adhesive small bowel obstruction remains challenging for the digestive surgeon. The Bologna guidelines recommend that conservative management of aSBO. The literature reports that this form of management has a failure rate between 10 and 40%.

A radiological score has been proposed and was associated with an increased risk of failure of conservative management.

This tool is promising to select patients further requiring surgery but it has to be assessed in a multi centric prospective cohort.


Eligibility criteria: Inclusion Criteria:

* all the consecutive patients admitted for initial non-surgical management for aSBO
* during the period of inclusion

Exclusion Criteria:

* the cause of SBO was functional or other than adhesive
* patients requiring initial surgical management.
* absence of computed tomography performed at admission

Primary outcomes:
measure: Angers CT score
timeFrame: immediately after the completion of the CT-scan
Secondary outcomes:
Other outcomes:
Locations:
city: Angers
country: France
facility: university hospital of Angers
Study officials:
References:
Clinical trial NCT05016557: The Muscle Protein Synthetic Response of Algal and Fungal Protein
Official title: The Muscle Protein Synthetic Response Following the Ingestion of a Single Bolus of Algal Protein When Compared to Fungal Protein in Healthy Young Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Muscle Metabolism
Keywords: Amino Acids
Protein metabolism
Resistance exercise
Muscle protein synthesis
Lead sponsor: University of Exeter
Sponsor class: OTHER
First posted: 2021-08-23
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Dietary protein intake is vital for the maintenance of skeletal muscle mass and health. The production of animal-based proteins sources is associated with growing environmental and ethical challenges. As such, sustainable alternatives are needed. Algae are sustainably produced high-protein sources and it is predicted that algae will become one of the most consumed proteins in the next decades. However, the effects of algae on the stimulation of muscle mass growth are unknown. Therefore, we aim to assess the rate of digestion and absorption, and the effects on muscle growth of two types of algae (spirulina and chlorella) when compared to a sustainable non-animal derived fungal reference protein (mycoprotein), a source known to elicit a robust anabolic response.


Eligibility criteria: Inclusion Criteria:

* BMI between 18.5 and 30
* Recreationally active (\<3 times per week structured resistance exercise training)

Exclusion Criteria:

* Any metabolic impairment
* Any cardiovascular impairment
* High blood pressure (\>140/90 mmHg)
* A personal history of epilepsy, seizures or schizophrenia
* Smoking
* Chronic (\>1 month) use of over the counter pharmaceuticals
* Chronic (\>2 months) use of amino acid or protein supplements
* Allergic to Quorn/mycoprotein or algae products

Primary outcomes:
measure: Muscle Protein Synthesis
timeFrame: 7.5 hours
Secondary outcomes:
measure: Plasma Amino Acid Kinetics
timeFrame: 7.5 hours
measure: Serum Insulin
timeFrame: 7.5 hours
measure: Blood Glucose
timeFrame: 7.5 hours
measure: mTOR phosphorylation
timeFrame: 7.5 hours
Other outcomes:
Locations:
city: Exeter
country: United Kingdom
facility: University of Exeter
state: Devon
Study officials:
affiliation: Professor of Nutritional Physiology
name: Benjamin T Wall, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02732457: Allogeneic Hematopoietic Stem Cell Transplantation in HIV-1 Infected Patients
Official title: Allogeneic Hematopoietic Stem Cell Transplantation in HIV-1 Infected Patients
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: HIV-1 Infection
Keywords: HIV
Persistence
Reservoirs
Stem Cell Transplant
Functional Cure
Lead sponsor: Kirby Institute
Sponsor class: OTHER_GOV
First posted: 2016-04-08
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with HIV infection requiring a HSCT

Brief summary: The purpose of this study is to assess the impact of allogeneic hematopoietic stem cell transplantations (HSCT) in HIV infected patients on the persistence of HIV and the HIV immune response.

Detailed description: 1. To assess the impact of HSCT on the immune response to HIV by measuring HIV specific antigens in peripheral blood (via immune assays such as ELISA and Western blot) longitudinally.
2. To measure the decay of persisting HIV by sequencing and quantitating HIV RNA in plasma, and HIV DNA and RNA in peripheral blood cells including CD4+ T cells and CD4+ T cell subsets, as well as in tissue cells derived from fine needle lymph node aspirates, and/or bone marrow aspirates, and/or rectal tissue.
3. To determine the presence of the CCR5 delta 32 allele in the patient prior to and following HSCT which will provide information regarding the presence of this gene in the donor cells.
4. To correlate these findings to the clinical outcome of the individuals enrolled in this study based on their clinical standard of care assessments following HSCT.

Eligibility criteria: Inclusion Criteria:

* HIV-1 infection, requiring allogeneic, haematopoietic SCT as determined by their treating Physician (Haematologist).
* Over 18 years of age
* Provision of written, informed consent

Exclusion Criteria:

* In the opinion of the investigator that the patient is not able to provide informed consent
* Hb \< 9 (g/dL)
* CD4+ T cell count \<100 (cells/µl)
* Serious coagulation abnormalities, platelet count \< 50.
* Patients currently taking medications that significantly affect the bleeding time (e.g. warfarine, clexane, FXa antagonists)
* History of allergy to local anaesthetics
* Pregnancy

Primary outcomes:
measure: Reduction in HIV-1 DNA levels in CD4+ T cells measured by real-time PCR
timeFrame: 3 years
Secondary outcomes:
measure: Reduction in HIV-1 Antigens and Antibodies measured by ELISA and Western Blot
timeFrame: 3 years
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: St Vincent's Hospital
state: New South Wales
Study officials:
affiliation: St Vincent's Hospital, Sydney
name: Mark Polizzotto, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02307357: The Effects of Newcomball Training on Physical Fitness and Mood State of Middle Age Women in Israel
Official title: The Effects of Newcomball Training on Physical Fitness and Mood State of Middle Age Women in Israel
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
Collaborators: name: Wingate Institute
First posted: 2014-12-04
Enrollment: 120
Sex: FEMALE
Minimum age (years): 28
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Habitual physical activity was found to be positively related to better health and well-being. One of the most popular physical activity forms is ball games. In Israel, there is a growing popularity in a new ball game - Newcomball - which is being played by many middle age, non-athlete, women. However, so far, no study had evaluated the contribution of the game to improvement in the participants' physical fitness. The aim of this study, therefore, is to evaluate the effects of six month two weekly Newcomball training sessions to the physical fitness of middle age women.

Detailed description: Physical fitness will be evaluated by six different physical tests: 1. agility T test, 2. "shuttle run" test for aerobic capacity, 3. vertical jump, 4. power ball throw, 5. "sit and reach" flexibility test , 6. 20 m all-out run speed test.

Eligibility criteria: Inclusion Criteria:

* healthy adults women

Exclusion Criteria:

non healthy, using drugs, competitive athletes women-

Primary outcomes:
measure: Evaluation of physical fitness of newcomball players vs. non active women
timeFrame: six month
measure: Evaluation of physical fitness of newcomball players vs. non active women
timeFrame: six month
measure: Evaluation of physical fitness of newcomball players vs. non active women
timeFrame: six month
measure: Evaluation of physical fitness of newcomball players vs. non active women
timeFrame: six month
measure: Evaluation of physical fitness of newcomball players vs. non active women
timeFrame: six month
measure: Evaluation of physical fitness of newcomball players vs. non active women
timeFrame: six month
Secondary outcomes:
Other outcomes:
Locations:
city: Netanya
country: Israel
facility: Wingate Institute
Study officials:
affiliation: Wingate Institute
name: sharon tsuk, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04562857: Effects of Exercise Training in Patients With Atrial Fibrillation and Sleep Apnea: A Pilot Study
Official title: Effects of Exercise Training in Patients With Atrial Fibrillation and Sleep Apnea: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Deprivation
Lead sponsor: Cairo University
Sponsor class: OTHER
Collaborators: name: Swinburne University of Technology
name: National Heart Institute, Egypt
First posted: 2020-09-24
Enrollment: 19
Sex: ALL
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Background: There are still many gaps in research concerning the effect of different physical training modalities on sleep deprivation in the population with different types of sleep apnea. Aims: The purpose of this study was to examine the effect of moderate-intensity interval training (MITT) on patients with different types of sleep apnea.

Detailed description: Methods: 15 Participants aged 45-65 years were randomized into two groups: obstructive sleep apnea group (OSA), and central sleep apnea group (CSA). The training lasted ten consecutive weeks with 30 uninterrupted sessions. The actigraph together with the Pittsburg sleep quality index (PSQI) was used in sleep quality assessment. The actigraph (Actiwatch Minimitter Company, Incorporated (INC) - Sunriver, OR, USA) was placed on the non-dominant wrist and activities were monitored continuously while being recorded at one-minute intervals. The participants kept the device for a period of 96 hours, filled PSQI, and did 6MWT before the first and last training sessions.

Eligibility criteria: Inclusion Criteria:

1. Patients who have AF confirmed by ECG
2. Their ages range from 45 and 65 years of age
3. Medically stable patients.
4. Current complaint of poor Sleep quality (SQ) (score \> 5 of the SQ scale)
5. Patients who have OSA or CSA confirmed by polysomnography

Exclusion Criteria:

* Any patient was known to have any unstable medical condition;or with any known musculoskeletal or neurological conditions that might interfere with the execution or the assessment of the exercise, was excluded from the study.

Primary outcomes:
measure: Sleep quality scores (0 is best, 3 is worst)
timeFrame: 10 weeks
measure: sleep latency (in min)
timeFrame: 10 weeks
measure: Total sleep time (in hours)
timeFrame: 10 weeks
measure: Sleep fragmentation index (in %) (the more means worse)
timeFrame: 10 weeks
measure: cutpoints
timeFrame: 10 weeks
Secondary outcomes:
measure: six minute walking distance (in meters)
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: National heart institute
state: Cairo
Study officials:
affiliation: Cairo University
name: Hady Balabel
role: PRINCIPAL_INVESTIGATOR
References: