louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02385890: PERFECT Project - Part 1 - Study 3
Official title: Pulse EnRiched Food and Exercise Clinical Trials (PERFECT Project): Part 1 - Acute Effects of Pulse Ingredients in Snack Products on Appetite, Blood Glucose, and Food Intake in Adults - Study 3
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Prevention
Obesity Prevention
Lead sponsor: University of Manitoba
Sponsor class: OTHER
Collaborators: name: Saskatchewan Pulse Growers
name: Alberta Pulse Growers
First posted: 2015-03-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The objectives are to test the acute effects of different bagels containing pulse ingredients on: 1) post-prandial blood glucose, insulin and appetite for two hours, and 2) food intake two hours following consumption of pulse products.

The investigators hypothesize that bagels containing pulse ingredients will lead to lower blood glucose, insulin, appetite and food intake responses compared to non-pulse bagels.


Eligibility criteria: Inclusion Criteria:

* Normoglycemic (\<5.6 mmol/L) and normotensive (systolic blood pressure \<140 mm Hg and diastolic blood pressure below \< 90 mm Hg)
* BMI of 18.5-29.9 kg/m2

Exclusion Criteria:

* Restrained eaters
* Regularly skip breakfast
* Smokers
* Those who are active (organized activities or athletic training at a high intensity; ≥ 150 min per week of moderate to vigorous physical activity)
* Those on medications that may influence study outcomes or have experienced any gastrointestinal related health conditions/surgeries over the past year.
* Those unable to walk for an hour continuously

Primary outcomes:
measure: Plasma Glucose and Insulin Concentrations
timeFrame: 0-200
measure: Food Intake
timeFrame: at 120 min
measure: Subjective Appetite
timeFrame: 0-200 min
Secondary outcomes:
measure: Palatability of meal
timeFrame: at 140 mins
measure: Palatability of treatments
timeFrame: at 5 mins
measure: Physical comfort
timeFrame: 0 - 200 min
measure: Energy/fatigue measured by VAS questionnaire
timeFrame: 0 - 200 mins
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: Richardson Centre for Functional Foods and Nutraceuticals, University of Manitoba
state: Manitoba
Study officials:
affiliation: University of Manitoba, Richardson Centre for Functional Foods and Nutraceuticals
name: Peter JH Jones, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05797064: Establishment of a Feasibility Model for NOSE Surgery Based on Machine Learning
Official title: Establishment of a Feasibility Model for Predicting Natural Orifice Specimen Extraction Surgery (NOSES) Based on Machine Learning.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Machine Learning
Surgery
Rectosigmoid Cancer
Natural Orifice Specimen Extraction Surgery
Lead sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
Sponsor class: OTHER
First posted: 2023-04-04
Enrollment: 460
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with resectable rectosigmoid cancer.

Brief summary: The goal of this observational study is to test in patients with resectable rectosigmoid cancers. The main question it aims to answer is establishment of a feasibility model for predicting natural orifice specimen extraction surgery (NOSES) based on machine learning.


Eligibility criteria: Inclusion Criteria:

1. Patients diagnosed with colorectal cancer or large adenoma who are suitable for laparoscopic colorectal surgery;
2. Tumor staging ≤ T3 without invasion of surrounding organs;
3. No abdominal seeding or distant organ metastasis;
4. Clear and complete imaging data (CT, pelvic MRI) that can be processed by a computer;
5. Feasible evaluation and determination for obtaining specimens through the rectal channel during preoperative and intraoperative assessments.

Exclusion Criteria:

1. Contraindications for laparoscopic colorectal surgery;
2. Tumor staging is T4, or there are cancer nodules;
3. Presence of metastasis or distant organ metastasis;
4. Incomplete imaging data;
5. Preoperative intestinal obstruction;
6. Tumor or specimen diameter larger than the transverse diameter of the pelvic outlet;
7. Previous rectal radiotherapy;
8. Unsuitable evaluation and determination for obtaining specimens through the rectal channel during preoperative and intraoperative assessments.

Primary outcomes:
measure: The number of successful operations performed
timeFrame: 3 years
measure: The number of successful operations actually completed.
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: GuangZhou
country: China
facility: The Sixth Affiliate Hospital of Sun Yat-Sen University
state: Guangdong
Study officials:
References:
Clinical trial NCT01206790: Immunological Changes Through Narrative Treatment of Post-Traumatic Stress Disorder (PTSD) in Torture Victims
Official title: Immunological Changes Through Narrative Treatment of PTSD in Torture Victims
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PTSD
Keywords: PTSD
Narrative Exposure Therapy
torture victims
immune system
Lead sponsor: University of Konstanz
Sponsor class: OTHER
Collaborators: name: German Research Foundation
First posted: 2010-09-22
Enrollment: 47
Sex: ALL
Minimum age (years): 16
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Posttraumatic stress disorder (PTSD) is associated with poor health, high health care utilization, and an increased risk for a variety of somatic, inflammatory and autoimmune diseases. Research, including our own findings, indicates immunological alterations in PTSD patients. The aim of this study is to investigate whether alterations in the immune system of PTSD patients are reversible through a trauma-specific short-term therapy (Narrative Exposure Therapy).


Eligibility criteria: Inclusion Criteria:

* PTSD diagnosis
* experiences of organized violence/torture

Exclusion Criteria:

* psychotic disorder
* chronic inflammatory diseases

Primary outcomes:
measure: PTSD diagnosis and severity score according to the Clinicians Administered PTSD Scale (CAPS)
timeFrame: 4 month after completion of treatment
Secondary outcomes:
measure: changes in immunological parameters
timeFrame: 4 months after completion of treatment
Other outcomes:
Locations:
city: Konstanz
country: Germany
facility: University of Konstanz, Department of Psychology
Study officials:
affiliation: University of Ulm
name: Iris-Tatjana Kolassa, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03688464: Treatment of Nighttime Pruritus in Atopic Dermatitis
Official title: Efficacy of Melatonin and Diphenhydramine Versus Placebo in Treatment of Nighttime Pruritus in Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: EARLY_PHASE1
Conditions: Atopic Dermatitis
Lead sponsor: University of Nebraska
Sponsor class: OTHER
Collaborators: name: Children's Hospital and Medical Center, Omaha, Nebraska
First posted: 2018-09-28
Enrollment: 0
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will look at melatonin vs. first generation antihistamine vs. placebo in improving nighttime itching in children with atopic dermatitis.

Detailed description: This will be a 6 week study to determine the efficacy of melatonin vs. first generation antihistamine vs. placebo in improving nighttime pruritus in children with atopic dermatitis.

Secondary aims will include:

1. Determine efficacy of melatonin vs. first generation antihistamine in management of sleep disturbance in children with atopic dermatitis
2. Compare differences between treatment groups in disease improvement
3. Compare differences between treatment groups in quality of life

Eligibility criteria: Inclusion Criteria:

* Physician diagnosed eczema covering more than 5% of body surface area
* Ages 2-12 years old

Exclusion Criteria:

* Sleep disorder, including underlying insomnia
* Neuropsychiatric disorder
* Condition that requires use of antihistamines
* On systemic eczema therapy or monoclonal antibody for allergic diseases
* Unable to discontinue other antihistamine use
* Autoimmune disease as melatonin is contraindicated

Primary outcomes:
measure: POEM (Patient Oriented Eczema Measure)
timeFrame: 6 weeks
measure: EASI score
timeFrame: 6 weeks
Secondary outcomes:
measure: 5D Pruritus survey
timeFrame: 6 weeks
measure: ESS-CHAD
timeFrame: 6 weeks
measure: Actigraphy
timeFrame: 6 weeks
Other outcomes:
Locations:
Study officials:
affiliation: University of Nebraska
name: Kylie Liermann, DO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05656664: Mitigation Efforts in Arsenic Exposure With Folic Acid Supplementation
Official title: Mitigation Efforts in Arsenic Exposure With Folic Acid Supplementation: Reducing Toxicity and Exploring the Impact on Lung Health
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Arsenic and/or Arsenic Compound Adverse Reaction
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: National Institute of Environmental Health Sciences (NIEHS)
First posted: 2022-12-19
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Study procedures will consist of recruitment of 100 subjects, 50 each in the treatment (Folic Acid, 800 mcg) and placebo groups respectively. Folic Acid 800 mcg or placebo pill bottles will be provided to the participants with instructions to take one pill orally daily. Both the investigators and subjects will be blinded. Compliance will be measured via pill count.
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate the effects on folic acid supplementation in a population living in an environment with chronic arsenic exposure in Birmingham, Alabama.

Detailed description: Folic acid supplementation effects urinary arsenic excretion. In this project investigators propose to investigate if oral folic acid dietary supplementation can increase urinary arsenic metabolite excretion

Eligibility criteria: Inclusion Criteria:

* ≥18 years of age
* Resident of the superfund site
* Clinically stable with no significant changes in general health status in the past 4 weeks prior to screening as assessed by the investigator
* Provide written informed consent

Exclusion Criteria:

* Pregnancy
* Ongoing folic acid nutritional supplementation
* Methotrexate use
* Megaloblastic anemia
* Alcoholic liver disease
* Malabsorptive syndromes - celiac disease, inflammatory bowel disease

Primary outcomes:
measure: Measurement of urine and blood arsenic metabolites
timeFrame: 12 weeks
Secondary outcomes:
measure: Respiratory Symptom Questionnaire
timeFrame: 12 weeks
measure: Pooled Cohort Probability Score
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: UAB Lung Health Center
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Kevin G Dsouza, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bozack AK, Hall MN, Liu X, Ilievski V, Lomax-Luu AM, Parvez F, Siddique AB, Shahriar H, Uddin MN, Islam T, Graziano JH, Gamble MV. Folic acid supplementation enhances arsenic methylation: results from a folic acid and creatine supplementation randomized controlled trial in Bangladesh. Am J Clin Nutr. 2019 Feb 1;109(2):380-391. doi: 10.1093/ajcn/nqy148.
Clinical trial NCT03966690: Rate of Leg Curl to Leg Press During Isokinetic Testing
Official title: Maximum Strength and Ratio of Leg Extension and Leg Flexion in Elite Soccer Players. A Comparison of an Open Versus Closed Isokinetic System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Muscle Strain
Lead sponsor: University of Erlangen-Nürnberg Medical School
Sponsor class: OTHER
First posted: 2019-05-29
Enrollment: 28
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: The functional condition of the leg muscles is not only relevant to performance in sports, but is also of great importance in health, prevention and rehabilitation, where not only the general strength level is decisive but also the relationship between individual muscle groups. Among other things the H-Q-ratio (strength ratio of "hamstring" muscles to quadriceps muscles) is often used to diagnose possible imbalances. Isokinetic force measurements have established themselves as the gold standard in competitive football. In this context, however, force tests in the open kinetic chain (OKC) have almost exclusively been used so far. Especially force measurements in the closed kinetic chain (CKC) could have a higher relevance regarding functionality. The H-Q-ratio should better be called the flex-ext-ratio in the CKC due to the involvement of the hip muscles. There is little data in the literature on leg force or flex-ext-ratio in CKC. In particular, there is hardly any comparative data for isokinetic measurement systems in the CKC. Using a cross over design and randomly allocating 28 competitive football players into two groups (n=14 each) that either started tests with the leg press or legcurl device, the investigators assumed (1) a significantly lower flex-ext-ratio in the CKC compared to the OKC, (2) a correlation between the isokinetic measurement systems in the OKC and the CKC, and (3) a significant superiority of the leg press to predict functional performance of the lower limbs.


Eligibility criteria: Inclusion Criteria:

* male elite soccer players (5th-6th German soccer division)

Exclusion Criteria:

* no acute injuries

Primary outcomes:
measure: Leg extension/leg-flexion rate
timeFrame: at baseline
Secondary outcomes:
measure: Isokinetic leg extensors strength
timeFrame: at baseline
measure: Isokinetic leg flexors strength
timeFrame: at baseline
measure: Y-Balance Test
timeFrame: at baseline
measure: Maximum jumping height
timeFrame: at baseline
Other outcomes:
Locations:
city: Erlangen
country: Germany
facility: Institute of Medical Physics, University of Erlangen-Nurnberg
Study officials:
affiliation: Institute of Medical Physics, University of Erlangen-Nürnberg, Germany
name: Wolfgang Kemmler, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT03216590: The Effect of Draping on Swelling in Shoulder Arthroscopy
Official title: Can Preoperative Compressive Draping Reduce Soft Tissue Swelling During Shoulder Arthroscopy? A Prospective Randomized Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Shoulder Arthroscopy
Soft Tissue Swelling
Keywords: Shoulder Arthroscopy
Soft Tissue Swelling
Rotator Cuff Repair
Shoulder Arthroscopy Complications
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2017-07-13
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: After signing an informed consent participants will be randomised to one of the two study groups.
Primary purpose: PREVENTION

Brief summary: Strategies to minimize soft tissue swelling during shoulder arthroscopy are constantly sought after. The investigators propose an unfamiliar method which may reduce tissue swelling during shoulder arthroscopy.

Detailed description: Fluid extravasation into the surrounding tissue is common in shoulder arthroscopy. It frequently leads to soft tissue swelling and edema which results in poor visualization and prolonged surgical time. While usually resolves uneventfully within 12 hours, excessive fluid extravasation into the soft tissue around the shoulder may lead to serious consequences and complications such as airway compromise, tracheal deviation, neuropraxias, habdomyoloysis and skin necrosis have been reported in the literature. Methods aimed at reducing soft tissue swelling during shoulder arthroscopy in order to avoid complications (e.g., low pump pressure, short arthroscopic time) are routinely practiced. Nevertheless, fluid extravasation and soft tissue swelling remains a concern in shoulder arthroscopy.

The purpose of the current study is to evaluate whether applying local compression to the shoulder by preoperative compressive draping will reduce soft tissue swelling during shoulder arthroscopy. To the investigators' knowledge, no previous study evaluated the influence of applying compressive draping to the shoulder on soft tissue swelling in shoulder arthroscopy.

Eligibility criteria: Inclusion criteria for the study are defined as:

1. Surgery indicated for chronic symptomatic RC tear unresponsive to non-operative treatment over a minimal period of 6 months.
2. Small to medium size tears (\<3 cm).
3. Age older than 18 years.
4. ASA score 1or 2.
5. Body mass index (BMI) \< 35.
6. Willingness to provide an informed consent.

Exclusion criteria:

1. Pregnant women.
2. Arthroscopic procedure that was converted to an open ("mini-open") surgery.
3. Patients who do not meet the above mentioned inclusion criteria.

Primary outcomes:
measure: Change on shoulder circumference
timeFrame: Immediate post-operative
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Hillel Yaffe Medical Center
name: Ofir Uri
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01845090: The Effect of Lanthanum Carbonate on Fibroblast Growth Factor 23
Official title: Compared the Effect of Lanthanum Carbonate on Fibroblast Growth Factor 23 With Calcium Carbonate in Hemodialysis Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Other Nonspecific Abnormal Serum Enzyme Levels
Lead sponsor: Camillians Saint Mary's Hospital Luodong
Sponsor class: OTHER
First posted: 2013-05-03
Enrollment: 30
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: To compare the effect of lanthanum carbonate with calcium carbonate on serum FGF23 levels in hemodialysis patients.

Detailed description: The investigators enrolled patients on maintenance hemodialysis and randomized them to two groups. One group will receive lanthanum carbonate and another group will receive calcium carbonate. The investigators will compare serum FGF23 levels between two groups after they receive above medication for 6 months.

Eligibility criteria: Inclusion Criteria:

* Age \> 18 years old
* Chronic renal failure on maintenance hemodialysis 3 times a week for at least 3 months Serum calcium:8-10.5 mg/dL
* Serum phosphate:3.5-6 mg/dL(before washout period)
* Serum phosphate ≧6 mg/dL after washout period
* Serum i-PTH: 150-600 pg/mL

Exclusion Criteria:

* Diabetes mellitus
* Post parathyroidectomy
* Life expectancy\< 6 months
* Liver disease(hepatitis B,C or liver dysfunction)
* Severe gastrointestinal disorders or other severe comorbidity
* Poor compliance
* Intolerance to lanthanum or calcium carbonate
* Active infection
* Malnutrition(serum albumin\<3 g/dL or clinical assessment)
* Kt/V\< 1.2 (inadequate dialysis)
* Serum phosphate\>7.5 mg/dL after washout period

Primary outcomes:
measure: serum level of fibroblast growth factor
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Saint Mary's hospital-Lotung
Study officials:
affiliation: Saint Mary's hospital-Lotung
name: Shih-Ching Tsai, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chang YM, Tsai SC, Shiao CC, Liou HH, Yang CL, Tung NY, Hsu KS, Chen IL, Liu MC, Kao JL, Jhen RN, Huang YT. Effects of lanthanum carbonate and calcium carbonate on fibroblast growth factor 23 and hepcidin levels in chronic hemodialysis patients. Clin Exp Nephrol. 2017 Oct;21(5):908-916. doi: 10.1007/s10157-016-1362-9. Epub 2016 Dec 7.
Clinical trial NCT01374490: Safety and Tolerability of Crofelemer for HIV-Associated Diarrhea
Official title: A Phase 3, Multicenter, Open-Label Evaluation of the Safety and Tolerability of Crofelemer in HIV-Positive Subjects With Diarrhea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: HIV Enteropathy
Diarrhea With HIV
Keywords: HIV +
HIV positive
HIV associated diarrhea
AIDS
Diarrhea
Lead sponsor: Bausch Health Americas, Inc.
Sponsor class: INDUSTRY
First posted: 2011-06-16
Enrollment: 250
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: This study is being conducted to evaluate the safety and tolerability of crofelemer 125 mg twice a day, taken orally, over 48 weeks of therapy in human immunodeficiency virus-positive (HIV+) subjects with diarrhea.


Eligibility criteria: Inclusion Criteria:

* Male or female ≥ 18 years old
* History of HIV-1 infection
* On an antiretroviral therapeutic regimen for treatment of HIV-1 disease and associated conditions (including prophylactic antibiotics for Pneumocystis jirovecii or infection) for at least 4 weeks prior to screening
* Self-reported presence of diarrhea necessitating ADM use for at least 4 weeks

Exclusion Criteria:

* CD4 counts \< 100 cells/mm3
* Oral temperature greater than 38.0° C, or unintentional weight loss of 5.0 kg or greater during the prior 2 months
* Bright red blood per rectum judged not to be of an anal (e.g., hemorrhoid, fissure) origin
* Immediate need for GI surgery or intervention for active GI bleeding, pancreatitis, peritonitis, intestinal obstruction, or intra-abdominal abscess

Primary outcomes:
measure: Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs).
timeFrame: 48 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
state: Arizona
city: Little Rock
country: United States
state: Arkansas
city: Bakersfield
country: United States
state: California
city: Beverly Hills
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: San Diego
country: United States
state: California
city: Fort Lauderdale
country: United States
state: Florida
city: Fort Lauderdale
country: United States
state: Florida
city: Miami Beach
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Wilton Manors
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Chicago
country: United States
state: Illinois
city: Detroit
country: United States
state: Michigan
city: Santa Fe
country: United States
state: New Mexico
city: New York
country: United States
state: New York
city: Rochester
country: United States
state: New York
city: Cincinnati
country: United States
state: Ohio
city: Portland
country: United States
state: Oregon
city: Houston
country: United States
state: Texas
Study officials:
References: