louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01515150: The Out-patient, Non Antibiotic Management of Patients With Acute Uncomplicated Colonic Diverticulitis
Official title: Management of Patients With Uncomplicated Diverticulitis as Out-patient and Without Antibiotics
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colonic Diverticulitis
Keywords: diverticulitis
Out-patient management
Antibiotics
Lead sponsor: Uppsala University
Sponsor class: OTHER
First posted: 2012-01-23
Enrollment: 161
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with CT- scan varified acute uncomplicated diverticulitis how are abel to underwent out-patients managment

Brief summary: Previous multicentre study NCT 01008488 indicates that a patient with CT-proven uncomplicated diverticulitis has a very low risk (1.4%) of developing severe complications such as perforations or abscesses. The question is whether or not hospitalization is necessary, and if patients in that case could return home without antibiotics.

The purpose of this study is to evaluate if out-patients managements in uncomplicated colonic diverticulitis is possible without readmission or complications.

Detailed description: At the emergency room all patients with computed tomography verified acute uncomplicated diverticulitis will be asked about participation in the study. If They accept the participation, They will be send home with pain relief medicine. Every morning a nurse from our colorectal unit call the patient asking about the condition. The patients will have a visit at the surgery unit within 10 days.

Eligibility criteria: Inclusion Criteria:

* Adults (age above 18 years, acute abdominal pain (Duration\< 3 days), abdominal tenderness, elevated inflammatory parameters, CT- scan sign of uncomplicated diverticulitis(without sign of abscess or free air).

Exclusion Criteria:

* diffuse peritonitis sepsis or abscess, drying Patients who are unable to intake of fluids orally, severe pain with need of repeated parenteral morphine treatment, immunological deficient patients incl. steroid treatment, pregnancy, dementia, patients who need hospitalization of other reasons

Primary outcomes:
measure: Number of admission and complications among participant within three months follow-up.
timeFrame: Three months
Secondary outcomes:
measure: To evaluate reason of hospital admission, late complications, need of bowel rest and costs
timeFrame: Three months
Other outcomes:
Locations:
city: Västerås
country: Sweden
facility: Colorectal unit, department of surgery Västmanland Hospital Västerås
state: Västmanland
Study officials:
affiliation: Centre of Clinical Research of Uppsala University, Västmanlands Hospital Västerås
name: Mats Enlund, Ass. Prof
role: STUDY_CHAIR
References:
Clinical trial NCT01636050: Effect of Squat Training on Body Composition, Muscular Strength and Motor Fitness for Youth- Randamized Trial
Official title: Phase 1 Study of Child Exercise Training
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Physical Conditioning
Keywords: squat exercise
Lead sponsor: National Institute of Fitness and Sports in Kanoya
Sponsor class: OTHER
First posted: 2012-07-10
Enrollment: 2
Sex: ALL
Minimum age (years): 12
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to determine the effects of body mass-based squat training on body composition, muscular strength and motor fitness in adolescents.

Detailed description: Body composition Percent body fat by bioimpedance muscle thickness at the thigh anterior by ultrasound

Muscle strength Maximal voluntary knee extension torque by myometer

Motor fitness sprint velocity by non-motorized treadmill Jump height by a matswitch system.

Eligibility criteria: Inclusion Criteria:

* Healthy adolescents

Exclusion Criteria:

* Participants do not have medical and orthopedic disorder.

Primary outcomes:
measure: Percent body fat by bioelectrical impedance
timeFrame: Eight week
Secondary outcomes:
measure: knee extension strength by myometer
timeFrame: eight weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05465850: Shade Matching Potential of Universal Shade Resin Composite Materials Compared to Multi Shade Resin Composite in Restoration of Carious Cervical Lesions in Anterior Teeth
Official title: Shade Matching Potential of Universal Shade Resin Composite Materials Compared to Multi Shade Resin Composite in Restoration of Carious Cervical Lesions in Anterior Teeth ( Randomized Clinical Trial ) - 1 Year Follow up
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Class V Dental Caries
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-07-20
Enrollment: 60
Sex: ALL
Minimum age (years): 25
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to clinically evaluate the shade matching and clinical performance of the Universal shade composites Omnichroma and GC Essentia versus the multi shade composite Filtek Z350XT in restoring cervical lesions of anterior teeth.


Eligibility criteria: Inclusion Criteria:

* Class V carious lesions in anterior teeth
* Vital upper or lower anterior teeth with no signs of irreversible pulpitis and necrosis.
* Presence of favorable occlusion and teeth are in normal contact with the adjacent teeth

Exclusion Criteria:

* Deep carious defects ( Close to pulp, less than 1 mm distance)
* Periapical pathology or signs of pulpal pathology
* Endodontically treated teeth
* Tooth hypersensitivity
* Possible prosthodontic restoration of teeth
* Heavy occlusion and occlusal contacts or history of bruxism
* Severe periodontal affection
* Lesions in premolars and molars
* Posterior teeth

Primary outcomes:
measure: Clinical performance (USPHS criteria)
timeFrame: baseline: 1 week
measure: Clinical performance (USPHS criteria)
timeFrame: 6 months
measure: Clinical performance (USPHS criteria)
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05161650: Hemodynamic Effects of Chronic Ketosis.
Official title: Modulation of Circulating Levels of the Ketone Body 3-hydroxybutyrate in Patients With Chronic Heart Failure: Cardiovascular Effects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Heart Failure
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2021-12-17
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Heart Failure (HF) is a major public health issue because the disease affects 1-2% of the Western population and the lifetime risk of HF is 20%. Despite major improvements in the management and care of patients with HF, the 1-year mortality in patients with HF is 13% and \>50% of HF patients are admitted during a 2.5 year period. Furthermore, patients with HF have markedly decreased physical capacity and quality of life. Thus, there is a need for new treatment modalities in this group of patients.

We have shown, using positron emission tomography, that ketone body infusion reduces myocardial glucose uptake and increases myocardial blood flow in healthy subjects. Data from another study conducted by our group show a 40% increase in cardiac output during infusion of 3-OHB in patients with HF and reduced left ventricular ejection fraction (HFrEF).

Presently there are no data on the clinical cardiovascular effects of long-term oral ketone-supplementation in patients with chronic HF.

In this study we aim to investigate the effect of 14 days modulation of circulating ketone body levels on cardiac function and exercise capacity in patients with HFrEF.


Eligibility criteria: Inclusion Criteria:

* Chronic heart failure with NYHA II-III
* Left ventricular ejection fraction ≤40%
* Negative urine-HCG for women with childbearing potential

Exclusion Criteria:

* Known diabetes or HbA1c ≥48 mmol/mol
* Significant cardiac valve disease
* Severe stable angina pectoris
* Age \<18 years

Primary outcomes:
measure: Resting cardiac output (L/min)
timeFrame: 14 days of dietary supplement
Secondary outcomes:
measure: Resting pulmonary capillary wedge pressure (PCWP)
timeFrame: 14 days of dietary supplement
measure: Peak exercise pulmonary capillary wedge pressure (PCWP)
timeFrame: 14 days of dietary supplement
measure: Peak exercise cardiac output (L/min)
timeFrame: 14 days of dietary supplement
measure: Exercise capacity (METs)
timeFrame: 14 days of dietary supplement
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
Study officials:
References:
Clinical trial NCT05239650: Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX07+HLX10 +mFOLFOX6 or HLX07 Monotherapy in Patients With mCRC
Official title: An Open-label, Multicenter, Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX07 (Recombinant Humanized Anti-EGFR Monoclonal Antibody Injection) + HLX10 (Recombinant Humanized Anti-PD-1 Monoclonal Antibody Injection) + mFOLFOX6 or HLX07 Monotherapy in Patients With Metastatic Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: CRC
Lead sponsor: Shanghai Henlius Biotech
Sponsor class: INDUSTRY
First posted: 2022-02-15
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is An Open-label, Multicenter, Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX07 (Recombinant Humanized Anti-EGFR Monoclonal Antibody Injection) + HLX10 (Recombinant Humanized Anti-PD-1 Monoclonal Antibody Injection) + mFOLFOX6 or HLX07 Monotherapy in Patients with Metastatic Colorectal Cancer.


Eligibility criteria: Inclusion Criteria:

* Age\>=18Y and ≤75Y
* Good Organ Function
* Expected survival time ≥ 3 months
* mCRC that have been diagnosed histologically
* KRAS/NRAS/BRAF WT verified by PCR or NGS of tumor tissue
* ECOG score 0-1;

Exclusion Criteria:

* HIV infection
* Active clinical severe infection;
* A history of other malignancies within two years, except for cured carcinoma in situ of the cervix or basal cell carcinoma of the skin.

Primary outcomes:
measure: ORR
timeFrame: up to 3 years
measure: PFS
timeFrame: : from the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier)，up to 3 years
Secondary outcomes:
measure: OS
timeFrame: up to 5 years
Other outcomes:
Locations:
Study officials:
affiliation: Fudan University Affiliated Oncology Hospital
name: Peng Junjie
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02867150: A Retrospective Analysis of the Effects of Red Light Therapy on Body Contouring
Official title: A Retrospective Analysis of the Effects of Red Light Therapy on Body Contouring
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: Ward Photonics LLC
Sponsor class: INDUSTRY
First posted: 2016-08-15
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether red light therapy using LED 635nm red light for body contouring of the waist, hips and thighs is as effective as red light therapy using Laser 635nm red light.

Detailed description: Red light laser therapy using 635nm red light laser technology has previously been shown to cause lipolysis in subcutaneous fat as a non-surgical method to promote weight loss and body contouring. This study hypothesizes that red LED light therapy using 635nm red light LED (light emitting diode) technology produces similar results to the laser device (red LASER 635nm) when performed using a specified treatment protocol.

Furthermore, it is hypothesized that the UltraSlim Cold Light therapy program achieves the results after a single 32-minute treatment. The predicate 635nm laser device (Zerona by Erchonia) achieves its results after six treatments combined with a diet and exercise regimen.

UltraSlim Cold Light® is a patented process using the Photonica Professional device for fat removal using LED red light therapy. This multi-site study reviews results from 58 randomly selected patients after a single treatment using the Photonica Professional device (i.e. UltraSlim Cold Light®).

Eligibility criteria: Inclusion Criteria:

* 18 years or older.
* Male or female.
* Generally good health.

Exclusion Criteria:

* Pregnancy.
* Active cancer within the past year.
* Diminished ability to void waste (liver or kidneys).
* Photosensitive condition or medication.

Primary outcomes:
measure: Fat Reduction in Treatment Zone as Measured in Inches Lost
timeFrame: Single 32-minute treatment session
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Managing Director
name: Terry J Ward, M.H.A.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05589350: High-fat Yogurt and Plasma Lipids Profile
Official title: Comparison of the Impact of Saturated Fat From High-fat Yogurt or Low-fat Yogurt and Butter on Cardiometabolic Risk Markers: a Randomized Cross-over Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Plasma Lipid Profile
Lead sponsor: Shahid Beheshti University
Sponsor class: OTHER
First posted: 2022-10-21
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The goal of this clinical trial is to compare the effect of saturated fat intake from different source on cardiometabolic risk markers in healthy subjects. The main question it aims to answer are:

-Does intake of saturated fat in the form of high-fat yogurt have a different effect on cardiometabolic risk factors than intake of the same amount from butter? In this study, in two periods of 4 weeks, the effect of receiving saturated fat from high-fat yogurt compared to receiving the same amount of saturated fat from butter and low-fat yogurt on the plasma concentration of lipids, cholesterol, insulin, and some inflammatory factors will be studied in healthy subjects.


Eligibility criteria: Inclusion Criteria:

* Healthy people who do not use lipid-lowering, blood pressure control or diabetes medications

Exclusion Criteria:

* Taking supplements of omega-3 fatty acids, or antioxidants

Primary outcomes:
measure: Plasma lipid profile
timeFrame: 4 weeks
Secondary outcomes:
measure: Glycemic measures
timeFrame: 4 weeks
Other outcomes:
measure: Inflammatory markers
timeFrame: 4 weeks
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Clinical Nutrition Research Unit, National Nutrition and Food Technology Research Institute
Study officials:
References:
Clinical trial NCT03457350: Office Hysteroscopy Versus Cervical Probing for Cervical Stenosis
Official title: Small-caliber Office Hysteroscopy Versus Blind Cervical Probing for Tight Primary Cervical Stenosis in Nulliparous Women: a Preliminary Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hysteroscopy
Keywords: hysteroscopy
cervical stenosis
probing
Lead sponsor: Woman's Health University Hospital, Egypt
Sponsor class: OTHER
First posted: 2018-03-07
Enrollment: 128
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This study aims to estimate if performing a small caliber office hysteroscopic cervical negotiation would succeed to bypass tight markedly stenotic cervix in comparison to blind cervical probing done under general anesthesia. Moreover, the investigators test the impact of drawing a detailed diagram after this procedure on the success of ET in participants with failed mock or actual trials of embryo transfer (ET).

Detailed description: It comprises 122 nulliprous women with failed cervical sounding on vaginal examination in the office. Participants were divided into 2 groups. Group A comprised 64 cases subjected to small-caliber office hysteroscopic cervical negotiation while 58 cases were subjected to cervical probing under general anesthesia. Main outcome measures included success to bypass primary cervical stenosis and complication rate

Eligibility criteria: Inclusion Criteria:

* Nulliprous women.
* Failed cervical sounding on vaginal examination in the office.

Exclusion Criteria:

* Previous operation on the cervix.
* Use of any medication to prime the cervix (primary).
* Multiparity: weather delivered vaginally or by cesarean sectrion

Primary outcomes:
measure: How many cases of access to the endometrial cavity
timeFrame: 20 minutes
Secondary outcomes:
measure: complication rate
timeFrame: 20 minutes
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Woman's Health University Hospital
Study officials:
affiliation: Woman's |Health University Hospital
name: Atef Darwish
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04652050: Evaluation of Tolsura When Used as Prophylaxis After Lung Transplantation
Official title: Evaluation of Tolsura When Used as Prophylaxis After Lung Transplantation
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Lung Transplant Infection
Keywords: lung transplant
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2020-12-03
Enrollment: 0
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: lung transplants on Tolsura that meet entry criteria

Brief summary: This is a single-center, observational study of Tolsura PK sampling in lung transplant recipients

Detailed description: Patients who are receiving Tolsura as part of their clinical care will be asked to enroll and EMR data and excess biological samples will be collected

Eligibility criteria: Inclusion Criteria:

* 18 years of age and older
* hospitalized at UPMC
* placed on Tolsura prophylactically by clinical team
* patients who have had or will have a lung transplant.

Exclusion Criteria:

* redo lung transplant
* recipient with dual liver-lung transplant
* patients with previous history of SOT
* including other organ transplantation
* patients with known pre-transplant colonization with moulds resistant to azoles
* patients with intra-transplant positive cultures for moulds in either transplant recipient or his/her donor
* patients with a history of hypersensitivity reaction to an azole agent
* patients who are kept NPO (nothing by mouth, including meds)
* recipients or donor with HepC PCR positive

Primary outcomes:
measure: PK Sampling-measure amount of drug in system
timeFrame: one day PK sampling
Secondary outcomes:
measure: rates of infection post treatment with Tolsura
timeFrame: 6 months
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: UPMC
state: Pennsylvania
Study officials:
affiliation: UPMC and PITT
name: Hong Nguyen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01209650: LUX Lung Special Access Scheme Australia Named Patient Use (NPU)
Official title: Expanded Access Program BIBW 2992 for Non Small Cell Lung Cancer ( NSCLC) Last Line Treatment
Study type: EXPANDED_ACCESS
Overall status: APPROVED_FOR_MARKETING
Conditions: Carcinoma, Non-Small-Cell Lung
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2010-09-27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: The program will provide early access to the investigational drug BIBW 2992 to treat patients with advanced NSCLC who have failed at least 12 weeks on erlotinib or gefitinib.

The Compassionate Use Programme will also provide additional safety and efficacy information on BIBW 2992 use.

Named Patient Use (NPU)


Eligibility criteria: Inclusion criteria:

* Patients with pathologic confirmation of adenocarcinoma of the lung Stage IIIB with pleural effusion or Stage IV

Exclusion criteria:

* Brain metastases which are symptomatic; patients with treated, asymptomatic brain metastases are eligible with stable brain disease for at least four 4 weeks without the requirement for steroids or anti epileptic therapy
* Significant or recent acute gastrointestinal disorders with diarrhea as a major symptom as judged by the investigator.
* Patients who have any other life-threatening illness or organ system dysfunction, which in the opinion of the investigator, would either compromise patient safety or interfere with the evaluation of the safety of the test drug
* History of cardiac disease that is clinically significant, as judged by the investigator or uncontrolled cardiac disease (including congestive heart failure, angina, myocardial infarction, arrhythmia, including New York Heart Association (NYHA) functional classification of 3)
* Cardiac left ventricular function with resting ejection fraction of less than 50%
* Bilirubin 1.5 mg / dl (26 mol / L, SI unit equivalent)
* Aspartate amino transferase (AST) or alanine amino transferase (ALT) three times the upper limit of normal (if related to liver metastases five times the upper limit of normal)
* Serum creatinine 1.5 times of the upper normal limit or calculated/measured creatine clearance 45ml/min
* Women of child-bearing potential or men who are able to father a child unwilling to use a medically acceptable method of contraception during the trial
* Pregnancy or breast feeding
* Patients unable to comply with the protocol
* Patients with known HIV, active hepatitis B or active hepatitis C
* Pre-existing Interstitial Lung Disease (ILD)
* Requirement for treatment with any of the prohibited concomitant medications listed in Section 4.2.2.1.
* Patients already pre-treated with BIBW 2992

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: North Ryde
country: Australia
facility: 1200.47.1 Boehringer Ingelheim Investigational Site
state: New South Wales
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: