louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04680182: Early Complications After Axillary and Inguinal Lymph Node Dissection in Stage III Melanoma Patients
Official title: Axillary and Inguinal Lymph Node Dissection in Stage III Melanoma Patients: A Prospective Randomized Trial of Two Approaches to Wound Drainage
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Melanoma
Complication
Keywords: Melanoma
Complication
Drain
Non-inferior study
Randomized study
Seroma
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2020-12-22
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Non-inferiority randomised study.
Primary purpose: TREATMENT

Brief summary: This prospective randomized non-inferiority study is designed to compare the rate and severity of complications after axillary and inguinal lymph node dissection in stage III melanoma patients in a study group where the drain is left in place for three weeks and a control group consisting of patients managed according to the standard institutional protocol. Furthermore, variables associated with complications will be examined.

Detailed description: Consecutive stage III melanoma patients 18 years or older referred to our institution for axillary or inguinal lymph node dissection is eligible for inclusion of the study. A bipolar vessel sealing device (LigaSure, Covidien) will be used for dissection in all procedures. All patients will be scheduled for an outpatient visit with an experienced nurse three weeks after the surgery. Any deviation from the normal postoperative course will be recorded in the electronic patient journal. Complications are graded according to the Clavien-Dindo classification. Patients with complications or with suspected complications at the three-week follow up will be scheduled for new an outpatient visit. Patient demographics, clinicopathological characteristics of the primary melanoma, indication for the procedure, length of postoperative stay and early complications and treatment for complications will be collected for analysis

Eligibility criteria: Inclusion Criteria:

* stage III melanoma patients with confirmed metastases to lymph nodes in axilla or groin

Exclusion Criteria:

* unable to follow instructions or provide an informed written consent

Primary outcomes:
measure: Non-inferiority of overall early complications
timeFrame: 3-week follow up, total 3 months
Secondary outcomes:
measure: Rate and severity of early complications
timeFrame: 3-week follow up, total 3 months
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
References:
Clinical trial NCT01570582: A Phase IIclinical Trial of Carboplatin and Paclitaxel or Carboplatin and Gemcitabine in Platinum-sensitive, Recurrent Ovarian, Fallopian Tube, and Primary Peritoneal Cancer
Official title: A Phase II Randomized Controlled Clinical Trial of Carboplatin and Paclitaxel or Carboplatin and Gemcitabine in Platinum-sensitive, Recurrent Ovarian, Fallopian Tube, and Primary Peritoneal Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Fallopian Tube Cancer
Ovarian Cancer
Primary Peritoneal Cancer
Keywords: recurrent ovarian
ECG
GOG performance
Hematologic g
Blood chemistry and urinalysis h
Lead sponsor: Korean Gynecologic Oncology Group
Sponsor class: OTHER
First posted: 2012-04-04
Enrollment: 314
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: purpose Primary endpoint

* To evaluate the 24 month disease free survival Second endpoints
* To evaluate the 24 month overall survival To analyze the toxicity and the quality of life

Detailed description: Approximately 48 month from the date of IRB approval

Patients enrolled in this study targets approximately 314 people. Completion of patient enrollment is expected to take approximately 24 month, approximately 24 month follow-up period is expected to be needed

Eligibility criteria: Inclusion Criteria:

* Patients with epithelial ovarian, fallopian tube cancer bokmakam or pathological diagnosis of recurrent states there must be must be present.
* Pathologically Serous adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, transitional cell carcinoma, malignant Brenner's Tumor, or adenocarcinoma not otherwise specified (NOS) have been diagnosed with possible participation.
* Patients with CA-125 (biochemical recurrence), as described below elevation or clinically measurable lesions or the measurement is not possible, as there should be evidence of recurrence.
* If at least one (record as the longest diameter) can be accurately measured in at least one lesion that is defined. For each lesion, such as MRI or CT, when measured by traditional methods should be at least 20mm spiral CT (spiral CT) have been measured to be less than 10mm when.
* Neutrophil (ANC) by 1500 / ㎣ more Platelet count 100,000 / ㎣ more Serum creatinine concentration 1.5mg/dL (133mol / l) or creatinine clearance less than 60ml/min should be at least two.

Exclusion Criteria:

* Patients must be at least 18 years of age.
* Patients with epithelial ovarian, fallopian tube cancer bokmakam or pathological diagnosis of recurrent states there must be must be present.

Primary outcomes:
measure: 24month progression free survival
timeFrame: 24 months
Secondary outcomes:
measure: Toxicity Profile
timeFrame: 24 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea Institute of Radiological and Medical Sciences
Study officials:
References:
Clinical trial NCT01223482: A Study Looking at Women's Experiences After a Miscarriage
Official title: An Investigation of Women's Experiences Following Karyotyping Products of Conception After a Miscarriage
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Miscarriage
Keywords: Miscarriage
Karyotyping
Genetic testing
Lead sponsor: California State University, Stanislaus
Sponsor class: OTHER
Collaborators: name: Stanford University
First posted: 2010-10-19
Enrollment: 400
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The investigators are targeting woman based on the inclusion and exclusion criteria provided below.

Brief summary: Studies have shown that a majority of pregnancies that end in miscarriage are due to a chromosome abnormality usually involving a duplicated or missing chromosome. Often this happens by chance and is not likely to occur in future pregnancies. For many women, a miscarriage can be a traumatic experience and can cause feelings of loss and grief. The option of genetic testing, such as karyotyping, may offer an explanation for the miscarriage and may help some women find closure in their loss. However, no literature exists on a women's experience with genetic testing following a miscarriage. This assumption that the knowledge that can be gained from karyotyping may be a positive experience for a woman following a miscarriage should be studied and the results published. This study will address whether routine karyotyping should be offered following a miscarriage for the purpose of benefiting the patient's experience.


Eligibility criteria: Inclusion Criteria:

* The inclusion criteria for this project will be females, 18 years or older, of any ethnicity that have had a 1st trimester miscarriage within the last one year, who currently reside in the US and have done so for the past one year.

Exclusion Criteria:

* Exclusion criteria will be males, females younger than 18 years of age, females with a miscarriage over one year, non-US residents and US residents where the miscarriage occurred outside of the US.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Http://Www.Surveymonkey.Com/S/Miscarriagestudy3
state: California
Study officials:
References:
Clinical trial NCT02080182: Effect of Acetylcysteine in Pediatric Acute Pyelonephritis.
Official title: Study of the Effect of Acetylcysteine on Inflammation Biomarkers in Pediatric Acute Pyelonephritis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pyelonephritis
Keywords: Acute Pyelonephritis
Acetylcysteine
Pediatric
Lead sponsor: Shahid Beheshti University of Medical Sciences
Sponsor class: OTHER
First posted: 2014-03-06
Enrollment: 70
Sex: ALL
Minimum age (years): 1
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In different studies, it has been shown that "antioxidant" utilization has favorable therapeutic effects not only on control of acute symptoms but also on prevention of delayed problems from acute and chronic pyelonephritis.

According to the efficacy of acetylcysteine as a potent antioxidant, safety of this drug and side effects of similar or either less than placebo, this study was designed to evaluate the efficacy of this drug on inflammatory biomarkers of pediatric acute pyelonephritis. It is a triple-blind placebo controlled study on a population of 64 patients 1-16 years old that have "definite" or "probable" diagnosis of acute pyelonephritis in "Mofid" hospital.

After randomization, patients will be given acetylcysteine or placebo with dosing according to their weight. Results of treatment are evaluated according to serum procalcitonin, C reactive protein and leukocyte count before drug prescription (baseline) and 5 days after drug prescription. Side effects are also recorded in both groups. Patients will be receiving their routine antimicrobial drugs in addition to acetylcysteine.


Eligibility criteria: Inclusion Criteria:

* Patients between the ages of 1 and 16
* Having the diagnosis of "definite" or "probable" urinary tract infection according to guidelines of "pediatric infectious disease research center

Exclusion Criteria:

* Patients younger than 1 or older than 16 years old
* Patients without the diagnosis of "definite" or "probable" urinary tract infection according to guidelines of "pediatric infectious disease research center"
* Patients with acute/ chronic infectious or inflammatory diseases other than pyelonephritis.

Primary outcomes:
measure: Serum procalcitonin
timeFrame: Change from baseline serum procalcitonin at 5 days
Secondary outcomes:
measure: Serum C Reactive Protein
timeFrame: Change from baseline serum C Reactive Protein at 5 days
measure: Leukocyte count
timeFrame: Change from baseline leukocyte count at 5 days
measure: Probable adverse effects (nausea, vomiting, bad tasting, stomatitis, ...)
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 5 days
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Pediatric Infections Research Center
Study officials:
References:
Clinical trial NCT02089282: Clavicular Shortening Post-fracture - Does it Change? - a Prospective Study of 70 Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stability of Clavicular Fractures Within the First 3 Weeks
Lead sponsor: Holbaek Sygehus
Sponsor class: OTHER
Collaborators: name: Odense University Hospital
First posted: 2014-03-17
Enrollment: 70
Sex: ALL
Minimum age (years): 17
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Clavicular fractures

Brief summary: In an attempt to answer if clavicular length changes after a fracture e.g. that any shortening becomes worse or better, 70 patients will be followed 3 times over 21 days using a novel ultrasound method.


Eligibility criteria: Inclusion Criteria:

All patients who sustain a displaced medial, mid and lateral clavicle fracture from March 2014 to August 2015 referred from Slagelse and Holbæk emergency departments are eligible. The last patients are seen end of mid-July 2015 given the 21 days of follow up.

Exclusion Criteria:

Patients that have bilateral clavicle fractures and/or prior operations involving the clavicle are excluded. Malignant diagnoses are excluded.

Primary outcomes:
measure: Change in clavicular length
timeFrame: 3 weeks
Secondary outcomes:
measure: Oxford shoulder score
timeFrame: 21 days
Other outcomes:
measure: Constant score
timeFrame: 21 days
Locations:
city: Holbæk
country: Denmark
facility: Holbæk sygehus
state: Vest-sjælland
Study officials:
References:
Clinical trial NCT05011682: The Effect of 'Medical Nutrition Therapy' on Post-bariatric Hypoglycemia 2-4 Years After Gastric Bypass Surgery
Official title: The Effect of Nutrition and Medical Therapy on Post-bariatric Hypoglycemia Patients 2-4 Years After a Roux-en-Y Gastric Bypass: a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypoglycemia
Obesity, Morbid
Keywords: Gastric bypass
Diet therapy
Blood sugar variation
Quality of Life
Lead sponsor: Helse Nord-Trøndelag HF
Sponsor class: OTHER
Collaborators: name: Norwegian University of Science and Technology
First posted: 2021-08-18
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Participants are their own controls. All participants will follow their usual diet in the first 2 weeks, and then during the next 2 weeks the 10-point nutrition plan according to Joslin Diabetes Center.
Primary purpose: TREATMENT

Brief summary: This is a pilot study to explore the effect of 'medical nutritional therapy' in patients diagnosed with post-bariatric hypoglycemia (PBH), 2-4 years after gastric bypass surgery. The study is largely inspired by the findings presented in the meta-analyses from Joslin Diabetes Center, where a treatment strategy is proposed to reduce the symptoms of PBH. This treatment strategy is mainly based on clinical observations and experience, while there is little or no objective data to support that this strategy improves PBH. The data from this pilot study can then be used to set up larger studies where a conclusion on treatment of PBH may be drawn.


Eligibility criteria: Inclusion Criteria:

* patient in Nord-Trøndelag 2-4 years after Roux-en-y gastric bypass surgery
* visits Namsos outpatient clinic for follow-up.
* having at least 3 symptoms of hypoglycemia presented in the dumping severity scale (DSS).
* at least one of these symptoms must be a neuroglycopenic symptom
* all these symptoms have an intensity of 2 or 3 on DSS.

Exclusion Criteria:

* severe surgery-related complication
* revisional surgery
* life threatening health conditions.
* diabetes mellitus or other metabolic diseases
* pregnancy or breast feeding

Primary outcomes:
measure: blood sugar variation
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Namsos
country: Norway
facility: Obesity Outpatient Clinic, Surgical Clinic, Nord-Trøndelag Hospital Trust, Hospital of Namsos
state: Trøndelag
Study officials:
affiliation: Helse Nord-Trøndelag HF
name: Bodil Landstad, phd
role: STUDY_DIRECTOR
References:
Clinical trial NCT03623282: Study Regarding the Clinical Efficacy of Synatura® in Patients With Chronic Bronchitis Type COPD
Official title: Study Regarding the Clinical Efficacy of Synatura® in Patients With Chronic Bronchitis Type COPD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Bronchitis, COPD
Keywords: Synatura
Chronic Obstructive Pulmonary Disease
Ahn Gook Pharmaceuticals
Lead sponsor: Ahn-Gook Pharmaceuticals Co.,Ltd
Sponsor class: INDUSTRY
First posted: 2018-08-09
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Experimental(Single arm):

The enrolled patients will be prescribed Synatura® following measurement of pre-dose pulmonary functions, quality of life and systemic inflammatory state. Pulmonary functions, quality of life and systemic inflammatory state will be repeatedly measured after taking Synatura® for 3 months, and the changes from pre-dose measurements will be observed.
Primary purpose: TREATMENT

Brief summary: This study aims to examine the clinical efficacy of synatura in patients with chronic bronchitis type COPD in Korea.

Detailed description: Synatura® is a drug commonly used to suppress cough and sputum in patients with acute upper respiratory tract infection and chronic inflammatory bronchitis. According to the Phase III studies conducted in Korea, the safety and efficacy of Synatura® on antitussive and expectorant effects were confirmed in patients with acute upper respiratory infection and chronic inflammatory bronchitis. However, no studies have been conducted for the effects of Synatura® in patients with COPD. COPD is divided into emphysema type and chronic bronchitis type, while typical clinical symptoms of chronic bronchitis are cough and sputum. Therefore, Synatura®, which is effective for chronic bronchitis, is expected to be effective in patients with chronic bronchitis accompanied by COPD.

Eligibility criteria: Inclusion Criteria:

1. Post bronchodilator FEV1/FVC \< 0.7
2. Smoking history of ≥10 packs per year
3. 40 to \<75 years of age
4. Patients with symptoms of chronic bronchitis (in case they have symptoms of cough or sputum over 3 months)

Exclusion Criteria:

1. Patients with acute exacerbation
2. Patients with pneumonia
3. Patients with active tuberculosis
4. Pregnant women
5. Breast-feeding women
6. Patients with fructose intolerance

Primary outcomes:
measure: COPD assessment test (CAT)
timeFrame: Baseline, At 12weeks
Secondary outcomes:
measure: Efficacy of pulmonary function in bronchitis type COPD patients
timeFrame: Baseline, At 12weeks
measure: Efficacy of inflammation throughout the body in bronchitis type COPD patients
timeFrame: Baseline, At 12weeks
measure: Total number of Bronchitis Severity Score (BSS)
timeFrame: Baseline, At 12weeks
Other outcomes:
Locations:
city: Soeul
country: Korea, Republic of
facility: Seoul St. Mary's hospital
Study officials:
affiliation: Seoul St. Mary's Hospital
name: Chinkook Rhee, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05713682: Peri-implantitis Between Periodontitis and Nonperiodontitis Sites With ARP
Official title: Prevalence of Peri-implantitis Between Periodontitis and Nonperiodontitis Sites Treated With Alveolar Ridge Preservation: A Retrospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peri-Implantitis
Keywords: peri-implantitis, periodontitis, alveolar ridge preservation
Lead sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor class: OTHER
First posted: 2023-02-06
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: We enrolled consecutive patients who received dental extraction and ARP simultaneously and dental implant treatment at least 4 months after ARP at the Division of Periodontics, Kaohsiung Medical University Hospital

Brief summary: The goal of this observational study is to compare the prevalence of peri-implantitis between periodontitis and nonperiodontitis sites treated with alveolar ridge preservation.

The main question it aims to answer is:

• whether the occurrence of PI is associated with reasons for dental extraction because of periodontitis and nonperiodontitis after alveolar ridge preservation.

Researchers will compare the prevalence of peri-implantitis between periodontitis and nonperiodontitis sites treated with alveolar ridge preservation.


Eligibility criteria: Inclusion Criteria

1. patients aged ≥ 20 years
2. patients who required tooth extraction and implant therapy
3. at least two bite-wing radiographs: baseline and at least a 6-month follow-up

Exclusion Criteria

1. a medical condition as a contraindication to dental surgery, autoimmune disorder, immunosuppression, or uncontrolled diabetes (HbA1c \> 7%);
2. ong-term nonsteroidal anti-inflammatory drug use
3. oral bisphosphonate therapy
4. pregnancy or lactation
5. the absence of follow-up bite-wing radiograph
6. cigarette consumption \>10 per day
7. a history of head and neck radiotherapy.

Primary outcomes:
measure: occurrence of peri-implantitis
timeFrame: 2013-2020
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: School of Dentistry, College of Dental Medicine, Kaohsiung Medical University, Kaohsiung, Taiwan
name: Yu-Hsiang Chou, Master
role: STUDY_CHAIR
References:
Clinical trial NCT00895882: Study to Evaluate Different Regimens of Vaniprevir (MK7009) for the Treatment of Chronic Genotype 1 Hepatitis C Virus Infection in Treatment-naive Patients (MK-7009-019)(WITHDRAWN)
Official title: A Phase II Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of Different Regimens of MK7009 When Administered Concomitantly With Pegylated Interferon and Ribavirin in Treatment-Naive Patients With Chronic Genotype 1 Hepatitis C Virus Infection
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Chronic Genotype 1 Hepatitis C Virus Infection
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2009-05-08
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the safety, tolerability, and efficacy of vaniprevir when administered concomitantly with pegylated interferon (peg-IFN) and ribavirin (RBV) to treat treatment-naive genotype 1 hepatitis C virus (HCV)-infected patients.


Eligibility criteria: Inclusion Criteria:

* Patient has chronic genotype 1 HCV infection
* Patient has had a liver biopsy without evidence of cirrhosis
* Patient has had an eye exam prior to the start of study
* Female patients capable of having children and male patients with female partners capable of having children agree to use two forms of birth control throughout the study

Exclusion Criteria:

* Patient has had previous treatment with: 3 or more doses IFN, peg-IFN, and/or RBV; and stopped treatment due to intolerance of one of the drugs; other antiviral or investigational therapies or vaccines for HCV
* Female patient is pregnant or breastfeeding
* Patient has chronic hepatitis not caused by HCV
* Patient has evidence of cirrhosis of the liver
* Patient has HIV
* Patient has active hepatitis B infection
* Patient has non-genotype 1 HCV infection
* Patient consumes excessive amounts of alcohol

Primary outcomes:
measure: Proportion of patients achieving SVR24 in Treatment Regimens 1 to 4
timeFrame: 24 weeks after end of study therapy
measure: Evaluate the safety and tolerability of the MK7009 treatment regiments as assessed by review of the accumulated safety data
timeFrame: 72 Weeks
Secondary outcomes:
measure: 1) Proportion of patients achieving SVR24 in Treatment Regimen 5
timeFrame: 1) 24 weeks after end of study therapy
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References: