louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00165958: Comparison of Excision Versus Punch Incision in the Treatment of Epidermal Cysts
Official title: Comparison of Excision Versus Punch Incision in the Treatment of Epidermal Cysts
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Epidermal Cyst
Keywords: Epidermal cyst
Epidermoid cyst
Sebaceous cyst
Pilar cyst
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2005-09-14
Enrollment: 40
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: The purpose of this trial is to compare two standard of care treatments for removing epidermal cysts. Surgical excision removes the entire cyst but requires a larger hole in the skin. A punch incision makes a smaller hole through which the cyst can be removed. The trial's purpose is to determine if one method is better than another in terms of recurrence, infection, or other side effects.

Detailed description: The purpose of this trial is to compare two standard of care treatments for removing epidermal cysts. Surgical excision removes the entire cyst but requires a larger hole in the skin. A punch incision makes a smaller hole through which the cyst can be removed. The trial's purpose is to determine if one method is better than another in terms of recurrence, infection, or other side effects.

Patients with epidermal cysts will be randomized to having the cyst removed by surgical excision or by a smaller punch incision followed by removal of the cyst through the smaller hole. The skin will be stitched shut in both cases. A short survey about how the cyst affects the patient will be given before the cyst is removed. When the stitches are removed 2 weeks later, photographs will be taken and a survey regarding satisfaction with the procedure will be given. Two additional phone surveys, given at 4 and 12 months after the procedure, wil be given to ask about recurrence, satisfaction with the procedure, side effects, and how the cyst affected the patient's life. The study doctor will be blinded as to which procedure each subject underwent. Forty subjects will be recruited at the Atlanta Veteran's Administration Medical Center

Eligibility criteria: Inclusion Criteria:

* Adult 18 years or older
* Epidermal cyst 1-3 cm in diameter on the trunk

Exclusion Criteria:

* Infected cyst requiring systemic antibiotics
* Pregnant females
* Unable to return to clinic for suture removal
* Previous excision of target cyst

Primary outcomes:
measure: Number of Participants With Cyst Recurrence
timeFrame: 16 months
Secondary outcomes:
Other outcomes:
Locations:
city: Decatur
country: United States
facility: Atlanta VA Medical Center
state: Georgia
Study officials:
affiliation: Emory University Department of Dermatology
name: Suephy C Chen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00002458: Monoclonal Antibody Therapy in Treating Children With Metastatic Neuroblastoma in Second Remission
Official title: Phase II Study of Adjuvant Therapy With Antiganglioside GD2-Specific Mouse Monoclonal Antibody 3F8 for Metastatic Neuroblastoma in Second Remission
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Neuroblastoma
Keywords: disseminated neuroblastoma
recurrent neuroblastoma
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2004-08-30
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.

PURPOSE: Phase II trial to study the effectiveness of monoclonal antibody in treating children with metastatic neuroblastoma in second remission.

Detailed description: OBJECTIVES: I. Evaluate the efficacy of ganglioside GD2-specific monoclonal antibody 3F8 as adjuvant therapy in patients with Stage IV neuroblastoma in second remission.

OUTLINE: Biological Response Modifier Therapy. Antiganglioside GD2-specific Monoclonal Antibody 3F8, MOAB 3F8.

PROJECTED ACCRUAL: A maximum of 20 patients will be entered.

Eligibility criteria: DISEASE CHARACTERISTICS: Histologically confirmed, Stage IV neuroblastoma in second or subsequent complete remission, defined by the complete disappearance of all evidence of tumor on the following: Physical examination Second-look surgery Bone scan Bone marrow aspiration and biopsy Chest x-ray CT MIBG Urinary catecholamines If marrow is infiltrated by tumor, complete elimination of tumor cells from the marrow compartment must be demonstrated by histology and immunofluorescence (based on simultaneous bone marrow aspiration and biopsy samples from at least 4 separate sites)

PATIENT CHARACTERISTICS: Age: Under 18 Performance status: Not specified Life expectancy: Greater than 12 weeks Hematopoietic: Grade 4 cytopenias allowed Grade 3 marrow hypoplasia allowed Hepatic: Not specified Renal: No renal dysfunction worse than grade 3 Cardiovascular: No cardiac dysfunction worse than grade 2 Pulmonary: No pulmonary dysfunction worse than grade 2 Other: No neurologic dysfunction worse than grade 2 Hearing deficit allowed

PRIOR CONCURRENT THERAPY: Prior murine antibody therapy allowed provided circulating HAMA titer is less than 1,000 U/mL serum by ELISA

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Nai-Kong V. Cheung, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT03025958: Radiation Plus Concurrent Nimotuzumab in Elderly Patients With Locoregionally Advanced Nasopharyngeal Carcinoma
Official title: Concurrent Nimotuzumab and Intensity-modulated Radiotherapy for Elderly Patients With Locally Advanced Nasopharyngeal Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Nasopharyngeal Carcinoma
Lead sponsor: Zhejiang Cancer Hospital
Sponsor class: OTHER
First posted: 2017-01-20
Enrollment: 30
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Concomitant nimotuzumab was given weekly at a dose of 200 mg from one week before the start of IMRT.
Primary purpose: TREATMENT

Brief summary: Radiation Plus Concurrent Nimotuzumab in Elderly Patients With Locoregionally Advanced Nasopharyngeal Carcinoma

Detailed description: Elderly patients with locoregionally advanced nasopharyngeal carcinoma were given an initial dose of nimotuzumab (200 mg) 7days before receiving concurrent radiotherapy, weekly nimotuzumab (200 mg/week).

Eligibility criteria: Inclusion Criteria:

* Previously untreated and histologically confirmed locoregionally advanced nasopharyngeal carcinoma

Exclusion Criteria:

* A history of another invasive cancer, prior RT to the head and neck area, prior cytotoxic chemotherapy or anti-EGFR therapy or the presence of any serious medical conditions, supposed to live less than 6 months.

Primary outcomes:
measure: Complete response (CR) rate at 1 month after radiotherapy
timeFrame: 1 month after radiotherapy
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Xiaozhong Chen
state: Zhejiang
Study officials:
affiliation: Zhejiang Cancer Hospital
name: Xiaozhong Chen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01034358: Immune Response to the Human Papillomavirus Vaccine in Young Women With Inflammatory Bowel Disease
Official title: Comparison of Immune Response to the Human Papillomavirus Vaccine in Young Women With and Without Inflammatory Bowel Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Inflammatory Bowel Disease
Uterine Cervical Dysplasia
Keywords: inflammatory bowel disease
Crohn disease
ulcerative colitis
Papillomavirus vaccines
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2009-12-17
Enrollment: 15
Sex: FEMALE
Minimum age (years): 9
Maximum age (years): 26
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The Gardasil vaccine, a vaccine targeted towards the human papillomavirus (HPV), has been shown to prevent the transmission of several strains of HPV in young women. Women with inflammatory bowel disease (IBD) may not respond as well to this vaccine, either due to having IBD or due to immunosuppressants used to control IBD. This study will test how well women with IBD respond to the Gardasil vaccine.

Detailed description: Although guidelines exist for immunization of patients with inflammatory bowel disease, few studies exist demonstrating vaccine efficacy in this population. In patients with inflammatory bowel disease, lower than normal humoral responses have been shown with the tetanus toxoid booster, oral cholera, and influenza vaccinations. It is currently uncertain whether women with inflammatory bowel disease (IBD) have an increased risk of cervical dysplasia and cancer. Gardasil, a vaccine against human papilloma viruses (HPV) 6, 11, 16, and 18, has been approved for the prevention of cervical dysplasias and cancers in women ages 9-26 years. However, its immune response in immunocompromised or immunosuppressed patients is unknown.

Young women with inflammatory bowel disease who have not received the HPV vaccine will receive the vaccine. The vaccine is given in 3 doses over 6 months. Response to the vaccine will be measured 6 months after completing the vaccine series.

Eligibility criteria: Inclusion Criteria:

1. Women 9-26 years of age
2. Have inflammatory bowel disease (ie. Crohns disease or ulcerative colitis)

Exclusion Criteria:

1. Pregnancy
2. Taking corticosteroids
3. Allergy to yeast aluminum component of the HPV vaccine
4. Positive for all HPV types in the Gardasil vaccine-6, 11, 16, 18

Primary outcomes:
measure: Twelve Month Antibody Response to the Human Papillomavirus (HPV) Vaccine (Geometric Mean Titers [GMT])
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Jeanne Tung, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03124758: Accuracy of Noninvasive Hemoglobin Sensor (Rainbow Reusable DCI)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Masimo Corporation
Sponsor class: INDUSTRY
First posted: 2017-04-24
Enrollment: 354
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: In this study, the accuracy of a noninvasive hemoglobin sensor(s) will be assessed by comparison to hemoglobin measurements from a laboratory hematology analyzer. Blood samples are collected from healthy volunteers who are enrolled in either a blood draw procedure or a hemodilution procedure wherein blood is repeatedly sampled as the concentration of hemoglobin is reduced in a controlled manner by administering fluids intravenously.


Eligibility criteria: A. Hemodilution Test Procedure

Inclusion Criteria:

* Weight of more than 110 lbs and less than 220 lbs.
* Physical status of ASA I of II
* Able to read and communicate in English
* Has signed written informed consent
* Female, non pregnant. Female subjects will be provided with a pregnancy test free of charge.

Exclusion Criteria

* Age less than 18 yrs and greater than 35 years
* Weight of less than 110 lbs or more than 220 lbs.
* Hemoglobin less than 12 g/dL
* ASA physical status of III. IV, V.
* Pregnant
* Subject has known drug or alcohol abuse
* Subject has skin abnormalities affecting the digits such as psoriasis, eczema, angioma, scar tissue, burn, fungal infection, substantial skin breakdown, nail polish or acrylic nails.
* Subject has experienced a head injury with loss of consciousness within the last year
* Subject has known neurological and psychiatric disorder that interferes with the subjects level of consciousness
* Known or concurrent chronic usage of psychoactive or anticonvulsive drugs within the last 90 days, or any use in the last 7 day (i.e. tricyclic antidepressants, MAO inhibitors, Lithum, neuroleptics, anxiolytics or antipsychotics, except SSRIs).
* Subject has any medical condition which in the judgment of the investigator, renders them inappropriate for participation in this study, such as Reynauds Syndrome.
* Hypertension: Systolic BP \>140 mmHg or Diastolic BP \> 90 mmHg.
* Baseline heart rate \< 50 bpm.
* Inability to tolerate sitting still or minimal movement for up to 90 minutes
* Discretion of investigator

B. Blood Draw Test Procedure

Inclusion Criteria:

-Subjects must understand and consent to be in the study.

Exclusion Criteria

* Subjects less than 18 years of age.
* Subjects who do not understand the study and the risks involved.
* Anyone deemed ineligible by test personnel.

Primary outcomes:
measure: Accuracy of Sensor by Arms Calculation
timeFrame: 1-5 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Irvine
country: United States
facility: Masimo Corporation
state: California
Study officials:
References:
Clinical trial NCT04311658: Safety and Efficacy of the Effect of Isosorbide Mononitrate in Reducing Pain During Levonorgestrel-releasing Intrauterine Device Insertion
Official title: Safety and Efficacy of the Effect of Isosorbide Mononitrate in Reducing Pain During Levonorgestrel-releasing Intrauterine Device Insertion in Adolescents and Young Women
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Contraception
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-03-17
Enrollment: 88
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: the aim of the study is to evaluate the safety and efficacy of isosorbide mononitrate vaginal administration in reducing pain during LNG-IUD insertion in adolescents and young women


Eligibility criteria: Inclusion Criteria:

* adolescents and young women requesting LNG-IUD insertion

Exclusion Criteria:

* heavy vaginal bleeding,pregnancy, contraindications to IUD insertion, allergy or contraindication to isosorbide mononitrate, uterine anomaly

Primary outcomes:
measure: pain during IUD insertion
timeFrame: 5 minutes
Secondary outcomes:
measure: duration of IUD insertion
timeFrame: 5 minutes
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04722458: Turkish Validation and Reliability of LURN SI-29 Questionnaire in Patients With Lower Urinary Tract Symptoms
Official title: Turkish Validity and Reliability of LURN SI-29 Questionnaire Form in Patients With Lower Urinary Tract Symptoms
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lower Urinary Tract Symptoms
Urinary Incontinence
Keywords: Lower urinary tract symptoms
Patient reported outcomes
Questionnaire
Lead sponsor: Istanbul Medeniyet University
Sponsor class: OTHER
First posted: 2021-01-25
Enrollment: 290
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with lower urinary tract symptoms over 18 will be included

Brief summary: Lower urinary tract symptoms is quite frequent in men and women. To better understand the the symptoms that characterize lower urinary tract, the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) has established the Symptoms of Lower Urinary Tract Dysfunction Research Network (LURN). In this study we aim to validate the LURN-29 score to Turkish language


Eligibility criteria: Inclusion Criteria:

* Patients with lower urinary tract symptoms, Over 18 years old,Patient with the cognitive ability to read

Exclusion Criteria:

* Patients above 18 years old

Primary outcomes:
measure: LURN SI-29 Questionnaire
timeFrame: 3 months
measure: International Prostate Symptom Score-IPSS
timeFrame: 3 months
measure: UROGENITAL DISTRESS INVENTORY- 6
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Medeniyet University
Study officials:
References:
citation: Cella D, Smith AR, Griffith JW, Flynn KE, Bradley CS, Gillespie BW, Kirkali Z, Talaty P, Jelovsek JE, Helfand BT, Weinfurt KP; LURN Study Group. A new outcome measure for LUTS: Symptoms of Lower Urinary Tract Dysfunction Research Network Symptom Index-29 (LURN SI-29) questionnaire. Neurourol Urodyn. 2019 Aug;38(6):1751-1759. doi: 10.1002/nau.24067. Epub 2019 Jun 21.
citation: Cella D, Smith AR, Griffith JW, Kirkali Z, Flynn KE, Bradley CS, Jelovsek JE, Gillespie BW, Helfand BT, Talaty P, Weinfurt KP; LURN Study Group. A New Brief Clinical Assessment of Lower Urinary Tract Symptoms for Women and Men: LURN SI-10. J Urol. 2020 Jan;203(1):164-170. doi: 10.1097/JU.0000000000000465. Epub 2019 Jul 31.
Clinical trial NCT01501058: Parent-supported Social Skills Training for Teens With Autism Spectrum Disorders (PEERS-K)
Official title: Parent-Assisted Social Skill Training Program in the Adolescents With Autism Spectrum Disorder
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Autism Spectrum Disorders
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2011-12-29
Enrollment: 40
Sex: ALL
Minimum age (years): 11
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study aims to develop a parent-assisted social skills training program for adolescents with autism spectrum disorder(ASD) and verify therapeutic effects of the program through case-control study.

1. Both the case and the control of this study shall be a high-functioning group consisting of adolescents aged 11 to 18 years with ASD and an IQ of 80 or over. A total of 40 adolescents will be recruited and divided into two groups of twenty. One will be the case group and the other will be the waitlist control group. Again, the case will be divided into two sub-groups of ten and carry out this new developed program for both parents and adolescents. That is, the program will be carried out two times in each of both groups. The waitlist control group will be allowed to receive personal outpatient treatment and general therapeutic intervention from community while waiting.
2. Effects of the program will be measured both at the case and the control by using a scale which measures social interaction, quality of peer relationship, disposition of autism and social anxiety. Equal assessments for both the case and the control will be conducted right before the beginning of the program and right after the completion of the program and some of the survey will be retried in order to see mid- and long-term effects three months after the completion of the program.


Eligibility criteria: Inclusion Criteria:

* 11 to 18 years with ASD and an IQ of 65 or over

Exclusion Criteria:

* Adolescents who are hard to understand the content of treatment and carry out the task due to their IQs or limited linguistic abilities
* Adolescents who are uncooperative in the treatment, lack motives and are hard to participate voluntarily
* Adolescents who have behavior problems so clinically significant that they affects the therapeutic procedure or problems in controlling their emotion

Primary outcomes:
measure: Change from baseline in Test of Adolescent Social Skills Knowledge(TASSK) at 3month
timeFrame: baseline,3month
Secondary outcomes:
measure: Change from baseline in Social Skills Rating Scale (SSRS) at 3 month
timeFrame: baseline,3month
measure: Change from baseline in Friendship Qualities Scale (FQS) at 3month
timeFrame: baseline,3month
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
Study officials:
References:
Clinical trial NCT05129358: Testing of an Electronic Patch During Mild Dehydration
Official title: Testing of an Electronic Patch During Dehydration in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dehydration
Keywords: Dehydration
Rehydration
Lead sponsor: Mode Sensors AS
Sponsor class: INDUSTRY
Collaborators: name: Oslo University Hospital
First posted: 2021-11-22
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open-labeled
Primary purpose: OTHER

Brief summary: The purpose of this study is to investigate the ability of a wearable bioimpedance sensor to detect mild dehydration in healthy volunteers following the administration of Furosemide. In addition, the study will investigate changes in bioimpedance related to normal variation in tissue hydration (circadian changes, skin thickness, posture, and moderate activity). The study will also provide information on the durability of the sensor.

Detailed description: The subjects will use the patches for ten days. During the ten-day period, subjects are exposed to an intervention on day 2 or 3 while being monitored by health personnel:

* Subjects are given a diuretic (Furosemide) and monitored for two hours without any intake.
* The intervention is followed by intake of a rehydration solution (up to 1500 ml), containing glucose and electrolytes (Resorb Sport, Nestle S.A.).

Eligibility criteria: Inclusion Criteria:

* BMI: 18-30
* Age: 18-60
* Willing to refrain from exercise for the duration of the study
* Willing to refrain from bathing, swimming and other physical activity causing considerable sweating/movement (e.g. cycling, mountain hiking, climbing)

Exclusion Criteria:

* Hypersensitivity to diuretics
* Diarrhea
* Hypotension or orthostatic hypotension
* Urinary retention
* Pregnancy or breast feeding
* Allergy to medical adhesive or gel
* Any planned medical examination during the intervention period
* Pacemaker
* Use of medication with a significant impact on the body's fluid balance, such as diuretic

Primary outcomes:
measure: Change in impedance following mild dehydration
timeFrame: 2 hours
Secondary outcomes:
measure: Change in impedance following rehydration
timeFrame: 1 hour
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
affiliation: Mode Sensors AS
name: Sigve N Aas, PhD
role: STUDY_DIRECTOR
References: