louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00173251: The Difference in Presentation Level of Variant Receptors in Female Breast Tissue in Macromastia and Micromastia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Aging
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2005-09-15
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: ECT

Brief summary: There are more and more macromastic women in Taiwan, which may due to the high cholesterol foods. Patients with macromastia not only suffered from physical problems but also psychological discomforts.

Detailed description: Large breasts cause neck and back pain, irritating grooves, cut in the skin of the shoulders by the pressure of brassiere straps, breast pain, and maceration and dermatoses in the inframammary region. From a psychological point of view, excessively large breasts can be troublesome focus of embarrassment for the teenager as well as the woman in her senior years. Unilateral hypertrophy with asymmetry heightens embarrassment. Thus, patients seek to reduce the size of their breasts.

In the human female, variant receptors were detected in epithelial cells in normal breast tissue, benign breast lesions, breast carcinoma tissue, and breast cancer cell lines2-11. The cause of the difference in breast development status is still unclear. Abnormalities at the tissue receptor level may be important in the pathophysiology of macromastia. This study aimed to make clear the difference in variant receptor levels between breast hypertrophy patients and macromastia ones by examining the receptor levels in breast tissue. Then, we could explore the possible etiology of mammary hypertrophy and macromastia.

Eligibility criteria: Inclusion Criteria:

* patients receiving reduction mammoplasty

Exclusion Criteria:

-

Primary outcomes:
measure: difference in receptor expression level
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: National Taiwan University Hospital
name: Hao-Chih Tai, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00638651: Topical Imiquimod in Conjunction With Nd:YAG Laser for Tattoo Removal
Official title: Topical Imiquimod in Conjunction With Nd:YAG Laser for Tattoo Removal
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Tattoos
Black/blue tattoos
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: Graceway Pharmaceuticals, LLC
First posted: 2008-03-19
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy of tattoo removal using topical imiquimod, 5% cream in conjunction with the 1064nm Nd:YAG laser. This procedure for tattoo removal will be compared to a laser removal alone.

Detailed description: Inclusion criteria includes: patients of both genders with Fitzpatrick skin types I-IV who are 18-65 years of age and who has 2 tattoos from 2 to 10 cm in diameter, of similar age which contains black and/or blue ink in areas that can be covered. Exclusion criteria includes: tattoos in chronically sun exposed areas, larger than 25 cm2,pregnancy,breast feeding state, immunosuppressed patients, history of autoimmune or connective tissue disorders, hypersensitivity to imiquimod, active sunburn, current tan, use of coumadin, aspirin , vitamin E or non-steroidal anti-inflammatory agents for the past 10 days.

Eligibility criteria: Inclusion Criteria:

* 2 tattoos no larger than 25cm2, professionally made, with approximately the same age, containing blue/black ink.

Exclusion Criteria:

* Hypersensitivity to imiquimod
* Current sun tan
* Use of vitamin E, non-steroid anti-inflammatory drugs, coumadin or aspirin for the past 10 days
* Amateur tattoos
* Pregnancy
* Breast-feeding status
* Immunosuppression
* Auto-immune diseases.

Primary outcomes:
measure: Efficacy of Tattoo Removal Using Topical Imiquimod 5% Cream
timeFrame: approximately 14 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: Mohs, Dermatologic and Laser Surgery
state: Florida
Study officials:
affiliation: University of Miami
name: Keyvan Nouri, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Elsaie ML, Nouri K, Vejjabhinanta V, Rivas MP, Villafradez-Diaz LM, Martins A, Rosso R. Topical imiquimod in conjunction with Nd:YAG laser for tattoo removal. Lasers Med Sci. 2009 Nov;24(6):871-5. doi: 10.1007/s10103-009-0709-9. Epub 2009 Jul 15.
Clinical trial NCT05379751: Surgical Repair of Spigelian Hernia in a Cohort of Patients
Official title: Tentacle Shaped Mesh for Fixation Free Spigelian Hernia Repair
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spigelian Hernia
Lead sponsor: University of Cagliari
Sponsor class: OTHER
First posted: 2022-05-18
Enrollment: 54
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A cohort of 54 patients diagnosed with Spigelian hernia who underwent open surgical repair with the tentacle shaped implant (Freedom Octomesh VHR XS produced by Insightra Medical Inc. - USA) forms the body of this study
Primary purpose: TREATMENT

Brief summary: Repair of Spigelian hernias with a tentacle shaped implant and highlighting the results of the procedure

Detailed description: The surgical treatment of Spigelian hernias is mainly carried out with prosthetic meshes made of biocompatible material. In prosthetic repair of abdominal protrusions, mesh fixation and overlap of the mesh are source of complications. To avoid these problems, for a fixation free repair of Spigelian hernias has been developed a tentacle shaped implant, that should also assure a broader defect overlap. This study should highlight in a cohort of patients the long-term results of fixation free repair of Spigelian hernias carried out with tentacle mesh.

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with Spigelian hernia

Exclusion Criteria:

* Patients not having Spigelian hernia,

Primary outcomes:
measure: Fixation free prosthetic repair of Spigelian hernias with tentacle mesh
timeFrame: Intraoperative
measure: Granting a broad implant overlap in prosthetic repair of Spigelian hernias with tentacle mesh
timeFrame: between 6 and 84 months postop
Secondary outcomes:
measure: Intra-operative features
timeFrame: intraoperatively
measure: Postoperative features 1
timeFrame: between 6 and 84 months postop
measure: Postoperative features 2
timeFrame: between 6 and 84 months postop
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02380651: Functional Outcomes and HRQoL in Upper-extremity Sarcoma Patients After Limb Salvage
Official title: Functional Outcomes and Health Related Quality of Life in Upper-extremity Sarcoma Patients After Limb Salvage: a Prospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer of Muscle
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
Collaborators: name: Tampere University Hospital
First posted: 2015-03-05
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Upper extremity sarcoma patient who underwent limb-salvage surgery

Brief summary: This study aims to assess the functional ability and health-related quality of life (HRQoL) of upper extremity sarcoma patients who have undergone limb salvage surgery.

Detailed description: The purpose of this study is to assess the functional capabilities and health-related quality of life (HRQoL) of upper-extremity sarcoma patients who have undergone limb salvage surgery.

Patient hospital records are retrospectively reviewed for demographic and clinical data.

The patient recruitment takes place at the outpatient clinic of the Comprehensive Cancer Center, Helsinki University Hospital, and Tampere University Hospital. The study includes a cross-sectional assessment at six months follow-up with five validated questionnaires. A follow-up is conducted two and five years after surgery in the outpatient clinic.

Eligibility criteria: Inclusion Criteria:

* Upper extremity soft tissue sarcoma locating in between scapula to arm
* No metastasis at the time of diagnosis
* Undergone limb salvage surgery
* A minimum of 6 months follow-up
* Written consent
* Age \> 18

Exclusion Criteria:

* Age \<18
* No limb-salvage surgery due to sarcoma
* Deceased

Primary outcomes:
measure: Health-related quality of life and upper-extremity functional capability
timeFrame: 6 months to five years
Secondary outcomes:
measure: Sarcoma recurrence
timeFrame: 6 months to five years
measure: Quality of Life Questionnaire-Core 30
timeFrame: 6 months to five years
measure: the 15D health-related quality of life instrument
timeFrame: 6 months to five years
measure: The QuickDASH
timeFrame: 6 months to five years
measure: The MSTS upper extremity section
timeFrame: 6 months to five years
measure: The TESS upper extremity section
timeFrame: 6 months to five years
Other outcomes:
measure: Visual Analogue Scale for pain
timeFrame: 6 months to five years
Locations:
city: Helsinki
country: Finland
facility: Helsinki University Central Hospital
state: Uusimaa
city: Tampere
country: Finland
facility: Tampere University Hospital
Study officials:
affiliation: Helsinki University Central Hospital
name: Erkki J Tukiainen, MD, PhD
role: STUDY_DIRECTOR
affiliation: Helsinki University Central Hospital
name: Carl Blomqvist, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00976651: Low Dose Human Chorionic Gonadotropin: Influence on the Endometrium
Official title: Influence of Ovarian Stimulation With 200 IU of hCG, (Administered in the Late Follicular Phase Among ICSI Patients Undergoing a GnRH-antagonist Protocol), on the Endometrium on the Day of Oocyte Pick-up
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Infertility
Keywords: infertility
ICSI
hCG
infertility treatment
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2009-09-14
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 36
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the present study is to assess the influence of the administration of low dose hCG on the endometrium. The study is a randomised trial where 2 groups of patients, undergoing a gonadotropin-releasing hormone antagonist protocol for in vitro fertilization, are studied. In addition to the histological findings, by analysing the correlation of the morphological pattern and gene expression profile of human endometrium on the day of oocyte retrieval in patients of both treatment groups, the investigators want to study the implantation potential.


Eligibility criteria: Inclusion Criteria:

* \< 36 years on day of randomisation
* FSH \< 12 in the early follicular phase
* Normal ultrasound scan
* BMI between 18 and 29 (both inclusive)
* Randomisation at outpatient clinic

Exclusion Criteria:

* Endometriosis ≥ grade 3
* PCO syndrome
* Poor responder
* Endocrine or metabolic abnormalities

Primary outcomes:
measure: number of oocytes
timeFrame: 2 weeks after start of the treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Laarbeeklaan 101
country: Belgium
facility: UZ Brussel
state: Brussels
Study officials:
References:
citation: Blockeel C, De Vos M, Verpoest W, Stoop D, Haentjens P, Devroey P. Can 200 IU of hCG replace recombinant FSH in the late follicular phase in a GnRH-antagonist cycle? A pilot study. Hum Reprod. 2009 Nov;24(11):2910-6. doi: 10.1093/humrep/dep253. Epub 2009 Jul 17.
Clinical trial NCT03754751: Enhanced Recovery in Laparoscopic Cholecystectomy
Official title: Modified Enhanced Recovery Program in Patients With Acute Cholecystitis Undergoing Laparoscopic Cholecystectomy: Prospective Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Cholecystitis
Gangrenous Cholecystitis
Keywords: enhanced recovery
intraperitoneal anesthesia
low pressure pneumoperitoneum
cholecystitis
in-hospital stay
laparoscopic cholecystectomy
Lead sponsor: Pirogov Russian National Research Medical University
Sponsor class: OTHER
First posted: 2018-11-27
Enrollment: 189
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 study assesses the impact of the modified enhanced recovery protocol on the results of surgical treatment of patients with acute cholecystitis.

Detailed description: Laparoscopic cholecystectomy (LC) is the most common surgical procedures in the world. Elective LC is commonly performed as one-day surgery, while in an emergency setting of acute cholecystitis the in-hospital stay averages 4.5 days. Causes of prolonged rehabilitation period are often associated with severe pain syndrome, dyspepsia and postoperative complications. The complications rate after LC is about 6% and has no tendency to decrease. The implementation of enhanced recovery after surgery (ERAS) programs may potentially reduce stress-associated complications and improve the quality of rehabilitation. A few retrospective studies examined their advantages and setbacks in the treatment of acute cholecystitis with encouraging results. The aim of this randomized control study is to evaluate the modified ERAS program for patients with acute cholecystitis.

Eligibility criteria: Inclusion Criteria:

* Grade I and II acute cholecystitis according to Tokyo Guidelines 2013 classification (TG13)
* ASA I and II.

Exclusion Criteria:

* Severe acute cholecystitis (Grade III on TG13);
* Patient's refusal to participate;
* The language barrier;
* Transfer to the intensive care unit after surgery;
* ASA class ≥ III;
* Conversion to open procedure;
* Biliary hypertension detected during preoperative examination or intraoperatively.

Primary outcomes:
measure: Postoperative length of stay (pLOS)
timeFrame: 30 days
Secondary outcomes:
measure: Complication rate
timeFrame: 30 days
measure: Readmission rate
timeFrame: 30 days
measure: Postoperative pain
timeFrame: 24 hours
measure: Shoulder pain incidence
timeFrame: 24 hours
measure: Shoulder pain level
timeFrame: 24 hours
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Taras Nechay
Study officials:
affiliation: Pirogov Russian National Research Medical University
name: Alexander Sazhin, Prof.
role: STUDY_CHAIR
References:
Clinical trial NCT01692951: Serum Free Fatty Acid Metabolite Biomarkers of Lung Cancer
Official title: Serum Free Fatty Acid Metabolite Biomarkers of Lung Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer
Biomarkers
Fatty Acids
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2012-09-26
Enrollment: 220
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patient samples are retrieved from the Cleveland Clinic Biobank.

Brief summary: This study aims to evaluate the performance of serum free fatty acids as biomarkers for the identification of lung cancer.

Detailed description: We will compare the concentration of free fatty acids and their metabolites between patients with lung cancer and control pulmonary patients without known cancer. The diagnostic accuracy will be assessed for potential predictors.

Eligibility criteria: Inclusion Criteria:

* Age from 40 to 80
* Lung adenocarcinoma with pathological diagnosis
* Lung squamous cell carcinoma with pathological diagnosis
* Control patients should have at least one of the following criteria: (1) current or ex-smoker with at least a 10 pack-year history, (2) a first-degree relative with a history of lung cancer, or (3) a clinical diagnosis of COPD.

Exclusion Criteria:

- Lung cancer patient without serum sample before the initiation of treatment

Primary outcomes:
measure: Compare Concentration of Fatty Acids and Their Metabolites
timeFrame: At the time of diagnosis, prior to the initiation of lung cancer treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Daniel Sessler, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00005451: WINCATI Software Tool for Survey Research
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Heart Diseases
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Sponsor class: NIH
First posted: 2000-05-26
Sex: MALE
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: To design Computer Aided Telephone Interviewing (CATI) software tools for survey research.

Detailed description: BACKGROUND:

CATI (Computer Aided Telephone Interviewing) became a primary means of obtaining quality epidemiological data. Its use steadily increased and in 1995 it was a major technology in use by almost every NIH Institute. Although CATI had been used for many years, its implementation had not kept up with technological developments in computers. Available CATI software products were deficient in features, inflexible, difficult to learn to use and had copious problems. Modern computer technology had the potential to satisfy the growing need for an improved product. This product had applications in over 3000 U.S. companies engaged in public opinion and market research.

DESIGN NARRATIVE:

In Phase I the investigators identified approaches that could be used to develop this software; justified and chose an approach; created requirements and designed specifications for the tool; developed a prototype; and produced a detailed project plan for implementation. In Phase II, the investigators completed and improved the prototype software and tested it in several areas

Eligibility criteria: No eligibility criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02599051: Transobturator Verus Single Incision Slings
Official title: Transobturator Versus Single Incision Slings: 1 Year Results of a Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Incontinence, Stress
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2015-11-06
Enrollment: 98
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A randomized control trial to compare the efficacy of the single incision mini-sling to the transobturator sling

Detailed description: Transobturator slings are one type of sling that has become standard treatment for stress urinary incontinence. However, this procedure involves a total of 3 incisions to perform.

In contrast, single incision slings have been developed to treat stress urinary incontinence by using only one incision.

However, to date the success and complications of these two procedures have not been compared or studied.

Eligibility criteria: Inclusion Criteria:

* Patients with urodynamically proven stress urinary incontinence who were planning on undergoing surgery for treatment.

Exclusion Criteria:

* Patients with prior incontinence surgery, a urodynamic diagnosis of intrinsic sphincter deficiency and mixed incontinence with a predominance of detrusor overactivity were excluded.

Primary outcomes:
measure: Objective Stress Urinary Incontinence
timeFrame: 1 year
Secondary outcomes:
measure: Quality of Life Questionnaire UDI-6
timeFrame: 1 year
measure: Subjective Patient Reported Recurrent or Persistent Stress Urinary Incontinence
timeFrame: 1 year
measure: Number of Participants Who Completed Self- Assessment of Cure
timeFrame: 1 year
measure: Quality of Life Questionnaire IIQ-7
timeFrame: 1 year
measure: Quality of Life Questionnaire ICIQ
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: Cleveland Clinic Florida
name: G Willy Davila, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05141851: The Impact of Thread Length on Implant Stability
Official title: The Impact of Thread Length on Implant Stability
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Implant Stability
Keywords: implant stability; implant threads
Lead sponsor: University of Lisbon
Sponsor class: OTHER
First posted: 2021-12-02
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Some studies show that different types of threads in tapered implants result in differences in primary stability. The aim of this study is to a perform a prospective, controlled, randomized clinical trial comparing primary and secondary stability between long and standard thread implants in the treatment of partial edentulous patients.

Detailed description: The study sample consists of 23 maxillary partial edentulous patients, where 32 implants were placed, with threads of 0.7 mm or 0.3 mm in the location of premolars and molars. The comparison, in terms of primary stability, is made by measuring the ISQ value (implant stability quotient), in four locations (buccal, palatal, mesial and distal). Statistical analysis was performed using the independent T-Test.

Eligibility criteria: Inclusion Criteria:

* Minimum 18 years;
* No systemic conditions that contraindicate surgery;
* Periodontal health or periodontal disease treated as part of a periodontal support program and having a high level of plaque control;
* Partial edentulous patients, in the upper jaw, specifically in the location of premolars and molars;

Exclusion Criteria:

* Patients with insufficient quantity of bone for implant placement without bone regeneration procedures;
* Patients who underwent medication that could affect stability and osteointegration up to 3 months prior to study initiation;
* Patients with untreated periodontal pathology or who have not followed periodontal supportive treatment;
* Smokers, Pregnant or lactating women.

Primary outcomes:
measure: primary dental implant stability
timeFrame: On the 1 day of implants placement
Secondary outcomes:
Other outcomes:
Locations:
city: Lisboa
country: Portugal
facility: Vanessa Rodirgues
Study officials:
affiliation: University of Lisbon
name: Paulo Mascarenhas, PhD
role: STUDY_DIRECTOR
affiliation: University of Lisbon
name: Susana Noronha, PhD
role: STUDY_DIRECTOR
affiliation: University of Lisbon
name: Vanessa Rodrigues, Dr
role: PRINCIPAL_INVESTIGATOR
References: