louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00584207: Radiofrequency Ablation of Uterine Fibroids
Official title: Radiofrequency Ablation of Uterine Fibroids
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: EARLY_PHASE1
Conditions: Uterine Fibroids
Keywords: uterine fibroids
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2008-01-02
Enrollment: 15
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This research study is being conducted to evaluate the safety and effectiveness of ablation (destruction) of uterine leiomyomas (fibroids) using electrocautery heating guided by ultrasound. We are doing this to look for a less invasive method of treatment for patients with uterine fibroids. One method that is being used in other areas of the body to treat masses is radiofrequency electrocautery. This method may be performed for the treatment of uterine fibroids by placing a small diameter needle through the wall of the vagina into the fibroid guided by an ultrasound probe. An optional approach is to place the needle through the skin of the abdomen into the fibroid guided by an ultrasound probe. Once the needle is in the fibroid, the electrocautery current is applied and the fibroid is destroyed by heating. This would be done before hysterectomy (removal of the uterus). We are trying to test to see if this type of treatment can be applied to uterine fibroids. We are trying to develop radiofrequency electrocautery as one of the methods to treat fibroids without surgery.


Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* Diagnosed with uterine leiomyomas (fibroids)
* Patient will undergo surgical hysterectomy
* Patient is willing to sign informed consent form

Exclusion Criteria:

* Patients with acute infection
* Patients with bleeding disorders
* Patients who are not candidates for surgery or general anesthesia

Primary outcomes:
measure: Following the hysterectomy, the study pathologist will perform a histological examination of the treated fibroid specimen to determine the size and volume of the ablation that was created with radiofrequency electrocautery.
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: UC Davis Medical Center
state: California
Study officials:
affiliation: University of California, Davis
name: John P. McGahan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00192907: Inflammation and Infection in Trauma, Role in Posttraumatic Complications
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Trauma
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2005-09-19
Enrollment: 380
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: PROSPECTIVE

Brief summary: The purpose of this study is to investigate the relationship between trauma, the immune system, biochemical changes in the first 24 h and subsequent complications and mortality

Detailed description: The immune system plays a role in the development of complications after severe trauma, but we do not know how. Equally, biochemical changes measured in the blood after trauma (eg. bloodglucose, GC-globulin, coagulation parameters etc.) may predict the prognosis and the degree of complcations. Two significant complications are infection and organ failure, which may prolong hospitalisation and increase mortality.

In the study we collected samples from blood and body surfaces to determine changes in cytokines, biochemistry, bacterial flora, and subsequent complications. We compare the changes in between groups of the cohort.

Eligibility criteria: Inclusion Criteria:

* Clinical suspicion of multiple trauma
* Age \>/= 18 years
* Direct referral from scene of accident

Exclusion Criteria:

* Major burn injury
* HIV positiv
* Pregnancy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: DK-2100 Copenhagen
country: Denmark
facility: Rigshospitalet, Copenhagen University Hospital
Study officials:
affiliation: Rigshospitalet, Denmark
name: Jakob Stensballe, MD
role: STUDY_CHAIR
References:
citation: Johansson PI, Stensballe J, Rasmussen LS, Ostrowski SR. A high admission syndecan-1 level, a marker of endothelial glycocalyx degradation, is associated with inflammation, protein C depletion, fibrinolysis, and increased mortality in trauma patients. Ann Surg. 2011 Aug;254(2):194-200. doi: 10.1097/SLA.0b013e318226113d.
Clinical trial NCT06877507: Rapid Diagnostic Technology for AUGIB Based on Analysis of VOCs in Exhaled Breath
Official title: Rapid Diagnostic Technology for Acute Upper Gastrointestinal Bleeding Based on Analysis of Volatile Organic Compounds (VOCs) in Exhaled Breath
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Volatile Organic Compound
Gastrointestinal Hemorrhage
Keywords: Volatile Organic Compound
Acute Upper Gastrointestinal Bleeding
Exhaled Breath
Lead sponsor: Beijing 302 Hospital
Sponsor class: OTHER
First posted: 2025-03-14
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients requiring endoscopy for suspected AUGIB

Brief summary: This study aims to develop a non-invasive and rapid diagnostic technology for acute upper gastrointestinal bleeding (AUGIB) by analyzing volatile organic compounds (VOCs) in exhaled breath. Clinically confirmed patients will be divided into three groups (no bleeding, minor bleeding, major bleeding) based on endoscopic findings. VOC profiles will be analyzed to construct a predictive model, validated for sensitivity and specificity (both targets ≥0.7). This approach addresses the limitations of endoscopy in emergency or resource-limited settings, improving diagnostic efficiency and reducing mortality.

Detailed description: Acute upper gastrointestinal bleeding (AUGIB) is a common emergency with an annual incidence of 100-180/100,000 and mortality of 2%-15%. Endoscopy, the gold standard, is invasive and equipment-dependent, limiting its use in primary care or emergencies. Exhaled breath VOCs analysis, a non-invasive and portable method, has been applied in other diseases but not yet explored for AUGIB.

Objectives:

1. Identify characteristic VOC profiles in exhaled breath of AUGIB patients.
2. Develop a VOC-based predictive model with sensitivity and specificity ≥0.7.
3. Establish rapid diagnostic criteria to enhance clinical decision-making.

Eligibility criteria: Inclusion Criteria:

1. Age ≥18 years;
2. Clinical suspicion of AUGIB (e.g., hematemesis, melena);
3. Fasting ≥4 hours;
4. Signed informed consent.

Exclusion Criteria:

1. Severe pulmonary dysfunction or recent lung infection (within 1 week);
2. Cardiac/renal failure or disseminated intravascular coagulation;
3. Contraindications to endoscopy;
4. High-risk conditions (e.g., massive ascites);
5. Alcohol consumption within 24 hours;
6. Pregnancy.

Primary outcomes:
measure: Sensitivity and specificity of the diagnostic model
timeFrame: 4 months
Secondary outcomes:
measure: Identification of key VOCs
timeFrame: 4 months
measure: Differences in VOC concentrations across 3 bleeding severity groups
timeFrame: 4 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02873507: Prediction of Donor Liver Adipose Content by Magnetic Resonance Imaging
Official title: Pilot Study for the Prediction of Donor Liver Adipose Content by Magnetic Resonance Imaging
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Fatty Liver
Steatosis of Liver
Keywords: transplantation, liver
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2016-08-19
Enrollment: 0
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: A pilot prospective cohort study assessing the clinical utility of MRI evaluation of graft steatosis prior to transplantation will be conducted. An MRI of the donor liver within the transport cooler will be obtained on its way to the operating room.

Detailed description: The images from MRI will be analyzed to obtain information of fat content in all eight segments of the liver. Demographic, intra-operative, and post-operative patient data will be collected for each imaged graft.

Eligibility criteria: Inclusion Criteria:

* Patients who are scheduled to orthoptic liver transplant

Exclusion Criteria:

* Patient's who do not agree to sign consent

Primary outcomes:
measure: Percent Hepatic Steatosis of a Donor Liver Prior to Transplantation
timeFrame: Measured immediately prior to liver transplant
Secondary outcomes:
measure: Comparison of steatosis percentages provided by biopsy to MRI results
timeFrame: Baseline
measure: Length of hospitalization of transplant recipient
timeFrame: Days to hospital discharge, approximately 2 weeks
measure: Mortality of liver transplant recipient at 1 year post transplantation
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: Vanderbilt University Medical Center
name: Bret D Alvis, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05203107: Urdu Version of Menstrual Attitude Questionnaire: A Reliability and Validity Study
Official title: Cross-cultural Adaptation of Urdu Version of Menstrual Attitude Questionnaire: A Reliability and Validity Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Menstruation
Keywords: Attitude
Menstruation
females
psychometric properties
Menstrual Attitude Questionnaire
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2022-01-24
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 36
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant or Breastfeeding Women

Brief summary: To determine the validity and reliability of Urdu version of Menstrual Attitude Questionnaire

Detailed description: Menstrual Attitude Questionnaire has been distributed in 200 women who were recruited by convenience sampling technique under the pre defined inclusion and exclusion criteria after signing the informed consent forms .

This study's findings will assist determine the Menstrual Attitude Questionnaire's reliability and validity in individuals with neck pain and impairment. This scale's reliability will be evaluated utilising internal consistency and test-retest methods. Cronbach's alpha value checks internal consistency. The interclass correlation will be used to examine the test-retest reliability.

Eligibility criteria: Inclusion Criteria:

1. A history of lower abdominal pain for more than 6 menstrual cycle.
2. No elective treatment counting TENS inside 1 month earlier to enrollment within the ponder.
3. Provision of informed consent prior to enrollment in the study.

Exclusion Criteria:

1. Pregnant or Breastfeeding
2. History of surgery of the lower abdomen.
3. Heart disease.
4. Cancer.
5. Severe mental disorder

Primary outcomes:
measure: Menstrual attitude questionnaire(MAQ)
timeFrame: 1st day
measure: Beliefs about and Attitudes toward Menstruation Questionnaire
timeFrame: 1st day
Secondary outcomes:
Other outcomes:
Locations:
city: Faisalabad
country: Pakistan
facility: Ripah International University
state: Punjab
Study officials:
affiliation: Riphah International University
name: Muhammad Kashif
role: STUDY_CHAIR
References:
Clinical trial NCT06995807: EL-SHIN Therapy for Depressive Symptoms
Official title: Enhancing the Efficacy of Depression and Low Mood Treatment: A Novel Adjunctive Approach
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Depressive Disorder
Lead sponsor: Monash University Malaysia
Sponsor class: OTHER
First posted: 2025-05-30
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned to either continue standard treatment with a control activity (Group A) or receive EL-SHIN® Therapy alongside their usual care (Group B).
Primary purpose: SUPPORTIVE_CARE

Brief summary: This is a research aiming to find the effectiveness of an innovative therapy, EL-SHIN THERAPY, in ameliorating depressive symptoms.

Detailed description: This study evaluates the effectiveness of EL-SHIN® Therapy, a novel adjunctive intervention in alleviating depressive symptoms.

There are three components in this therapy:

1. Lavender Therapy
2. GRATEFULNESS® Therapy
3. Fasting with exercise and light therapy

The study includes two phases: a quantitative clinical trial and a qualitative focus group.

Assessments will use DASS-21, MHQoL, and SQS scales with the intervention delivered in English over 3-4 weeks.

Eligibility criteria: Inclusion Criteria:

* Age: Above 18 yrs old
* DASS-21 scores:

"Moderately Depressed (Score: 14-20)", "Moderately Anxious (Score: 10-14)" \& "Moderately Stressed (Score: 19-25)"

* Non-Muslim (Due to legal restriction in Malaysia for this religion)
* English literate
* Believers in Creationism

Exclusion Criteria:

* Muslim (legal restrictions in Malaysia for this religion).
* Non-English literate (research will be conducted in English only).
* Individuals with any other medical conditions or on current medication To reduce potential complications or confounding factors).

Primary outcomes:
measure: DASS-21 Scale
timeFrame: 3 to 4 weeks
measure: Mental Health Quality of Life (MHQoL)
timeFrame: 3 to 4 weeks
measure: Sleep Quality Scale (SQS)
timeFrame: 3 to 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Monash University Malaysia
name: AI SHIN LIM, PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05610007: Comparison of Hyperbaric Prilocaine 2% 50 Mg and Hyperbaric Bupivacaine 0.5% 12.5 Mg Against Spinal Anesthesia Recovery Time in Cystoscopy Procedure
Official title: Comparison of Hyperbaric Prilocaine 2% 50 Mg and Hyperbaric Bupivacaine 0.5% 12.5 Mg Against Spinal Anesthesia Recovery Time in Cystoscopy Procedure
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Anesthesia
Anesthesia; Reaction
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2022-11-08
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Data regarding the comparison of recovery time from spinal anesthesia between prilocaine and bupivacaine are still relatively limited. The aim of this study was to compare the speed of recovery of spinal anesthesia with hyperbaric prilocaine 2% 50 mg compared to hyperbaric bupivacaine 0.5% 12.5 mg in cystoscopy procedures. By knowing the speed of recovery time, it is hoped that the patient will recover faster, be transferred to the treatment room faster, be safer, and the length of treatment will be shorter so that the quality of service for cystoscopy procedures and patient satisfaction is getting better.

Detailed description: This study is a double-blind randomized clinical trial. This study compared the speed of recovery from spinal anesthesia, as many as 66 subjects were divided into two groups, namely hyperbaric prilocaine 2% 50 mg and hyperbaric bupivacaine 0.5% 12.5 mg who would undergo a cystoscopy procedure. This research was conducted in the urological surgery room of RSCM in January - October 2022, after passing the ethical review and obtaining a location permit.

Eligibility criteria: Inclusion Criteria:

* Male or female over the age of 18,
* ASA physical status I - III,
* Normal body mass index according to Quetelet's index,
* Willing to be a research participant and comply with the research rules.

Exclusion Criteria:

* Have a history of allergy to prilocaine or bupivacaine,
* Have a previous history of walking disorders
* Spinal anesthesia is contraindicated.

Primary outcomes:
measure: Visual analog scale (VAS)
timeFrame: 24 hour
Secondary outcomes:
measure: Complication
timeFrame: 24 hour
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: Cipto Mangunkusumo Cental National Hospital
state: DKI Jakarta
Study officials:
References:
Clinical trial NCT00437307: Hycamtin Plus Carboplatin Versus Established Regimens for the Treatment of Ovarian Cancer Relapse
Official title: Topotecan Plus Carboplatin im Vergleich Zur Standardtherapie (Paclitaxel Plus Carboplatin Oder Gemcitabin Plus Carboplatin) in Der Therapie Von Patientinnen Mit Platin-sensitivem Rezidivierten Epithelialen Ovarialkarzinom, Peritonealkarzinom Oder Tubenkarzinom
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ovarian Cancer
Lead sponsor: North Eastern German Society of Gynaecological Oncology
Sponsor class: OTHER
First posted: 2007-02-21
Enrollment: 550
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Determination of progression free survival after 12 months of FU

Determination of total survival, response and quality of life

Detailed description: In Germany there are two established therapy regimes for platin sensitive ovarian cancer: the combination of carboplatin and paclitaxel as well as the combination of carboplatin with gemcitabine. Choice of therapy is individual due to missing randomized comparisons between the regimes. Topotecan has shown good efficacy in second-line therapy of ovarian cancer as well as a good, especially, non-hematoxic toxicity profile. Several phase II-studies have demonstrated a synergistic effect of topotecan in combination with carboplatin exhibiting good efficacy and tolerability.

It shall be tested in this randomized phase III-study if the combination of topotecan and carboplatin shows improvement of progression-free survival in comparison to the standard regimes.

Eligibility criteria: Inclusion Criteria:

* Women ≥18 years of age with platinum-sensitive recurrent ovarian cancer occurring at least six months after completion of primary standard therapy are eligible
* Patients with measurable or assessable lesions or CA-125 ≥ 2x ULN an Eastern Co-operative Oncology Group (ECOG) performance status ≤ 2
* All patients will provide written informed consent

Exclusion Criteria:

* Patients with more than two chemotherapies in their history
* Progress less than six months after completion of primary standard therapy
* Simultaneous or planned radiation
* Any known hypersensitivity to topotecan, carboplatin, paclitaxel or gemcitabine
* Patients with infection
* Patients who are pregnant or breast feeding

Primary outcomes:
measure: progression-free survival
timeFrame: after 1 year-follow-up
Secondary outcomes:
measure: overall survival, efficacy and tolerability of the regimes and quality of life
timeFrame: during study and follow-up
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité Campus Virchow Klinikum
Study officials:
affiliation: Charité Campus Vichow Klinikum
name: Jalid Sehouli
role: STUDY_CHAIR
References:
Clinical trial NCT02239107: N-acetyl Cysteine for Ovulation Induction in Clomiphene Citrate Resistant Polycystic Ovary Syndrome
Official title: N-acetyl Cysteine as an Adjuvant Therapy to Laparoscopic Ovarian Drilling in Clomiphene Citrate Resistant Polycystic Ovary Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Polycystic Ovary Syndrome
Keywords: polycystic ovary syndrome
laparoscopic drilling
clomiphene citrate
n acetyl cysteine
insulin resistance
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2014-09-12
Enrollment: 70
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Polycystic ovary syndrome is a major endocrinological disorder affecting 5-8% of reproductive aged women. Anovulation is a major feature of the syndrome, managed primarily by clomiphene citrate. Failure to respond to clomiphene citrate is termed clomiphene resistance and second line treatment is either laparoscopic ovarian drilling or gonadotrophin ovulation induction. Although laparoscopic drilling is effective in restoring ovulation and achieving pregnancy, some women still remain anovulatory and infertile after the procedure. N-acetyl cysteine has emerged as a novel therapeutic adjuvant to laparoscopic drilling to improve ovulation and pregnancy rate.

Detailed description: Resistance to ovulation induction therapy with clomiphene citrate (CC) is a significant problem affecting as many as 25% of patients. Laparoscopic ovarian drilling is an accepted second line treatment option, achieving ovulation in 75-90% and pregnancy in 50-69% of the CC resistant patients.

Adjuvants to laparoscopic drilling have been explored by researchers some studies have shown evidence of improved outcome with the use of N-Acetyl cystiene (NAC), a long used mucolytic drug which has been used for various other indications including detoxification and cancer chemoprotection. Several studies have addressed the possibility of using NAC as adjuvant therapy to Clomiphene citrate for induction of ovulation in resistant patients with some showing encouraging results. The use of NAC as adjuvant to laparoscopic ovarian drilling was addressed in a single pilot study showing good results with improved ovulation and pregnancy rates compared to the non users.

Eligibility criteria: Inclusion Criteria:

* PCOS patients according to Rotterdam criteria who failed to respond to 6 month ovulation induction therapy with clomiphene citrate,
* normal semen analysis of partner
* normal tubo-peritoneal anatomy as assessed by laparoscopy

Exclusion Criteria:

* patients who have other causes of infertility
* patients receiving gonadotrophin ovulation induction

Primary outcomes:
measure: ovulation rate
timeFrame: 6 month
Secondary outcomes:
measure: pregnancy rate
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
References: