louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03577067: Complicated Outcome Prediction After Liver Resection
Official title: Complicated Outcome Prediction After Liver Resection: the Role of Renal Resistive Index
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Liver Neoplasms
Lead sponsor: University of Milan
Sponsor class: OTHER
First posted: 2018-07-05
Enrollment: 183
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients resectable and affected by primary and secondary liver disease

Brief summary: Although mortality after liver surgery reduced during the last three decades to less than 2%, post-operative course is still complicated in a range of 20-50% of cases.The identification of one or few factors which could detect the real risk of complicated post-operative outcome, may help anesthesiologist to decide whether admit a patient to ICU or not.The primary aim of this study was to evaluate whether RRI, alone or along with other items, can predict post-operative complication after hepatic resection.


Eligibility criteria: Inclusion Criteria:

Patients resectable and affected by primary and secondary liver disease

Exclusion Criteria:

Subjects affected by kidney disease and/or cirrhosis and pregnant patients were excluded from the trial. Patients who should have needed nephrectomy during the operation would be also excluded.

Primary outcomes:
measure: renal resistive index (RRI)
timeFrame: up to 7 days after surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Humanitas University
name: Guido Torzilli, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00440180: Aromatase Inhibitors in the Treatment of Male Infertility
Official title: The Role of Aromatase Inhibitors in the Treatment of Infertility in Obese Male
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Obesity
Oligospermia
Keywords: Obesity
Low sperm count
Male infertility
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2007-02-26
Enrollment: 20
Sex: MALE
Minimum age (years): 16
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Obesity is associated with an increase in blood levels of estrogen. Estrogen or "female hormone" is believed to have a negative effect on sperm production. Aromatase inhibitors such as anastrozole work to decrease the production of estrogen and increase testosterone in the body. By decreasing the level of estrogen, sperm production should improve. In this study, the investigators will try to determine the benefit of anastrozole in obese men and follow pregnancy outcomes.


Eligibility criteria: Inclusion Criteria:

1. Male partner of a couple presenting for infertility work up after one year of unprotected intercourse
2. Moderate oligozoospermia (defined as mean sperm count ≤ 20 × 106/mL and ≥ than 3 × 106/mL) of at least two separate occasions spanning a minimum of two weeks
3. Obese men BMI ≥ 30
4. FSH and LH levels \< 10 mIU/mL

Exclusion Criteria:

1. Severe Oligozoospermia: Sperm count \< than 3 × 106/mL, including azoospermia
2. Age less than 18 or greater than 65 years
3. Pyospermia or leukospermia: defined by white blood cells ≥ 1 million leukocytes per milliliter of semen
4. Cryptorchidism
5. Vasectomy reversal
6. Regular use of tobacco products
7. BMI \< 30
8. Use of anabolic steroids or testosterone replacement
9. All patients with abnormal initial liver function tests "AST or ALT" will be excluded form the study

Primary outcomes:
measure: Pregnancy Rate
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: University of Utah
name: Ahmad O Hammoud, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01671280: Drug Use Investigation Of Azithromycin IV For Pneumonia Or Pelvic Inflammatory Disease (Regulatory Post Marketing Commitment Plan)
Official title: Drug Use Investigation Of Azithromycin Iv
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pneumonia
Pelvic Inflammatory Disease
Keywords: pneumonia
pelvic inflammatory disease
Zithromax
Zithromac
Japanese
Regulatory Post Marketing Commitment Plan
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2012-08-23
Enrollment: 403
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The patients whom an investigator involviong A0661207 prescribes the Zithromac IV.

Brief summary: To collect the efficacy and safety information of Azithromycin IV related to their appropriate use in daily practice


Eligibility criteria: Inclusion Criteria:

* Male or Female patients who are prescribed Zithromac IV for pneumonia or pelvic inflammatory disease.

Exclusion Criteria:

* Subjects who have been prescribed Zithromac IV for pneumonia or pelvic inflammatory disease.

Primary outcomes:
measure: Number of Participants With Treatment-Related Adverse Events
timeFrame: 29 days
Secondary outcomes:
measure: Clinical Effectiveness Rate in Participants With Pneumonia
timeFrame: 29 days
measure: Clinical Effectiveness Rate in Participants With Pelvic Inflammatory Disease
timeFrame: 29 days
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT02235480: Efficacy and Safety of Tazarotene Gel in Nail Psoriasis
Official title: A Phase II Trial to Evaluate the Anti-psoriatic Efficacy and Tolerability of Tazarotene in a Gel Formulation in Patients With Mild to Moderate Nail Psoriasis - Parallel Group Comparison
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Nail Psoriasis
Lead sponsor: Almirall, S.A.
Sponsor class: INDUSTRY
First posted: 2014-09-10
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to determine the efficacy and safety of topical application of the gel compared to placebo in nail psoriasis.


Eligibility criteria: Inclusion Criteria:

* Key inclusion criteria:
* Mild to moderate nail psoriasis on at least one fingernail

Exclusion Criteria:

Key exclusion criteria:

* any other skin condition, with a potential to affect the nails or to interfere with evaluation of the disease;
* history of hypersensitivity to retinoids or to other components of the trial medication
* topical treatment of nails with antipsoriatics in the 4 weeks preceding the treatment phase;
* systemic treatment of psoriasis within the three months before the treatment phase of the trial or during the trial
* intralesional steroid injection before the treatment phase of the trial
* phototherapy before the treatment phase of the trial;
* any chronic infection or condition capable of interfering with the conduct of the trial;
* evidence of drug or alcohol abuse;
* symptoms of a clinically significant illness that may influence the outcome of the trial in the four weeks preceding the treatment phase of the trial;
* participation in another clinical trial within the last 4 weeks prior to first treatment in this clinical trial;
* pregnancy or nursing;

Primary outcomes:
measure: % reduction in the Nail Psoriasis Severity Index ( NAPSI )
timeFrame: Day85
Secondary outcomes:
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: Day 85
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Investigational site 3
city: Berlin
country: Germany
facility: Investigational site 4
city: Hamburg
country: Germany
facility: Investigational 2
city: Hamburg
country: Germany
facility: Investigational site 1
Study officials:
References:
Clinical trial NCT02959580: Medical and Surgical Treatment for Idiopathic Granulomatous Mastitis
Official title: Evaluation of Topical Steroids and Surgical Treatment for Idiopathic Granulomatous Mastitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Granulomatous Mastitis
Keywords: Granulomatous
Mastitis
topical steroids
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2016-11-09
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluates the clinical response rate of topical steroids in the treatment of idiopathic granulomatous mastitis in female adults. Half of the participants will receive topical steroid and the other half will receive local wide surgical excision.

Detailed description: Idiopathic granulomatous mastitis (IGM) is a rare benign inflammatory breast disease of unknown etiology.It may present with many findings that clinically and radiologically mimic breast cancer.

Although IGM as a disease has been known for nearly four decades, the optimal treatment approach has not been established. Surgical intervention in the form of wide surgical excision was the mainstay of treatment before 1980, and is still performed depending on local expertise and preference.

Currently,surgical treatment and systemic steroid treatment are frequently employed. With the consideration of side effects of longterm systemic (oral) steroid usage, topical steroid without systemic use were assessed and showed satisfactory curative effect. But the data concerning the use of topical steroid therapy are still very limited.

Eligibility criteria: Inclusion Criteria:

* Idiopathic Granulomatous Mastitis

Exclusion Criteria:

* Breast Carcinoma

Primary outcomes:
measure: clinical response rate
timeFrame: six months
Secondary outcomes:
measure: granulomatous mastitis recurrence
timeFrame: two years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Department of Breast Surgery,Peking Union Medical College Hospital
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Qiang Sun, master
role: PRINCIPAL_INVESTIGATOR
References:
citation: Altintoprak F, Kivilcim T, Yalkin O, Uzunoglu Y, Kahyaoglu Z, Dilek ON. Topical Steroids Are Effective in the Treatment of Idiopathic Granulomatous Mastitis. World J Surg. 2015 Nov;39(11):2718-23. doi: 10.1007/s00268-015-3147-9.
citation: Sheybani F, Naderi HR, Gharib M, Sarvghad M, Mirfeizi Z. Idiopathic granulomatous mastitis: Long-discussed but yet-to-be-known. Autoimmunity. 2016 Jun;49(4):236-9. doi: 10.3109/08916934.2016.1138221. Epub 2016 Feb 1.
citation: Benson JR, Dumitru D. Idiopathic granulomatous mastitis: presentation, investigation and management. Future Oncol. 2016 Jun;12(11):1381-94. doi: 10.2217/fon-2015-0038. Epub 2016 Apr 12.
Clinical trial NCT06365580: Dose Escalation Study of Kylo-0603 in Healthy Subjects
Official title: A Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Food Effect of Single and Multiple Ascending Doses of Kylo-0603 Capsules in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Nonalcoholic Steatohepatitis
Lead sponsor: Kylonova (Xiamen) Biopharma co., LTD.
Sponsor class: INDUSTRY
First posted: 2024-04-15
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This clinical trial is the first-in-human study of Kylo-0603. The purpose of this randomized, double-blind, placebo-controlled phase 1 study is to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and effect of food of Kylo-0603 in healthy Chinese adult subjects.

Detailed description: The study consists of three parts: single ascending doses (Part 1), food effect (Part 2) and multiple ascending doses (Part 3).

Eligibility criteria: Inclusion Criteria:

* Men and women aged 18 to 55 years old, inclusive;
* Body mass index (BMI) between 19 kg/m2 and 30 kg/m2, inclusive；
* Having no clinically significant disorder, condition or disease at screening and before first dosing;
* Female subjects must not be able to get pregnant and male subjects must agree to adhere to contraception restrictions;
* Willing to comply with protocol required visits and assessments, and provide written informed consent.

Exclusion Criteria:

* History of cardiovascular, respiratory, digestive, liver, urinary, hematological, endocrine, metabolic, immune, cutaneous, or psychoneurotic diseases；
* History of evidence of malignant tumor or Gilbert syndrome;
* Positive screen of Hepatitis B surface antigen, hepatitis C virus, human immunodeficiency virus or syphilis infection;
* History of tuberculosis infection;
* History of alcohol abuse within 12 months before dosing;
* History of drug abuse within 3 months before screening;
* History of blood donations or blood loss of 400 ml and more within 3 months before dosing;
* Pregnant or breast-feeding women;
* Other exclusion criteria applied per protocol.

Primary outcomes:
measure: incidence of adverse events
timeFrame: up to 3 weeks
Secondary outcomes:
measure: Pharmacokinetics (PK) parameter of maximum observed concentration (Cmax)
timeFrame: up to 3 weeks
measure: PK parameter of time of maximum observed concentration (Tmax)
timeFrame: up to 3 weeks
measure: PK parameter of area under the concentration time curve (AUC)
timeFrame: up to 3 weeks
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The first affiliated hospital, Zhejiang University School of Medicine
state: Zhejiang
Study officials:
References:
Clinical trial NCT00219180: Clinical Study to Evaluate Efficacy and Safety of Aliskiren (150mg & 300mg) Administered Alone and in Combo With Valsartan (160mg and 320mg) in Patients With High Blood Pressure
Official title: An 8-week Multi-center, Dose Escalation Study to Evaluate the Efficacy and Safety of Aliskiren (150 mg and 300 mg) Administered Alone and in Combination With Valsartan (160 mg and 320 mg) in Patients With Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Keywords: Hypertension, Aliskiren
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-09-22
Enrollment: 1797
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: To evaluate the efficacy and safety of aliskiren alone and in combination with valsartan given to patients with essential hypertension


Eligibility criteria: Inclusion Criteria

* Patients with essential hypertension
* Patients who are eligible and able to participate in the study

Exclusion Criteria

* Severe hypertension
* History or evidence of a secondary form of hypertension
* History of Hypertensive encephalopathy or cerebrovascular accident

Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Change from baseline in diastolic blood pressure after week 8
Secondary outcomes:
measure: Change from baseline in systolic blood pressure after week 8
measure: Diastolic blood pressure < 90 mmHg or a reduction of > 10 mmHg after 4 and 8 weeks
measure: Blood pressure control target of < 140/90 mmHg after 4 and 8 weeks
measure: Evaluate 24-hour ambulatory blood pressure monitoring in a subset of patients
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Novartis Pharmaceuticals
state: New Jersey
city: Investigative Centers
country: Germany
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Oparil S, Yarows SA, Patel S, Fang H, Zhang J, Satlin A. Efficacy and safety of combined use of aliskiren and valsartan in patients with hypertension: a randomised, double-blind trial. Lancet. 2007 Jul 21;370(9583):221-229. doi: 10.1016/S0140-6736(07)61124-6.
Clinical trial NCT06378580: The Prognostic Impact of Surufatinib for the Treatment of Advanced Pancreatic Ductal Adenocarcinoma
Official title: The Prognostic Impact of Surufatinib for the Treatment of Advanced Pancreatic Ductal Adenocarcinoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreatic Cancer
Lead sponsor: Zhejiang Cancer Hospital
Sponsor class: OTHER
First posted: 2024-04-22
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patients with mPDAC who received the surufatinib regimen treatment between July 2022 and July 2023 at Zhejiang Cancer Hospital.

Brief summary: Pancreatic ductal adenocarcinoma (PDAC) is a highly aggressive tumor with a poor prognosis, despite the emergence of chemotherapies, unmet medical needs and limited treatment options still exist for patients with metastatic PDAC (mPDAC). Surufatinib is a small-molecule tyrosine kinase inhibitor that targets vascular endothelial growth factor (VEGFR) 1, 2, 3, fibroblast growth factor receptor 1 (FGFR1), and colony stimulating factor 1 receptor (CSF-1R), and ex vivo experiments have demonstrated its effect on PC models.

A retrospective analysis of patients with PDAC who underwent surufatinib at Zhejiang Cancer Hospital (Hangzhou,China) from July 2022 to July 2023.The database was extracted from the preoperative demographics, blood markers, and surgical pathology information of patients undergoing surufatinib in the investigators' hospital.


Eligibility criteria: Inclusion Criteria:

(i) were over 18 years old; (ii) had a histological diagnosis of pancreatic adenocarcinoma; (iii) had at least one measurable lesion; (iv) had undergone at least two cycles of surufatinib treatment.

Exclusion Criteria:

(i)non-R0 resection; (ii) Combined with other malignant tumors.

Primary outcomes:
measure: Median progression-free survival
timeFrame: 5 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Zhejiang Province Cancer Hospital
state: Zhejiang
Study officials:
References:
Clinical trial NCT04302480: A Brief Intervention Programme on ASP
Official title: A Brief Intervention Programme on Alternative Smoking Products
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Alternative Smoking Products
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2020-03-10
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The brief intervention comprises a 4-page worksheet used in the classroom (main intervention) and subsequent weekly e-messages through WhatsApp (booster intervention). The worksheets for both groups will be printed in colour, and mainly contain pictures and simple texts. Students will be asked to provide smartphone numbers of themselves and their parents for receiving the booster interventions. After sending 4-6 e-messages in 4 weeks, students will complete a 1-month follow-up assessment.


Eligibility criteria: Inclusion Criteria:

* Parents and children should understand Chinese.
* Parents' consent to their children's participation.

Exclusion Criteria:

* N/A

Primary outcomes:
measure: Knowledge on the harms and misleading marketing strategies of ASPs
timeFrame: Immediately after intervention
measure: Attitudes towards ASPs
timeFrame: Immediately after intervention
Secondary outcomes:
measure: Intention to use ASPs
timeFrame: Immediately after intervention
measure: Knowledge on the harms and misleading marketing strategies of ASPs
timeFrame: 1-month follow-up
measure: Attitudes towards ASPs
timeFrame: 1-month follow-up
measure: Intention to use ASPs
timeFrame: 1-month follow-up
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Local primary schools
Study officials:
affiliation: The University of Hong Kong
name: Sai Yin Ho, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02813980: Neural Circulatory Control and SUDEP Risk.
Official title: Neural Circulatory and Respiratory Control in Patients With Epilepsy and the Risk of Sudden Unexpected Death.
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Epilepsy
Seizures
Keywords: SUDEP
Sudden cardiac death
Sudden unexpected death in epilepsy
Sleep
Polysomnography
Autonomic
Cardiovascular
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: American Heart Association
First posted: 2016-06-27
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with epilepsy.

Brief summary: The investigators believe epilepsy alters the way the body controls blood pressure, heart rate and breathing, and these changes increase the risk of sudden unexpected death in patients with epilepsy (SUDEP). SUDEP-7 is a risk scoring tool which may correlate with these changes to the heart and blood vessels. This research study measures those differences which may help identify new markers to help predict those patients at greatest risk in the future.

Detailed description: The investigators overall goals are to determine whether measures of neural-circulatory control during the interictal waking and sleep states, as well as during the ictal/peri-ictal periods, are associated with SUDEP-7 score risk profiles in refractory epilepsy patients, and to translate these measures into tools for risk-stratification and preventative strategies for SUDEP.

Eligibility criteria: Inclusion Criteria:

* Adults aged 18-90
* Able to consent

Exclusion Criteria:

* History of non-epileptic spells/seizures,
* Children/adolescents under age 18 years
* Pregnancy
* Non-compliance with Epilepsy Monitoring Unit safety procedures
* Unable to consent
* History of dysautonomia
* Chronic Obstructive Pulmonary Disease (COPD)
* Asthma (active requiring therapy)
* Pulmonary hypertension
* Known Structural Heart Disease
* Heart failure
* Myocardial infarction
* Stroke
* Seizures due to traumatic injury
* Prior surgery for epilepsy
* Vasculitis
* Raynaud's
* Smoking (current or within the last 6 months)

Primary outcomes:
measure: Abnormal neural circulatory control in patients with epilepsy and high SUDEP-7 scores compared to patients with epilepsy and low SUDEP-7 scores.
timeFrame: 24 hours
measure: Abnormal neural and respiratory control in the ictal and peri-ictal phase of patients with epilepsy and a high SUDEP-7 score when compared to patients with epilepsy and a low SUDEP-7 score.
timeFrame: 3-7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Virend K Somers, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: