louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01615848: Comparison Between Mediterranean Diet and High Protein Diet in Women With Polycystic Ovary Syndrome (PCOS)
Official title: Comparison Between Mediterranean Diet and High Protein Diet in Women With Pcos: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Polycystic Ovary Syndrome
Keywords: polycystic Ovary syndrome (PCOS)
diet
mediterranean diet
high protein diet
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2012-06-11
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Polycystic ovary syndrome (PCOS) affects 5-10% of women and is the most common endocrine syndrome.PCOS is associated with infertility, risk for obesity and type 2 diabetes. The elevated insulin characteristic of PCOS is likely to play a major role in its symptoms. restricted calorie High protein diet and mediterranean diet may improve insulin sensitivity and therefore lower androgen production in women with pcos women.the purpose of this study is to determine which diet is more effective in improving metabolic and reproductive outcomes.

Detailed description: Polycystic ovary syndrome (PCOS) is a heterogeneous syndrome affecting 5-10% of women of reproductive age. It is characterized by elevated circulating insulin, reduced insulin sensitivity, infertility, hyperandrogenism, and a multitude of symptoms that result in a decreased quality of life. The elevated insulin characteristic of PCOS is likely to play a major role in its pathogenesis by reducing insulin sensitivity and stimulating excess androgen production hence causing an hormonal imbalance.

Low calories diets have shown to improve pcos symptoms but the optimal diet for all pcos women is still unknown.

In this study, our purpose is to compare two lowering insulin restricted calories diets in order to find the optimal diet for improving metabolic and endocrin outcomes in pcos women we will also investigate which diet has the best long lasting compliance.

Eligibility criteria: Inclusion Criteria:

* Polycystic ovary syndrome

Exclusion Criteria:

* Pregnancy
* Lactation 6 month prior to study
* Known hyperandrogenism
* More then 5 kg weight loss 6 month prior to study
* Imbalance pituitary hormones
* Alcohol or drug abuse
* Chronic disease - kidney/heart/diabetes/lung
* Psychiatric disease
* Drug use accept contraceptive pills

Primary outcomes:
measure: improvement in metabolic outcomes of women with pcos
timeFrame: 18 months
Secondary outcomes:
measure: improvement in clinical symptoms: acne, hirsutism and menstrual regularity
timeFrame: 18 months
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Clalit Health Services
Study officials:
affiliation: Clalit Health Services
name: Adam Geva, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03933748: Therapeutic Drug Monitoring of Teicoplanin in Children
Official title: Therapeutic Drug Monitoring of Teicoplanin in Children
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Bacterial Infections
Lead sponsor: Shandong University
Sponsor class: OTHER
Collaborators: name: Qianfoshan Hospital
name: Shandong Provincial Hospital
name: Affiliated Hospital of Qinghai University
name: Jinan children's hospital
name: Yantai Yuhuangding Hospital
name: Jinan Central Hospital
name: Liaocheng People's Hospital
name: Shandong Tumor Hospital
name: Weifang People's Hospital
name: Linyi People's Hospital
name: Jining Medical University
name: Weihai maternal and child health care hospital
name: The Second Hospital of Shandong University
First posted: 2019-05-01
Enrollment: 500
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children with gram-positive coccus infection

Brief summary: In this study, the therapeutic drug monitoring of teicoplanin is carried out among children to obtain the drug concentration, clinical efficacy and safety data of children patients in different gender and age groups. Then we analyze the relationship between blood drug concentration and efficacy and safety, and provide recommendations for the treatment window of teicoplanin in Chinese children.


Eligibility criteria: Inclusion Criteria:

* Teicoplanin was administered intravenously;
* Teicoplanin was used for therapeutic purposes;
* Age:≤18 years;
* Clinician confirms and plans to diagnose the patient with gram-positive coccus infection;
* Patients with therapeutic concentration monitoring of teicoplanin.

Exclusion Criteria:

* Teicoplanin was administered non-intravenously;
* Teicoplanin was used for prophylactic purposes;
* Patients without therapeutic concentration monitoring of teicoplanin;
* Patients who die within 24 hours of the use of teicoplanin；
* The blood concentrations of the patient was not approved by the quality control center.

Primary outcomes:
measure: Plasma drug concentration
timeFrame: Through study completion, an average of 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Ji'nan
country: China
facility: Shandong Provincial Qianfoshan Hospital
state: Shandong
Study officials:
References:
Clinical trial NCT05963048: Rituxmab Versus IL-6 in Treating ILD
Official title: Comparative Study About Effect of Rituximab Versus IL-6 Inhibitor in Induction of Remission in Active ILD in Scleroderma Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Interstitial Lung Disease
Scleroderma
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-07-27
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: All SSc patients should know if they have been diagnosed with interstitial lung disease, or pulmonary hypertension and keep results from his/her last pulmonary function test, chest imaging, echocardiogram and stress test

Detailed description: All SSc patients should know if they have been diagnosed with interstitial lung disease, or pulmonary hypertension and keep results from his/her last pulmonary function test, chest imaging, echocardiogram and stress test Diffuse infiltrative lung disease (ILD): progressive shortness of breath is the most frequently presentation going to ER pulmonary unit first. It should be considered in case of persistent dry cough or dyspnea, which should be looked for in any patient with SSc. an etiological assessment must be conducted in order not to mistakenly attribute ILD to the SSc.

Eligibility criteria: Inclusion Criteria:

* active ILD scleroderma

Exclusion Criteria:

* abnormal liver enzymes renal impairment neutropenia \<1000 cells/mm3 thrombocytopenia \< 50,000 cells/mm3

Primary outcomes:
measure: forced vital capacity
timeFrame: 6 months
Secondary outcomes:
measure: computed tomography chest
timeFrame: 1 year
measure: modified rodnan skin score
timeFrame: 6 months
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Manal Hassanien
state: Yes
Study officials:
affiliation: Assiut University
name: Manal Hassanien, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05622357: Prospective Study of Short Course Radiation Therapy Followed by Neoadjuvant Chemotherapy and Surgery in Locally Advanced Rectal Cancer
Official title: Prospective Phase II Study of Hypofractionated Short Course Radiation Therapy Followed by Neoadjuvant Chemotherapy and Surgery in Locally Advanced Rectal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Locally Advanced Rectal Carcinoma
Keywords: advanced rectal cancer- short course radiation - chemotherapy-surgery
Lead sponsor: National Cancer Institute, Egypt
Sponsor class: OTHER
First posted: 2022-11-18
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to investigate total neoadjuvant therapy (TNT) using short course radiation therapy (SCRT) followed by full course of chemotherapy then surgery in locally advanced rectal cancer. The main questions it aims to answer are:

* Is total neoadjuvant treatment in this design safe \& tolerable?
* Impact of this design on treatment related outcomes in terms of pathological and clinical responses.

Detailed description: Patients will be assigned to an experimental arm in which preoperative short course 5 x 5 Gy radiation therapy is followed by six cycles of combination chemotherapy (capecitabine and oxaliplatin) and surgery within 4-6 weeks

Eligibility criteria: Inclusion Criteria:

* Histopathological proof of rectal adenocarcinoma.
* Tumors located within 15 cm and not less than 4 cm from anal verge.
* Age: ≥ 18 years.
* Locally advanced resectable rectal cancer (cT3/4 N0- Any T N+ve).
* ECOG Performance Status: 0-2.

Exclusion Criteria:

* Non-epithelial rectal malignancy such as sarcoma or lymphoma.
* Unresectable tumors in which surgery will never be possible even if substantial tumor downsizing is seen.
* Recurrent rectal cancer.
* Previous history of malignancy within the last 5 years.
* Previous pelvic irradiation.
* Psychiatric or addictive disorder that would preclude study therapy.
* Concurrent uncontrolled medical conditions.
* Pregnancy or breast feeding.
* Any contraindication to surgery.
* Extensive peripheral neuropathy.

Primary outcomes:
measure: pathological complete response (pCR)
timeFrame: within 30 days
measure: clinical complete response(cCR)
timeFrame: within 30 days
measure: Sphincter saving surgery
timeFrame: within 6 months
Secondary outcomes:
measure: Local control
timeFrame: 3 years
measure: Overall survival
timeFrame: 3 years
measure: Disease free survival
timeFrame: within 3 years
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: National Cancer Institute
state: الجيزة
Study officials:
References:
Clinical trial NCT00332748: A Phase I Study of BMS-275183 (Oral Taxane) Given on a Daily Schedule in Combination With Esomeprazole (Nexium) in Patients With Advanced Cancer
Official title: Effect of Esomeprazole on the Pharmacokinetics of BMS-275183 in Patients With Advanced Malignancies
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Cancer
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2006-06-02
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine what effects Esomeprazole (Nexium) has on increasing or decreasing the amount of oral taxane in the blood, and to determine the safety of oral taxane and effect of oral taxane on the cancer.


Eligibility criteria: Inclusion Criteria:

* Advanced cancers excluding cancers within the blood
* Adequate kidney and liver function
* \> = 4 weeks from last course of chemotherapy

Exclusion Criteria:

* Inability to swallow capsules
* Other active medical disorder
* Abnormal heart function or use of drugs that affect the heart

Primary outcomes:
measure: To assess the safety of taking Nexium in combination with oral taxane and the effect this combination has on oral taxane's exposure levels in the body.
Secondary outcomes:
measure: To assess the safety of a single dose of oral taxane followed by a therapeutic regimen of oral taxane administered twice weekly
Other outcomes:
Locations:
city: Newark
country: United States
facility: Local Institution
state: Delaware
city: Louisville
country: United States
facility: Local Institution
state: Kentucky
city: Las Vegas
country: United States
facility: Local Institution
state: Nevada
city: Amsterdam
country: Netherlands
facility: Local Institution
Study officials:
References:
Clinical trial NCT00245648: Female Sex is an Independent Predictor of Death and Bleeding Among Fibrinolytic Treated Patients With AMI
Official title: Female Sex is an Independent Predictor of Death and Bleeding Among Fibrinolytic Treated Patients With AMI; Results of the Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries - V Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Myocardial Infarction
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: The Cleveland Clinic
name: Centocor, Inc.
name: Eli Lilly and Company
First posted: 2005-10-28
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: This study evaluated differences between men and women in the presentation, management and outcome of heart attacks within the GUSTO V study.

Detailed description: The Global Use of Strategies to Open Occluded Arteries in Acute Coronary Syndromes (GUSTO) V trial examined a large, contemporary cohort of women and men with ST elevation myocardial infarction (STEMI) treated with fibrinolytic therapy. The objective of the present study was to evaluate sex differences in presentation, management and outcome in GUSTO V.

Eligibility criteria: Inclusion Criteria:

* inclusion into GUSTO V

Exclusion Criteria:

* lack of availability of data (database study)

Primary outcomes:
measure: Primary Outcome
timeFrame: 30 days
Secondary outcomes:
measure: Secondary Outcomes
timeFrame: 7 days
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU School of Medicine
state: New York
Study officials:
affiliation: NYU School of Medicine
name: Harmony Reynolds
role: PRINCIPAL_INVESTIGATOR
References:
citation: Topol EJ; GUSTO V Investigators. Reperfusion therapy for acute myocardial infarction with fibrinolytic therapy or combination reduced fibrinolytic therapy and platelet glycoprotein IIb/IIIa inhibition: the GUSTO V randomised trial. Lancet. 2001 Jun 16;357(9272):1905-14. doi: 10.1016/s0140-6736(00)05059-5.
citation: Lincoff AM, Califf RM, Van de Werf F, Willerson JT, White HD, Armstrong PW, Guetta V, Gibler WB, Hochman JS, Bode C, Vahanian A, Steg PG, Ardissino D, Savonitto S, Bar F, Sadowski Z, Betriu A, Booth JE, Wolski K, Waller M, Topol EJ; Global Use of Strategies To Open Coronary Arteries Investigators (GUSTO). Mortality at 1 year with combination platelet glycoprotein IIb/IIIa inhibition and reduced-dose fibrinolytic therapy vs conventional fibrinolytic therapy for acute myocardial infarction: GUSTO V randomized trial. JAMA. 2002 Nov 6;288(17):2130-5. doi: 10.1001/jama.288.17.2130.
citation: Reynolds HR, Farkouh ME, Lincoff AM, Hsu A, Swahn E, Sadowski ZP, White JA, Topol EJ, Hochman JS; GUSTO V Investigators. Impact of female sex on death and bleeding after fibrinolytic treatment of myocardial infarction in GUSTO V. Arch Intern Med. 2007 Oct 22;167(19):2054-60. doi: 10.1001/archinte.167.19.2054.
Clinical trial NCT01388348: Diagnosis of Bladder Outlet Obstruction Using Dynamic Urine Vibration "Holter" in Comparison to Pressure Flow Study
Official title: Diagnosis of Bladder Outlet Obstruction Using Dynamic Urine Vibration "Holter" in Comparison to Pressure Flow Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bladder Outlet Obstruction
Keywords: benign prostatic hyperplasia (BPH)
acoustic vibration
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2011-07-06
Enrollment: 100
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Current gold standard of bladder outlet diagnosis is pressure flow study. This study is invasive time consuming and requires expensive and complex set-up. In this study the investigators plan to evaluate an alternative technology that presumably is able to diagnose bladder outlet obstruction using a Dynamic Urine Vibration "Holter" based on a Urine Flow Vibration Analysis technology. The acoustic vibration sensor is a small device that records the vibration due to urine flow. The patient attaches the sensor to the penis using a disposable sensor patch for the duration of approximately one minute during one urination. The analysis is performed off-line and the results are compared to the results of a standard pressure flow study. The innovative technology for the diagnosis of bladder outlet obstruction is noninvasive, rapid and does not involve complex setup.


Eligibility criteria: Inclusion Criteria:

* clinical diagnosis of benign prostatic hyperplasia (BPH)
* has indication for urodynamic evaluation

Primary outcomes:
measure: Efficacy of Holter to confirm or exclude of bladder outlet obstruction
timeFrame: one recording at the time of urodynamic testing.approximatly one minute
Secondary outcomes:
Other outcomes:
Locations:
city: Kfar Saba
country: Israel
facility: Meir Medical Center
Study officials:
References:
Clinical trial NCT00000248: Dose Response Trial of Pergolide for Cocaine Dependence - 1
Official title: Dose Response Trial of Pergolide for Cocaine Dependence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cocaine-Related Disorders
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 1999-09-21
Enrollment: 0
Sex: ALL
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and safety of pergolide for treatment of cocaine dependence.


Eligibility criteria: Please contact site for information.

Primary outcomes:
measure: Side effects
measure: Drug use
measure: Retention
measure: Cocaine withdrawal
measure: Compliance
measure: Effectiveness of medication for global improvements
Secondary outcomes:
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Robert Malcolm, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Malcolm R, Moore JW, Kajdasz DK, Cochrane CE. Pergolide mesylate. Adverse events occurring in the treatment of cocaine dependence. Am J Addict. 1997 Spring;6(2):117-23. doi: 10.3109/10550499709137022.
Clinical trial NCT06841848: Fundus Camera Module for Early Detection of Alzheimer's Disease
Official title: Fundus Camera Module for Early Detection of Alzheimer's Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Alzheimer Disease
Lead sponsor: I.R.C.C.S. Fondazione Santa Lucia
Sponsor class: OTHER
First posted: 2025-02-24
Enrollment: 80
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population is enrolled by Santa Lucia Foundation

Brief summary: Alzheimer's Disease (AD) affects tens of millions of people just in Europe. It is typically detected in its late stage when irreversible damage has already occurred, and current treatments are mostly conservative or palliative. Here we developed a device performing high-resolution multispectral imaging of the eye fundus to detect AD in its early stage. After clinical testing, the proposed device has a high potential to become a method for routine population screening, as it is non-invasive and affordable. The possibility of AD detection in an early stage is crucial for developing a new pharmaceutical treatment that would dramatically improve the lives of millions and save the expenses connected to lifelong healthcare assistance to people with AD in later stages.


Eligibility criteria: Inclusion Criteria:

* 55 years or older
* Diagnosis:

  1. For AD group: Clinically diagnosed with Alzheimer's disease (mild to moderate stage) based on Mini-Mental State Examination (MMSE) score between 10-26 and confirmed by PET imaging or CSF.
  2. For Control group: No diagnosis of Alzheimer's disease or other neurodegenerative disorders.
* Signed informed consent by the patient. If there are any doubts that the patient is mentally capable of giving informed consent, the patient will be examined and verified to be mentally capable by an independent physician/ neurologist, prior to the initiation of any study specific procedure

Exclusion Criteria:

* Severe cognitive impairment (MMSE \<10) preventing cooperation during the imaging process.
* Inability to remain still during the fundus imaging procedure.

Primary outcomes:
measure: Validation of Multispectral Fundus Imaging for Alzheimer's Disease Detection
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Santa Lucia Foundation
Study officials:
References:
Clinical trial NCT01826448: A Phase 1b Open Label, Dose Escalation Study of PLX3397 in Combination With Vemurafenib in V600-mutated BRAF Melanoma
Official title: A Phase 1b Open Label, Dose Escalation Study to Assess Safety, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of PLX3397 in Combination With Vemurafenib in V600-mutated BRAF Unresectable or Metastatic Melanoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: V600-mutated BRAF Unresectable Melanoma
V600-mutated BRAF Metastatic Melanoma
Stage III or Stage IV Metastatic Melanoma That Has Not Been Previously Treated With a Selective BRAF Inhibitor
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
Collaborators: name: Plexxikon
First posted: 2013-04-08
Enrollment: 13
Sex: ALL
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: The purpose of this research study is to test the safety of an investigational new drug called PLX3397 when used in combination with Vemurafenib (Zelboraf™) at different dose levels. Vemurafenib has been approved by the United States Food and Drug Administration (FDA)/European Medicines Agency (EMA) for the treatment of a specific category of unresectable or metastatic melanoma.


Eligibility criteria: Inclusion Criteria:

* Male or female ≥18 years old.
* Patients with histologically confirmed unresectable Stage III or Stage IV metastatic melanoma who have not been previously treated with a selective BRAF inhibitor.
* Presence of a BRAF V600 mutation in the tumor tissue using the cobas BRAF mutation assay or comparable standard of care methodology.
* Measurable disease per RECIST v. 1.1 criteria.
* ECOG performance status 0 or 1.

Exclusion Criteria:

* Radiation therapy within 14 days of C1D1.
* Investigational drug use within 28 days of C1D1.
* Patients with active CNS lesions are excluded (i.e., those with radiographically unstable, symptomatic lesions). However, patients treated with stereotactic therapy or surgery are eligible if they remain without evidence of disease progression in the brain for ≥3 weeks.

Primary outcomes:
measure: Percentage of Participants With Adverse Events Who Received PLX3397 in Combination With Vemurafenib in V600-mutated BRAF Melanoma
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA
state: California
city: Aurora
country: United States
facility: University of Colorado, Denver
state: Colorado
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
city: Seattle
country: United States
facility: Seattle Cancer Care Alliance
state: Washington
city: Paris
country: France
facility: Institute Gustave Roussy
city: Essen
country: Germany
facility: University Hospital Essen
Study officials:
References: