louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01357473: Stop Menstruation and Pregnancy Rates in Antagonist Protocol
Official title: Is Hormonal Exposure of Endometrium on the First Day After Menstruation Associated With the Probability of Pregnancy in Patients Treated With Rec-FSH/ GnRH Antagonist? A Prospective Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infertility
Keywords: hormonal values
menstruations
pregnancy
antagonist
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2011-05-20
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 37
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Infertility women treated with rec FSH/antagonist protocol

Brief summary: The proposal of this study is to evaluate the association between the achievement of ongoing pregnancy and hormonal levels on the first day after the period had stopped in rec-FSH/GnRH- antagonist cycles.

Detailed description: Ovarian stimulation will be achieved by rec- FSH, Puregon® starting on day 2 of the cycle at a dose of 200 IU/day. The dose of rec-FSH remains unchanged during stimulation until day 10 of the cycle. If it is necessary to increase the dose of rec-FSH after 10 days of stimulation, or to decrease the dose of rec-FSH due to a risk of OHSS, the patient will be dropped out of the study.

To inhibit premature LH surge daily GnRH - antagonist (orgalutran 0,25mg ) is used from the morning of day 6 of stimulation.

Final oocyte maturation will be achieved by administration of 10.000 IU of HCG (Pregnyl®) as soon as ≥ 3 follicles ≥ 17 mm are present. E2 levels should not be criteria for HCG administration. Oocyte retrieval will be carried out 36 hours after HCG administration. Conventional IVF or ICSI will be carried out. Embryo transfer will be carried out day3 or day5 after oocyte retrieval.

Similar luteal support for all patients with vaginal administration of 600mg natural micronised progesterone in three separate doses (Utrogestan® 200mg 3xday) starting one day after oocyte retrieval will be used. Hormonal assessment (E2,FSH,LH,Progesterone) will be performed at initiation of stimulation, on the first day after the period had stopped and every 2 days until the day of HCG administration.

Eligibility criteria: Inclusion Criteria:- Age ≤ 39 years

* Body mass index between 18 and 29 kg/m²¬
* Regular cycles between 25-34 days
* Presence of both ovaries
* Basal levels of estradiol (≤ 80 pg/ml) and progesterone (≤ 1.6ng/ml) on day one of the cycle
* Treatment with IVF/ICSI
* Embryo transfer day 3 or day 5 (1 or 2 embryos)
* Patients can enter in the study only once

Exclusion Criteria:

* Presence of endometriosis stage ≥3(AFS)
* Polycystic ovarian syndrome (Rotterdam criteria)
* Need for preimplantation genetic diagnosis (PGD)
* Azoospermia testicular sperm extraction (TESE)

Primary outcomes:
measure: Ongoing pregnancy rate.
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: CRG UZ Brussel
name: DIMITRA KYROU, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04347473: ILUMYA in Combination With HALOG Ointment 0.1% for Plaque Psoriasis.
Official title: A Single Center Study to Evaluate the Effectiveness and Safety of ILUMYA in Combination With HALOG Ointment 0.1% for the Treatment of Moderate to Severe Plaque Psoriasis.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Psoriasis
Lead sponsor: Psoriasis Treatment Center of Central New Jersey
Sponsor class: OTHER
Collaborators: name: Sun Pharmaceutical Industries Limited
First posted: 2020-04-15
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: open label
Primary purpose: TREATMENT

Brief summary: Patient with moderate-to-severe plaque psoriasis will receive Ilumya with or without Halog ointment.

Detailed description: 25 adult subjects with moderate to severe plaque psoriasis will receive Ilumya 100mg subcutaneously at weeks 0, 4 and 16.

At week 16, patients with remaining BSA ˃3% will be given HALOG ointment 0.1% to apply BID for 4 weeks. Patients who have ≤3% BSA at week 16 will remain on Ilumya monotherapy.

Patients will continue to be evaluated at weeks 20 and 24.

Eligibility criteria: Inclusion Criteria:

1. Male or female adult ≥ 18 years of age;
2. Diagnosis of moderate-to-severe chronic plaque-type psoriasis as defined by

   * BSA 10%
   * PGA ≥3
   * PASI ≥12
3. Must be a candidate for phototherapy and/or systemic therapy
4. Females of childbearing potential (FCBP) must have a negative serum pregnancy test at Screening and negative urine pregnancy test at Baseline. FCBP who engage in activity in which conception is possible must use one of the approved contraceptive options: hormonal contraception; intrauterine device (IUD); tubal ligation; or partner's vasectomy; Male or female condom diaphragm with spermicide, cervical cap with spermicide, or contraceptive sponge with spermicide.

Exclusion Criteria:

1. Non-plaque forms of psoriasis
2. Women of childbearing potential who are pregnant, intend to become pregnant, or are lactating
3. Presence of significant uncontrolled medical condition that in the opinion of the investigator would affect patient safety during the trial.
4. Active or untreated latent tuberculosis (TB)

Primary outcomes:
measure: Body surface area
timeFrame: 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: East Windsor
country: United States
facility: Psoriasis Treatment Center of Central New Jersey
state: New Jersey
Study officials:
References:
Clinical trial NCT01716273: Use of White Granulated Sugar on Wounds
Official title: A Randomised Controlled Trial to Investigate the Clinical and Cost-effectiveness of White Granulated Sugar Dressing Compared With Standard Treatment in the Management of Exudating Wounds With Parallel Economic Evaluation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Infected Wounds
Lead sponsor: University Hospital Birmingham
Sponsor class: OTHER
Collaborators: name: Laboratoires URGO
name: University of Wolverhampton
name: University of Birmingham
First posted: 2012-10-29
Enrollment: 108
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: How effective is sugar in reducing the debriding of sloughy, necrotic or infected exudating wounds compared with standard treatment?

Detailed description: Patients for whom all the following apply:

Have an exudating wound sizes 5cm2 and 40cm2 A minimum of 25% slough, infected and necrotic tissue No dry necrotic eschar present Ankle Brachial Pressure Index of greater than 0.6 Are over 18 years Independently and willingly consent

Eligibility criteria: Inclusion Criteria:

* Exudating wound sizes 5cm2 and 40cm2
* A minimum of 25% slough, infected and necrotic tissue
* No dry necrotic eschar
* Ankle Brachial Pressure Index of greater than 0.6
* Age over 18 years
* Able to independently and willingly consent

Exclusion Criteria:

* Participants in a trial evaluating other therapies for their wound
* Have previously been in this trial
* Women who are pregnant
* Participants not able to tolerate daily dressing change

Primary outcomes:
measure: Time to debridement of wound
timeFrame: 4 weeks
Secondary outcomes:
measure: Reduction in wound surface area
timeFrame: 4 weeks
Other outcomes:
measure: Quality of life
timeFrame: 4 weeks
Locations:
city: Birmingham
country: United Kingdom
facility: University Hospital Birmingham NHS Foundation Trust
state: West Midlands
Study officials:
affiliation: University Hospital Birmingham NHS Fondation Trust
name: Malcolm Simms, MBBSFRCS
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Wolverhampton
name: Moses Murandu, PhD student
role: STUDY_DIRECTOR
References:
citation: Murandu M, Webber MA, Simms MH, Dealey C. Use of granulated sugar therapy in the management of sloughy or necrotic wounds: a pilot study. J Wound Care. 2011 May;20(5):206, 208, 210 passim. doi: 10.12968/jowc.2011.20.5.206.
Clinical trial NCT00344773: First-line Treatment for Adenocarcinoma Patients With Epidermal Growth Factor Receptor (EGFR) Mutation
Official title: An Open-label, Multi-centre Study to Evaluate Efficacy and Safety of Gefitinib as the First-line Treatment for Locally Advanced (IIIB), Metastatic (IV) or Recurrent Pulmonary Adenocarcinoma Patients With Epidermal Growth Factor Receptor (EGFR) Mutation.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pulmonary Cancer
Keywords: Locally advanced (IIIB) pulmonary adenocarcinoma with EGFR mutation
Metastatic (IV) pulmonary adenocarcinoma with EGFR mutation
Recurrent pulmonary adenocarcinoma with EGFR mutation
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2006-06-27
Enrollment: 46
Sex: ALL
Minimum age (years): 19
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 study is to evaluate the overall objective tumor response rate (ORR) of Gefitinib.


Eligibility criteria: Inclusion Criteria:

* Patients require histological biopsy and paraffin block more than 5mg from the original tumour or metastatic site to perform EGFR mutational analysis
* WHO Performance Status 0-2
* No prior chemotherapy, biological or immunological therapy/surgery

Exclusion Criteria:

* Any evidence of clinically active interstitial lung disease
* Newly diagnosed CNS metastases that have not yet been definitively treated with surgery /radiation
* Patients with previously diagnosed and treated CNS metastases or spinal cord compression

Primary outcomes:
measure: Percentage of Participants Who Had an Objective Response Rate(ORR) Based on Response Evaluation Criteria In Solid Tumors (RECIST) Criteria.
timeFrame: baseline to 12 months
Secondary outcomes:
measure: Progression Free Survival (PFS)
timeFrame: baseline to 4 months
measure: Overall Survival (OS)
timeFrame: baseline to 12 months
measure: Safety Profile: Participants With Adverse Events
timeFrame: baseline to end of study
Other outcomes:
Locations:
city: Seongnam-Si
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: HyeJong Yoo
role: STUDY_DIRECTOR
References:
citation: Kim DW, Lee SH, Lee JS, Lee MA, Kang JH, Kim SY, Shin SW, Kim HK, Heo DS. A multicenter phase II study to evaluate the efficacy and safety of gefitinib as first-line treatment for Korean patients with advanced pulmonary adenocarcinoma harboring EGFR mutations. Lung Cancer. 2011 Jan;71(1):65-9. doi: 10.1016/j.lungcan.2010.04.005.
Clinical trial NCT01878773: Prostate Delineation: High Quality Volume CT
Official title: Prostate Delineation During Radiation Treatment Planning for Prostate Cancer: Comparison of High Quality Volume Computerized Tomography With Conventional Tomography and Magnetic Resonance Imaging
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Keywords: Prostate Cancer
MRI scan
External beam radiotherapy
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Princess Margaret Hospital, Canada
First posted: 2013-06-17
Enrollment: 10
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: This study will look at how feasible it is to use a certain type of Computed Tomography (CT) to scan prostate cancer, called a high quality volume CT scan. It is hoped that this technique will help doctors provide a higher-quality image of the prostate cancer, making it easier to plan the area that will be treated. Using this type of CT scan will also lessen the amount of time patients spend in the scanner.

This study will not offer patients a different treatment for their prostate cancer. Patients will receive the most appropriate standard treatment whether or not they are in this study.


Eligibility criteria: Inclusion Criteria:

1. At least 18 years old
2. Subjects undergoing radical external beam radiotherapy for prostate cancer
3. Ability to provide written informed consent

Exclusion Criteria:

1. Age ≤ 18 years
2. Subjects not suitable for MRI scanning
3. 3 usable image sets not obtained during treatment planning scans.

Primary outcomes:
measure: Using different scanning methods for patients undergoing radical external beam radiotherapy for prostate cancer to determine inter-observer variability in prostate gland delineation on the images.
timeFrame: 6 months
Secondary outcomes:
measure: Determine the concordance between delineators in identifying the prostate apex on the 2 CT image sets. MRI will be considered the "gold-standard" for identifying the prostate apex.
timeFrame: 6 months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University Health Network, The Princess Margaret
state: Ontario
Study officials:
References:
Clinical trial NCT02108431: Prospective Randomized Trial Comparing Urinary Diversion After Robot-assisted Radical Prostatectomy
Official title: Superior Postoperative Patient Comfort in Suprapubic Drainage Versus Transurethral Catheterization Following Robot-assisted Radical Prostatectomy: A Prospective Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Keywords: urinary diversion
urethral catheter
suprapubic tube
radical prostatectomy
robotic surgery
discomfort
pain
Lead sponsor: St. Antonius Hospital Gronau
Sponsor class: OTHER
First posted: 2014-04-09
Enrollment: 160
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to determine, whether the urinary diversion via suprapubic cystostomy compared to transurethral catheterization after robot-assisted radical prostatectomy superior the postoperative patient comfort and reduce the postoperative bacteriuria.


Eligibility criteria: Inclusion Criteria:

1. Minimum age of 18 Years
2. Voluntarily agreement to participate in this study
3. Written informed-consent
4. Release of medical records for regulatory or research purposes
5. Clinically organ-confined prostate cancer

Exclusion Criteria:

1. BMI \>40
2. History of catheterization
3. History of radiation
4. History of chemotherapy
5. Person's participating in any other research
6. Unable to provide informed consent

Primary outcomes:
measure: Change of postoperative pain related to urinary drainage objectified by numeric rating scale (NRS) questionnaire within 5 days
timeFrame: postoperatively on day 1, 2, 3, 4 and 5 in the morning, at noon and in the evening
Secondary outcomes:
measure: Number of patients with bacteriuria
timeFrame: 5th day after the surgery
Other outcomes:
Locations:
city: Gronau
country: Germany
facility: Department of Urology, Pediatric Urology and Urologic Oncology; St. Antonius-Hospital Gronau GmbH
Study officials:
affiliation: St. Antonius Hospital Gronau
name: Jawid Habibzada, MD.
role: STUDY_CHAIR
affiliation: St. Antonius Hospital Gronau
name: Michael Godes, MD.
role: STUDY_CHAIR
References:
Clinical trial NCT01406431: Pharmacokinetic Study of Livalo® Fixed Combination Drug in Healthy Subjects
Official title: A Single Dose, Sequence-randomized, Open-label, 2x2 Crossover Study to Compare Pharmacokinetics Between Pitavastatin and Valsartan Co-administration and Livalo® Fixed Combination Drug in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hyperlipidemia
Hypertension
Keywords: pitavastatin
Livalo
Lead sponsor: JW Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2011-08-01
Enrollment: 48
Sex: MALE
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The purpose of this study is to compare pharmacokinetics between Pitavastatin and Valsartan co-administration and Livalo fixed combination drug in healthy male subjects.


Eligibility criteria: Inclusion Criteria:

* Healthy male volunteers
* Age 20-55 years at the time of Screening
* BMI 19-26 kg/m2 at the time of Screening

Exclusion Criteria:

* Received other investigational drug within 90 days prior to the first dose of study drug

Primary outcomes:
measure: Cmax of study drugs after single oral administration
timeFrame: 0-48hrs
measure: AUClast of study drugs after single oral administration
timeFrame: 0-48hrs
Secondary outcomes:
measure: AUCinf, Tmax and t1/2β of study drugs after single oral administration
timeFrame: 0-48hrs
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Asan Medical Center
name: Kyun Seop Bae, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03564431: The Imaging Genetic Study of Type 2 Diabetes and Depression
Official title: The Study of Structural and Functional Brain Abnormalities and the Association With the Genetic Polymorphism in the Type 2 Diabetes Patient With Depression
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: T2DM
Lead sponsor: Kunming Medical University
Sponsor class: OTHER
First posted: 2018-06-20
Enrollment: 120
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: T2DM and depression patients

Brief summary: To investigate the structural/functional abnormalities and the possible genetic endophenotypes of in the Type 2 Diabetes Patient With Depression.

Detailed description: Diabetes and depression are harmful to human health,but they often co-exist.At present, the pathophysiological mechanisms underlying the comorbidity of diabetes and depression are discussed, including hypothalamic-pituitary-adrenal axis dysfunction, inflammation, epigenetics, disturbed circadian rhythms, environmental and behavioral factors,neuroimaging,etc.the purpose of the investigator's study is to investigate the structural/functional abnormalities and the possible genetic endophenotypes of in the Type 2 Diabetes Patient With Depression.

Eligibility criteria: Inclusion Criteria:

conform to type 2 diabetes, depression, diagnostic criteria of unrelated normal controls the han nationality patients; Aged 30 to 70 years of age, gender not limited; The patient or legal guardian have signed informed consent of patients.

Exclusion Criteria:

Magnetic resonance imaging has the contraindication, such as metal implants, claustrophobic, etc.

With severe body diseases, including inflammatory diseases and autoimmune diseases; Current or past history of nervous system disease or brain injury. Merge other severe mental illness or existing psychotic symptoms; Always have a mania, hypomania attack; Has a history of substance abuse; Pregnant women and nursing mothers; Estimated compliance is poorer, not partners; Is being treated for a mental drug therapy, and ECT, TMS; Patients with a body mass index \> 35; There are currently no taking corticosteroids, immune regulator, etc. Now or ever did not suffer from patients with other diagnosis to the dsm-iv axis I; Merge the endocrine system disease, thyroid, adrenal gland and pituitary gland diseases, etc.

Primary outcomes:
measure: the neuroimaging of Type 2 Diabetes and Depression
timeFrame: from 2017-12 to 2019-12
Secondary outcomes:
Other outcomes:
Locations:
city: Kunming
country: China
facility: Psychiatry department, The 1st Affiliated Hospital of Kunming Medical University
state: Yunnan
Study officials:
affiliation: Psychiatry department of KMU
name: Xiufeng Xu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03218631: Oxandrolone in Healthy Adults: A Relative Bioavailability Study
Official title: Pharmacokinetics of a Medium Chain Triglyceride Oil Oxandrolone Solution vs. Tablets in Healthy Adults: A Relative Bioavailability Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Bioavailability
Keywords: oxandrolone, cardiac
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2017-07-14
Enrollment: 6
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 1. Male
2. Age 18 to 35 years (inclusive) at the time of screening
3. Body mass index \[BMI, body weight (kg)/height (m)2\] below 30 kg/m2
4. Medically healthy
Primary purpose: TREATMENT

Brief summary: To assess the pharmacokinetics and relative bioavailability of a single dose of approximately 0.1 mg/kg of a medium chain triglyceride (MCT) oil oxandrolone solution vs. tablets in a small cohort of healthy adults.

Detailed description: The results of this study will provide data regarding the relative bioavailability of a novel preparation of oxandrolone in MCT oil, which will allow dosing in neonates and small infants. This pilot study will provide information to design a larger multicenter study of neonates undergoing surgery for complex congenital heart disease.

Eligibility criteria: Inclusion Criteria:

1. Male
2. Age 18 to 35 years (inclusive) at the time of screening
3. Body mass index \[BMI, body weight (kg)/height (m)2\] below 30 kg/m2
4. Medically healthy

Exclusion Criteria:

1. Known allergy to anabolic steroids
2. Use of any prescription medication currently or within 14 days prior to dosing
3. Use of tobacco or nicotine containing products (including smoking cessation products), within 6 months prior to dosing
4. Any chronic medical condition
5. Seated blood pressure \<90/40 mmHg or \>140/90 mmHg at screening
6. Heart rate \<40 or \>99 at screening
7. Subjects who have taken any investigational drug within 30 days prior to first dose in the current study

Primary outcomes:
measure: Peak Plasma Concentration (Cmax) curve
timeFrame: Measurement of Peak Plasma Concentration (Cmax) at 15 min, 30 min, 1, 2, 3, 4, 8, 24, 48 hours on Days 1 and 8
measure: Area under the plasma concentration versus time curve (AUC)
timeFrame: Measurements at 15 min, 30 min, 1, 2, 3, 4, 8, 24, 48 hours on Days 1 and 8
Secondary outcomes:
measure: Safety will be assessed by recording adverse events and assessment of hepatic function at baseline and one week following oxandrolone dosing.
timeFrame: Liver function will be assessed by measuring serum transaminase levels at baseline and 1 week after each oxandrolone dose in the study participants, and any adverse events throughout the study period and up to 1 week after final dosing will be recorded.
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: Primary Children's Hospital
state: Utah
Study officials:
affiliation: University of Utah
name: Phillip T. Burch, MD
role: PRINCIPAL_INVESTIGATOR
References: