louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00482300: Systematic Pelvic Lymphadenectomy Versus no Lymphadenectomy in Clinical Stage I-II Endometrial Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endometrial Cancer
Keywords: Histologically proved endometrial carcinoma preoperatively supposed stage I-II
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2007-06-05
Sex: FEMALE
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this trial is to determine whether the addition of systematic pelvic lymphadenectomy to hysterectomy with bilateral adnexectomy improves disease-free survival (DFS) and overall survival (OS) in patients with preoperatively supposed Stage I-II endometrial cancer


Eligibility criteria: Inclusion Criteria:

* Histologically proven endometrioid or adenosquamous endometrial carcinoma.
* Patients having myometrial invasion
* Age =/\< 75 years
* Informed consent.

Exclusion Criteria:

* Serous papillary and clear cell tumors.
* Karnofsky index \< 80 or severe diseases contraindicating surgery
* Concomitant neoplasia (basalioma cutis excluded)
* Distant metastasis or abdominal metastasis detected intraoperatively.
* Absence of myometrial invasion at frozen section.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Department of Obstetrics and Gynecology University La Sapienza of Rome
name: Pierluigi Benedetti Panici, Full Professor
role: STUDY_CHAIR
References:
citation: Benedetti Panici P, Basile S, Maneschi F, Alberto Lissoni A, Signorelli M, Scambia G, Angioli R, Tateo S, Mangili G, Katsaros D, Garozzo G, Campagnutta E, Donadello N, Greggi S, Melpignano M, Raspagliesi F, Ragni N, Cormio G, Grassi R, Franchi M, Giannarelli D, Fossati R, Torri V, Amoroso M, Croce C, Mangioni C. Systematic pelvic lymphadenectomy vs. no lymphadenectomy in early-stage endometrial carcinoma: randomized clinical trial. J Natl Cancer Inst. 2008 Dec 3;100(23):1707-16. doi: 10.1093/jnci/djn397. Epub 2008 Nov 25.
Clinical trial NCT00005100: Measurement of Outcome of Surgical Treatment in Patients With Acromegaly
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acromegaly
Keywords: acromegaly
endocrine disorders
rare disease
Lead sponsor: National Center for Research Resources (NCRR)
Sponsor class: NIH
Collaborators: name: Columbia University
First posted: 2000-04-07
Enrollment: 165
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes

Brief summary: OBJECTIVES: I. Compare growth hormone (GH) levels at baseline and after glucose suppression measured with both a polyclonal radioimmunoassay and a highly sensitive immunoradiometric assay (IRMA) in patients with acromegaly and normal volunteers.

II. Measure the levels of IGF-I and its binding protein, IGFBP-3, in these cohorts.

III. Determine any correlation between levels of IGF-I and IGFBP-3 and GH suppressibility as assessed by sensitive IRMA.

IV. Determine if patients who demonstrate biochemical features of mild GH excess are at risk for progression to active disease.

Detailed description: PROTOCOL OUTLINE: Blood samples are collected and assessed for growth hormone and IGF-I by polyclonal radioimmunoassay (RIA) and immunoradiometric assay (IRMA). Growth hormone is measured at baseline and 60, 90, and 120 minutes after a 100 g glucose drink. Serum glucose is measured at baseline and at 2 hours post dextrose administration by the glucose hexokinase method.

Clinical scores are determined for headache, perspiration, fatigue, joint pain, and acne.

Exams and tests may be repeated every 6 months for 2 years.

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Diagnosis of acromegaly and treated with transsphenoidal surgery

Biochemically and histologically confirmed growth hormone secreting tumor

OR

Healthy volunteers

--Prior/Concurrent Therapy--

Surgery:

* See Disease Characteristics
* Greater than 6 months since prior surgery

Other: At least 1 month since prior bromocriptine or octreotide

--Patient Characteristics--

Performance status: Ambulatory

Hepatic: No active hepatic disease

Renal: No active renal disease

Other:

* No diabetes mellitus
* No glucose intolerance
* Hypopituitarism allowed if on stable doses of replacement therapy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University College of Physicians and Surgeons
state: New York
Study officials:
affiliation: Columbia University
name: Pamela U. Freda
role: STUDY_CHAIR
References:
Clinical trial NCT00157300: PROTECT: Prospective Trial on Erythropoietin in Clinical Transplantation
Official title: PROTECT: Prospective Trial on Erythropoietin in Clinical Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Patients Receiving a Kidney From a Non-Heart-Beating Donor
Keywords: erythropoietin
kidney transplantation
delayed graft function
Lead sponsor: Leiden University Medical Center
Sponsor class: OTHER
First posted: 2005-09-12
Enrollment: 92
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: PREVENTION

Brief summary: Randomized, double blind, placebo controlled, prospective trial investigating the effect of erythropoietin in renal transplantation.

The investigators postulate that erythropoietin reduces the risk of delayed graft function.

Detailed description: Randomized, double blind, placebo controlled, prospective trial in patients, receiving a kidney transplantation. Patients will be randomized to receive either Epoetin Beta (Neorecormon; Roche) or placebo.

The primary endpoint will be delayed graft function. The anticipated duration of this trial is 2 year and the target sample size is 60 patients per arm.

Eligibility criteria: Inclusion Criteria:

* Adult patients
* Receiving a kidney from a non-heart-beating donor category 3

Exclusion Criteria:

* Donor related factors: a prolonged warm ischaemic time (\> 45 min); a cold ischaemic time of \> 24 hours; serum creatinin of \> 150 umol/l

Primary outcomes:
measure: incidence of delayed graft function and primary non function after kidney transplantation
timeFrame: within12 weeks after transplantation
Secondary outcomes:
measure: duration of dialysis treatment
timeFrame: within 12 weeks after transplantation
measure: incidence of acute rejection episodes
timeFrame: till one year after transplantation
measure: renal function at 3, 6 and 12 months
timeFrame: 3, 6 and 12 months after transplantation
measure: patient and graft survival
timeFrame: one year
Other outcomes:
Locations:
city: Leiden
country: Netherlands
facility: Leiden University Medical Center
city: To Be Determined
country: Netherlands
facility: Other transplantation centers
Study officials:
affiliation: Leiden University Medical Center
name: Ton Rabelink, MD, PhD
role: STUDY_CHAIR
References:
citation: Ehrenreich H, Hasselblatt M, Dembowski C, Cepek L, Lewczuk P, Stiefel M, Rustenbeck HH, Breiter N, Jacob S, Knerlich F, Bohn M, Poser W, Ruther E, Kochen M, Gefeller O, Gleiter C, Wessel TC, De Ryck M, Itri L, Prange H, Cerami A, Brines M, Siren AL. Erythropoietin therapy for acute stroke is both safe and beneficial. Mol Med. 2002 Aug;8(8):495-505.
Clinical trial NCT01921400: The Pathogenesis of Hepatitis C Virus Vertical Transmission
Official title: The Pathogenesis of Hepatitis C Virus Vertical Transmission
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis C
Infection Transmission, Maternal-Fetal
Keywords: Hepatitis C (HCV)
Infection Transmission, Maternal-Fetal
Placenta
Trophoblast
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: University of Maryland
name: Cairo University
name: Merck Sharp & Dohme LLC
First posted: 2013-08-13
Enrollment: 38
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women with HCV infection who present to our collaborating institution in Egypt, and at UNC

Brief summary: To evaluate for the presence of HCV Core protein, HCV RNA and SPP in the placenta and fetal membranes using paraffin-embedded sections and post-delivery specimens respectively. In parallel, we will assess placental tissue for evidence of HCV infection using a novel in situ hybridization technique and translate our in vitro findings to these in vivo samples.

Our overall hypothesis is that cytotrophoblasts at the maternal-fetal interface within the placenta serve as a "barrier" that must be crossed during vertical transmission and that cytotrophoblasts are permissive to HCV at a low level that may be enhanced under certain conditions. By comparing the regulation of key steps in the intracellular life cycle of HCV in cytotrophoblasts to highly permissive hepatocytes, significant differences in HCV regulation should be revealed.

Based on our preliminary data, our working hypothesis is that HCV Core protein is differentially processed in cytotrophoblasts compared to hepatocytes.


Eligibility criteria: Inclusion Criteria:

* Pregnant women with HCV infection
* Pregnant women without HCV infection

Exclusion Criteria:

* None

Primary outcomes:
measure: To evaluate for the presence of HCV Core protein, HCV RNA and SPP in the placenta and fetal membranes using paraffin-embedded sections and post-delivery specimens respectively.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
city: Giza
country: Egypt
facility: Cairo University
Study officials:
affiliation: UNC Department of Pediatrics: Division of Allergy, Immunology, Rheumatology and Infectious Diseases
name: Ravi Jhaveri, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jhaveri R, Hashem M, El-Kamary SS, Saleh DA, Sharaf SA, El-Mougy F, Abdelsalam L, Ehab M, El-Ghazaly H. Hepatitis C Virus (HCV) Vertical Transmission in 12-Month-Old Infants Born to HCV-Infected Women and Assessment of Maternal Risk Factors. Open Forum Infect Dis. 2015 Jun 26;2(2):ofv089. doi: 10.1093/ofid/ofv089. eCollection 2015 Apr.
Clinical trial NCT03140800: Use Sonography in Patients With Intrauterine Device Presenting With Bleeding
Official title: Intrauterine Contraceptive Device:Clinical and Sonographic Correlation in Patients Presenting With Bleeding
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Contraception
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-05-04
Enrollment: 60
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients using intrauterine contraceptive device complaining of bleeding

Brief summary: Intrauterine contraceptive device is one of the most efficient and reversible methods of birth control with low cost and long duration of use However, in the first year after insertion, between 5 and 15% of women will have their Intrauterine contraceptive device removed because of irregular uterine bleeding which have been attributed to the effect of contact between the device and the endometrium and even the pressure on the uterine muscle . The disharmonious relationship between the Intrauterine contraceptive device and the uterus is the cause of most of the bleeding complaints, so bleeding is related to improper position rather than the contraceptive method itself which should be excluded before abandoning the Intrauterine contraceptive device for any other method of birth control


Eligibility criteria: Inclusion Criteria:

patients using intrauterine contraceptive device complaining of bleeding

Exclusion Criteria:

* a-Associated uterine, cervical,or adenexal pathology b-Associated pelvic infection c-Generalized bleeding disorders d-Medications causing coagulation defects e-Medical disorders causing bleeding e.g hypertention f-Endocrine disorder as thyroid dysfunction g-Who refuse to share in the study

Primary outcomes:
measure: The intrauterine device-Endometrial distance
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04096300: An Integrative Approach for Idiopathic Granulomatous Mastitis.
Official title: Traditional and Complementary Medicine: a Cure for Idiopathic Granulomatous Mastitis?
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Idiopathic Granulomatous Mastitis
Keywords: Integrative Medicine
Ethnomedicine
Hirudotherapy
Idiopathic Granulomatous Mastitis
Medical Cupping Therapy
Traditional and Complementary Medicine
Lead sponsor: Medipol University
Sponsor class: OTHER
First posted: 2019-09-19
Enrollment: 30
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients receiving Traditional and Complementary Medicine (T\&CM) for IGM will be retrospectively analyzed.

Brief summary: Collaboration is established between Turkish Holistic \& Integrative Medicine Association and Traditional \& Complementary Medicine Society of Istanbul Medipol University.

Study is carried out on idiopathic granulomatous mastitis patients who are followed in the Breast Clinic at Istanbul Medipol University Hospital for between September 2015 and September 2019. Hirudotherapy and medical cupping therapy were applied as traditional and complementary medicine integratively.

Following initial radiological imaging, microbiological- and histological testing, side effects and relapses are analyzed. Follow-up examination is also carried out at the end of the treatment, which consisted of clinical breast exam and radiological imaging.


Eligibility criteria: Inclusion Criteria:

* IGM patients, either ones newly diagnosed or had previously received different types of treatments, currently refusing conventional treatments with immunosuppressives etc, or/and surgical management, and now und

Exclusion Criteria:

* Patients currently using any conventional treatment, and/or contraindication to hirudotherapy and cupping.

Primary outcomes:
measure: Change of Breast Mass Size
timeFrame: Up to 12 months
measure: Change of Breast Mass Size
timeFrame: Up to 48 months
Secondary outcomes:
measure: Change of Breast Mass Size
timeFrame: Up to 48 months
Other outcomes:
Locations:
city: Beykoz
country: Turkey
facility: Medipol University
state: Istanbul
Study officials:
References:
Clinical trial NCT03944200: A Study to Investigate the Bioequivalence Test of DA-1229_01(A) at Fed State
Official title: Randomized, Open Label, Single Oral Administration at Fed State, 2 x 2 Crossover Study to Investigate the Bioequivalence Test of DA-1229_01(A)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type2 Diabetes
Lead sponsor: Dong-A ST Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2019-05-09
Enrollment: 30
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: A study demonstrates the bioequivalence of DA-1229_01(A) at Fed State when compared with Sugamet sustained-release(SR) Tab 5/1000mg® in healthy adults


Eligibility criteria: Inclusion Criteria:

* Adult patients over 19 years of age at the time of health examination
* Female patients who were confirmed to be not pregnant at health examination
* Patients without a history of mental illness in the past 5 years

Exclusion Criteria:

* Patients who have taken medications which could affect the results of the clinical trial in the past 10 days of participating in the clinical trial
* Patients with a congestive heart failure which requires medicinal treatment
* Patients who have made a whole blood donation in the past 2 months or an apheresis donation in the past 2 weeks of participating in the clinical trial
* Female patients who are lactating

Primary outcomes:
measure: Area under the concentration-time curve(AUCt)
timeFrame: Hour -1 ~ Hour 24
measure: Maximum plasmaconcentration of drug in plasma(Cmax)
timeFrame: Hour -1 ~ Hour 24
Secondary outcomes:
measure: Area under the plasma drug concentration-time curve from time 0 to infinity(AUCinf)
timeFrame: Hour -1 ~ Hour 24
measure: AUCt/AUCinf
timeFrame: Hour -1 ~ Hour 24
measure: Time to reach the maximum plasma concentration(Tmax)
timeFrame: Hour -1 ~ Hour 24
measure: Terminal elimination rate constant(ramda z)
timeFrame: Hour -1 ~ Hour 24
measure: Terminal elimination half-life(t1/2)
timeFrame: Hour -1 ~ Hour 24
Other outcomes:
Locations:
city: Anyang si
country: Korea, Republic of
facility: Metro Hospital
state: Gyeonggi-do
Study officials:
affiliation: Metro Hospital
name: Sung Dae Kwon, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06386900: The Impact of Grand Tour Cycling on Sleep and the Hematological and Metabolomic Profile in World-class Cyclists
Official title: The Impact of Grand Tour Cyling on Sleep and the Hematological and Metabolomic Profile in World-class Cyclists
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Overreaching
Keywords: Cycling
Grand Tour
Sleep
Metabolomics
Lead sponsor: KU Leuven
Sponsor class: OTHER
First posted: 2024-04-26
Enrollment: 16
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Elite cyclist participating in a Grand Tour (e.g. Tour de France, Vuelta a España, Giro d'Italia)

Brief summary: This project aims to identify the effect of a 3-week Grand Tour (e.g. Tour de France, Giro d'Italia, and Vuelta a España) on sleep, hematological parameters and the serum metabolome in world-class cyclists.


Eligibility criteria: Inclusion Criteria:

* Cylist participating in a Grand Tour (e.g. Tour de France, Vuelta a España, Giro d'Italia)

Exclusion Criteria:

* /

Primary outcomes:
measure: Serum metabolome abundance of cyclists participating in a Grand Tour
timeFrame: Start of the Grand Tour - restday 1 of the Grand Tour - restday 2 of the Grand Tour - last day of the Grand Tour
measure: Sleep efficiency during the Grand Tour
timeFrame: Every night starting from one week before till the last night of the Grand Tour
measure: Total sleep time during the Grand Tour
timeFrame: Every night starting from one week before till the last night of the Grand Tour
measure: Blood haemoglobin concentration
timeFrame: Start of the Grand Tour - restday 1 of the Grand Tour - restday 2 of the Grand Tour - last day of the Grand Tour
Secondary outcomes:
measure: Wakefulness after sleep onset
timeFrame: Every night starting from one week before till the last night of the Grand Tour
measure: Light sleep
timeFrame: Before the start of the Tour - restday 1 - restday 2 - end of Grand Tour
measure: Deep sleep
timeFrame: Before the start of the Tour - restday 1 - restday 2 - end of Grand Tour
measure: REM sleep
timeFrame: Before the start of the Tour - restday 1 - restday 2 - end of Grand Tour
measure: Red blood cell concentration
timeFrame: Start of the Grand Tour - restday 1 of the Grand Tour - restday 2 of the Grand Tour - last day of the Grand Tour
measure: Subjective fatigue
timeFrame: Start of the Grand Tour - restday 1 of the Grand Tour - restday 2 of the Grand Tour - last day of the Grand Tour
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: KU Leuven
state: Vlaams-Brabant
Study officials:
References:
Clinical trial NCT06955000: Efficacy of Interval Aerobic Training Versus Laser Puncture Therapy on Restless Leg Syndrome in Copd Patient
Official title: Efficacy of Interval Aerobic Training Versus Laser Puncture Therapy on the Severity of Restless Leg Syndrome in Chronic Obstructive Lung Disease Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: restless leg syndrom,lazer puncture therapy
Lead sponsor: Pharos University in Alexandria
Sponsor class: OTHER
First posted: 2025-05-02
Enrollment: 60
Sex: MALE
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: DETERMINE HOW TO IMPROVE THE QUALITY OF LIFE FOR PATIENTS WITH COPD BY DECREASING TINTENSITY OF THE RESTLESS SYNDROME

Detailed description: Patients with restless legs syndrome can benefit greatly from aerobic exercise, and a novel treatment for enhancing quality of life is laser puncture therapy.

Eligibility criteria: Inclusion Criteria:

* Men with COPD who were between the ages of 40 and 60 and had a BMI between 25.5 and 29.0 were eligible to enroll if they had received a diagnosis of COPD at least two years priorAn intense desire to move the legs is frequently accompanied by unpleasant and uncomfortable leg sensations. Patients usually experience worsening symptoms when they are at rest, sitting, or lying down. Walking and stretching are examples of physical activity that can help reduce these symptoms to some or all of their intensity

Exclusion Criteria:

* 1) Individuals suffering from acute infections and malignant diseases; 2) Individuals with a history of kidney disease, hiatus hernia, severe gastro-esophageal reflux, and osteoporosis 3) Patients with severe anemia and congestive heart failure 4) Individuals with severe neurological and musculoskeletal conditions.

Primary outcomes:
measure: Restless Legs Syndrome Rating Scale (IRLS):
timeFrame: 3 month
measure: Fatigue severity scale (FSS):
timeFrame: 3 month
measure: Six mint walk test:
timeFrame: 3 month
Secondary outcomes:
measure: Hemoglobin Test:
timeFrame: 3 month
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Ola Mohamed Elsayed Elgohary
Study officials:
References: