louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03630731: Maintenance Treatment of Chidamide in Stage IV or Relapsed/Refractory Extranodal NK/T-cell Lymphoma
Official title: Maintenance Treatment of Chidamide in Chemotherapy-responded Stage IV or Relapsed/Refractory Extranodal Natural Killer/T-cell Lymphoma, Nasal Type
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Natural Killer/T-Cell Lymphoma, Nasal and Nasal-Type
Lead sponsor: ChineseAMS
Sponsor class: UNKNOWN
First posted: 2018-08-15
Enrollment: 32
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: Extranodal natural killer/T-cell lymphoma, nasal type (NKTCL) is a highly aggressive peripheral T-cell lymphoma (PTCL). Patients with newly diagnosed stage IV and relapsed/refractory have poor prognosis. 5-year progression-free survival was reported only 55%. Chidamide is a selective histone deacetylase inhibitor which was approved by FDA in treating relapsed or refractory PTCL. In phase I and II studies of chidamide, patients with relapsed or refractory NKTCL achieved a higher overall remission. Patients who obtained complete or partial remission had much favourable duration of remission. Thus, the invesgator design this study to evaluate the role of maintenance treatment of chidamide for induction chemotherapy-responded newly-diagnosed advanced and relapsed/refractory NKTCL patients.


Eligibility criteria: Inclusion Criteria:

1. diagnosis of NKTCL with typical morphology and immunophenotype, according to the 2008 World Health Organization classification of lymphomas;
2. newly-diagnosed stage IV disease or relapsed or refractory disease；
3. age ≥ 18 years;
4. ECOG performance status 0-2;
5. at least one measurable lesion;
6. adequate hematological, hepatic, and renal functions; e.g., absolute neutrophil count ≥ 1.5 × 109/L, platelet count ≥ 80 × 109/L, total bilirubin ≤ 1.5 × upper limit of normal, alanine transaminase and aspartate transaminase ≤ 2 × upper limit of normal, and creatinine ≤ 1.5 mg/dl;
7. life expectancy of more than 3 months.

Exclusion Criteria:

1. Patients with newly-diagnosed stage I-II disease;
2. pregnancy or lactation;
3. any coexisting medical problems of sufficient severity to prevent full compliance with the study protocol.

Primary outcomes:
measure: PFS
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Hospital and Institute, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC)
state: Beijing
Study officials:
affiliation: Cancer Hospital, Chinese ACademy of Medical Science
name: Mei Dong
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03638427: Screening for Cervical Intraepithelial Neoplasia Using Self-collected Menstrual Blood
Official title: Screening for Cervical Intraepithelial Neoplasia Using Self-collected Menstrual Blood
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HPV - Anogenital Human Papilloma Virus Infection
Keywords: menstrual blood, high risk HPV
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2018-08-20
Enrollment: 159
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Menstruating women over the age of 18.

Brief summary: The purpose of this study is to investigate the feasibility and efficacy of assessing HR-HPV DNA and HPV E6/E7 mRNA via self-collected menstrual blood in a smart menstrual pad. In other words, can the investigators detect the high risk strains of the human papilloma virus (HPV) that are associated with cervical cancer in self-collected menstrual blood, as an alternative to collecting vaginal swabs.


Eligibility criteria: Inclusion Criteria:

There will be two study groups: 1) menstruating women over the age of 18 who have previous history of HR-HPV in the last 18 months and 2) menstruating women over the age of 18 who do not have a previous history of HR-HPV.

Exclusion Criteria:

* Women younger than 18 years old or are not menstruating regularly

Primary outcomes:
measure: Agreement Between Modified Menstrual Pad and Clinician-Collected Specimen
timeFrame: 2-4-months after initial clinician collected samples were obtained and sent for HR-HPV DNA or HPV E6/E7 mRNA
measure: Agreement Between Self-collected Vaginal Swabs vs Clinician-collected Cervical Specimens With High-risk HPV-Positive Results
timeFrame: 2-4-months after initial positive screen for HR-HPV DNA or HPV E6/E7 mRNA
Secondary outcomes:
measure: Number of Participants Who Preferred the Modified Menstrual Pad to Clinician-collected Cervical Specimens
timeFrame: 2-4-months after initial positive screen for HR-HPV DNA or HPV E6/E7 mRNA
measure: Number of Participants Who Opted Out of Self-swab Due to Discomfort With the Procedure
timeFrame: 2-4-months after initial positive screen for HR-HPV DNA or HPV E6/E7 mRNA
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford Gynecology Clinic
state: California
Study officials:
affiliation: Stanford University, Department of OB/GYN
name: Paul D Blumenthal, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Naseri S, Young S, Cruz G, Blumenthal PD. Screening for High-Risk Human Papillomavirus Using Passive, Self-Collected Menstrual Blood. Obstet Gynecol. 2022 Sep 1;140(3):470-476. doi: 10.1097/AOG.0000000000004904. Epub 2022 Aug 3.
Clinical trial NCT02688127: Efficacy of Tranexamic Acid In Reducing Blood Loss During Cesarean Section Because Of Placenta Previa
Official title: Efficacy of Tranexamic Acid In Reducing Blood Loss Among Pregnant Women During Cesarean Section Because Of Placenta Previa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Postpartum Haemorrage Sever Bleeding After Delivery
Keywords: obstetric bleeding placenta previa
Lead sponsor: Medical Research Council
Sponsor class: OTHER_GOV
First posted: 2016-02-23
Enrollment: 52
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study evaluate role of tranexamic acid in reducing blood loss among pregnant women undergoing cesarean section because of placenta previa .Half of participants will receive tranexamia acid drug While the other half will receive placebo.

Detailed description: Tranexamic Acid used in the field of obstetrics to decrease blood loss during and after cesarean section .

Tranexamic Acid is an antifibrinolytic agent which cause reversible and competitive blockade of the lysine binding sites in plasminogen molecules . It is a synthetic analog of amino acid lysine and its action is to reduce blood loss

Eligibility criteria: Inclusion Criteria:

* age 18 -38 Body mass index \<30 , Diagnosis of placenta previa

Exclusion Criteria:

* patient with bleeding disorder , hepatic and renal disease. contraindication to tranexamic acid as allergy , hypersensitivity to tranexamic acid and known thromboembolic event during pregnancy .

other causes ofantepartum haemorrhage eg :accidental haemorrhage, rupture uterus.

type 1,2 of placenta previa anterior type 3,4 of placenta previa posterior causes of overdistended uterus like :multiple pregnancy, polyhydraminos

Primary outcomes:
measure: Amount of Actual blood loss in each group
timeFrame: 6hour after operation
Secondary outcomes:
measure: Difference in haemoglobin before operation and 24 hours after operation
timeFrame: 24 hours
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05243927: Comparison of Aerobic Exercise and Spinal Stabilization Exercises in Women With Primary Dysmenorrhea
Official title: Comparison of Aerobic Exercise and Spinal Stabilization Exercises in Women With Primary Dysmenorrhea
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Primary Dysmenorrhea
Lead sponsor: Ankara Yildirim Beyazıt University
Sponsor class: OTHER
First posted: 2022-02-17
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to compare the effects of aerobic exercise and spinal stabilization exercises in women with primary dysmenorrhea (PD) complaints.

Detailed description: PD is the cramping pain that comes before or during a period. Different exercise approaches have positive effects in PD. Comparing the effects of these exercise approaches is needed to determine the effects on PD.

Eligibility criteria: Inclusion Criteria:

Women with primary dysmenorrhea complaint according to the Primary Dysmenorrhea Consensus Guide, Over 18 years of age, Having a mean pain intensity of moderate and higher according to the Visual Analogue Scale in the last 6 months, Having a regular menstrual cycle (28±7 days), Volunteered to participate in the study.

Exclusion Criteria:

Having a pathological history and radiological findings pointing to secondary dysmenorrhea, Using oral contraceptives/antidepressants at least 6 months, Receiving hormone therapy, Undergoing pelvic surgery, Pregnant, Giving birth, Using an intrauterine device, Having neurological, orthopedic and/or rheumatological diseases Having a history of ischemic heart disease (recently myocardial infarction, angina pectoralis, uncontrolled hypertension, etc.), Having a psychiatric disease, Having a history of malignancy

Primary outcomes:
measure: Menstrual pain intensity
timeFrame: change from baseline at 8 weeks
Secondary outcomes:
measure: Menstrual symptoms
timeFrame: change from baseline at 8 weeks
measure: Impacts of academic/work performance
timeFrame: change from baseline at 8 weeks
measure: Impacts of life quality
timeFrame: change from baseline at 8 weeks
measure: Functional and emotional effects
timeFrame: change from baseline at 8 weeks
measure: Sleep quality
timeFrame: change from baseline at 8 weeks
measure: Trunk muscle endurances
timeFrame: change from baseline at 8 weeks
measure: Posture
timeFrame: change from baseline at 8 weeks
measure: Pelvic tilt
timeFrame: change from baseline at 8 weeks
measure: Functional capacity
timeFrame: change from baseline at 8 weeks
measure: Subjective perception of improvement
timeFrame: After exercise program (at 8 week)
Other outcomes:
Locations:
Study officials:
affiliation: Ankara Yildirim Beyazıt University
name: Seyda Toprak Celenay
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02472327: Decreasing Patient Dissatisfaction With Unplanned Cesarean Sections
Official title: Decreasing Patient Dissatisfaction With Unplanned Cesarean Sections: A Prospective Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patient Satisfaction
Cesarean Section
Lead sponsor: Albany Medical College
Sponsor class: OTHER
First posted: 2015-06-15
Enrollment: 208
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Patient satisfaction after an unplanned cesarean section was studied and in the previous study it was noted that there were common themes that lead to patient dissatisfaction. The four common themes were: lack of trust regarding the indications for surgery, communication issues, loss of control, and fear during the situation. The purpose of this second phase of this study is to try and improve patient dissatisfaction by offering additional emotional support prior to the c/s with the hope of decreasing the trust issues toward physicians, decreasing the communication barriers, and decreasing the fear and loss of control. The additional emotional support that will be received prior to the cesarean section will be scripted based upon the findings of the investigators' prior study - the patient will be asked four questions and each question addresses the four themes that were noted in the previous study.

Detailed description: All patients admitted to the Labor and Delivery unit at Albany Medical College who are in labor or being evaluated for possible indicated delivery will receive information regarding the study. Those who consent to participation, if they are then determined to need a cesarean birth will be randomized into two groups. The first group will receive pre-operative counseling by the obstetrics resident who will be performing the cesarean, the second group will receive usual care. The counseling sheet was determined based upon the findings of a previous study done at this institution, and addresses four themes that were recurrent aspects of patient dissatisfaction after cesarean birth: poor communication, trust of physicians, loss of control, and fear of surgery.

Two weeks after the cesarean section, patients participating in the study are called on the phone by one of the investigators. A patient satisfaction survey, using a Likert scale is administered. This investigator is blinded as to whether the patient has received the additional counseling or not. Comparison of these scores will be used to determine whether pre-operative counseling can reduce dissatisfaction in patients undergoing unplanned cesarean sections.

Eligibility criteria: Inclusion Criteria:

* pregnant patient admitted at Albany Medical Center
* Faculty group patient

Exclusion Criteria:

--Patients who have scheduled cesarean sections

Primary outcomes:
measure: Patient satisfaction
timeFrame: 2 weeks postpartum
Secondary outcomes:
Other outcomes:
Locations:
city: Albany
country: United States
facility: Albany Medical College
state: New York
Study officials:
References:
Clinical trial NCT03082027: Pre-operative Sonographic Assessment of The Median Nerve in Carpal Tunnel Syndrome. Does it Affect The Operative Procedure?
Official title: Pre-operative Sonographic Assessment of The Median Nerve in Carpal Tunnel Syndrome. Does it Affect The Operative Procedure?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: CTS
Keywords: ultrasonography
carpal tunnel syndrome
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2017-03-17
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Thirty patients diagnosed as CTS were referred from the orthopedic clinics Another thirty healthy asymptomatic persons were included in this study as a control group

Brief summary: Sonographic Assessment of The Median Nerve in Carpal Tunnel Syndrome to assess the surgical importance and added value of superficial ultrasonography in assessment of the median nerve in CTS.

Detailed description: Abstract Objective: To assess the surgical importance and added value of superficial ultrasonography in assessment of the median nerve in CTS.

Methods: The study was conducted on thirty patients with CTS with electrophysiological confirmation; twelve males and eighteen females with mean age 43.93±4.51 (range 35-52y), and another thirty normal subjects; fifteen males and fifteen females, with their mean age 36.7±4.86 (range 29-45y). The cross sectional area (CSA) and flattening ratio (FR) at different levels were measured on both groups. Data from the study and control groups were compared. The accuracy of the ultrasonographic diagnostic criteria for CTS was evaluated using receiver operating characteristic (ROC) analysis. All the patients had surgical carpal tunnel release and the operative details were correlated with the ultrasonographic data.

Eligibility criteria: Inclusion Criteria:

* Carpal tunnel syndrome

Exclusion Criteria:

* bifid median nerve, carpal tunnel mass lesions, persistent median artery

Primary outcomes:
measure: cross sectional area
timeFrame: three minutes
measure: flattening ratio
timeFrame: three minutes
Secondary outcomes:
measure: cross sectional area difference
timeFrame: three minutes
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00023127: Reducing Indoor Allergen Exposures in Northern Manhattan and the South Bronx
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Allergy
Keywords: Asthma
Allergen
Cockroach
Lead sponsor: National Institute of Environmental Health Sciences (NIEHS)
Sponsor class: NIH
First posted: 2001-08-24
Enrollment: 40
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Controlled trial of an intervention to reduce indoor exposures to cockroach allergens among asthmatic children in NYC.


Eligibility criteria: Ages 6-18

Doctor-diagnosed asthma

Skin-test reactivity to cockroach antigen

Daily cockroach sitings in home

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Mailman School of Public Health at Columbia University
state: New York
Study officials:
References:
Clinical trial NCT00727727: SEDPARK2: Post Marketing Surveillance to Observe Safety and Efficacy of Piribedil in Parkinson's Disease (PIR-002/K)
Official title: Stabilization on, or Change-Over to the Non-Ergot Dopamine Agonist Piribedil in Patients With Morbus Parkinson - a Post Marketing Surveillance Study in Private Practices.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson's Disease
Keywords: Piribedil (trade name: Clarium)
non-ergot dopamine agonist
Morbus Parkinson
Tolerability
Efficacy
Post Marketing Surveillance
Lead sponsor: Desitin Arzneimittel GmbH
Sponsor class: INDUSTRY
First posted: 2008-08-04
Enrollment: 750
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Morbus Parkinson who require therapy with dopamine agonists

Brief summary: The objective of the Post Marketing Surveillance Study is to investigate the use of the non-ergot dopamine agonist piribedil (trade name: CLARIUM) in mono- and combination therapy in patients with Morbus Parkinson. Neurologists in private practices in Germany should document the safety and course of the disease/change of parkinsonian symptoms during stabilisation on, or change over from other dopamine agonist treatment under routine conditions. Piribedil should be prescribed according to its marketing authorisation.


Eligibility criteria: Inclusion Criteria:

* Male and female patients 18 years and older.
* Indication: Morbus Parkinson.
* Treatment with piribedil for the first time.
* Monotherapy with piribedil.
* Combination therapy with L-Dopa (from the beginning or secondary in combination with other antiparkinsonian drugs).

Exclusion Criteria:

Primary outcomes:
measure: to monitor use in daily routine practice including adverse events
timeFrame: 3 months
Secondary outcomes:
measure: to monitor use in daily routine practice including efficacy aspects
timeFrame: 3 months
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: Medical Practice for Neurology
city: Wedel
country: Germany
facility: Medical Practice for Neurology
Study officials:
References:
citation: Castro-Caldas A, Delwaide P, Jost W, Merello M, Williams A, Lamberti P, Aguilar M, Del Signore S, Cesaro P; Parkinson-Control Study Group. The Parkinson-Control study: a 1-year randomized, double-blind trial comparing piribedil (150 mg/day) with bromocriptine (25 mg/day) in early combination with levodopa in Parkinson's disease. Mov Disord. 2006 Apr;21(4):500-9. doi: 10.1002/mds.20750.
citation: Rascol O, Dubois B, Caldas AC, Senn S, Del Signore S, Lees A; Parkinson REGAIN Study Group. Early piribedil monotherapy of Parkinson's disease: A planned seven-month report of the REGAIN study. Mov Disord. 2006 Dec;21(12):2110-5. doi: 10.1002/mds.21122.
citation: Rascol O, Pathak A, Bagheri H, Montastruc JL. Dopaminagonists and fibrotic valvular heart disease: further considerations. Mov Disord. 2004 Dec;19(12):1524-5. doi: 10.1002/mds.20328. No abstract available.
Clinical trial NCT07009327: Efficacy and Safety of Photodynamic Therapy for CIN3
Official title: Efficacy and Safety of Photodynamic Therapy for Cervical Intraepithelial Neoplasia 3(CIN3):A Multicenter Prospective Cohort Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Precancerous Cervical Lesion
Keywords: PDT
HPV
CIN 3
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2025-06-06
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To investigate the efficacy and safety of photodynamic therapy (20% 5-amino-ketovalerate 630nm red light) in the treatment of cervical intraepithelial neoplasia 3(CIN 3)in women in the real world


Eligibility criteria: Inclusion Criteria:

* CIN3, photodynamic therapy was required,
* type 1 2 transformation area, colposcopy was sufficient
* the lesion boundary was completely visible
* The ECC did not indicate high-grade lesions

Exclusion Criteria:

* coexistence or suspicion of cancer;
* TCT HSIL
* involving glands
* Porphyria patients, or suspected allergic to red and blue light.
* severe medical comorbidities；

Primary outcomes:
measure: Efficacy of the treatment
timeFrame: 1 month after the treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Unniversity Third Hospital
Study officials:
affiliation: Peking Unniversity Third Hospital
name: Qin Han
role: STUDY_CHAIR
References: