louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01429870: Steroids Added to Dithranol and Narrow Band UVB(Ultraviolet B) (UVBnb) in Psoriasis
Official title: A Phase IV, Randomized, Double Blind, Placebo Controlled, Single-center Study of the Impact of Topical Steroids on Narrow Band UVB (Ultraviolet B) and Dithranol Combination Treatment of Psoriasis (DIPSO)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Psoriasis
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2011-09-07
Enrollment: 0
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: Objective(s):

(i) To assess the effect of adjunctive topical steroids in the combined treatment with UVBnb and dithranol on the remission time after therapy till a relapse of psoriasis defined as 50% loss of PASI (Psoriasis Area and Severity Index) improvement obtained through the antecedent treatment.

(ii) To assess the impact of adjuvant topical steroids in the combined treatment with UVBnb and dithranol on the clearing time of psoriasis lesions under therapy (PASI 75).

* Trial with medicinal product

Detailed description: (i) To assess the effect of adjunctive topical steroids in the combined treatment with UVBnb and dithranol on the remission time after therapy till a relapse of psoriasis defined as 50% loss of PASI (Psoriasis Area and Severity Index) improvement obtained through the antecedent treatment.

(ii) To assess the impact of adjuvant topical steroids in the combined treatment with UVBnb and dithranol on the clearing time of psoriasis lesions under therapy (PASI 75).

* Trial with medicinal product

Eligibility criteria: Inclusion criteria:

* Moderate to severe psoriasis of the chronic-plaque and / or guttata type

Exclusion criteria:

* Participation in a Goeckerman therapy regimen within 6 months previous to the present study

Primary outcomes:
measure: Relapse 50% PASI after treatment, time to PASI 75% on treatment
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Dermatology Department
Study officials:
affiliation: University Hospital Zurich, Division of Dermatology
name: Guenther Hofbauer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06468670: Short-course Radiotherapy Combined With Sintilimab for Neoadjuvant Treatment of Esophageal Squamous Cell Carcinoma
Official title: Short-course Radiotherapy Combined With Sintilimab for Neoadjuvant Treatment of Esophageal Squamous Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Esophageal Squamous Cell Carcinoma
Lead sponsor: Fujian Cancer Hospital
Sponsor class: OTHER_GOV
First posted: 2024-06-21
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is aimed to evaluate the efficacy and safety of short-course radiotherapy combined with sintilimab in neoadjuvant treatment of stage III, locally advanced esophageal squamous cell carcinoma.

Detailed description: This study was designed as a single arm, phase II trial. Subjects will receive short-course radiotherapy combined with sintilimab as neoadjuvant therapy of stage III, locally advanced esophageal squamous cell carcinoma. The primary endpoint is pathologic complete response(pCR).

Eligibility criteria: Inclusion Criteria:

* 18 years old and ≤75 years old

  * Esophageal squamous cell carcinoma diagnosed biopsy histopathology
  * Patients with resectable esophageal squamous cell carcinoma confirmed by pathology (including histology or cytology) , with pathological stage T3-4 or N+
  * At least one measurable lesion
  * Eastern cooperative oncology group (ECOG) performance status of 0 to 1
  * With adequate organs function

Exclusion Criteria:

* Patients with active malignancy within 5 years other than the tumor studied in this study or a localized tumor that has been cured such as resected basal or squamous cell carcinoma, superficial bladder cancer, cervical carcinoma in situ, or breast cancer
* Patients who have a higher risk of bleeding or perforation due to the tumor\&amp;#39;s obvious invasion of the adjacent organs (aorta or trachea) of the esophageal lesion, or patients who have formed a fistula
* Patients who have received any anti-tumor therapy for the research disease in the past, including radiotherapy, chemotherapy, immunotherapy (including but not limited to interleukin, interferon, thymus hormone) and traditional Chinese medicine therapy

Primary outcomes:
measure: Pathological complete response
timeFrame: 4 weeks after surgery
measure: Incidence rate of adverse events
timeFrame: 3 years
Secondary outcomes:
measure: overall survival
timeFrame: 3 years
measure: Disease-free survival
timeFrame: 3 years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01784770: Special Investigation Of Azithromycin IV For Legionnaires' Disease (Regulatory Post Marketing Commitment Plan)
Official title: Zithromac Iv Special Investigation For Legionella Infection.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Legionnaires' Disease
Legionella Pneumophila Infections
Keywords: Legionnaires' disease
Legionella pneumophila
Zithromax
Zithromac
Japanese
Regulatory Post Marketing Commitment Plan
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2013-02-06
Enrollment: 21
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The patients whom an investigator involving A0661208 prescribes the Zithromac IV.

Brief summary: To collect retrospectively the efficacy and safety information of azithromycin IV on patients with Legionnaires' disease related to their appropriate use in daily practice.


Eligibility criteria: Inclusion Criteria:

* All patients who are prescribed Azithromycin (Zithromac) IV for Legionnaires' disease.

Exclusion Criteria:

* Patients who have been prescribed Zithromac or Zithromac SR.

Primary outcomes:
measure: Number of Participants With Treatment-Related Adverse Events
timeFrame: 29 days
Secondary outcomes:
measure: Clinical Effectiveness Rate in Participants
timeFrame: 29 days
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT05310370: HRD and Resistance to PAPPi in EOC Patients
Official title: Correlation Between Homologous Recombination Deficiency Status and Resistance to PARP Inhibitors in Chinese Epithelial Ovarian Cancer Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Epithelial Ovarian Cancer
Homologous Recombination Deficiency
Homologous Recombination Repair Gene Mutation
Poly(ADP-ribose) Polymerase Inhibitor
Drug Resistance
Progression-free Survival
Overall Survival
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2022-04-04
Enrollment: 400
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Chinese cohort confirmed of epithelial ovarian cancer after the complete or partial remission of disease

Brief summary: The association between homologous recombination (HR) gene mutations and homologous recombination deficiency (HRD) status in Chinese epithelial ovarian cancer (EOC) patients has been investigated in previous studies (NCT04190667 and NCT04651920). This study is to investigate the correlation between HRD and the resistance to poly(ADP-ribose) polymerase inhibitors (PARPi) in a Chinese cohort confirmed of epithelial ovarian cancer. The mutated genes, HRD score model and their relationship with the prognosis is the primary endpoint in this study. All enrolled patients will accept PARPi as maintenance therapy after the complete or partial remission of targeted lesions. A multiple panel testing of germline and somatic genes, including BRCA1/2, and HRD score are provided for all participants.


Eligibility criteria: Inclusion Criteria:

* Aged 18 years or older
* Pathological confirmation of epithelial ovarian cancer
* With available tumor tissues
* Given consents to participate the study
* With detailed follow-up outcomes

Exclusion Criteria:

* Not meeting all of the inclusion criteria
* Declining to accept PARPi as maintenance therapy after the major treatment for cancer

Primary outcomes:
measure: Progression-free survival
timeFrame: One year
Secondary outcomes:
measure: Overall survival
timeFrame: One year
measure: Severe adverse events
timeFrame: One year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Lei Li
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Lei Li, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05407870: Efficacy and Safety of Etomidate Sedation in Gastric Endoscopic Submucosal Dissection
Official title: A Comparative Study of the Efficacy and Safety of Etomidate Compared to Propofol in Gastric Endoscopic Submucosal Dissection: a Prospective, Single-center, Randomized, Double-blind, Non-inferiority Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sedation Complication
Endoscopic Submucosal Dissection
Esophagogastroduodenoscopy
Keywords: Etomidate
Propofol
Lead sponsor: Korea University Anam Hospital
Sponsor class: OTHER
First posted: 2022-06-07
Enrollment: 138
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: During endoscopy, the patient is sedated to relieve pain and improve the ease of the procedure. Sedation endoscopy using propofol is effective, but has the disadvantage that cardiopulmonary side effects are frequently observed. However, etomidate is known to have hemodynamic and respiratory stability.The purpose of this study was to compare the efficacy and safety of etomidate and propofol in sedated gastric endoscopic submucosal dissection.


Eligibility criteria: Inclusion Criteria:

* Age 19-80
* American Society of Anesthesiologists Physical Status Classification System (ASA) score of I, II, III
* Scheduled endoscopy

Exclusion Criteria:

* Pregnancy
* Previous study History of hypersensitivity to drugs or substances containing soy or egg ingredients
* Those who think that tracheal intubation will be difficult
* Obstructive sleep apnea
* History of side effects from previous sedatives
* People with severe liver disease, kidney disease, or heart disease
* Those who want a non-sleeping endoscope
* A person who refuses to provide consent
* SBP \&lt; 80mmHg or SpO2 \&lt; 90%
* Patients with adrenocortical dysfunction, chronic steroid users

Primary outcomes:
measure: Respiratory adverse event
timeFrame: during gastric endoscopic submucosal dissection
Secondary outcomes:
measure: ESD clinical outcomes
timeFrame: From enrollment to the first clinic visit (within 60 days)
measure: Adverse events and procedure interruptions
timeFrame: during gastric endoscopic submucosal dissection
measure: Sedation-related profile
timeFrame: From initial administering the sedative drug to endoscopy room discharge (up to 2 hours); dose (ml)
measure: Satisfaction assessment
timeFrame: From initial administering the sedative drug to endoscopy room discharge; satisfaction score (0-10, 10 is the highest score)
measure: Hemodynamic changes
timeFrame: From date of randomization until the date of first documented progression (up to 2 hours)
measure: Factors associated with adverse events
timeFrame: From date of randomization until the date of first documented progression (up to three days)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
state: Seoung-buk Gu
Study officials:
References:
Clinical trial NCT05918770: Side Effects Screening and Early Intervention to Impact in Quality of Life of Gynaecological Cancer Patients
Official title: Telemedicine-guided Patients Reported Outcome Measures (PROMs): Side Effects Screening and Early Intervention to Impact in Quality of Life of Gynaecological Cancer Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Quality of Life
Gynaecological Cancer
Lymphedema, Lower Limb
Sexual Dysfunction
Keywords: quality of life
Gynaecological cancer
Lead sponsor: Hospital Universitario 12 de Octubre
Sponsor class: OTHER
First posted: 2023-06-26
Enrollment: 168
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goal of this randomized study is to assess the impact on self-perceived quality of life (QoL) of systematic screening and early treatment of aftereffects in patients with gynaecological cancers. The main question it aims to answer is if systematic screening with validated questionaries (see in detailed description), diagnosis and early treatment of lower-limb lymphoedema, anxiety-depression, sexual dysfunction and sarcopenia-malnutrition all have a positive impact on the self-perceived QoL by gynaecological cancer patients. Participants will access the screening questionnaires and QoL questionaries on a free online app on their mobile devices. In the experimental group, in case of positive screening, patients will be referred to specialised care to early treatment of the aftereffects. Researchers will compare this group with standard usual care (opportunistic treatment) to see if systematic screening and early treatment lead to a better QoL.

Detailed description: validated screening scales used: Gynecologic Cancer Lymphedema Questionnaire (GCLQ) Hospital Anxiety and Depression Scale (HADS) Sexual Function Abbreviated Index (IFSFA-6) Short Nutritional Assessment Questionnaire (SNAQ) Sarcopenia Formulary (SARC-F) along with self-perceived quality of life questionnaires from EORTC: QLQ-C30 EN-24 or OV-28 or CX-24

Eligibility criteria: Inclusion Criteria:

* Women aged ≥18 diagnosed with ovarian, tubal and primary peritoneal, cervical and endometrial cancer who are candidates for surgery during the study period.

Exclusion Criteria:

* Patients unable to complete by themselves the screening questionnaires included.

Primary outcomes:
measure: Quality-of-life questionaries score
timeFrame: up to 20 months
Secondary outcomes:
measure: Quality-of-life questionaries score related to endometrial cancer
timeFrame: up to 20 months
measure: Quality-of-life questionaries score related to cervical cancer
timeFrame: up to 20 months
measure: Quality-of-life questionaries score related to ovarian cancer
timeFrame: up to 20 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04675970: Long Term Follow up Patients With Premature Ovarian Failure ex Vivo Gene Therapy
Official title: Long Term Follow up Patients With Premature Ovarian Failure ex Vivo Gene Therapy Using Autologous Mesenchymal Stem Cell and Mesenchymal Stem Cell Lyophilisate
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Primary Ovarian Insufficiency
Premature Ovarian Failure
Keywords: Premature ovarian failure
stem cell therapy
mesenchymal stem cell
Lead sponsor: Ukraine Association of Biobank
Sponsor class: OTHER
First posted: 2020-12-19
Enrollment: 86
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with premature ovarian insufficiency (Diagnostic criteria of ESHRE) who have been treated with ex vivo gene therapy product in a Institute Bio-Stem Cell Rehabilitation UAB clinical study.

Brief summary: This is a multi-centers of long term safety and efficacy follow up study for patients with premature ovarian failure (the women aged younger than 40 years, who present with amenorrhoea, hypergonadotropic hypogonadism, and infertility) who have been treated with ex vivo gene therapy drug product in Institute of Bio-Stem Cell Rehabilitation UAB - sponsored clinical studies. After completing the parent clinical study (approximately 6 month), eligible subject will be followed for additional 2 years for total of 2 years and 6 month post drug product infusion. No investigation drug product will be administered in the study


Eligibility criteria: Inclusion Criteria:

Provision of written informed consent for this study by subjects or as applicable parent legal guardian. Treated with drug product for therapy of premature ovarian insufficiency in a Institute Bio-Stem Cell Rehabilitation UAB clinical study.

Diagnosed of premature ovarian insufficiency ESHRE:

* Women age of 18 to 40 years
* Have experienced 4 months of oligo/amenorrhea
* Two serum follicle-stimulating hormone (FSH was \>40 mIU/ml levels in the menopausal range, obtained at least a month apart
* lower FSH levels ( 25 mIU/ml)
* anti-Müllerian hormone (AMH) serum levels ( 3.0 ng/ml)

Exclusion Criteria:

There are no exclusion criteria for this study

Primary outcomes:
measure: Antral follicular count (AFC) serum levels
timeFrame: 2 years
measure: anti-Müllerian hormone (AMH) serum levels
timeFrame: 2 years
Secondary outcomes:
measure: Regular menstruation and/or pregnancy
timeFrame: 2 years
Other outcomes:
Locations:
city: Kharkov
country: Ukraine
facility: Institute of Bio-Stem Cell Rehabilitation
Study officials:
References:
Clinical trial NCT05303870: Impact of Psychological Therapies on Emergency Medical Patients
Official title: Exploring the Transferability of Improving Access to Psychological Therapies (IAPT) to a General Hospital Emergency Inpatient Ward
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Health Disorder
Mental Disorder
Mental Health Wellness 1
Lead sponsor: East Suffolk and North Essex NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: University of Essex
First posted: 2022-03-31
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Prevalence of anxiety and depression in the general population is known, but is under researched in the acute hospital setting and there is little evidence on the prevalence of anxiety and depression within the emergency medical admission population. A potential intervention for treating such mental health prevalence would be in the form of IAPT methodology which has been utilised in other parts of the NHS demonstrating good outcomes. Therefore, this feasibility study will explore the utility of IAPT in the acute setting.

This study will explore the prevalence of anxiety and depression in the emergency medical population within medical inpatient wards , utilising the assessment tools adopted by the IAPT services and explained in detail below.

The study will explore a) feasibility of introducing psychological intervention to an emergency medical ward and b) provide preliminary data on the outcome of this intervention on hospital length of stay and readmission rates.


Eligibility criteria: Inclusion Criteria:

* Patients admitted to Ipswich Hospital into a ward that cares for patients who are medical emergencies.
* Patients who score 3 or higher on one or both of the GAD 2 and PHQ 2.
* Patients that have capacity to consent.
* Over 18 years old.
* Ability to speak and read in English as the study will not have the resources to employ interpreters or to get documentation translated.
* Participants that are not deemed suicidal via screening and medical and nurse assessment.

Exclusion Criteria:

* Patients not receiving care on a ward caring for medical emergencies.
* Patients under the age of 18 years old.
* Patients scoring \< 3 on both GAD 2 and PHQ 2.
* Patients who do not have capacity to consent.
* Participants that are suicidal as via screening and medical and nurse assessment.

Primary outcomes:
measure: Number of participants with moderate or severe anxiety
timeFrame: Up to 6 months
Secondary outcomes:
measure: IAPT views
timeFrame: Up to 6 months
Other outcomes:
Locations:
city: Ipswich
country: United Kingdom
facility: East Suffolk and North Essex NHS Foundation Trust
Study officials:
References:
Clinical trial NCT05939570: DOSC and Association With Neighborhood Opportunity: Phase II
Official title: Pediatric Day-of-Surgery Cancellations and the Association With Neighborhood Opportunity and Indices of Vulnerability : Phase II
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pediatric Day of Surgery Cancellations
Keywords: Pediatrics
Day of Surgery Cancellations
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2023-07-11
Enrollment: 30
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Parents/guardians of children \<18 who had a day of surgery cancellation

Brief summary: Prospective, qualitative interview study to explore factors associated with pediatric day of surgery cancellations (DOSC) from the prospective of parents with hopes the interviews will reveal additional vulnerabilities not included in COI 2.0 that predispose to DOSC.

Detailed description: We plan to prospectively study vulnerability factors that contribute to day of surgery cancellations (DOSC) by conducting a qualitative study using semi-structured interviews with families cancelled the day of surgery. We plan to enroll between 20-30 families using convenience sampling. Based on preliminary data, we anticipate that most families will come from minority racial and ethnic groups and parents of non-English primary language (NEPL) - these interviews will be conducted via an interpreter. Interviews will be structured to explore surgical care utilization themes based on the Gelberg-Anderson Behavioral Model for Vulnerable Populations including 1) Parental knowledge and attitudes regarding surgical services, 2) family and community resources, 3) Perceived surgical conditions and perceived need for surgical services, and 4) use of surgical services and difficulties accessing them. Family recruitment will be ongoing and will continue until we have reached saturation of themes. The data generated from this study will lay the foundation for a multi-layered intervention at the hospital level to allow patients to be triaged according to COI 2.0, race/ethnicity, NEPL status, and other vulnerabilities. This will enable adaptation of hospital pre-operative procedures (i.e. NPO preoperative calls) to reduce DOSC.

Eligibility criteria: Inclusion Criteria:

* Parents/guardians of children \<18 who had a day of surgery cancellation
* Parents/guardians speak English, Spanish, Somali, Nepali or Arabic.

Exclusion Criteria:

* Parents/guardians speak a different language other than above listed.

Primary outcomes:
measure: Factors associated with DOSC
timeFrame: Identified during interview.
Secondary outcomes:
measure: Additional vulnerabilities not included in COI 2.0 that predispose to DOSC
timeFrame: Identified during interview.
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
References: