louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06353308: Effectiveness of an Online Intervention Using a Feminist Approach on Gender Equality Promotion and Sexual Violence Prevention in China
Official title: Effectiveness of an Online Intervention Using a Feminist Approach on Gender Equality Promotion and Sexual Violence Prevention in China: A Cluster Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sexual Violence
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2024-04-09
Enrollment: 422
Sex: ALL
Minimum age (years): 18
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This paper presents the findings of a clustered randomized controlled trial (cRCT) that evaluated the effectiveness of an online feminist sexual health intervention among Chinese young adults, providing insights into the impacts of this innovative approach and contribute to the growing body of literature on feminist interventions for sexual health and equality promotion.


Eligibility criteria: Inclusion Criteria:

1. Young adults aged between 18-29 years old who possessed a mobile phone
2. Had prior experience in using social media
3. Were able to read and understand Chinese

Exclusion Criteria:

1. Those with a physical impediment (e.g., blindness) preventing them from accessing the mobile content

Primary outcomes:
measure: Rape myth acceptance
timeFrame: From enrollment to the end of treatment at one week and three months
Secondary outcomes:
measure: Sociocultural Attitudes toward Appearance
timeFrame: From enrollment to the end of treatment at one week and three months
measure: Sexual Attitudes Scale
timeFrame: From enrollment to the end of treatment at one week and three months
measure: Sexual Desire Inventory
timeFrame: From enrollment to the end of treatment at one week and three months
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The university of Hong Kong
Study officials:
References:
Clinical trial NCT03362008: Compare the Pharmacokinetic Characteristics and the Safety Between Zeropix and Champix in Healthy Adult Male Subjects.
Official title: A Randomized, Open-label, 2-Way, 2-Period, Single-Dose Crossover Clinical Study to Compare the Pharmacokinetic Characteristics and the Safety Between Zeropix Tablet 1 mg and Champix® Tablet 1 mg in Healthy Adult Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Smoking, Cigarette
Lead sponsor: Jeil Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2017-12-05
Enrollment: 31
Sex: MALE
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study is a randomized, open-label, 2-way, 2-period, single-dose crossover clinical study to compare the pharmacokinetic characteristics and the safety between zeropix tablet 1 mg and champix® tablet 1 mg in healthy adult male subjects


Eligibility criteria: Inclusion Criteria:

1. Healthy male older than 19 to 45 years at the time of screening
2. Body weight more than 50kg and Body Mass Index(BMI) 18\~29 kg/m2 ☞ BMI = (weight \[kg\])/(height \[m\])2 3. Subject judged to be eligible by physical examination and interview conducted according to the study protocol. Thus, Subject should not have congenital/chronic disease or pathological symptoms/findings

Exclusion Criteria:

1. Subject currently with or has a history of cardiovascular , respiratory, hepatic, renal, neurological, endocrine, hemato-oncology, psychiatric, urinary diseases that is clinically significant
2. Subject with a history of significant hypersensitivity or clinically significant hypersensitivity reaction to varenicline and other drugs (aspirin, antibiotic...etc.)
3. Systolic blood pressure ⩽100mmHg or ⩾ 150mmHg, diastolic blood pressure⩽55mmHg or ⩾ 95mmHg
4. Subject with a history of gastrointestinal disease (i.e. Crohn's disease, ulcer...etc.) or gastrointestinal surgery (not including, simple appendectomy or hernia surgery) that can affect drug absorption
5. Subject with the following results in the clinical laboratory tests

   * Aspartate Transaminase(AST) or Alanine Transaminase(ALT) \> 2 x upper limit of normal range
   * Total Bilirubin \> 2.0 mg/dl
   * CK \> 2 x upper limit of normal range
   * eGFR \< 60 mL/min/1.73m2
6. Subject who takes alcohol \> 21 units/week, 1unit=10g=12.5ml of pure alcohol) or can't stop drinking during the clinical trials
7. Subject who smokes\> 10 cigarettes/day or can't stop smoking during the clinical trials

Primary outcomes:
measure: AUCt of Varenicline
timeFrame: 96 hours
measure: Cmax of Varenicline
timeFrame: 96 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital
Study officials:
References:
Clinical trial NCT06222008: Study on Symptom Clusters During Chemotherapy in Ovarian Cancer Patients With Different Chinese Medicine Constitution
Official title: Correlation Study of Symptom Clusters and Negative Emotions During Chemotherapy in Ovarian Cancer Patients With Different Chinese Medicine Constitution
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ovarian Cancer
Radiotherapy Side Effect
Symptom Cluster
Lead sponsor: Affiliated Hospital of Jiaxing University
Sponsor class: OTHER
First posted: 2024-01-24
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Postoperative patients with ovarian malignant tumors undergoing chemotherapy

Brief summary: The goal of this observational study is to learn about in Patients treated with postoperative chemotherapy for ovarian tumors. The main questions it aims to answer are: • \[What symptom clusters are present in patients treated with postoperative chemotherapy for ovarian tumors\] • \[Are there differences in symptom clusters for patients with different TCM body types\] Participants will \[complete questionnaires prior to the start of chemotherapy and after the 1st, 3rd, and 6th chemotherapy treatments\].


Eligibility criteria: Inclusion Criteria:

Pathologic diagnosis of ovarian cancer, the treatment plan adopts surgery combined with chemotherapy.

Age ≥ 18 years old, know the real situation of the disease, the expected survival period \> 1 year.

General condition is good, no history of psychiatric disease, no serious heart, brain, liver, kidney function abnormality.

Informed consent and voluntarily participate in this study.

Exclusion Criteria:

those who have other tumors or whose diagnosis is unclear. those who cannot communicate properly, understand the questionnaire or complete the scale assessment.

those who receive additional psychological interventions during the study period.

Primary outcomes:
measure: Chemotherapy Symptoms
timeFrame: Average 1 year
Secondary outcomes:
measure: Chemotherapy symptom clusters
timeFrame: Average 1 year
Other outcomes:
Locations:
city: Jiaxing
country: China
facility: The First Hospital of Jiaxing
Study officials:
References:
Clinical trial NCT05965908: Effect of Liraglutide in Obese Women With Polycystic Ovary Syndrome
Official title: Effect of Liraglutide on Different Parameters (Clinical , Metabolic and Hormonal) in Obese Women With Polycystic Ovary Syndrome
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Polycystic Ovary
Keywords: polycystic ovary
liraglutide
Lead sponsor: Beni-Suef University
Sponsor class: OTHER
First posted: 2023-07-28
Enrollment: 120
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to compare the hormonal, metabolic and clinical effects of metformin and liraglutide in infertile women with PCOs.

Detailed description: It is a Prospective randomized controlled trial .The study will include 80 randomly selected infertile women aged between 18 and 45 years, from Gynecology and obstetrics department Beni-Suef University Hospital whom diagnosed with polycystic ovarian syndrome (PCOS), The study will include two groups; each group consists of 40 patients:-

* Group1 (n=40) will be treated by liraglutide monotherapy.
* Group 2 (n=40) will be treated by metformin monotherapy.
* Group 3 (n=40) will be a control group.

To assess the metabolic effect of each treatment, the following parameters will be assessed before and after the treatment

* To assess the hormonal effect of each treatment, the following tests will be assessed before and after treatment
* Total Testosterone (TT)
* Dehydroepiandrosterone (DHEA)

To assess the clinical effect of the drugs, the following will be assessed before and after treatment:

The number of medium size follicles and large size follicles and the endometrium thickness were assessed on the tenth or eleventh day of menstruation. The chemical and clinical pregnancy rates were evaluated

Eligibility criteria: Inclusion Criteria:

* aged between 20 and 45 years
* PCO

Exclusion Criteria:

1. congenital adrenal hyperplasia
2. poorly controlled thyroid disease
3. Taking antidiabetic drugs which can affect insulin resistance
4. chronic kidney disease and history of recurrent urinary tract infections
5. liver dysfunction
6. documented use of oral hormonal contraceptives and hormone-releasing implants

Primary outcomes:
measure: Body weight loss
timeFrame: 1 months
Secondary outcomes:
Other outcomes:
Locations:
city: Banī Suwayf
country: Egypt
facility: Beni-suef university Hospital
state: Beni Suef
Study officials:
affiliation: Clinical Pharmacy Faculty of Pharmacy Beni-Suef University
name: Beni-Suef University
role: STUDY_DIRECTOR
References:
Clinical trial NCT04517708: Effectiveness of Nutritional Interventions for Cancer Patients Undergoing Chemotherapy
Official title: Effectiveness of Nutritional Interventions for Cancer Patients Undergoing Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastric Cancer
Colon Cancer
Lead sponsor: Hanoi Medical University
Sponsor class: OTHER
Collaborators: name: Ministry of Health of Vietnam
First posted: 2020-08-18
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study aims to estimate the effects of nutritional interventions on the improvement of nutritional status and quality of life (QoL) among gastrointestinal patients in Vietnam

Detailed description: A quasi-experiment with intervention and control groups for pre- and post-intervention assessment was carried out at the Department of Oncology and Palliative Care - Medical University Hospital from 2016 to 2019. 60 gastrointestinal cancer patients were recruited in each group. At stage 1, we selected patients of the intervention group who met the inclusion criteria to receive nutritional counseling and diet at the hospital. At stage 2, we chose patients who were eligible but did not accept the nutritional counseling and diet at the hospital. Participants in both groups were paired together according to the following criteria: 1) Age group: \<40 years old, 40-65 years old and \>65 years old; 2) Gender: Male and female; 3) Types of cancer: stomach cancer and colon cancer; 4) Disease stages: stage 1-2 and stage 3-4.

Eligibility criteria: Inclusion Criteria:

* aged 18 years old or above
* diagnosed with stomach or colon cancer;
* at the initial of receiving chemotherapy treatment;
* indicated for oral feeding;
* not having co-morbidities of chronic diseases such as kidney failure, heart failure, liver failure, diabetes;
* having ability to communicate with data collectors and both attending doctors and agreeing to involve in the study

Exclusion Criteria:

* treated by other methods such as radiation, endocrine, immunity;
* undergoing terminal palliative care;
* having contraindications to oral feeding/enteral nutrition

Primary outcomes:
measure: Change of nutritional status after 8 weeks
timeFrame: Baseline and 8 weeks
measure: Change of quality of life after 8 weeks: European Organisation for Research and Treatment of Cancer (EORTC) version 3.0
timeFrame: Baseline and 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Nguyen LT, Dang AK, Duong PT, Phan HBT, Pham CTT, Nguyen ATL, Le HT. Nutrition intervention is beneficial to the quality of life of patients with gastrointestinal cancer undergoing chemotherapy in Vietnam. Cancer Med. 2021 Mar;10(5):1668-1680. doi: 10.1002/cam4.3766. Epub 2021 Feb 7.
Clinical trial NCT00879008: SYMPROVE III: Health Services Research Study for Treatment of the Moderate and Severe Acute Exacerbations of Chronic Bronchitis (AECB)
Official title: SYMPROVE III: Health Services Research Study for Treatment of the Moderate and Severe AECB
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Bronchitis
Keywords: Disease Exacerbation
Acute Exacerbations of Chronic Bronchitis
AECB
Avelox
Bronchitis
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2009-04-09
Enrollment: 345
Sex: ALL
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: It is a multicentre study in the ambulatory sector. Every primary care physician or pulmologist should inclose the first 5 patients with AECB from Anthonisen type I or II

Brief summary: In this study data of patients with moderate or severe acute exacerbations of chronic bronchitis (AECB) were collected. There were two different cohorts which were compared (Moxifloxacin and other antibiotics) concerning effectiveness and tolerance. It was a prospective study which was accomplished in 100 ambulatory practice offices.

Detailed description: The study design was slightly changed to adapt the target population. Due to these changes the study was restarted on 8th December 2009.

Eligibility criteria: Inclusion Criteria:

* Acute exacerbation of chronic bronchitis from Anthonisen type I or II
* FEV1 of \< 50 %
* Patient must be ensured in the statutory health insurance
* Further contraindications of the prescribed pharmaceutical products must be considered

Exclusion Criteria:

* Patients who change from one cohort to the other

Primary outcomes:
measure: Effectiveness and tolerance of/to the different therapies
timeFrame: within the first 14 days
measure: Possible hospitalisation rate
timeFrame: within the first 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Many Locations
country: Germany
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT03115138: Evaluation of Circulating Tumor DNA as a Theranostic Marker in the Management of Glioblastomas.
Official title: Evaluation of Circulating Tumor DNA as a Theranostic Marker in the Management of Glioblastomas.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Glioblastoma
Molecular Disease
Keywords: Biopsy
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2017-04-14
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Glioblastomas (GBM) are rare tumors of poor prognosis and their treatment is based on surgery followed by radiochemotherapy. Clinical and imaging evaluation is not always straightforward: the more or less complete surgery, the pseudo-progression after radiochemotherapy, the radionecrosis, the diagnosis of the relapse and the follow-up under anti-angiogenic can pose problems Clinicians and radiologists. Accessibility to a plasma tumor molecular marker would greatly facilitate the follow-up of these patients.

It is now established for many cancers that circulating tumor DNA (cTNA) has the same molecular abnormalities as those identified in the primary tumor cells. Numerous studies have shown the prognostic value and diagnosis of the exploration of cDNA.


Eligibility criteria: Inclusion Criteria:

* Patients with grade IV glial tumor (glioblastoma according to WHO criteria) for which an indication of surgical excision with radiochemotherapy was chosen at a specialized multidisciplinary meeting of neuro-oncology at the CHU Amiens-Picardy.
* Patients should:

  * be able to be followed at the CHU of Amiens throughout their treatment,
  * be at least 18 years of age,
  * be informed (or trusted) of the conditions and objectives of the study,
  * having given their free and informed consent in writing,
  * have a life expectancy of more than 6 months,
  * be affiliated to a social security scheme.

Exclusion Criteria:

* Patients with recurrent tumors.
* Patients supported for another histology.
* Medical, psychological or social conditions that do not allow for proper understanding of the procedures inherent in the study.
* Patients under tutelage, curatorship.

Primary outcomes:
measure: Presence of a correlation between the molecular abnormalities of the primary tumor and the circulating tumor DNA
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens Picardie
state: Picardie
Study officials:
References:
Clinical trial NCT04283838: Humanistic Care in Healthcare Workers in Coronavirus Disease 2019
Official title: The Effect of Humanistic Care in Healthcare Workers Participated in the Treatment of Coronavirus Disease 2019
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Coronavirus Disease 2019
Keywords: coronavirus disease 2019
Humanistic Care
mental health
post-traumatic stress disorder
Healthcare Workers
Lead sponsor: Second Affiliated Hospital of Xi'an Jiaotong University
Sponsor class: OTHER
First posted: 2020-02-25
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: As of February 17th, 2020, China has 76396 confirmed cases of coronavirus disease 2019 (COVID-19), including 2348 deaths. The impact factors of clinical outcomes among hospitalized patients still need to be clarified. The healthcare workers faced greater mental and physical pressure under long-term, high-intensity, high-risk working conditions. Investigators aim to evaluate the positive effect of humanistic care for healthcare workers participated in the treatment of COVID-19.

Detailed description: As of February 17th, 2020, China has 76396 confirmed cases of coronavirus disease 2019 (COVID-19), including 2348 deaths. As the national medical team sent to Wuhan, the investigators proposed a psychological and physical rehabilitation based humanistic care regimen generated from experience in treating patients with COVID-19. The healthcare workers faced greater mental and physical pressure under long-term, high-intensity, high-risk working conditions. The investigators want to apply this regimen to the healthcare workers who participated in the treatment of COVID-19, to evaluate the positive effect of humanistic care on preventing depression and post-traumatic stress disorder.

Eligibility criteria: Inclusion Criteria:

* Healthcare-personnel who are working for treating COVID-19
* Agree to informed consent

Exclusion Criteria:

* disagree to consent

Primary outcomes:
measure: Self-rating depression scale
timeFrame: 1 month
Secondary outcomes:
measure: Incidence of PTSD
timeFrame: 1 month
Other outcomes:
Locations:
Study officials:
affiliation: Second Affiliated Hospital of Xi'an Jiaotong University
name: Shouping Gong, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00707538: A Phase I Study in Healthy Volunteers to Assess Dosimetry and Safety Following Injection of BMS747158 at Stress
Official title: A Phase I Dosimetry, Biodistribution and Safety Study of BMS747158 in Healthy Subjects Undergoing 2-Day Rest/Stress Positron Emission Tomography
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Lantheus Medical Imaging
Sponsor class: INDUSTRY
First posted: 2008-07-01
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this clinical research study is to learn the biodistribution of injection of BMS747158 at stress and assess the safety of two doses of BMS747158


Eligibility criteria: Inclusion Criteria:

* age 18-40
* BMI 18-30 kg/m2
* No active or chronic illnesses
* If female: not pregnant, use of birth control or not of child-bearing potential

Exclusion Criteria:

* Significant active or chronic illness
* Any neurological disorder
* GI disease within 3 months
* Recent infection
* Major surgery within 4 weeks
* Donation of blood within 4 weeks
* Blood transfusion within 4 weeks
* Recent history drug/alcohol abuse
* Head trauma
* Significant screening ECG, EEG, lab tests, physical exam and vital signs abnormalities
* Prescription or OTC drugs within 2 weeks
* Exposure to any other investigational

Primary outcomes:
measure: Dosimetry analysis following whole body imaging after stress injection
timeFrame: Imaging takes place approximately 0 - 300 minutes post injection
Secondary outcomes:
measure: Safety analysis following vital signs, ECGs, EEG, neuro and physical exams, telephone and visit follow up, and blood draws for chemistry and hematology post injection of BMS747158 at rest and stress
timeFrame: Screening (14 days prior to dosing) through 14 days post dose administration
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA Medical Center
state: California
city: Baltimore
country: United States
facility: John Hopkins University
state: Maryland
Study officials:
affiliation: University of California, Los Angeles
name: Jamshid Maddahi, MD
role: PRINCIPAL_INVESTIGATOR
References: