louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04929860: Intervention to Change Handwashing Behaviour in India
Official title: A Cluster Randomised Trial to Evaluate and Intervention to Change Handwashing Behaviour in Rural Indian Households
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hygiene
Handwashing
Behaviour
Keywords: diarrhoea
handwashing
hygiene
Lead sponsor: London School of Hygiene and Tropical Medicine
Sponsor class: OTHER
Collaborators: name: St. John's Research Institute
First posted: 2021-06-18
Enrollment: 1747
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The research will test the hypothesis that a scalable behaviour change intervention can improve hand-washing practices in rural Indian households. The intervention will be designed using a social marketing approach and will use motivational messages targeting key audiences rather than educational messages about germs and disease which previously have been found ineffective. The intervention will be designed for low-cost, scaleable delivery using a series of visits to target villages by a two-person team on a motorbike. The key goal of the study is to determine the effectiveness of a scaleable, social marketing intervention to promote hand-washing with soap.

The study will take the form of a cluster-randomized, controlled intervention trial. Villages will be randomized to receive either the intervention or no intervention. The primary outcome measure will be the proportion of key events (defecation, faecal contact or food handling) accompanied by hand-washing with soap. These data will be collected by direct observation. A secondary outcome measure will be the number of soap movement episodes. These data will be collected in a sub-sample of households by using electronic motion detectors embedded in bars of soap. Additionally, questionnaires will be used to collect data on social norms, self-reported soap use and habitual soap use. All data will be collected pre and post-intervention.


Eligibility criteria: Inclusion Criteria:

* households with children of primary school age or younger

Exclusion Criteria:

* households without school-aged or younger children

Primary outcomes:
measure: Handwashing with soap directly observed
timeFrame: one months after interventions is terminated
Secondary outcomes:
measure: Soap use measured by motion detectors embedded in soap bars
timeFrame: soap movements over one week one month after assessment of the primary outcome
Other outcomes:
Locations:
city: Palamener
country: India
facility: St. John's Research Institute
state: Andra Pradesh
Study officials:
References:
Clinical trial NCT00460460: Phase I, Open-label, Dose Escalation of AZD4877 in Hematologic Malignancies
Official title: A Phase I, Open-label, Dose Escalation Study to Assess the Safety, Tolerability & Pharmacokinetics of AZD4877 Administered Once Weekly in Adult Patients With Recurrent or Refractory AML, PH Negative ALL, NHL or MN
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Lymphoma
Keywords: Phase I
cancer
lymphoma
leukemia
myeloma
AML
ALL
NHL
MM
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2007-04-16
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary purpose of this study is to find out what the maximum tolerated dose is for an experimental drug called AZD4877 based on the side effects experienced by patients that receive AZD4877 on a weekly basis in these diseases.


Eligibility criteria: Inclusion Criteria:

* Patients with AML, a certain type of ALL, NHL and MM
* certain types of cancer of the lymph nodes
* certain types of leukemias (blood cancers)
* disease has or will fail with other treatments
* relatively good overall health other than your cancer

Exclusion Criteria:

* poor bone marrow function (not producing enough blood cells)
* serious heart conditions
* poor liver or kidney function

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Research site
state: New York
city: New York
country: United States
facility: Research Site
state: New York
city: Toronto
country: Canada
facility: Research Site
state: Ontario
Study officials:
affiliation: AstraZeneca
name: Judith Ochs, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05673694: To Evaluate a Phase Ia/Ib Clinical Study of EG017 in Patients With Advanced Breast Cancer.
Official title: A Phase Ia/Ib Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of EG017 in Androgen Receptor-positive, Estrogen Receptor-positive, and Human Epidermal Growth Factor Receptor-2-negative Patients With Advanced Breast Cancer.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Breast Cancer
Lead sponsor: Changchun GeneScience Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-01-06
Enrollment: 70
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the safety, tolerability, pharmacokinetics and efficacy of EG017 in androgen receptor-positive, estrogen receptor-positive, and human epidermal growth factor receptor-2-negative patients with advanced breast cancer.

Detailed description: The major aims of the study are to define the safety profile of this new drug, and to determine a recommended.

Eligibility criteria: Inclusion Criteria:

1. Female, 18-75 years old;
2. Expected survival ≥ 12 weeks;
3. Subjects with ECOG score of physical state 0\~1;
4. Histologically confirmed recurrent or metastatic advanced breast cancer;

Exclusion Criteria:

1. Those who have had a severe allergic reaction to any drug or its components in this study in the past;
2. Present with primary central nervous system (CNS) malignancies; Subjects with CNS metastasis who have failed local treatment (except asymptomatic BMS, or symptomatic BMS with complete remission of symptoms ≥ 2 weeks after treatment for BMS);
3. Has any disease or syndrome that requires or is likely to require systemic steroid therapy during the study period;
4. Gastrointestinal disorders or gastrointestinal diseases will significantly affect the absorption of test drugs (such as ulcerative disease, uncontrolled vomiting, diarrhea, malabsorption syndrome, biliary drainage status, etc.), or subjects cannot take drugs orally:

Primary outcomes:
measure: Safety and Tolerability of EG017 as Measured by the Number of Participants Experiencing Dose-limiting Toxicities (DLTs), Adverse Events (AEs), and Serious Adverse Events (SAEs).
timeFrame: 28 Days
measure: The effectiveness of EG017 in humans was evaluated by clinical benefit rate
timeFrame: 24 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Hospital of CAMS
state: Benjing
city: Zhengzhou
country: China
facility: First Affiliated Hospital of Zhengzhou University
state: Henan
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
state: Henan
city: Wuhan
country: China
facility: Wuhan Union Hospital
state: Hubei
city: Changsha
country: China
facility: Hunan Cancer Hospital
state: Hunan
Study officials:
References:
Clinical trial NCT05075694: Cukurova University Faculty of Medicine Non-interventional Clinical Research Institutional Ethics Committe
Official title: the Effect of Therapeutic Touch on Sleep Quality and Fatigue in Menopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Menopause
Sleep
Fatigue
Therapeutic Touch
Keywords: Menopause
Sleep
Fatigue
Therapeutic touch
Lead sponsor: Cukurova University
Sponsor class: OTHER
First posted: 2021-10-13
Enrollment: 48
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study was conducted as a parallel randomized-controlled, single-blind, single-centered, interventional study with a pre-test and post-test design
Primary purpose: SUPPORTIVE_CARE

Brief summary: This research was carried out to determine the effect of therapeutic touch on sleep quality and fatigue in menopausal women.

Detailed description: Methods: This randomized controlled experimental study was conducted with 48 (24 in the intervention group and 24 in the control group) women who sought treatment in the gynecological outpatient clinic of a public hospital. According to the study procedure, while the intervention group received therapeutic touch, the control group received SHAM therapeutic touch for 10 minutes a day for five consecutive days. Data were collected through the Personal Information Form, the Pittsburgh Sleep Quality Index, and the Piper Fatigue Scale.

Results: The median post-test total sleep quality score was significantly lower in the intervention group than in the control group (p=0.010). However, the mean total fatigue scores did not differ significantly between the groups (p=0.917).

Conclusions: The results of this study showed that therapeutic touch was effective in improving sleep quality, but it did not affect fatigue in menopausal women.

Eligibility criteria: Inclusion Criteria:

The study included women who agreed to participate in the study, lived in the city center, were at least literate, were in the natural premenopausal (irregular menstrual cycle within the last three months), perimenopausal (amenorrhea for 3-11 months or increased irregular menstruation), or postmenopausal (amenorrhea for more than 12 months) periods, were open to communication and cooperation, and could speak Turkish.

Exclusion Criteria:

The women who received hormone replacement treatment, used drugs for sleep problems and depression, were diagnosed with a medical psychiatric disease, and had sensitivity or problems about touching were excluded.

Primary outcomes:
measure: Sleep Quality
timeFrame: 9 months
measure: Fatigue
timeFrame: 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Adana
country: Turkey
facility: Ozlem Yalcinkaya
state: Saricam
Study officials:
affiliation: Cukurova University
name: Ebru GOZUYESIL, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT05123794: Shortened Depression Assessment Study
Official title: Using the Long to Short Approach to Develop Rapid Depressions Scales
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Depression
Keywords: Depression Moderate
Depression Severe
Survey Methodology
Lead sponsor: University of Toronto
Sponsor class: OTHER
First posted: 2021-11-17
Enrollment: 39000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants from all countries worldwide are eligible

Brief summary: Participants will be asked to fill out an online questionnaire about their demographics information and all 42 items from the Depression Anxiety Stress Scale (DASS-42). A series of machine learning techniques will be applied to the dataset to develop a shortened assessment using the most important demographics and DASS-42 items from the original questionnaire, to predict depression levels indicated by DASS-42.

Detailed description: Clinical depression affects 5-10% of the world population each year and is a serious mental health issue globally. There are many traditional psychological scales that assess levels of depression in adults, where their items are often redundant in the information they carry, and their scoring is not necessarily linear to the item scores. Thus, machine learning techniques can help find the redundancy in the items, as well as the nonlinear relationship between the item scores and the final prediction. Using the Depression Anxiety Stress Scale 42 (DASS-42) as the basis, participants will be asked to fill out an online questionnaire about their demographics information (age, gender, country of residence, race, etc.) and all 42 items of DASS-42 to provide a dataset for this study. Feature selection techniques such as MRMR and Gini feature importance were applied to identify the most important features in the dataset. Then, using machine learning methods such as Logistic Regression, XGBoost, and Ensemble models, models will be fitted on the most important features to develop a shortened depression scale (7-9 items consisting of demographics items and DASS items) that accurately predicted the levels of depression (as measured by the AUC, ROC and F1 scores.

Eligibility criteria: Inclusion Criteria:

* Adults aged 18 and above
* Must be able to read English
* Must have access to the Internet worldwide

Exclusion Criteria:

* Children aged 17 and under
* Persons who cannot read English
* Persons that do not have access to Internet

Primary outcomes:
measure: Rapid Depression Assessment Tool based on Depression Anxiety Stress Scale 42
timeFrame: All participants completed the same assessments, which took 10-15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University of Toronto
state: Ontario
Study officials:
affiliation: University of Toronto
name: Kang Lee
role: STUDY_CHAIR
References:
Clinical trial NCT04566094: Lung Herniation After Uniportal VATS
Official title: Lung Herniation After Uniportal VATS. Rarity or Common Finding?
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Lung Hernia
Thoracoscopy
Postoperative
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2020-09-28
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Every patient submitted to uniportal VATS anatomic lung resection from January 2016 until March 2019 who has had a postoperative radiological follow up.

Brief summary: During patient follow up the investigators noticed the occasional occurence of a lung herniation after uniportal Video assisted thoracoscopic surgery (VATS). Most of These patients were asymptomatic and didn't require any kind of treatment. To analyse the incidence of postoperative lung herniation after uniportal and the presence of symptoms the investigators decided to review every postoperative CT scan from January 2016 until March 2019 to radiologically identify postoperative lung herniations. Afterwards the investigators will contact the respective patient to ask for a follow-up physical examination and symptom evaluation (after consent was signed).


Eligibility criteria: Inclusion Criteria:

* Anatomical lung resection using uniportal VATS

Exclusion Criteria:

* Non anatomical lung resection
* Open surgery
* Pneumonectomy
* Informed consent not signed

Primary outcomes:
measure: Lung herniation
timeFrame: Postoperative follow-up up to 6 months
Secondary outcomes:
measure: Symptoms
timeFrame: Postoperative follow-up to 5 years
measure: Risk factors
timeFrame: At the time of operation
Other outcomes:
Locations:
Study officials:
affiliation: Department of General Thoracic Surgery Bern University Hospital
name: Jon Lutz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06434194: Serrantor OCT Study
Official title: Serranator OCT: Understanding the Mechanism of Action of Serration Angioplasty by Serranator Versus Conventional Balloon Angioplasty for below-the Knee (BTK) Artery Disease Using Optical Coherence Tomography (OCT)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Critical Limb Ischemia
Lead sponsor: Cagent Vascular LLC
Sponsor class: INDUSTRY
First posted: 2024-05-30
Enrollment: 60
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: TA prospective randomized control trial to evaluate the serration angioplasty effect in BTK arteries with varying degrees of calcified plaque.


Eligibility criteria: Inclusion Criteria:

* Rutherford clinical category 4-6 of the target limb
* Age of subjects is \>18 years old
* Patients has given informed consent to participate in this study

Exclusion Criteria:

* De novo or restenotic (without prior stent) stenosis (≥70%) or occlusion
* Target lesion is in the BTK arteries, including below the knee popliteal, tibioperoneal trunk, tibial, peroneal, and pedal arteries.
* Angiographic visual estimated reference vessel diameter is between 2.0 and 5.0 mm.
* Lesion length less than 220 mm

Primary outcomes:
measure: Residual Lumen Volume Stenosis
timeFrame: Baseline
Secondary outcomes:
measure: OCT Residual Diameter Stenosis
timeFrame: Baseline
measure: Angiography Residual Diameter Stenosis
timeFrame: Baseline
measure: Dissection Pattern
timeFrame: Baseline
measure: Correlation of Luminal Gain and Plaque Modification
timeFrame: Baseline
measure: Rate of Optimal PTA
timeFrame: Baseline
measure: Bail-out Stenting
timeFrame: Baseline
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University
state: New York
city: New York
country: United States
facility: Weill Cornell Medical
state: New York
Study officials:
References:
Clinical trial NCT03077594: Characterization of the Neo-squamous Epithelial Barrier
Official title: Prospective Characterization of the Neo-squamous Epithelial Barrier Following Successful Endoscopic Therapy in Barrett's Esophagus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Barrett's Esophagus With Dysplasia
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2017-03-13
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who have successfully completed endoscopic ablation (one endoscopy with no evidence of intestinal metaplasia).

Brief summary: To prospectively assess the functional aspects of the the esophageal squamous epithelial barrier and correlate this with tissue inflammation and intercellular space dilation in patients who have successfully completed endoscopic radiofrequency ablation versus balloon cryotherapy for Barrett's Esophagus related metaplasia.

Detailed description: The investigators will measure and correlate mucosal impedance (measured using a novel endoscopic mucosal impedance catheter), intercellular space as measured with transmission electron microscopy and tissue levels of prostaglandin E2 in patients undergoing surveillance following successful endoscopic therapy (defined as two negative endoscopic surveillance histology for intestinal metaplasia).

Mucosal impedance will be measured by an endoscopic probe. Research biopsies will also be obtained for measurement of tissue levels of prostaglandin E2 and intracellular space with transmission electron microscopy.

Volumetric laser endomicroscopy will measure the precise thickness of and area of subsquamous structures underneath the neosquamous epithelium.

Eligibility criteria: Inclusion Criteria:

* Adults (age 18-90) who underwent an ablative program for BE

Exclusion Criteria:

* Patients that have not achieved complete remission of intestinal metaplasia.
* Patients unable to consent.
* Pregnant women

Primary outcomes:
measure: Mucosal Impedance as measured by an endoscopic probe
timeFrame: Up to two years
Secondary outcomes:
measure: Tissue levels of prostaglandin E2
timeFrame: Up to two years
measure: Intracellular space
timeFrame: Up to two years
measure: Volumetric Laser Endomicroscopy
timeFrame: Up to two years
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
Study officials:
affiliation: Mayo Clinic
name: Prasad Iyer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01910194: Impact of Combined of Lantus(Insulin Glargine) and Lyxumia (Lixisenatide) on Insulin Secretion and Gastric Emptying
Official title: A Bicentric Open-label, Randomized, Two-parallel-group Study Investigating the Impact of Combined Lantus Insulin Glargine) and Lyxumia(Lixisenatide) on Insulin Secretion and Gastric Emptying in Subjects With Type 2 Diabetes Mellitus Not Adequately Controlled on Diet and Oral Antidiabetic Medication
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes Mellitus
Lead sponsor: Profil Institut für Stoffwechselforschung GmbH
Sponsor class: INDUSTRY
Collaborators: name: Sanofi
First posted: 2013-07-29
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Impact of combined Lantus (insulin glargine) and Lyxumia(lixisenatide) on insulin secretion and gastric emptying

Detailed description: Impact of combined Lantus (insulin glargine) and Lyxumia(lixisenatide) on insulin secretion and gastric emptying

Eligibility criteria: Inclusion Criteria:

* Patients with type 2 diabetes mellitus diagnosed at least one year before the screening visit not previously treated with glitazones, insulin or GLP-1 agonists
* Inadequately controlled diabetes mellitus

Exclusion Criteria:

* Subjects with type 1 diabetes, maturity onset diabetes of the young (MODY) or secondary forms of diabetes such as due to pancreatitis

Primary outcomes:
measure: AUCISEC(0-10min)
timeFrame: Within 0 to 10 min after iv glucose challenge
Secondary outcomes:
Other outcomes:
Locations:
city: Bochum
country: Germany
facility: St. Josef-Hospital, University Hospital, Ruhr
city: Neuss
country: Germany
facility: Profil Institut für Stoffwechselforschung GmbH
Study officials:
References: