louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05936255: Pilot Examination of a Telehealth, Cognitive-behavioral Therapy for Adolescents
Official title: Pilot Examination of a Telehealth, Cognitive-behavioral Therapy for Adolescents
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Suicide Prevention
Suicidal Ideation
Lead sponsor: Florida State University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2023-07-07
Enrollment: 5
Sex: ALL
Minimum age (years): 14
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This project is designed to refine a 6-week telehealth therapy intervention targeting negative interpersonal beliefs among community-dwelling youth with elevated levels of psychopathology. The study design is a single-arm open trial. The intervention is comprised of weekly teen and parent group cognitive-behavioral therapy, regular check-ins with the youths, and a module embedded throughout treatment that targets negative interpersonal beliefs (i.e., perceived social disconnection, burdensomeness). The goal of the study is to evaluate the feasibility of the treatment and assessment protocol, refine the intervention based on qualitative feedback, and evaluate changes in negative interpersonal beliefs. Youths complete two qualitative interviews about their interpersonal relationships and their feedback about the intervention.


Eligibility criteria: Inclusion Criteria:

* 14-17 years of age
* endorsement of perceived burdensomeness (score of greater than 3 on the Interpersonal Needs Questionnaire)
* emotional/behavioral problems broadly defined (Pediatric Symptom Checklist score greater than 14)
* The family being under-resourced (i.e., family is below the US census poverty line; family is receiving economic or medical government aid; child is receiving reduced fee lunch; or primary caregiver is currently unemployed) or living in an under-resourced community (i.e., majority of households in the family's census block lives under the poverty line).

Exclusion Criteria:

* Current need for acute psychiatric care (e.g., inpatient hospitalization)
* autism spectrum disorder
* psychosis
* other condition(s) related to pronounced cognitive impairment (i.e., marked impairment that precludes completion of questionnaires, verbal communication)
* Wards of the state

Primary outcomes:
measure: Qualitative interview on acceptability
timeFrame: Posttreatment assessment (week 6)
measure: Interpersonal needs questionnaire
timeFrame: Pretreatment (baseline) and week 6
Secondary outcomes:
Other outcomes:
Locations:
city: Tallahassee
country: United States
facility: Florida State University
state: Florida
Study officials:
affiliation: Florida State University
name: Victor Buitron, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01460355: Comparison of Two Treatments for Strabismus Correction: Botulinum Toxin A Associated to Surgery and Surgery Alone
Official title: Surgery Associated to Intraoperative Botulinum Toxin A for Large Angle Horizontal Strabismus: a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Esotropia
Exotropia
Keywords: strabismus surgery
botulinum toxin
esotropia
exotropia
blepharoptosis
Lead sponsor: University of Campinas, Brazil
Sponsor class: OTHER
First posted: 2011-10-26
Enrollment: 23
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Two different treatments were given to large angle horizontal strabismus (eso and exotropia) adult patients who agree to participate of the study. Inform consents were required for participants. Group 1 (12 patients) received conventional recess-resect surgery plus intraoperative injection of botulinum toxin A (5U). Group 2 (11 patients) received only conventional recess-resect surgery. The patients were randomly located in one of the groups. The angles of horizontal deviation were compared between the groups before and six months after treatment.

Detailed description: Patients underwent recess/resection surgery on the non-fixating eye using conventional technique under local anesthesia. The extent of surgery was determined based on our usual amounts. Before re-attaching the recessed muscle to the sclera, 5 units of botulinum toxin in 0.1 ml of hyaline solution were, or 0.1 ml of hyaline solution alone were was injected into the posterior muscle belly by the surgeon who was unaware of the contents of each syringe.

Eligibility criteria: Inclusion Criteria:

* adults with large angle horizontal strabismus

Exclusion Criteria:

* oblique muscle disfunction
* previous strabismus surgery
* dissociated vertical deviation
* paretic or restrictive deviation

Primary outcomes:
measure: percentage of decrease of the initial angle of strabismus
timeFrame: 6 to 12 months
Secondary outcomes:
measure: frequency of induced blepharoptosis
timeFrame: From the first to the last post operative day of follow up
Other outcomes:
Locations:
city: Campinas
country: Brazil
facility: State University of Campinas
state: São Paulo
Study officials:
affiliation: University of Campinas, Brazil
name: Nilza Minguini, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Owens PL, Strominger MB, Rubin PA, Veronneau-Troutman S. Large-angle exotropia corrected by intraoperative botulinum toxin A and monocular recession resection surgery. J AAPOS. 1998 Jun;2(3):144-6. doi: 10.1016/s1091-8531(98)90004-0.
citation: Khan AO. Two horizontal rectus eye muscle surgery combined with botulinum toxin for the treatment of very large angle esotropia. A pilot study. Binocul Vis Strabismus Q. 2005;20(1):15-20.
citation: Ozkan SB, Topaloglu A, Aydin S. The role of botulinum toxin A in augmentation of the effect of recession and/or resection surgery. J AAPOS. 2006 Apr;10(2):124-7. doi: 10.1016/j.jaapos.2005.11.011.
Clinical trial NCT01737255: Magnetic Resonance Imaging Screening in Li Fraumeni Syndrome
Official title: Magnetic Resonance Imaging Screening In Li Fraumeni Syndrome: An Exploratory Whole Body MRI Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Li-Fraumeni Syndrome
Keywords: Li-Fraumeni Syndrome
Whole Body Magnetic Resonance Imaging
TP53
Psychological Impact
Lead sponsor: Institute of Cancer Research, United Kingdom
Sponsor class: OTHER
Collaborators: name: Cancer Research UK
name: National Institute for Health Research, United Kingdom
First posted: 2012-11-29
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The TP53 mutation carriers will be recruited from genetics clinics and through advertising.

The population controls will be recruited through advertising

Brief summary: This study is aimed at exploring the use of whole body MRI for early cancer detection in TP53 mutation carriers and population controls, with the hypothesis that more cancers will be detected in the TP53 mutation carrier group. A secondary end-point will be the number of incidental findings detected and subsequent investigations required. A series of questionnaires will be used to assess the psychological impact of screening on both the study and control group.


Eligibility criteria: Inclusion Criteria:

* Carrier of germline TP53 mutation which, in the view of the geneticist, is not known to be low penetrance OR non-related individual with no personal history of malignancy and no first degree relatives diagnosed with malignancy under the age of 50 years
* Please note, TP53 carrier cohort is complete and no longer open to recruitment
* Age between 18 and 60
* Able to give informed consent

Exclusion Criteria:

* Individual with low penetrance TP53 mutation
* Individual with TP53 variant of unknown significance.
* Previous malignancy diagnosed \< 5 years ago in TP53 carriers (except non-melanomatous skin cancer or cervical CIS) Previous history of malignancy in non-related controls (except non-melanomatous skin cancer or cervical CIS)
* Current symptoms suggestive of malignancy
* Contraindication to MRI (such as non-MR compatible metal implants) as specified by the standard MR safety checklist
* Claustrophobia
* ECOG performance status \>2

Primary outcomes:
measure: Diagnosis of malignant disease
timeFrame: Within 12 months of MRI scan
Secondary outcomes:
measure: Diagnosis of relevant non-malignant disease
timeFrame: 12 months following MRI scan
measure: Diagnosis of non-relevant disease, number and type of investigations required
timeFrame: 12 months following MRI
measure: Psychological impact of MRI screening
timeFrame: 12 months following MRI screening
Other outcomes:
Locations:
city: Sutton
country: United Kingdom
facility: Cancer Genetics Unit, Royal Marsden Hospital
state: Surrey
Study officials:
affiliation: Institute of Cancer Research, Surrey, UK
name: Rosalind Eeles, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05258955: Title: Comparison of Anti-plaque Efficacy of Natural Honey With Chlorhexidine Mouthwash: A Randomized Controlled Trial
Official title: Comparison of Anti-plaque Efficacy of Natural Honey With Chlorhexidine Mouthwash: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Dental Plaque
Keywords: Dental plaque, Honey, Chlorhexidine
Lead sponsor: Liaquat National Hospital & Medical College
Sponsor class: OTHER
Collaborators: name: Liaquat College of Medicine and Dentostry
First posted: 2022-02-28
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The participants divided into two groups. one group will received honey based oral rinses and other group received chlorhexidine mouthwash and will evaluate the reduction of dental plaque
Primary purpose: TREATMENT

Brief summary: The rationale of our study is to compare the efficacy of natural honey base preparation with other commercially available mouthwashes i.e chlorhexidine base in prevention of dental plaque formation as honey is readily available and cost effective and organic in nature. This study will help to provide the data of our community and positive result may provide a new method of oral hygiene maintenance with fewer side effects. We will be able to deliver the best anti-plaque agent.

Detailed description: In this study, participants will assigned into 2 group those who will fulfilled the inclusion and exclusion criteria. After the informed consent, they were divided into 2 group. Group A will received Chlorhexidine mouthwash and Group B will provided with honey based mouthwash. The participant will blinded as solution will be provided in dark color bottle to mask the study. After which the baseline plaque index will be taken followed by recording plaque index on 7th, 14th, and 21st day. The statistical analysis will be done to compare the mean difference between these 2 groups

Eligibility criteria: Inclusion Criteria:

1. Individual aged between 18-25
2. Retained 28 number of teeth excluding wisdom teeth

Exclusion Criteria:

1. Individual with medical illness affecting oral cavity like diabetes, sjögren syndrome, crohn disease etc
2. Multiple extraction , overhang restoration, wearing any appliance
3. Periodontal problem with pocket depth more than 3mm
4. Current or recent history of antibiotic consumption
5. Noncompliance that is unable to maintain their hygiene.
6. Pan, Betel quid and any other oral habit will not be included in study

Primary outcomes:
measure: Dental Plaque
timeFrame: reduction of plaque index will be assessed on 7th day, 14th day and on 21st day
Secondary outcomes:
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Liaquat College of Medicine and Dentistry
state: Sindh
Study officials:
affiliation: Registrar, Periodontology Liaquat College of Medicine and Dentistry
name: Muhammad Abid, BDS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00220155: Phase II Fixed Dose Rate Gemcitabine for Advanced or Metastatic Colorectal Cancer
Official title: A Phase II Trial of Fixed Dose Rate Gemcitabine in Patients With Advanced or Metastatic Colorectal Cancer.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Colorectal Cancer
Lead sponsor: Royal Marsden NHS Foundation Trust
Sponsor class: OTHER
First posted: 2005-09-22
Enrollment: 16
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: To assess the efficacy and safety of gemcitabine given by fixed dose rate intravenous infusion in patients with pretreated metastatic colorectal cancer.

Detailed description: Previous lines of treatment recorded. Adjuvant and palliative.

Treatment will continue until clinical indication due to PD or toxicity, or until completion of 6 cycles of gemcitabine, whichever comes first.

All patients will be assessed for toxicity and followed up for disease recurrence/progression.

The study will be divided into two accrual stages - the first consisting of 17 patients. If 6 or more patients achieve tumour response or stabilisation in the first stage, the second stage will commence accrual of a further 20 patients. Hence, the total planned accrual will be 37 patients.

Eligibility criteria: Inclusion Criteria:

* Age \>18 years
* Histologically proven colorectal adenocarcinoma.
* Locally advanced (inoperable) or metastatic colorectal carcinoma treated with at least one prior chemotherapy regimen.
* Progressive disease documented by CT either during or within 3 months of completion of previous chemotherapy
* No previous malignant disease other than non-melanotic skin cancer or carcinoma-in-situ of the uterine cervix.
* Unidimensional measurable disease as assessed by CT.
* Adequate bone marrow function; Hb \>10g/dl, platelets \>100 x109/l, WBC \>3x109/l, Neut \>1.5x109/l.
* Adequate liver function: Serum Bilirubin \<1.5 x upper limit of normal
* Adequate renal function: Serum Creatinine \< 0.11 mmol/L
* No concurrent uncontrolled medical conditions
* WHO performance status 0,1 or 2
* Adequate contraceptive precautions, if appropriate
* Informed written consent
* Negative pregnancy test in women of child bearing age
* Life expectancy \> 3 months

Exclusion Criteria:

* Medical or psychiatric condition that comprise the patient's ability to take informed consent.
* Patients within 4 weeks of chemotherapy or radiotherapy (6 weeks for nitrosureas or mitomycin C).
* Previous treatment with gemcitabine.
* Patients with uncontrolled cerebral metastases.

Primary outcomes:
measure: Proportion of patients obtaining disease control in the form of tumour response or stabilisation
Secondary outcomes:
measure: Treatment related toxicity
measure: Progression free survival
Other outcomes:
Locations:
city: Sutton
country: United Kingdom
facility: Royal Marsden Hospital
state: Surrey
Study officials:
affiliation: Royal Marsden NHS Foundation Trust
name: David Cunningham
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05421455: Surgery Versus Biologics for Stricturing CD--a RCT
Official title: Surgical Intervention Versus Biologics Treatment for Symptomatic Stricturing Crohn's Disease (SIBTC): an Open-label, Single-center, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Crohn Disease
Lead sponsor: Jinling Hospital, China
Sponsor class: OTHER
First posted: 2022-06-16
Enrollment: 138
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The management of stricturing Crohn's disease (CD) remains challenging. Although surgical resection may be the final way to solve it, the efficacy of biologics for symptomatic CD associated strictures was acceptable. In clinical practice, the chioce of treatment is particularly difficult. Therefore, a clinical trial of biologics versus surgery is needed to assess which one is prefered.


Eligibility criteria: Inclusion Criteria:

1. with intestinal obstructive symptoms;
2. confirmed intestinal strictures;
3. traditional drugs failed to induce remission;
4. envidence of active bowel inflammation;
5. inappropriate for EBD;
6. acquirement of written informed consent of participant;

Exclusion Criteria:

1. unsuccessful medical treatment of intestinal obstruction;
2. complete obstruction;
3. contraindication for biologics;
4. penetrating disease;
5. short smaal bowel;
6. suspicion of bowel tumor;
7. no confirmed strictures;
8. comitant severe disese of other system;
9. obstructive symptoms under over 2 targets of biologics;
10. successful treatment with traditional drugs;
11. participate other clinical research.

Primary outcomes:
measure: clinical remmision rate within 1 year
timeFrame: within 1 year
Secondary outcomes:
measure: inflammatory bowel disease score
timeFrame: within 1 and 5 year
measure: Crohn's disease obstructive score
timeFrame: within 1 and 5 year
measure: endoscopic recurrence
timeFrame: within 1 and 5 year
measure: medical cost
timeFrame: within 1 and 5 year
measure: sugical recurrence
timeFrame: within 1 and 5 year
measure: clinical remmision rate within 5 year
timeFrame: within 5 year
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Department of General Surgery, Jinling hosptal,Medical School of Nanjing University
state: Jiangsu
Study officials:
References:
Clinical trial NCT00185055: The Relative Effects of Olmesartan Medoxomil, Irbesartan and Valsartan on the Activity of the Blood Pressure Control System in Healthy Subjects
Official title: The Relative Effects of Single Doses of Olmesartan Medoxomil, Irbesartan and Valsartan at High Dosage Levels on the Renin-Angiotensin-Aldosterone System in Healthy Normal Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Healthy
Keywords: olmesartan
valsartan
irbesartan
renin-angiotensin-aldosterone system
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
First posted: 2005-09-16
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To assess the effects of 3 blood pressure drugs, called angiotensin receptor blockers, on the blood pressure control systems in healthy subjects.


Eligibility criteria: Inclusion Criteria:

* Men and women between the ages of 18 to 65
* In good health

Exclusion Criteria:

* Any serious health problems
* Positive test for HIV, Hepatitis B and C
* History of drug and alcohol abuse

Primary outcomes:
measure: To characterize the plasma renin activity (PRA) and urinary aldosterone response patterns to single doses of olmesartan medoxomil, irbesartan, and valsartan compared to placebo in normal volunteers.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04761055: Study of iBreast, a Handheld Device to Detect Breast Abnormalities During Screening Visits for Breast Cancer
Official title: Detection of Breast Lesions Utilizing iBreast Exam: A Comparison With Clinical Breast Exam
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Breast Screening
Keywords: Breast Abnormalities
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: UE LifeSciences Inc.
name: Earlier.org
First posted: 2021-02-18
Enrollment: 310
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study will test the iBreastExam device to find out whether it can detect a mass or lump in the breast as accurately as a routine breast cancer screening examination.

The iBreastExam is a handheld device that performs a painless electronic palpation (examination by touch) of the breast. The device is designed to detect breast abnormalities that may require breast imaging and additional clinical examination by a nurse or doctor. The iBreastExam device creates a color map of the breast, with red spots indicating areas that may be abnormal.


Eligibility criteria: Inclusion Criteria:

* Female patient
* Over 18 years of age, able to consent
* RLC patients presenting to RLC or BAIC for mammogram and CBE
* Asymptomatic and symptomatic patients will be included

Exclusion Criteria:

* Male patients
* Patients under 18 years of age, unable to consent
* Pregnant patients
* Lactating patients
* Non-intact skin

Primary outcomes:
measure: Compare the Outcomes of the iBE Examinations to Clinical Breast Examinations (CBE)by Estimating the Sensitivity of the Device Using Imaging Results
timeFrame: approximately one month after imaging scan
measure: Compare the Outcomes of the iBE Examinations to Clinical Breast Examinations by Estimating the Specificity of the Device Using Imaging Results
timeFrame: approximately one month after imaging scan
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: MSK at Ralph Lauren (All Protocol Activities)
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center (All Protocol Activities)
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Victoria Mango, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05719155: Pharmacokinetics and Safety/Tolerability of CKD-379
Official title: A Randomized, Open-label, Single Dose, 2-period, 2-treatment, Crossover Study to Compare the Pharmacokinetics and Safety/Tolerability of CKD-379 and Coadministration of D759, D745 and D150 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type II Diabetes Mellitus
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2023-02-08
Enrollment: 32
Sex: ALL
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A study to compare the pharmacokinetics and safety/tolerability between CKD-379 tablet and D759, D745, D150 combination

Detailed description: A randomized, open-label, single dose, 2-period, 2-treatment, crossover study to compare the pharmacokinetics and safety/tolerability of CKD-379 in healthy subjects under fed conditions

Eligibility criteria: Inclusion Criteria:

* Between 19 aged and 50 aged in healthy adult
* 50.0kg≤Body weight≤90.0kg and 18.0kg/m2≤body mass index(BMI)≤27.0kg/m2

Exclusion Criteria:

* Have clinical significant medical history or disease that hepatobiliary system, kidney, nervous system, immune system, respiratory system, digestive system, urinary system, endocrine system(Type I or Type II Diabetes Mellitus, diabetic ketoacidosis etc.), hematological system, cardiovascular system(heart failure, Torsades de pointes etc.), mental illness
* Have clinical significant medical history or disease that urinary tract infection or genital infection including urosepsis, pyelonephritis
* Have a gastrointestinal disease(Crohn's disease, ulcer etc.) history that can effect drug absorption or surgery
* Those who are pregnant or breastfeeding
* Those who are deemed inappropriate to participate in clinical trial by investigators

Primary outcomes:
measure: Cmax
timeFrame: 0~48hours
measure: AUClast
timeFrame: 0~48hours
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: Jongno-gu
Study officials:
affiliation: Seoul National University Hospital
name: Jaeseong Oh, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: