louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00010478: Acupuncture and Hypertension
Official title: Acupuncture and Hypertension-Efficacy and Mechanisms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Lead sponsor: National Center for Complementary and Integrative Health (NCCIH)
Sponsor class: NIH
First posted: 2001-02-05
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: Although traditional Chinese medicine advocates the use of acupuncture not only to induce analgesia but also to treat essential hypertension, acupuncture's postulated antihypertensive efficacy in humans has not been subjected to rigorous Western scientific testing. Before advocating acupuncture as an effective complementary/alternative medicine strategy for essential hypertension, it is necessary to demonstrate that the beneficial effects of acupuncture are scientifically robust, long-lasting, and explicable in terms of modern scientific mechanisms. In spontaneously hypertensive rats, acupuncture-like electrical stimulation of thinly myelinated (Group III) somatic afferents activates central endorphin (naloxone-sensitive) pathways that elicit long-lasting decreases in sympathetic nerve activity (SNA) and blood pressure. The ability to record SNA with microelectrodes in conscious humans provides a new opportunity to test this novel mechanistic hypothesis in patients undergoing electroacupuncture, a modification of the ancient technique that provides a quantifiable and reproducible stimulus to human skeletal muscle afferents. Using a randomized, double-blind placebo-controlled design, we will test the following major hypotheses: Electroacupuncture produces a long-lasting reduction in SNA, thereby providing a safe and effective complementary treatment of human hypertension. Given the enormous interest in acupuncture by our lay public, but the paucity of Western scientific data about its efficacy in cardiovascular disorders, our studies in normotensive and hypertensive humans should provide a conceptual framework for deciding whether to accept or reject the large body of Chinese (and Russian) literature advocating acupuncture as a safe and effective treatment of essential hypertension and other cardiovascular disorders (such as heart failure, and myocardial ischemia).


Eligibility criteria: Inclusion Criteria:

* Patients with normal blood pressures or blood pressures over 120/80 up to 165/105

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: UT Southwestern
state: Texas
Study officials:
References:
Clinical trial NCT01891578: Evaluation of Immunological Reconstitution After Haploidentical Bone Marrow Transplantation
Official title: Evaluation of Immunological Reconstitution After Haploidentical Bone Marrow Transplantation Using a Nonmyeloablative Preparative Regimen and Post-transplant Cyclophosphamide, in Patients With Poor Prognosis Lymphomas
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lymphoma
Lead sponsor: Istituto Clinico Humanitas
Sponsor class: OTHER
First posted: 2013-07-03
Enrollment: 23
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: Patients with lymphoma (any histology)

Brief summary: Evaluation of immunological reconstitution after haploidentical BMT using a nonmyeloablative preparative regimen and post-transplant cyclophosphamide in patients with poor prognosis lymphoma


Eligibility criteria: Inclusion Criteria:

* Patients with lymphoma (any histology) relapsed after high dose chemotherapy and in partial remission, complete remission or stable disease after the last CT line that
* Signed informed consent to perform an haploidentical allo-BMT using a nonmyeloablative preparative regimen and post-transplant cyclophosphamide

Exclusion Criteria:

none

Primary outcomes:
measure: Evaluation of T lymphocytes and NK cells absolute number
timeFrame: 1 year
Secondary outcomes:
measure: Evaluation of discrete T-cells populations
timeFrame: 1 year
measure: Evaluation of antigen-specific T cell populations
timeFrame: 1 year
measure: Evaluation of antigen-specific T lymphocyte's functionality
timeFrame: 1 year
measure: Evaluation of cytokines production by IL-2 and anti-CD16 activated NK cells
timeFrame: 1 year
Other outcomes:
Locations:
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
state: MI
Study officials:
affiliation: Istituto Clinico Humanitas
name: Armando Santoro, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01645878: Effect of Education on Breast Feeding on Primiparous Women
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Breastfeeding
Keywords: Primiparous Mothers
self-efficacy,
hands off,
hands on ,
social cognitive theory
Lead sponsor: Mashhad University of Medical Sciences
Sponsor class: OTHER
First posted: 2012-07-20
Enrollment: 136
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Exclusive breastfeeding is very important for an infant's growth and development. Self-efficacy is a modifiable psychological variable in sustained breastfeeding that is defined as a mother's confidence in her perceived ability about successful exclusive breastfeeding. Self- efficacy beliefs function as an important set of human motivation , affect , and action which operate on action, through motivation, cognitive and affective interventing process. teaching strategies ,based on Bandura,s self-efficacy theory and adult learning principles were incorporated in this research design. In regards with the importance of education in increasing breastfeeding self-efficacy and exclusive breastfeeding, the current study was conducted in order to compare of the effectiveness of two educational methods, i.e., "Hands on" and" Hands off" on breastfeeding self-efficacy in primiparous mothers.

In the present clinical trial, 136 nursing mother were randomly assigned to one of the three groups. Participants in the experimental groups received one of the structured one-on-one educational sessions (i.e., hands off or hands on) within the first two hours of giving birth. Mothers in control group received usual postpartum care. Follow-up assessments were conducted one, four, and eight weeks after the birth. Data collection was done through interview forms, examination and observation, checklist of breastfeeding status, breastfeeding self-efficacy and daily-feeding form.


Eligibility criteria: Inclusion Criteria:

vaginal normal delivery normal neonate lack of maternal- neonatal lactation problems contact number satisfying in participation in study

Exclusion criteria would not like to continue used tranquilizers or experienced stressful events

Primary outcomes:
measure: Breast feeding self-efficacy
timeFrame: up to 2 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06995378: Patient-centered Precision Medicine Lab Result Communication for Older Adults
Official title: Patient-Centered Lab Result Communication Tool for Older Adults With Elevated Hemoglobin A1c (A1c) or Chronic Kidney Disease (CKD)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Kidney Disease, Chronic
Keywords: lab result
lab result communication tool
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2025-05-29
Enrollment: 5
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: For adults \>65 years and their providers, the investigators will test the usability and design of a tool to replace standard uniform reporting of lab results to patients and their providers with a new personalized EHR lab result communication tool that: 1) extracts patient-level data from the EHR; 2) calculates individual risk; and 3) for patients with very low risk, communicates the individualized risk information. The investigators will employ a range of user experience research methods to understand how patient and provider users interact with the new lab result communication tool and to assess their comprehension of the lab results.


Eligibility criteria: Inclusion Criteria:

Patient Inclusion Criteria: Older adults (aged \>65 years) with a UCLA primary care provider who are:

* Enrolled in the patient portal;
* English-speaking (as the language of the tool is currently only in English, and it would be impractical to have validated translations created for all of the potential variations and derivatives of the tool mock-ups); and
* Without dementia or other neurocognitive disease.

Provider Inclusion Criteria:

-UCLA Health providers who care for large numbers of older adults in outpatient settings.

Exclusion Criteria:

Patient Exclusion Criteria:

* Have lab results outside of the defined inclusion ranges;
* Do not have a UCLA PCP;
* Are under the age of 65;
* Are not English speaking (as the tool prototypes are only in English until final verbiage is determined);
* Are not enrolled in the UCLA MyChart patient portal; or
* Are diagnosed with dementia

Provider Exclusion Criteria:

-Do not care for large numbers of older adults in outpatient settings

Primary outcomes:
measure: Change in self-reported anxiety about lab results after using the personalized tool
timeFrame: Immediately after the user experience session
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA Health System
state: California
Study officials:
References:
Clinical trial NCT04933578: Preferences About Personal Protective Equipment
Official title: Children and Parents' Preferences About the Appearance of Dentists With Respect to Personal Protective Equipment in Pediatric Dentistry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dental Anxiety
Behavior, Child
Preference, Patient
Keywords: Personal protective equipment
dental anxiety
parents
preferences
health care professionals
Lead sponsor: Recep Tayyip Erdogan University Training and Research Hospital
Sponsor class: OTHER
First posted: 2021-06-21
Enrollment: 500
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: children who presented for the first time to the Faculty of Dentistry in Rize and their parents

Brief summary: Personal protective equipment (PPE) gained importance during the Coronavirus Disease 2019 (COVID-19) pandemic, which is a global hot topic for all healthcare staff.

Detailed description: To assess children and parents preferences about dentists' appearance concerning their PPE and to determine the relationship between the preferences of the children and their parents.

A total of 250 children aged with 6-12 years and their parents were enrolled in the study. Standardised pictures with different sex, attire, eye protector, hair protector, mask and gloves were shown to children and their parents separately and asked to chose their preferences. Dental anxiety of children and their parents were determined with MCDASf and MDAS, respectively. Decayed-missing-filled teeth (DMFT) index was employed to the children.

Eligibility criteria: Inclusion Criteria:

* aged 6-12 years and their parents,
* intellectually sufficient to complete the questionnaire,
* with voluntariness to take part in the study

Exclusion Criteria:

* had mental or physical disorders, cooperation problems or dental pain

Primary outcomes:
measure: To assess children and parents preferences about dentists' appearance concerning their PPE and to determine the relationship between the preferences of the children and their parents according to dental anxiety levels.
timeFrame: for two months from the beginning of the study
Secondary outcomes:
Other outcomes:
Locations:
city: Rize
country: Turkey
facility: Sema Aydinoğlu
Study officials:
References:
Clinical trial NCT05617378: Exploring the Risk Factors for Colorectal Cancer in Our General Population Using Asian Pacific Screening Score: a Survey From Pakistan
Official title: Exploring the Risk Factors for Colorectal Cancer in Our General Population Using Asian Pacific Screening Score: a Survey From Pakistan
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Colorectal Neoplasms
Keywords: colorectal carcinoma
Pakistan
Lead sponsor: Sindh Institute of Urology and Transplantation
Sponsor class: OTHER
First posted: 2022-11-15
Enrollment: 558
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: attendants to the patients visiting outpatient department or admitted in hospital.

Brief summary: In Pakistan, due to the lack of a National based cancer registry exact number of CRC cases is unknown. However, minimal data that is present in literature shows an increase in CRC cases with a concerning increase in incidence in younger age groups11. This makes it pertinent to understand current pattern of CRC and its risk factors from a local perspective. This will direct future strategies in an attempt to reduce the incidence and mortality associated with CRC in our general population.


Eligibility criteria: Inclusion Criteria:

* Individuals visiting SIUT as attendants to the patients visiting outpatient department or admitted in hospital.

Exclusion Criteria:

* Attendants / whose patients visit GI, colon and oncology OPD outpatient department or admitted in GI wards.

Primary outcomes:
measure: Risk factor
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Sindh Institute of Urology and Transplantation
state: Sindh
Study officials:
affiliation: Sindh Institute of Urology and Transplantation
name: Muhammad Shadab Khan
role: PRINCIPAL_INVESTIGATOR
affiliation: Sindh Institute of Urology and Transplantation
name: Bushra Shirazi
role: STUDY_CHAIR
affiliation: Sindh Institute of Urology and Transplantation
name: Muhammad Arsalan Khan
role: STUDY_CHAIR
References:
Clinical trial NCT03799978: A Clinical Study to Investigate the Food Effect on the Pharmacokinetics of ACT-541468 in Healthy Male Subjects
Official title: A Single-center, Open-label, Randomized, Two Way Crossover Study to Investigate the Food Effect on the Pharmacokinetics of ACT-541468 in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Idorsia Pharmaceuticals Ltd.
Sponsor class: INDUSTRY
First posted: 2019-01-10
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Two way crossover
Primary purpose: OTHER

Brief summary: This is a single-center, open-label, randomized, two way crossover study to investigate the food effect on the pharmacokinetics of ACT-541468 in healthy male subjects.


Eligibility criteria: Inclusion Criteria:

* Signed informed consent prior to any study-mandated procedure
* Healthy male subjects aged between 18 and 45 years (inclusive) at Screening
* Body mass index (BMI) of 18.0 to 28.0 kg/m2 (inclusive) at Screening
* No clinically relevant findings on the physical examination at Screening

Exclusion Criteria:

* History of major medical or surgical disorders, which, in the opinion of the investigator, are likely to interfere with the absorption, distribution, metabolism, or excretion of the study treatments (appendectomy and herniotomy allowed, cholecystectomy not allowed)
* Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol
* Modified Swiss Narcolepsy Scale total score \< 0 at screening or history of narcolepsy or cataplexy

Primary outcomes:
measure: Pharmacokinetic endpoint: AUC0-24
timeFrame: Multiple timepoints; duration: up to 48 hours in each treatment period
Secondary outcomes:
Other outcomes:
measure: Pharmacokinetic endpoint: AUC0-inf
timeFrame: Multiple timepoints; duration: up to 48 hours in each treatment period
measure: Pharmacokinetic endpoint: Cmax
timeFrame: Multiple timepoints; duration: up to 48 hours in each treatment period
measure: Pharmacokinetic endpoint: tmax
timeFrame: Multiple timepoints; duration: up to 48 hours in each treatment period
measure: Pharmacokinetic endpoint: t½
timeFrame: Multiple timepoints; duration: up to 48 hours in each treatment period
measure: Treatment-emergent adverse events
timeFrame: From study treatment administration up to EOT; duration: up to 48 hours in each treatment period
measure: Serious treatment-emergent adverse events
timeFrame: From study treatment administration up to EOT; duration: up to 48 hours in each treatment period
Locations:
city: Pilsen
country: Czechia
facility: CEPHA s.r.o.
Study officials:
affiliation: Idorsia Pharmaceuticals Ltd.
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT00985478: First in Man Study With SLV342
Official title: A Double-blind, Randomized, Placebo-controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SLV342 in Young Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Pharmacokinetics
Keywords: First in Man
SLV342
Atherosclerosis
Lead sponsor: Abbott
Sponsor class: INDUSTRY
Collaborators: name: Quintiles, Inc.
First posted: 2009-09-28
Enrollment: 48
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: First in man study with single and multiple rising doses with SLV342


Eligibility criteria: Inclusion Criteria

* Healthy

Exclusion Criteria

* Not healthy

Primary outcomes:
measure: Safety and tolerability parameters: adverse event, vital signs, 12-Lead ECG, continuous lead II ECG monitoring, laboratory safety variables and physical examination
timeFrame: 28 Days
Secondary outcomes:
measure: Pharmacokinetic parameters: Plasma: Cmax, tmax, AUC, t½, λz, CL/F, and Vz/F. Urine: Aeurine, fe, and CLR
timeFrame: 28 days
measure: Pharmacodynamic parameters: biochemistry and 24 h Holter monitoring
timeFrame: 28 days
measure: Midazolam PK parameters
timeFrame: 24 hours
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Site Reference ID/Investigator# 61142
Study officials:
affiliation: Abbott Healthcare Products B.V
name: Ingrid Meuwsen, MS
role: STUDY_DIRECTOR
References:
Clinical trial NCT00000278: Disulfiram for Cocaine-Alcohol Abuse - 3
Official title: Disulfiram for Cocaine-Alcohol Abuse
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alcohol-Related Disorders
Cocaine-Related Disorders
Keywords: Cocaine-Related Disorders
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: VA Connecticut Healthcare System
First posted: 1999-09-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate disulfiram for cocaine-alcohol abuse.


Eligibility criteria: Please contact site for information.

Primary outcomes:
measure: Side effects
measure: Cocaine effects
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: VA Connecticut Healthcare System
state: Connecticut
Study officials:
affiliation: VA Connecticut Healthcare System
name: Thomas R Kosten, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Biol Psy. 37: 560-563, 1995. NIDA Research Monograph, 174:138, 1997. Ther Drug Monograph, 18:460-464, 1996.
Clinical trial NCT01965678: Epidemiological Study of Quality of Life in Osteopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Muscle Skeletal Disorders
Keywords: Osteopathic manipulative treatment
muscle-skeletal disorder
quality of life
Lead sponsor: European Institute for Evidence Based Osteopathic Medicine
Sponsor class: OTHER
First posted: 2013-10-18
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Aim of this study is to evaluate the effectiveness of osteopathy in changing quality of life in a large sample of naive patients undergoing osteopathic manipulative treatment.


Eligibility criteria: Inclusion Criteria:

* older than 18 years old
* affected by muscle-skeletal disorder

Exclusion Criteria:

* younger than 18 years old
* OMT undertaken during the last 12 months
* Any manual therapy received during the last 12 months

Primary outcomes:
measure: change from baseline in General Health score
timeFrame: baseline and 1 month
Secondary outcomes:
measure: change from baseline in Physical Component score
timeFrame: baseline and 1 month
measure: change from baseline in Mental Component score
timeFrame: baseline and 1 month
Other outcomes:
Locations:
city: Pescara
country: Italy
facility: Accademia Italiana Osteopatia Tradizionale
Study officials:
References:
citation: Cerritelli F, Verzella M, Barlafante G. Quality of life in patients referring to private osteopathic clinical practice: a prospective observational study. Complement Ther Med. 2014 Aug;22(4):625-31. doi: 10.1016/j.ctim.2014.05.007. Epub 2014 May 24.