louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04053036: Effects of Drugs on Responses to Brain and Emotional Processes
Official title: Effects of MDMA on Responses to Affective Touch in Individuals With a Range of Autistic Traits
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Autism Spectrum Disorder
Healthy
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2019-08-12
Enrollment: 22
Sex: ALL
Minimum age (years): 21
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: To study the effects of a psychostimulant on responses to affective touch in individuals with a range of autistic traits


Eligibility criteria: Inclusion Criteria:

* BMI between 19 and 30 (no one under 130 lbs)
* Smokers smoking less than 25 cigarettes per week
* Have used ecstasy no more than 40 times with no adverse responses.

Exclusion Criteria:

* High blood pressure
* Any medical condition requiring regular medication
* Individuals with a current (within the last year) DSM-IV Axis 1 diagnosis
* Individuals with a history of dependence on stimulant drugs.
* Women who are pregnant or trying to become pregnant

Primary outcomes:
measure: Change in Responses to Affective Touch
timeFrame: 1.5 hrs after drug or placebo administration.
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
Study officials:
affiliation: Principal Investigator
name: Harriet de Wit
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00227136: Effect of Oral 5-HTP Intake on Urinary 5-HIAA Excretion
Official title: Effect of Oral 5-HTP Intake on Urinary 5-HIAA Excretion
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Carcinoid Tumors
Neuroendocrine Tumors
Keywords: 5Hydroxytryptamine
Chromogranin A
5HIAA
carcinoid
Lead sponsor: Western University, Canada
Sponsor class: OTHER
First posted: 2005-09-27
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: This is a research study looking at the effect of 5-Hydroxy Tryptophan (5-HTP) on urine excretion of 5-Hydroxyindolacetic acid (5-HIAA). 5-HTP is a common over the counter product that is sold in natural food stores and via the Internet. Increased levels of 5-HIAA in the urine can be found in a specific type of cancer, called carcinoid tumor. This study will examine the effect of oral 5-HTP intake on 5-HIAA excretion. Understanding this effect may help to determine which tests should be done in a patient with increased 5-HIAA excretion who's also taking 5-HTP.

Detailed description: 5-HTP is a common over the counter product that is sold in natural food stores and via the Internet. It is claimed to improve sleep problems, depression, anxiety, compulsive disorders, restless leg syndrome, migraines, fibromyalgia, and low pain threshold.Increased levels of 5-HIAA in the urine can be a of a specific type of cancer, called carcinoid tumor. Urinary 5-HIAA levels can also be increased by a number of food products and drugs. Oral 5-HTP is not known as a cause of elevation of 5-HIAA in urine. However, recent information suggests that 5-HTP may cause an increase.

In this study we examine the effect of oral 5-HTP intake (100 mg at bedtime for 10 days) on 5-HIAA excretion in the urine, following a prospective, double-blind placebo-controlled study design.

Understanding this effect may help to determine which tests should be done in a patient with increased 5-HIAA excretion who's also taking 5-HTP.

Eligibility criteria: Inclusion Criteria:

* 18 years and older
* in good health

Exclusion Criteria:

* Pregnancy
* Intake of drugs that affect 5-HIAA excretion in urine
* Anti-depressants
* Participation in other studies

Primary outcomes:
measure: Urinary excretion of 5-HIAA
measure: Plasma Chromogranin A
Secondary outcomes:
measure: Side effects
Other outcomes:
Locations:
city: London
country: Canada
facility: St. Joseph's Health Care
state: Ontario
Study officials:
affiliation: Western University, Canada
name: Stan HM Van Uum, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04752436: Supra High-intensity Interval Training for Police Officers
Official title: Supra High-intensity Interval Training for Austin Police Officers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Fitness
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
First posted: 2021-02-12
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Police work is extreme in terms of the physical activity and physical exertion spectrum as it is composed of a mixture of enforced sitting and sudden physical exertion. Police officers remain sitting for the majority of their working hours. In theory, regular physical activity exerts a number of health and fitness benefits that could act on most issues that police officers suffer from. Supra high-intensity interval training (supra HIIT) appears to be a perfect solution for police officers as the training modality can be accomplished in less than 5 minutes. The primary purpose of this proposal is to create and assess supra HIIT program that is suitable for police officers and then to assess feasibility of such exercise program in a small pilot study.


Eligibility criteria: Inclusion Criteria:

• Police officers in the local Police Department who are capable of performing physical exercise

Exclusion Criteria:

* Being pregnant
* Having had a recent illness
* History of diabetes, heart disease, or other cardiovascular problems
* Recent surgery, orthopedic, or musculoskeletal injuries

Primary outcomes:
measure: Aerobic power
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Austin
country: United States
facility: University of Texas at Austin
state: Texas
Study officials:
References:
Clinical trial NCT05795036: Using a mHealth Intervention to Promote Physical Activity in Phase III Cardiac Rehabilitation Clients
Official title: Using a mHealth Intervention to Promote Physical Activity in Phase III Cardiac Rehabilitation Clients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cardiac Rehabilitation
Physical Activity
Lead sponsor: AdventHealth University
Sponsor class: OTHER
First posted: 2023-04-03
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: In this study, the investigators will implement a pilot project of using activity tracker (i.e., Fitbit) with phase III CR clients. The study will record the participants' daily steps and sleep patterns for 8 consecutive weeks in natural settings. Two specific aims are identified for this project:

1. Develop an intervention protocol using mHealth to promote Phase III CR clients' self-monitoring of PA.
2. Examine the efficacy of the intervention on clients' PA, sleep patterns, functional capacity and QoL.

Detailed description: In this study, the investigators will implement a pilot project of using activity tracker (i.e., Fitbit) with phase III CR clients. The study will record the clients' daily steps and sleep patterns for 8 consecutive weeks in natural settings. Two specific aims are identified for this project:

1. Develop an intervention protocol using mHealth to promote Phase III CR clients' self-monitoring of PA.
2. Examine the efficacy of the intervention on clients' PA, sleep patterns, functional capacity and QoL.

Eligibility criteria: Inclusion Criteria:

* currently receiving Phase III CR at Hope Clinic
* are 18 years of age or older
* can read and communicate in English
* able to follow instructions to walk
* provided signed informed consent
* willing to wear Fitbit throughout the study
* owns a smartphone with text messaging capability (participants need to decide ahead of time if they have a phone plan that is compatible with taking additional text messages without undue financial burden for themselves)
* willing to receive text messages and phone calls from the research team.

Exclusion Criteria:

* are pregnant or lactating
* have scheduled surgery or traveling within the next 8 weeks
* currently participating in other health promotion program
* sufficiently or overly active, as determined by a physical activity monitor worn for one week, indicating averaging ≥ 7,500 steps per day ("somewhat overly active").

Primary outcomes:
measure: Clients' demographic information will be obtained using a paper questionnaire administered at screening phase
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Orlando
country: United States
facility: AdventHealth University
state: Florida
Study officials:
References:
Clinical trial NCT06772636: Effect of Music in Reducing Pain and Anxiety During Hysterosalpingography in Women With Primary Infertility
Official title: Effect of Music in Reducing Pain and Anxiety During Hysterosalpingography in Women With Primary Infertility: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pain
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-01-13
Enrollment: 110
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study aims to demonstrate the value of music in lowering pain and anxiety during hysterosalpingography in women with primary infertility

Detailed description: This study aims to demonstrate the value of music in lowering pain and anxiety during hysterosalpingography in women with primary infertility

Eligibility criteria: Inclusion Criteria:

* Women aged 18-45 years. Diagnosed with primary infertility (no prior pregnancy after at least 12 months of unprotected intercourse) and scheduled for HSG as part of infertility evaluation.

Exclusion Criteria:

* Using analgesics before or after the procedure, using antidepressants or sedative medications, being allergic to radio-opaque material, Current pregnancy or suspicion of pregnancy.Active pelvic inflammatory disease or history of severe pelvic infections within the last 6 months.

Primary outcomes:
measure: Intensity of pain
timeFrame: 10 minutes
Secondary outcomes:
measure: anxiety during procedure
timeFrame: 10 minutes
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05865236: Comparative Effect of Air Heat Versus Infra Red Heat on Pain and Wound Healling After Vaginal Delivery Episiotomy
Official title: Comparative Effect of Air Heat Versus Infra Red Heat on Pain and Wound Healling After Episiotomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Episiotomy Wound
Keywords: Air Heat
Infrared Heat
Episiotomy
Kegel Exercises
Pain Relief
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2023-05-18
Enrollment: 32
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To become "mother" is a beautiful gift given by God to woman. Giving birth is a powerful and life changing even with a lasting impact on women and their families. Pregnancy and labor are exceptional occasions in women's lives. Post-delivery is very decisive period for compassionate woman who had under gone episiotomy which is a throbbing and disquiet procedure during this time. Episiotomy wound healing takes weeks to years depending on health conditions and treatment of the perineum itself. Episiotomy care is very essential, if neglected it can lead to severe complications like infection, wound gapping.


Eligibility criteria: Inclusion Criteria:

* Primiparous women
* Postnatal mothers delivered within 12-24hours.
* Have a normal vaginal delivery with episiotomy
* fand Second degree episiotomy.

Exclusion Criteria:

* Instrumental Delivery ( Forceps/ventous)
* Lower segment Cesarian section
* History of medical problem as hypertension and diabetes or anemia
* Perineal tear
* Infected wound
* Twin pregnancy

Primary outcomes:
measure: REEDA Scale
timeFrame: 4 weeks
Secondary outcomes:
measure: NPRS Numerical Pain Rating Scale
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Lady Willington
state: Punjab
Study officials:
affiliation: Riphah International University
name: mariya tariq, ms-whpt
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03523936: Gut Microbiota and Antibiotics - Prevention of Side Effects by New Prebiotics
Official title: Gut Microbiota and Antibiotics - Prevention of Side Effects by New Prebiotics
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Changes in the Gut Microbiota During an Antibiotic Treatment
Keywords: antibiotics, prebiotics, dysbiosis
Lead sponsor: Turku University Hospital
Sponsor class: OTHER_GOV
Collaborators: name: VTT Technical Research Centre of Finland
First posted: 2018-05-14
Enrollment: 30
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double blind placebo controlled trial
Primary purpose: PREVENTION

Brief summary: Antibiotics disturb the balance of gut microbiota causing dysbiosis. The purpose of this double-blind placebo controlled intervention study is to investigate whether a new prebiotic product could prevent the side effects of antibiotics.

Detailed description: Thirty children (2-6 years of age), who require antibiotic treatment assessed by a doctor, will be enrolled in the study. The children will be randomized to receive either the prebiotic product or placebo during the course of antibiotic treatment.

The children will give a faecal sample in the beginning and at the end of the study. The samples will be used for the analysis of microbiota and differences in the microbiota between the groups.

Eligibility criteria: Inclusion Criteria:

* An infection requiring antibiotic treatment assessed by a doctor

Exclusion Criteria:

* Coaeliac disease or allergy to cereals, use of other prebiotic/probiotic product during the study

Primary outcomes:
measure: Changes of gut microbiota during antibiotic treatment
timeFrame: One week
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03237936: Effect of IKERVIS® Eye Drops Once Daily on the Quality of Vision in Dry Eye Disease Patients With Severe Keratitis
Official title: A Phase IV, Prospective, Open-label, Multicentre, Single Arm, 3-month Proof of Concept Study to Assess the Effect of IKERVIS® Eye Drops Administered Once Daily on the Quality of Vision in Dry Eye Disease (DED) Patients With Severe Keratitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Keratitis
Lead sponsor: Santen SAS
Sponsor class: INDUSTRY
First posted: 2017-08-03
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The proposed 3-month study is a prospective, open-label, multicentre, phase IV, proof of concept study. The study is designed to assess the effect on the quality of vision of IKERVIS® (1mg/mL ciclosporin) eye drops administered once daily in dry eye disease (DED) patients with severe keratitis, as well as its safety and efficacy.

Detailed description: In this phase IV clinical trial the Month 3 visit assessments will be used to assess the efficacy (quality of vision and other parameters) and safety of IKERVIS® in DED patients with severe keratitis.

To assess the effect on the quality of vision of IKERVIS® (1mg/ml ciclosporin) eye drops administered once daily in adult dry eye disease (DED) patients with severe keratitis over 3 months of treatment.

To assess the safety of DED patients with severe keratitis treated with IKERVIS® (1mg/mL ciclosporin) for 3 months.

Eligibility criteria: Inclusion Criteria:

* Patient eligibility is determined according to the following criteria:

  1. In the opinion of the investigator, the patient is capable of understanding and complying with protocol requirements.
  2. The patient signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures
  3. Male or female patient is aged 18 years or above.
  4. DED patients with persistent severe keratitis at the Screening and

     Baseline Visits defined as the following:

     • CFS score of 3, 4 or 5 on the modified Oxford scale
  5. Patient must be willing and able to undergo and return for scheduled study-related examinations.
  6. The same eye (eligible eye) should fulfill all the above criteria.

Exclusion Criteria:

* Patients with history of ocular trauma or ocular infection (viral, bacterial, fungal, protozoal) within 90 days before the Screening Visit and any ocular diseases other than dry eye disease requiring topical ocular treatment during the course of the study.

Primary outcomes:
measure: Correlation Between the Change From Baseline in VMR Measured With FVA System at Month 3 and the Change From Baseline in the CFS at Month 3.
timeFrame: at month 3
Secondary outcomes:
Other outcomes:
Locations:
city: Brest
country: France
facility: CHU de Brest
Study officials:
affiliation: CHU Bretonneau
name: Pierre-Jean PISELLA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01284036: A Single Dose Study Of The Safety And Investigational Product Level Measurement In Healthy Subjects
Official title: Ascending Single Dose Study Of The Safety, Tolerability, And Pharmacokinetics Of PF-05230905 Administered Subcutaneously Or Intravenously To Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Healthy subject
safety
PK study
healthy volunteers
Lead sponsor: Ablynx, a Sanofi company
Sponsor class: INDUSTRY
First posted: 2011-01-26
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The purpose of this study is to find the safety and side effects of investigational drug in healthy volunteers. See how quickly investigational drug enters the bloodstream, is distributed in the body, broken down and removed in healthy male and female volunteers. See if your body makes antibodies to this investigational drug (how your immune system responds).

Detailed description: First in human study to collect safety and pharmacokinetics (PK) of single ascending dose in Healthy subjects

Eligibility criteria: Inclusion Criteria:

* Healthy male and/or female subjects between the ages of 18 and 55 years.
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs).

Exclusion Criteria:

* Treatment with an investigational drug within 30 days (or as determined by the local requirement, whichever is longer) or 5 half-lives preceding the first dose of study medication.
* Receipt or treatment with an investigational or marketed biologic drug.
* blood donation of approximately 1 pint (500 mL) within 56 days prior to dosing.

Primary outcomes:
measure: Safety endpoints will be evaluated by comparing reported adverse events in subjects receiving PF-05230905 versus subjects receiving placebo.
timeFrame: day 168
measure: Incidence and severity of clinical laboratories including absolute hepatic transaminases and bilirubin levels will be evaluated.
timeFrame: day 168
measure: Mean change from baseline in vital signs measurements. Mean change from baseline in 12 lead echocardiogram (ECG) will be compared to ensure safety of the subjects.
timeFrame: day 168
Secondary outcomes:
measure: Incidence of development of Anti Drug Antibody.
timeFrame: day 168
measure: Serum PF-05230905 concentrations will be determined by a validated assay, and noncompartmental pharmacokinetics (PK) parameters.
timeFrame: day 168
measure: Urine pharmacokinetics (PK) parameters amount excreted in urine (Ae) and renal clearance will be determined.
timeFrame: day 168
Other outcomes:
Locations:
city: Tacoma
country: United States
facility: Investigational Site
state: Washington
Study officials:
affiliation: Ablynx, a Sanofi company
name: Josefin-Beate Holz, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04392336: Tracking and Improving Trust/Respect
Official title: Development and Validation of a Feedback System for Tracking and Improving Trust/Respect in an Economically Disadvantaged Behavioral Health Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Impact of Feedback on Symptoms and Trust/Respect on Outcomes
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Merakey Behavioral Health
First posted: 2020-05-18
Enrollment: 185
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study will examine the efficacy of a feedback system for providers that tracks patient trust/respect on an ongoing basis and to test the hypothesis that receiving feedback on trust/respect will lead to improvements in patient satisfaction, functioning, symptoms, and trust/respect.

.

Detailed description: This is a randomized effectiveness trial in which real-world providers will be given feedback on patient trust/respect. Approximately 40 clinicians, and up to 180 consumers will be enlisted participate in the randomized effectiveness trial. All enrolled patients will complete the BASIS-24, the Satisfaction with Care scale, and the Satisfaction with Social Roles and Activities Scale on handheld tablets or desktop computers at baseline. Patients will be randomized to one of two conditions. Patients in the first condition will attend therapy with clinicians who have received a standard automated outcome report, plus a report that contains information on the patient's trust/respect with suggestions for interventions if low/declining trust/respect is apparent. Patients in the second condition will attend therapy and complete the same measures as patients in the first condition, but their therapists will only receive a standard automated outcome report, without any patient information on trust/respect. At the time of the first therapy appointment and for all remaining therapy appointments, patients will complete four total measures: the new measure of trust/respect, the BASIS-24, the Satisfaction with Care scale, and the Satisfaction with Social Roles and Activities scale.

Eligibility criteria: Inclusion Criteria:

* Ability to read at least at the 4th grade level
* 18 years of age and older
* Willingness to participate in research.

Exclusion Criteria:

* N/A

Primary outcomes:
measure: Change in PROMIS SF v2.0 scores
timeFrame: Up to 12 sessions, an average of 3 months
Secondary outcomes:
measure: Change in BASIS-24 scores
timeFrame: Up to 12 sessions, an average of 3 months
measure: Change in Opinions about My Doctor/Therapist scores
timeFrame: Up to 12 sessions, an average of 3 months
measure: Change in Satisfaction with Care scores
timeFrame: Up to 12 sessions, an 3 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
References: