louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05225519: Effects of Far Infrared Radiation on Fibromyalgia Patients
Official title: Effects of Far Infrared Radiation on Fibromyalgia Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Lead sponsor: Clinical Academic Center (2CA-Braga)
Sponsor class: OTHER
First posted: 2022-02-04
Enrollment: 16
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aimed to evaluate the effectiveness of infrared radiation in improving the various symptoms of fibromyalgia syndrome, by using a long-sleeved white shirt impregnated with a long-infrared irradiating bioceramic, as well as the adherence to it and its applicability in daily routines.

A prospective, experimental, randomized, and double-blind study was carried. The study was implemented over 7 months, with a total of 5 visits for each patient. Participants were randomly allocated in experimental or control group. Those included in the experimental group received a shirt impregnated with ceramic emitting long infrared waves while participants in the placebo group received an exactly looking shirt, but not impregnated with ceramic emitting long infrared waves. Each visit comprised clinical evaluation and self-report scales filling (WPS, SS and FIQR scales).


Eligibility criteria: Inclusion Criteria:

* age superior to 18 years-old
* ability to freely sign the informed consent form
* generalized pain index scores (WPI ≥ 7 and SS score ≥ 5, or WPI ≥ 3 and ≤ 6 with SS ≥ 9, presence of abdominal pain and / or with depression and / or headache, in the last 6 months, at the screening consultation).

Exclusion Criteria:

* dermatological diseases
* Other rheumatic and /or autoimmune diseases

Primary outcomes:
measure: WPI
timeFrame: Change between baseline and after 4, 8 and 12 weeks of wearing the shirt.
measure: SS
timeFrame: Change between baseline and after 4, 8 and 12 weeks of wearing the shirt.
Secondary outcomes:
measure: FIQR
timeFrame: Change between baseline and after 4, 8 and 12 weeks of wearing the shirt.
measure: Tender Points
timeFrame: Change between baseline and after 4, 8 and 12 weeks of wearing the shirt.
measure: EQ-5D
timeFrame: Change between baseline and after 4, 8 and 12 weeks of wearing the shirt.
Other outcomes:
Locations:
city: Braga
country: Portugal
facility: 2CA-Braga
Study officials:
References:
Clinical trial NCT06452719: Letrozole and Misoprostol for Early Pregnancy Loss Management
Official title: Letrozole and Misoprostol for Early Pregnancy Loss Management: A Prospective Pilot Cohort Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Early Pregnancy Loss
Miscarriage in First Trimester
Miscarriage
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2024-06-11
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A pilot cohort study to preliminarily investigate the efficacy of pretreatment with letrozole 10 mg daily for three consecutive days followed by treatment with misoprostol 800 mcg vaginally for medical management of early pregnancy loss in a US population. Patients will be followed to assess efficacy of this treatment regimen, as well as additional interventions needed, side effects, adverse events, and patient acceptability.


Eligibility criteria: Inclusion Criteria:

* Able to participate in the informed consent process and provide a signed and dated consent form
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Access to working mobile phone
* English-speaking
* Age 18 years or older
* Confirmed diagnosis of intrauterine embryonic/fetal demise or anembryonic gestation (ultrasound examination demonstrates a fetal pole without cardiac activity measuring between 5.3 and 40 mm or an abnormal growth pattern diagnostic of early pregnancy failure)

Exclusion Criteria:

* Incomplete or inevitable abortion
* Contraindication of allergy to letrozole or misoprostol
* Unable to return for clinic-based follow-up
* Twin or multiple pregnancy

Primary outcomes:
measure: Treatment Efficacy
timeFrame: Visit 2 (Days 10-11)
Secondary outcomes:
measure: Acceptability
timeFrame: 30 days
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: PEACE / Penn Medicine
state: Pennsylvania
Study officials:
References:
Clinical trial NCT02702219: Effect of Flexibility Training Versus Static Stretching on Hamstring Muscle Length and Patterns of Lumbar Flexion
Official title: Effect of Dynamic Flexibility Training Versus Prolonged Static Stretching on Length of the Hamstrings Muscles and Patterns of Lumbar Flexion in Healthy Adults -a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Static Stretching
Dynamic Stretching
Muscle
Low Back
Lead sponsor: Luleå Tekniska Universitet
Sponsor class: OTHER
First posted: 2016-03-08
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Mobility training in the form of stretching and flexibility training of our skeletal muscle is a common exercise. However, the evidence are scare and there are only a few studies comparing the effect of prolonged static stretching (\> 90 sec) and dynamic flexibility training as to which of these methods has the best length-enhancing effect over time. Further, in clinical practice concerning low back pain, the possibility of a thigh hamstrings muscles to affect movement control of the spine is often mentioned, a link not fully explored in a controlled condition. The purpose of this study is to compare the effect of eight weeks of dynamic flexibility training versus prolonged static stretching on mobility in the hamstring muscles in adults with reduced mobility in the muscles at the back of the thigh. The aim is also to compare the sustained effect of flexibility training between the two groups, eight weeks after completion of the intervention. Furthermore, the aim is to explore how different forms of flexibility training affects movement patterns of the lumbar spine in adult persons with reduced mobility in the hamstrings.


Eligibility criteria: Inclusion Criteria:

* Restricted hip flexion \< 80 degress due to thight hamstrings muscles

Exclusion Criteria:

* discomfort or illness from musculoskeletal system which significantly affects the person in his/her everyday life
* previous injury (within 12 weeks) in the hamstring muscle prior to study entry
* known RA diagnosis
* known neurological disease
* medication affecting the musculskeletal system

Primary outcomes:
measure: Change of Range of motion of hip flexion
timeFrame: Change from Baseline to after intervention (8 weeks), Change from Baseline to follow-up at 16 weeks
measure: Change of Fingertip to floor distance
timeFrame: Change from Baseline to after intervention (8 weeks), Change from Baseline to follow-up at 16 weeks
Secondary outcomes:
measure: Change in Waiters bow
timeFrame: Change from Baseline to after intervention (8 weeks), Change from Baseline to follow-up at 16 weeks
measure: Change in Sitting bilateral knee extension
timeFrame: Change from Baseline to after intervention (8 weeks), Change from Baseline to follow-up at 16 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05553119: A Study of Home-based Pulmonary Rehabilitation and Health Coaching to Treat Bronchiectasis
Official title: Home-based Pulmonary Rehabilitation and Health Coaching in Bronchiectasis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bronchiectasis
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2022-09-23
Enrollment: 35
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: Subjects with a medical diagnosis of bronchiectasis being see in the Mayo Clinic Bronchiectasis Clinic in Rochester, MN.

Brief summary: The purpose of this study is to gather information on the effectiveness on a home-based pulmonary rehabilitation in patients with bronchiectasis.

Detailed description: The purpose of this study is to gather information on the effectiveness on a home-based pulmonary rehabilitation in patients with bronchiectasis. We hope that by participating in home-rehab that patients with bronchiectasis will become more physically active in their daily lives.

Pulmonary Rehabilitation in a medical center has proven to have a positive impact on physical activity and shortness of breath in patients with chronic lung disease. However, travel and access can make going to a center difficult.

Study participation involves completing gentle flexibility exercises and walking practice using a provided computer tablet, pulse oximeter and an activity tracker for 12 weeks. During that time, you will talk to a health coach once a week on the phone. At the end of the 12 weeks, someone will call you and ask you questions about your experience with the home-based rehab. Health Coaching calls will be recorded so that it can later be transcribed. All identifying information will be removed and the answers will be lumped together.

Eligibility criteria: Inclusion Criteria:

* Having a diagnosis of non-cystic fibrosis bronchiectasis (primary inclusion criteria) ,confirmed by records, that are symptomatic.
* Ability to communicate in English.

Exclusion Criteria:

* Inability to walk (orthopedic/neurologic/cardiac limitation causing immobility).
* Cognitive impairment or inability to understand and follow instructions.
* Traditional PR completed within 3 months of study recruitment.
* Hospice or end-of-life care at the time of screening.
* Acute exacerbation at the time of screening.

Primary outcomes:
measure: Change in patient-reported quality of life
timeFrame: Baseline, after completion of the 12-week intervention.
Secondary outcomes:
measure: Physical activity
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Roberto Benzo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00180219: Clinical Trial to Assess the Influence of Gestational Stage and Maternal Age on Arterial Stiffness of the Mother
Official title: An Open Clinical Trial to Assess the Influence of Gestational Stage and Maternal Age on Arterial Stiffness of the Mother (Hormonal and Age Related Changes of the Aortal Elasticity)
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Pregnancy Trimester, First
Pregnancy Trimester, Second
Pregnancy Trimester, Third
Keywords: G08.520.769.550.408
G08.520.769.550.490
G08.520.769.550.520
Lead sponsor: Technische Universität Dresden
Sponsor class: OTHER
First posted: 2005-09-16
Enrollment: 0
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: three age groups

Brief summary: This is a single-centre, open, parallel-group study with three age groups; no study medication or intervention will be provided. This is a longitudinal follow-up of physiological parameters.

Detailed description: The subjects will be investigated as outpatients. For each subject, 4 individual dates with a duration of approximately 30 minutes each are scheduled - at the end of the first trimenon, at the end of the second trimenon, 4 weeks prior to the calculated date of birth, and 6 weeks after the effective date of birth.

Eligibility criteria: Inclusion Criteria:

* Pregnant women without major concomitant disease
* Willing and able to provide informed consent
* Age (three age groups):

  * 20 to 22 years
  * 30 to 32 years
  * 40 to 42 years

Exclusion Criteria:

* Non pregnant women
* Men
* No informed consent
* Age not included in inclusion criteria
* Major concomitant disease

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: Medizinische Fakultät der Technischen Universität Dresden
Study officials:
affiliation: Technische Universität Dresden
name: Joachim Siegert, MD, DPharm, Phd
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02128919: Transcranial Direct Current Stimulation (tDCS) As A Treatment For Cigarette Craving and Cognitive Deficits in Schizophrenic
Official title: Transcranial Direct Current Stimulation (tDCS) As A Treatment For Cigarette Craving and Cognitive Deficits in Schizophrenic
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Cognition
Cigarette Smoking
Keywords: Schizophrenia
Cigarette smoking
Cognition
Craving
MATRICS
Lead sponsor: Nathan Kline Institute for Psychiatric Research
Sponsor class: OTHER
First posted: 2014-05-01
Enrollment: 33
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: This is a study of the effects of tDCS on smoking, craving for cigarettes, cognition, and psychiatric symptoms in schizophrenic patients who are current smokers or have a history of regular cigarette smoking. It assesses smoking with CO monitoring, nicotine and nicotine levels, and craving with QSU scale and response to craving slides. Cognition is measured by MCCB, symptoms are measured by PANSS and hallucination scale.

This is a double-blind sham-controlled study with active tDCS 2ma or 20 minutes over 5 days, and sham tDCS for 40 seconds on each sham occasion.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of schizophrenia spectrum disorder History of cigarette smoking

Exclusion Criteria:

* Seizure disorder or current treated neurological illness Current Acute exacerbation of psychotic state

Primary outcomes:
measure: Change From Baseline in Cigarette Craving
timeFrame: Baseline and after 5 tDCs sessions (mean time 8.7[SD 2.7] days after basleine)
Secondary outcomes:
measure: Change From Baseline in Cognitive Performance
timeFrame: Baseline and 1-3 days (mean 1.8 [SD 1.4] days after 5 tDCS sessions( mean 8.7 days after baseline)
Other outcomes:
measure: Change From Baseline in Psychiatric Symptoms
timeFrame: Baseline and after 5 tDCS sessions
Locations:
city: Orangeburg
country: United States
facility: Nathan Kline Institute for Psychiatric Research
state: New York
Study officials:
affiliation: Nathsan Kline Institute for Psychiatric Research
name: Robert C Smith, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Smith RC, Boules S, Mattiuz S, Youssef M, Tobe RH, Sershen H, Lajtha A, Nolan K, Amiaz R, Davis JM. Effects of transcranial direct current stimulation (tDCS) on cognition, symptoms, and smoking in schizophrenia: A randomized controlled study. Schizophr Res. 2015 Oct;168(1-2):260-6. doi: 10.1016/j.schres.2015.06.011. Epub 2015 Jul 17.
Clinical trial NCT02063919: Association Between Confocal Laser Endomicroscopic (CLE) Features and Colorectal Mucosal Microbiome
Official title: Association Between Confocal Laser Endomicroscopic (CLE) Features and Colorectal Mucosal Microbiome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Neoplasia
Colorectal Inflammation
Hyperplasia
Mucosal Microbiome
Lead sponsor: Shandong University
Sponsor class: OTHER
First posted: 2014-02-17
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with indications for colonoscopy in Qilu Hospital outpatient and inpatient department are the study population of this study.

Brief summary: The purpose of this study is to determine whether an association between endomicroscopic pattern and colorectal mucosal microbiome exists.

Detailed description: The gut microbiome plays a pivotal role in the intestinal pathophysiology. The mucosal microbiome is in the front face of microbiome-host cross-talk. Confocal laser endomicroscopy (CLE) can provide realtime mucosal images during ongoing endoscopy. We hypothesized that the mucosal pattern, here evaluated by endomicroscopy, may constitute specific microbiome niches and participate the evolvement of the mucosal microbiome.

Eligibility criteria: Inclusion Criteria:

* 18 years old ≤ age \< 80 years old
* Scheduled for colonoscopy in Qilu Hospital

Exclusion Criteria:

* antibiotic usage within 2 months
* probiotic or prebiotic usage within 2 months
* ascites
* jaundice
* liver cirrhosis
* impaired renal function
* coagulopathy
* fever
* pregnancy
* breastfeeding
* inability to provide informed consent
* known allergy to fluorescein sodium

Primary outcomes:
measure: The operational taxonomy unit in the colorectal mucosal microbiome.
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Jinan
country: China
facility: Department of Gastroenterology, Qilu Hospital, Shandong University
state: Shandong
Study officials:
affiliation: Department of gastroenterology, Qilu Hospital, Shandong University
name: Yanqing Li, PhD., MD.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03638219: Prognostic Significance of Bioscore in Nonmetastatic Breast Cancer
Official title: Prognostic Significance of Bioscore in Nonmetastatic Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-08-20
Enrollment: 317
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: non metastatic breast cancer patients presenting to our department during period of our study.

Brief summary: assess the validity of applying the bioscore system to predict the disease-free survival (The percentage of people in a study or treatment group who have not experienced disease relapse in a defined period of time.) in breast cancer patients presenting to our

Detailed description: Retrospective cohort analysis of breast cancer patient's records for patients treated with surgery as an initial intervention at our department from 2015 to 2018 will be identified. Multivariate analyses of factors, including pathological stage (PS), T stage (T), nodal stage (N), grade (G), estrogen receptor (ER) status (E) and human epidermal growth factor receptor (HER2) status will be recorded to identify associations with disease-free survival DFS. A score of 0-4 will be assigned for each factor by considering the hazard ratio magnitude.

Analysis of the correlation between pathological stage, T stage (T), nodal stage (N), grade (G), estrogen receptor (ER) status (E) and human epidermal growth factor receptor (HER2) status combined score and the disease free survival (DFS ).

Eligibility criteria: Inclusion Criteria:

- Female patients Newly diagnosed breast cancer patients presented to clinical oncology department, Assiut University in the period between (2015_2018).

Histologically confirmed invasive breast carcinoma (IBC) Age: ≥18 and older Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2. Complete medical records and follow up

Exclusion Criteria:

* Male patients No definitive surgery Incomplete medical records or follow-up status Unavailability of hormonal receptor status Carcinoma in situ or other rare tumors of the breast as phylloides tumors, pregnancy and lactation

Primary outcomes:
measure: the correlation between pathological stage, T stage (T), nodal stage (N), grade (G), estrogen receptor (ER) status (E) and human epidermal growth factor receptor (HER2) status combined score and the disease specific survival (DSS)
timeFrame: Non metastatic breast cancer patients presented at our department from 2015 to 2018.. Then follow up till 2020
Secondary outcomes:
Other outcomes:
Locations:
city: Asyut
country: Egypt
facility: Assiut University hospital
Study officials:
References:
citation: Ferlay J, Soerjomataram I, Dikshit R, Eser S, Mathers C, Rebelo M, Parkin DM, Forman D, Bray F. Cancer incidence and mortality worldwide: sources, methods and major patterns in GLOBOCAN 2012. Int J Cancer. 2015 Mar 1;136(5):E359-86. doi: 10.1002/ijc.29210. Epub 2014 Oct 9.
Clinical trial NCT00927719: Safety Surveillance Study of ACAM2000® Vaccinia Vaccine
Official title: A Phase IV Enhanced Safety Surveillance Study of ACAM2000® in Military Personnel
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Smallpox
Keywords: Smallpox
Smallpox Vaccine
Vaccinia virus
Military
Lead sponsor: Emergent BioSolutions
Sponsor class: INDUSTRY
First posted: 2009-06-25
Enrollment: 897227
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants that had received ACAM2000®, vaccinia virus Smallpox vaccine.

Brief summary: This is an enhanced safety surveillance study that will occur within the military Service Member population.

Primary Objective:

* To evaluate the rates of suspected, probable, and confirmed myocarditis and/or pericarditis in temporal association with ACAM2000® vaccination.

Secondary Objectives:

* To evaluate the rates of cardiovascular adverse events in temporal association with ACAM2000® vaccination.
* To evaluate the rates of neurological adverse events in temporal association with ACAM2000® vaccination.

Detailed description: The Armed Forces Health Surveillance Activity (AFHSA) will perform comprehensive health surveillance through the operation of the Defense Medical Surveillance System (DMSS). Demographic and medical information gathered within monthly reports from the DMSS will be collected from approximately 100,000 to 200,000 military Service Members who received the ACAM2000® smallpox vaccine.

Eligibility criteria: Inclusion Criteria :

* Male and female military personnel \>= 17 years of age.
* Have received the ACAM2000® smallpox vaccine.

Exclusion Criteria :

* Not applicable.

Primary outcomes:
measure: To provide information concerning the safety following vaccination with ACAM2000® vaccinia vaccine
timeFrame: Entire study duration
Secondary outcomes:
Other outcomes:
Locations:
city: Twentynine Palms
country: United States
state: California
city: Fort Campbell North
country: United States
state: Kentucky
city: Fort Bliss
country: United States
state: Texas
city: Fort Hood
country: United States
state: Texas
Study officials:
affiliation: Emergent BioSolutions
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Decker MD, Garman PM, Hughes H, Yacovone MA, Collins LC, Fegley CD, Lin G, DiPietro G, Gordon DM. Enhanced safety surveillance study of ACAM2000 smallpox vaccine among US military service members. Vaccine. 2021 Sep 15;39(39):5541-5547. doi: 10.1016/j.vaccine.2021.08.041. Epub 2021 Aug 26.