louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05359159: Follow-up of Patients With Previous SARS-CoV-2 Infection: Long-term Damage Assessment
Official title: Follow-up of Patients With Previous SARS-CoV-2 Infection: Long-term Damage Assessment
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: COVID-19
Keywords: Long-COVID
post-COVID
SarS-CoV2
Lead sponsor: University of L'Aquila
Sponsor class: OTHER
First posted: 2022-05-03
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients admitted to Ospedale San Salvatore dell'Aquila over 18 years during Sars-CoV2 pandemics, with or without Sars-CoV2 related disease

Brief summary: People affected by SARS-CoV-2 infection, whether patients have developed mild forms or a severe form of the disease, complain of nonspecific and entirely new symptoms or complain about the persistence pf them.Investigators intend to follow over time the post-infectious phase of patients discharged from sub-intensive care unit. The aim is to identify symptoms and their frequency of presentation in the SARS-CoV-2 population in the post-acute period.


Eligibility criteria: Inclusion Criteria:

* Patients over 18

Exclusion Criteria:

* Patients under 18

Primary outcomes:
measure: Greater understanding of SARS-CoV-2 disease
timeFrame: 24 months
Secondary outcomes:
measure: Measurement of psychological impact of SARS-CoV-2 disease
timeFrame: 24 months
Other outcomes:
Locations:
city: L'Aquila
country: Italy
facility: Clara Balsano
state: Italy/L'Aquila
city: L'Aquila
country: Italy
facility: University of L'Aquila
Study officials:
References:
Clinical trial NCT02634359: Evaluation of EarlySense for Monitoring Ovulation Cycles and Detection of Early Stages of Pregnancy in Home Environment
Official title: Protocol for Evaluation of EarlySense - a Contact-less Heart and Respiration Device for Monitoring Ovulation Cycles and Detection of Early Stages of Pregnancy in Home Environment
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Reproduction
Lead sponsor: EarlySense Ltd.
Sponsor class: INDUSTRY
First posted: 2015-12-18
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The study objective is to collect data to assess the accuracy and reliability of Earlysense fertility cycle monitoring performance vs. acceptable known reference methods such as blood tests and intra-vaginal Ultrasound currently used as validated methods to detect ovulation and pregnancy. In addition the collected data will be used to further enhance and improve the existing algorithms.

Detailed description: The study objective is to assess the accuracy and reliability of Earlysense cycle monitoring to detect ovulation and implantation vs. acceptable known reference methods including blood tests and Ultrasound examination that are currently used as validated methods to detect ovulation and pregnancy. In addition the collected data will be used to further enhance and improve the existing algorithms that detect menses.

Eligibility criteria: Inclusion Criteria:

1. Age 18 years ≤ 40 years
2. Healthy women with no significant background illness or Consenting women that arrive to IVF clinic for frozen embryo transfer on spontaneous cycle, or Consenting women that arrive for cycle evaluation or insemination on spontaneous cycle (infertile women).
3. Healthy women volunteers with regular menstrual cycles - not using contraceptives
4. Is willing to sign the consent form.
5. Sleeps on a mattress which allows placing a sensor under that mattress(so Earlysense sensor can be inserted under the mattress)
6. Regular cycle

Exclusion Criteria:

* Age \< 18 years or \> 40 years old
* Is not willing to sign the consent form.
* Does not sleep on a mattress that allows placing EarlySense sensor under it .(e.g., Futon0 Taking any significant medication or have major chronic diseases: e.g. Diabetes, CHF, COPD, Heart disease or pacemaker
* Taking pills (oral contraceptives or medical IUD w. progesterone)
* Women with irregular cycles (PCOS) or un-ovulation

Primary outcomes:
measure: Detecting Ovulation or Early Pregnancy
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Herzelia
country: Israel
facility: Herzelia Medical Center
Study officials:
affiliation: EarlySense Ltd.
name: Dalia Argaman
role: STUDY_DIRECTOR
References:
Clinical trial NCT05940259: 68Ga-P3 PET/CT Imaging in Prostate
Official title: A Study to Evaluate 68Ga-P3 PET/CT Imaging of PSMA Expression in Prostate
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Neoplasms
Keywords: [68Ga]P3
PSMA
PET/CT
Neoplasms
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
First posted: 2023-07-11
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Prostate-specific membrane antigen (PSMA) is a type II transmembrane glycoprotein that consists of 750 amino acids. It is highly expressed on most prostate cancer cells and neovascular endothelial cells of tumors, making PSMA a highly specific and significant imaging target for malignancies.

\[68Ga\]P3, a novel molecular probe of PET imaging agent that targets PSMA, can be used in the diagnosis and research of a wide variety of PSMA high-expression malignanciesr.

Detailed description: Prostate-specific membrane antigen (PSMA) is a type II transmembrane glycoprotein that consists of 750 amino acids. It is highly expressed on most prostate cancer cells and neovascular endothelial cells of tumors, making PSMA a highly specific and significant imaging target for malignancies.\[68Ga\]P3, a novel molecular probe of PET imaging agent that targets PSMA, can be used in the diagnosis and research of a wide variety of PSMA high-expression malignanciesr.

Eligibility criteria: Inclusion Criteria:

patients with confirmed or suspected cancer; Signed written informed consent

Exclusion Criteria:

Primary outcomes:
measure: The diagnostic efficacy of 68Ga-P3 PET/CT in the evaluation of Prostate
timeFrame: 1 year
measure: The detection efficacy of 68Ga-P3 PET/CT in the evaluation of Prostate
timeFrame: 1 year
Secondary outcomes:
measure: The dosimetry of 68Ga-P3
timeFrame: 1 year
measure: Quantitative evaluation of 68Ga-P3
timeFrame: 1 year
measure: Correlation with pathological expression
timeFrame: 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT01496859: Observational Study of Baska Mask, a New Supraglottic Airway Device
Official title: Observational Study of Baska Mask, a New Supraglottic Airway Device
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Performance and Safety of a New Supraglottic Airway Device
Keywords: Baska mask
supraglottic airway
airway management
Lead sponsor: University College Hospital Galway
Sponsor class: OTHER
First posted: 2011-12-21
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The Baska mask is a new supraglottic airway device . The investigators would like to assess its performance in setting in which the current standard - LMA device - is being used.

Detailed description: Our group has performed a number of studies on novel airway devices. In this study we would like to evaluate a new supraglottic airway named Baska mask. We would like to monitor certain parameters (time to and ease of insertion, failure rate, seal pressures, complications etc) as regarding the performance and safety profile of this device. This is a descriptive case series of patients undergoing airway management under general anaesthesia.

Eligibility criteria: Inclusion Criteria:

* Written informed Consent
* No relevant drug allergies
* Body-mass index (BMI) 20-35
* Age 18-65
* Non-urgent surgery of planned duration 0-2 hrs

Exclusion Criteria:

* Inability of patient/parent to understand or consent for the trial
* Non-English speakers
* Neck pathology
* Previous or anticipated problems with the upper airway or upper GI tract (reflux, hiatus hernia, oropharyngeal tumour, upper respiratory tract infection in the last 10 days etc)
* BMI \>35
* Expected Difficult airway
* Live Pregnancy
* Increased risk for Gastric Aspiration

Primary outcomes:
measure: Device Placement Success rate
timeFrame: within 30 mins of anaesthesia commencement
measure: time to placement of device
timeFrame: within 30 mins of anaesthesia commencement
Secondary outcomes:
measure: airway leak pressure of the device
timeFrame: within 30 mins of anaesthetic commencement
measure: user-rated ease of insertion of device
timeFrame: within 30 mins of anaestesia commencement
measure: complication rates
timeFrame: From the moment general anaesthesia commenced up to 1 day postoperatively
measure: patient comfort indices
timeFrame: from the moment the patient awake up to 1 day postoperatively
Other outcomes:
Locations:
city: Galway
country: Ireland
facility: Galway University Hospitals
Study officials:
affiliation: National University of Ireland, Galway and Galway University Hospitals
name: John G Laffey, FFARCSI
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03988959: Surgical Management of Multiple Mucoepidermoid Carcinoma and Adenocarcinoma
Official title: Surgical Management of Multiple Mucoepidermoid Carcinoma and Adenocarcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adenocarcinoma; Mucoepidermoid Carcinoma
Keywords: salivary gland tumor
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2019-06-18
Enrollment: 7
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: a case series was performed on 7 patients having mucoepidermoid carcinoma
Primary purpose: TREATMENT

Brief summary: A case series of patient having mucoepidermoid carcinoma, had standard treatment protocol and surgeries and followup was performed and the patient postoperative quality of life and recurrent rate was recorded

Detailed description: This case series presents mucoepidermoid carcinoma. Palatal mass was resected with safety margin then immediate opturator inserted; superficial parotidectomy was also done for parotid lesion sparing facial nerve. Post-operative radiotherapy was recommended by pathologist due to evident perineural spread. The patient is tumor free after one year follow-up.

Clinical reports about synchronous multiple salivary tumors are very rare, consequently there is little known about its management and clinical presentation. Presence of one or more risk factor should favor expectation of multiple tumors and mandate examination of all salivary tissues. Each tumor should be diagnosed and treated separately according to its nature and extension.

Eligibility criteria: Inclusion Criteria:

* patients suffering from salivary gland tumor

Exclusion Criteria:

* healthy patients with no tumors

Primary outcomes:
measure: Quality of life
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain shams university
Study officials:
affiliation: Dean of Faculty
name: Mohamed Diaa, Prof Dr
role: STUDY_DIRECTOR
References:
Clinical trial NCT02930759: Sun Protection Factor Assay (SPF Assay 200/2016)
Official title: Sun Protection Factor (SPF) Assay: UVA Protection Factor Assay Minimal Persistent Pigment-Darkening Dose
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sunscreening Agents
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2016-10-12
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: To evaluate the Sun Protection Factor efficacy on human skin.


Eligibility criteria: Inclusion Criteria:

* Fitzpatrick Skin Type l, ll and/or lll for UVB testing. Fitzpatrick Skin Type ll, lll and/or lV for UVA testing.
* Male and female.
* Aged between 18-70 years old.
* Good health as determined from the HRL SHF (Subject History Form).
* Signed and dated Informed Consent Form.
* Signed and dated HIPAA (Health Insurance Portability and Accountability Act) form.
* An unambiguous MED (Minimal Erythema Dose) or MPPD (Minimal Persistent Pigment Darkening Dose).

Exclusion Criteria:

* Subjects on test at any other research laboratory or clinic.
* Known allergy or sensitivity to sunscreens, cosmetics and toiletries, topical drugs and/or ultraviolet light.
* Pre-existing dermatologic conditions which have been diagnoses by a medical professional (e.g. psoriasis, eczema, etc.) which would interfere with this study.
* Pre-existing other medical conditions (e.g. adult asthma, diabetes).
* Treatment with antihistamines or corticosteroids within one week prior to initiation of the test.
* Treatment with antibiotics within two weeks prior to initiation of the test.
* Chronic medication which could affect the results of the study.
* Known pregnant or nursing women.

Primary outcomes:
measure: Minimal Erythema Dose (MED)
timeFrame: Up to 15 minutes
measure: Minimal Persistent Pigment Darkening Dose (MPPD)
timeFrame: Up to 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Union
country: United States
state: New Jersey
Study officials:
References:
Clinical trial NCT02100059: Motor and Sensory Deficits Following Partial Meniscectomy
Official title: Motor and Sensory Deficits Following Partial Meniscectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Meniscus Tear
Keywords: meniscectomy
arthroscopic partial meniscectomy
meniscus
Lead sponsor: Creighton University
Sponsor class: OTHER
First posted: 2014-03-31
Enrollment: 60
Sex: ALL
Minimum age (years): 15
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To determine changes in thigh muscle function and knee pain after a partial meniscectomy surgery and to also determine the effects of applying electrical stimulation to the knee to determine if this improves thigh muscle function and decreases pain.

Detailed description: The objective for this study is to determine the differences in corticospinal excitability and central sensitization of nociceptive pathways in individuals with a history of arthroscopic partial meniscectomy compared to healthy controls. Our central hypothesis is that quadriceps weakness following partial meniscectomy is due to higher levels of corticospinal excitability and central sensitization of nociceptive pathways, which can be modified with therapeutic interventions.

Eligibility criteria: Inclusion Criteria:

* Age 15-65
* Arthroscopic partial meniscectomy with in the past 15 years

Exclusion Criteria:

* History of traumatic spine or lower extremity injury within the last 6 months
* Previous adverse reaction to electrical stimulation (i.e. burns or hypersensitivity)
* Cardiac pacemaker
* Metal implants in head
* Current pregnancy
* Neurological disorders
* History of seizures
* Unable to give consent or understand the procedures of this study

Primary outcomes:
measure: Changes in quadriceps force output and voluntary activation
timeFrame: Single Study Visit
Secondary outcomes:
Other outcomes:
Locations:
city: Omaha
country: United States
facility: Creighton University
state: Nebraska
Study officials:
affiliation: Creighton University
name: Terry L Grindstaff, PhD, PT, ACT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02570659: Investigating the Effect of an Information Video for Neck Injuries in a Emergency Department Setting
Official title: A Randomized Controlled Trial Evaluating the Effect of an Information Video in a Acute Whiplash Population
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Whiplash Syndrome
Keywords: WAD
Whiplash
Information Video
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2015-10-07
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: A randomized controlled trial (RCT) to investigate the effect of a information video, consisting of a multiprofessional team, on patients with acute Whiplash Associated Disorder (WAD).

Detailed description: Patients seeking medical care at Södersjukhuset Hospital, Sweden, after a motor vehicle accident resulting in neck trauma are offered to be included in the study. Inclusion criterias involve spine fractures, need for in house care, \<18\<65 years of age and low knowledge of the Swedish language.

A randomization is performed with two arms, one being "treatment as usual" i.e. an information folder with physiotherapeutic exercises, the other one being the Information Video.

The patients are contacted per telephone and a questionnaire with baseline data is sent via e-mail within a week after the accident. They also receive a link to the websites with the information.

The follow up time is 6 months and after that the patients receive a new questionnaire with questions regarding neck-specific status (WDQ), health related quality of life (SF-12) and pain.

The primary outcome is level of pain (NRS)

Eligibility criteria: Inclusion Criteria:

* Knowledge of the swedish language
* Traffic injury with neck pain

Exclusion Criteria:

* Fractures
* In house care needed

Primary outcomes:
measure: Pain
timeFrame: 6 months
Secondary outcomes:
measure: Whiplash Disability Questionnaire (WDQ)
timeFrame: 6 months
measure: SF-12
timeFrame: 6 months
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Eric Rydman
Study officials:
References:
Clinical trial NCT01988259: Head-neck Coordination Analysis After Minimally Invasive Surgery in the Dorsal Cervical Spine
Official title: Comparison of Open vs Minimally Invasive Dorsal Approaches for Foraminotomy and Laminoplasty in the Cervical Spine Through Performance of Head-neck-coordination Analysis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Multilevel Cervical Spinal Stenosis
Single Brachial Radiculopathy
Lead sponsor: Schoen Klinik Hamburg Eilbek
Sponsor class: OTHER
Collaborators: name: Jacek Cholewicki PhD
name: MSU Center for Orthopedic Research
First posted: 2013-11-20
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To proof patients' benefit of minimally invasive surgery in the dorsal cervical spine an apparatus to examine head-neck-coordination was constructed.

Two different surgical techniques will be compared:

Laminoplasty: open approach vs minimally invasive surgery (MIS)-approach; Foraminotomy: open approach vs MIS-approach. Each patient will be tested before surgery, postoperative as well as 3 and 12 month follow-up.

Hypothesis is that patients after MIS-approaches perform better in their head-neck-coordination as patients with open approaches.


Eligibility criteria: Inclusion Criteria:

* radicular or myelopathic compression syndrome in the cervical spine

Exclusion Criteria:

* neurological diseases with influence on the neuromuscular function
* previous surgery on the cervical spine

Primary outcomes:
measure: Performance of head-neck-coordination after surgery of the dorsal cervical spine
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: Schoen Klinik Hamburg Eilbek
Study officials:
affiliation: Spine Unit @ Schoen Klinik Hamburg Eilbek
name: Ralph Kothe, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04845659: Avatrombopaq In Patients With Cirrhosis
Official title: Treatment With Avatrombopaq in Patients With Cirrhosis Undergoing Small Invasive Procedure: A Prospective Case Series
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Thrombocytopenia; Drugs
Cirrhosis, Liver
Procedural Bleeding
Keywords: Cirrhosis
Thrombocytopenia
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
First posted: 2021-04-15
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Thrombocytopenia is a frequent issue in patients with cirrhosis undergoing various types of procedures (e.g. liver biopsy, endoscopy and minor surgical interventions). Thrombocytopenia \< 50\*10\^9/L increases the risk of perioperative and postoperative bleedning and might prevent patients with cirrhosis to undergo important procedures. Doptelet is a small molecular trombopoetin agonist, which results in proliferation and differentiation of megakaryocytes in the bone marrow resulting in increased levels of thrombocytes. It is given orally as a pill and is used to increase platelet count in patients with severe thrombocytopenia (\< 50\*10\^9/L) and cirrhosis and thus not to normalize platelet count. This study investigates the safety and efficacy of Doptelet in patients with cirrhosis and thrombocytopenia (\< 50\*10\^9/L) undergoing minor procedures like Transjugular Adjusted Liver Biopsy (TJALB) and gastroscopy.


Eligibility criteria: Inclusion Criteria:

* Age: \>17 years and ≤80 years
* ASA I-III
* Patients who read, understood and signed informed consent.
* Patients with a diagnosis of cirrhosis
* Thrombocytopenia \<50\*109
* The patient is scheduled for one of the following procedures: Transjugular Adjusted Liver Biopsy (TJALB), gastroscopy or percutan paracentesis of ascites in the following month.

Exclusion Criteria:

* Patients who do not speak and understand Danish.
* Patients who cannot cooperate within the trial.
* Patients who did not sign an informed consent regardless of the cause.
* Active drug abuse - to the discretion of the investigator.
* Thrombocytes \>50\*10\^9
* Patients with hereditary trombolic diseases (e.g. Factor V Leiden, antithrombin deficiency, protein S and C deficiency, prothrombin G202110A mutation).
* INR \> 1,7
* Ongoing infection verified by blood culture, clinical examination, and acute phase reactants (e.g. CRP)

Primary outcomes:
measure: Adverse Events
timeFrame: 3 months postprocedural
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: