louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05594316: New Treatment of Alopecia Areata
Official title: Efficacy of Trichloroacetic Acid in Patients of Alopecia Areata : Clinico-histopathological Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alopecia Areata
Keywords: alopecia areata AA
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2022-10-26
Enrollment: 40
Sex: ALL
Minimum age (years): 16
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Abstract: Alopecia areata is believed to be an autoimmune disease resulting from a breach in the immune privilege of the hair follicles causing non scarring hair loss.

Methods: our study included 40 patients from may 2019 to july 2022 diagnosed clinically, dermatoscopically and pathologically as alopecia areata Data were enrolled from department of dermatology and venereology, Al-Hussein hospital.

Detailed description: For each patient the following will be done :

1. History taking including ( age, sex, disease duration, family history, history of drug intake, smoking and history of any associated disease ).
2. All patients will give a written, informed consent for induction.
3. Basic photographs will be taken to assess site, size (by cm), number, Extent of the patch using D5300 camera with lens (18-55).
4. Patients will be subjected to 3 session of trichloroacetic acid (TCA) 35% one month apart.
5. serial photographs and dermoscopic examination every month will be done and patient will be score.
6. Efficacy will be assessed using prognostic scoring system for density, pigmentation, and texture of growing hair.
7. histopathological examination will be done before the first session and one month after third session.

Eligibility criteria: Inclusion Criteria:

* Alopecia areata multilocularis and alopecia totalis. Age from 16-60 years old. Ophiasis pattern alopecia areata.

Exclusion Criteria:

* Age less than 16 and more than 60years old. Alopecia areata of the face.
* Patient under treatment.

Primary outcomes:
measure: Mac Donald Hull and Norris grading system
timeFrame: 4 weeks after the end of treatment
measure: Scoring of texture of regrown hair
timeFrame: after each session and 4 weeks after the end of treatment
measure: Scoring of pigmentation of regrown hair
timeFrame: after each session and 4 weeks after the end of treatment
measure: Scoring for density of hair regrowth
timeFrame: after each session and 4 weeks after the end of treatment
measure: Scoring of overall response at the end of the study
timeFrame: after each session and 4 weeks after the end of treatment
measure: histopathological changes
timeFrame: after each session and 4 weeks after the end of treatment
measure: trichoscopic parameters
timeFrame: after each session and 4 weeks after the end of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Al-Azhar university, faculty of medicine
city: Cairo
country: Egypt
facility: Al-Azhar university
Study officials:
References:
Clinical trial NCT05092516: Home-based Brain Stimulation Treatment for Post-acute Sequelae of COVID-19 (PASC)
Official title: Home-based Transcranial Direct Current Stimulation (tDCS) for Treatment of Cognitive Post-acute Sequelae of COVID-19 (PASC)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Dysexecutive Syndrome
Post-Acute Sequelae of COVID-19
Keywords: Transcranial Direct Current Stimulation
EEG
Sustained attention
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2021-10-25
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main goal of this study is to improve dysexecutive symptoms (e.g., sustained attention, processing speed) in patients exhibiting post-acute sequelae of COVID-19 (PASC) through home-based transcranial direct current stimulation (tDCS), a noninvasive method that uses low intensity electric currents delivered to the brain through stimulation electrodes on the scalp.


Eligibility criteria: Inclusion Criteria:

* Ability to provide informed consent
* A diagnosis of PASC as indicated by past COVID-19 infection, and persistent symptoms, including 'brain fog', confusion, short-term memory deficits, trouble concentrating, delirium, difficulties in multitasking.

Exclusion Criteria:

* History of epilepsy
* Metallic implants in the head and neck,
* Brain stimulators
* Pacemakers
* Pregnancy
* Active substance dependence (except for tobacco)
* Premorbid major neurological illness
* Severe mental illness (e.g., bipolar disorder, schizophrenia)
* Attention Deficit Hyperactivity Disorder

Primary outcomes:
measure: Change in inhibitory control
timeFrame: 8 weeks
measure: Change in processing speed
timeFrame: 8 weeks
measure: Change in EEG P300 event-related potential
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Charlestown
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
References:
Clinical trial NCT05453916: Comparing the Efficacy of Nitazoxanide Versus Rifaximin in Adult Patients With Irritable Bowel Syndrome Without Constipation
Official title: A Randomized Single-Blind Controlled Trial Comparing the Efficacy of Nitazoxanide Versus Rifaximin in Adult Patients With Irritable Bowel Syndrome Without Constipation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Irritable Bowel Syndrome With Diarrhea
Lead sponsor: Sadat City University
Sponsor class: OTHER
First posted: 2022-07-12
Enrollment: 84
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 study aim to compare the efficacy of nitazoxanide in 2-week course of treatment with rifaximin in treating diarrhea associated with IBS. We also aim to study its effect over 10 weeks after treatment to evaluate its efficacy in eradicating symptoms of IBS in the long run.


Eligibility criteria: Inclusion Criteria:

* Patients 18 years of age or older.
* Patients suffering from diarrhea-predominant IBS according to Rome III criteria.
* Active symptoms for at least 2 weeks
* Abdominal Pain Intensity: weekly average of worst daily (in past 24 hours) abdominal pain score of \> 3.0 on a 0-to-10-point scale and Stool Consistency: at least one stool with a consistency of Type 6 or Type 7 Bristol stool score (BSS) on at least 2 days per week
* Report no restriction whatsoever on their diet.

Exclusion Criteria:

* Presence of liver disease, malignancy, severe malabsorption, bedridden, endocrinological disorders, or severe chronic obstructive pulmonary disease.
* Patients who have undergone abdominal surgeries except for appendectomy and/or cholecystectomy and/or hysterectomy.
* Patients who consumed any medications that may affect bowel function within the last 2 weeks such as antibiotics, probiotics, prebiotics, antispasmodics, antidiarrheals, narcotics, or any other medication that may alter bowel function
* Patients on antidepressants or antipsychotics starting within the last six weeks before eligibility check.

Primary outcomes:
measure: Proportion of Subjects Who Had Adequate Relief of Global IBS Symptoms for at Least 2 of the 4 Weeks During the Primary Evaluation Period
timeFrame: 6 weeks
Secondary outcomes:
measure: Proportion of Subjects Who Had Adequate Relief of IBS-related Bloating for at Least 2 of the 4 Weeks During the Primary Evaluation Period (ie, Weeks 3 Through 6)
timeFrame: 6 weeks
Other outcomes:
measure: Biological markers
timeFrame: 6 weeks - 12 weeks
Locations:
city: Sadat City
country: Egypt
facility: Faculty of Pharmacy, University of Sadat city
state: Menoufia
Study officials:
References:
Clinical trial NCT04964024: SaRS-Cov-2 Antibodies Following Exposure to Coronavirus Disease 2019 (COVID-19) and/or Vaccination in Nursing Homes
Official title: SaRS-Cov-2 Antibodies Following Exposure to COVID-19 and/or Vaccination in Nursing Homes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19 Infection
Keywords: SARS-CoV-2
Antibodies
Vaccination
Nursing Homes
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2021-07-15
Enrollment: 1293
Sex: ALL
Minimum age (years): 20
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Residents of the 9 Nursing Homes that participate in this study Health professionals working these Nursing Homes

Brief summary: Presence of SaRS-Cov-2 antibodies following exposure to Coronavirus Disease 2019 (COVID-19) and/or vaccination is a major indicator of immunization. Few data exit about serology response in nursing homes (NHs), i.e. in the most vulnerable population for developing severe forms of the disease.

Residents and health professionals in 9 nursing homes (NHs) with SaRS-Cov-2 antibodies detection after exposure (either COVID-19 or vaccine) All biological tests were performed in the frame of the standard care of residents and health professionals and all participants did not express opposition for using anonymously their data for the purpose of this academic analysis. In addition all Directors and Physicians of these NHs accepted to participate in this study


Eligibility criteria: Inclusion Criteria:

For Residents:

* Living in one of the 9 Nursing Homes that participate in this study
* Having a SARS-COV-2 post vaccination serology.
* Having no objection for using the results of the serology for the purpose of this analysis

For Health Professionals:

* Working in one of the 9 Nursing Homes that participate in this study,
* Having a SARS-COV-2 post vaccination serology.
* Having no objection for using the results of the serology for the purpose of this analysis

Exclusion Criteria:

* None

Primary outcomes:
measure: Levels of SARS-COV-2 antibodies
timeFrame: Through study completion average 6 months Retrospective analysis
Secondary outcomes:
Other outcomes:
Locations:
city: Vandoeuvre les Nancy
country: France
facility: CHRU de Nancy, Université de Lorraine
state: US And Canada Only
Study officials:
References:
Clinical trial NCT03476824: Pelvic Fractures in the Elderly
Official title: PelvFx - Pelvic Fractures in the Elderly Patient Influence of Fracture Classification According to Rommens & Hofmann on Mobility, Operation and Independence
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pelvic Fracture
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2018-03-26
Enrollment: 400
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The patients are filtered out of our electronic patient system on the basis of the diagnosis "pelvic ring fracture". Subsequently, patients under the age of 60 and patients after high-energy trauma are excluded.

Brief summary: The aim of the project is to predict the patient under conservative therapy as a function of the patient Classification of Rommens and Hofmann and other potential prognostic factors. A corresponding prognostic score may be used in the future by patients and attending physicians support joint decision between surgical and conservative treatment.


Eligibility criteria: Inclusion Criteria:

* Pelvic fracture after low-energy trauma
* Treatment in the years 2006 to 2016
* patients equal to or older than 60 years

Exclusion Criteria:

* Pelvic fracture after a high-energy space
* Pathological fracture in the area of a tumor or a bony metastasis
* Existence of a documented refusal

Primary outcomes:
measure: mortality
timeFrame: from pelvic fracture until year 1
measure: loss of independence
timeFrame: from pelvic fracture until year 1
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital Switzerland, Traumatology
Study officials:
affiliation: University Hospital, Basel, Switzerland
name: Michaela Ramser, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01350024: Comparison of Postoperative Pain With Two Different Types of Local Anesthesia in Surgery for a Drooping Eyelid
Official title: Comparison of Postoperative Pain With Two Different Types of Local Anesthesia in Surgery for a Drooping Eyelid
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blepharoptosis
Keywords: Conjunctival Mullerectomy
Blepharoptosis
Ptosis surgery
Pain Control
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2011-05-09
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Conjunctival Mullerectomy is a well known procedure used to correct upper lid ptosis via a posterior approach. Patients who undergo this procedure are often given local anesthesia to alleviate intraoperative and postoperative pain. Local anesthesia can be given via frontal nerve block or subconjunctival injection combined with sedation in most cases. Both techniques are currently acceptable options for local anesthesia, however postoperative pain has not been systematically evaluated between these two techniques.

The investigators aim to compare intra-operative and postoperative pain with these two techniques in patients undergoing conjunctival Mullerectomy for ptosis repair. Patients will be randomized to receive local anesthesia via frontal nerve block or via subconjunctival injection. In addition, the investigators will measure the surgical outcomes of the ptosis surgery with standard measures.


Eligibility criteria: Inclusion Criteria:

* 18 years of age and older
* Patient with ptosis that requires correction
* Patient is able to consent for themselves

Exclusion Criteria:

* Patient unable to complete survey
* Patient had prior lid surgery
* Patient taking chronic pain medication

Primary outcomes:
measure: Pain control
timeFrame: 24 hour after surgery
Secondary outcomes:
measure: Efficacy of ptosis surgery
timeFrame: 2 months
measure: Pain Control
timeFrame: 1 hour after surgery
Other outcomes:
Locations:
city: Miami
country: United States
facility: Bascom Palmer Eye Institute
state: Florida
Study officials:
References:
Clinical trial NCT02756624: A Multi-Center, Vehicle-Controlled, Parallel-Group Study Evaluating the Safety of AC-170 Ophthalmic Solution
Official title: A Multi-Center, Double-Masked, Randomized, Vehicle-Controlled, Parallel-Group Study Evaluating the Safety of AC-170 Ophthalmic Solution
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Healthy Subjects
Lead sponsor: Nicox Ophthalmics, Inc.
Sponsor class: INDUSTRY
Collaborators: name: ORA, Inc.
First posted: 2016-04-29
Enrollment: 516
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is study is evaluating the safety and tolerability of AC-170 Ophthalmic Solution

Detailed description: Central Cornea Endothelial Cell Counts will be done on a subset of approximately 150 subjects to complete 100 subjects as part of the safety measures.

Eligibility criteria: Inclusion Criteria:

* at least 2 years of age
* be able to self-administer eye drops or have a parent/legal guardian available for this purpose
* if less than 18 years old have a history or family history of atopic disease (including allergic conjunctivitis)
* have ocular health within normal limits

Exclusion Criteria:

* known contraindications or sensitivities to the study medication or its components
* any ocular condition that, in the opinion of the investigator, could affect the subjects safety trial parameters
* use of disallowed medication during the period indicated prior to the enrollment or during the study
* be pregnant, nursing, or planning a pregnancy

Primary outcomes:
measure: Tolerability of AC 170 0.24% at Visit 1 (Day 1)
timeFrame: Upon instillation, 30 Seconds Post-Instillation, 1 minute Post-Instillation
measure: Tolerability of AC 170 0.24% at Visit 2 (Day 8)
timeFrame: Upon instillation, 30 Seconds Post-Instillation, 1 minute Post-Instillation
measure: Tolerability of AC 170 0.24% at Visit 3 (Day 22)
timeFrame: Upon instillation, 30 Seconds Post-Instillation, 1 minute Post-Instillation
measure: Number of Treatment Related Adverse Events
timeFrame: up to 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Andover
country: United States
facility: Ora Clinical Site Network
state: Massachusetts
Study officials:
affiliation: Sedeinberg Protzko Eye Associates
name: Eugene Protzko, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ophthalmology Associates
name: Ranjan Malhotra, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Philadelphia Eye Associates
name: Stacey Ackerman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Haider Eye Care
name: M. Ali Haider, DO
role: PRINCIPAL_INVESTIGATOR
affiliation: R&R Eye Research
name: Robert Rice, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Andover Eye Associates
name: Gail Torkildsen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02624024: Clinical Performance Evaluation of AQT90 FLEX TnI and TnT
Official title: AQT90 FLEX TnI and TnT - Clinical Sensitivity and Specificity Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myocardial Infarction
Lead sponsor: Radiometer Medical ApS
Sponsor class: INDUSTRY
First posted: 2015-12-08
Enrollment: 1743
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects 21 years of age or older presenting to the emergency department (ED) with acute chest pain or equivalent ischemic symptoms suggestive of acute coronary syndromes (ACS) or acute myocardial infarction (MI).

Brief summary: The AQT90 FLEX Troponin I (TnI) and Troponin T (TnT) Tests are in vitro diagnostic assays intended as an aid in the diagnosis of myocardial infarction (MI) in point-of-care and laboratory settings. The purpose of the study is to establish the clinical performance of the AQT90 FLEX TnI and TnT assays for both whole blood and plasma in the intended use population.


Eligibility criteria: Inclusion Criteria:

* Subject is 21 years of age or older.
* Subject is able to understand information given, and willing and able to voluntarily give their consent to participate in this study.
* Subject is presenting to the ED with acute chest pain or equivalent ischemic symptoms suggestive of ACS or MI (e.g., acute chest pain/pressure, shortness of breath, discomfort in upper extremity, jaw or epigastrium, diaphoresis, nausea, vomiting, lightheadedness, dizziness, weakness, and/or syncope).

Exclusion Criteria:

* Subject is pregnant or may be pregnant.
* Subject has an invalid written informed consent or has withdrawn consent.

Primary outcomes:
measure: Diagnosis of acute myocardial infarction (MI)
timeFrame: during the first 24 hours after presentation to the emergency department
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Honor Health Scottsdale Osborn Medical Center
state: Arizona
city: Scottsdale
country: United States
facility: Honor Health Scottsdale Shea Medical Center
state: Arizona
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
city: Muncie
country: United States
facility: Indiana University Health Ball Memorial Hospital
state: Indiana
city: Worcester
country: United States
facility: UMASS Memorial Medical Center
state: Massachusetts
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: Cincinnati
country: United States
facility: University of Cincinnati Department of Emergency Medicine
state: Ohio
city: Tacoma
country: United States
facility: Catholic Health Initiatives Institute for Research and Innovation -CHI Franciscan Health
state: Washington
Study officials:
References:
Clinical trial NCT02777424: CPP Versus PFC to Correct Coagulation Disorders in Adult Neurosurgical Patients
Official title: Prothrombin Complex Concentrate Versus Fresh Frozen Plasma to Correct Coagulation Disorders in Adult Neurosurgical Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Intracranial Hemorrhages
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2016-05-19
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This prospective, randomized, multicenter study is performed to determine whether prothrombin complex concentrates confers any benefits over fresh frozen plasma in adult neurological patients with coagulation disorders (PT value less than 60%).

Detailed description: The coagulation disorders increase the risk of bleeding and are a risk factor of intracranial hemorrhagic complications in neurosurgical patients. They are diagnosed more often in emergency on a PT value less than 60% and so they should be corrected as soon as possible. Two therapeutic strategies are proposed by French or international recommendations: transfusion of fresh frozen plasma (FFP) or administration of prothrombin complex concentrates (PCC).

This prospective, randomized, multicenter study with blinded assessment of the primary endpoint, is performed to determine whether PCC confers any benefits over FFP in the neurological patients with coagulation disorders.

Eligibility criteria: Inclusion Criteria:

* Patient with spontaneous intracranial hemorrhage or traumatic intracranial hemorrhage or patient requiring neurological surgery
* Coagulation disorder defined by PT less than 60%

Exclusion Criteria:

* Concomitant use with oral anticoagulant drugs
* Acquired deficiency of coagulation factors whose treatment is established
* Hypersensitivity to a PCC
* History of thrombocytopenia induced by heparin
* Disseminated intravascular coagulation
* Extracranial active bleeding
* Hypersensitivity to vitamin K

Primary outcomes:
measure: Proportion of patients with correction of prothrombin time (PT more than 60%)
timeFrame: End of treatment administration (an average of 1 hour)
Secondary outcomes:
Other outcomes:
Locations:
city: Lille
country: France
facility: CHU de Lille
city: Nancy
country: France
facility: CHU de NANCY
city: Paris
country: France
facility: Fondation Ophtalmologique Adolphe de Rothschild (FOR)
city: Suresnes
country: France
facility: Hôpital Foch
Study officials:
References: