louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02898519: Immune Response After Leptospirosis Infection
Official title: Serological Response in Patients Infected by Leptospirosis 1 to 7 Years Earlier
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Leptospirosis
Lead sponsor: Centre Hospitalier Universitaire de la Réunion
Sponsor class: OTHER
Collaborators: name: Institut Pasteur
First posted: 2016-09-13
Enrollment: 175
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: Leptospirosis-cured subjects that have undergone leptospirosis

Brief summary: Leptospirosis is a zoonotic infection induced by pathogen bacteria (genus: Leptospira) growing in water polluted by animal fluids. Due to its 10 fold occurence in French overseas aera, and especially in Reunion Island, as compared to metropoly, it is considered as a major public health issue.

An important inter-individual variability in humoral immune response suggests that vaccination should be recommended in exposed subjects.

This cohort study aimed to determine if subjects that have been infected by leptospirosis for 1 to 7 years still remain immunized, and then do not need vaccination.

Detailed description: Every year more than 500 000 severe forms of leptospirosis are diagnosed in Reunion Island. The risk of mucocutaneous contact with contaminated media remains important due to highly aqueous environment.

Cured subjects that have been infected for 1, 2, 3, 4, 5, 6 or 7 years will be enrolled. The qualitative and quantitative humoral immune response to leptospirosis infection will also be evaluated to determine whether they still get protective immunization. Leptospirosis immunization will be evaluated using micro-agglutination test.

Graded immune responses related to the severity and the length of the infection will also be investigated.

Finally, 3 methods used for leptospirosis diagnosis will be compared. It is expected from this study to evaluate the appropriate conditions in which new vaccination could be required to prevent further leptospirosis infection in cured subjects.

Eligibility criteria: Inclusion Criteria:

* Subjects diagnosed for leptospirosis by polymerase chain reaction measured in Reunion Island Hospital between 209-2015
* with social security issue

Exclusion Criteria:

* Leptospirosis diagnosis not confirmed by polymerase chain reaction
* subject exhibiting immunodepressive status (cancers, transplantation, immune deficit, blood disorders)
* under medication: corticoids, immunosuppressor, chemiotherapy

Primary outcomes:
measure: Leptospirosis immunization assessed by serum immunoglobulin
timeFrame: 1-7 years after leptospirosis infection
Secondary outcomes:
measure: rate of still-immunized patients
timeFrame: 1-7 years after leptospirosis infection
measure: comparison of 3 diagnosis method for leptospirosis
timeFrame: 1-7 years after leptospirosis infection
Other outcomes:
Locations:
Study officials:
affiliation: CHU DE LA REUNION
name: NICOLAS TRAVERSIER, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04747119: Effect of MET on Meralgia Paraesthesia Postpartum "Muscle Energy Technique"
Official title: The Effect of Muscle Energy Technique on Femoral Meralgia Paraesthesia in Postpartum: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Meralgia Paresthetica
Femoral Neuropathy
Lead sponsor: October 6 University
Sponsor class: OTHER
First posted: 2021-02-10
Enrollment: 30
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: the control group received the conventional selected exercise program and the study group received the same exercise training program in addition to muscle energy technique
Primary purpose: TREATMENT

Brief summary: To investigate the effect of muscle energy technique on Femoral meralgia paraesthesia in a postpartum female. BACKGROUND: meralgia paraesthesia is one of the serious disorders in the postpartum female which results in pain and less physical activities.

.........HYPOTHESES:

This study hypothesized that:

muscle energy technique will have a significant effect on Femoral meralgia paraesthesia in postpartum female

Detailed description: Thirty meralgia paraesthesia postpartum females will participate in this study.

The patients will randomly be divided into two equal groups; the control group received the conventional selected exercise program and the study group received the same exercise training program in addition to muscle energy technique, three times per week for four weeks.

The evaluation methods by Femoral nerve conduction velocity will be measured via the Neuropack S1 MEB9004 EMG device before the exercise program and after finishing the exercise program, and also the Pelvic compression test and Pain numeric rating scale

Eligibility criteria: Inclusion Criteria:

* Thirty meralgia paraesthesia postpartum female Patients
* with positive Pelvic compression test
* age ranging from 25:40 years
* post vaginal delivery or post-operative (postpartum) persistent dysthesia in anterolateral thigh (one side or both)
* body mass index (20:29.9) Kg/m2

Exclusion Criteria:

* difficulty to communicate or to understand program instructions
* other conditions that caused pain (for example fibromyalgia and arthritis)
* any psychiatric or cognitive symptoms any other musculoskeletal disorders or neurologic diseases of the lower extremities and spine

Primary outcomes:
measure: Femoral nerve conduction latency
timeFrame: 4 weeks
Secondary outcomes:
measure: Pelvic compression test
timeFrame: four weeks
measure: Numeric Pain Rating Scale (NPRS)
timeFrame: four weeks
Other outcomes:
Locations:
city: Al Jīzah
country: Egypt
facility: Lama S Mahmoud
state: Select State
Study officials:
affiliation: October 6 University
name: Lama Saad Mahmoud, PHD
role: STUDY_CHAIR
References:
Clinical trial NCT04985019: A Validation Study of Mobile Virtual Reality-Based Self-Care and Exposure Therapy Contents for the Treatment of Panic Disorder
Official title: A Validation Study of Mobile Virtual Reality-Based Self-Care and Exposure Therapy Contents for the Treatment of Panic Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Panic Disorder
Lead sponsor: Gangnam Severance Hospital
Sponsor class: OTHER
First posted: 2021-08-02
Enrollment: 40
Sex: ALL
Minimum age (years): 19
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether mobile-based virtual reality exposure treatement can reduce the symptoms of panic disorder and the symptoms of depression and anxiety than the waitlist group


Eligibility criteria: Inclusion Criteria:

- Meet Diagnostic Statistical Manual criteria for panic disorder(with or without agoraphobia) .

No change in drug dosage during the study period

Exclusion Criteria:

- Patients with a history of major neurological or significant medical illness, or met the diagnostic criteria of current substance misuse

Primary outcomes:
measure: The Panic Disorder Severity Scale
timeFrame: 4 weeks
Secondary outcomes:
measure: The heart rate variability
timeFrame: 4 weeks
measure: The Hamilton Rating Scale for Depression
timeFrame: 4 weeks
measure: The State and Trait Anxiety questionnaire
timeFrame: 4 weeks
measure: The Korean Inventory of Depressive Symptomatology
timeFrame: 4 weeks
measure: The Perceived Stress Scale
timeFrame: 4 weeks
measure: The Albany Panic and Phobia Questionnaire
timeFrame: 4 weeks
measure: The Hospital Anxiety and Depression Scale
timeFrame: 4 weeks
measure: The Body Sensations Questionnaire
timeFrame: 4 weeks
measure: The Anxiety Sensitivity Index
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital
Study officials:
References:
citation: Shin B, Oh J, Kim BH, Kim HE, Kim H, Kim S, Kim JJ. Effectiveness of Self-Guided Virtual Reality-Based Cognitive Behavioral Therapy for Panic Disorder: Randomized Controlled Trial. JMIR Ment Health. 2021 Nov 22;8(11):e30590. doi: 10.2196/30590.
Clinical trial NCT00410319: Information or Physical Activity for Chronic LBP
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Low Back Pain
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
First posted: 2006-12-12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare a specific fear-reducing information with symptom-based exercise


Eligibility criteria: Inclusion Criteria:

* Daily LBP, dominating over possible pain in leg or other joints/muscles
* Pain og \> 4 (scale 0-10) for more than 4 months

Exclusion Criteria:

* Cancer, inflammatory disease, previous back surgery, pregnancy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Southern Denmark
name: Tom Bendix, dr.med prof
role: STUDY_DIRECTOR
References:
citation: Sorensen PH, Bendix T, Manniche C, Korsholm L, Lemvigh D, Indahl A. An educational approach based on a non-injury model compared with individual symptom-based physical training in chronic LBP. A pragmatic, randomised trial with a one-year follow-up. BMC Musculoskelet Disord. 2010 Sep 17;11:212. doi: 10.1186/1471-2474-11-212.
Clinical trial NCT02504619: Allogeneic SCT of CordIn™, in Patients With Hemoglobinopathies
Official title: Allogeneic Stem Cell Transplantation of CordIn™, Umbilical Cord Blood-Derived Ex Vivo Expanded Stem and Progenitor Cells, in Patients With Hemoglobinopathies
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Sickle Cell Disease
Thalassemia
Lead sponsor: Gamida Cell ltd
Sponsor class: INDUSTRY
First posted: 2015-07-22
Enrollment: 1
Sex: ALL
Minimum age (years): 2
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: CordIn™ is a cryopreserved stem/progenitor cell-based product of purified CD133+ cells composed of ex vivo expanded allogeneic UCB cells. The overall study objectives are to evaluate the safety and efficacy of CordIn™.

Detailed description: CordIn™ is a cryopreserved stem/progenitor cell-based product of purified CD133+ cells composed of ex vivo expanded allogeneic UCB cells.

The trial ends when the last patient completes their last visit. The overall study objectives are to evaluate the safety and efficacy of CordIn™: single ex-vivo expanded cord blood unit transplantation in patients with hemoglobinopathies (sickle cell disease or thalassemia major) following a preparative therapy.

Eligibility criteria: Inclusion Criteria:

* Patient is a candidate for allogeneic SCT for treatment of SCD or thalassemia
* Patients must have one partially HLA-matched CBUs
* Adequate Karnofsky Performance score or Lansky Play-Performance scale
* Sufficient physiological reserves
* Signed written informed consent

Exclusion Criteria:

* Prior allogeneic HSCT
* Evidence of HIV infection or HIV positive serology
* Evidence of active Hepatitis B, Hepatitis C or EBV as determined by serology or PCR
* Active or uncontrolled infection
* Pregnancy or lactation

Primary outcomes:
measure: Number of Participants With no Acute Toxicity Associated With the Infusion of CordIn, Within 24 Hours Post-infusion.
timeFrame: 24 hours
measure: The Percentage of Patients With Donor-derived Engraftment at 42 Days Following Transplantation
timeFrame: 42 days
Secondary outcomes:
measure: Percentage of Overall Survival at 365 Days After Transplantation
timeFrame: 365 days
Other outcomes:
Locations:
city: Oakland
country: United States
facility: UCSF Benioff Children's Hospital
state: California
city: Washington
country: United States
facility: Children's National
state: District of Columbia
city: Paris
country: France
facility: Hôpital Robert Debré
Study officials:
affiliation: Robert Debre, Paris, France
name: Jean-Hugues Dalle, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: IRCCS Ospedale Pediatrico Bambino Gesu, Rome, Italy
name: Franco Locatelli, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Children's National, Washington DC
name: Allistair Abraham, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00856219: Comparison of Enteral Versus Parenteral Feeding in Healthy Human Subjects
Official title: Comparison of Enteral Versus Parenteral Feeding in Healthy Human Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Immune System
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
First posted: 2009-03-05
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Literature suggests that route of feeding and/or certain nutrients may cause alterations in the body's immune cells. Immune cells help protect the body and fight infection/disease. Tube feeding (TF) is a method of delivering nutrition directly to the stomach/intestines via a small tube. The immune system may respond differently when receiving continuous TF as compared to receiving intermittent TF. Heart rate variability (HRV, the intervals between heartbeats) is a measurement of the nervous system's response to a stress/illness. The differences in immune cells and/or HRV may influence how the body reacts to complications such as infection.


Eligibility criteria: Inclusion Criteria:

* General good health as demonstrated by medical history, physical\& laboratory tests
* Age between 18 and 40 years
* Written informed consent prior to the performance of any study related procedures

Exclusion Criteria:

* History of cancer, rheumatoid arthritis, or immunological, renal, hepatic, endocrine, neurologic, heart disease or hypertension
* Any medication taken in past 48 hrs (except birth control)
* Recent history of alcohol or drug abuse
* Unable to provide written informed consent
* Exposure to any experimental agent or procedure within 30 days of study
* Pregnant or breast-feeding

Primary outcomes:
measure: Route and type of feeding on Immune response
timeFrame: Day 1- Day 4
Secondary outcomes:
Other outcomes:
Locations:
city: New Brunswick
country: United States
facility: Rutgers-RWJMS
state: New Jersey
Study officials:
affiliation: Rutgers-RWJMS
name: Siobhan Corbett, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03868319: Lung-protective Ventilation During Robot-assisted Laparoscopic Radical Cystectomy
Official title: Effect of Lung-protective Ventilation During Robot-assisted Laparoscopic Radical Cystectomy on Postoperative Pulmonary Complication
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung-protective Ventilation
Keywords: lung-protective ventilation strategy
low tidal volume
positive end-expiratory pressure
Lung ultrasound
postoperative pulmonary complications
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2019-03-11
Enrollment: 258
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Lung-protective ventilation(LPV) group (low tidal volume 6 ml kg-1 predicted ideal body weight (PBW)+ 7 cmH2O positive end-expiratory pressure(PEEP)) vs. nonprotective group (control group) (large tidal volume 9 ml kg-1 + zero PEEP (ZEEP)) mechanical ventilation in patients undergoing RARC
Primary purpose: PREVENTION

Brief summary: Robot-assisted laparoscopic radical cystectomy (RARC) increases the incidence of postoperative complications. We conducted a study to determine the effect of lung-protective ventilation strategy.

Detailed description: Robot-assisted laparoscopic radical cystectomy (RARC) performed with patient in the steep Trendelenburg position under pneumoperitoneum increases the incidence of postoperative complications. Approach termed lung-protective ventilation (LPV) strategy which refers to the use of low tidal volumes and positive end-expiratory pressure (PEEP) may lead to a reduction in inflammation and prevent the occurrence of atelectasis. Computed tomography (CT) requiring transportation is the golden standard for measuring atelectasis, which is not suitable for perioperative observation. Lung ultrasound (LUS) which is noninvasive and easily repeatable at the bedside appears to be an accurate diagnostic tool for early detection of atelectasis. Thus, we conducted the trial to determine whether an LPV strategy has benefits in patients scheduled for RARC through a multifaceted method. We hypothesized that the use of prophylactic low tidal volume and PEEP would decrease postoperative inflammation and atelectasis, thereby, improve outcomes, as compared with the standard of nonprotective mechanical ventilation.

Eligibility criteria: Inclusion Criteria:

* scheduled for elective RARC

Exclusion Criteria:

* history of lung surgery
* patients' refusal or inability to give informed consent

Primary outcomes:
measure: occurrence of postoperative pulmonary complications (PPCs)
timeFrame: during the first 90 days after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Renji Hospital, Shanghai Jiao Tong University, School of Medicine
state: Shanghai
Study officials:
affiliation: The Second Affiliated Hospital of Soochow University, China
name: Hong Xie, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT05819619: Prophylactic Analgesic and Antiemetic Regimen for Medical Abortion < 70 Days
Official title: Prophylactic Analgesic and Antiemetic Regimen for Medical Abortion < 70 Days
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Nausea
Pain
Keywords: medical abortion
prophylactic use
nausea
pain
patient satisfaction
Lead sponsor: Hackensack Meridian Health
Sponsor class: OTHER
First posted: 2023-04-19
Enrollment: 168
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Randomized trial which will aim to evaluate whether prophylactic use of ondansetron and ibuprofen will decrease side effects associated with medical abortion and increase patient satisfaction.


Eligibility criteria: Inclusion Criteria:

* Healthy
* English speaking
* female volunteers undergoing medical abortion whether for voluntary interruption of pregnancy or missed abortion
* Gestational age \</= 70 days confirmed via ultrasound
* Access to a time keeping device
* Willingness to complete a telephone or in-clinic follow up

Exclusion Criteria:

* chronic medical problems including but not limited to cardiac conditions, malignancy or organ damage
* Failed medical abortion resulting in surgical management
* Known intrauterine infection
* Known allergy to ondansetron or ibuprofen
* Subjects chronically receiving analgesic drugs
* Subjects unable to give consent
* Subjects taking medications that interact with ondansetron or ibuprofen

Primary outcomes:
measure: Patient satisfaction
timeFrame: At follow up visit, within 2 weeks from the administration of misoprostol
measure: Patient satisfaction based on recommendation of regimen
timeFrame: At follow up visit, within 2 weeks from the administration of misoprostol
Secondary outcomes:
measure: Pain management at 6-8 hours
timeFrame: Within 6-8 hours from the administration of misoprostol
measure: Pain management at 24 hours
timeFrame: Within 24 hours from the administration of misoprostol
measure: Nausea Management
timeFrame: Within 6-8 hours from the administration of misoprostol
measure: Nausea Management
timeFrame: Within 24 hours from the administration of misoprostol
measure: Need for pain management medication.
timeFrame: Within 24 hours from the administration of misoprostol
measure: Need for anti-nausea medication.
timeFrame: Within 24 hours from the administration of misoprostol
Other outcomes:
Locations:
city: Hackensack
country: United States
facility: Antonia Oladipo
state: New Jersey
Study officials:
affiliation: Hackensack Meridian Health
name: Melissa Figueroa, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06064019: Evaluation of Nevisense as Support Tool for the Diagnose of Keratinocyte Skin Cancer
Official title: Evaluation of the Clinical Utility of a New Diagnostic Support Tool, Based on Electrical Impedance Spectroscopy (NEVISENSE), for Keratinocyte Skin Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Keratinocyte Skin Cancer
Keywords: Electrical Impedance Spectroscopy
Lead sponsor: SciBase AB
Sponsor class: OTHER
First posted: 2023-10-03
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This is a prospective study to assess efficacy of the Nevisense device in identifying keratinocyte skin cancer (KC) in patients suspected of having skin cancer based on the initial physician's assessment.

All skin lesions with a suspicion of Basal cell carcinoma (BCC), Invasive Squamos cell Carcinoma (iSCC), Bowen's disease (BD) or actinic keratosis (AK) and destined for excision or biopsy for further histopathological analysis will be considered for inclusion in the study.


Eligibility criteria: Inclusion Criteria:

* All male or female patients of any ethnicity, ≥ 18 years with skin lesions of a clinical uncertain diagnosis suspicious for KC (such as BCC, iSCC, BD or AK)

Exclusion Criteria:

* Metastases of recurrent lesions
* Lesion located on acral skin, e.g. sole or palm
* Lesion located on areas of scars, crusts, psoriasis or similar skin conditions
* Lesion on hair-covered areas, e.g. scalp, beards, moustaches
* Lesion located on genitalia
* Lesion located in an area that has been previously biopsied or subjected to any kind of surgical intervention or traumatized
* Lesion located on mucosal surfaces
* Lesion with foreign matter, e.g. tattoo or splinter
* Lesion and / or reference located on acute sunburn
* Skin surface not measurable, e.g. lesion on a stalk
* Skin surface not accessible, e.g. inside ears, under nails

Primary outcomes:
measure: Nevisense Sensitivity and Specificity
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Wuppertal
country: Germany
facility: CentroDerm
Study officials:
affiliation: CentroDerm GmbH
name: Thomas Dirschka, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: