louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01720485: Comparison of Desloratadine Associated With Prednisolone (Tablet)Versus Dexchlorpheniramine Associated With Betamethasone (Tablet) for Adult Persistent Allergic Rhinitis Treatment
Official title: A Double-blind,Double Dummy, Randomized, Multicenter Parallel-group Study on Efficacy of Desloratadine and Prednisolone Association Compared to Dexchlorpheniramine and Betamethasone Association in Adults With Moderate - Severe Persistent Allergic Rhinitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Allergic Rhinitis
Lead sponsor: EMS
Sponsor class: INDUSTRY
First posted: 2012-11-02
Enrollment: 234
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: The purpose of this study is to evaluate the non-inferiority clinical efficacy of two different drug associations in the treatment of Moderate - Severe Persistent Allergic Rhinitis in Adults.


Eligibility criteria: Inclusion Criteria:

* Signed Consent of the patient;
* Clinical diagnosis of moderate - severe persistent allergic rhinitis according to ARIA classification(Allergic Rhinitis and Its Impact on Asthma);
* Adults aged ≥ 18 years old;
* Evidence of sensitization to aeroallergens in examination (immediate skin tests or serum specific IgE) in the 12 months prior to inclusion.

Exclusion Criteria:

* Decongestants dependent patients or patients receiving allergen specific immunotherapy;
* Patients who were in use of oral antihistamines or decongestants in the past 15 days;
* Patients who were treated with systemic corticosteroids in the last month;
* Patients on treatment with monoamine oxidase inhibitors (MAOIs);
* Patients with history of hypersensitivity to any of the formula compounds;
* Patients with any clinically significant disease that in the investigator opinion can not participate in the study
* Patients who have uncontrolled asthma, chronic sinusitis, drug related rhinitis and nasal anatomic abnormalities.
* Participation in clinical trial in 30 days prior to study entry;

Primary outcomes:
measure: Efficacy of treatment in persistent allergic rhinitis based on nasal symptoms score
timeFrame: 7 days
Secondary outcomes:
measure: Safety will be evaluated by the adverse events occurrences
timeFrame: 7 days
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: IMA - Instituto de Pesquisa Clínica e Medicina Avançada
Study officials:
References:
Clinical trial NCT06206785: Resting Energy Expenditure in Palliative Cancer Patients
Official title: Resting Energy Expenditure in Palliative Cancer Patients (REPAT) - an Explorative Study in Patients With Incurable Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cancer
Cachexia
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
name: UiT The Arctic University of Norway
First posted: 2024-01-16
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The population is patients diagnosed with an incurable malignant disease and hospitalized at the cancer clinic, St. Olavs Hospital in the period from september 2023 to june 2026. They have to be 18 years or older and able to provide written informed consent and comply with all study procedures.

Brief summary: The study purpose is to measure REE by indirect calorimetry and to determine limits of agreement with confidence intervals between measured REE and predictive equations for determination of energy requirements in patients with incurable cancer. Clinical factors associated with hyper- and hypometabolism will be elucidated. Data will be obtained from patient journals in combination with measurements of REE and registration of survival. Data will be collected at one timepoint and survival will be monitored prospectively.


Eligibility criteria: Inclusion Criteria:

* A verified diagnosis of an incurable malignant disease
* Hospitalized at the Cancer clinic, St. Olavs Hospital
* ≥ 18 years of age
* Able to provide written informed consent
* Able to comply with all study procedures

Exclusion Criteria:

* Cognitive impairment
* In need of supplementary oxygen
* Receiving invasive or noninvasive ventilation

Primary outcomes:
measure: Measurement of resting energy expenditure (REE) in patients with incurable cancer measured with the COSMED Q-NRG+ Indirect Calorimeter with a Canopy Hood.
timeFrame: Throughout study completion, approximately 3 years.
Secondary outcomes:
measure: Clinical factors associated with hyper- and hypometabolism
timeFrame: Throughout study completion, approximately 3 years.
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: Cancer Clinic, St. Olavs Hospital, Trondheim University Hospital
Study officials:
References:
Clinical trial NCT04449185: Change of Gut Microbiome and Symptom After H.Pylori Eradication Therapy in Patients With Functional Dyspepsia
Official title: Change of Gut Microbiome and Symptom After H.Pylori Eradication Therapy in Patients With Functional Dyspepsia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Dyspepsia
Keywords: Dyspepsia
Microbiome
Eradication therapy
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2020-06-26
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aims of the investigators' study are to investigate the effect of H.pylori eradication on the human gut microbiome and symptoms of functional dyspepsia.

Detailed description: Accumulating evidence shows that Helicobacter pylori protects against some metabolic and immunological diseases in which the development of these diseases coincide with temporal or permanent dysbiosis. Helicobacter pylori eradication therapy has the potential to improve symptoms of functional dyspepsia. The aims of our study are to investigate the effect of H.pylori eradication on the human gut microbiome and symptoms of functional dyspepsia.

Eligibility criteria: Inclusion Criteria:

* Patients who has diagnosed with functional dyspesia by Rome IV criteria

Exclusion Criteria:

* Known GI malignancy
* Previous Helicobater pylori eradication history
* Severe systemic disease
* Previous GI surgery
* Uncorrectable coagulopathy: INR \> 1.5 or platelet \< 50,000/ml
* Pregnant or breastfeeding women
* Atrophic gastritis, open type

Primary outcomes:
measure: Change of gut microbiome
timeFrame: at 3 months, and 6 months
Secondary outcomes:
measure: Symptom of dyspepsia
timeFrame: at 3 months, and 6 months
measure: Eradication of helicobacter pylori
timeFrame: at 3 months
measure: Histologic finding of UGI tract
timeFrame: at initial and 3 months
Other outcomes:
Locations:
Study officials:
affiliation: Asan Medical Center
name: Kee Wook Jung, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03544385: Effect of Ocular Hygiene on Scleral Lens Wear
Official title: Effect of Ocular Hygiene on Scleral Lens Wear
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Scleral Contact Lenses
Lead sponsor: University of Houston
Sponsor class: OTHER
First posted: 2018-06-01
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a study to evaluate the performance of Lid Scrubs when added to the daily regimen of scleral lens wear. Lid Scrubs contain surfactants and chemically developed Ringer's solution with microbial attributes. Lid Scrubs are typically used in the treatment of blepharitis. This study is geared towards showing added benefits to scleral lens patients when adding Lid Scrubs to their daily regimens. This study will also show if Lid Scrubs are capable of antimicrobial properties on scleral lens accessories.


Eligibility criteria: Inclusion Criteria:

* • Age: 18 years old to - 85 years old Scleral Lens Correction criteria: Patients should be habitual scleral lens wearers. Patients should use scleral lenses for at least 8 hours a day and for at least 5 days of the week

Exclusion Criteria:

* Exclusions to participate in the study include: adults unable to consent, age restrictions, pregnant women, prisoners, non-english speaking patients (as consent forms are only available in the English language), current optometry students and faculty as these patients may be biased to which products they are using.

Primary outcomes:
measure: length of scleral lens wear
timeFrame: one month
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Houston- College of Optometry
state: Texas
Study officials:
References:
Clinical trial NCT05645185: Characterisation of Clinical Phenotypes and Outcomes of Ma2 Patient
Official title: Characterisation of Clinical Phenotypes and Outcomes of Ma2 Patient
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Autoimmune Encephalitis
Paraneoplastic Syndromes
Keywords: Neurological paraneoplastic syndrome
auto immune encephalitis
Ma2 antibody
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2022-12-09
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with anti-Ma2 paraneoplastic neurological syndromes with or without cancer

Brief summary: Paraneoplastic neurological syndromes (PNS) are rare complications of cancer occurring in 0.01% of cases. Their clinical, biological and radiological presentation is heterogeneous and may constitute a diagnostic challenge. Anti-Ma2 PNS are rare diseases with a guarded prognosis. They are most often associated with a seminoma-like testicular tumor but can also be associated with lung cancer. Classically, they present as limbic, diencephalic and/or brainstem encephalitis. Anti-Ma2 antibodies target intracellular receptors and are characteristic of a particular form of encephalitis. Atypical manifestations including narcolepsy-cataplexy, weight gain, sexual dysfunction and motor neuron syndrome have been described and explain the difficulty in diagnosing anti-Ma2 associated PNS. It seems interesting to better characterize the phenotypes of Ma2 patients in order to optimize the diagnosis and follow-up.


Eligibility criteria: Inclusion Criteria:

* Neurological disorder
* Anti-Ma2 positivity in sera or CSF
* Patient \> 18 years old

Exclusion Criteria:

* Patient without clinical data
* Patient without Ma2 antibody in sera or CSF

Primary outcomes:
measure: Rankin score
timeFrame: 12 month after diagnosis
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Centre de référence des syndromes neurologiques paranéoplasiques et encéphalites autoimmunes
Study officials:
References:
Clinical trial NCT02679885: Teriflunomide Male Transmission Study
Official title: Assay of Teriflunomide Concentrations in Males Taking Teriflunomide for Treatment of Multiple Sclerosis and Their Female Sexual Partners
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Lead sponsor: Griffin Hospital
Sponsor class: OTHER
First posted: 2016-02-10
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants in this study will include approximately twenty heterosexual couples. The male partner will be a subject who has been taking teriflunomide as part of his multiple sclerosis treatment for at least three months and engaging in active sexual relations with his female spouse or partner.

Brief summary: It is known that teriflunomide, a treatment for relapsing forms of multiple sclerosis, can be found in low concentrations in semen. Because the drug has been associated with teratogenicity in laboratory animals, the question is raised as to whether the drug can be detected in female partners of sexually active males who are taking the drug to treat their multiple sclerosis.

Detailed description: A total of 10 couples were enrolled in the study. Females partners had undetectable or borderline levels of teriflunomide.

Eligibility criteria: Inclusion Criteria:

1. Males with relapsing forms of multiple sclerosis appropriately treated with teriflunomide 14 mg po daily;
2. Continuous treatment for three months with good compliance as assessed by the investigator
3. Age between 18 and 55
4. Penile-vaginal intercourse with a female partner at least twice a month with unimpeded ejaculation.
5. Compliance with safety assessments, e.g., regular bloodwork for complete blood count and liver function testing as recommended in the Package Insert
6. Able to give informed consent

Females

1. Regular sexual intercourse with a male partner who is actively taking teriflunomide
2. Age between 18 and 55
3. Able to give informed consent
4. Negative urine pregnancy test at the time of blood sampling
5. Reliable contraception that does not involve barrier methods

Exclusion Criteria:

1. Use of barrier methods of contraception
2. For males, contraindications to the continued use of teriflunomide
3. Couples that are actively trying to conceive
4. For males, noncompliance with teriflunomide therapy
5. Inability or unwilling to give consent or comply with the protocol
6. Pregnancy of the female sexual partner.

Primary outcomes:
measure: Serum levels of teriflunomide in males and their female partners
timeFrame: Up to one year
Secondary outcomes:
Other outcomes:
Locations:
city: Derby
country: United States
facility: Multiple Sclerosis Treatment Center at Griffin Hospital
state: Connecticut
Study officials:
affiliation: MSTC
name: Joseph Guarnaccia, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01899885: Acute High-risk Abdominal Surgery Study - an Optimized Perioperative Course
Official title: Acute High-risk Abdominal Surgery Study - an Optimized Perioperative Course
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Perforated Viscus
Intestinal Obstruction
Keywords: Emergency laparotomy
Emergency laparoscopy
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
First posted: 2013-07-16
Enrollment: 1200
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: The objective of this study is to implement an optimized perioperative course for patients undergoing acute high-risk abdominal surgery in order to improve the outcome.

The optimized perioperative course consists of a number of interventions carried out before, during and after surgery.

Detailed description: Emergency surgery is associated with high mortality rates, post-operative complications and prolonged duration of hospital admission. The investigators will implement a multidisciplinary optimized perioperative course consisting of a number of interventions carried out before, during and after surgery.

Hypothesis: An optimized perioperative course will reduce the 30-day mortality in emergency abdominal surgery patients.

The investigators will do a post-hoc analysis of the data registered.

Eligibility criteria: Inclusion Criteria:

* patients undergoing primary emergency laparotomy or laparoscopy
* patients undergoing reoperation after abdominal surgery.
* Age \> 18 years

Exclusion Criteria:

* Appendectomy
* Emergency laparoscopic cholecystectomy
* Emergency diagnostic laparoscopy without intervention

Primary outcomes:
measure: mortality rate
timeFrame: Within 30 days of surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Hvidovre
country: Denmark
facility: Hvidovre University Hospital
Study officials:
affiliation: Hvidovre University Hospital
name: Line T Tengberg, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tengberg LT, Bay-Nielsen M, Bisgaard T, Cihoric M, Lauritsen ML, Foss NB; AHA study group. Multidisciplinary perioperative protocol in patients undergoing acute high-risk abdominal surgery. Br J Surg. 2017 Mar;104(4):463-471. doi: 10.1002/bjs.10427. Epub 2017 Jan 23.
Clinical trial NCT04206085: Comparison of the Viveve Treatment and Cryogen-Only Treatment Versus Sham Treatment for Stress Urinary Incontinence
Official title: Comparison of the Viveve Treatment and Cryogen-Only Treatment Versus Sham Treatment for Stress Urinary Incontinence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress Urinary Incontinence
Lead sponsor: Viveve Inc.
Sponsor class: INDUSTRY
First posted: 2019-12-20
Enrollment: 38
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 is a prospective, randomized, single-blind, study comparing both the Viveve Treatment (RF plus cryogen) and cryogen alone treatment versus sham treatment in patients with mild to moderate stress urinary incontinence.


Eligibility criteria: Inclusion Criteria:

* Pre-menopausal females, ≥ 18 years of age. Premenopausal is defined as a woman who has had menstrual cycles over the previous 12 months.
* Subjects with a BMI of ≤ 35 kg/m².
* 1-hr pad weight at Baseline with a 5 to 50 g net increase from the pre-test pad weight

Exclusion Criteria:

* Subjects who are currently breastfeeding or have discontinued breastfeeding fewer than 6 months prior to screening.
* Subjects who are pregnant or plan to become pregnant during the course of the study.
* Subjects who have undergone other stress urinary incontinence treatments, excluding behavioral modifications (e.g., Kegel exercises).
* Has any implantable electrical device \[e.g., implantable pacemaker, automatic implantable cardioverter-defibrillator (AICD)\].
* Subjects who have started or changed dose of local vaginal hormones \<6 weeks before Screening.
* Subjects who have started pelvic floor physical therapy within the last 3 months.
* Undergone previous elective surgical or non-invasive procedure(s) in the vaginal canal (including the Viveve Treatment or any other genital radiofrequency treatment; injectable bulking agent, cosmetic, laser, surgical, and/or genital enhancement procedure, and previous dilation and cuterage within 12 months of the subject's Pre-Screening Visit).

Primary outcomes:
measure: 1-hour Pad Weight Test
timeFrame: Change in 1 hour Pad Weight Test Values at 5 Months from Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: Canada
facility: Milestone Research
state: Ontario
city: Sarnia
country: Canada
facility: Bluewater Clinical Research Group
state: Ontario
city: Woodstock
country: Canada
facility: Devonshire Clinical Research
state: Ontario
Study officials:
References:
Clinical trial NCT00836485: Evaluation of the Safety and Efficacy of Ketotifen 4.0% Patch as Compared to Placebo Patch, Olopatadine 0.2% Ophthalmic Solution, and Artificial Tears in the Conjunctival Allergen Challenge (CAC) Model of Acute Allergic Conjunctivitis
Official title: A Prospective, Multi-Center, Double-Masked, Randomized, Placebo-Controlled Evaluation of the Safety and Efficacy of Ketotifen 4.0% Patch as Compared to Placebo Patch, Olopatadine 0.2% Ophthalmic Solution, and Artificial Tears in the Conjunctival Allergen Challenge (CAC) Model of Acute Allergic Conjunctivitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Allergic Conjunctivitis
Lead sponsor: Senju USA, Inc.
Sponsor class: INDUSTRY
First posted: 2009-02-04
Enrollment: 122
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 is a phase 2 study that will consist of 4 visits over a 5 week period. Drug will be evaluated using the conjunctival allergen challenge model of allergic conjunctivitis.


Eligibility criteria: Inclusion Criteria:

* 18 years of age of either sex and any race
* positive history of ocular allergies and a positive skin test reaction to cat hair, cat dander, dog dander, grasses, ragweed, trees, dust mites, and/or cockroaches within the past 24 months
* able and willing to avoid all disallowed medication for the washout period and during the study

Exclusion Criteria:

* active ocular infection or skin condition
* ocular surgery within the past 3 months
* pregnancy or nursing

Primary outcomes:
measure: Ocular itching and bulbar conjunctival redness
timeFrame: Visit 3 and Visit 4
Secondary outcomes:
measure: Ocular: Ciliary, episcleral, and inferior palpebral conjunctival redness; chemosis; lid swelling; tearing; ocular mucous discharge
timeFrame: Visit 3 and Visit 4
measure: Nasal: Rhinorrhea; ear or palate pruritis; nasal pruritis; nasal congestion; and a composite score of all nasal symptoms
timeFrame: Visit 3 and Visit 4
Other outcomes:
Locations:
city: Andover
country: United States
facility: Ora
state: Massachusetts
Study officials:
affiliation: ORA, Inc.
name: Gail Torkildsen, MD
role: PRINCIPAL_INVESTIGATOR
name: TBD TBD
role: PRINCIPAL_INVESTIGATOR
References: