louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03537807: Expanded Access Protocol of BHV-0223 for Patients With Amyotrophic Lateral Sclerosis (ALS)
Official title: BHV-0223 Expanded Access Protocol in Patients With Amyotrophic Lateral Sclerosis
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Amyotrophic Lateral Sclerosis
ALS
Lou Gehrig Disease
Lou Gehrig's Disease
Lou-Gehrigs Disease
Motor Neuron Disease, Amyotrophic Lateral Sclerosis
Keywords: Amyotrophic Lateral Sclerosis
ALS
Lou Gehrig Disease
Lou Gehrig's Disease
Lou-Gehrigs Disease
Motor Neuron Disease, Amyotrophic Lateral Sclerosis
Riluzole
Rilutek®
Sublingual
Oral formulation
Neuroprotective Agents
Administration, Sublingual
Administration, Oral
Biological Availability
Lead sponsor: Biohaven Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2018-05-25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: This is an open label expanded access protocol for the treatment of up to approximately 250 adult patients with amyotrophic lateral sclerosis (ALS) who have difficulty swallowing oral riluzole tablets and may be able to derive benefit from treatment with an alternative oral formulation of riluzole.

Detailed description: Riluzole is indicated in the U.S. for the treatment of patients with amyotrophic lateral sclerosis (ALS). The commercially available dosage form is a 50mg oral tablet. This expanded access protocol (EAP) is designed to provide access to a dissolving tablet formulation of riluzole designed for sublingual (SL) administration, in patients with ALS who, in the opinion and clinical judgement of the treating physician, would benefit from treatment with BHV-0223.

Eligibility criteria: Inclusion Criteria:

* Patients with diagnosed ALS of any type or duration
* Current or previous treatment with oral riluzole tablets, or patients who have never taken riluzole oral tablets, or patients who have successfully completed a clinical trial with BHV-0223 and were not withdrawn prematurely due to adverse events
* Swallowing difficulties, or patient or caregiver report choking one or more times per week, or investigator deems appropriate to treat with sublingual BHV-0223 because (s)he deems the patient cannot be satisfactorily treated with Rilutek®
* Adequate hepatic function

Exclusion Criteria:

* Patient with history of severe hypersensitivity reaction to riluzole oral tablets or BHV-0223
* Patient is known to have any other acute or chronic liver disease

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04243707: Cobalamin Deficiency - Diagnosis and Therapy
Official title: Diagnostics and Therapy of a Cobalamin Deficiency
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vitamin B 12 Deficiency
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2020-01-28
Enrollment: 3000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: potential cobalamin deficiency

Brief summary: In a retrospective study with existing values of vitamin B12 and holotranscobalamin 4 strategies are simulated and the results and costs are compared.

Generally, cobalamin ist substituted by intramuscular administration. However, oral preparations are also available. Aims of the focus groups are to investigate the awareness of a (potential) deficiency and to identify a therapy for best adherence.

Detailed description: Various diagnostic strategies exist for the identification of a cobalamin deficiency. In a retrospective study with existing serum values of vitamin B12 and holotranscobalamin 4 strategies are simulated and the results and costs are compared.

A cobalamin deficiency can have various causes: Dietary habits (vegetarian, vegan), advanced age, pernicious anaemia, gastrectomy, drug interactions (metformin, proton pump blocker). Therapy is often performed by intramuscular administration of cobalamin. However, oral preparations are also available in very different dosages. Investigators want to investigate with focus groups whether different patient groups are aware of a (potential) deficiency, how cobalamin is actually substituted (with registered or otherwise acquired products) and which therapy would lead to best adherence.

Eligibility criteria: Inclusion Criteria:

* potential cobalamin deficiency

Exclusion Criteria:

* refusal to take part in a survey

Primary outcomes:
measure: diagnostic strategies
timeFrame: 2017 - 2018
measure: supplementation of cobalamin deficiency
timeFrame: 2020
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Pharmaceutical Care Research Group
Study officials:
affiliation: Pharmaceutical Care Research Group
name: Isabelle Arnet, PD Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02280707: Intervention to Promote Water Consumption in School Lunchrooms
Official title: Grab a Cup, Fill it up! An Intervention to Promote Convenience of Drinking Water and Increase Student Water Consumption During School Lunch.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Water Consumption
Schools
Lead sponsor: Harvard School of Public Health (HSPH)
Sponsor class: OTHER
First posted: 2014-10-31
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study, randomized, delivered, and analyzed at the school level, evaluated the effect of simple, structural changes to school lunch rooms to make drinking water easier for students during lunch time. Half of the schools received posters promoting drinking water and installed cup dispensers stocked with cups next to lunchroom water fountains, while the other half received no intervention. The intervention outcomes were average water consumption and the proportion of students in the lunchroom who opted to drink water, as well as the proportion of students with sugary drinks at lunch. No identifying information on individual children was collected.


Eligibility criteria: Inclusion Criteria: School in Boston Public School district in Boston, MA; had to have plumbed drinking water access in school cafeteria -

Exclusion Criteria: School had no plumbed drinking water access in cafeteria.

-

Primary outcomes:
measure: Change in average student water consumption at lunch
timeFrame: March 2013-June 2013, up to 4 months
Secondary outcomes:
measure: Change in proportion of students drinking water at lunch
timeFrame: March 2013-June 2013, up to 4 months
measure: Change in proportion of students with sugar-sweetened beverages at lunch
timeFrame: March 2013-June 2013, up to 4 months
Other outcomes:
Locations:
Study officials:
References:
citation: Kenney EL, Gortmaker SL, Carter JE, Howe MC, Reiner JF, Cradock AL. Grab a Cup, Fill It Up! An Intervention to Promote the Convenience of Drinking Water and Increase Student Water Consumption During School Lunch. Am J Public Health. 2015 Sep;105(9):1777-83. doi: 10.2105/AJPH.2015.302645. Epub 2015 Jul 16.
Clinical trial NCT00010907: Preliminary Human Trial of NPI-028
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Alcoholism
Lead sponsor: National Center for Complementary and Integrative Health (NCCIH)
Sponsor class: NIH
First posted: 2001-02-05
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: This research will determine whether the Chinese herbal medicine (NPI-028) can make a significant contribution to the management of withdrawal and to follow-up treatment aimed at preventing or managing relapse in both women and men alcoholics. The herbal preparation has been used historically in the treatment of alcohol intoxication and is still prescribed in China and Southeast Asia. Efficacy has been documented but awaits the application of current research methods to establish efficacy, safety, and probable mechanisms of action. Preclinical studies have been carried out in alcohol-preferring rats and vervet monkeys to test efficacy in reducing voluntary alcohol intake, measure tolerance effects, and toxicological affects. The proposed human trial will develop a placebo, establish quality control, test methods of administration, and examine compliance issues. Following these preliminary steps, a placebo controlled trial will be conducted using 160 subjects (80 subjects per treatment condition with 40 of each gender). Alcohol use, craving, health status, psychological status, and at rates will be assessed using established measures that are current in addiction research.


Eligibility criteria: Inclusion Criteria:

* Able to participate as an outpatient
* Considered of acceptable health as determined by physical examination
* English speaking/reading
* Meets DSM-IV criteria for Alcohol Dependence
* Have at least 10 drinking days in the past month

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Hennepin County Medical Center, Minneapolis
name: Milton L. Bullock, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06622707: EFFECT OF KINESIO TAPING ON POST-C-SECTION PAIN AND COMFORT
Official title: EFFECT OF KINESIO TAPING ON POST-C-SECTION PAIN AND COMFORT
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: C-Section
Keywords: Kinesio Taping
Pain
Postpartum Comfort
Lead sponsor: Şırnak Üniversitesi
Sponsor class: OTHER
First posted: 2024-10-02
Enrollment: 60
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Kinesio taping gently stretches the skin and creates a gap between the dermis and fascia, increasing lymphatic and vascular flow and reducing pain without restricting movement. It is used to provide rehabilitation after surgical operations. This study will be conducted to determine the effect of kinesio taping on the mother\&#39;s pain and comfort after cesarean section. It is planned to include 60 women who gave birth by cesarean section in the obstetrics and gynecology department at Şırnak State Hospital. Research data will be collected with the visual analog scale and postpartum comfort scale. If the data shows normal distribution, Unrelated Samples t Test, Related Samples t Test and Repeated Measures ANOVA (Repeated Measures) tests will be used.


Eligibility criteria: Inclusion Criteria:

* patients having C-section delivery in the 37th and 40th gestational weeks,
* patients giving birth to just a baby,
* patients with no chronic disease (such as allergy, diabetes, or hypertension),
* patients having no problems with communication,
* patients with no dermatological disease.

Exclusion Criteria:

* patients whose babies are in the neonatal intensive care unit,
* patients with deep vein thrombosis, open wounds, or skin irritation,
* patients who did not want to participate in the study,

Primary outcomes:
measure: vas
timeFrame: VAS will be applied at the 10th hour, 24th hour, 48th hour and 72nd hour after cesarean section.
measure: Postpartum comfort questionnaire
timeFrame: It will be filled in at the 10th and 72th hours after birth.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01441609: Expression of Th9 Cells and Poor/Non-responsiveness to Hepatitis B Vaccination
Official title: Effect of the Expression Level of Th9 Cells and IL-9 In Poor/Non-responsiveness to Hepatitis B Vaccination
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hepatitis B
Keywords: Th9 cells
IL9
non/poor responsiveness to hepatitis B
collect blood samples after vaccination
Lead sponsor: Beijing Municipal Science & Technology Commission
Sponsor class: OTHER
First posted: 2011-09-27
Enrollment: 94
Sex: ALL
Minimum age (years): 3
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 94 subjects divided into 4 groups

Brief summary: An observational study will be performed in subjects aged 3-65 years old to describe the dynamic changes of cellular immunity after vaccination of hepatitis B vaccine, and to find out the expression levels of Th9 cells and IL9 in subjects with different response to the primary immunization (3 single -dose injunctions).

Detailed description: This study selected 74 volunteers which had the hepatitis B vaccine (immunization programs 0,1,6) , anti-HBs≤10mIU as the research subjects, and choose 20 volunteers which anti-HBs≥1000mIU as the control group, revaccination the groups according to the normal immunization programs, then the blood samples would be collected at 7th day, separate the PBMC and detect the expression levels of Th9 cells and IL9 by FCM, trying to find out the effects of Th9 and IL9 of non/poor -responsiveness subjects to hepatitis B.

Eligibility criteria: Inclusion Criteria:

* volunteer
* between 3-60 years old
* healthy
* have the history of vaccination of hepatitis B.
* Recent serological testing result show HBsAg, HBeAg, anti-HBe, anti-HBc, HBV DNA and Pre-S1 should be negative.
* informed consent
* not allergic to the component of the vaccine

Exclusion Criteria:

Primary outcomes:
measure: Th9 cells
timeFrame: blood sample of 7th day after each vaccination
Secondary outcomes:
Other outcomes:
Locations:
city: Chifeng
country: China
state: Inner Mongolia
Study officials:
affiliation: main investigator
name: Wu Jiang
role: STUDY_DIRECTOR
References:
Clinical trial NCT04657809: Clinical Assessment of Insulin Fast Dissolving Film in Treatment of Post Infection Anosmia
Official title: "Insulin Fast Dissolving Film for Intranasal Delivery Via Olfactory Region, a Promising Approach for the Treatment of Anosmia in COVID 19 Patients: Design, In-vitro Characterization and Clinical Evaluation."
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Anosmia
Lead sponsor: Deraya University
Sponsor class: OTHER
Collaborators: name: Minia University
First posted: 2020-12-08
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study aimed to investigate the efficacy of insulin in a new dosage form ( fast dissolving film) in treatment of anosmia in patients post infested with Covid-19. The study implication based in two methods evaluations

1. Threshold test
2. identification test.

Detailed description: This study was designed to improve smell disorders after corona infection that is very anxious for all patients.

Inclusion criteria were loss of smell, post covid-19 infection, age from 18 to 70 years and accept sharing and follow up.

The application of dosage form by ENT specialist at otorhinolaryngology clinic at Minia University hospital. Dose was 100iu of insulin 3 times weekly for 4 weeks. The new dosage form with insulin was compared with a placebo to ensure statistical improvement.

The tests were performed in each visit. Primary outcome was the improvement of smell sensors in those patients

Eligibility criteria: Inclusion Criteria:

* anosmia post covid-19 infection

Exclusion Criteria:

* nasal polyps or fractions or syrgery in nose from 6 months or less

Primary outcomes:
measure: Smell sensation improvement
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Minya
country: Egypt
facility: Soad
Study officials:
affiliation: Deraya
name: Soad Mohamed
role: STUDY_DIRECTOR
References:
citation: Webster KE, O'Byrne L, MacKeith S, Philpott C, Hopkins C, Burton MJ. Interventions for the prevention of persistent post-COVID-19 olfactory dysfunction. Cochrane Database Syst Rev. 2022 Sep 5;9(9):CD013877. doi: 10.1002/14651858.CD013877.pub3.
citation: O'Byrne L, Webster KE, MacKeith S, Philpott C, Hopkins C, Burton MJ. Interventions for the treatment of persistent post-COVID-19 olfactory dysfunction. Cochrane Database Syst Rev. 2022 Sep 5;9(9):CD013876. doi: 10.1002/14651858.CD013876.pub3.
Clinical trial NCT02052609: A Phase 3 Clinical Study of KHK 4827
Official title: An Extension Study of KHK4827 in Subjects With Plaque Psoriasis (Psoriasis Vulgaris, Psoriatic Arthritis), Pustular Psoriasis (Generalized) and Psoriatic Erythroderma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Psoriasis Vulgaris
Psoriatic Arthritis
Pustular; Psoriasis, Palmaris Et Plantaris
Psoriatic Erythroderma
Lead sponsor: Kyowa Kirin Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2014-02-03
Enrollment: 155
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: This study is designed to evaluate the safety and efficacy of long-term exposure to KHK4827 in subjects with plaque psoriasis (psoriasis vulgaris, psoriatic erythroderma) who have completed Study 4827-003 (Study 003)and in subjects with pustular psoriasis (generalized) or psoriatic erythroderma who have completed the Study 4827-004 (Study 004).


Eligibility criteria: Inclusion Criteria:

* Subject has voluntarily signed the written informed consent form to participate in this study
* Subject has completed the week 52 evaluation either in Study 003 or 004

Exclusion Criteria:

* Subject has had a serious infection, defined as requiring systemic treatment with antibiotics or antivirals (excluding oral administration)
* Subject has been judged to be ineligible for participation in the study by the investigators/sub investigators

Primary outcomes:
measure: Incidence and types of adverse events and adverse reactions
timeFrame: 28 weeks
measure: Anti-KHK4827 antibody
timeFrame: 28 weeks
Secondary outcomes:
measure: Change in psoriasis area and severity index (PASI) compared to the data obtained before the first dose of investigational product in this study.
timeFrame: 28 weeks
measure: Percent improvement in PASI
timeFrame: 28 Weeks
measure: PASI 50, 75, 90, and 100
timeFrame: 28 Weeks
measure: Static physician's global assessment (sPGA) of "0 (clear) or 1(almost clear)"
timeFrame: 28 Weeks
measure: sPGA of "0 (clear)
timeFrame: 28 weeks
measure: Change in body surface area involvement (BSA) of lesion
timeFrame: 28 weeks
measure: Clinical Global Impression (CGI)
timeFrame: 28 weeks
measure: American College of Rheumatology (ACR) 20
timeFrame: 28 weeks
measure: Pustular symptom score
timeFrame: 28 weeks
measure: Serum KHK4827 concentration
timeFrame: 28 weeks
Other outcomes:
Locations:
city: Chiyoda-ku
country: Japan
facility: For additional information regarding investigative sites for this trial, contact Kyowa Kirin
state: Tokyo
Study officials:
References:
Clinical trial NCT00686309: Comparison of On-line and Off-line Measurements of Exhaled Nitric Oxide (NO)
Official title: Comparison of On-line and Off-line Measurements of Exhaled NO
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Asthma
Primary Ciliary Dyskinesia
Keywords: exhaled NO
off line
on line
comparison
Bland altman method
Lead sponsor: Ziv Hospital
Sponsor class: OTHER_GOV
First posted: 2008-05-29
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: General population bth healthy and with respiratory illness such as asthma, COPD, PCD, Rhinitis

Brief summary: Asthma is a major health problem worldwide. The measurement of fractional exhaled nitric oxide (FENO) has been established as a valuable non invasive and simple tool in the diagnosis of asthma and may also act as a useful surrogate inflammatory marker on which to base treatment decisions in asthma management algorithms. The measurement is useful also in other respiratory diseases. Current methods of measuring FENO include on line measurements by heavy duty expensive analyzers which are not widely and easily available. Off line measurements of breath samples which can be analysed later may be a simple solution. We hypothesize tha toff line measurements of NO will be as reliable and valid as those measured on-line


Eligibility criteria: Inclusion Criteria:

* Volunteer to participate
* Filed a short health questionnaire

Exclusion Criteria:

* None

Primary outcomes:
measure: Off line measurement of exhaled NO
timeFrame: Two types of breathing in the same day
Secondary outcomes:
Other outcomes:
Locations:
city: Safed
country: Israel
facility: Pediatric Department, Ziv Medical Center
Study officials:
References:
Clinical trial NCT04318509: Market Research - Acceptability Study for a New PKU Protein Substitute
Official title: Market Research - Acceptability Study for a New PKU Glycomacropeptide Based Protein Substitute (Dr Schär- Mevalia Amino Acids) Mevalia PKU GMPower - Vanilla
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PKU
Phenylketonurias
Inborn Errors of Metabolism
Metabolic Disease
Lead sponsor: Dr. Schär AG / SPA
Sponsor class: INDUSTRY
First posted: 2020-03-24
Enrollment: 8
Sex: ALL
Minimum age (years): 3
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The aim of this study is to demonstrate that a new protein substitute is acceptable and well tolerated in children with PKU.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of PKU or PKU variant requiring a protein substitute.
* Subjects who were already taking a phenylalanine-free/low phenylalanine protein substitute and were willing to try the study product for 7 days.
* Patients aged 3 years of age to adulthood.
* Written informed consent obtained from participant or parental caregiver (as appropriate).

Exclusion Criteria:

* Presence of serious concurrent illness
* Investigator's uncertainty about the willingness or ability of the patient to comply with the protocol requirements
* Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study.
* Any patients having taken antibiotics over the previous 2 weeks leading up to the study.
* Patients less than 3 years of age.

Primary outcomes:
measure: Gastrointestinal tolerance
timeFrame: 7 days
measure: Product compliance
timeFrame: 7 days
measure: Product palatability
timeFrame: 7 days
measure: Product acceptability
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United Kingdom
facility: Birmingham Children's Hospital
city: Bristol
country: United Kingdom
facility: Bristol Royal Hospital for Children
Study officials:
References: