louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00892229: Buccal Versus Vaginal Misoprostol in Surgical Termination of the First Trimester Missed Abortion in Erbil
Official title: Buccal Versus Vaginal Misoprostol for Cervical Ripening Prior to Surgical Termination of the First Trimester Missed Abortion in Erbil
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Missed Abortion
Keywords: First trimester missed abortion
Misoprostol
buccal
vaginal
cervical ripening
first trimester
missed abortion
Lead sponsor: Hawler Medical University
Sponsor class: OTHER
Collaborators: name: NEGATIVE
First posted: 2009-05-04
Enrollment: 100
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the effectiveness of buccal misoprostol and comparing this with vaginal route of the same drug.


Eligibility criteria: Inclusion Criteria:

* first trimester missed abortion

Exclusion Criteria:

* history or evidence of disorders that represent contraindication to the use of misoprostol:

  * severe pulmonary diseases
  * congenital or acquired heart diseases
  * glaucoma
  * prolonged use of corticosteroid
  * sickle cell anemia and adrenal insufficiency
  * smokers
  * known hypersensitivity to drugs
  * any evidence of infection
* patient's refusal to participate in the study
* patients with abnormal results of investigations
* patients with previous operations on cervix like conisation, cauterization, previous dilatation and curettage
* patients with complete abortion
* patients with severe bleeding that required emergency surgical evacuation of the uterus
* patients with partially dissolved tablets at the site of application in both groups

Primary outcomes:
measure: To compare the efficacy of buccal administration to the more commonly vaginal route for preoperative cervical and priming in patients with first trimester surgical abortion. (Buccal Vs. Vaginal Misoprostol in the First Trimester Missed Abortion.)
timeFrame: March 2007 to March 2008
Secondary outcomes:
measure: The secondary objectives are to compare the side effects and acceptability by the subjects.
timeFrame: March 2007 to March 2008
Other outcomes:
Locations:
city: Risafa
country: Iraq
facility: Iraqi Medical Specialization
state: Baghdad
Study officials:
affiliation: IRAQI MEDICAL SPECIALIZATION/IRAQ
name: BASHAR Y F HANOOSHI, CABOG
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00018629: Cognitive - Behavioral Therapy
Official title: Rehabilitation of Older Patients With Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Schizoaffective Disorder
Schizophrenia
Keywords: Aging
Neuropsychology
Psychotherapy
Rehabilitation
Schizophrenia
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2001-07-05
Enrollment: 76
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to determine if Cognitive - Behavioral Social Skills Training (CBSST) improves functioning in older patients with schizophrenia.

Detailed description: This is a randomized-control clinical trial. After completion the baseline assessment, subjects will be randomly assigned to either standard pharmacotherapy or SP+CBSST and will be followed for 18 months. The subjects will be 180 outpatients over the age of 45 with a diagnosis of schizophrenia or schizoaffective disorder.

Eligibility criteria: Inclusion Criteria:

Patients must be 45 years of age or older with a diagnosis of schizophrenia or schizoaffective disorder.

Exclusion Criteria:

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: VA San Diego Healthcare System, San Diego
state: California
Study officials:
affiliation: VA San Diego Healthcare System, San Diego
name: Eric L. Granholm, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02097329: Study Of Three Different Stomach Acid Reducing Agents When Given With Palbociclib (PD-0332991) And Food
Official title: A Phase 1, Open-Label, 3-Period Crossover Study Of The Effect Of An Antacid, A Proton Pump Inhibitor And An H2-Receptor Antagonist On Palbociclib (PD-0332991) Bioavailability Under Fed Conditions In Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: bioavailability
antacid
rabeprazole
famotidine
palbociclib
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2014-03-27
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: To investigate the effect of acid reducing agents (an antacid and an H2-receptor antagonist and a proton pump inhibitor) on palbociclib bioavailability in the presence of food.


Eligibility criteria: Inclusion Criteria:

* Healthy male and/or female subjects of non-childbearing potential between the ages of 18 and 55 years, inclusive.
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs).
* Willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion Criteria:

* Evidence or history of clinically significant diseases (hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease).
* Use of tobacco or nicotine containing products within 3 months of screening.
* A positive urine drug screen.

Primary outcomes:
measure: Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]
timeFrame: 6 days
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: 6 days
Secondary outcomes:
measure: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
timeFrame: 6 days
measure: Apparent Oral Clearance (CL/F)
timeFrame: 6 days
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax)
timeFrame: 6 days
measure: Apparent Volume of Distribution (Vz/F)
timeFrame: 6 days
measure: Plasma Decay Half-Life (t1/2)
timeFrame: 6 days
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Pfizer Investigational Site
state: Connecticut
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT02051829: Comparison of Preoperative Screening Score for Obstructive Sleep Apnea (OSA)
Official title: Comparison of Preoperative Screening Score for OSA
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sleep Apnea, Obstructive
Lead sponsor: Astes
Sponsor class: OTHER
First posted: 2014-01-31
Enrollment: 1584
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients (\> 18 years) presenting for preoperative assessment before surgery at SLBO.

Brief summary: Comparison of preoperative screening score for OSA. In a preoperative population, comparison of the STOP-BANG, DES-OSA, P-SAP and OSA50 score.

Detailed description: Comparison of preoperative screening score for OSA (Obstructive Sleep Apnea). In a preoperative population, comparison of the STOP-BANG, DES-OSA, P-SAP and OSA50 score.

Comparison between scores and if applied with the results of a polysomnography (PSG).

Eligibility criteria: Inclusion Criteria:

* All adults patients (\> 18 years) performing a preoperative assessment at the ASTES Doctor's Office (ASTES is an acronym with the name of Medical Doctors involved in this office)

Exclusion Criteria:

* Patients \< 18 years

Primary outcomes:
measure: Number of patients with a positive DES-OSA score
timeFrame: Baseline
Secondary outcomes:
measure: Number of patients with a positive STOP-Bang score and a positive PSG (PolySomnoGraphy)
timeFrame: Baseline
Other outcomes:
Locations:
city: Jambes
country: Belgium
facility: Cabinet Medical ASTES
Study officials:
affiliation: Astes
name: Eric P DEFLANDRE, MD, FCCP
role: PRINCIPAL_INVESTIGATOR
References:
citation: Deflandre E, Degey S, Brichant JF, Donneau AF, Frognier R, Poirrier R, Bonhomme V. Pre-Operative Ability of Clinical Scores to Predict Obstructive Sleep Apnea (OSA) Severity in Susceptible Surgical Patients. Obes Surg. 2017 Mar;27(3):716-729. doi: 10.1007/s11695-016-2352-4.
Clinical trial NCT04651829: Suspicion of Non IgE-mediated Cow's Milk Protein Allergy: Prevalence and Evolution
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Food Allergy in Infants
Proctocolitis
Atopic Dermatitis
Reflux, Gastroesophageal
Tolerance
Lead sponsor: Hôpital Armand Trousseau
Sponsor class: OTHER
First posted: 2020-12-03
Enrollment: 100
Sex: ALL
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All infants under 4 months of age consulting for delayed symptoms evoking CMPA are prospectively included. All these infants benefit from a CMP elimination diet by replacing their usual formula with an extensive CMP hydrolysate, hydrolysed rice-protein formula, or an amino acid-based formula (AAF). Only children whose symptoms disappear after this exclusion diet are selected for the study.

Brief summary: Cow's milk protein allergy (CMPA) is often evoked in infants, in particular in front of delayed symptoms such as rectal bleeding, atopic dermatitis, excessive crying, reflux, failure to thrive... But in case of non IgE-mediated CMPA, the only way to diagnose this allergy is to proceed to an elimination-reintroduction test over a period of 2 to 4 weeks, to improve symptoms first, and then provoke them. Even if the diagnosis is confirmed, we speculate that non IgE-mediated CMPA has a faster resolution than other CMPA.

The first aim of this study is to estimate the prevalence of non IgE-mediated CMPA in a cohort of infants with delayed symptoms which could be relied to a CMPA. The second goal is evaluate the age of tolerance in non IgE-mediated CMPA with oral food challenge for milk ever 2 months after 4 months of age.


Eligibility criteria: Inclusion Criteria:

* infants under 4 months age with delayed symptoms evoking CMPA

Exclusion Criteria:

* exclusively breastfed infants
* no improvement of symptoms despite amino acid formula
* patients with symptoms of food protein induced enterocolitis
* patients who do not have diagnostic oral food challenge within 3 months after the start of elimination diet

Primary outcomes:
measure: prevalence of CMPA in patients with suspicion of non IgE-mediated CMPA
timeFrame: 2 to 8 weeks after inclusion
Secondary outcomes:
measure: age of tolerance of confirmed non IgE-mediated CMPA
timeFrame: after 4 months of age, and at least after 2 months of elimination diet, and then ever 2 months until tolerance
Other outcomes:
Locations:
city: Paris
country: France
facility: Pediatric nutrition and gastroenterology department, Trousseau Hospital, APHP
Study officials:
References:
Clinical trial NCT05849129: Adjunctive Intravenous Ascorbic Acid for Advanced Non-Small Cell Lung Cancer
Official title: Adjunctive Intravenous Ascorbic Acid for Advanced Non-Small Cell Lung Cancer: A Double Blind, Placebo Controlled, Phase II Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Lung Cancer
Lead sponsor: The Canadian College of Naturopathic Medicine
Sponsor class: OTHER
Collaborators: name: Ottawa Hospital Research Institiute
First posted: 2023-05-08
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This is a two arm RCT evaluating the effect of intravenous vitamin C versus placebo in patients with incurable non-small cell lung cancer. Participants in both arms will be receiving platinum doublet chemotherapy with or without concurrent immunotherapy as standard care. We plan to enroll 90 patients over 5 years.


Eligibility criteria: Inclusion Criteria:

1. Adults (≥18 years of age) seen at TOHCC with stage IIIB or IV primary non-small cell lung cancer
2. Eligible and scheduled for first line platinum-doublet chemotherapy with or without concurrent immunotherapy

Exclusion Criteria:

1. ECOG status greater than 2
2. Previously received IVC within 6 months prior to randomization
3. Biochemical deficiency in G6PD
4. Estimated Glomerular Filtration Rate (eGFR) less than 45 mL/min
5. Currently taking insulin or warfarin
6. History of severe renal dysfunction or hemochromatosis
7. Previously undergone cytotoxic chemotherapy or immunotherapy within 12 months prior to randomization
8. If pregnant or planning to become pregnant: not a carrier of the gene for G6PD deficiency
9. Currently taking an investigational product or participation in an investigational study within the past 30 days
10. Any reason which, under the discretion of the Principal Investigator or delegate, would preclude the patient from participating

Primary outcomes:
measure: Change in Quality of Life
timeFrame: Baseline, Chemo cycles 1-4, 6 months, 12 months
Secondary outcomes:
measure: Chemotherapy-Related Toxicities
timeFrame: 12 months
measure: Frequency of Discontinuation of Chemotherapy
timeFrame: 6 months
measure: Change in General Symptom Burden
timeFrame: Baseline, chemo cycles 1-4, 6 months, 12 months
measure: Change in C-Reactive Protein Levels
timeFrame: Baseline, chemo cycles 1-4, 6 months, 12 months
measure: Tumour Progression
timeFrame: 12 months
measure: Survival
timeFrame: 24 months
measure: Safety
timeFrame: 6 months
measure: Cytotoxicity
timeFrame: 12 months
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: The Ottawa Hospital
state: Ontario
Study officials:
References:
Clinical trial NCT01941680: High Risk Adult T-cell Leukemia/Lymphoma (ATLL-HR) and Allogeneic Transplant
Official title: Observational Prospective Study, Evaluating the Standard of Care as Recommend by International Consensus With Zidovudine-Pegylated Interferon +/-Polychemotherapy in High Risk Adult-T-cell Lymphoma/Leukaemia (T-cell Lymphoma/Leukaemia) Followed by Allogeneic Transplant Among Eligible Patients Younger Than 65 Years Old
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: T-cell Lymphoma
Leukaemia
Lead sponsor: University Hospital Center of Martinique
Sponsor class: OTHER
First posted: 2013-09-13
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Populations of French Caribbean Islands and Guyana with ATLL-HR. .

Brief summary: Patients are recruited at diagnosis or at relapse of ATLL-HR in French Caribbean islands and Guyana. They all receive Zidovudine and Pegylated Interferon (ZPI). For patients younger than 65 years old, an allogeneic donor is searching out. Patients included at relapse and with lymphoma clinico-biological subtype also receive chemotherapy (CT). Responses are assessed during ZPI+/-CT and eligible patients (depending on age, comorbidities and response criteria) receive allogeneic transplant. Patient follow-up is planned for 3 years old


Eligibility criteria: Inclusion Criteria:

* Patient \>18 years old and ≤ 75 years old, with ATLL-HR who signed informed consent.

Exclusion Criteria:

* Pregnant or nursing women are not eligible; neither are women of childbearing potential unless using effective contraception as determined by the patient's physician.

Primary outcomes:
measure: Number of patients with relapse
timeFrame: Up to 3 year
Secondary outcomes:
measure: Evidence of presence of gene expression of Tax and HBZ confirmed by Rt-PCR
timeFrame: 1 year
Other outcomes:
Locations:
city: Pointe à Pitre
country: Guadeloupe
facility: CHU Pinteà Pitre/Abymes
city: Fort de France
country: Martinique
facility: CHU de Martinique
Study officials:
References:
Clinical trial NCT00578929: Safety and Efficacy of Olopatadine HCl Nasal Spray in 6-11 Year Old Patients
Official title: Safety and Efficacy of Olopatadine HCl Nasal Spray in 6-11 Year Old Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Seasonal Allergic Rhinitis
Keywords: allergic rhinitis
allergies
seasonal allergies
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2007-12-21
Enrollment: 2388
Sex: ALL
Minimum age (years): 6
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A study to demonstrate the superiority of test article nasal spray relative to vehicle nasal spray for the treatment of seasonal allergic rhinitis for a 2 week period in patients aged 6 to 11 years with a history of seasonal allergic rhinitis.


Eligibility criteria: Inclusion Criteria:

* Male or female; minimum of 6 years of age and less than 12 years
* 2 year history of seasonal allergic rhinitis

Exclusion Criteria:

* Concurrent disease that might interfere with the investigation or evaluation of te study medication
* Confirmed diagnosis of chronic rhinosinusitis within the last year
* Asthma, with the exception of mild intermittent asthma
* Anatomical nasal deformity
* Nasal obstruction
* Known non-responder to antihistamines for symptoms of Seasonal Allergic Rhinitis (SAR)
* Chronic or intermittent use of of inhaled, oral, intramuscular intravenous corticosteroids ot topical steroids
* Ocular disorder other that allergic conjunctivitis

Primary outcomes:
measure: Percent Change From Baseline in the Reflective Total Nasal Symptom Score (TNSS)
timeFrame: Baseline through 2 weeks after randomization
Secondary outcomes:
measure: Percent Change From Baseline in the Reflective Total Ocular Symptom Score (TOSS)
timeFrame: Baseline through 2 weeks after randomization
Other outcomes:
Locations:
city: Kenilworth
country: United States
facility: Kenilworth/IL
state: Illinois
Study officials:
affiliation: ed.tumaian@alconlabs.com
name: Ed Tumaian
role: STUDY_DIRECTOR
References:
citation: Meltzer EO, Blaiss M, Fairchild CJ. Comprehensive report of olopatadine 0.6% nasal spray as treatment for children with seasonal allergic rhinitis. Allergy Asthma Proc. 2011 May-Jun;32(3):213-20. doi: 10.2500/aap.2011.32.3448. Epub 2011 Apr 8.
Clinical trial NCT00659880: Clinical Application of BioCleanse Meniscus
Official title: Clinical Application of BioCleanse Meniscus Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tear of Meniscus of Knee
Keywords: Meniscus transplant
Meniscal allograft
MAT
Knee
Lead sponsor: RTI Surgical
Sponsor class: INDUSTRY
First posted: 2008-04-16
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients, between the ages of 18 and 55 years, who have selected meniscal allograft transplantation (MAT) using BioCleanse allografts will be eligible to participate in the MAT registry.

Brief summary: This study will follow patients after routine surgery of a meniscal allograft transplant.

Detailed description: The BioCleanse meniscus is available to to all orthopedic surgeons for transplantation. The purpose of this registry is to allow close monitoring of a subgroup of patients receiving the BioCleanse Meniscus. All patients who have selected a BioCleanse Meniscus for their Meniscal Allograft transplant will be asked to join the registry. Outcomes will be measured by subjective subject questionnaires as well as X-rays and MRI.

Eligibility criteria: Inclusion Criteria:

* All patients, up to 10 who have selected a BioCleanse Meniscus transplant

Exclusion Criteria:

* Anyone not eligible for a meniscal transplant

Primary outcomes:
measure: Knee Injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: 60 months
Secondary outcomes:
measure: MRI Assessments
timeFrame: 12 months
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: OrthoIndy
state: Indiana
Study officials:
affiliation: OrthoIndy -Orthopaedic Research Foundation, Inc
name: Jack Farr, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00424580: Airway Responses to Montelukast and Desloratadine.
Official title: Airway Responses to Montelukast and Desloratadine.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Lead sponsor: University of Saskatchewan
Sponsor class: OTHER
First posted: 2007-01-19
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Montelukast (for asthma) and desloratadine (for allergies) are effective therapy for their current uses. Part of what happens when your allergies trigger your asthma should be prevented by either of these drugs. This project is being conducted to determine if these drugs are effective, either alone or in combination, on controlling asthma that is triggered by allergies.


Eligibility criteria: Inclusion Criteria:

* baseline FEV1 \> or = 65% predicted
* positive methacholine challenge (i.e. methacholine PC20 \< or = 16mg/ml
* positive allergen challenge

Exclusion Criteria:

* negative skin prick test
* lung condition/disease other than asthma
* currently use montelukast and/or desloratadine

Primary outcomes:
measure: Late asthmatic response (maximum percent decrease in FEV1)
Secondary outcomes:
measure: Early asthmatic response (maximum percent decrease in FEV1
measure: Changes in sputum cell/mediator content
measure: Changes in airway hyperresponsiveness (methacholine PC20)
Other outcomes:
Locations:
city: Saskatoon
country: Canada
facility: Room 346 Ellis Hall
state: Saskatchewan
Study officials:
affiliation: University of Saskatchew Full Professor
name: Donald W Cockcroft, MD, FRCP(C)
role: PRINCIPAL_INVESTIGATOR
References:
citation: Davis BE, Illamperuma C, Gauvreau GM, Watson RM, O'Byrne PM, Deschesnes F, Boulet LP, Cockcroft DW. Single-dose desloratadine and montelukast and allergen-induced late airway responses. Eur Respir J. 2009 Jun;33(6):1302-8. doi: 10.1183/09031936.00169008. Epub 2009 Jan 22.