louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00816972: Desloratadine With Oxybutynin for the Treatment of Seasonal Allergic Rhinitis and Post-Nasal Drip (Study P04258)(COMPLETED)
Official title: Pilot Efficacy and Safety Field Trial of Desloratadine Administered Concomitantly With Oxybutynin, in Subjects With Seasonal Allergic Rhinitis and Post-Nasal Drip
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Post-nasal Drip
Seasonal Allergic Rhinitis
Rhinorrhea
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2009-01-06
Enrollment: 540
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 was a 1-week study of desloratadine (DL) plus oxybutynin (OXY) at two dose levels in the treatment of post-nasal drip in participants with seasonal allergic rhinitis. Participants received either desloratadine twice a day, oxybutynin twice a day, desloratadine plus lower-dose oxybutynin twice a day, desloratadine plus higher-dose oxybutynin twice a day, or placebo for 7 days.


Eligibility criteria: Inclusion Criteria:

Subjects must:

* be \>=18 years of age,
* be free of any clinically significant disease that would interfere with study, other than seasonal allergic rhinitis (SAR),
* have a documented diagnosis of SAR for \>=2 years,
* have had a positive skin-prick test,
* be sufficiently symptomatic at the Screening visit,
* for the 3 calendar days immediately prior to baseline visit, plus the AM of the baseline visit, the seven twice-daily run-in diary PRIOR total nasal symptom scores must have totaled \>=42, the Total Non-Nasal Symptoms score must have totaled \>=28, and the total Post Nasal Drip score must have totaled \>=14,
* be in general good health.

Exclusion Criteria:

Subjects who have:

* certain medical conditions or medical histories,
* allergies to any of the components in any of the study medications,
* nasal structure abnormalities,
* dependency to nasal, oral, or ocular decongestants, nasal topical antihistamines, or nasal steroids,
* used any investigational drug use in past 30 days,
* received immunotherapy (desensitization)
* are pregnant

Primary outcomes:
measure: Change from baseline in mean daily AM/PM Prior post-nasal drip scores averaged over the entire treatment period
timeFrame: Days 1 to 7 +/- 2 days
Secondary outcomes:
measure: Anterior rhinorrhea averaged over Days 1 to 8
timeFrame: Days 1 to 8
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04021472: Evaluate Health Coaching Support in Technology-based Interventions for Meeting Health Goals
Official title: Evaluate Health Coaching Support in Technology-based Interventions for Goal Setting (PEC 15-470)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Disease Prevention
Keywords: Disease prevention
Digital health
Text messaging
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2019-07-16
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: One-group trial
Primary purpose: PREVENTION

Brief summary: This was a pilot evaluation conducted to test procedures for a possible future trial and provide preliminary insights regarding whether text messages sent to Veterans could help support nutrition and/or physical activity health goals. For the purposes of the pilot, the goal was to enroll one participant.

Detailed description: The investigators prepared procedures for a one-group pilot intended to evaluate the delivery of automated text messages to Veterans. Completion of this pilot will provide preliminary insights regarding the delivering automated text messages focused on nutrition and/or physical activity health goals, and potential impacts on outcomes like self-efficacy, goal commitment, and health confidence.

Eligibility criteria: Inclusion Criteria:

* Patient at designated VA site
* Ownership of a cellular phone
* Over age 18
* Pre-screened by their primary care physician for study inclusion for medical contraindication to physical activity and diet change

Exclusion Criteria:

* Patient outside designated VA site
* Non-ownership of a cellular phone
* Under age 18
* Not pre-screened by their primary care physician for study inclusion for medical contraindication to physical activity and diet change or deemed ineligible to participate by primary care physician

Primary outcomes:
measure: Self-efficacy: Healthful Eating Via Revised Eating Self-Efficacy Scale (ESES-R)
timeFrame: Change from Baseline to 2 months
measure: Goal Commitment: Healthful Eating Via the Hollenbeck, Williams, and Klein Goal Commitment Scale
timeFrame: Change from Baseline to 2 months
measure: Self-efficacy: Physical Activity Via the Self-efficacy for Exercise Behaviors Scale
timeFrame: Change from Baseline to 2 months
measure: Goal Commitment - Physical Activity Via the Hollenbeck, Williams, and Klein Physical Activity Scale
timeFrame: Baseline
Secondary outcomes:
measure: Health Confidence: the Health Confidence Score
timeFrame: Change from Baseline to 2 months
Other outcomes:
Locations:
city: Bedford
country: United States
facility: VA Bedford HealthCare System, Bedford, MA
state: Massachusetts
Study officials:
affiliation: VA Bedford HealthCare System, Bedford, MA
name: Timothy Patrick Hogan, PhD MS BS
role: PRINCIPAL_INVESTIGATOR
affiliation: VA Bedford HealthCare System, Bedford, MA
name: Lisa M. Quintiliani, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02350972: Inducing Systemic Immunity and Regressions in Metastatic Melanoma
Official title: Inducing Systemic Immunity and Regressions in Metastatic Melanoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Metastatic Malignant Melanoma
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2015-01-30
Enrollment: 88
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: In patients with multiple metastatic nodules of melanoma, the investigators evaluated whether autologous cytokines injected into cutaneous metastases would induce a systemic immune response as evidenced by the accumulation of dense lymphocytic infiltrates in metastases that had never been injected. Such immune responses were observed, and often the never-injected metastasis regressed completely. 20% of patients remained free of disease for greater than 5 years.

Detailed description: Lymphocytic infiltrates were seen in never-injected nodules only after several weeks of injections elsewhere. No adverse events were seen. The tumor-infiltrating lymphocytes were able to kill autologous melanoma ex vivo. Some patients who experienced complete regressions of all metastases lived without disease for over 10 years.

Eligibility criteria: Inclusion Criteria:

* Multiple cutaneous or subcutaneous metastases of melanoma

Exclusion Criteria:

* Visceral metastases on admission.
* No current chemotherapy or immunotherapy.
* Note study performed between 1978 and 2002 before current therapies were available.

Primary outcomes:
measure: Immune responses as evidenced by lymphocytic infiltrates in never-injected nodules.
timeFrame: Cutaneous nodules were biopsied by a surgeon afer 8 to 20 weeks of injections.
Secondary outcomes:
measure: Complete regression of a metastasis
timeFrame: Complete regressions of all injected and never-injected metastases occurred in different pts after 13 weeks to 48 months of injections. Pts with progressive disease were switched to chemotherapy at any point in the study.
Other outcomes:
Locations:
Study officials:
affiliation: NYU Langone Health
name: Fred T. Valentine, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03881072: Evaluating the Endometrial Receptivity of FET Patient by Ultrasounicelastography
Official title: Evaluating the Endometrial Receptivity of FET Patients by Ultrasounicelastography and Predicting the Pregnancy Outcome.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Assisted Reproductive Technology
Ultrasonography
Keywords: Ultrasounicelastography
Frozen embryo transplantation
Endometrial Receptivity
pregnancy outcome
Lead sponsor: Jinling Hospital, China
Sponsor class: OTHER
First posted: 2019-03-19
Enrollment: 100
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective study
Primary purpose: PREVENTION

Brief summary: Prospective clinical study ：observing the correlation between endometrial elasticity score, endometrial blood flow index (PI, RI, S/D, endometrial thickness, morphology) and clinical pregnancy rate. In order to find a non-invasive, convenient and comprehensive evaluation method of evaluating the endometrial receptivity, and to provide effective means for the frozen embryo transplantation patients to improving pregnancy outcome.

Detailed description: Randomly selecting 20-40 years patients were prepared to accept frozen embryo transplant ; HRT cycle preparation of endometrium；choosing HRT plan to prepare the transplantation endometrium.Establishing a strict standard of exclusion and exclude standard to exclude endometrial lesions and underlying disease.The patients were given elastography for 5-7 days afterEndometrium transformation.Observing the correlation between endometrial elasticity score, endometrial blood flow index (PI, RI, S/D, endometrial thickness, morphology) and clinical pregnancy rate. In order to find a non-invasive, convenient and comprehensive evaluation method of evaluating the endometrial receptivity, and to provide effective means for the frozen embryo transplantation patients to improving pregnancy outcome.

Eligibility criteria: Inclusion Criteria:

1. the volunteers voluntarily signed the informed consent.
2. female patients between 20-40 years old.
3. HRT cycle.
4. no uterine cavity operation was performed within 3 months.

Exclusion Criteria:

1. endometrial polyps, abnormal uterine cavity, intrauterine adhesions and dysplasia of uterus.
2. hydrosalpinx was not ligated.
3. patients with uterine myoma and uterine fibroids;

Primary outcomes:
measure: endometrial receptivity
timeFrame: Month 12
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Yao Bing
state: Jiang Su
Study officials:
References:
Clinical trial NCT03565172: Efficacy of a Long Term, High Intensity and Long Time Stretch Training Program on Viscoelasticity Plantarflexors Muscle in Children With Cerebral Palsy (CP).
Official title: Efficacy of a Long Term, High Intensity and Long Time Stretch Training Program on Viscoelasticity Plantarflexors Muscle in Children With Cerebral Palsy (CP).
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cerebral Palsy, Spastic
Children, Only
Keywords: cerebral palsy
stretching
isokinetic dynamometer
ultrasound
ankle
children
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2018-06-21
Enrollment: 1
Sex: ALL
Minimum age (years): 8
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The methodology used is : Single Case Experimental Design (SCED).
Primary purpose: BASIC_SCIENCE

Brief summary: Children with cerebral palsy present early in the childhood altered muscular properties, as soon as structural or stiffness. In the gastrocnemius muscle, altered muscular properties are characterized by short muscle belly length and increased stiffness which contribute to contracture and limiting joint range of motion.

Detailed description: This study assess efficacy of a long term stretching program of plantarflexors muscle on their viscoelasticity properties and maximal dorsiflexion angle gain. Stretching program is characterized by 3 phases: baseline, intervention and follow-up.

Eligibility criteria: Inclusion Criteria:

* Children aged 8 to 16 years
* Children diagnosed spastic cerebral palsy
* Children with decrease maximal dorsiflexion angle under +5° in the last four weeks
* Children who don't understand instructions

Exclusion Criteria:

* Children who had damage orthopedics or surgical operation contraindicating realization of the experimental protocol
* Hospitalization incompatible with the progress of the protocol.
* Children who had botulinum injection, extensions casts or the implementation of new equipment (night or day orthosis) for less than three months or the progress of the protocol.
* Children having analgesic treatment in progress

Primary outcomes:
measure: slope of the torque-angle curve
timeFrame: up to 12 weeks
Secondary outcomes:
measure: Maximal dorsiflexion angle
timeFrame: up to 12 weeks
measure: Slope of the torque- MyoTendinous Junction (MTJ) displacement
timeFrame: up to 12 weeks
measure: MyoTendinous Junction (MTJ) displacement of muscle triceps sural
timeFrame: up to 12 weeks
measure: muscle triceps sural, muscle body of the medial gastrocnemius muscle and Achilles tendon
timeFrame: up to 12 weeks
measure: discomfort level
timeFrame: up to 12 weeks
Other outcomes:
Locations:
city: Saint-Étienne
country: France
facility: CHU Saint-Etienne
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Vincent GAUTHERON, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02457572: Pulse Pressure Variation Measured During Valsalva Maneuver to Predict Fluid Responsiveness Under Open-chest Condition
Official title: Pulse Pressure Variation Measured During Valsalva Maneuver to Predict Fluid Responsiveness Under Open-chest Condition in the Patients Undergoing Off-pump Coronary Arterial Bypass Grafting
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Surgical Procedures
Thoracic Surgical Procedures
Sternotomy
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2015-05-29
Enrollment: 55
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients undergoing elective off-pump coroanry arterial bypass grafting

Brief summary: Pulse pressure variation (PPV) is a well-known dynamic preload indicator to predict fluid responsiveness. However, its usefulness in open-chest conditions has been equivocal. The investigators evaluated whether PPV measured during Valsalva maneuver can predict fluid responsiveness after sternotomy.


Eligibility criteria: Inclusion Criteria:

- Adult patients undergoing elective off-pump coronary arterial bypass grafting

Exclusion Criteria:

* Preoperative LV EF \<= 35%
* Moderate or severe valvular heart disease
* Cardiac arrhythmia
* Intracardiac shunt
* Severe renal or liver disease
* Moderate to severe pulmonary hypertension (mean PAP \> 35 mmHg)
* Patients with bullous lung disease or combined pneumothorax

Primary outcomes:
measure: Pulse pressure variation during Valsalva maneuver
timeFrame: during Valsalva maneuver
Secondary outcomes:
measure: Pulse pressure variation after sternotomy
timeFrame: 5 min after sternotomy
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
References:
citation: Min JJ, Kim TK, Lee JH, Park J, Cho HS, Kim WS, Lee YT. Evaluation of augmented pulse pressure variation using the Valsalva manoeuvre as a predictor of fluid responsiveness under open-chest conditions: A prospective observational study. Eur J Anaesthesiol. 2017 May;34(5):254-261. doi: 10.1097/EJA.0000000000000613.
Clinical trial NCT04495972: Intestinimonas for Prevention of Type 2 Diabetes Mellitus
Official title: Novel Intestinal Microbiota-based Product for Preventing Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PreDiabetes
Keywords: Prediabetic State
Metabolic Syndrome
Lead sponsor: Caelus Pharmaceuticals BV
Sponsor class: INDUSTRY
First posted: 2020-08-03
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Double-blind, randomized, placebo-controlled study
Primary purpose: TREATMENT

Brief summary: The study aims to assess the effects of a microbiota-based product containing Intestinimonas in adults with pre-diabetes. The purpose is to determine the safety and efficacy of the microbiota-based product on insulin sensitivity in a target group of prediabetic individuals. In particular, the objective is to evaluate whether Intestinimonas is able to improve the insulin sensitivity, the response to the oral glucose tolerance test (OGTT) and whether it is able to modulate the microbiota composition in the study subjects.

Detailed description: The study aims to assess the effects of a microbiota-based product containing Intestinimonas in adults with pre-diabetes.

Intestinimonas is an aerobic microorganism which produces butyrate and interacts with the local microbiota in small and large intestine.

In preclinical studies, it was demonstrated that the insulin sensitivity can be enhanced by Intestinimonas and similar microbiota.

The purpose is to determine the safety and efficacy of the microbiota-based product on insulin sensitivity in a target group of prediabetic individuals.

The study participants will be subjects who are overweight and are at risk of developing Type 2 diabetes.

The key objective of this randomized, placebo-controlled study is to evaluate whether Intestinimonas is able to improve the insulin sensitivity, to assess the response to the oral glucose tolerance test (OGTT) and whether it is able to modulate the microbiota composition in the study subjects.

Furthermore, in a open-label follow-up of 14 weeks the effect of a high-dose of Intestinimonas will be compared with the low-dose tested in the initial double-blind Randomised Controlled Trial (RCT).

Eligibility criteria: Inclusion Criteria:

* increased BMI \> 25,
* Fasting Plasma Glucose (FPG) 100-125 mg/dl or glucose \> 140 after OGTT, or HbA1c 5.7% - 6.4%

Exclusion Criteria:

* Type 2 diabetes

Primary outcomes:
measure: Insulin sensitivity
timeFrame: 12 weeks
Secondary outcomes:
measure: Concentration of Fasting glucose
timeFrame: 12 weeks
measure: Level of 2-hour blood glucose Area Under the Curve (AUC)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Vercelli
country: Italy
facility: University Piemonte Orientale
Study officials:
References:
Clinical trial NCT03127072: Study Comparing Radio Frequency Ablation Plus Chemotherapy and Chemotherapy Alone in Patients With Unresectable CRLM
Official title: A Prospective, Randomized, One-center Study Assessing Overall Survival Using RFA Plus Chemotherapy ± Target Therapy and Chemotherapy ± Target Therapy Alone in Patients With Unresectable Unresectable Colorectal Cancer Liver Metastases
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Colorectal Cancer Liver Metastasis
Keywords: colorectal cancer
liver metastasis
Radiofrequency Ablation
chemotherapy
target therapy
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2017-04-25
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To date no prospective trials have been completed that demonstrated whether RFA is an effective adjunct to systemic chemotherapy (target therapy) with respect to advantages in overall survival compared with chemotherapy (target therapy) alone. The primary objective of this trial is to determine overall survival for patients with colorectal cancer liver metastasis are treated with radiofrequency ablation plus chemotherapy ± target therapy, compared to chemotherapy ± target therapy only.


Eligibility criteria: Inclusion Criteria:

All patients must meet the following criteria:

Patients must have incurable CRLM

Patients must have no more than 10 liver metastases (LMs) remaining after surgical resection, with diameter less than 5cm

Patients is medically eligible to receive RFA, as determined by the MDT (multidisciplinary team)

Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1

Age \> 18 years

Subject life expectancy \> 3 months

Platelets \> 100×103/mm3

Total bilirubin \<1.5mg/dl

Creatinine level \< 2.0 mg/dl

All patients must sign an informed consent form

Exclusion Criteria:

The CRLM is amenable to curative surgical therapy

Uncorrectable coagulopathy

Subject is pregnant, nursing, or wishes to become pregnant during the study

Other serious medical condition (uncontrolled infection, uncontrolled cardiac disease) would preclude study treatment or impact survival

Current or planned treatment with any experimental chemotherapy or target drugs

Primary outcomes:
measure: Overall survival in subjects receiving RFA plus chemotherapy ± target therapy compared to chemotherapy ± target therapy alone was assessed from the date of study entry until death from the disease.
timeFrame: 3 years
Secondary outcomes:
measure: The differences in the incidence or severity of adverse events in the RFA plus chemotherapy ± target therapy arm compared to the chemotherapy ± target therapy only arm were was assessed by of complications after therapy.
timeFrame: 30 days post therapy
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan hosptial, Fudan University
Study officials:
affiliation: Fudan University
name: Jianmin Xu, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT03660072: Postmarketing Study of Empliciti in Korean Patients With Multiple Myeloma
Official title: Empliciti (Elotuzumab) Postmarketing Surveillance in Korean Patients With Multiple Myeloma
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Multiple Myeloma
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2018-09-06
Enrollment: 0
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Korean participants with Multiple Myeloma

Brief summary: This study is a regulatory postmarketing surveillance study for Empliciti with a representative sample of the overall Korean multiple myeloma (MM) population.


Eligibility criteria: Inclusion Criteria:

* Adult participants who have a confirmed diagnosis of Multiple Myeloma (MM)

Exclusion Criteria:

* Participants who use Empliciti for therapeutic indications which are not approved for Empliciti combination therapy in Korea
* Patients in whom treatment with Empliciti (as clarified in the Korean label) is contraindicated

Other protocol defined inclusion/exclusion criteria could apply

Primary outcomes:
measure: Incidence of AE's and SAE's
timeFrame: 24 Months
Secondary outcomes:
measure: Overall response of Empliciti treatment with lenalidomide and dexamethasone
timeFrame: 24 Months
measure: Incidence of infusion-related reactions associated with Empliciti treatment in combination with lenalidomide and dexamethasone
timeFrame: 24 Months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: