louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00833885: Tolerability and Measurability of the Efficacy of Non Pharmaceutical Measures to Prevent Seasonal Influenza
Official title: Tolerability and Measurability of the Efficacy of Non Pharmaceutical Measures to Prevent Seasonal Influenza
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Influenza
Keywords: Non pharmaceutical measures
Lead sponsor: Robert Koch Institut
Sponsor class: OTHER_GOV
First posted: 2009-02-02
Enrollment: 300
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: With this study the investigators will try to assess the tolerability and measurability of the efficacy of non pharmaceutical measures to prevent seasonal influenza in individual households. Households with an identified index case of influenza will be randomised into one of three intervention arms: 1. group, where the household will receive general information about transmission of influenza virus and means to prevent it (Controls); 2. group, which will receive surgical masks and be asked to wear them whenever they are in close contact with the index case or other persons of the household that became ill during the observation period; 3. group, which will be given and asked to wear surgical masks as well as to execute intensified hand hygiene.

In addition to assessing the secondary attack rate as our primary outcome measure, the investigators will also try to evaluate compliance to those interventions by questionnaires.


Eligibility criteria: Inclusion Criteria:

* influenza like illness symptoms
* positive rapid test for influenza
* inclusion within 48h of symptom onset
* inclusion of at least 3 members of a household (including index case)

Exclusion Criteria:

* severe illness
* other cases of similar symptoms within 14 days before onset of symptoms in index patient
* severe asthma or COPD
* pregnancy of index

Primary outcomes:
measure: Secondary infection with influenza of the household members who are healthy at the start of the study
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Robert Koch Institute
Study officials:
References:
citation: Jefferson T, Del Mar CB, Dooley L, Ferroni E, Al-Ansary LA, Bawazeer GA, van Driel ML, Jones MA, Thorning S, Beller EM, Clark J, Hoffmann TC, Glasziou PP, Conly JM. Physical interventions to interrupt or reduce the spread of respiratory viruses. Cochrane Database Syst Rev. 2020 Nov 20;11(11):CD006207. doi: 10.1002/14651858.CD006207.pub5.
citation: Suess T, Remschmidt C, Schink SB, Schweiger B, Nitsche A, Schroeder K, Doellinger J, Milde J, Haas W, Koehler I, Krause G, Buchholz U. The role of facemasks and hand hygiene in the prevention of influenza transmission in households: results from a cluster randomised trial; Berlin, Germany, 2009-2011. BMC Infect Dis. 2012 Jan 26;12:26. doi: 10.1186/1471-2334-12-26.
Clinical trial NCT00187785: Doctor-Patient Communication in Spanish
Official title: Doctor-Patient Communication in Spanish
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Upper Respiratory Infection
Hypertension
Diabetes
Keywords: Hispanic
communication
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2005-09-16
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: ECT

Brief summary: Does use of a translator or use of less than perfect Spanish diminish provider-patient communication compared to a native speaker.

Detailed description: Spanish speaking drop-in patients will be consented then randomized to receive care by a native Spanish speaker, an English speaker using a translator, or an English speaker with intermediate Spanish skills using Spanish. After the visit, the researcher will enquire about patient satisfaction, when the next appointment is, whether medication has been changed, and what instructions their provider gave them. Each provider will do a similar questionnaire. A blinded researcher will score a concordance of plans between provider and patient to see if there is a significant difference in retained information between the groups.

Eligibility criteria: Inclusion Criteria:

* Spanish speaker

Exclusion Criteria:

-

Primary outcomes:
measure: retention of medical information
Secondary outcomes:
measure: patient satisfaction
Other outcomes:
Locations:
city: Fresno
country: United States
facility: UMC Family Health Center
state: California
Study officials:
affiliation: Department of Family Practice
name: Roger B Mortimer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01242085: Preoperative Alignment of Total Knee Replacement
Official title: Alignment of Total Knee Components Using Standard or Custom Instrumentation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Knee Arthritis
Keywords: alignment
Lead sponsor: VA Palo Alto Health Care System
Sponsor class: FED
Collaborators: name: DePuy Orthopaedics
First posted: 2010-11-16
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The hypothesis of this study is that total knee alignment will be improved by preoperative planning from CT scans and the production of custom instruments compared to the use of standard instruments.

Detailed description: Patients will be randomized to have either customized knee instruments or standard generic instrumentation for primary total knee replacement. Postoperative CT scan will be used to determine alignment of each group.

Eligibility criteria: Inclusion Criteria:patients undergoing primary total knee replacement -

Exclusion Criteria:patients who have hardware involving the hip, knee or ankle

-

Primary outcomes:
measure: Alignment of Knee - Measured Mechanical Axis From CT Data
timeFrame: postoperatively - CT done within 1 week of surgery
Secondary outcomes:
measure: Surgical Time
timeFrame: intraoperative surgical time
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Palo Alto VA HCS
state: California
Study officials:
References:
Clinical trial NCT05942885: Hypnosis: a Path to Appeasement
Official title: Hypnosis: a Path to Appeasement
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hematologic Cancer
Keywords: hypnosis
Diffuse large cell B-cell lymphoma
follicular lymphoma
anxiety
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2023-07-12
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Hypnosis is a technique allowing the patient to focus his mental attention on a thought or a sensation, with the aim of reducing or modulating the intensity of a negative feeling or an ordeal encountered during the course of treatment. This tool can be used when patients are faced with chronic disorders (pain, anxiety, ...) or iatrogenic effects (nausea, asthenia, ...).

The patient is referred to hypnosis care by the doctor, psychologist or paramedics who follow him, when they detect a need.

Several scientific studies have shown the effectiveness of hypnosis in improving the quality of life of patients with breast cancer and in reducing pain during invasive procedures. On the other hand, in hematology, no research has measured the evolution of anxiety, over time, in patients receiving hypnotherapy.


Eligibility criteria: Inclusion Criteria:

* Patients over 18 years old, fluent in French.
* Patients starting hypnotherapy for anxiety disorders.
* Anxiety score on the HADS scale (Hospital Anxiety and Depression Scale) greater than or equal to 8/21
* Patients with diffuse large cell B-cell lymphoma or follicular lymphoma, whatever the stage of the disease.
* Diagnosis announcement less than 2 months old

Exclusion Criteria:

* Persons deprived of their liberty by a judicial or administrative decision
* Adults subject to a legal protection measure

Primary outcomes:
measure: Evolution of anxiety
timeFrame: Week 6 after 2 hypnosis sessions
Secondary outcomes:
measure: Evolution of anxiety before hypnotherapy and after 3 months of follow-up in hypnotherapy
timeFrame: Month 3 after 3 hypnosis sessions
measure: Evolution of anxiety between D0 and M3 according to the type of lymphoma
timeFrame: Month 3 after 3 hypnosis sessions
measure: Evolution of anxiety between D0 and W6 according to the type of lymphoma
timeFrame: Week 6 after 2 hypnosis sessions
measure: Evolution of anxiety between D0 and W6 according to the gender of the patient
timeFrame: Week 6 after 2 hypnosis sessions
measure: Evolution of anxiety between D0 and M3 according to the gender of the patient
timeFrame: Month 3 after 3 hypnosis sessions
measure: Evolution of anxiety between D0 and W6 according to age category
timeFrame: Week 6 after 2 hypnosis sessions
measure: Evolution of anxiety between D0 and M3 according to age category
timeFrame: Month 3 after 3 hypnosis sessions
Other outcomes:
Locations:
city: Lyon
country: France
facility: Service MB1 - Hôpital Lyon Sud - HCL
state: Pierre-Bénite
Study officials:
affiliation: Hospices Civils de Lyon
name: Thomas BERT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00894985: Efficacy and Safety of Sodium Heparin
Official title: Randomized Clinical Trial of Sodium Heparin Effectiveness and Security in Patients Submitted to Heart Surgery Using Bypass
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cardiac Surgery
Keywords: heparin cardiac surgery
Lead sponsor: Azidus Brasil
Sponsor class: INDUSTRY
First posted: 2009-05-07
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The objective of this study is to verify, through a randomized, open, multicentre, parallel and comparative study, the effectiveness of heparin sodium of porcine origin in patients undergoing heart surgery at that require the aid of cardiopulmonary bypass, through the control of hemostasis during and after surgery, based on the strengths of markers of coagulation TCA, TTPA, Anti-Xa, heparin bioavailable and loss of excessive blood (bleeding) at the end of the surgery.


Eligibility criteria: Inclusion Criteria:

* Patients who agree with all aspects of the study and sign the FICT;
* Patients of both sexes;
* Patients aged above 18 years;
* Patients with cardiac surgery and requiring movement; AND
* Extracorporeal.

Exclusion Criteria:

* Patients with hematological disorders that compromise the surgical changes (eg myeloproliferative syndromes, anemia Hb \<11.0 g / dL,
* Platelets \< 150,000 mm3);
* Patients with disorders of hemostasis (INR\> 1.40) (rTTPA\> 1.40);
* Patients with renal dysfunction (creatinine\> 1.50);
* Patients with deep hyperthermia;
* Liver disease (AST and ALT\> 2 times that of the reference value);
* Patients with a history of allergy to heparin or protamine;
* Patients with history of heparin-induced thrombocytopenia;
* Tables infection (eg endocarditis, infection of immune human (HIV), hepatitis B and C, septicemia and pneumonia);
* Reoperations;
* Use of antiplatelet (clopidogrel and ticlopidine) for less than 7 days;
* Use of acetylsalicylic acid is less than 5 days;
* Use of low molecular weight heparin for less than 24 hours; OR
* Use of non-fractioned heparin for less than 12 hours.

Primary outcomes:
measure: Comparison of TTPA, Anti-Xa and ACT
timeFrame: Pre - Operative (T0) Pre Heparinization (T1) Top of Extracorporeal (T2) Period Intraoperative (T3) Termination Extracorporeal (T4) Postoperative
measure: Comparison of bleeding
timeFrame: Pre - Operative (T0) Pre Heparinization (T1) Top of Extracorporeal (T2) Period Intraoperative (T3) Termination Extracorporeal (T4) Postoperative
Secondary outcomes:
measure: adverse reactions
timeFrame: Pre - Operative (T0) Pre Heparinization (T1) Top of Extracorporeal (T2) Period Intraoperative (T3) Termination Extracorporeal (T4) Postoperative
Other outcomes:
Locations:
city: Valinhos
country: Brazil
facility: Lal Clinica Pesquisa E Desenvolvimento Ltda
state: SP
Study officials:
References:
Clinical trial NCT05856656: Music Therapy as a Tool for Anxiety Reduction in Localized Breast Cancer
Official title: Music Therapy as a Tool for Anxiety Reduction in Localized Breast Cancer
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Anxiety
Breast Cancer
Chemotherapy
Lead sponsor: Institut Cancerologie de l'Ouest
Sponsor class: OTHER
First posted: 2023-05-12
Enrollment: 27
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Breast cancer is the number one cancer in women worldwide, with 58,500 new cases in metropolitan France in 2018. The announcement of the cancer, the treatment methods and their side effects can generate unpleasant emotions, such as fear, for example, and the resources for coping with them differ according to the patient. Coming to the hospital as an outpatient for chemotherapy is in itself a source of anxiety.

The use of music in the treatment process is a therapy that can help patients to reduce the intensity of their unpleasant emotions. Active music therapy involves the patient playing an instrument, including voice and body movement in rhythm, without requiring any musical skills. The presence of a qualified music therapy professional is essential, particularly in the reception of the emotions that may be generated during the sessions. These sessions can be collective or individual. In breast cancer, music therapy has been shown to be effective in reducing pain, anxiety, depressive symptoms and length of hospitalisation in patients undergoing mastectomy.


Eligibility criteria: Inclusion Criteria:

* Patient with localized breast cancer
* Indication for adjuvant or neoadjuvant chemotherapy
* Patient \> 18 years of age
* Patient with signed consent
* Patient affiliated to a social security scheme

Exclusion Criteria:

* Metastatic patient
* Triple negative patient
* Patient not eligible for curative surgery
* Patient who has already received chemotherapy
* Unaided deaf patient
* Women who are pregnant, likely to be pregnant or breastfeeding
* A patient presenting a depressive episode or a psychotic pathology at the time of the initial consultation
* Patient who does not understand French
* Cognitive disorder or inability to understand,
* Patient protected by law, under court protection, guardianship or curatorship

Primary outcomes:
measure: To evaluate the impact of music therapy on anxiety in breast cancer patients undergoing adjuvant or neoadjuvant chemotherapy.
timeFrame: 5 months
Secondary outcomes:
Other outcomes:
Locations:
city: Angers
country: France
facility: Institut de Cancérologie de l'Ouest
Study officials:
affiliation: Institut de Cancérologie de l'Ouest
name: Sandra PIQUIN
role: STUDY_DIRECTOR
References:
Clinical trial NCT01245556: Safety and Efficacy Study of BMS-908662 in Combination With Ipilimumab in Subjects With Advanced Melanoma
Official title: A Phase 1 Study of a RAF Inhibitor (BMS-908662) Administered in Combination With Immunotherapy (Ipilimumab) in Subjects With Unresectable Stage III or Stage IV Melanoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Melanoma
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2010-11-22
Enrollment: 8
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 purpose of the study is to identify a safe and tolerable dose of BMS-908662 in combination with ipilimumab; and then to evaluate the anti-tumor response to BMS-908662 when administered in combination with ipilimumab.


Eligibility criteria: Inclusion:

* Male and female subjects ≥ 18 years of age with a histologic or cytologic diagnosis of Stage III or Stage IV (unresectable) melanoma
* Enrollment to cohort expansion will be limited to only those subjects whose tumors demonstrate the B-Raf V600E mutation
* ECOG ≤ 1
* Adequate organ \& marrow function

Exclusion:

* Uncontrolled or significant cardiovascular disease
* Cohort expansion: Prior therapy with a RAF inhibitor

Primary outcomes:
measure: Toxicity will be evaluated according to the NCI Common Toxicity Criteria for Adverse Events (CTCAE) version 3
timeFrame: Assessments approximately every 3 weeks throughout the duration of the trial
Secondary outcomes:
measure: Efficacy as determined by estimates of objective response rates and response duration
timeFrame: Efficacy measured every 6 weeks until week 48, then every 12 weeks
measure: PK for BMS-908662 as determined by minimum and maximum observed concentrations, time of maximum observed concentration, area under the concentration curve for one dosing interval and the accumulation index
timeFrame: PK measured during first 4 weeks on study
measure: PD will be assessed by evaluating markers of RAS/RAF pathway activity
timeFrame: PD assessed during the first 4 weeks on study
Other outcomes:
Locations:
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center & Research Institute
state: Florida
city: New York
country: United States
facility: Jedd D. Wolchok, Md,Phd
state: New York
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT01414556: GIP Effects at Insulin Induced Hypoglycemia in Patients With Type 2 Diabetes
Official title: Effects of Glucose-dependent Insulinotropic Polypeptide at Insulin Induced Hypoglycemia in Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: University Hospital, Gentofte, Copenhagen
Sponsor class: OTHER
First posted: 2011-08-11
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Investigation of GIP effects at fasting and hypoglycemia


Eligibility criteria: Inclusion Criteria:

* Caucasians 18 years or older with Type 2 diabetes (WHO criteria)

Exclusion Criteria:

* HbA1c \>9 %
* Liver disease (ALAT/ASAT \>2 x upper normal limit)
* Diabetic nephropathy (s-creatinine \>130 µM or albuminuria)
* Proliferative diabetic retinopathy (anamnestic)
* Severe arteriosclerosis or heart failure (NYHA group III og IV)
* Anemia
* treatment with medication not applicable to pause for 12 hours
* Fasting plasma glucose \>15 mM on screening day.

Primary outcomes:
measure: glucagon/insulin(c-peptide) absolute, incremental and area under curve values
timeFrame: approx. 15 minutes intervals, time 0 to 120 min
Secondary outcomes:
measure: plasma gut hormones and nutrients
timeFrame: approx. 15 minutes intervals, time 0 to 120 min
Other outcomes:
Locations:
city: Hellerup
country: Denmark
facility: Gentofte Hospital
Study officials:
References:
citation: Veedfald S, Vedtofte L, Skov-Jeppesen K, Deacon CF, Hartmann B, Vilsboll T, Knop FK, Christensen MB, Holst JJ. Glucose-Dependent Insulinotropic Polypeptide Is a Pancreatic Polypeptide Secretagogue in Humans. J Clin Endocrinol Metab. 2020 Mar 1;105(3):dgz097. doi: 10.1210/clinem/dgz097.
citation: Christensen MB, Calanna S, Holst JJ, Vilsboll T, Knop FK. Glucose-dependent insulinotropic polypeptide: blood glucose stabilizing effects in patients with type 2 diabetes. J Clin Endocrinol Metab. 2014 Mar;99(3):E418-26. doi: 10.1210/jc.2013-3644. Epub 2013 Dec 11.
Clinical trial NCT03472456: Endodontic Medications for Irreversible Pulpitis: Articaine or Eugenol?
Official title: Articaine or Eugenol: a Study on the Choice of Endodontic Medication in the Emergency Management of Irreversible Pulpitis of a Mature Permanent Tooth
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulpitides
Endodontic Inflammation
Toothaches
Operative Dentistry
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2018-03-21
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients from the University Hospital (Dental Service) of Strasbourg (HUS)

Brief summary: The objective of the study is to determine which of the two commonly used endodontic medications (Eugenol VS Articaine) is most effective in controlling postoperative pain in irreversible pulpitis of the mature permanent tooth in adults. To do so, an assessment of the pain felt by patients will be carried out a few days apart. The supposed results are that the medications are equivalent in terms of effectiveness on the pain, but could then present different economic arguments

Detailed description: In irreversible pulpitis of the mature permanent tooth, the enrolled patients receive endodontic medications (Eugenol or Articaine) in order to determine which one is the more efficient to control the pain.

These patients would have received the same medication without this study. That's why this is an obsevationnal study.

Eligibility criteria: Inclusion Criteria:

* Adult patient, major, affiliated to a social health insurance scheme
* Patient having agreed to participate in the study
* Urgent consultant patient for irreversible pulpitis
* Patient understanding French

Exclusion Criteria:

* Refusal of the patient to participate in the study
* Impossibility of performing the surgical procedure
* Impossibility to give the subject information enlightened (difficulty of understanding ...)
* Subject under the protection of justice, or under guardianship
* General contraindication to endodontic treatment in 2 sessions (high risk of infectious endocarditis, for example)
* Chronic intake of analgesic drugs

Primary outcomes:
measure: Pain evolution (decrease or increase the intensity of the pain)
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Les Hôpitaux Universitaires de Strasbourg
Study officials:
affiliation: Les Hôpitaux Universitaires de Strasbourg
name: Damien OFFNER
role: PRINCIPAL_INVESTIGATOR
References: