louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02515006: Impact of Homeopathy for Persistent Insomnia in Patients With Cancer
Official title: Randomized Controlled Trial of Homeopathy Compared With Treatment As Usual for Persistent Insomnia in Patients With Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Insomnia
Cancer
Lead sponsor: Adwin Life Care
Sponsor class: INDUSTRY
Collaborators: name: Center For Homeopathy Research, India
name: Sonal Foundation, India
First posted: 2015-08-04
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Persistent insomnia is highly prevalent complaint in cancer survivors, but is seldom satisfactorily addressed. The adaptation to cancer care of a validated, cost-effective intervention may offer a practicable solution. The aim of this study was to investigate the clinical effectiveness of homeopathy for insomnia.


Eligibility criteria: Inclusion Criteria:

* scheduled to begin chemotherapy or radiotherapy
* chemotherapy or radiotherapy
* meet diagnostic criteria for chronic insomnia (i.e., lasting for at least one month)
* Chronic insomnia has been defined in previous research:as the presence of (1) three or more episodes of insomnia (i.e., ≥ 30minuteSOL, ≥ 60minute wake after sleep onset (WASO), or ≤ 6.5 hour total sleep time (TST) per night) of per week and (2) daytime effects of insomnia, such as irritability, difficulty concentrating, or fatigue for at least one month.
* have the permission of their oncologists to participate.

Exclusion Criteria:

* untreated alcohol or substance abuse or dependence,
* bipolar, or psychotic disordermedical conditions such as seizure disorder, restless leg disorder, or Parkinson's disease
* untreated sleep disorders such as sleep apnea
* Taking other alternative medicines

Primary outcomes:
measure: Changes in sleep efficiency on the Insomnia Severity Index
timeFrame: From baseline to 6 Months
Secondary outcomes:
measure: Change in Anxiety and Depression on Hospital Anxiety Depression Scale
timeFrame: From Baseline to 6 Months
measure: Change in Quality of Life on Short Form-36 Scale
timeFrame: From Baseline to 6 Months
Other outcomes:
Locations:
city: Ahmedabad
country: India
facility: Center for Homeopathy Research
state: Gujarat
city: Jaipur
country: India
facility: Center for Homeopathy Research
state: Rajasthan
Study officials:
affiliation: Center for Homeopathy Research
name: Tejendra H Patel, BBA
role: STUDY_DIRECTOR
affiliation: NMP Medical Research Institute
name: Neha Sharma, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Adwin Life Care
name: Govind Sharma, MD
role: STUDY_CHAIR
References:
Clinical trial NCT00763906: Norepinephrine Weaning in Septic Patients
Official title: Continuous Administration of Norepinephrine Assisted by Fuzzy Logic Assisted Control in Septic Shock Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Septic Shock
Keywords: septic shock
fuzzy logic
norepinephrine weaning
Lead sponsor: Association pour le Développement de la Recherche et de l'Enseignement en Médecine d'Urgence
Sponsor class: OTHER
First posted: 2008-10-01
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The weaning rate of vasopressors drugs is usually chosen empirically by the clinician in critically patients. The investigators applied fuzzy logic principles to modify intravenous norepinephrine infusion rates during norepinephrine infusion in septic patients in order to reduce the duration of shock. The investigators goal was to reduce the duration of poorly controlled hemodynamic status.


Eligibility criteria: Inclusion Criteria:

* Septic shock

Exclusion Criteria:

* Less than 18 years
* Pregnancy
* Weight above 135 kg
* Requirement for continuous epinephrine infusion
* Severe head injury, stroke, a comatose state following cardiac arrest

Primary outcomes:
measure: Time to shock resolution defined as cessation of vasopressor support
Secondary outcomes:
measure: 28 days survival, total amount of norepinephrine infused, duration of mechanical ventilation, and length of stay in the ICU
Other outcomes:
Locations:
city: Bobigny
country: France
facility: Réanimation
state: Seine-Saint-Denis
Study officials:
References:
citation: Merouani M, Guignard B, Vincent F, Borron SW, Karoubi P, Fosse JP, Cohen Y, Clec'h C, Vicaut E, Marbeuf-Gueye C, Lapostolle F, Adnet F. Norepinephrine weaning in septic shock patients by closed loop control based on fuzzy logic. Crit Care. 2008;12(6):R155. doi: 10.1186/cc7149. Epub 2008 Dec 9.
Clinical trial NCT02732106: Characterization of Adipose Derived Regenerative Cells (ADRCs) From Patients With Chronic Heart Disease
Official title: Characterization of Adipose Derived Regenerative Cells (ADRCs) From Excess Tissue and Cells Designated for Discard From Patients With Chronic Heart Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Heart Failure
Keywords: ADRCs, cell characterization
Lead sponsor: Cytori Therapeutics
Sponsor class: INDUSTRY
First posted: 2016-04-08
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with chronic heart disease

Brief summary: Human adipose tissue is now recognized as an acceptable, highly abundant source of adipose-derived regenerative cells (ADRCs). ADRCs are a heterogeneous or mixed population of cells found in adipose tissue including adult stem cells, leukocytes, connective tissue and vessel-associated cells. Autologous adult regenerative cells are thought to promote healing of scarred or injured tissue. While the investigators are learning more about the exact mechanisms every day, it is believed that this heterogeneous population of cells influences the local environment via cell-to-cell signaling, immune modulation, and differentiation into other cell types. The use of ADRCs in the treatment of many different medical conditions (including cardiovascular disease, soft tissue defects, wound healing, and many more) is being evaluated in numerous clinical and preclinical studies around the world. While there is a considerable amount of information regarding the cellular composition of ADRCs isolated from healthy donors, basically there is no much data regarding the ADRC composition from cardiac patients. In this study, adipose tissue or cells from chronic heart ischemia patients, that would otherwise be thrown away in waste, will be provided to researchers who will study these cells with the objective to characterize ADRCs derived from patients with a heart disease and to compare if a heart disease state does impact ADRC cell composition.


Eligibility criteria: Inclusion Criteria:

* Patients enrolled in the ATHENA clinical trial that donated their leftover material to be studied.

Exclusion Criteria:

-

Primary outcomes:
measure: Adipose-Derived Regenerative Cells (ADRCs)- Cell Characterization
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Scripps Clinic - Torrey Pines, Scripps Green Hospital
state: California
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Minneapolis
country: United States
facility: Minneapolis Heart Institute
state: Minnesota
city: Houston
country: United States
facility: Texas Heart Institute
state: Texas
Study officials:
affiliation: Cytori Therapeutics
name: Steven Kesten, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00812006: A Study of Rizatriptan for the Treatment of Acute Migraine in Patients on Topiramate for Migraine Prophylaxis
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Crossover Trial to Evaluate the Efficacy and Tolerability of Rizatriptan 10 mg ODT for the Treatment of Acute Migraine in Patients on Topiramate for Migraine Prophylaxis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Migraine
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2008-12-19
Enrollment: 108
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: This study will provide additional efficacy data for rizatriptan when used for an acute migraine attack in patients already taking topiramate for migraine prophylaxis.


Eligibility criteria: Inclusion Criteria:

* Patient has a history of migraine with or without aura for more than one year, with between 2 and 8 moderate to severe attacks per month
* Patient is currently taking at least 50 mg topiramate daily for migraine prophylaxis
* Patient can distinguish between migraine and other types of headache
* Patient agrees to remain abstinent or use effective birth control during the study

Exclusion Criteria:

* Patient is pregnant or breast-feeding
* Patient has a history of mostly mild migraines or migraines that resolve within 2 hours
* Patient has more than 15 headache-days per month or has taken medication for acute headache on more than 10 days per month in the 3 months prior to screening.
* Patient was \> 50 years old at age of migraine onset
* Patient has history of heart disease
* Patient has uncontrolled hypertension
* Patient has had cancer within 5 years of screening (excepting certain skin and cervical cancers)
* Patient has started taking Selective Serotonin Reuptake Inhibitors (SSRIs) or Serotonin-Norepinephrine Reuptake Inhibitors (SNRIs) or has changed doses within 3 months of screening
* Patient is taking more than one other migraine prophylactic medication
* Patient has repeatedly failed to respond to or tolerate rizatriptan

Primary outcomes:
measure: Pain Relief (PR)
timeFrame: 2 hours post dose
Secondary outcomes:
measure: Sustained Pain Relief (SPR)
timeFrame: 2 - 24 hours post dose
measure: Pain Freedom (PF)
timeFrame: 2 hours post dose
measure: Normal Rating of Functional Disability (NRFD)
timeFrame: 2 hours post dose
measure: Treatment Satisfaction (TS)
timeFrame: 24 hours post dose
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Seeburger JL, Cady RK, Winner P, MacGregor A, Valade D, Ge Y, Zhang Y, Hustad CM, Strickler N, Schaefer E, Connor KM, Ho TW. Rizatriptan for treatment of acute migraine in patients taking topiramate for migraine prophylaxis. Headache. 2012 Jan;52(1):57-67. doi: 10.1111/j.1526-4610.2011.02027.x. Epub 2011 Nov 11.
Clinical trial NCT06015906: Guided Bone Regeneration Using Polydioxanone (PDO) Membrane in Sockets After Tooth Extraction
Official title: Guided Bone Regeneration Using Polydioxanone (PDO) Membrane in Sockets After Tooth Extraction: a Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Surgery, Oral
Keywords: Guided bone regeneration
Resorbable membrane
Plenum® Guide
Dental implant
Extraction socket preservation
Lead sponsor: M3 Health
Sponsor class: INDUSTRY
Collaborators: name: São Paulo State University
First posted: 2023-08-29
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to compare the maintenance of socket volume in the groups treated by a resorbable regenerative membrane (Plenum® Guide) covered or not with mucous tissue, with control without treatment. The main question it aims to answer is the effectiveness of the Plenum® Guide membrane in the process of guided bone regeneration, exposed or not, through the preservation and neoformation of bone tissue in the tooth extraction socket procedures.

Detailed description: Patients will be submitted to tooth extraction, the surgical procedure of guided bone regeneration using regenerative membranes and synthetic bone graft, and subsequent installation of dental implants. The 05 groups will be compared to observe if the proposed medical devices effectively will maintain the socket's bone volume during the healing phase before the installation of the dental implants (1. socket filled only with clot, 2. socket associated with exposed absorbable membrane, 3. socket associated with covered absorbable membrane, 4. socket filled with synthetic bone graft and covered absorbable membrane, 5. socket filled with synthetic bone graft and exposed absorbable membrane).

Eligibility criteria: Inclusion Criteria:

* Possess the four bone walls after the extraction procedure;
* Over 18 years old;
* And who have signed the TCLE.

Exclusion Criteria:

* Uncontrolled systemic impairments;
* Teeth in areas of tumor lesions;
* Acute infectious processes;
* Deciduous dental elements;
* Untreated periodontal problems;
* Smokers;
* Radiated in the head or neck region;
* Allergy to any component used in the research;
* Psychological disorders;
* Pregnant and lactating women.

Primary outcomes:
measure: Rate of alveolar repair
timeFrame: Comparison of exams obtained in the preoperative period, immediate postoperative period (7 days) and late postoperative period (3 months)
measure: Rate of newly formed bone tissue, soft tissue and residual bone graft material
timeFrame: 4 months after extraction
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Study Director
name: Sybele Saska Specian, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06249906: Efficacy of Bioceramic Materials for Bone Defects Repair
Official title: Clinical Study of Bioceramic Materials in Bone Defect Repair
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bone Lesion
Cartilage Degeneration
Osteo Arthritis Knee
Bone Fracture
Bone Injury
Bone Loss
Lead sponsor: Nanjing First Hospital, Nanjing Medical University
Sponsor class: OTHER
First posted: 2024-02-08
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to demonstrate the effect of bioceramic implants on the repair of human bone defects, and to explore the application of bioceramic materials in bone defects, bone implantation, and bone fusion. The surface microstructure of β-tricalcium phosphate bioceramic implants can be effectively controlled to guide the regeneration of bones, promote the restoration of bones, accelerate the speed of recovery, and improve bone quality, which is of great clinical and social significance.

Detailed description: The surface microstructure of β-tricalcium phosphate bioceramic implants can be effectively controlled to guide the regeneration of bones, promote the restoration of bones, accelerate the speed of recovery, and improve bone quality, which is of great clinical and social significance.

Eligibility criteria: Inclusion Criteria:

1. Patients who voluntarily take the test and sign the informed consent form;
2. Patients aged 18-65 years old with no history of allergies;
3. Patients able to communicate well with the investigator and follow the requirements of the entire trial.

Exclusion Criteria:

1. Patients who refuse to sign the informed consent form to participate in the trial;
2. Patients who are not in the age range of 18 to 65 years;
3. Patients with diseases unsuitbale for the trial: history of allergies, severe cardiopulmonary disease, coagulation dysfunction, Alzheimer's disease, cerebral atrophy, acute phase or sequelae of cerebrovascular disease, cognitive impairment;
4. Patients in the acute phase of local or systemic bacterial infections;
5. Patients who cannot cooperate with the operation and evaluate the effect;
6. Other conditions that are considered inappropriate by the investigator to participate in the study.

Primary outcomes:
measure: Quality of life (SF-36)
timeFrame: 12 months
measure: Level of bone healing
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
measure: Pain self-efficacy (PSEQ)
timeFrame: through study completion, about 12 months
measure: Incidence of nonunion
timeFrame: through study completion, about 12 months
measure: Incidence of infections
timeFrame: through study completion, about 12 months
Locations:
city: Nanjing
country: China
facility: Nanjing First Hospital
state: Jiangsu
Study officials:
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: Qingqiang Yao, phD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04550806: Glycated Albumin Combined With Body Composition for Gestational Diabetes Mellitus Prediction
Official title: The Predictive Ability of Glycated Albumin Combined With Body Composition for Gestational Diabetes Mellitus Diagnosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gestational Diabetes Mellitus in Pregnancy
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2020-09-16
Enrollment: 300
Sex: FEMALE
Minimum age (years): 22
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: pregnant women at first trimester

Brief summary: This study is going to investigate the predictive ability of glycated albumin combined with body composition, including body weight, BMI, fat free mass and fat mass for gestational diabetes mellitus (GDM) diagnosis.

Detailed description: The prevalence of GDM is increasing all over the world. It has bad influence for both pregnant women and fetus. Early treatment is useful for GDM prevention. Therefore early screening is important for healthcare doctors to detect the potential patients. Glycated albumin (GA) is an optimal index for blood glucose evaluation compared to HbA1c, however it may be influenced by body weight and composition. The investigators are going to investigate the predictive ability of glycated albumin combined with body composition, including body weight, BMI, fat free mass and fat mass for gestational diabetes mellitus (GDM) diagnosis. This study recruit pregnant women before 12 weeks of their pregnant age and test GA level and body composition via bioelectrical impedance analysis. During 24-28 weeks of pregnant age, all participants will do the glucose tolerant test for GDM diagnosis.

Eligibility criteria: Inclusion Criteria:

* Age between 20-45
* Healthy, without heart disease, liver or kidney dysfunction, immune system or metabolic or infectious disease,

Exclusion Criteria:

* Diabetes that appeared before pregnancy
* Pregnant with medical disease, such as asthma, hypertension, cardiovascular diseases, kidney diseases or liver disease.
* Hormone use in the recent 1 year
* Assisted reproduction pregnancy
* Multiple births
* Cannot complete the blood test or body composition examination

Primary outcomes:
measure: Area under the curve of GA combined with body composition for GDM diagnosis
timeFrame: May 2021
Secondary outcomes:
measure: correlative factors for GDM
timeFrame: May 2021
measure: GDM prediction model establishment
timeFrame: May 2021
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
affiliation: Clinical nutrition department of Peking Union Medical College Hospital
name: Kang Yu, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04995406: Validating the Use of Blood Transcriptomic Signatures for the Diagnosis of Active Pulmonary Tuberculosis
Official title: Validating the Use of Blood Transcriptomic Signatures for the Diagnosis of Active Pulmonary Tuberculosis With the ISIT-TB Prototype in Adults Living in a High Burden Setting
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: TUBERCULOSIS, PULMONARY
Keywords: Tuberculosis
Mycobacterium infections
Bacterial infections
Diagnosis
Lead sponsor: BioMérieux
Sponsor class: INDUSTRY
First posted: 2021-08-09
Enrollment: 722
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: Active TB cases will be prospectively recruited from the primary care TB clinics and participating hospitals. Healthy adults will be recruited using the healthy participant database of the participating hospitals. For LTBI population, individuals presenting to primary care facilities for reasons other than suspected TB will be approached and invited to participate as possible LTBI should they be assessed as being at increased risk for TB infection as described in the inclusion/exclusion criteria. Non-infectious respiratory disease controls will be recruited from the participing hospitals.

Brief summary: ISIT-TB Prototype is a diagnostic assay based on a transcriptional blood signature suggestive of the detection of Mycobacterium tuberculosis.

Detailed description: This device will be investigated for use as a screening tool to facilitate diagnosis of ATB in conjunction with risk assessment, clinical context and diagnostic information. Whole blood samples will be collected in Tempus™ Blood RNA Tubes and processed on an automatized platform. The detection of a combination of under or over-expressed selected genes, constituting a transcriptional signature, will allow the characterization of ATB.

Eligibility criteria: Inclusion Criteria:

* Symptoms suggestive of TB disease: cough for more than two weeks plus at least one of the following: fever, malaise, weight loss, night sweats, haemoptysis, chest pain or loss of appetite.
* Willingness to give consent to take part in the study.
* Aged \>18 years old.
* Healthy control : no history of TB treatment, no respiratory symptoms, no evidence of active infectious disease, no history of close contacts of active pulmonary TB patients.

Exclusion Criteria:

* Pregnant woman
* A person who has received treatment for active TB or LTBI in the past 24 months

Primary outcomes:
measure: Evaluation of performance of the diagnostic tool
timeFrame: Time to bacteriological confirmation 60 days
Secondary outcomes:
Other outcomes:
Locations:
city: Cape Town
country: South Africa
facility: University of Cape Town Lung Institute
Study officials:
affiliation: University of Cape Town
name: Keertan Dheda, Pr
role: PRINCIPAL_INVESTIGATOR
References: