louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00253890: Insomnia and Drug Relapse Risk
Official title: Insomnia and Drug Relapse Risk
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Poor Quality Sleep
Opiate Addiction
Keywords: sleep quality
methadone
substance use
Lead sponsor: Butler Hospital
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2005-11-15
Enrollment: 137
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: The purposes of this study are:

1. to evaluate the relationship between subjective complaints of sleep and objective measures of sleep quality, as measured through polysomnography, and
2. to evaluate the efficacy of trazodone, as compared to placebo, in individuals early in methadone maintenance.

Detailed description: Individuals new to methadone maintenance will be asked to participate in this 6-month, double-blind, randomized control trial. All participants will complete a baseline interview, a medical screening and follow-up interviews at 1, 3 and 6-months post-baseline. These interviews take approximately 60 minutes, and survey various areas of the participants' experiences, including basic demographic information, mood, sleep and substance use areas. All participants will also be asked to complete a 2-night sleep monitoring at the time of the baseline interview and again at the 1-month follow-up interview. Participants will also receive study medication; half of the participants will receive a placebo medication, and the other half will receive Trazodone, a widely-prescribed, well-tolerated, low side-effect medication. Neither the participant nor the study staff will know which medication the participant is taking while the participant is actively enrolled in the study. This information can be available to the participant at the end of his/her study participation.

Eligibility criteria: Inclusion Criteria:

* Recent methadone maintenance enrollment
* Sleep complaints as measured by the Pittsburgh Sleep Quality Index (PSQI)
* No medical contraindications to trazodone

Exclusion Criteria:

* Methadone maintenance enrollment not recent
* No sleep complaints as measured by the PSQI
* Medical contraindications to trazodone

Primary outcomes:
measure: Sleep Quality, as Measured by Total Sleep Time
timeFrame: Baseline to 1-month
Secondary outcomes:
Other outcomes:
Locations:
city: Providence
country: United States
facility: Butler Hospital
state: Rhode Island
Study officials:
affiliation: Rhode Island Hospital
name: Michael D Stein, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Miriam Hospital
name: Rogers Griffith, MD
role: STUDY_DIRECTOR
References:
citation: Kurth ME, Sharkey KM, Millman RP, Corso RP, Stein MD. Insomnia among methadone-maintained individuals: the feasibility of collecting home polysomnographic recordings. J Addict Dis. 2009 Jul;28(3):219-25. doi: 10.1080/10550880903014155.
Clinical trial NCT02718690: Importance of the Current Density in TENS
Official title: Importance of the Current Density: Effects of TENS About H-reflex. A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spasticity
Keywords: H-Reflex
Current Density
TENS
Lead sponsor: University of Castilla-La Mancha
Sponsor class: OTHER
First posted: 2016-03-24
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is demonstrate the importance of density current of TENS in the effect about H-reflex in healthy volunteers.

Detailed description: TENS have been used to treatment against pain and reflex modulation. However, the most part of evidence do not show the current density. This parameter has been demonstrated like a important factor in the effect of the current about the outcome measures.

This study show the difference between the same subjective sensation "strong but comfortable" in current density and the relation with the effect about H-reflex.

Eligibility criteria: Inclusion Criteria:

* Participants will be volunteer healthy students of Physiotherapy, University of Castilla - La Mancha, older than 18 years.

Exclusion Criteria:

* Neuromuscular disease.
* Epilepsy.
* Trauma, surgery or pain affecting the upper limb, shoulder girdle or cervical area.
* Osteosynthesis material in the upper limb.
* Diabetes.
* Cancer.
* Cardiovascular disease.
* Pacemaker or other implanted electrical device.
* Take any drug (NSAIDs, corticosteroids, antidepressants, analgesics, antiepileptics, ...) during the study and in the previous 7 days.
* Presence of tattoos or other external agent introduced into the treatment or assessment area.
* Pregnancy.
* Sensitivity disturbance in lower limb.

Primary outcomes:
measure: Baseline H reflex
timeFrame: baseline at 0 min.
measure: During treatment H reflex
timeFrame: During treatment at 33min.
measure: Post-treatment H reflex
timeFrame: Immediately after treatment at 40 min.
Secondary outcomes:
measure: Change Current Density
timeFrame: At 1 min. treatment session, at 40 min. treatment session
Other outcomes:
Locations:
Study officials:
affiliation: Hospital Nacional de Parapléjicos de Toledo
name: Diego Serrano-Muñoz, MsC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03590990: Diagnostic Outcomes Of The Females Presenting With Breast Lump In Surgical Department Services Hospital Lahore
Official title: Diagnostic Outcomes Of The Females Presenting With Breast Lump In Surgical
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Lump in Females Presenting to Surgical OPD
Lead sponsor: Services Hospital, Lahore
Sponsor class: OTHER_GOV
First posted: 2018-07-18
Enrollment: 200
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: population from lahore with adjacent towns

Brief summary: It is a simple crossectional study in which we are trying to identify the outcomes of female breast lump presenting to surgical OPD of services hospital lahore.


Eligibility criteria: Inclusion Criteria:female patients with breast lump aged from 20 to onwards

-

Exclusion Criteria:

* female patients with breast abscess

Primary outcomes:
measure: Outcome of breast lump in female patients
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00171990: Efficacy and Safety of Oral Famciclovir in Patients With Active Recurrent Genital Herpes
Official title: Efficacy and Safety of Oral Famciclovir in Patients With Active Recurrent Genital Herpes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Recurrent Genital Herpes
Keywords: genital herpes
herpes
famciclovir
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-09-15
Enrollment: 1461
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a phase III, multicenter, randomized, double-blind, parallel-group study to compare the efficacy and safety of a two-day treatment with famciclovir (500 mg loading dose followed by 250 mg 12-hourly) to standard five-day treatment with famciclovir (125 mg 12-hourly) in patients with active recurrent genital herpes.

This study is not recruiting patients in the United States.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of genital herpes
* Had at least 2 recurrences in past 12 months or 1 recurrence in past 6 months

Exclusion Criteria:

* - Currently taking suppressive herpes antiviral therapy
* Females who are pregnant, breast feeding or planning to become pregnant during study
* History of allergy to famciclovir or similar products (e.g. aciclovir, valaciclovir)

Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Estimated probability being not lesion-free(i.e. not healed) 5.5 elapsed days (132 hours) after patient self-initiation therapy.
Secondary outcomes:
measure: Safety and tolerability assessed by AEs.
measure: Time between recurrences of genital herpes.
measure: Proportion of aborted (i.e. lesions did not appear)genital herpes recurrences. Change from baseline in symptoms or impairment. Change form baseline in functioning or disability.
Other outcomes:
Locations:
city: North Ryde
country: Australia
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharma AG
role: STUDY_CHAIR
References:
Clinical trial NCT06216990: Metastatic or Refractory Soft Tissue Sarcomas and Metronomic Cyclophosphamide: Further Assessment of Efficacy and Safety
Official title: Metastatic or Refractory Soft Tissue Sarcomas and Metronomic Cyclophosphamide: Further Assessment of Efficacy and Safety
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sarcoma
Soft Tissue Sarcoma
Keywords: Cyclophosphamide
Administration, Metronomic
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2024-01-22
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients over 18 with inoperable or metastatic STS, treated with MCP in non curative settings.

Brief summary: Metronomic Cyclophosphamide's use in monotherapy as a palliative treatment against non-resectable and metastatic Soft Tissue Sarcomas relies on small retrospective cohorts' data.

Current litterature needs external validation of its efficacy and safety profile in these settings of usually frail patients.

The investigators assessed further data and aimed to identify predictive factors of metronomic cyclophosphamide impact in metastatic Soft Tissue Sarcomas.


Eligibility criteria: Inclusion Criteria:

* patients over 18
* with inoperable or metastatic Soft Tissue Sarcoma
* treated with Metronomic Cyclophosphamide
* in 3 cancer care institutions located in 2 French regions (Bourgogne and Franche-Comté)
* between January 2005 and December 2021

Exclusion Criteria:

* patients with bone, chondral sarcomas, desmoid, or gastrointestinal stromal tumors

Primary outcomes:
measure: Progression-Free Survival (PFS)
timeFrame: From date of first administration of Metronomic Cyclophosphamide until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Secondary outcomes:
measure: Overall Survival
timeFrame: From date of first administration of Metronomic Cyclophosphamide until the date of death from any cause, assessed up to 100 months
measure: Progression Rate
timeFrame: 3 and 6 Months
measure: Response Rate (RR)
timeFrame: From date of first administration of Metronomic Cyclophosphamide until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
measure: Control Rate
timeFrame: From date of first administration of Metronomic Cyclophosphamide until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Other outcomes:
measure: Imputable Toxicity Occurence
timeFrame: From date of first administration of Metronomic Cyclophosphamide until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Locations:
Study officials:
affiliation: CHU Besançon
name: Clément BOLOGNINI
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00049790: Safety and Efficacy Study of rhAngiostatin Administered in Combination With Paclitaxel and Carboplatin to Patients With Non-Small-Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Carcinoma, Non-Small-Cell Lung
Keywords: Advanced non-small cell lung cancer
Lead sponsor: CASI Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2002-11-15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the safety and efficacy of rhAngiostatin protein administered in combination with paclitaxel and carboplatin to patients with non-small-cell lung cancer.


Eligibility criteria: Inclusion:

* Histological or cytological confirmed Stage IIIB NSCLC with malignant pleural effusions, or Stage IV NSCLC or recurrent NSCLC
* No previous chemotherapy for NSCLC
* Have one lesion that is bidimensionally measurable by physical exam, MRI, or CT greater than 1 cm in diameter
* Specified lab parameters
* Life expectancy of at least 12 weeks
* ECOG performance status of 0 or 1
* Understand requirements of study
* Agree to use effective contraceptive methods

Exclusion:

* Have CNS metastases
* Have any active cancer in addition ot NSCLC
* Participated in clinical trial involving conventional or investigational drugs within previous 4 weeks
* Have any contraindication to paclitaxel or carboplatin
* Have had Grade 3 or greater peripheral neuropathies
* Be pregnant or lactating
* Have a history of myocardial infarction or angina pectoris/angina in the last 6 months
* Have had significant (30 mL or more) hemoptysis with the past 3 months
* Have an active infection
* Have a history of bleeding diathesis, hypercoagulable condition, or an active bleeding disorder
* Be receiving concurrent treatment with therapeutic doses of heparin or coumadin
* Have had major surgery within 4 weeks of stating therapy
* Have additional uncontrolled serious medical conditions or psychiatric illness
* Received rhAngiostatin in other clinical protocols

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana Cancer Pavilion, Indiana University
state: Indiana
Study officials:
References:
Clinical trial NCT02292290: Trial for People With Established Type 2 Diabetes During Ramadan
Official title: A Randomised Controlled Trial for People With Established Type 2 Diabetes During Ramadan: Liraglutide vs. a Sulphonylurea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 2 Diabetes
Keywords: Diabetes
Liraglutide
Ramadan
fasting
Lead sponsor: University of Leicester
Sponsor class: OTHER
Collaborators: name: University Hospitals, Leicester
name: University Hospital Birmingham
First posted: 2014-11-17
Enrollment: 99
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: Dual therapy with metformin and Liraglutide is more effective at helping people with established Type 2 Diabetes Mellitus (T2DM) observing Ramadan achieve a triple composite endpoint of weight reduction and/or maintenance and improved HaemaglobinA1c (HbA1c) and no severe hypoglycaemic events.

Detailed description: Participants in the control arm will essentially continue with their standard routine care and those in the intervention groups will either receive Liraglutide in addition to metformin or those on dual therapy will switch from their sulphonylurea/pioglitazone to Liraglutide and continue with metformin. Informed consent and baseline data will be collected 4-8 weeks prior to the start of Ramadan. This will allow time for a run in period for the titration of Liraglutide prior to the fasting period. Ramadan is followed by Eid-al-Fitr a 3-day Islamic holiday that marks the end of this holy month. Tradition includes amongst early morning prayers/celebration through feasting. Therefore, participants will be invited to attend the first follow-up after this event (between weeks 2 - 4) and then at 12 weeks post Ramadan. Randomisation will not be revealed until after the baseline data have been collected.

Eligibility criteria: Inclusion Criteria:

* Individuals ≥ 18 years old with established T2DM on metformin only
* or dual therapy of metformin plus a sulphonylurea or pioglitazone
* with a HbA1c between 7 - 11 % if on monotherapy and between 6.5 - 12% if on dual therapy

Exclusion Criteria:

* Are pregnant or breast feeding
* Suffer from terminal illness
* Have significant renal or liver impairment
* Are unable to provide informed consent
* Have severe and enduring mental health problems
* Are not primarily responsible for their own care
* Are receiving insulin therapy
* Type 1 diabetes

Primary outcomes:
measure: Composite
timeFrame: 12 weeks following post Ramadan cinical assessment
Secondary outcomes:
measure: HbA1c only
timeFrame: same as primary, 12 weeks following post Ramadan cinical assessment
Other outcomes:
Locations:
city: Leicester
country: United Kingdom
facility: University Hospitals of Leicester
state: Leicestershire
city: Birmingham
country: United Kingdom
facility: University Hospital Birmingham
state: West Midlands
Study officials:
affiliation: University of Leicester
name: Melanie J D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05373290: A Cohort Study of Environmental Endocrine Disrupting Chemicals and Female Reproductive Health
Official title: Adverse Effects and Mechanism of Environmental Endocrine Disrupting Chemicals on Female Reproductive health--the Peking University and Environment Reproductive Health Cohort
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: IVF
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2022-05-13
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All the couples intended to receive the treatment of IVF can be included in the study.

Brief summary: Infertility is a disease that seriously affects the physical and mental health of women of childbearing age. The incidence of infertility has been increasing in recent years. Studies have shown that the occurrence of infertility may be related to environmental endocrine disrupting substances. This project was designed to establish a cohort study on environmental endocrine disrupting substances and in vitro fertilization (IVF) treatment, collect blood, urine, semen, follicular fluid, granulosa cells, chorionic decidua biological specimens, and then follow up on the pregnancy outcomes. The concentration of disrupting substances was detected and then found the associations between environmental endocrine disrupting substances and female reproductive health.


Eligibility criteria: Inclusion Criteria:

Clinical diagnosis of infertile patients undergoing IVF treatment

Exclusion Criteria:

Donor egg transplants excluded

Primary outcomes:
measure: Number of eggs retrieved
timeFrame: immediately after the eggs retrieved
measure: the number of available embryos
timeFrame: 1 week after the eggs retrieved
measure: the clinical pregnancy rate
timeFrame: 4 weeks after the embryos transfer
measure: the miscarriage rate
timeFrame: 7 months after embryos transfer
measure: the live birth rate
timeFrame: 40 weeks after embryos transfer
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT04711590: Microcirculation in Spontaneous Breathing Trial
Official title: Association Between Change of Microcirculation After Spontaneous Breathing Trial and Ventilator Weaning
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Critically Ill
Keywords: ventilator
weaning
microcirculation
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2021-01-15
Enrollment: 59
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Critically ill patients who are ready for weaning ventilator support and receive spontaneous breathing trial.

Brief summary: Weaning ventilator support in critically ill patients is crucial. Both delayed extubation and unexpected early reintubation are harmful to the patients. Weaning parameters and spontaneous breathing trial are used to investigate the indication and predict the successful extubation. Hemodynamic stability and physical reserve are important indicators as well. Microcirculation parameters are known to be more sensitive to the change of hemodynamic status than macrocirculation parameters. We hypothesize that the change of sublingual microcirculation before and after spontaneous breathing trial is different between the the patients with successful extubation and the patients with failed extubation. Thus, this study measures sublingual microcirculation in patients receiving spontaneous breathing trial and record the extubation status (successful or failed). The microcirculation parameters before and after spontaneous breathing trial are compared between the the patients with successful extubation and the patients with failed extubation.


Eligibility criteria: Inclusion Criteria:

* critically ill patients received ventilator longer than 12 hours
* ready for spontaneous breathing trial
* GCS coma score equal or higher than 8

Exclusion Criteria:

* aged less than 20 years
* patient with tracheostomy
* patient and patients' relatives are non-native speakers

Primary outcomes:
measure: Initial total vessel density
timeFrame: 0 hour
measure: Change of total vessel density
timeFrame: baseline and 1 hour
Secondary outcomes:
measure: Initial perfused vessel density
timeFrame: 0 hour
measure: Change of perfused vessel density
timeFrame: baseline and 1 hour
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
References: