louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04009902: Evaluation of Depression and Sleep Disorders in Endometriosis Patients
Official title: Evaluation of Depression and Sleep Disorders in Endometriosis Patients Preoperatively and Postoperatively
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endometriosis
Sleep
Depression
Lead sponsor: Kanuni Sultan Suleyman Training and Research Hospital
Sponsor class: OTHER
First posted: 2019-07-05
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study group included patients with indications for operation and who agreed to test for depression and sleep disorders.

Brief summary: The aim of this study was to compare the depression and sleep disturbances of operated endometriosis patients before and after the operation. The main objective here is to provide data on how patients' psychological states and sleep patterns are affected by the symptoms of endometriosis and how these effects can be corrected. In this way, it is aimed to determine whether the patients have psychological support needs and to give the planned treatment due to endometriosis in the early period. As a secondary goal, it is planned to keep the patients in follow-up with their improved sleep and psychological conditions, and to improve their adherence to treatment and quality of life.


Eligibility criteria: Inclusion Criteria:

* 18-49 years of age with no known psychiatric disorder and
* Endometriosis patients with indications for operation

Exclusion Criteria:

* Patients receiving only medical treatment without any indication for operation,
* those with a known psychiatric disease,
* patients with sleep disorders due to another reason,
* Patients over the age of 49, patients under the age of 18,
* Patients with malignancy,
* pregnant women

Primary outcomes:
measure: Beck Depression Scale
timeFrame: 1 week
measure: Pittsburgh Sleep Quality Index
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Kanuni Sultan Süleyman Training and Research Hospital
city: Istanbul
country: Turkey
facility: Pınar Kadiroğulları
Study officials:
References:
Clinical trial NCT03950102: SBRT as Bridging Therapy for Hepatocellular Carcinoma Patients on Transplant Waitlist
Official title: Prospective Study of Stereotactic Body Radiation Therapy as a Bridging Therapy for Hepatocellular Carcinoma Patients on Waiting List for Liver Transplantation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hepatocellular Carcinoma
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2019-05-15
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a single center, prospective study to assess the efficacy and safety of using stereotactic body radiation therapy (SBRT) as bridging treatment for hepatocellular carcinoma (HCC) patients on transplant waitlist.

Detailed description: The study population includes patients 18 years of age or older with HCC, who are accepted on waiting list for deceased donor liver transplantation (DDLT).

Patient will be assessed in a multidisciplinary committee and they will receive SBRT unless otherwise contraindicated. Patients will undergo SBRT under standard protocol.

Patients with HCC beyond University of California, San Francisco criteria (UCSF) will be removed from waitlist.

Eligibility criteria: Inclusion Criteria:

1. Radiological diagnosis of HCC confirmed according to AASLD criteria
2. All patients who are accepted on deceased donor waiting list
3. HCC within UCSF criteria (defined as solitary tumor \<=6.5cm OR up to 3 tumors \<=4.5cm, total sum \<=8cm)

Exclusion Criteria:

1. age \<18 year old;
2. Child's C cirrhosis;
3. Eastern Cooperative Oncology Group (ECOG) score \>2;
4. presence of extrahepatic metastasis;
5. radiological tumor invasion to portal, hepatic vein or its branches;
6. absolute contraindications to RT (e.g. previous RT to liver);
7. positive pregnancy test;
8. unwilling or unable to adhere to study requirements and procedure;
9. any other condition, in the investigator's judgment, that increases the risk of SBRT or prevents safe trial participation.

Primary outcomes:
measure: Risk of classical radiation induced liver disease (RILD) after SBRT
timeFrame: From time of SBRT to 3 months afterwards
measure: Rate of transplant complication
timeFrame: From time of transplant to 1 months afterwards
Secondary outcomes:
measure: Rate of dropout from transplant waitlist
timeFrame: From time of enrolment to up to 2 years
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
Study officials:
affiliation: The University of Hong Kong
name: Tiffany Wong, MBChB
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wong TC, Lee VH, Law AL, Pang HH, Lam KO, Lau V, Cui TY, Fong AS, Lee SW, Wong EC, Dai JW, Chan AC, Cheung TT, Fung JY, Yeung RM, Luk MY, Leung TW, Lo CM. Prospective Study of Stereotactic Body Radiation Therapy for Hepatocellular Carcinoma on Waitlist for Liver Transplant. Hepatology. 2021 Nov;74(5):2580-2594. doi: 10.1002/hep.31992. Epub 2021 Sep 30.
Clinical trial NCT05790902: COMPARISON OF SILODOSIN AND TAMSULOSIN IN MEDICAL EXPULSIVE THERAPY OF DISTAL URETERIC CALCULI
Official title: COMPARISON OF SILODOSIN AND TAMSULOSIN IN MEDICAL EXPULSIVE THERAPY OF DISTAL URETERIC CALCULI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Silodosin, Tamsulosin, Medical Expulsive Therapy, Distal Ureteric Calculi
Lead sponsor: Armed Forces Institute of Urology, Rawalpindi
Sponsor class: OTHER
First posted: 2023-03-30
Enrollment: 142
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: to compare efficacy and safety of Silodosin and Tamsulosin in Medical expulsive therapy of Distal Ureteric Calculi.

Detailed description: to compare efficacy and safety of Silodosin and Tamsulosin in Medical expulsive therapy of Distal Ureteric Calculi in our local setup to find out the optimal drug which promptly and quickly cures the disease thus enabling the person to return to routine activity with less adverse effects.

Eligibility criteria: Inclusion Criteria:

* symptomatic, unilateral, single, uncomplicated Distal Ureteric Calculi of \<10 mm in size (on plain CT KUB)

Exclusion Criteria:

* solitary kidney, bilateral ureteric stones, UTI, renal impairment, high-grade hydronephrosis (Grades 3 and 4), any history of previous endoscopic or surgical interventions, pregnancy, diabetes mellitus,

Primary outcomes:
measure: Stone clearance rate
timeFrame: upto 4 weeks
Secondary outcomes:
measure: Stone expulsion time
timeFrame: upto 4 weeks
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: AFIU Rawalpindi
state: Punjab
Study officials:
References:
Clinical trial NCT03129802: Incidence and Risk Factors of Extubation Failure in Pediatric Resuscitation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Respiratory Insufficiency
Keywords: extubation
pediatric resuscitation
reintubation
failures of extubation.
Respiratory Insufficiency
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2017-04-26
Enrollment: 60
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children hospitalized in pediatric intensive care, under 18 years, intubated, ventilated for more than 2 hours and for which planning extubation or intubated children for whom an unplanned extubation just happened.

Brief summary: The failure of extubation in pediatric resuscitation is most often described as the need for reintubation within 48 hours after extubation. The failure rate of extubation in pediatric intensive care varies in the literature there is 4 to 22% failure. These failures result in increased mortality, morbidity with a use of larger tracheostomy, a prolonged residence time. Some risk factors are well defined in the literature as the duration of intubation, ENT and neurological history, the persistence of a respiratory disease, a high level of sedation. Other factors are more controversial as age, ventilatory parameters just before extubation before extubation blood gases, the interest of a leak test.

Also pediatric populations are extremely heterogeneous, so the investigators would like to highlight to extubation failure risk factors in Hautepierre pediatric ICU to better support these high-risk children.


Eligibility criteria: Inclusion Criteria:

* Children hospitalized in pediatric intensive care, under 18 years, intubated, ventilated for more than 2 hours and for which planning extubation or intubated children for whom an unplanned extubation just happened.
* Children whose holding parental authority are not opposed to the use of clinical data from their child for research purposes.

Exclusion Criteria:

* Refusal to participate in the study

Primary outcomes:
measure: Failure of extubation
timeFrame: need for a new intubation within the first 48 hours after extubation
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Reanimation Pediatrique Specialisee - S. Continue
Study officials:
References:
Clinical trial NCT02626702: Immune Modulators and IVF
Official title: Immune Modulators in Women Undergoing IVF----a Prospective Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: In Vitro Fertilization
Keywords: immune modulators
IVF outcomes
relationship
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
First posted: 2015-12-10
Enrollment: 500
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects undergoing In Vitro Fertilization.

Brief summary: Exploring the immune mediators of early pregnancy prospectively may help to identify new early interventions that will increase the likelihood of success and help women make informed decisions regarding their pregnancies.

Detailed description: Sera will be obtained from 500 women undergoing IVF at five time periods: cycle Day 2, post HCG, Day 24, Day 28, and/or Day 35.Aliquots of sera will be tested by commercial ELISA kits for concentrations of immune modulators suggestive to be predictive of IVF outcome, such as cytokines (interleukins, tumor necrosis factor, and interferon), neurotrophins (BDNF), protease inhibitors (HE4) and insulin-like growth factors (IGF-1, IGF-2, IGFBP). The results will be correlated with IVF outcomes.

Eligibility criteria: Inclusion Criteria:

* All fresh transfers

Exclusion Criteria:

* PGD

Primary outcomes:
measure: To explore the relationship between immune mediators and IVF outcome prospectively in women who receive in vitro fertilization treatment.
timeFrame: 35 days
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Ronald O. Perelman and Claudia Cohen Center for Reproductive Medicine
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Steven Spandorfer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02956902: A Smartphone Intervention With Telemedicine Support for Management of Post-traumatic Stress Disorder: A Randomized Trial
Official title: A Smartphone Intervention With Telemedicine Support for Management of Post-traumatic Stress Disorder: A Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PostTraumatic Stress Disorder
Lead sponsor: Ontario Shores Centre for Mental Health Sciences
Sponsor class: OTHER
Collaborators: name: US Department of Veterans Affairs
First posted: 2016-11-06
Enrollment: 67
Sex: ALL
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study tests whether people receiving clinician support to use a mobile application on their smartphone can manage their post-traumatic stress disorder (PTSD) symptoms better than those who do not. Half of the participants will receive the clinician supported smartphone application intervention and the other half will remain on the waiting list.


Eligibility criteria: Inclusion Criteria:

* on the waiting list for the Ontario Shores traumatic stress clinic;
* score ≥ 31 on the PCL-5
* have access to a smartphone or tablet to which they are willing to download the app.

Exclusion Criteria:

* active suicidal ideation

Primary outcomes:
measure: Change in PTSD symptom severity
timeFrame: 8 weeks
Secondary outcomes:
measure: Clinically significant change in PTSD symptom severity
timeFrame: 8 weeks
measure: Change in Depression Severity
timeFrame: 8 week
measure: Average App Use per Week (Intervention group only)
timeFrame: 8 weeks
measure: Goal Achievement (Intervention group only)
timeFrame: 8 weeks
measure: Clinician Fidelity to Protocol
timeFrame: 8 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01733602: tDCS to Enhance Cognitive Training in Schizophrenia
Official title: Does Transcranial Direct Current Stimulation (tDCS) Enhance Outcomes From Computerised Cognitive Remediation in Patients With Schizophrenia?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Schizophrenia
Lead sponsor: The University of New South Wales
Sponsor class: OTHER
First posted: 2012-11-27
Enrollment: 52
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: TREATMENT

Brief summary: The primary aim for the study is to determine whether transcranial direct current stimulation (tDCS) enhances training gains on cognitive training (CT) tasks. Secondary aims are to determine whether tDCS combined with CT causes larger transferable improvements on non-trained tasks (i.e., generalisation effects) and whether these generalisation effects are maintained over time (i.e., maintenance effects).

Specific hypotheses are:

1. CT combined with active tDCS will produce greater training gains on CT tasks compared to a similar control group receiving CT with sham tDCS.
2. CT combined with active tDCS will produce greater generalisation effects on non-trained cognitive tasks compared to CT with sham tDCS.
3. The cognitive improvements gained by patients from both interventions will be maintained over 1 month follow-up.


Eligibility criteria: Inclusion Criteria:

1. Subjects are 18 years of age or above.
2. Subjects meet criteria for a DSM -IV schizophrenia or schizoaffective disorder but with a stable mental status as demonstrated by a stable Positive and Negative Symptom Score (PANSS) score over a period of 2 weeks.
3. Subjects have had no medication changes in the 2 weeks prior to obtaining informed consent.
4. Subjects are right-handed.
5. Subjects able to give informed consent for the trial.

Exclusion Criteria:

1. Drug or alcohol abuse or dependence (preceding 3 months).
2. Concurrent anticonvulsant or long acting benzodiazepine medication, as these medications may interfere with the effects of tDCS.
3. Subject requires a rapid clinical response due to inanition, psychosis or high suicide risk.
4. Clinically defined neurological disorder or insult, including history of seizures, cerebral aneurysm or trauma, significant head trauma with loss of consciousness for ≥ 30 minutes.
5. Subject has metal in the cranium, skull defects, or skin lesions on scalp at proposed electrode sites.
6. Female subject of child bearing age, sexually active and not using reliable contraception

Primary outcomes:
measure: Progression score on cognitive training task.
timeFrame: Post treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: Mental Health Rehabilitation Unit (MHRU) at the Sutherland hospital
state: New South Wales
Study officials:
References:
Clinical trial NCT01239602: The Variation of Movement Related Cortical Potential, Cortico-cortical Inhibition, and Motor Evoked Potential in Intracerebral Implantation of Antologous Peripheral Blood Stem Cells(CD34)in Old Ischemic Stroke
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stroke
Keywords: changes in cortical excitability in subjects with chronic stroke after stem cell therapy
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
First posted: 2010-11-11
Enrollment: 36
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 36 patients suffered from old cerebral infarction (middle cerebral artery territory as documented on the T2 weight image \[T2WI\] of MRI) between 6 months and 5 years of onset who had initial scores on the National Institute of Health stroke scale (NIHSS) of between 9 and 20.

Brief summary: Stem cell theray in old stroke patients is a study to treat stroke patients approved before in our hospital. We recruit these patients who received stem cell therapy and completed the study. We adopted movement-related cortical potential,and cortico-cortical inhibition to assess the stroke patients with or without stem cell therapy. Further analyzing the correlation of the motor related cortical potential and cortico-cortical inhibition among them. We wanted to find out if there are changes in cortical excitability in subjects with chronic stroke after stem cell therapy.


Eligibility criteria: Inclusion Criteria:

* 1.old cerebral infarction (middle cerebral artery territory as documented on the T2 weight image \[T2WI\] of MRI) 2.between 6 months and 5 years of onset 3.National Institute of Health stroke scale (NIHSS) of between 9 and 20.

Exclusion Criteria:

* 1.Seizure history 2. Pacemaker insertion

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: China Medical University Hospital
Study officials:
References:
Clinical trial NCT01842802: Clinical Investigation of Non Invasive Fat Reduction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Subcutaneous Fat
Lead sponsor: Cynosure, Inc.
Sponsor class: INDUSTRY
First posted: 2013-04-30
Enrollment: 8
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The purpose of this study is to compare non invasive treatments using a YAG and Didode Laser to reduce the volume of fat.


Eligibility criteria: Inclusion Criteria:

* A healthy non-smoking male or female between 20-60 years of age
* Subjects presenting excess abdominal tissue (fat and skin), are candidates for an abdominoplasty procedure and are willing to allow the use of this device on their skin
* Subjects who will allow the excess skin removed as part of the abdominoplasty to be sent for laboratory analysis
* Understand and accept the obligation associated with the procedure
* Subjects with Fitzpatrick skin types I to III.
* Subjects who are willing to consent to participate in the study will be asked to undergo biopsies, ultrasound measurements, and blood testing as outlined for each group and defined in section 6.0.
* Subjects must agree to maintain the same diet and exercise regime throughout the study

Exclusion Criteria:

* Any previous liposuction/lipo-sculpture or any type of procedure in the abdominal area in the past 6 months
* A history of allergic reactions to medications or anesthesia required for the procedure
* A history of thrombophlebitis
* A history of acute infections
* A history of heart failure
* Received or is anticipated to receive antiplatelets, anticoagulants, thrombolytics, vitamin E or anti-inflammatories within 2 weeks pre treatment
* Intolerance to anesthesia or medications to be prescribed before or after the procedure.
* Any medical condition, that, in the investigator's opinion would interfere with the patient's participation in the study including EMLA cream or percocet
* Taking medications that are photosensitive
* A history of keloid formation
* A study subject must not be pregnant or have been pregnant in the last 3 months
* The physician has the right to make determination of eligibility as he/she deems clinically significant based on standard of care treatment

Primary outcomes:
measure: Biopsy of Tissue Samples as a Measure of Effectiveness
timeFrame: 5 months post treatment
measure: Ultrasound Measurement to Evaluate Reduction of Fat
timeFrame: 5 months post treatment
Secondary outcomes:
measure: Lipid level blood testing to evaluate changes post treatment
timeFrame: 5 months post treatment
Other outcomes:
Locations:
city: Staten Island
country: United States
facility: Aesthetic Pavilion
state: New York
Study officials:
affiliation: Cynosure, Inc.
name: Patricia Krantz
role: STUDY_DIRECTOR
References:
Clinical trial NCT06547502: Pharmacokinetics and Safety Profile of a Single Dose GZR4 in Subjects with Renal Impairment
Official title: The Study of Pharmacokinetics and Safety of a Single Dose of GZR4 Injection in Subjects with Mild to Moderate Renal Impairment and Subjects with Normal Renal Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Keywords: GZR4
kidney
Lead sponsor: Gan and Lee Pharmaceuticals, USA
Sponsor class: INDUSTRY
First posted: 2024-08-09
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will be conducted to investigated the effect of decreased kidney function on PK and safety of GZR4 and to guide dosing recommendations in people with kidney impairment.


Eligibility criteria: Inclusion Criteria:

* Male or female, aged 18-75 years (both inclusive) at the time of signing informed consent
* Meeting the pre-defined Glomerular Filtration Rate (GFR) values

Exclusion Criteria:

* Known or suspected hypersensitivity to trial product
* Drugs known to affect creatinine clearance including cimetidine within 14 days or 5 half-lives prior to the day of dosing of GZR4 and during this trial
* Individuals who routinely undergo dialysis or have a history of renal transplantation, hepatorenal syndrome, or acute kidney injury

Primary outcomes:
measure: AUC0-inf
timeFrame: Day1-Day29
measure: AUC0-last
timeFrame: Day1-Day29
measure: Cmax
timeFrame: Day1-Day29
Secondary outcomes:
measure: Incidence of TEAE
timeFrame: Day1-Day29
measure: AUC0-168h
timeFrame: Day1-Day29
measure: Tmax
timeFrame: Day1-Day29
measure: T1/2
timeFrame: Day1-Day29
Other outcomes:
Locations:
city: Suzhou
country: China
facility: Site 1
state: Jiangsu
Study officials:
References: