louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02740244: Effect of Intermittent ThetaBurst Stimulation in Treatment-resistant Bipolar Depression
Official title: Effects of Intermittent Theta Burst Stimulation Applied Over the Left Dorsolateral Prefrontal Cortex in Patients With Treatment-resistant Bipolar Depression
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Bipolar Depression
Lead sponsor: Hôpital le Vinatier
Sponsor class: OTHER
First posted: 2016-04-15
Enrollment: 20
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: OTHER

Brief summary: The aim is to evaluate the evaluate the clinical interest and the safety of repetitive transcranial magnetic stimulation (rTMS) delivered as intermittent Theta burst stimulation(iTBS) on severity of depression in patients with treatment-resistant bipolar disorder.

Detailed description: Methods: A double-blind randomized sham-controlled pilot study will be conducted in 40 patients with bipolar treatment-resistant depression receiving either active (n=20) or sham (n=20) iTBS over the left dorsolateral prefrontal cortex.

Depression severity will be assessed by an investigator blinded to iTBS condition before and after 10 to 30 iTBS sessions depending on remission onset. Remission will be defined as Beck Depression Inventory, BDI score\<10.

Objective/Hypothesis: The investigators hypothesized the superiority of active iTBS over sham ITBS

Eligibility criteria: Inclusion Criteria:

* Bipolar disorder according to Diagnostic and Statistical Manual of Mental Disorders, DSM-IV criteria
* Montgomery and Asberg depression scale \> 20

Exclusion Criteria:

* other psychiatric features, rapid cycles
* Benzodiazepines intake
* pregnancy

Primary outcomes:
measure: Beck Depression Inventory
timeFrame: 2 time point measure, before and after the end of stimulation sessions (changes from baseline BDI scores at 6 weeks)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital, Grenoble
name: David Szekely, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06754644: A Study to Evaluate Efficacy, and Safety of QL2107 Plus Chemo and Compare With Keytruda in Participants With IV nqNSCLC
Official title: A Randomized, Double-blind, Multicenter Phase III Clinical Study to Compare the Efficacy and Safety of QL2107 Versus Keytruda® in Combination With Chemotherapy in the Treatment of Metastatic Non-squamous Non-small-cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: NSCLC
Lead sponsor: Qilu Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-01-01
Enrollment: 808
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 goal of this clinical trial is to compare the efficacy similarities between QL2107 and Keytruda in metastatic non-squamous NSCLC.


Eligibility criteria: Inclusion Criteria:

* Subjects who voluntarily participate, sign the Informed Consent Form (ICF), and are able to comply with the study procedures;
* Subjects aged ≥ 18 and ≤ 75 years at enrollment, male or female;
* Histologically or cytologically confirmed metastatic (stage IV) non-squamous NSCLC as per the American Joint Committee on Cancer (AJCC) 8th Edition; if multiple tumor histologies are present, the predominant cell type should be classified;
* No EGFR sensitive mutations or ALK gene translocations.
* Expected survival ≥ 3 months;
* Eastern Cooperative Oncology Group (ECOG) performance status score: 0 or 1;

Exclusion Criteria:

* Pulmonary radiation therapy \> 30 Gy within 6 months prior to the first dose;
* Palliative radiation therapy completed within 7 days prior to the first dose;
* Any other form of anti-tumor therapy expected to be required during the study;
* Uncontrolled or symptomatic pericardial effusion, pleural effusion and ascites requiring repeated paracentesis and drainage;
* Presence of metastases to brain stem, meninges and spinal cord or compression;

Primary outcomes:
measure: clinical equivalence
timeFrame: 24-week
Secondary outcomes:
Other outcomes:
Locations:
city: Jinan
country: China
facility: Shandong First Medical University Cancer Hospital
state: Shandong
Study officials:
References:
Clinical trial NCT01886040: Factors Affecting the Prognosis of Patients With Endometrial Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endometrial Cancer
Lead sponsor: Far Eastern Memorial Hospital
Sponsor class: OTHER
First posted: 2013-06-25
Enrollment: 100
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: the cases with endometrial cancer

Brief summary: Endometrial cancer is the second common gynecologic malignancy in Taiwan. The prevalence has been overcome the epithelial ovarian cancer because of the change of life style to western style recently. Most patients with endometrial cancer are stage I \& II, the most histology is still "endometrioid adenocarcinoma" (type I endometrial cancer). In statistics, advanced stage (FIGO stage III and IV) is approximately 16% of all cases.

Most patients has good outcome of endometrial cancer because their surgical stage is belonged to "early stage". However, the recurrence, distant metastases and mortality are high if the diseases is confirmed to be advanced stage. The adjuvant therapies after staging/debulking operation are systemic chemotherapy and whole pelvic radiation therapy/ brachytherapy. Whether the adjuvant therapy can cure the disease of not is still controversial.

Because of the rarity of the advanced endometrial cancer, varies adjuvant therapeutic modalities, eg. chemotherapy only, pelvic radiation therapy only, combination of chemotherapy and radiation therapy or sequential "sandwich" therapy were ever used for such group patients in each medical center. But the case number is insufficient and limited to show the survival or progression free benefit during the statistics. Besides, the surgical procedures and adjuvant therapy for early endometrial cancer is still remained to be determined. The investigators are also interested to analyze the factors affecting their survival.

The investigators will perform a retrospective study to review the data of patients with endometrial cancer in Department of Obstetrics \& Gynecology in Far Eastern Memorial Hospital.


Eligibility criteria: Inclusion Criteria:

1. Time interval: from 1991 to date.
2. Comprehensive surgical staging or debulking procedure.
3. All female patients with endometrial cancer who underwent surgery for endometrial cancer at Far Eastern Memorial Hospital.

Exclusion Criteria:

1. Not comprehensive staging/debulking procedure.
2. Patients who died of postoperative complications within 30 days after surgery were excluded from the survival analysis.

Primary outcomes:
measure: Factors affecting overall survival and disease-free survival of endometrial cancer
timeFrame: 20 years
Secondary outcomes:
Other outcomes:
Locations:
city: Banqiao
country: Taiwan
facility: Far Eastern Memorial Hospital
state: New Taipei
Study officials:
References:
Clinical trial NCT01536444: Use of the Epidermal Micrografts for Wound Healing After Mohs or Excisional Surgery for Skin Cancer
Official title: Use of the Epidermal Expansion System to Harvest and Place Suction Blister Epidermal Grafts on Wounds in Patients After Mohs or Excisional Surgery for Skin Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Neoplasm of Skin
Keywords: Mohs surgery
Excisional skin surgery
Micrografting
Lead sponsor: Momelan Technologies
Sponsor class: INDUSTRY
First posted: 2012-02-22
Enrollment: 12
Sex: ALL
Minimum age (years): 35
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This case series will assess the use of suction blister epidermal grafts harvested by a novel device on select patients that have wounds from Mohs or excisional surgery.

Detailed description: This study evaluates a novel micrografting technique to determine how it will influence the healing and cosmetic result of selected post surgical wounds in 12 subjects. The Epidermal Expansion System (designed by MoMelan Technologies) will generate an array of small microblisters and transfer the micrografts to a sterile wound dressing for application to the subject's surgical area. The sponsor hypothesizes that applying expanded micrografts to wounds that otherwise would have healed by second intention alone will hasten healing and possibly reduce scarring.

Eligibility criteria: Inclusion Criteria:

* Adult males and females between 35 and 90 years of age
* Status post skin cancer removal on the scalp, ear or leg with a wound that would otherwise be allowed to heal by secondary intention or grafting
* Wound considered appropriate by physician to receive epidermal grafting
* Willingness to participate in study by evidence of informed consent

Exclusion Criteria:

* Female patients reported to be breastfeeding, pregnant or planning to become pregnant
* Clinical signs of infection
* Subjects currently on immunosuppressive medications, chemotherapy or a cytotoxic agent
* Participation in another interventional study with potential exposure to an investigational drug or device within the past 30 days or planned study entry within 90 days after study entrance.

Primary outcomes:
measure: Wound healing/scarring
timeFrame: 6 weeks
Secondary outcomes:
measure: Incidence of adverse events
timeFrame: 6 weeks
measure: Physician global satisfaction
timeFrame: 6 weeks
measure: Subject global satisfaction
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Naperville
country: United States
facility: DuPage Medical Group
state: Illinois
Study officials:
affiliation: DuPage Medical Group
name: Ashish C. Bhatia, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05609344: Barbershop Talk: Reducing Excessive Alcohol Consumption Among Black Men
Official title: Barbershop Talk: Reducing Excessive Alcohol Consumption Among Black Men
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Drinking Behavior
Drinking Excessive
Drinking
Lead sponsor: University of Arkansas
Sponsor class: OTHER
First posted: 2022-11-08
Enrollment: 600
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Socially disadvantaged Black men are at increased risk for unhealthy drinking habits that may, in turn, increase preventable chronic disease. This project seeks to test the effectiveness of a Screening, Brief Intervention, and Referral to Treatment (SBIRT) intervention for use within barbershop settings to reduce average drinking days and the number of unhealthy drinking days. Data from this study will further our understanding of how to reduce the risk of alcohol-related morbidity and mortality among Black men. Data will also improve our understanding of strategies that can improve the implementation of evidence-based care models in non-clinical settings; thus, extending the reach of evidence-based care to communities with the highest need.


Eligibility criteria: Inclusion Criteria:

* self-identify as Black
* aged 18 or older
* low income as defined by any indicator (e.g., Medicaid; Earned Income Tax Credit; Children's Health Insurance Plan; subsidized housing; child care subsidies; food stamps; low-income energy assistance; free/reduced lunch program; supplemental nutrition program; Head Start program).

Exclusion Criteria:

-

Primary outcomes:
measure: Alcohol Use - total number of drinking days
timeFrame: Baseline
measure: Alcohol Use - total number of drinking days
timeFrame: 3 months
measure: Alcohol Use - total number of drinking days
timeFrame: 6 months
measure: Alcohol Use - number of unhealthy drinking days
timeFrame: Baseline
measure: Alcohol Use - number of unhealthy drinking days
timeFrame: 3 months
measure: Alcohol Use - total number of unhealthy drinking days
timeFrame: 6 months
measure: Mental Health - depression
timeFrame: Baseline
measure: Mental Health - depression
timeFrame: 3 months
measure: Mental Health - depression
timeFrame: 6 months
measure: Mental Health - Posttraumatic Stress Disorder (PTSD)
timeFrame: Baseline
measure: Mental Health - Posttraumatic Stress Disorder (PTSD)
timeFrame: 3 months
measure: Mental Health - Posttraumatic Stress Disorder (PTSD)
timeFrame: 6 months
measure: Social Support
timeFrame: Baseline
measure: Social Support
timeFrame: 3 months
measure: Social Support
timeFrame: 6 months
measure: Healthcare Utilization
timeFrame: Baseline
measure: Healthcare Utilization
timeFrame: 3 months
measure: Healthcare Utilization
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: UAMS
state: Arkansas
Study officials:
affiliation: University of Arkansas
name: Tiffany F Haynes, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00989144: Preliminary Study of Early, Primary HIV Infection in a High Risk Cohort
Official title: Preliminary Study of Early, Primary HIV Infection in a High Risk Cohort.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infections
Keywords: HIV seronegative
acute infection
Lead sponsor: Thai Red Cross AIDS Research Centre
Sponsor class: OTHER
Collaborators: name: Walter Reed Army Institute of Research (WRAIR)
First posted: 2009-10-02
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The client from the Voluntary Counseling and Testing (VCT) facilities at the Thai Red Cross Anonymous Clinic in Bangkok, Thailand.

Brief summary: The study of early, acute HIV infection is critical to understanding subtype-specific pathophysiologic differences, since up to 50% of acute HIV infections may be incapacitating. This study will establish whether the patient population of the Thai Red Cross Anonymous Clinic is suitable for the study of early, acute infection.

Detailed description: This study will utilize existing (collected after 1 January 2006) and prospectively collected HIV seronegative clinical specimens not used as part of any research protocol. The specimens in this study are discarded anonymous samples from the Voluntary Counseling and Testing (VCT) facilities at the Thai Red Cross Anonymous Clinic in Bangkok, Thailand. The specimens cannot be linked to the tested subjects. The samples will be labeled using the anonymous clinic identification number which is a 7 digit number with the first 2 digits representing the year and the following 5 digits representing the sequence of which the client sought care in that calendar year. Preliminary Study of Early, Primary HIV Infection in a High Risk Cohort.

Eligibility criteria: Inclusion Criteria:

* All clients who access services included in the "Health Check Up Packages by Age Groups" at the Thai Red Cross AIDS Research Centre.

Exclusion Criteria:

* None

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Thai Red Cross AIDS Research Centre
Study officials:
References:
Clinical trial NCT02478944: Esophageal Motility Disease Screening in Patient With Suspicion or Diagnosis of IBD
Official title: Esophageal Motility Disease Screening in Patient With Suspicion or Diagnosis of IBD
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Inflammatory Bowel Disease
Keywords: Inflammatory bowel disease
Manometry
Lead sponsor: University Hospital Erlangen
Sponsor class: OTHER
First posted: 2015-06-23
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: Aims: Prospective evaluation of patients with a suspicion or diagnosis of Inflammatory bowel disease (IBD) to evaluate osophageal motility before and during therapy

Material and methods: The investigators prospectively perform manometry in patients with or with symptoms consistent with IBD. The investigators evaluate esophageal motility with high resolution manometry before, during and after IBD therapy. Clinical data are also collected to find possible correlations. The study do not modify the planned IBD therapy, but observe motility findings.

Detailed description: Oesophageal motility is measured with the high resolution manometry in order to detect pathologic peristaltic amplitude values among patient before and after therapy (mesalazine, steroids, biologicals) compared to the standard values detected among the normal population. Diagnosic intervention like oesophagoduodenoscopy, colonoscopy and stenosis ballon dilation are allowed as are part of the IBD therapy and follow up.

No other interventions are administered to participants during this study.

Eligibility criteria: Inclusion Criteria:

* Inflammatory bowel disease
* Suspicion of inflammatory bowel disease

Exclusion Criteria:

* Pregnancy

Primary outcomes:
measure: Manometry finding (peristaltic amplitude values mmHG) compared to normal population findings
timeFrame: 1 year
measure: Correlation with gastrointestinal symptoms to manometry findings (peristaltic amplitude values)
timeFrame: 1 year
Secondary outcomes:
measure: Manometry findings (peristaltic amplitude values, mmHG) during therapy
timeFrame: 1 year
Other outcomes:
Locations:
city: Erlangen
country: Germany
facility: University Hospital Erlangen Nuremberg
state: Bavaria
Study officials:
affiliation: UK Erlangen
name: Heinz Albrecht, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01823744: Harmonized Micronutrient Project
Official title: A New Strategy to Analyze Gene-Nutrient Interaction in Children and Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Genomic
Keywords: micronutrient
genomic
SAM/SAH ratio
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2013-04-04
Enrollment: 146
Sex: ALL
Minimum age (years): 9
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this trial is to better define how individuals with different genetic make-ups will require different interventions to improve their methylation potential and nutrient status.

Detailed description: Despite the increasing incidence of overweight and obesity among children, nutritional deficiencies are still a concern.

A low intake of vitamins and minerals is associated with a reduction in the antioxidant capacity. Some vitamins are associated with chronic diseases including overweight and obesity.

S-adenosylmethionine (SAM) and S-adenosylhomocysteine (SAH) are the substrate and product of essential reactions; the SAM:SAH ratio has been associated with health and is an indicator of cellular DNA methylation potential.

Low level of this ratio may affect short and long term health. In this explorative knowledge building open interventional study, subject to be enrolled are children or adolescents 9 to 13 years of age per year (n=180 per year, over 2 years). The study consists of 6 weeks nutritional intervention followed by a 6 weeks follow up.

In this study, genomics, proteomics, lipidomics analysis will be performed, in addition to biochemistry, hematology and vitamins analysis.

Eligibility criteria: Inclusion Criteria:

* Children or adolescents 9 to 13 years of age.
* Clinically stable.
* Normal weight, overweight and obese.

Exclusion Criteria:

* Disease diagnosis.
* At least one episode of axillary temperature \>37°C over the prior 15 days.
* Three or more episodes of liquid or semi-liquid stools over the prior 24 hours.
* Supplementation with vitamins and/or minerals.
* On a supervised diet for reducing weight or any other type of diet restriction.
* Currently participating or having participated in another clinical study during the last 4 weeks prior to the beginning of this study.

Primary outcomes:
measure: SAM/SAH ratio
timeFrame: baseline and after 6 weeks of product intake
Secondary outcomes:
measure: SNP arrays, proteomics, metabolomics, micronutrient levels
timeFrame: baseline, after 6 weeks of product intake and after 6 weeks of follow up
measure: SAM/SAH ratio
timeFrame: after 6 weeks product intake and after 6 weeks of follow up
Other outcomes:
Locations:
city: Ribeirão Preto
country: Brazil
facility: Campus Universitário USP, Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto
state: São Paulo
Study officials:
affiliation: Campus Universitário USP, Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto
name: Jacqueline Pontes Monteiro, Profa. Dra.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01632644: Identifying Skin Biopsy Sites
Official title: Pilot Study of Skin Biopsy Sites: A Consensus Approach Based on Patient and Physician Interviews
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Identification of Skin Cancer Biopsy Sites
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2012-07-03
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Physicians will be recruited by email obtained through directories.

Patients will be those who have had biopsies at the Northwestern University Department of Dermatology.

Brief summary: The primary objective of this study is to investigate the patient experience during skin biopsy.


Eligibility criteria: Inclusion Criteria:

* Age 18 and Over
* The subjects are in good health.
* The subjects have the willingness and the ability to understand and provide informed consent for the use of their tissue and communicate with the investigator.
* Patients who have had one or multiple skin biopsies OR board-certified dermatologists.

Exclusion Criteria:

* Under 18 years of age.
* Subjects who are unable to understand the protocol or give informed consent.

Primary outcomes:
measure: Review of Physician and Patient Experience
timeFrame: Last four weeks of study
Secondary outcomes:
measure: Physician's Experience with Skin Biopsy Sites
timeFrame: First four weeks of study
measure: Patient's Experience with Skin Biopsy Sites
timeFrame: First four weeks of study
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University Dermatology
state: Illinois
Study officials:
affiliation: Northwestern University
name: Murad Alam, MD
role: PRINCIPAL_INVESTIGATOR
References: