louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05710536: Safety and Efficacy of Formulation for Improving Vagina Laxity: A Pilot Study
Official title: Safety and Efficacy of Formulation Containing Stem Cell Secretome and Liquorice Root Extract for Improving Vagina Laxity of Women in Malaysia: A Pilot Study.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Healthy
Keywords: Vagina laxity
Lead sponsor: Ungku Shahrin Medical Aesthetic Research & Innovation (USMARI) Centre
Sponsor class: INDUSTRY
First posted: 2023-02-02
Enrollment: 18
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This study is conducted to investigate the safety and efficacy of the formulation containing stem cell secretome and licorice root extract in improving vagina laxity (VL) condition of women in Malaysia. This formulation may stimulate cell rejuvenation and trigger cell renewal efficiently as they contained rich mixture of natural, bioavailable polypeptides and plant extracts and these might help improving the VL condition in women. The study duration is 5 weeks and vagina assessment will be carried out at baseline, week 2 and week 5.The main objectives of this study are:

1. To assess the vagina laxity of women in Malaysia after using the formulation.
2. To observe any adverse effect occurrence with the use of the formulation.


Eligibility criteria: Inclusion Criteria:

* Malaysian women ( age 40 to 55 years old)
* Complaint of vagina laxity
* Willingness to participate in the study

Exclusion Criteria:

* Pregnant and breastfeeding women
* Doing any surgical or non-surgical procedures to improved vaginal laxity condition such as laser and radiofrequency before participating in the study that might affect the study outcome
* Presence of illness or taking any medication that might impact the study outcome or participants well-being

Primary outcomes:
measure: Change in vagina laxity condition from baseline and at week 2 and week 5 after using the product
timeFrame: Baseline, Week 2 and Week 5
measure: Change in vagina tone from baseline and at week 2 and week 5 after using the product
timeFrame: Baseline, Week 2 and Week 5
measure: Adverse effect after using the formulation
timeFrame: week 5
Secondary outcomes:
Other outcomes:
Locations:
city: Petaling Jaya
country: Malaysia
facility: Ungku Shahrin Medical Aesthetic Research & Innovation (USMARI) Centre
state: Selangor
Study officials:
References:
Clinical trial NCT04255836: Durvalumab Combined With Chemotherapy and Stereotactic Body Radiotherapy (SBRT) in Patients With Oligometastatic Non-small Cell Lung Cancer (NSCLC)
Official title: A Pilot Study of Durvalumab Combined With Chemotherapy and Stereotactic Body Radiotherapy (SBRT) in Patients With Oligometastatic Non-small Cell Lung Cancer (NSCLC)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Carcinoma, Non-Small-Cell Lung
Lead sponsor: Zhejiang Cancer Hospital
Sponsor class: OTHER
First posted: 2020-02-05
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a Phase II, multi-center pilot study assessing the efficacy and safety of durvalumab combined with chemotherapy and stereotactic body radiotherapy (SBRT) in patients with oligo-metastatic non-small cell lung cancer (NSCLC).


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed non-small cell lung cancer
* ≤3 metastatic organs and ≤5 metastatic lesions (supraclavicular and mediastinal lymph nodes are not classified as distant metastasis; other lymph node
* metastasis一group lymph node region will be classified as one metastatic lesion）
* Tissue biopsy prior to treatment
* ECOG performance score 0-1

Exclusion Criteria:

* EGFR mutation or ALK positive.
* Evidence on pulmonary interstitial disease or symptoms of active non-infectious pneumonia.
* Active infection including tuberculosis, hepatitis B, hepatitis C, or human immunodeficiency virus.
* Previous treatment with antibody against pd -1, pd - L1, pd - L2, CD137 or CTLA-4 (including ipilimumab or any antibody or drug against T cell co-stimulation or checkpoint pathway).

Primary outcomes:
measure: PFS
timeFrame: up to 2 years
Secondary outcomes:
measure: Safety (AESI, AEs/SAEs)
timeFrame: up to 2 years
measure: To assess the treat failure patterns
timeFrame: up to 2 years
measure: Objective response rate(ORR)
timeFrame: up to 2 years
measure: and OS Overall Survival(OS)
timeFrame: up to 2 years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04085549: Effects of a Berry Oil Cream on Atopic Eczema and Skin
Official title: Effects of a Berry Oil Cream on Atopic Eczema and Skin
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Atopic Dermatitis Eczema
Lead sponsor: Aromtech Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Cliniscan Ltd
First posted: 2019-09-11
Enrollment: 83
Sex: ALL
Minimum age (years): 12
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Atopic eczema is a chronic inflammatory skin disease associated with itch and inflammatory lesions in typical skin areas. The objective of this study is to investigate the effects of a cream containing berry and plant oils and humectants on atopic eczema and dry skin.


Eligibility criteria: Inclusion Criteria:

* Atopic Eczema (mild or medium severity)

Exclusion Criteria:

* Other serious skin conditions (for example psoriasis)
* Known hypersensitivity to ingredients of the study creams
* Medication seriously affecting immune function

Primary outcomes:
measure: Change in severity of atopic eczema
timeFrame: Part 1: Baseline, 2 weeks. Part 2: Baseline, 5 weeks
measure: Change in severity of symptoms
timeFrame: Part 1: Baseline, 2 weeks. Part 2: Baseline, 2 weeks, 5 weeks
measure: Change in sensation of itch
timeFrame: Part 1: Baseline, 2 weeks. Part 2: Baseline, 2 weeks, 5 weeks
measure: Change in transepidermal water loss (TEWL)
timeFrame: Part 1: Baseline, 2 weeks. Part 2: Baseline, 2 weeks, 5 weeks
measure: Change in skin hydration
timeFrame: Part 1: Baseline, 2 weeks. Part 2: Baseline, 2 weeks, 5 weeks
measure: Change in skin pH
timeFrame: Part 1: Baseline, 2 weeks. Part 2: Baseline, 2 weeks, 5 weeks
Secondary outcomes:
measure: Change in symptoms of itching, dryness, flaking of skin
timeFrame: Part 1: Baseline, 2 weeks. Part 2: Baseline, 2 weeks, 5 weeks
Other outcomes:
Locations:
city: Turku
country: Finland
facility: Mehiläinen (Private Clinic)
Study officials:
affiliation: Cliniscan Ltd
name: Risto Oksman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02430649: Irreversible Electroporation(IRE) For Unresectable Prostatic Neoplasms
Official title: Irreversible Electroporation(IRE) For Unresectable Prostatic Neoplasms: Phase I and Phase II Clinical Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Prostatic Neoplasms
Keywords: irreversible electroporation
Unresectable Prostatic Neoplasms
Lead sponsor: Fuda Cancer Hospital, Guangzhou
Sponsor class: OTHER
First posted: 2015-04-30
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and efficacy of irreversible electroporation (IRE) for unresectable Prostatic Neoplasms.

Detailed description: By enrolling patients with unresectable Prostatic Neoplasms adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of percutaneous IRE for unresectable Prostatic Neoplasms.

Eligibility criteria: Inclusion Criteria:

* Prostatic Neoplasms diagnosed by positive biopsy or non-invasive criteria,
* Not suitable for surgical resection,
* Eastern Cooperative Oncology Group (ECOG) score of 0-1,
* A prothrombin time ratio \> 50%,
* Platelet count \> 80x10\^9/L,
* Ability of patient to stop anticoagulant and anti-platelet therapy for seven days prior to and seven days post NanoKnife procedure,
* Able to comprehend and willing to sign the written informed consent form (ICF),
* Have a life expectancy of at least 3 months.

Exclusion Criteria:

* Cardiac insufficiency, ongoing coronary artery disease or arrhythmia,
* Any active implanted device (eg Pacemaker),
* Women who are pregnant or women of child-bearing potential who are not using an acceptable method of contraception,
* Have received treatment with an investigational agent/ procedure within 30 days prior to treatment with the NanoKnife™ LEDC System,
* Are in the opinion of the Investigator unable to comply with the visit schedule and protocol evaluations.

Primary outcomes:
measure: Number of participants with Adverse events
timeFrame: 6 month
Secondary outcomes:
measure: Percentage of lesions that show no sign of recurrence 12 months after IRE
timeFrame: 12 months
measure: Voltage (A minimum and maximum range of voltage for safe and effective IRE)
timeFrame: 3 months
measure: Progress free disease (PFS)
timeFrame: 12 months
measure: Overall survival (OS)
timeFrame: 36 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Biological treatment center in Fuda cancer hospital
state: Guangdong
Study officials:
affiliation: Fuda Cancer Hospital
name: Lizhi Niu, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT05674149: Image Data Collection Using a Multi-spectral Camera for Computer Vision Algorithms Research and Development
Official title: Image Data Collection Using a Multi-spectral Camera for Computer Vision Algorithms Research and Development
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Vascular Lesion
Pigmented Lesions
Lead sponsor: Lumenis Be Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Emek Medical Center
First posted: 2023-01-06
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This is an observational, single-center, open-label photography evaluation. Any patient that arrives for consultation or treatment at the clinic, presenting the required lesions detailed in the protocol can be included.

Detailed description: This is an observational, single-center, open-label photography evaluation. Any patient that arrives for consultation or treatment at the clinic, presenting the required lesions detailed in the protocol can be included.

The specified lesions can be located on any area of the face or body. For consenting subjects at least 5 close-up images of at least one lesion and one reference image (e.g., subject's skin without any lesion) will be obtained using the Multi-spectral SMART camera. An additional reference image of the lesion area will be taken with a regular camera. Optional images may be taken using a dermatoscop

Eligibility criteria: Inclusion Criteria:

Subjects must meet all the following inclusion criteria to be entered into the study:

Any patient, male or female of at least 18 years old, who is willing to sign an informed consent form and present at least one of the following conditions:

1. Photoaging (type I - III per Glogau classification)- mixed conditions
2. Epidermal pigmentation / Lentigines (age spots, sun spots)
3. Facial rosacea (Erythematotelangiectatic rosacea and papulopustular rosacea)
4. Facial telangiectasia
5. Poikiloderma
6. Seborrheic keratosis
7. Melasma (Chloasma)

Exclusion Criteria:

Any of the following will exclude the subject from the study:

The study is intended to gather image data so, any patient can be included in the study, and no exclusion criteria apply.

Primary outcomes:
measure: Images collection
timeFrame: through study completion, up to 4 months
Secondary outcomes:
measure: Images data collection
timeFrame: through study completion, up to 4 months
Other outcomes:
Locations:
city: Afula
country: Israel
facility: Ha'Emek Medical Center
Study officials:
References:
Clinical trial NCT03497949: Peri-operative Vasopressor Support in Patients Operated for an Acute Hip Fracture (AHF)
Official title: Peri-operative Vasopressor Support in Patients Operated for an Acute Hip Fracture (AHF)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hip Fractures
Intraoperative Hypotension
Lead sponsor: Sahlgrenska University Hospital
Sponsor class: OTHER
First posted: 2018-04-13
Enrollment: 997
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Single center study of patients operated with an acute hip fracture

Brief summary: The incidence of hypotension perioperatively during operation of an acute hip fracture is unknown. As a surrogate factor the usage of vasopressor support is more adequate as the registration of vasopressor drugs are many times not complete in records. The investigators retrospectively investigated the anesthetic journals of 1100 patients with an acute hip fracture (AHF) noting confounding factors and the usage of vasopressors either by injections or infusions and then correlated these results to mortality at 30-, 90- and 365- days

Detailed description: The incidence of hypotension perioperatively during operation of an acute hip fracture is unknown. As a surrogate factor the usage of vasopressor support is more adequate as the registration of vasopressor drugs are many times not complete in records. The investigators retrospectively investigated the anesthetic journals of 1100 patients with an acute hip fracture (AHF) noting confounding factors and the usage of vasopressors either by injections or infusions and then correlated these results to mortality at 30-, 90- and 365-days Confounding factors were; all comorbitity, age, ASA grade as well as type of anesthesia

Eligibility criteria: Inclusion Criteria

* Patients with an acute hip fracture

Exclusion Criteria

* Only one fracture within time-limit.
* Unretreivable mortality data

Primary outcomes:
measure: Mortality
timeFrame: 365 days
Secondary outcomes:
Other outcomes:
Locations:
city: Molndal
country: Sweden
facility: SahlgrenskaUH
state: VGR
Study officials:
References:
Clinical trial NCT05949749: A Retrospective Study Reveals the Relationship Between gp42-IgG Epitopes and EBV-associated NPC
Official title: A Retrospective Study Reveals the Relationship Between gp42-IgG Epitopes and EBV-associated NPC
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Nasopharyngeal Carcinoma
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2023-07-18
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Chinese.

Brief summary: Epstein-barr virus (EBV) infection is a necessary factor of nasopharyngeal carcinoma (NPC). The incidence of NPC in endemic regions reaches 24.60/100,000 people, far higher than that of the worldwide average. However, no EBV prophylactic vaccines is clinically available so far, which is largely hampered by the difficulties in selecting optimal vaccine design target out of 13 glycoproteins on the surface of EBV. In this study, we utilized humanized gp42-IgG antibodies to explore the dominant epitopes of gp42, one of the functional EBV glycoproteins during virus entry, to facilitate prophylactic vaccine design.


Eligibility criteria: Inclusion Criteria:

* Controls underwent physical examinations or primary NPC cases confirmed by pathology or cytology.
* If cases, at stage I-IVB diagnosed by radiology according to AJCC/UICC 8th.
* If cases, Karnofsky score (KFS)≥70, estimated survival span\>12 months.
* If cases, no disordered of major organs is found; blood test, liver, and kidney functions are basically normal.
* If cases, at least one measurable lesion according to Response Evaluation Criteria in Solid Tumours (RECIST) 1.1.

Exclusion Criteria:

* History of other malignant diseases.
* History of severe systemic diseases or heart, lung, liver, or kidney disfunction.
* History of severe neurological, metal, endocrine diseases.
* History of HBV, HCV, HIV, TP, or TB infection.
* If controls, physical examination reveals systemic diseases including malignant diseases.
* If cases, incomplete blood and pathological sample data.
* If cases, not receiving primary treatment in this facility.
* Other individuals investigators find not suitable for the trial.

Primary outcomes:
measure: Dominant gp42-IgG epitopes in cases
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen Memorial Hospital
state: Guangdong
Study officials:
affiliation: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
name: Xiao-Ming Huang, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03218449: Inflammatory Markers for Postoperative Complications in Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy
Official title: The Prognostic Value of Inflammatory Markers for Postoperative Complications in Patients Undergoing Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy (HIPEC)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cytoreductive Surgery With Hyperthermic Intraperitoneal Chemotherapy
Lead sponsor: Gangnam Severance Hospital
Sponsor class: OTHER
First posted: 2017-07-14
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Between September 2014 and April 2017, all patients who underwent cytoreductive surgery and HIPEC for peritoneal carcinomatosis

Brief summary: Infective complications after cancer surgery had a significant impact on disease-free and overall survival. Postoperative inflammatory markers have been proven useful in predicting infective complications. However, it remains unknown whether these markers can predict postoperative infection in patients receiving cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (HIPEC) which causes the systemic inflammatory response syndrome. Between September 2014 and April 2017, all patients who underwent cytoreductive surgery and HIPEC for peritoneal carcinomatosis were assessed for postoperative complications. Patients were divided into two groups according to the presence of infective complications. Presence of abscess, positive blood, surgical site, urine or sputum cultures, or clinical signs and symptoms with comparable radiologic findings were defined as infective complications. Retrospectively, C-reactive protein (CRP), neutrophil-to-lymphocyte ratio, white blood cell count, platelet count, mean platelet volume, platelet-to-lymphocyte ratio, albumin were collected from preoperative day and postoperative days (POD) 0-14.


Eligibility criteria: Inclusion Criteria:

* Between September 2014 and April 2017, all patients who underwent cytoreductive surgery and HIPEC for peritoneal carcinomatosis

Exclusion Criteria:

* A Patient treated the dexmedetomidine.

Primary outcomes:
measure: inflammatory markers
timeFrame: up to 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital
Study officials:
affiliation: Gangnam Severance Hospital
name: Yon Hee Shim
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05839249: The Impact of Covid 19 Pandemic on Ureteric Stents Complications.
Official title: The Impact of Covid 19 Pandemic on Ureteric Stents Complications.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Determine Effect of Urological Malpractice During Covid 19 on Patient Complications
Keywords: urological stents , COVID19
Lead sponsor: South Valley University
Sponsor class: OTHER
First posted: 2023-05-03
Enrollment: 100
Sex: ALL
Minimum age (years): 6
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: all patients performing JJ stent placement from January 2020 to December 2021

Brief summary: The pandemic of coronavirus disease 2019 (COVID-19) has serious implications on urology practice and raises particular questions for urologists about the management of different conditions. It was recommended to cancel most of the elective urological surgeries. (1) The least invasive intervention modalities that can be completed in local or regional anesthesia will serve the best interest of patients and urologists. 10 14 Endoscopic surgery is considered relatively safe.(2) After end of pandemic we facing complication of this era, one of most common complication was JJ stents complications as most of patient and doctors prefers to defer most of elective management by just JJ insertion and postpone definitive treatment. (3) In this study we discuss retrospectively the complication of JJ stenting during Covid 19 pandemic.

Detailed description: Type of the study: retrospective clinical study

* Study Setting: Qena University Hospital 3- Study subjects:

  a. Inclusion criteria: all patients performing JJ stent placement during Covid 19 pandemics b. Exclusion criteria: Patients refuse to participate in this study c. Sample Size Calculation: all patients performing JJ stent placement from March 2020 to December 2021
* Study tools (in detail, e.g., lab methods, instruments, steps, chemicals, ...):

  * Medical history
  * Complete physical examination.
  * All patents presented was investigated by

    1. Abdominal U.S
    2. Plain X Ray
    3. Non contrast CT
    4. Serum Creatinine
    5. Urine Analysis
* Research outcome measures:

  1. Primary (main): determine effect of urological malpractice during Covid 19 on patient complications
  2. Secondary (subsidiary): determine JJ stent complications during Covid 19 pandemics

Eligibility criteria: Inclusion Criteria:

* all patients performing JJ stent placement during Covid 19 pandemics

Exclusion Criteria:

* Patients refuse to participate in this study

Primary outcomes:
measure: jj stents complications during covid 19 pandimics
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Qinā
country: Egypt
facility: South Valley University
state: Qina
Study officials:
References: