louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03647592: Real World Study on Erlotinib/Gefitinib Combined With Bevacizumab in Advanced Non-aquamous Non-small Cell Lung Cancer
Official title: Real World Study to Evaluate the Efficacy and Resistant Mechanism of Erlotinib/Gefitinib Combined With Bevacizumab in First Line EGFR Mutation Positive Advanced Non-aquamous Non-small Cell Lung Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Non Small Cell Lung Cancer
Keywords: Non-small Cell Lung Cancer
Bevacizumab
Erlotinib/Gefitinib
EGFR mutation positive
Lead sponsor: Hunan Province Tumor Hospital
Sponsor class: OTHER
First posted: 2018-08-27
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 30 non-saquamous non-small cell lung cancer with EGFR mutation positive (19del/L858R) were inrolled in this study.

ECOG PS 0-1 All the patients recieved the treatment of erlotinib combined with Bevacizumab.

Brief summary: This study aims to explore the efficacy and safety of Erlotinib/Gefitinib combined with bevacizumab in the real world for advanced non-squamous cell lung cancer with EGFR mutation, explore new drug resistance mechanisms under the A+T regimen and consistency between plasma and tissue detection driving genes, and finally assess the predictive value of plasma dynamic detection driving gene mutation profiles in predicting disease. The role of disease progression risk.

Detailed description: A retrospective study of 30 cases of advanced non-squamous non-small cell lung cancer (NSCLC) with EGFR mutation positive treated with A+T was conducted to observe the efficacy and safety of A+T regimen in the real world. Exploratory research contents are as follows: 1. Consistency between tissue gene test (NGS) and plasma gene test (NGS) at the initial diagnosis; 2. Consistency between tissue gene test (NGS) and plasma gene test (NGS) at the progression of A + T treatment; 3. New drug resistance mechanism of A + T treatment; 4. Plasma dynamics during A + T treatment. Detection (the first efficacy evaluation and a blood sampling before imaging PD) exploration and imaging progress sequence; 5. Plasma large panel dynamic drive gene mutation spectrum analysis to build disease progression risk model.

Eligibility criteria: Inclusion Criteria:

* EGFR mutation(19del/L858R)
* advanced non-saquamous non-small cell lung cancer
* primary treatment of first diagnosis
* performance status（0-1)

Exclusion Criteria:

* other genes mutation
* saquamous

Primary outcomes:
measure: PFS
timeFrame: Approximately 1 years
Secondary outcomes:
measure: OS
timeFrame: Approximately 1 years
measure: DCR
timeFrame: Approximately 1 years
Other outcomes:
Locations:
city: Changsha
country: China
facility: Hunan Provincal Tumor Hospital
state: Hunan
Study officials:
References:
Clinical trial NCT01784692: Pilot Study to Evaluate Immunopotentiating Effects of Immulina in Elderly Individuals
Official title: Pilot Study to Evaluate Immunopotentiating Effects of Immulina in Elderly Individuals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Elderly Immune Senescence
Keywords: Immulina
Elderly
Immune
Lead sponsor: University of Mississippi Medical Center
Sponsor class: OTHER
First posted: 2013-02-06
Enrollment: 21
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This will be a small study aimed at determining the effects of oral Immulina consumption on the immune system in elderly individuals.


Eligibility criteria: Inclusion Criteria:

* Age 60 and older;
* Generally otherwise healthy for age and not taking medications/supplements that could be expected to affect stress responses and/or impact immune parameters (example - systemic steroids, beta blockers, antidepressants, anti-anxiety drugs, Echinacea supplements, ginseng supplements or Spirulina supplements).

Exclusion Criteria:

* Inability to comprehend and speak English;
* Any history of major psychological or psychiatric illness (example - dementia, psychotic disorder, acute mania, current substance abuse) that may limit participant cooperation or compromise the integrity of self-reported clinical or psychological data;
* Presence of a confounding underlying systemic illness which could interfere with immunological profiles (example - severe cardiovascular, pulmonary, hepatic, gastrointestinal, renal, neurological, musculoskeletal endocrine , or metabolic systems; other gross physical impairments; or any history of significant convulsive disorder). Specifically, patients with congestive heart failure, recent viral or bacterial illness in the past 3 weeks, chronic kidney disease, thyroid disorder, autoimmune disease will be excluded.

Primary outcomes:
measure: Interferon gamma (IFNg)
timeFrame: 8 weeks
Secondary outcomes:
measure: Psychological Measures
timeFrame: 8 weeks
measure: Optimal supplement regime
timeFrame: 8 weeks
measure: Demographic differences
timeFrame: 8 weeks
measure: Immune biomarkers
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
Study officials:
affiliation: University of Mississippi Medical Center
name: Gailen D. Marshall, Jr., MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03728192: In-vitro Effect of Mangosteen Pericarp Extract on Cell Lines
Official title: Inhibition and Cytotoxic Effects of Mangosteen on Cell Lines
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Apoptosis
Lead sponsor: Meenakshi Ammal Dental College and Hospital
Sponsor class: OTHER
First posted: 2018-11-02
Enrollment: 2
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study comprised of two groups A (Hela) and group B ( H357) . Each group was further subdivided into 3 subgroups- A1 -Untreated cells, A2- mangosteen treated cells and A3- cells treated with standard drug. Group B was divided into B1- Untreated cells, B2- mangosteen treated cells and B3 -cells treated with the standard drug healthy periodontium. Test group: (Chronic periodontitis patients) comprised of 25 participants with signs of clinical inflammation and bone los
Primary purpose: PREVENTION

Brief summary: The present study is an effort to investigate the hypothesis that in-vitro vitality and antiapoptotic effect of alcoholic crude extract of mangosteen on Oral cancer( H357) cell lines and Cevical cancer (HeLa) cell lines.

Detailed description: The oral and cervical cells were investigated by MTT (3-4,5- dimethylthiazol-2-yl)-2,5-diphenyl tetrazolium bromide) assay, DNA fragmentation detection by TUNEL (Terminal deoxynucleotidyl transferase-mediated d-UTP Nick End Labeling) assay and Apototic assay using Annexin V/FITC Kit.

Eligibility criteria: Inclusion Criteria:

* Patients with oral squamous cell carcinoma
* Patients with cervical carcinoma

Exclusion Criteria:

• Patients with leukaemia

Primary outcomes:
measure: apoptotic potential of ethanolic extract of mangosteen pericarp on oral and cervical cancer cell lines via apoptotic assay
timeFrame: 48 hrs at base line
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Meenakshi academy of higher education and research
name: Jaideep Mahendra, MDS,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06523192: Validation of the English Version of the Drug Hypersensitivity Quality of Life Questionnaire
Official title: The English Version of the Drug Hypersensitivity Quality of Life Questionnaire: Validity and Reliability in the British Population.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Drug Hypersensitivity
Quality of Life
Lead sponsor: University Hospitals, Leicester
Sponsor class: OTHER
First posted: 2024-07-26
Enrollment: 146
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Our target population are patients with diagnosed drug allergy.

Brief summary: We aim to validate the English (UK) translation of the DrHy-Q, and test its reliability in the UK population. This will facilitate for the subsequent economical evaluation of penicillin allergy delabelling.

This research project is part of an MSc in Allergy undertaken by the principal applicant, Dr Patricia Romero, supervised through Imperial College London.

Target population are patients with a drug allergy diagnosed by an Allergist prospectively at the Drug Allergy Clinic.

Is the English version of the Drug Hypersensitivity Quality of Life Questionnaire suitable to be used in the UK population?


Eligibility criteria: Inclusion Criteria:

* • Age \>18 years

  * Ability to read English and consent.
  * Confirmed diagnosis of a drug hypersensitivity reaction.
  * Written informed consent

Exclusion Criteria:

* • \< 18y/o.

  * Not able to read English. No mental capacity to consent or unwilling to consent.
  * Unconfirmed diagnosis of a drug hypersensitivity reaction.

Primary outcomes:
measure: Validation of the English version of the Drug Hypersensitivity Questionnaire
timeFrame: March 2023 May 2024
Secondary outcomes:
Other outcomes:
Locations:
city: Leicester
country: United Kingdom
facility: UNiversity Hospitals Leicester
Study officials:
References:
Clinical trial NCT01343992: Bed Rest or no Bed Rest?
Official title: Evaluation of the Influence of Bed Rest After Embryo Transfer in Outcome of IVF Treatment With Ovum Donation.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: In Vitro Fertilization
Keywords: Embryo transfer
Implantation rate
Pregnancy rate
bedrest
neutral
benevolent
deterious
implantation
gestation rates
Lead sponsor: Instituto Valenciano de Infertilidad, IVI VALENCIA
Sponsor class: OTHER
First posted: 2011-04-28
Enrollment: 240
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: A comparative study to determine whether bed rest after embryo transfer (ET) affects on IVF (In Vitro Fertilization)outcome. This study includes 240 patients undergoing IVF treatment with donated oocytes. All the procedures of IVF, of the embryo transfer, and of the administration of medications are performed as always and there are no variations. The only highlighted procedure in this study is immediately after the embryo transfer. There are two groups: one which will rest in bed for 10 minutes after the transfer and one which will not rest after the transfer. Both procedures are common, usually depending on the habitual clinical practice of each clinic internationally. Patients from both group receive the routine post transfer instructions and treatment.


Eligibility criteria: Inclusion criteria:

* Infertile Patients with fertility problems due to tubaric or ovarian problems with normozoospermatic couple
* Patient and her couple with ages between ages 20 - 49 years old
* BMI \< 25 kg/m2
* IVF treatment with oocyte donation
* Elective transfer of 2 embryos of day 3 embryos or day 5/6 embryos transferred
* First cycle of embryo transfer

Exclusion criteria:

* Patients with uterine abnormalities, significant uterine fibroids, Hydrosalphinx
* History of recurrent pregnancy loss
* severe male factor were excluded from the study

Primary outcomes:
measure: Live birth infant rate after delivery from both groups of study
timeFrame: 10 months
Secondary outcomes:
measure: Implantation rate
timeFrame: 2 months
measure: Miscarriage rate
timeFrame: 5 months
measure: Birth weight of live newborn infant after delivery
timeFrame: 10 months
measure: Birth height of live newborn infant after delivery
timeFrame: 10 months
measure: Cranial perimeter of live newborn infant after delivery
timeFrame: 10 months
measure: APGAR score of live newborn infant after delivery
timeFrame: 10 months
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Instituto Valenciano de Infertilidad
Study officials:
affiliation: Instituto Valenciano de Infertilidad
name: Dr. Sharayi Gaikwad, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gaikwad S, Garrido N, Cobo A, Pellicer A, Remohi J. Bed rest after embryo transfer negatively affects in vitro fertilization: a randomized controlled clinical trial. Fertil Steril. 2013 Sep;100(3):729-35. doi: 10.1016/j.fertnstert.2013.05.011. Epub 2013 Jun 10.
Clinical trial NCT00214292: Evaluation of Breast Cancer Surgical Margins Using Optical Spectroscopy
Official title: A Pilot Study of Intraoperative Margin Assessment Comparing Optical Spectroscopy and Frozen Section Analysis for Ductal Carcinoma In Situ of the Breast
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2005-09-21
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will apply optical spectroscopy to intraoperative margin assessment during surgery for breast cancer. We hypothesize that a combination of fluorescence spectroscopy and diffuse reflectance spectroscopy will reliably detect involved surgical margins. Twenty patients with ductal carcinoma in-situ will undergo a standard lumpectomy followed by scanning with a sterile optical spectroscopy probe. Frozen sections from the surgical cavity will be used to evaluate the margins. Optical spectroscopy data will be categorized as benign or malignant using a statistical algorithm and the results will be compared with the frozen and permanent section results.


Eligibility criteria: Inclusion Criteria:

* ductal carcinoma in-situ or invasive carcinoma diagnosed by image directed core biopsy who are planning to undergo breast conserving surgery

Exclusion Criteria:

* patients who were diagnosed with excisional biopsy and patients undergoing mastectomy

Primary outcomes:
measure: The goal of this research is to develop a minimally invasive technology with the capability of rapidly assessing surgical margins for breast cancer patients undergoing breast conserving therapy.
Secondary outcomes:
measure: Two potential benefits from developing this technology are:
measure: 1. Decreasing operative times by eliminating the need to wait for histologic margin assessment.
measure: 2 Intraoperative margin assessment will become available for surgeons performing breast conserving therapy in facilities in-house pathologists.
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Tara Breslin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05736289: Evaluation of Mitral Valve Insufficiency Under General Anesthesia
Official title: Evaluation of Mitral Valve Insufficiency Under General Anesthesia
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Mitral Regurgitation
Mitral Valve Disease
Mitral Valve Insufficiency
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
First posted: 2023-02-21
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with moderate or severe mitral valve insufficiency undergoing cardiothoracic surgery or percutaneous treatment for their mitral valve condition.

Brief summary: Observational study in adult humans undergoing surgical or cardiological intervention for mitral valve insufficiency. Investigators aim to evaluate hemodynamic changes on an arterial pressure waveform level in patients before and after mitral valve intervention using Nexfin (BMEYE, Amsterdam, the Netherlands) continuous non-invasive hemodynamic monitoring, using finger cuff based technology to register beat-to-beat data


Eligibility criteria: Inclusion Criteria:

* All patients with moderate or severe mitral valve insufficiency undergoing cardiothoracic surgery or percutaneous treatment for this condition
* Adult patients (\>18 years)

Exclusion Criteria:

* No informed consent

Primary outcomes:
measure: Arterial pressure waveform changes
timeFrame: Before and during general anesthesia for mitral valve repair or replacement, ranging from 1 to 5 hours.
Secondary outcomes:
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Amsterdam University Medical Center
Study officials:
affiliation: Amsterdam University Medical Center - University of Amsterdam
name: Denise P Veelo, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01420289: Effect of HPIPC for the Treatment of Ischemic Ulcers in Subjects With PAD
Official title: A Randomized, Controlled Trial to Evaluate High Pressure Rapid Sequence, Intermittent Pneumatic Compression (HPIPC) for the Treatment of Intermittent Claudication, Pain and Ulcer Healing in Subjects With PAD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PVD
Arterial Ulcers
Keywords: Ischemic ulcers
PAD
Intermittent Claudication Pain
Lead sponsor: Calvary Hospital, Bronx, NY
Sponsor class: OTHER
First posted: 2011-08-19
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the effects of HPIPC for the treatment of symptoms of PAD


Eligibility criteria: Inclusion Criteria:

* Intermittent claudication \>6mo
* Ischemic ulceration or ulcer of mixed (venous) etiology
* ABI \< 0.7
* Ambulatory
* Able to comply

Exclusion Criteria:

* Gangrene
* M.I. within 6mo
* Inability to walk
* Wound infection
* Systemic corticosteroids
* HBO, Apligraf, Dermagraft within 6mo
* Falsely elevated ankle to brachial index (ABI)
* Inflammatory condition affecting healing

Primary outcomes:
measure: Mean Percent Reduction in Wound Surface Area
timeFrame: baseline and 16 weeks
Secondary outcomes:
measure: Percent Improvement in Peak Walking Time
timeFrame: 16 weeks
measure: Perceived Improvement in Physical Function After 16 Weeks
timeFrame: 16 weeks
measure: Wound Pain as Determined by a Visual Analog 10 Point Scale (VAS) for Pain.
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Center for Curative and Palliative wound Care, Calvary Hospital
state: New York
Study officials:
affiliation: Director Wound Care Center
name: Oscar M Alvarez, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06048289: Prospective Observational Study to Predict the Response of Biliary Tract Tumors to Immunotherapy
Official title: Prospective Observational Study on Prediction of Response to First-line Immunotherapy in Patients With Biliary Tract Tumors
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Biliary Tract Tumor
Cholangiocarcinoma
Lead sponsor: Zhejiang Cancer Hospital
Sponsor class: OTHER
First posted: 2023-09-21
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a pathological diagnosis of biliary tract tumors who have agreed to receive first-line PD-1/PD-L1 inhibitors combined with chemotherapy

Brief summary: A prospective, observational study to explore multidimensional biomarkers for predicting the efficacy of immunotherapy In biliary tract tumors

Detailed description: Patient with unresectable advanced or metastatic biliary tract tumors will be enrolled and plan to receive PD-1/PD-L1 inhibitors combined with chemotherapy as first-line treatment. To explore the biomarkers, tumor tissues, acquired from puncture biopsies at baseline, will be collected and investigated by genomic panel sequencing , transcriptome sequencing, and mIHC. Meanwhile, baseline peripheral blood and feces were also collected for detection of plasma proteins, genomes, and metagenomes. Finally, the investigators will analysis and explore predictive biomarkers of immunotherapy in biliary tract tumors.

Eligibility criteria: Inclusion Criteria:

1. Over 18 years old;
2. Imaging evaluation indicates unresectable advanced or metastatic biliary tract tumors (including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder carcinoma);
3. Confirmed as adenocarcinoma by histology;
4. Has not received systemic therapy in the past (patients who have not progressed within six months after the completion of neoadjuvant therapy or adjuvant therapy can be enrolled);
5. At least one measurable lesion according to RECIST 1.1 standard;
6. Plan to receive PD-1/PD-L1 inhibitors combined with chemotherapy as first-line treatment;
7. Sign informed consent, has good compliance and can cooperate with follow-up.

Exclusion Criteria:

1. Suffering from other active malignant tumors within 5 years or simultaneously; Unable to collect baseline plasma or tissue samples.

Primary outcomes:
measure: Identifying predictive biomarkers of immunotherapy response
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
Study officials:
affiliation: Zhejiang Cancer Hospital
name: Biospecimen Retention Ying, Dr
role: PRINCIPAL_INVESTIGATOR
References: