louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06509555: Correlation Between Serum TK1 and Pathological Remission of Breast Cancer With Neoadjuvant Chemotherapy
Official title: Establishment of Serum TK1 Combined With MRI to Predict Pathological Remission of Breast Cancer With Neoadjuvant Chemotherapy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Neoplasms
TK1
Lead sponsor: Yunnan Cancer Hospital
Sponsor class: OTHER
First posted: 2024-07-19
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patient was diagnosed with breast cancer by biopsy.

Brief summary: The levels and changes of sTK1 among different outcome groups in BCs with different molecular types were compared by stratification to explore whether sTK1 can be used as one of the tumor markers to predict pathological remission of NACT in BC patients.The changes of serum sTK1 level and ADC before surgery were continuously monitored, and combined with other clinicopathological factors, the pathological remission prediction model of NACT in BC patients was constructed and verified.

Detailed description: Female patients diagnosed with breast cancer by breast biopsy and receiving neoadjuvant chemotherapy in our hospital from 2020 to 2024 were selected as the study objects, and their puncture pathology data, general clinical characteristics, hematology test data, imaging data and surgical pathology data were collected, and the data were collated for statistical analysis. The influencing factors of pCR after neoadjuvant therapy were determined by univariate and multivariate logistic regression analysis, and the nomogram and ROC curve were drawn. The model was verified internally through bootstrap resampling 1000 times, and the correction curve was drawn to evaluate the prediction ability of the model.

Eligibility criteria: Inclusion Criteria:

① The patient was diagnosed with breast cancer by biopsy, and there were complete pathological data. ② Complete the course of neoadjuvant chemotherapy; ③ After the end of neoadjuvant therapy, the operation was performed and the postoperative pathology was obtained; MRI and serum TK1 data were complete (baseline, after 2 cycles of chemotherapy, 4 cycles of chemotherapy, and 6 cycles of chemotherapy).

Exclusion Criteria:

① Distant metastasis at first diagnosis (stage IV); ② With other primary malignant tumors.

Primary outcomes:
measure: Correlation analysis of serum TK1 and pathological remission of breast cancer with neoadjuvant chemotherapy
timeFrame: 2026.02
Secondary outcomes:
Other outcomes:
Locations:
city: Kunming
country: China
facility: Yunnan Cancer Hospital
state: Yunnan
Study officials:
affiliation: Yunnan Cancer Hospital
name: Qi Tang, doctor
role: STUDY_CHAIR
References:
Clinical trial NCT02782455: Calcium Dobesilate vs Flavonoids for the Treatment of Early Hemorrhoidal Disease
Official title: Calcium Dobesilate vs Flavonoids for the Treatment of Early Hemorrhoidal Disease a Randomised Triple Blind Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hemorrhoids
Lead sponsor: Services Hospital, Lahore
Sponsor class: OTHER_GOV
First posted: 2016-05-25
Enrollment: 100
Sex: ALL
Minimum age (years): 13
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Haemorrhoids are vascular cushions in the anal canal that help in the control of stool. When inflamed they become pathological and may present with protrusion and bleeding. A randomized, triple blind , controlled study will be conducted to compare the efficacy of calcium dobesilate against flavanoids in the management of early haemorrhoidal disease.


Eligibility criteria: Inclusion Criteria:

* Grade I and Grade II hemorrhoids

Exclusion Criteria:

* CLD
* colorectal/ anorectal Malignancy
* self medication
* local Quack Hakeem medication
* pregnancy

Primary outcomes:
measure: Frequency of occurrence of rectal bleeding after usage of drug
timeFrame: 1 weeks
Secondary outcomes:
measure: regression of hemorrhoids
timeFrame: 1 weeks
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Services Hospital Lahore
state: Punjab
Study officials:
affiliation: Services Institute of Medical Sciences
name: Dr. Waris Farooka, MBBS, FCPS, FRCS, FACS
role: STUDY_DIRECTOR
References:
Clinical trial NCT02181855: Effect of Full-thickness Gastroplication With the GERD-X System on Atypical Gastro-esophageal-reflux-symptoms
Official title: Effect of Full-thickness Gastroplication With the GERD-X System on Atypical Gastro-esophageal-reflux-symptoms.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Atypical Gastroesophageal Reflux Symptoms
Objectified Gastroesophageal Reflux Disease
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
First posted: 2014-07-04
Enrollment: 23
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

Brief summary: Patients with atypical symptoms of objectified gastroesophageal reflux disease will be treated by full-thickness gastroplication and the effect of this intervention will be measured by questionnaires and clinical diagnostics (for example pH/MII).


Eligibility criteria: Inclusion Criteria:

* Age between 18 years and 80 years
* symptomatic, objectified reflux disease (atypical symptoms - Montreal-classification)

Exclusion Criteria:

* Rejection of study-participation,
* Pregnancy
* negative pH-metry / impedance monitoring (non-objectified reflux)
* hiatal hernia bigger than 2 cm or gastroesophageal junction \> Hill IV classification
* different potential reasons for atypical symptoms like heterotopic gastric mukosa in the cervikal esophagus
* Achalasia, esophageal spasm
* Presence of contraindications for the interventions

Primary outcomes:
measure: Reflux Symptom index
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Linz
country: Austria
facility: Krankenhaus der Barmherzigen Schwestern Linz, Klinik für Allgemein- und Viszeralchirurgie
city: München
country: Germany
facility: Klinikum rechts der Isar der Technischen Universität München, II. Med. Klinik und Poliklinik
state: Bavaria
city: München
country: Germany
facility: Klinikum rechts der Isar der Technischen Universität München, Klinik und Poliklinik für Chirurgie
state: Bavaria
city: Ludwigsburg
country: Germany
facility: Klinikum Ludwigsburg, Klinik für Innere Medizin, Gastroenterologie, Hämato-Onkologie, Diabetologie und Infektiologie
Study officials:
affiliation: Klinikum rechts der Isar, II. Med
name: Monther Bajbouj, PD Dr. med.
role: PRINCIPAL_INVESTIGATOR
affiliation: Klinikum rechts der Isar, II. Med
name: Simon Nennstiel, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03878355: A Study of Different Endoscopic Surgery Procedures in Eosinophilic Chronic Rhinosinusitis With Nasal Polyps
Official title: Long-term Outcomes of Radical Endoscopic Sinus Surgery Plus Draf 3 Procedure in Eosinophilic Chronic Rhinosinusitis With Nasal Polyps and Asthma: A 9-year Prospective Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Rhinosinusitis (Diagnosis)
Surgery
Lead sponsor: Beijing Tongren Hospital
Sponsor class: OTHER
First posted: 2019-03-18
Enrollment: 27
Sex: ALL
Minimum age (years): 24
Maximum age (years): 71
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients were randomly assigned 1:1:1 to receive FESS, RESS and RESS plus Draf 3 surgery.
Primary purpose: TREATMENT

Brief summary: CRS remains a common challenging clinical entity due to variable phenotypes with different underlying mechanisms that lead to persistence or recurrence polyps. The eosinophils dominant inflammation was considered as a major pathological hallmark and challenges of CRS with nasal polyps (CRSwNP). Differentiate surgical approaches towards eosinophilic CRSwNP (eCRSwNP) should be addressed on the basis of the inflammatory endotypes. eCRSwNP has been recognized as the most easily relapsed type of CRS, and the combination of asthma increases the difficulty of treatment. Till now there is no recognized surgical strategy for eCRSwNP with asthma.


Eligibility criteria: Inclusion Criteria:

* The diagnosis of CRSwNP was based on the standard criteria issued in the European Position Paper on Rhinosinusitis and Nasal Polyps guidelines.
* Participants had at least 1 previous sinus surgery underwent FESS (middle turbinate (MT) preserved), good gasification of frontal sinus and with concomitant asthma.
* The diagnosis of asthma was confirmed by a chest physician according to Global Initiative for Asthma (GINA) guidelines.
* Polyp biopsy was undertaken 1 week before surgery and the eCRSwNP was confirmed by the number of eosinophils exceeded 10% of total infiltrating inflammatory cells in the polyp tissue through the evaluation by using hematoxylin and eosin (H\&E) staining.

Exclusion Criteria:

* Patients were excluded if they had unilateral disease, allergic fungal rhinosinusitis, antrochoanal polyps, or cysts.

Primary outcomes:
measure: recurrence
timeFrame: 1 year after surgery
measure: recurrence
timeFrame: 3 years after surgery
measure: recurrence
timeFrame: 5 years after surgery
Secondary outcomes:
measure: Visual analogue scale of 4 major clinical symptoms
timeFrame: at baseline, and 1 year, 3years, 5 years after surgery
measure: Sinus-specific quality of life (QoL)
timeFrame: at baseline, and 1 year, 3years, 5 years after surgery
measure: Postoperatively endoscopic results
timeFrame: at baseline, and 1 year, 3years, 5 years after surgery
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00673855: Acute Comfort of Lubricant Eye Drops FID 112903
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Eye
Keywords: Dry eye
Artificial tear
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2008-05-07
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To evaluate the acute comfort and blurring profile between two artificial tears in dry eye patients.


Eligibility criteria: Inclusion Criteria:

* Documented diagnosis of dry eye
* Must not have worn contact lenses for 1 week preceding enrollment

Exclusion Criteria:

* Age related

Primary outcomes:
measure: Drop Comfort Upon Instillation
timeFrame: Three minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Mansfield
country: United States
facility: Mansfield
state: Texas
Study officials:
References:
Clinical trial NCT03120455: Effects of Almond Versus Pistachio on Weight Loss
Official title: Effects of Almond Versus Pistachio on Weight Loss of Obese and Overweight Female Adults During Hypoenergetic Diet - a Randomized, 12 Week Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Overweight
Keywords: weight loss
Almond
Pistachio
hypoenergetic diet
Nut
Lead sponsor: Novindiet Clinic
Sponsor class: OTHER
Collaborators: name: University of Nottingham
name: Tehran University of Medical Sciences
First posted: 2017-04-19
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the current study is comparing the effect of almond and pistachio, as the two common types of nuts, consumption on healthy obese and overweight female who following a hypocaloric diet for 12 weeks. The secondary aim of the current study is to evaluate of these two type of nuts on other cardiometabolic risk factors.


Eligibility criteria: Inclusion Criteria:

* Must be female
* Must be 18-45 years of age.
* Must have Body mass index (BMI) between 27-35 kg/ m².
* Must be able to have moderate exercise.
* Must be interested to have weight loss.

Exclusion Criteria:

* Have allergy to nuts
* Participating in a research project involving weight loss or physical activity in the previous six months.
* Pregnancy or lactation during the previous 6 months, or planned pregnancy in the next six months.
* Taking medication that could affect metabolism or change body weight.
* Report heart problems, chest pain, and cancer within the last five years.
* Smoking
* Menopause
* Diagnosis of any chronic disease such as fatty liver, cancer, chemo/radio therapy, heart disease, immune compromised conditions, abnormal thyroid hormone level.

Primary outcomes:
measure: Weight
timeFrame: 12 Weeks
Secondary outcomes:
measure: Waist circumference
timeFrame: 12 Weeks
measure: fasting blood glucose
timeFrame: 12 Weeks
measure: HbA1c
timeFrame: 12 Weeks
measure: HOMA-IR
timeFrame: 12 Weeks
measure: lipid profiles
timeFrame: 12 Weeks
measure: liver function tests
timeFrame: 12 Weeks
measure: Insulin
timeFrame: 12 Weeks
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: NovinDiet Clinic
Study officials:
affiliation: NovinDiet Clinic, School of Life Sciences, The University of Nottingham
name: Hamid R Farshchi, MD, PhD
role: STUDY_CHAIR
affiliation: NovinDiet Clinic, School of Life Sciences, The University of Nottingham
name: Ameneh Madjd, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03100955: A Study of Standard Treatment +/- Apatinib in Extensive Stage Small Cell Lung Cancer
Official title: A Study of Standard Treatment +/- Apatinib in Extensive Stage Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Progression Free Survival
Lead sponsor: Qingdao University
Sponsor class: OTHER
First posted: 2017-04-04
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To establish the progression free survival in patients with extensive stage small cell lung cancer treated with cisplatin and etoposide plus or not apatinib

Detailed description: Assess progression free survival, overall survival and toxicity of standard EP regimen combined or not with VEGF tyrosine kinase inhibitor-apatinib. Response measured by RECIST response criteria. Toxicity via physical exam, adverse event review, assessing signs and symptoms, quality of life assessment and blood testing.

Eligibility criteria: Inclusion Criteria:

1. Histologically or cytologically verified SCLC, extensive stages
2. WHO performance status 0, 1, 2
3. Age 18 years or older
4. Treatment naive
5. Anticipated survival more than 3 months
6. HB \>90g/L, ANC\>1.5 x 109/L, Platelets \>80 x109 /L
7. No prognancy
8. Signed informed consent

Exclusion Criteria:

1. Limited stage disease
2. Metastastic meningitis, spinal compression, Tumor to main vesicular less than 5mm
3. Uncontrolled hypertension
4. Uncontrolled heart failure
5. Coagulation problem
6. Surgery, trauma, uncontrolled ulcer in 4 weeks.
7. Required by physician

Primary outcomes:
measure: progression free survival
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Qingdao
country: China
facility: Affiliated Hospital of Qingdao University
state: Shandong
Study officials:
affiliation: The Affiliated Hospital of Qingdao University
name: Zhuang Yu, MD, Ph. D
role: STUDY_CHAIR
References:
Clinical trial NCT04403555: Ivermectin as a Novel Therapy in COVID-19 Treatment
Official title: The Efficacy of Ivermectin in COVID-19 Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: COVID
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2020-05-27
Enrollment: 164
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Efficacy of Ivermectin in COVID-19 treatment

Detailed description: Clinical Study Evaluating the Efficacy of Ivermectin in COVID-19 treatment

Eligibility criteria: Inclusion Criteria:

* All Adult Patients aging from 20 to 65 years-old with COVID-19 confirmed by pharyngeal swab PCR.

Exclusion Criteria:

* Allergy or contraindication to the drugs used in the study.
* Pregnant and lactating mothers.
* Patients with cardiac problems.

Primary outcomes:
measure: The number of patients with mortality
timeFrame: 1 month
Secondary outcomes:
measure: Length of hospital stay
timeFrame: 1 month
measure: The need for mechanical ventilation
timeFrame: 1 month
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Sherief Abd-Elsalam
Study officials:
affiliation: ass. Prof. Tropical Medicine
name: sherief Abd-Elsalam, Ass. Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03060655: Study of PLGA-Mg Material in Clinical Orthopedics
Official title: Randomized, Double Blind Trial of Study of PLGA-Mg Material in Clinical Orthopedics
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Fracture Dislocation
Keywords: PLGA-Mg
fracture
fixation
union
Lead sponsor: Hebei Medical University Third Hospital
Sponsor class: OTHER
First posted: 2017-02-23
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The different proportion samples of PLGA-Mg were made in this study. Then, they would be placed in the femoral condyle of the New Zealand rabbits. The appropriate proportion of PLGA-Mg is obtained after the experiment, which will be used to make the plate or screw to fix the fragments. Then, the clinical role for bone will be assessed.

Detailed description: The deposition of calcium could be facilitated by the increase of magnesium, which played an important role in fracture union. However, its degradation may be completed before the fracture line was disappeared. In addition, the hydrogen may be released during degradation. Thus, its clinical popularization was limited.

As a new polymer material, poly lactic-co-glycolic acid (PLGA) has been widely used clinically. The hydrolytic production of PLGA was acidic, which could neutralize the alkalinity of production degraded from magnesium. In addition, it was a long time before the total accomplishment of degradation of PLGA, which may postpone the degradation of magnesium.

The different proportion samples of PLGA-Mg were made in this study. Their physical and chemical properties were analyzed to estimate its safety of implantation. Then, they would be placed in the femoral condyle of the New Zealand rabbits. The osteogenesis and complication of samples are examined to select an appropriate proportion of PLGA-Mg is obtained. Then, the PLGA-Mg material will be used to fix the fracture of human as a fixation. The review of the patients will be conducted to assess its clinical role.

Eligibility criteria: Inclusion Criteria:

* 18-65 years old
* Closed fracture
* Sign the agreement of the experiment

Exclusion Criteria:

* Pathologic fracture
* Open fracture
* Refused to participate
* Follow-up insufficient 12 months

Primary outcomes:
measure: fracture union time
timeFrame: 4 months
Secondary outcomes:
measure: complication
timeFrame: 1 months
Other outcomes:
Locations:
city: Shijiazhuang
country: China
facility: Hebei Medical University Third Hospital
state: Hebei
Study officials:
affiliation: Third Hospital of Hebei Medical University Department of Orthopaedic Surgery
name: Ruipeng Zhang, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00419055: Outpatient Percutaneous Coronary Intervention
Official title: Outpatient Percutaneous Coronary Intervention in a Selected, Stable Patient Population
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Coronary Artery Disease
Keywords: percutaneous coronary intervention
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Abbott Medical Devices
name: The Medicines Company
First posted: 2007-01-08
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients less than 75 years who have undergone PCI

Brief summary: To determine the safety and feasibility of same day discharge after elective coronary percutaneous intervention in a selected stable patient population. The hypothesis to be tested is that in an appropriately selected stable coronary artery disease population post percutaneous coronary intervention, early discharge is safe and feasible.

Detailed description: A select stable population of patients undergoing percutaneous coronary intervention are randomized to standard of care in-hospital stay for one night or early discharge to a nearby hotel. During PCI, patients receive bivalirudin as their anti-coagulant and also must be eligible for an angioseal closure device. Patients that stay overnight in the hotel must be accompanied by a family member. They return to the cath lab the next day for groin check and blood work. Satisfaction questionnaires are filled out by all patients.

Eligibility criteria: Inclusion Criteria:

* Patients with stable coronary artery disease scheduled for elective percutaneous coronary intervention

Exclusion Criteria:

* Patients with acute coronary syndrome, patients with an MI within 30 days, an ejection fraction \<30%, those with history of IV Dye allergy, creatinine level\>2.2, those with increased risk of infection, those with history of bleeding diathesis or anemia (hemoglobin\<11.0 g/dl, platelets \<100,000 tho/ul)

Primary outcomes:
measure: The primary endpoints are patient satisfaction and safety.
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Pennsylvania
name: Howard C Herrmann, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pennsylvania
name: Ruchira Glaser, M.D.
role: PRINCIPAL_INVESTIGATOR
References: