louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05529355: Effect and Safety of Envafolimab Combined With Endostar/S-1 in Second-line of Advanced Non-small Cell Lung Cancer
Official title: An Exploratory Non-randomized Controlled Trial for Effect and Safety of Envafolimab Combined With Recombinant Human Endostartin Injection/S-1 in Second-line Treatment of Advanced Non-small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Carcinoma, Non-Small-Cell Lung
Lead sponsor: Anhui Chest Hospital
Sponsor class: OTHER
First posted: 2022-09-07
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The trial was a randomized, open-label, multicenter Phase II study of patients with advanced or metastatic NSCLC who don't harbor driver genes. The aim is to explore the efficacy and safety of Envafolimab Combined With Endostar/S-1 in second-line treatment of advanced non-small cell lung cancer.

Detailed description: Patients with advanced (stage IV. NSCLC), after signing informed consent, are screened to meet the admission requirements. All the candidates are not randomly placed in 3 treatment groups (which treatment regimen the patient chooses is determined by the clinical supervisor on a patient-by-case basis).

Eligibility criteria: Inclusion Criteria:

1. All patients are histologically or cytologically confirmed stage IV non-small cell lung cancer. Genetic testing identifies no driver gene mutations.
2. Male or female, age \> 18 years, \< 75 years.
3. Patients had not received PD-L1 inhibitors in first-line treatment.
4. KPS score ≥ 70 points (ECOG score 0-1 points), the expected survival ≥3 months;
5. No dysfunction of major organs. EcG, liver function, renal function, and blood count tests before treatment are normal or basically normal, but must meet the following experimental results:

   1. Blood routine test:

      Leukocyte WBC≥3.5×109/L; Neutrophil count (ANC) ≥ 1.5×109/L; Platelet (PLT) ≥ 80×109/L;
   2. Blood biochemical test:

Total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal values; Alanine aminotransferase (ALT/SGPT) and alanine transaminases (AST/SGOT) ≤ 2.5 times the normal high value (ULN), or ≤ 5 times the upper limit of normal value in patients with liver metastases; Serum creatinine (Cr) ≤ 1.5 times the upper limit of normal values; c. Cardiac function test: 50% of the left ventricular ejection function of the heart \>; 6) The subject has good compliance, and can cooperates with follow-up.

Exclusion Criteria:

-

Primary outcomes:
measure: objective response rate(ORR)
timeFrame: six weeks
measure: Adverse events
timeFrame: three weeks
Secondary outcomes:
measure: progression-free survival(PFS)
timeFrame: six weeks
measure: overall survival(OS)
timeFrame: six weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01915355: Pulsed Dye Laser Treatment of Onychomycosis
Official title: Pulsed Dye Laser Treatment of Onychomycosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Onychomycosis
Keywords: onychomycosis
nail
fungus
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
First posted: 2013-08-02
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this research is to investigate the use of the Candela V-beam Pulsed Dye Laser for the treatment of onychomycosis, or nail fungus.

Hypothesis: Complete nail clearance will occur in approximately half of patients after 3 laser treatments.

Detailed description: 10 patients will participate nationally. The investigators hope to enroll all 10 patients at Jefferson. Involvement in the study will last about 8-12 weeks for the subject. The entire study will take about 12 months to complete.

Eligibility criteria: Inclusion Criteria:

* Ages 18-65 years old
* Diagnosis of onychomycosis based on positive fungal culture for dermatophyte and positive PAS from toenail clipping

Exclusion Criteria:

* HIV/immunosuppression
* Candidal toenail infection
* Prior PO antifungal therapy within last 6 months
* Personal history of psoriasis, lichen planus, or significant photosensitivity disorder
* Any serious generalized medical condition

Primary outcomes:
measure: Total Nail Clearance
timeFrame: approximately 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Jefferson Dermatology Associates
state: Pennsylvania
Study officials:
affiliation: Jefferson Dermatology Associates
name: Nazanin Saedi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03133455: Repetitive Thoughts in Fibromyalgia: Impact of Rumination on the Emotional and Cognitive Dimensions of Fibromyalgia
Official title: Repetitive Thoughts in Fibromyalgia: Impact of Rumination on the Emotional and Cognitive Dimensions of Fibromyalgia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Keywords: Rumination
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2017-04-28
Enrollment: 107
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Dysfunctional chronic diffuse pain syndrome, concerning 2% of the French population, Fibromyalgia (FM) is classified either as a psychological disease or as a somatic disease. This dichotomous reasoning does not lead to a better understanding and does not allow the use or development of new psychological tools of care.

The issue of the proximity between FM and depression highlighted by some authors and the presence of anxious comorbidities may arise at a different level, that of the transdiagnostic approach. Rumination is one of these transdiagnostic processes that are the subject of recent studies and one of the dimensions of which (abstract analytical rumination) is at work in depression and a number of psychopathologies. The investigator therefore wishes to explore the process of rumination and its abstract analytical dimension in FM and to explore its link with the depressive and anxious manifestations frequently associated with this disorder.


Eligibility criteria: Inclusion Criteria:

* FM Criteria of the American College of Rheumatology ACR 1990.
* Major Patients
* free and informed consent signed
* stable treatment for at least one month
* Native French speaker
* Patient covered by health insurance.

Exclusion Criteria:

* Patient deprived of liberty or protected major (under guardianship or curatorship)

Primary outcomes:
measure: Analyze the rate of rumination and depression of a fibromyalgia patient using a questionnaire
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens Picardie
state: Picardie
Study officials:
References:
Clinical trial NCT04366414: Breathing Protocol in Breath-hold Divers
Official title: Breathing Protocol on Oxygen Saturation Recovery After a Dynamic Apnoea in Breath-hold Divers: a Single-blind, Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Exercise Training
Apnea
Breathholding
Breathing Exercises
Lead sponsor: Centro Universitario La Salle
Sponsor class: OTHER
First posted: 2020-04-28
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: parallel-group
Primary purpose: TREATMENT

Brief summary: The aim of this randomized controlled trial study was to assess the effects of an 4-week exercise program on the recovery capacity after a voluntary maximal apnea. Participants will be randomly allocated to perform an experimental breathing protocol (NR-HB), or an usual training using their usual breathing (UB) protocol.

Detailed description: It is a multi-center study. 2 different Spanish Freedivers Centres are included in the study (Madrid and Zaragoza).

Divers were randomly assigned to receive an experimental training (NR-HB) or to be included in the Control Group (UB).

The trial included two study visits. Each exercise training program will be applied sessions per week during 4 weeks. Participants received baseline assessments at the beginning of any intervention, and post-intervention assessments at the end of the fourth week.

Eligibility criteria: Inclusion Criteria:

* Absence of pain or illness
* No changes in cognitive ability
* Over 18 years old.
* Member of the Spanish Federation of Underwater Activities.
* Positive medical examination that allows the diver to practice voluntary apnea.

Exclusion Criteria:

* People with systemic diseases, tumors, infections, pacemakers, history of epilepsy, hydrophobia, pregnancy women, pharmacological treatment.
* To be participating in other physical activities during the experimental research

Primary outcomes:
measure: Oxygen Saturation change
timeFrame: Before and after training intervention (after 4 weeks)
Secondary outcomes:
measure: Heart Rate recovery
timeFrame: before and after training intervention (after 4 weeks)
measure: Lung function (forced spirometry)
timeFrame: before and after training intervention (after 4 weeks)
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Madrid FREEDIVERS association
Study officials:
References:
citation: Andersson JP, Liner MH, Runow E, Schagatay EK. Diving response and arterial oxygen saturation during apnea and exercise in breath-hold divers. J Appl Physiol (1985). 2002 Sep;93(3):882-6. doi: 10.1152/japplphysiol.00863.2001.
Clinical trial NCT00587314: The Effect of Ablation Therapy on Barrett's Esophagus
Official title: The Effect of Ablation Therapy on Barrett's Esophagus
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Barrett's Esophagus
Early Esophageal Adenocarcinoma
Keywords: Photodynamic Therapy
Barrett's Esophagus
Early Esophageal Adenocarcinoma
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2008-01-07
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have had or qualify for ablation therapy for treatment of their barrett's esophagus

Brief summary: To assess the effect of ablative therapy (Photodynamic Therapy or Radiofrequency ablation ) on Barrett's Esophagus

Detailed description: To assess the effect of ablation therapy on Barrett's esophagus. Proposal Ablation therapy is an FDA approved treatment to decrease cancer risk in Barrett's esophagus mucosa. This is being performed in our Barrett's Esophagus Unit on a regular basis. However, the longterm outcomes of this therapy is not established and there are patients who have been treated who later re-develop Barrett's mucosa. This study will allow us store tissue samples that can later be used to assess the effect of ablative therapy on Barrett's esophagus.

Eligibility criteria: Inclusion Criteria:

* Patients who have had or qualify for ablation therapy for treatment of their barrett's esophagus with high grade dysplasia or early esophageal adenocarcinoma
* Ability to provide informed consent

Exclusion Criteria:

* Eastern Cooperative Oncology Group performance status 3 or 4
* Inability to tolerate endoscopic procedures
* Pregnancy: Females of child-bearing age will be screened with pregnancy test.

Primary outcomes:
measure: Response to treatment
timeFrame: at time of surveillance intervals
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Cadman Leggett, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01873014: the Effect of Chinese Herbs to Treat Thyroid Diseases With Different Iodine Intake
Official title: the Effect of Chinese Herbs to Treat Thyroid Diseases With Different Iodine Intake
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Thyroid Diseases
Lead sponsor: Tianjin Medical University Cancer Institute and Hospital
Sponsor class: OTHER
First posted: 2013-06-07
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: safe study of Chinese Herbs to Treat Thyroid Diseases With Different Iodine

Detailed description: Based on the previous studies, the research choose the patients with different iodine intake,and improve our original Chinese Herbs thyroid III formula, in order to provide the patients the best individual treatment plan.

Eligibility criteria: Inclusion Criteria:

* patient with thyroid diseases

Exclusion Criteria:

* not meet the diagnostic criteria,women with pregnancy or lactation ,drug allergy ,need surgery

Primary outcomes:
measure: diameter，number of the tumor
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: doctor
name: yu yang, doctor
role: STUDY_DIRECTOR
References:
Clinical trial NCT02931214: Placebo-Controlled Single Dose Study to Evaluate Safety and Pharmacokinetics of GMI-1359 in Healthy Volunteers
Official title: A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GMI-1359 in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Healthy Subjects
Pharmacokinetics
Pharmacodynamics
Lead sponsor: GlycoMimetics Incorporated
Sponsor class: INDUSTRY
Collaborators: name: Celerion
First posted: 2016-10-12
Enrollment: 58
Sex: ALL
Minimum age (years): 19
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate safety and pharmacokinetics of single ascending IV doses of GMI-1359 in healthy adult subjects.

Detailed description: This is a randomized, double-blind, placebo-controlled, single ascending IV dose study conducted at one study center in the United States. Safety will be assessed throughout the study and serial blood samples and urine samples will be collected for the safety and pharmacokinetic assessment of GMI-1359.

Eligibility criteria: Inclusion Criteria:

1. Healthy adult male or females, 19-60 years of age (inclusive).
2. Medically healthy with no clinically significant screening results.
3. Females of childbearing potential must either be sexually inactive (abstinent) for 3 months prior to dosing or be using an acceptable birth control method
4. Females must have a negative pregnancy test at the time of screening and prior to dosing for inclusion in the study.
5. Understands the study procedures in the informed consent form, and be willing and able to comply with the protocol.

Exclusion Criteria:

1. Subject is mentally or legally incapacitated.
2. History of any illness that, in the opinion of the PI, might confound the results of the study or poses an additional risk to the subjects by their participation in the study.
3. Normal clinical laboratory values.
4. Normal heart rate and blood pressure.
5. Blood donation or significant blood loss within 56 days prior to dosing.
6. Plasma donation within 7 days prior to dosing.
7. Participation in another clinical trial within 28 days prior to dosing.

Primary outcomes:
measure: Treatment related adverse events
timeFrame: 15 days
Secondary outcomes:
measure: Pharmacokinetics
timeFrame: 48 hours
measure: Pharmacokinetics
timeFrame: 48 hours
measure: Pharmacokinetics
timeFrame: 48 hours
measure: Pharmacodynamics
timeFrame: 48 hours
Other outcomes:
Locations:
city: Lincoln
country: United States
facility: Celerion
state: Nebraska
Study officials:
affiliation: Celerion
name: Laura Sterling, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00935714: Exercise and Breast Cancer Related Lymphedema: Influence of Muscle Group and Sequence on Volume Change in Swollen and Normal Arms
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Lymphedema
Keywords: Arm
Lymphedema
Breast Cancer
Exercise
Breast Cancer related Lymphedema
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
Collaborators: name: Tel Aviv University
First posted: 2009-07-09
Enrollment: 18
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: Arm exercise influences arm volume and symptoms in breast cancer related lymphedema.


Eligibility criteria: Inclusion Criteria:

* unilateral arm lymphedema as a result of breast cancer treatment
* completion of breast cancer treatments
* arm lymphedema onset 3 months or more after surgery and persistent for at least 6 months
* in the maintenance phase of lymphedema treatment

Exclusion Criteria:

* women with recurrent cancer
* intercurrent diseases affecting the swollen arm
* lack of understanding of the Hebrew language

Primary outcomes:
measure: Improved arm volume measurement
timeFrame: Weekly for five weeks
Secondary outcomes:
measure: Quality of Life
timeFrame: Weekly for 5 weeks
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Hillel Yaffe Medical Center
Study officials:
References:
Clinical trial NCT00518414: The Evaluation of Cow Milk-Based Formulas
Official title: The Evaluation of Cow Milk-Based Formulas - Study A
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Term Infants
Keywords: infant, formula, LC PUFA
Lead sponsor: Mead Johnson Nutrition
Sponsor class: INDUSTRY
First posted: 2007-08-20
Enrollment: 136
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Infants will be fed infant formula and blood drawn to measure fatty acid levels in the blood.


Eligibility criteria: Inclusion Criteria:

* Healthy, term infant
* 10 to 18 days of age

Exclusion Criteria:

* Breast fed infants
* Infants with formula intolerance

Primary outcomes:
measure: Red Blood Cell (RBC) ARA and DHA
timeFrame: 120 Days of age
Secondary outcomes:
measure: Phospholipid fatty acids, tolerance
timeFrame: 120 Days of age
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Birmingham Pediatric Group
state: Alabama
city: Birmingham
country: United States
facility: Southlake Pediatrics
state: Alabama
city: Little Rock
country: United States
facility: Arkansas Pediatric Clinic
state: Arkansas
city: Tamarac
country: United States
facility: Children's Medical Association
state: Florida
city: Evansville
country: United States
facility: Welborn Clinic
state: Indiana
city: Omaha
country: United States
facility: The Center for Human Nutrition
state: Nebraska
city: Kingsport
country: United States
facility: Holston Medical Group
state: Tennessee
city: Longview
country: United States
facility: DCOL Center for Clinical Research
state: Texas
city: The Woodlands
country: United States
facility: Northwood Pediatrics
state: Texas
Study officials:
affiliation: Mead Johnson Nutritionals
name: Carol L Berseth, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT01841814: Evolution of Bone Mineral Density (BMD) in Patients With Lymphoma Undergoing Chemotherapy
Official title: Evolution of Bone Mineral Density (BMD) in Patients With Lymphoma Undergoing Chemotherapy: Prospective Longitudinal Study Over 12 Months.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Lymphoma
Osteoporosis
Keywords: Lymphoma
Osteoporosis
Chemotherapy
Patient with
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2013-04-29
Enrollment: 0
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: DIAGNOSTIC

Brief summary: The purpose of this study is to assess changes of bone mineral density (BMD) at 12 months during the therapeutic management of patients with lymphoma.


Eligibility criteria: Inclusion Criteria:

* Subjects aged 18 to 80 with lymphoma,
* Histological diagnosis of Hodgkin's lymphoma (HL) or non-Hodgkin lymphoma (NHL) of follicular or aggressive (large cell or other),
* Patients who have not yet started their chemotherapy or who have started for less than a month
* Patient has signed informed consent.

Exclusion Criteria:

* Pathological fractures at the time of initial diagnosis of lymphoma,
* Compression of neurological epidural,
* Patients receiving treatment for osteoporosis (including bisphosphonates, selective modulators of estrogen receptor, calcitonin and parathyroid hormone Teriparatide).
* Discovery of osteoporosis or osteopenia fracture during the initial evaluation requiring the establishment of an osteoporosis treatment,
* Radiotherapy to the lumbar spine or hip studied,
* Location of bone lymphoma in the lumbar spine or hip studied,
* History of disorders affecting bone metabolism (prostate cancer with androgen, stomach cancer, hyperparathyroidism, hyperthyroidism, uncontrolled ...)
* A person incapable of giving consent personally,
* Pregnant or breastfeeding women,
* Protected Person (under guardianship)
* Patient not affiliated with a social security system.

Primary outcomes:
measure: Measurement of bone mineral density (BMD).
timeFrame: Change from Baseline of bone mineral density at 12 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: Gandhi DAMAJ
state: Picardie
Study officials:
affiliation: CHU d'Amiens France
name: Gandhi DAMAJ, Doctor
role: PRINCIPAL_INVESTIGATOR
References: