louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05524025: The SPOT-HPV Study
Official title: Characterizing the Specificity and Sensitivity of Oral TTMV-HPV DNA Testing: the SPOT-HPV Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: HPV Infection
HPV Positive Oropharyngeal Squamous Cell Carcinoma
Keywords: HPV Infection
HPV-positive throat cancer
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
First posted: 2022-09-01
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Clinic schedules will be screened by the study team to identify eligible participants.

Brief summary: The purpose of this research is to evaluate a new test for oral HPV DNA in saliva ('oral rinse test').

Detailed description: This cross-sectional study will characterize the prevalence of salivary TTMV-HPV DNA among participants with and without HPV-positive throat cancer

Oral HPV infection is common among healthy adult men, but most of these infections resolve spontaneously and only a very small percentage of oral HPV infections turn into HPV-positive throat cancer. This study is trying to understand whether this new oral rinse test detects HPV DNA from infection, cancer cells, or both. If this test is ONLY positive in people WITH cancer, it may be useful for diagnosing HPV-positive throat cancer in the future.

Along with the oral rinse test study participants will complete brief surveys and participants with a positive salivary TTMV-HPV DNA tests may have repeat saliva testing, blood tests and head/neck exam.

It is expected that about 360 people will take part in this research study.

An external laboratory called Naveris is supporting this research study by providing testing for HPV DNA.

Eligibility criteria: Inclusion Criteria:

* Age 18+ years
* Able to provide informed consent
* Either one of the following:

  * Control cohort: Male individuals WITHOUT head and neck tumors that are, or may be, HPV-positive
  * Case cohort: Any individual WITH incident, untreated HPV-positive oropharynx squamous cell carcinoma

Exclusion Criteria:

* Unable to provide informed consent
* Head and neck tumors of non-oropharynx subsites that are or may be HPV-positive, including oral cavity, sinonasal, laryngeal, hypopharyngeal, or nasopharyngeal squamous cell carcinomas

Primary outcomes:
measure: Prevalence of salivary TTMV-HPV DNA
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham & Woman's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Eleni M Rettig, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04997525: Estradiol and Progesterone Levels Following Frozen Embryo Transfer
Official title: Estradiol and Progesterone Levels in Early Pregnancy After Natural, Estradiol + Progesterone or Gonadotrophin Stimulated Frozen Embryo Transfer Cycle
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Infertility
Lead sponsor: Copenhagen University Hospital at Herlev
Sponsor class: OTHER
Collaborators: name: Copenhagen University Hospital, Hvidovre
First posted: 2021-08-09
Enrollment: 305
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The aim of the present study is to investigate serum estradiol and progesterone levels in women conceiving after natural, estradiol + progesterone or gonadotropin stimulated frozen embryo transfer (FET) cycles.

Detailed description: Enrolled women will be randomized based on their ovulation pattern. Ovulatory women will be randomized to either natural cycle or estradiol + progesterone substituted cycle treatment for FET. Anovulatory women will be randomized to either estradiol + progesterone substituted cycle or gonadotropin stimulated cycle treatment for FET.

Included women will undergo blood testing every two weeks for serum estradiol and progesterone levels until gestational age 9+6. Routine vaginal ultrasounds will be performed as well as additional pregnancy ultrasounds.

Secondary obstetric outcomes will be investigated using the womens medical journals.

All the treatments are considered standard treatments for FET.

Eligibility criteria: Inclusion Criteria:

* Age \> 18 years \< 40 years
* BMI \< 35 kg/m2
* Normal wet smear within the past three years
* Thawed blastocysts (day 5 or 6) after either IVF or ICSI treatment

Exclusion Criteria:

* Age \< 18 years
* BMI \> 35 kg/m2
* Oocyte donation
* HIV/ hepatitis
* Undiagnosed vaginal bleeding
* Uterine malformations
* Persisting ovarian cysts
* Tumors in Hypothalamus, pituitary, thyroid or adrenal
* Previous breast cancer
* BRCA1/2
* Unregulated thyroid disease
* Cardiovascular disease
* Breast feeding
* Present or previous chemotherapy/radiation therapy
* Present or previous malignant disease
* Smoking
* Alcohol/drug abuse

Primary outcomes:
measure: Serum estradiol
timeFrame: 10 weeks
measure: Serum progesterone
timeFrame: 10 weeks
Secondary outcomes:
measure: Gestational age at delivery
timeFrame: At delivery
measure: Child birth weight
timeFrame: At delivery
measure: Obstetric complications
timeFrame: 9 months
measure: Child malformations
timeFrame: 9 months
Other outcomes:
Locations:
city: Herlev
country: Denmark
facility: Herlev University Hospital
Study officials:
References:
Clinical trial NCT04213625: Do Patients Perceive Surgeons Who Provide Personal Information as More Trustworthy and Empathetic?
Official title: Do Patients Perceive Surgeons Who Provide Personal Information ("Self-disclosure") as More Trustworthy and Empathetic?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Trust
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
First posted: 2019-12-30
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Prior studies have shown that patient trust in their physician is associated with better health outcomes and lower levels of emotional distress. Patients who have low levels of trust in their physician are less satisfied and less likely to adhere to their physician recommendations. As such, there is a need to better understand factors related to patient trust in their physician.

Purpose: To understand whether patient awareness of a surgeon's personal background improves patient trust in their surgeon.


Eligibility criteria: Inclusion Criteria:

* Patients (age 18 years or greater) visiting a single orthopaedic hand surgeon
* English fluency and literacy
* Ability to take informed consent

Primary outcomes:
measure: Wake Forest -Trust in Physician score
timeFrame: Immediately after the clinic visit, patients are given the survey to complete.
measure: Jefferson Scale of Perceived Physician Empathy
timeFrame: Immediately after the clinic visit, patients are given the survey to complete.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01768325: Evaluation of a New EUS-guided Needle (ProCore) Comparing to EUS-TCB Needle (Quick-Core)
Official title: Evaluation of a New EUS-guided Needle (ProCore) Comparing to Conventional EUS-TCB Needle (Quick-Core); A Prospective Randomized, Controlled Multi-center Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: GIST
Keywords: ProCore Needle
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2013-01-15
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to evaluate a new EUS-guided biopsy needle (ProCore®) comparing it to conventional EUS-TCB needle (Quick-Core®) in the diagnosis of your suspicious disorder.

This study needle (ProCore®) is a new EUS-guided biopsy needle and has been recently approved by the U.S. Food and Drug Administration (FDA) for use.

Detailed description: Primary Objective To compare the diagnostic accuracy of new EUS histology needle (19G, ProCore, Cook Medical Inc., Winston-Salem, NC) with the conventional histology needle (19G, Quick-Core, Cook Medical Inc., Winston-Salem, NC)

Secondary Objective To compare

* The number of needle passes requiring to acquire adequate specimen
* Length of core tissue obtained
* Diagnostic contribution of immunohistochemical staining
* Rates of complications

Eligibility criteria: Inclusion criteria:

* Solid tumors ≥ 2 cm in size.

Exclusion criteria:

* Thrombocytopenia

Primary outcomes:
measure: Diagnostic Accuracy.
timeFrame: 36 months
Secondary outcomes:
measure: Overall Specimen Length
timeFrame: 36 months
measure: Number of Needle Passes
timeFrame: 36 months
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University Hospital
state: Indiana
Study officials:
affiliation: Indiana University 550 N. University Hospital UH 4100 Indianapolis, IN 46202-5121
name: John M. DeWitt, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01014325: Safety and Efficacy Study With Allergen Extracts of House Dust Mites for Specific Sublingual Immunotherapy
Official title: Safety and Efficacy Study With Allergen Extracts of House Dust Mites for Specific Sublingual Immunotherapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Allergic Rhinitis
Lead sponsor: Roxall Medizin
Sponsor class: INDUSTRY
First posted: 2009-11-16
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this clinical trial is to assess the safety and efficacy of sublingual application of allergen extracts for specific immunotherapy in patients suffering from perennial allergic rhinitis due to house dust mites.


Eligibility criteria: Inclusion Criteria:

* Positive history of perennial allergic rhinitis
* Positive screening skin prick test (wheal diameter \> 3 mm)
* Compliance and ability of the patient to complete a Diary Card for self-evaluating of the symptoms and antisymptomatic medication
* Signed and dated patient´s Informed Consent,

Exclusion Criteria:

* Previous immunotherapy with allergen extracts within the last 3 years,
* Simultaneous participation in other clinical trials,
* Other reasons contra-indicating an inclusion into the trial according to the investigator´s estimation (e.g. poor compliance),
* Auto-immune disorders,
* Severe chronic inflammatory diseases,
* Malignancy,
* Alcohol abuse,
* Existing or intended pregnancy, lactation and/or lack of adequate contraceptive protection,
* Treatment with beta-blockers (incl. local application) and/or other contra-indicated drugs.

Primary outcomes:
measure: Symptom and medication score
timeFrame: 1 year
Secondary outcomes:
measure: Safety of sublingual application
timeFrame: 1 year
measure: Protocol of adverse events
timeFrame: 1 year
measure: Quality of Life Questionnaire
timeFrame: 1 year
measure: Evaluation of patients' related clinical global improvement
timeFrame: 1 year
Other outcomes:
Locations:
city: Madrid
country: Spain
Study officials:
References:
Clinical trial NCT03652025: The Effectiveness of Trans-catheter Foam Sclerotherapy of Pelvic and Atypical Lower Limb Varicosities
Official title: The Effectiveness of Trans-catheter Foam Sclerotherapy of Pelvic and Atypical Lower Limb Varicosities
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Venous Insufficiency
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-08-29
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: premenopausal women with dull aching pain with ovarian point tenderness and post coital pain.
Primary purpose: TREATMENT

Brief summary: pelvic congestion is the most recognized consequence of pelvi-perineal venous insufficiency .

chronic pelvic pain prevalence is about 26.6 %in egypt. this research is going to evaluate the effectiveness of foam sclerotherapy and to conclude diagnostic and therapeutic algorithm for this problem.

Detailed description: this study includes clinical and imaging and interventional aspects. detailed history and comprehensive examination of the patient. duplex ultrasonography to detect pelvic varices and presence of reflux. renal and left iliac venogram is usually the first step in the evaluation of compressive syndrome. then cannulate the gonadal and internal iliac veins selectively. contrast medium injected , the incompetent gonadal veins are generally dilated and the contrast pools in the pelvis after injection. embolization by injecting afoam sclerosant as distally as possible to occlude the pelvic venous plexus using occlusion balloon proximal.

follow up assessment by VAS score and duplex imaging.

Eligibility criteria: Inclusion Criteria:

* premenopausal women ovarian point tenderness post coital pain atypical lower limb varices

Exclusion Criteria:

* endometriosis diverticulitis fasciitis psychosexual dysfunction

Primary outcomes:
measure: The difference in pain score before and after therapy
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02795130: Short-Term Outcomes of Different Suture Materials for Sclerotomy Closure
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ophthalmologic Surgical Procedure
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
First posted: 2016-06-09
Enrollment: 40
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: Small-incision vitrectomy techniques have become increasingly popular, with a number of advantages over the older 20-gauge instrumentation. The beveled wounds created by the 23- and 25-gauge trocar systems theoretically do not require sutured closure. However, a certain fraction of cases, 1% for 25-gauge systems, and 4-38% for 23-gauge systems, do require suture placement. Poor wound closure puts the patient at increased risk of post-operative hypotony and is associated with increased risk of endophthalmitis. Currently, surgeons are divided as to which suture is the best for sclerotomy closure. The current standard of care is 8-0 polyglactin 910 (Vicryl, Ethicon, Cincinnati, OH). This suture is soft and easy to work with; however, it triggers a robust inflammatory response. The alternative is 6-0 plain gut suture, which is more difficult to manipulate and thicker, but causes less tissue inflammation1. The purpose of this study is to prospectively evaluate these two options for sclerotomy closure. The results of this study will enable us to minimize patients' post-operative discomfort while maximizing safety outcomes.


Eligibility criteria: Inclusion Criteria:

* Patient of Dr. Michael Dollin
* Age 18 years and older
* Scheduled to undergo 23-gauge pars plana vitrectomy for any indication that would most likely require sutures (E.g. retinal detachment)

Exclusion Criteria:

1. History of previous vitrectomy in the study eye
2. History of scleral buckling in the study eye
3. Currently on peri-operative corticosteroid medicines (topical or systemic)
4. Systemic chemotherapy within the preceding 6 months.
5. History of any disorder or medication use associated with conjunctival, scleral, or episcleral inflammation and/or scarring
6. History of narcotic abuse

Primary outcomes:
measure: Patient comfort
timeFrame: 1 month
Secondary outcomes:
measure: Scleral/conjunctival inflammation
timeFrame: 1 month
measure: Visual Acuity
timeFrame: 1 month
measure: Intraocular Pressure
timeFrame: 1 month
measure: Complications
timeFrame: 1 month
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00519948: Comfort and Cleaning Evaluation of Multipurpose Solutions in Contact Lens Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Patient Comfort
Lens Cleanliness
Lead sponsor: Innovative Medical
Sponsor class: INDUSTRY
First posted: 2007-08-23
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Intervention model: CROSSOVER

Brief summary: To compare patient comfort and overall lens cleanliness with consecutive use of two multipurpose lens solutions.


Eligibility criteria: Inclusion Criteria:

1. Patients 18 yrs or older
2. Males or females
3. Any race or ethnic background
4. CL patients using Opti-Free Express no-rub MPS currently
5. Patients using Focus night and day Lenses

Exclusion Criteria:

1. Corneal refractive surgery within 6 months of this study.
2. Corneal ectasia.
3. Current use of Restasis

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Worth
country: United States
facility: Eyeworks Group
state: Texas
Study officials:
affiliation: Eyeworks Group
name: Robert Chu, OD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03100630: Compare Bioavailability of RO7239361 After Subcutaneous Injection
Official title: An Open-label, Randomized, Parallel-group, Single Dose Study to Compare the Bioavailability of Subcutaneous Injections in the Arm, Thigh, and Abdomen and to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of RO7239361 in Healthy Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2017-04-04
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Randomized study in healthy men and women. Assess the similarity of RO7239361 when injected into the arm, thigh, or the stomach. Collect data on safety of RO7239361.


Eligibility criteria: Inclusion Criteria:

* Healthy participant as determined by no significant deviations in normal medical and surgical history and assessments
* Body Mass Index 18 kg/m2 to 32 kg/m2
* females must be of non-childbearing potential

Exclusion Criteria:

* tattoos or other skin findings on any of the potential injection sites
* history of chronic muscle pain within 30 days prior to study treatment
* prior history of IgG1 therapy

Other protocol defined inclusion and exclusion criteria apply

Primary outcomes:
measure: Maximum observed serum concentration (Cmax)
timeFrame: Up to 92 days
measure: AUC from time zero to time of last quantifiable concentration [AUC(0-T)]
timeFrame: Up to 92 days
measure: AUC from time zero extrapolated to infinite time [AUC(INF)]
timeFrame: Up to 92 days
Secondary outcomes:
measure: Incidence of Adverse Events ( AEs)
timeFrame: Up to 92 days
measure: Incidence of Serious Adverse Events (SAEs)
timeFrame: Up to 92 days
measure: Change from baseline in electrocardiogram findings
timeFrame: Up to 92 days
measure: Change from baseline in physical examination findings
timeFrame: Up to 92 days
measure: Change from baseline in clinical laboratory test findings
timeFrame: Up to 92 days
Other outcomes:
Locations:
city: Cypress
country: United States
facility: WCCT Global, Inc.
state: California
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT04214730: Study of NK Combined With Chemotherapy for Advanced Solid Tumor
Official title: Study of Natural Killer Cell Combined With Chemotherapy for Advanced Solid Tumor
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Solid Tumor
Lead sponsor: Yantai Yuhuangding Hospital
Sponsor class: OTHER
First posted: 2020-01-02
Enrollment: 60
Sex: ALL
Minimum age (years): 10
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Combinations Natural Killer Cell (NK) With chemotherapy treatment may enhance the immune response and stop cancer cells from growing.

Detailed description: Patients in group A will receive 4 cycles of NK treatments within 8 months. Patients in group B will have no immunotherapy. Chemotherapy are available in both groups.The investigators want to evaluate the efficacy of combination of NK with chemotherapy in patients with treatment-refractory solid tumors

Eligibility criteria: Inclusion Criteria:

1. Patients with treatment-refractory advanced solid cancer can not accept operation;
2. Age 10 to 90 years;
3. Eastern Cooperative Oncology Group (ECOG) score ≤ 2 points;
4. estimate survival \> 3 months;
5. Blood White Blood Cell(WBC)≥ 4×109/L, Hb ≥ 100g/L, Platelet Count (PLT)≥ 80×109/L; Alanine amino transferase (ALT) and aspartate amino transferase (AST)≤ 2 times of normal upper value; Serum Cr ≤ 2 normal upper value;
6. Without any other malignant disease;
7. With more than one scalable lesions;
8. Patients Voluntary attempt, and informed consent;
9. Women of child-bearing potential must have a negative pregnancy test because of the potentially dangerous effects of the preparative chemotherapy on the fetus.

Exclusion Criteria:

1. Patients who do not conform to the inclusion criteria;
2. Patients with uncontrolled infection; underlying disease that was severe or life-threatening (such as uncontrolled brain metastasis );
3. Patients who were pregnant or lactating;
4. ECOG perform status ≥ 2;4.
5. Other situations that the researchers considered unsuitable for this study (such as mental illness, drug abuse, etc.)

Primary outcomes:
measure: Disease Control Rates (DCR)
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Yantai
country: China
facility: Yantai Yuhuangding Hospital
state: Shandong
Study officials:
affiliation: Yantai Yuhuangding Hospital
name: Peiwen Lian, PhD
role: STUDY_DIRECTOR
References: