louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02103569: Drug Interaction Study of an OCP (Norethindrone (ND) Acetate and Ethinyl Estradiol (EE))With a Combination of Daclatasvir (DCV) Asunaprevir (ASV) and BMS-791325
Official title: Effect of a Combination of Daclatasvir, Asunaprevir, and BMS-791325 on the Pharmacokinetics of a Combined Oral Contraceptive Containing Ethinyl Estradiol and Norethindrone Acetate in Healthy Female Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hepatitis C
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2014-04-04
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The purpose of this study is to assess the effect of DCV/ASV/BMS-791325 fixed dose combination (FDC) + 75mg BMS-791325 on the Pharmacokinetics (PK) of the oral contraceptive agent.

Detailed description: IND Number: 79,599 and 101,943

Other: Phase 1 Clinical Pharmacology drug interaction study in healthy female subjects

Eligibility criteria: For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Healthy females within age of 18-40 years
* Must be a Women of Childbearing potential
* Must be on a stable regimen of oral contraceptive therapy for at least 3 consecutive months prior to study start

Exclusion Criteria:

* Subjects must not have any significant acute or chronic medical illnesses or conditions precluding safe use of oral contraceptives
* Prior exposure to DCV, ASV or BMS-791325 within 30 days of dosing on study day 1
* Smoking within 6 months of study start

Primary outcomes:
measure: Area under the concentration versus time curve in 1 dosing interval (AUC (TAU)) of Ethinyl Estradiol and Norethindrone
timeFrame: Day 21 to Day 49
measure: Maximum observed plasma concentration (Cmax) of Ethinyl Estradiol and Norethindrone
timeFrame: Day 21 to Day 49
Secondary outcomes:
measure: Dose-normalized area under the concentration versus time curve in 1 dosing interval (AUC (TAU)) of Ethinyl Estradiol and Norethindrone
timeFrame: Day 1 to Day 50
measure: Dose-normalized maximum observed plasma concentration (Cmax) of Ethinyl Estradiol and Norethindrone
timeFrame: Day 1 to Day 50
measure: Time of maximum observed plasma concentration (Tmax) of Ethinyl Estradiol and Norethindrone
timeFrame: Day 1 to Day 50
measure: Safety measured by occurrence of Adverse events (AEs), serious AEs and AEs leading to discontinuation
timeFrame: Day 1 to Day 50
measure: Safety measured by abnormalities in vital sign measurements
timeFrame: Day 1 to Day 50
measure: Safety measured by findings on Electrocardiogram (ECG) measurements and physical examinations
timeFrame: Day 1 to Day 50
measure: Safety measured by marked abnormalities in clinical laboratory test results
timeFrame: Day 1 to Day 50
Other outcomes:
Locations:
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT04695769: Combined Ribavirin With Sofosbuvir/Velpatasvir/Voxilaprevir in Retreatment of Chronic Hepatitis C Non-responders
Official title: The Role of Combined Ribavirin and Sofosbuvir/Velpatasvir/Voxilaprevir in Treatment of Chronic Hepatitis C Non-responders; A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Hepatitis C
Keywords: HCV
Relapse
treatment failure
Lead sponsor: Helwan University
Sponsor class: OTHER
First posted: 2021-01-05
Enrollment: 281
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: This study aims to assess the role of ribavirin as an adjuvant to sofosbuvir/velpatasvir/voxilaprevir combination in retreatment of chronic hepatitis C with previous treatment failure.


Eligibility criteria: Inclusion Criteria:

* Adult (≥ 18 years) patients with chronic hepatitis C and detectable HCV RNA by Polymerase Chain Reaction (PCR) after completion of previous direct-acting antiviral regimen, and eligible for antiviral treatment.

Exclusion Criteria:

* Patients with decompensated cirrhosis (Child-Pugh score B and C).
* Patients with platelet count less than 50000/ mm³.
* Patients with HCC or extrahepatic malignancy.
* Pregnancy or inability to use an effective contraceptive method.

Primary outcomes:
measure: Achievement of sustained virological response (SVR)
timeFrame: 12 weeks post treatment
Secondary outcomes:
measure: Tolerability
timeFrame: During 12 weeks of treatment
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of medicine Helwan University
Study officials:
References:
Clinical trial NCT04729569: Gingival Response and Marginal Adaptation of Zirconia Crowns With Two Subgingival Margin Designs
Official title: Gingival Response and Marginal Adaptation of Zirconia Crowns With Two Subgingival Margin Designs: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gingival Recession, Localized
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-01-28
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to evaluate the effect of feather edge finish line and deep chamfer finish line on gingival position, bleeding on probing and marginal adaptation.

Detailed description: The aim of the study is to evaluate the effect of feather edge finish line and deep chamfer finish line on gingival position, bleeding on probing and marginal adaptation.

Gingival bleeding on probing will be evaluated before treatment. Preparation for all ceramic full coverage restoration will be performed according to manufacturer instructions by one operator. Type of finish line (whether feather edge or deep chamfer finish line) will be selected randomly according to a computer generated randomization list. Restorative margins will be placed subgingivally. Zirconia crowns will be fabricated for the prepared teeth and cemented using resin luting agent. At 6 months and 12 months after the cementation, restorative margin position relative to the gingival margin will be recorded. Bleeding on probing and marginal adaptation will also be recorded.

Eligibility criteria: Inclusion Criteria:

* Patients 18 years to 50 years old
* Dentate patients planned for a single full coverage restoration in the posterior area.
* Patients with no active periodontal disease.
* \>2mm of keratinized tissue

Exclusion Criteria:

* Smoking (\>10 cigarettes a day)
* Substance abuse history
* Patients with poor oral hygiene and high caries index
* Patients suffering from abnormal occlusal habits for example clenching or bruxism
* Local or systemic disease (endocrine, renal, hematologic, hepatic, immunosuppressive)
* Current steroid/chemotherapy
* Head and neck irradiation
* Pregnancy
* Inability or unwillingness to return for follow up visits.

Primary outcomes:
measure: Position of the margin of the restoration in relation to the gingival margin position
timeFrame: 1 year
Secondary outcomes:
measure: Bleeding on probing
timeFrame: 1 year
Other outcomes:
measure: Marginal adaptation
timeFrame: 1 year
Locations:
Study officials:
References:
Clinical trial NCT01626469: Measurement of Eye Blood Flow and Renal Function in Healthy and Diabetic Patients
Official title: Eye Blood Flow and the Kidney
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2012-06-22
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to the determine the effect of salt intake and Captopril on the ophthalmic artery (OA) blood supply of individuals with Type 2 Diabetes Mellitus.

Detailed description: The overall objective of this study is to ascertain if salt intake affects ophthalmic artery (OA) blood flow. In addition, we will study both the eye and kidney response to ACE inhibition compared to placebo while controlling salt intake in subjects with Type 2 diabetes mellitus.

We hypothesize that salt intake will affect OA blood flow.

We will initially look at both eye and renal response to subjects on a low salt diet (10mEq Na/day) followed by response to high salt diet (200mEq Na/day). In addition, we may look at eye response while subjects consume their regular diet.

Eligibility criteria: Inclusion Criteria:

* Type 2 Diabetes Mellitus

Exclusion Criteria:

* Type 1 Diabetes Mellitus
* Heart Attack or Stroke within the last 6 months
* Pregnant or lactating females

Primary outcomes:
measure: Change in ophthalmic artery blood flow from baseline
timeFrame: 1 hour post drug, 2 hours post drug, 3 hours post drug
Secondary outcomes:
measure: Change in blood pressure from baseline
timeFrame: Every 15 minutes for 3 hours
measure: Change in renal plasma flow (RPF) from baseline
timeFrame: 1 hour post drug, 2 hours post drug, 3 hours post drug
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Norman K Hollenberg, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Brigham and Women's Hospital
name: Ebrahim Barkoudah, M.D.,M.P.H.
role: STUDY_DIRECTOR
References:
Clinical trial NCT07013669: Receptive Music Interventions During Intradermal Testing in Children
Official title: Receptive Music Interventions During Intradermal Testing in Children: A Randomized Controlled Trial Comparing Solfeggio Frequencies and Turkish Classical Music on Pain and Parental Anxiety
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Music Therapy
Anxiety
Pain Management
Skin Tests
Child
Lead sponsor: Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
Sponsor class: OTHER
First posted: 2025-06-10
Enrollment: 120
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The study summary and design were to assess procedural anxiety and stress in parents and pain perception in children during intradermal testing. Music medicine was incorporated into the study design as a nonpharmacological intervention. Two distinct auditory modalities were used: solfeggio frequencies-174 Hz, 285 Hz, 396 Hz, and 528 Hz-which have been suggested to interact with the human energy field through resonance-based mechanisms, and Turkish classical musical modes (makams), such as Rast, Hicaz, Uşşak, Neva, and Saba, which are modal systems that include microtonal intervals and follow specific melodic progressions that are often associated with different emotional and spiritual effects as well as sensory and emotional regulation potential.


Eligibility criteria: Inclusion Criteria:

1. Children aged between 2 and 17 years
2. Referred to the Pediatric Allergy Clinic for evaluation of suspected drug hypersensitivity reactions
3. Accompanied by a parent or legal guardian willing to participate
4. Written informed consent obtained from parents or legal guardians

Exclusion Criteria:

1. Known neurological, psychiatric, or developmental disorders in the child
2. Use of sedatives or analgesic medications within 24 hours prior to testing
3. Hearing impairment or auditory processing disorders in the child4.Non-consent or withdrawal of consent by parent or guardian
4. Inability of the parent to complete anxiety assessments (e.g., due to language or cognitive barriers)

Primary outcomes:
measure: Change in Parental State Anxiety Levels
timeFrame: within 5 minutes before and post procedure
measure: Pain Levels in Pediatric Patients During Intradermal Testing
timeFrame: within 2 minutes post-procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Prof Dr Cemil Tascioglu Education and Research Hospital Organization
state: Şişli
Study officials:
References:
Clinical trial NCT03007069: Preimplant Site Augmentation Using MPM Versus Autogenous Bone Graft
Official title: Implant Insertion in Defective Anterior Maxillary Ridge Augmented Using Mineralized Plasmatic Matrix Versus Autogenous Bone Graft
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bone Resorption
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-01-02
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Using growth factors obtained from patient's venous blood mixed with particulate autogenous bone the study compares bone gain by implant with gold standards.

Detailed description: To study the effectiveness of MPM in ridge augmentation with implant insertion compared with autogenous bone graft.

-PICO-

Population (P): Patients with defective maxillary alveolar ridge requiring implant insertion.

Intervention (I): Ridge augmentation with MPM.

Comparator (C): Autogenous bone graft.

Outcome (O): Patient satisfaction - Implant stability.

Eligibility criteria: Inclusion Criteria:

1. Medically free patients.
2. Evaluated bone height on CBCT to be (0-4 mm buccal bone dehiscence) and width (not less than 4.5 mm)
3. Patients with Anterior maxillary defective partially edentulous ridge.
4. Age between 18 and 40 years.
5. Both sexes.
6. Patients physically able to tolerate surgical and restorative procedures.
7. Patients with an opposing tooth to the pre-implant site.
8. Good oral hygiene.
9. Highly motivated patients.

Exclusion Criteria:

1. Patients allergic to local anesthetic agent.
2. Pregnant or lactating females.
3. Presence of any pathosis in the pre-implant site.
4. Presence of any mucosal disease.
5. Presence of parafunctional habits.
6. History of oral radiotherapy.
7. History of prolonged steroids use.
8. Psychological disorders.

Primary outcomes:
measure: Patient Satisfaction regarding esthetic results , outcome will be measure using questionnaire.
timeFrame: 5 months
Secondary outcomes:
measure: Stability of dental implants , this will be measured using Ostell device in ISQ units.
timeFrame: 5 months.
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05328869: The Effects Of Relaxation Training In Women With Primary Dysmenorrhea
Official title: The Effects Of Relaxation Training In Women With Primary Dysmenorrhea
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Primary Dysmenorrhea
Lead sponsor: Ankara Yildirim Beyazıt University
Sponsor class: OTHER
First posted: 2022-04-14
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study was to investigate the effects of relaxation training on menstrual pain severity, menstrual symptoms, impact of quality of life, impact of work/academic performance, impact of social activity level and anxiety level in women with primary dysmenorrhea (PD) complaints.

Detailed description: PD is the cramping pain that comes before or during a menstrual period. Relaxation training contributes to the reduction of stress and pain. Thus, there is a need to investigate the effects of relaxation training in dysmenorrhea.

Eligibility criteria: Inclusion Criteria:

* Women with primary dysmenorrhea complaint according to the Primary Dysmenorrhea Consensus Guide,
* Over 18 years of age,
* Having a mean pain intensity of moderate and higher according to the Visual Analogue Scale in the last 6 months,
* Having a regular menstrual cycle (28±7 days),
* Volunteered to participate in the study.

Exclusion Criteria:

* Having a pathological history and radiological findings pointing to secondary dysmenorrhea,
* Using oral contraceptives/antidepressants at least 6 months,
* Receiving hormone therapy,
* Undergoing pelvic surgery,
* Pregnant,
* Giving birth,
* Using an intrauterine device,
* Having neurological, orthopedic and/or rheumatological diseases
* Having a psychiatric disease,
* Having a history of malignancy

Primary outcomes:
measure: Menstrual pain intensity
timeFrame: change from baseline at an average of 2 weeks
Secondary outcomes:
measure: Menstrual symptoms
timeFrame: change from baseline at an average of 2 weeks
measure: Impacts of academic/work performance
timeFrame: change from baseline at an average of 2 weeks
measure: Impacts of life quality
timeFrame: change from baseline at an average of 2 weeks
measure: Impacts of social activity
timeFrame: change from baseline at an average of 2 weeks
measure: Anxiety level
timeFrame: change from baseline at an average of 2 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Ankara Yildirim Beyazıt University
name: Seyda Toprak Celenay
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02134769: Influence of Bionecteurs on Catheter-associated Infection
Official title: Incidence of Catheter-related Bloodstream Infections Using Bionecteur Device
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infection
Keywords: catheter-related bloodstream infections
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
Collaborators: name: Vygon GmbH & Co. KG
First posted: 2014-05-09
Enrollment: 221
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Bionecteur® is a protective non-touch applicator to ensure aseptic connection made by Vygon. However, there are no studies describing a positive effect of using Bionecteurs ® in regard to catheter-related bloodstream infections. In this study Bionecteur® will be used on central venous lines and arterial lines in postoperative patients of a 40-bed ICU. The incidence of catheter-related bloodstream infections will we compared to patients without inclusion of Bionecteur® devices.

Detailed description: * Prospective, randomised observational study
* Postsurgical patients in an anesthesiological ICU with ICU LOS (LOS: length of stay) \> 3 days

  * Inclusion:

    ---- Age ≥ 18 years

    ---. demand of central venous and arterial line

    --- written consent of patient and/or assignee
  * Exclusion

    * Handicapped patients
    * patient with ICU LOS \< 3 days
* Study design

  1. Three days after admission to ICU blood cultures are drawn to exclude preexisting blood stream infection
  2. Patients in a bed with even number are assigned to Bionecteur® group. Control group (without using bionecteurs) are patients with an odd bed number.
  3. Biconecteurs® are connected to all lumens of the central catheter and to arterial catheter. Control group is treated without using Bionecteurs®. Handling of vascular catheters are performed as described in institutional guidelines in both groups.
  4. Catheter-related bloodstream infections are monitored by an independent person during ICU treatment
  5. The study will be finished ab discharge of ICU or removal of catheters.

Eligibility criteria: Inclusion Criteria:

* Length of Stay (LOS) in ICU \> 3 days
* written consent by patient or notarial carers
* medical indication for central venous line/arterial line

Exclusion Criteria:

* handicap
* LOS ICU \< 3 days
* no consent

Primary outcomes:
measure: Incidence of catheter-related bloodstream infections using Bionecteurs
timeFrame: 1 year
Secondary outcomes:
measure: Length of Stay in ICU
timeFrame: 1 year
Other outcomes:
Locations:
city: Tuebingen
country: Germany
facility: University Hospital Tuebingen
Study officials:
affiliation: University Hospital Tuebingen, Germany
name: Helene A Haeberle, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Koeppen M, Weinert F, Oehlschlaeger S, Koerner A, Rosenberger P, Haeberle HA. Needle-free connectors catheter-related bloodstream infections: a prospective randomized controlled trial. Intensive Care Med Exp. 2019 Dec 2;7(1):63. doi: 10.1186/s40635-019-0277-7.
Clinical trial NCT04135469: Tax Preparation Pilot
Official title: Integration of Tax Preparation Into Pediatric Clinics: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Financial Stress
Maternal Distress
Keywords: Tax preparation service
Tax filing
Earned Income Tax Credit (EITC)
Child tax credit
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
Collaborators: name: Boston University
First posted: 2019-10-22
Enrollment: 69
Sex: ALL
Minimum age (years): 0
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The goal of this study to understand what percentage of families in the pediatric clinic at Boston Medical Center (BMC) currently file taxes and use free tax preparation and would accept and use referral to a free tax preparation service. The investigators specifically want to understand which of two methods of connecting to free tax preparation (referral versus navigated connection) is more effective. Also studied will be the feasibility of using surveys on financial wellness and other health indicators to track participants' health.

These pilot findings will be used to design a larger study that aims to assess whether integrating free tax preparation services into a pediatric clinic can increase tax filing rates and, as a result, the amount of money families receive in tax refunds. Additionally, the investigators hope to understand whether receiving this service impacts parental stress as well as how parents and babies are using the healthcare system.


Eligibility criteria: Inclusion Criteria:

* Guardian of a child 0-5 years
* English, Spanish, or Haitian-Creole -speaking
* Child is a Boston Medical Center pediatric primary care patient

Exclusion Criteria:

* Guardian not present at time of clinic visit
* Have no taxable income for the calendar year
* Not using BMC for pediatric primary care
* Have already filed their taxes for 2020

Primary outcomes:
measure: Financial well being
timeFrame: 12 months
measure: Tax refund
timeFrame: 12 months
measure: Tax credits
timeFrame: 12 months
Secondary outcomes:
measure: Maternal mental health
timeFrame: 12 months
measure: Maternal well being
timeFrame: 12 months
measure: Parenting skills
timeFrame: 12 months
measure: Maternal healthcare utilization
timeFrame: 12 months
measure: Child healthcare utilization
timeFrame: 12 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
Study officials:
affiliation: Boston Medical Center
name: Lucy Marcil, MD MPH
role: PRINCIPAL_INVESTIGATOR
References: