louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03356834: Change of Renal Function and Bone Mineral Density in CHB Patients Switch From TDF to TAF vs. Maintaining TDF
Official title: Change of Renal Function and Bone Mineral Density Marker in Chronic Hepatitis B Patients Switching From TDF to TAF vs. Maintaining TDF
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Hepatitis B
Keywords: Chronic hepatitis B
Efficacy, safety, and tolerability
Tenofovir alafenamide
Lead sponsor: Humanity and Health Research Centre
Sponsor class: OTHER
First posted: 2017-11-29
Enrollment: 575
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: In Chronic hepatitis B (CHB) patients receiving long-term sequential Neucleos(t)ides(NAs), majority of these CHB patients experienced drug resistance and switched to Tenofovir disoproxil fumaratate(TDF). However, some of patients on long term TDF experienced impairment of renal function and bone mineral density. After Tenofovir alafenamide(TAF) was in clinical practice, these group of patients got an clinical option to switch from TDF to TAF. The investigators designed a prospective cohort study to evaluate the real life effectiveness and safety in participants with chronic HBV infection switch from TDF to TAF vs. maintaining on TDF.

Detailed description: Tenofovir disoproxil fumarate(TDF) have been associated with renal toxicity and reduced bone mineral density. Tenofovir alafenamide(TAF) is a novel tenofovir prodrug that reduces tenofovir plasma concentrations by 90%, thereby decreasing off-target side-effects. The investigators aimed to assess whether efficacy, safety, and tolerability were non-inferior in participants switched to TAF versus in those remaining on TDF. This is a prospective clinical study.

Eligibility criteria: Inclusion Criteria:

1. Chronic hepatitis B,
2. Antiviral experienced,
3. Currently on long term TDF anti-HBV treatment,
4. HBV DNA \< 6 log IU/ml (LLOD)
5. Able to sign the consent form of anticipating in the study

Exclusion Criteria:

1. Co-infected with HCV, HIV or other viral hepatitis,
2. Diagnosis of HCC

Primary outcomes:
measure: Antiviral response of TAF
timeFrame: 60 months
Secondary outcomes:
measure: Improvement of renal function and bone mineral density in CHB patients switching to TAF
timeFrame: 60 months
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Humanity and Health GI and Liver Centre
Study officials:
References:
Clinical trial NCT02589834: The Effect of Quran of Post Operative Pain
Official title: The Effect of Listening to Quran During Cesarean Section on Postoperative Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Postoperative Pain
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2015-10-28
Enrollment: 118
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Postoperative pain management is crucial for surgical patients. Management of postoperative pain entails reducing painful symptoms, improving the quality of recovery and resuming normal daily living activities. In addition to the benefits derived from relieving postoperative pain in women undergoing cesarean section, prolonged immobility as a result of pain during puerperium is associated with risk of thromboembolic disease.

Postoperative pain has negative physiological and psychological impact on patients' well-beings and delays the postoperative recovery. Pain may also impair the mother's ability to provide an optimal care for her infant in the immediate postpartum period. Besides that, it also reduces the maternal ability to breast-feed her infant effectively.

Effective pain relief should not interfere with the mother's ability to move around and care for her infant, and that it results in no adverse neonatal effects in breast-feeding women.

Non-pharmacological techniques for reduction of pain are growing rapidly. Spiritual intervention with listening to Quran recitations as an adjunctive therapy in the postoperative period is a non-pharmacological technique that is inexpensive, non-invasive and has no side-effects. Spiritual and Islamic implication could improve postoperative pain 6-8 hours and 24-30 hours in Muslim patients undergoing abdominal surgery. However, there is limited number of published studies on the effect of spiritual and religious intervention on pain after cesarean section.

Listening to Quran recitation elicits a relaxation response of calmness, mindfulness, and peacefulness in Muslims. Pray therapy results in optimal harmonization, which improves psychological, social, spiritual, and physical health status.

The current study aims to investigate the effects of listening to Quran recitation on pain intensity among patients after cesarean section according to the cultural, social and economic differences in Egypt.


Eligibility criteria: Inclusion Criteria:

* Pregnant Muslim women
* Term (37-40 weeks) gestation
* uncomplicated singleton pregnancy
* scheduled for elective lower segment cesarean section under spinal anesthesia

Exclusion Criteria:

* Any medical diseases
* Hearing impairment
* Any contraindication to spinal anesthesia

Primary outcomes:
measure: Measurement of postoperative pain by Visual analogue scale
timeFrame: 4 months
Secondary outcomes:
measure: The amount of postoperative analgesics by mg
timeFrame: 4 months
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut university
Study officials:
References:
Clinical trial NCT04012034: Treatment With Radiofrequency in Patients With Chronic Pelvic Pain and History of Endometriosis
Official title: Treatment With Punction and Radiofrequency of Active Trigger Points in Patients With Pelvic Chronic Pain and History of Endometriosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Endometriosis
Chronic Pain
Quality of Life
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
First posted: 2019-07-09
Enrollment: 26
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Managing chronic pelvic pain in patients with a past history of endometriosis might be a challenge for the gynaecologist.

The objective of this study is to evaluate pelvic pain after treatment with radiofrequency in patients with chronic pelvic pain and surgery for endometriosis.

Detailed description: Patients with pelvic chronic pain and a past history of endometriosis without imaging evidence of endometriosis in the present will be enrolled in this study. The main objective of this study is to evaluate improvement of pelvic pain these patients. Moreover, quality of life and sexual function will be also assessed. Patients who are enrolled will come once a week per eight weeks to the hospital to have 30 minutes treatment with radiofrequency. They will be randomised in two groups, one receiving the radiofrequency and the other not (the device will be not give the energy). At the enrollement visit, the SF-36, VAS score, anxiety and depression tests and sexual function tests will be answered the patients. At the end of the treatment, and one month after the end, they will answer the same questionnaires.

Eligibility criteria: Inclusion Criteria:

* Chronic pelvic pain
* Past surgery for endometriosis

Exclusion Criteria:

* Active endometriosis, diagnosed by imaging techniques
* Presence of other diseases that can cause chronic pelvic pain
* Contraindication for the radiofrequency use: pregnancy, metallic prothesis

Primary outcomes:
measure: Pain: VAS score
timeFrame: Baseline (Before starting the study)
measure: Pain: VAS score
timeFrame: 1 month after study completion
Secondary outcomes:
measure: Quality of life: QoL SF-36
timeFrame: Before starting the study
measure: Quality of life: QoL SF-36
timeFrame: 1 month after study completion
measure: Female Sexual Function Index (FSFI)
timeFrame: Before starting the study
measure: Female Sexual Function Index (FSFI)
timeFrame: 1 month after study completion
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clinic
city: Barcelona
country: Spain
facility: Hospital Clinic
Study officials:
affiliation: Hospital Clinic of Barcelona
name: Francisco Carmona, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04751734: Impact of Maternal COVID-19 Vaccines on Breast Milk
Official title: Impact of Maternal COVID-19 Vaccination on Breast Milk Antibodies, Milk Bioactive Compounds and Maternal-child Health
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19 Vaccines
Keywords: breast milk
microbiota
metabolites
immune compounds
growth and development
Lead sponsor: Institute of Agrochemistry and Food Technology, National Research Council
Sponsor class: OTHER_GOV
Collaborators: name: Hospital Clínico Universitario de Valencia
name: Hospital Sant Joan de Deu
name: Hospital Universitario La Fe
name: Hospital Universitario Doctor Peset
name: Fundacion Para La Investigacion Hospital La Fe
name: Universitat Jaume I
name: University of Barcelona
First posted: 2021-02-12
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women is Spain

Brief summary: prospective multicenter study The main aim is to study the impact of maternal COVID-19 vaccination on breast milk immune, microbiological, and metabolic profile.


Eligibility criteria: Inclusion Criteria:

* Priority groups for coronavirus (COVID-19) vaccination (health and social care workers) following breastfeeding practices and receiving vaccines.

Exclusion Criteria:

* cessation of breastfeeding and vaccine side-effects requiring specific treatment and/or hospitalization.

Primary outcomes:
measure: Antibodies
timeFrame: 1st year
Secondary outcomes:
measure: breast milk bioactive composition
timeFrame: 1st year
measure: breast milk bioactive composition
timeFrame: 1st year
measure: breast milk bioactive composition
timeFrame: 1st year
measure: infant microbiota
timeFrame: 1st year
measure: infant growth and development
timeFrame: 1st year
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Fundacion Investigacion Sanitaria INCLIVA
city: Valencia
country: Spain
facility: Hospital Universitario y Politecnico la Fe
Study officials:
References:
citation: Selma-Royo M, Bauerl C, Mena-Tudela D, Aguilar-Camprubi L, Perez-Cano FJ, Parra-Llorca A, Lerin C, Martinez-Costa C, Collado MC. Anti-SARS-CoV-2 IgA and IgG in human milk after vaccination is dependent on vaccine type and previous SARS-CoV-2 exposure: a longitudinal study. Genome Med. 2022 Apr 21;14(1):42. doi: 10.1186/s13073-022-01043-9.
Clinical trial NCT02688634: The Role of Antibiotic Prophylaxis in Cleft Palate and Velopharyngeal Insufficiency Repair
Official title: The Role of Antibiotic Prophylaxis in Cleft Palate and Velopharyngeal Insufficiency Repair
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Cleft Palate
Keywords: Cleft Palate Surgery
Antibiotic treatment
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2016-02-23
Enrollment: 0
Sex: ALL
Minimum age (years): 1
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects undergoing independently scheduled elective Cleft Palate of VPI repair at an area hospital

Brief summary: Cleft Lip and Palate surgical repair is one of the most common procedures performed by Plastic and Reconstructive Surgeons in the World. With this in mind, it is curious that no consensus exists regarding the usage of postoperative antibiotics or the effects this might have on wound complications such as cellulitis, dehiscence, or fistula formation. The surgical bed in cleft lip/palate repair is known to harbor a myriad of pathological organisms, indeed the human bite is one of the more clinically and microbiologically significant injuries to treat. This research study is to elucidate the role, if any, that prophylactic antibiotics have in the prevention of complications post cleft palate (CP) and VPI repair and potentially establish a new paradigm of care.

Detailed description: This will be a randomized prospective research study. Participants who will undergo an elective CP or VPI surgery will be randomized to receive either 1) antibiotics or 2) nothing postoperatively. All participants will be evaluated for infection, fistula formation, and dehiscence upon discharge and at 30-day follow-up based on standards of care.

Eligibility criteria: Inclusion Criteria:

1. Ages 1 month to 60 years
2. Subjects undergoing independently scheduled elective Cleft Palate of VPI repair
3. Do not meet any exclusion criteria

Exclusion Criteria:

1. Any repeat repair
2. Symptoms of upper respiratory infection
3. Immunosuppressed
4. Allergy to Amoxicillin or any other Penicillins
5. Antibiotic usage \<2weeks prior to scheduled surgery other than immediate pre-operative antibiotics
6. Inability to follow up

Primary outcomes:
measure: Infection rates between the groups
timeFrame: 30 days
measure: Dehiscence and fistula formation between the groups
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: UF Health at Shands Hospital
state: Florida
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Ashley Lentz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00044434: Bupropion as a Smoking Cessation Aid in Alcoholics
Official title: Bupropion as a Smoking Cessation Aid in Alcoholics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Alcoholism
Smoking
Lead sponsor: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Sponsor class: NIH
First posted: 2002-08-30
Enrollment: 200
Sex: ALL
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to test the use of time-released bupropion (Wellbutrin) in patients receiving treatment for alcohol abuse/dependence as an aid to stop smoking. Patients will receive either a time-released bupropion or placebo. Both groups will receive nicotine replacement therapy during the 9 week study. A final followup assessment will be conducted 6 months from the start of treatment.


Eligibility criteria: Inclusion Criteria:

* Currently a patient in the Omaha VA Medical Center, Substance Abuse Treatment Center (SATC) or at Catholic Charities Campus for Hope.
* Have a diagnosis of alcohol abuse or alcohol dependence.
* Smoke 20 or more cigarettes/day (may also smoke pipes/cigars).
* Be interested in quitting smoking.
* Provide name, addresses, and phone numbers of at least two individuals who can provide information on their alcohol, nicotine, and other drug use during the follow-up period.
* If female, patient must a) be of non-childbearing potential, b) have a negative pregnancy test, c) sign a document stating they do not plan on becoming pregnant during the study.
* Agree to sign informed consent.
* Able to read and understand study-related forms and procedures.

Exclusion Criteria:

* Advanced cardiac, pulmonary, renal, or liver disease.
* History of seizures.
* History of brain tumor or significant head trauma.
* History of bulimia or anorexia nervosa.
* Current major depressive disorder or past history of panic disorders, schizophrenia, or bipolar affective disorder.
* Using psychoactive drugs.
* Receiving treatment with medications that lower seizure thresholds.
* Use of an investigational drug in any study in the past four weeks.
* Currently using any asthma medication.
* Used time-released bupropion in the past 12 months.
* Currently using any other treatments to stop smoking.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Omaha
country: United States
facility: VA/Nebraska/Western Iowa Health Care System
state: Nebraska
Study officials:
References:
Clinical trial NCT01322334: Singing Exercises to Improve Symptoms of Snoring and Sleep Apnea
Official title: A Single Blinded Prospective Randomized Controlled Trial to Investigate Whether Singing Exercises Can Improve Symptoms of Snoring and Sleep Apnea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Snoring
Upper Airway Resistance Syndrome
Obstructive Sleep Apnea
Keywords: Snoring
Sleep apnea
Pharyngeal muscle tone
Lead sponsor: Royal Devon and Exeter NHS Foundation Trust
Sponsor class: OTHER
First posted: 2011-03-24
Enrollment: 127
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: Upper airway resistance during sleep can present with a range of symptoms from simple snoring (SS) through to severe obstructive sleep apnea (OSA). Pharyngeal narrowing or collapse leads to reduction or cessation in airflow during sleep, and is associated with loud snoring.

The investigators hypothesized that regular singing exercises could strengthen pharyngeal muscles and/or increase their resting tone, and lead to an improvement of symptoms and thus quality of life in patients with all forms of snoring.


Eligibility criteria: Inclusion Criteria:

* age 18 years old or over
* history of simple snoring or sleep apnoea with RDI 10-40

Exclusion Criteria:

* severe sleep apnoea RDI \>40
* morbid obesity BMI \> 40
* unable to provide written informed consent

Primary outcomes:
measure: Epworth sleepiness scale
timeFrame: Entry to study (day one), and after 3 months of intervention
Secondary outcomes:
measure: Loudness of snoring
timeFrame: Entry to study (day one), and 3 months after intervention
measure: Frequency of snoring
timeFrame: Entry to study (day one), and 3 months after intervention
measure: SF-36 quality of life assessment tool
timeFrame: Entry to study (day one), and 3 months after intervention
measure: Compliance with exercises
timeFrame: After 3 months of intervention
Other outcomes:
Locations:
city: Exeter
country: United Kingdom
facility: Royal Devon & Exeter NHS Foundation Trust
Study officials:
affiliation: Royal Devon and Exeter NHS Foundation Trust
name: Malcolm P Hilton, BMBCh FRCS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04130334: Effects of Corneal Anatomical Match Between Donor and Recipient During DALK Surgery on Final Visual and Refractive Outcomes in Patients With KCN
Official title: Effects of Corneal Anatomical Match Between Donor and Recipient During DALK Surgery on Final Visual and Refractive Outcomes in Patients With KCN: a Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Keratoconus
Lead sponsor: Shahid Beheshti University of Medical Sciences
Sponsor class: OTHER
First posted: 2019-10-17
Enrollment: 52
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients with KCN who undergo cornea transplantation divided to 2 groups:

Group1: After mechanical trephination, horizontal meridian of donor's cornea sutured to horizontal meridian of recipient cornea Group 2: After mechanical trephination, horizontal meridian of donor's cornea sutured to vertical meridian of recipient cornea After suture removal, best corrected visual acuity, refractive error, corneal keratometry, irregularity of corneal surface and high order aberration of two groups will compare


Eligibility criteria: Inclusion Criteria:

* Patients with KCN who undergo DALK surgery

Exclusion Criteria:

* Penetrating Keratoplasty surgery
* Other corneal diseases
* dystrophies
* Corneal graft rejection

Primary outcomes:
measure: Best corrected visual acuity
timeFrame: 14 months
measure: graft astigmatism
timeFrame: 14 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Ophthalmic Research Center
Study officials:
References:
Clinical trial NCT04769934: Impact of Implant Insertion Torque on Peri-implant Bone Level.
Official title: Impact of Implant Insertion Torque on Peri-implant Bone Level.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Implant Complication
Lead sponsor: University of Geneva, Switzerland
Sponsor class: OTHER
First posted: 2021-02-25
Enrollment: 93
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: partially edentulous patients

Brief summary: Observational study with one single arm. The purpose of this study was to evaluate the impact of the insertion torque and of the implant stability on the marginal bone level changes for dental implants placed into healed ridges.

Detailed description: The primary outcome would be to evaluate the peri-implant bone level changes (marginal bone level) around the implant platform.

The secondary outcomes would be:

* To evaluate the Implant Stability Quotient (ISQ) changes according to the measurements performed with the instrument Penguin RFA
* To evaluate the implant and prosthetic failure rate as well as the implant and prosthetic complication rates
* The patient satisfaction related to the implant treatment

Eligibility criteria: Inclusion Criteria:

* All partially edentulous patients requiring simple Implant placement,
* being at least 18-year-old and able to sign an informed consent,
* The patients that will be enrolled must have a bone quantity that allows the placement of regular implants according to the radiographic evaluations (pre-operative radiographic examination).

Exclusion Criteria:

* Heavy smokers (more than 10 cigarettes/day).
* Immunosuppressed or immunocompromised patients
* Uncontrolled diabetes
* Active periodontal disease
* Patients with a full mouth marginal bleeding score higher than 20%
* Addiction to alcohol or drugs
* Psychiatric problems
* Severe caries, periapical lesions, acute infection (abscess)
* Immediate post-extractive implants (at least 2 months after extraction have to elapse)
* Patients unable to commit to 3-year follow-up.
* Patients treated or under treatment with intravenous amino- bisphosphonates.
* Patients participating to other studies, if the present protocol could not be fully adhered to.

Primary outcomes:
measure: radiographic marginal bone level changes around the implant platform
timeFrame: 3 years
Secondary outcomes:
measure: Implant Stability Quotient (ISQ) changes
timeFrame: 3 years
Other outcomes:
measure: implant failure rate
timeFrame: 3 years
measure: patient satisfaction related to the implant treatment
timeFrame: 3 years
measure: prosthetic failure rate
timeFrame: 3 years
measure: implant complications rate
timeFrame: 3 years
measure: prosthetic complications rate
timeFrame: 3 years
Locations:
city: Geneva
country: Switzerland
facility: University of Geneva
Study officials:
affiliation: University of Geneva
name: Irena Sailer, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: