cyrilzakka/clinical-trials huggingface dataset:
Determining the Utility of a Behavioral Intervention in Chronic Migraine

This proposal will involve a pilot study to evaluate the feasibility, acceptability, and outcomes of a lifestyle behavior protocol in managing chronic migraine. Additionally, the proposal will investigate biomolecules that are uniquely involved in chronic migraine patients who respond to the protocol. Successful completion of this proposal will inform the design of a future full-scale behavioral clinical trial to control chronic migraine.


Eligibility Criteria:
Inclusion Criteria:

* have chronic migraine for a minimum of 1-year
* aged 18 years and older

Exclusion Criteria:

* other headache disorders including secondary headache disorders
* children younger than 18 years old
* current pregnancy
Diode Laser 940 nm in Management of Loss of Taste Sensation

The global pandemic has recently emerged by transmission of SARS-CoV2 virus. The virus has had a massive impact on health, wealth and social aspects worldwide. Since the identification of this virus in Wuhan, China, millions of cases has been diagnosed worldwide with mortality rates ranging from 3% to 12 %

'Long COVID' is emerging as a phenomenon where patients have long-term unresolved symptoms (8,9). These could be prolonged symptoms of SARS-CoV2 or a posteSARS-CoV2 syndrome for which dysfunction of smell and taste sensation has been proposed.

The proposal presents the diode laser 940 as possible treatment for the loss of taste sensation in patients with long SARS-CoV2. The effect of low levels of laser energy was first discovered by Dr Endre Mester in 1967.5 Since then it has been used for various applications in the field of medicine and dentistry and is broadly termed 'low level laser therapy'(LLLT) or 'biostimulation' or 'phototherapy'. It is defined as a 'non-thermal' laser light application using photons (light energy) from the visible and infrared spectrum for tissue healing and pain reduction (North American Association of Laser Therapy-NAALT). Several in vitro studies have demonstrated that the effects of laser light on wound healing are much greater than obtained with light from other sources, such as light-emitting diodes (LEDs).(10-13)

Eligibility Criteria:
Inclusion Criteria:

A diagnosis of SARS-CoV2 with PCR. Age range from 18-60 years old Loss of taste sensation

Exclusion Criteria:

Pregnancy or contraceptive pills Lactation Any auto-immune disease that could affect the oral mucosa On any neoplastic therapy. Uncontrolled diabetes.
Efficacy of Modified Piezosurgery Alveolar Bone Cut With Osseodensification Drills in Expanding Narrow Alveolar Bone

The aim of the study is to determine the efficacy of modified piezosurgery with osseodensification drills in expanding narrow alveolar bone.

Atrophic maxilla or mandible can lead to lack of prosthesis retention because of an inadequate bearing area causing both functional and physiological problems for patient, these problems can be treated for patient satisfaction with an implant supported fixed or removable complete or partial denture. Atrophic edentulous jaws can represent a significant challenge to the successful use of endosseous implants for prosthetic reconstruction of the edentulous mandible.

A collapsed alveolar ridge demonstrating a narrow width (less than 5 mm in many cases) and grossly adequate alveolar height is the most common candidate for the RSP.

Beginners in RSP should initially choose a 4-5 mm thickness of an even maxillary alveolar ridge and strive to almost double it in width.

A 3-mm alveolar ridge generally consists of 3 thin bone layers (in a horizontal sandwich fashion): 2 cortical plates (about 1 mm each) separated by 1 cancellous layer (about 1 mm). The wider the cancellous bone layer (the layer where the split is done), the easier it will be to accomplish the RSP

Eligibility Criteria:
Inclusion criteria:

1. Patient's age ≥18 years.
2. Absence of any medical disease that compromise wound healing.
3. Patient with good oral hygiene.
4. Narrow alveolar bone (3-4 mm) with minimum alveolar bone height of (12 mm).

Exclusion criteria:

1. Uncontrolled medically compromised patients.
2. Heavy smokers (\> 10 cigarettes per day).
3. Patient with parafunctional habits.
4. Local infection at implant site.
Peer Learning and HBB in Managing Maternal Newborn and Child Health Emergencies in Rural Uganda

The aim of this study is to test an intervention that has potential to improve acute care skills and confidence related to safe delivery and newborn care for mid-level health providers in Uganda by the development of a 'mobile' simulation package including scale-up materials based upon research evidence. In this randomized study investigators will compare the impact of a peer learning package on skills, knowledge and team work regarding newborn care among health workers in rural south western Uganda.

The aim of this study is to test an intervention that has potential to improve acute care skills and confidence related to safe delivery and newborn care for mid-level health providers in Uganda by the development of a 'mobile' simulation package including scale-up materials based upon research evidence. In this randomized study investigators will compare the impact of a peer learning package on skills, knowledge and team work regarding newborn care among health workers in rural south western Uganda.

The cluster randomized study will have two arms; intervention arm receives peer learning program. In this program, two health workers at the same health facility teach each other using case scenarios. The case scenarios will be based on common neonatal conditions such as neonatal sepsis, hypothermia and prematurity.

The two study arms will both receive training on HBB and Essential care for every baby (ECEB)

Eligibility Criteria:
Inclusion Criteria:

* Health workers involved in performing deliveries of mothers at health center IVs and IIIs (i.e, county and subcounty level)

Exclusion Criteria:

* Health facilities based in municipalities, urban dwellings
Personalized Virtual Reality Naturalistic Scenarios in Cognitive Impairment

The goal of this feasibility study is to investigate the feasibility of a personalized naturalistic Virtual Reality scenario by assessing motion-sickness effects, engagement, pleasantness, and emotions felt considering a sample of individuals with cognitive impairment resident at the Azienda Pubblica di Servizi alla Persona (APSP) "Margherita Grazioli", a long-term care home in Trento (Italy) in collaboration with the Department of General Psychology - University of Padova (Italy) and the Centre for Health and Wellbeing-Fondazione Bruno Kessler (Italy). The current proof-of-concept and feasibility study is a one-session single-centre trial based on a mixed-methods approach inspired by the Obesity-Related Behavioral Intervention Trials (ORBIT) framework for the design (Phase Ib) of digital interventions and their preliminary testing (Phase IIa).

The impact of customizing VR scenarios is growing, showing different kinds of positive effects, such as an increased sense of presence and engagement in the virtual environment. A relaxing and customizable VR environment could allow the management of any interfering environmental factors that might also be present in the natural context. Additional investigations are still needed to obtain more consistent data on its feasibility and effectiveness.

Considering this evidence, the current proof-of-concept study is based on the following goals:

* evaluate the impact of VR on self-reported and observational levels of motion-sickness, engagement, and pleasantness in older adults living with cognitive impairment and residing in long-term care.
* investigate if personalized, relaxing virtual environments can positively impact feelings and state anxiety.
* investigate the VR apparatus's usability from the health staff's perspective.

Eligibility Criteria:
Inclusion Criteria:

* Italian mother tongue
* Clinical diagnosis of Cognitive Impairment (mild, moderate, or severe).

Exclusion Criteria:

* Palliative care
* Clinical diagnosis of psychosis
* Severe neurological damage
* A clinical diagnosis of epilepsy (or having first-degree relatives diagnosed with epilepsy) - - Cardiac pacemaker or other metal devices
* Infectious or gastrointestinal disorders
* Open wounds at the level of the face
* Motor or visual dysfunctions and neuromuscular pain that prevent the use of Oculus.
Use of Apremilast in Patients Who Are Dissatisfied With Stable Maintenance Topical Therapy

Sixteen week open label study of apremilast in combination with topical steroids with a four week safety follow up visit.

This is an open label, 16 week study of apremilast in combination with topical corticosteroids (TCS). Twenty qualified subjects will be enrolled. Visits will consist of Baseline, 8 week, 16 week and a 20 week safety follow up after 4 weeks off treatment. Subjects will dose with apremilast as per label. Topical corticosteroids (TCS) will be used for up to Week 4 as per label and then will be used on an as needed basis until Week 16. Assessments will include Static Physicians Global Assessment (sPGA), Psoriasis Area Severity Index (PASI), Psoriatic Body Surface Area (BSA), Dermatology Life Quality Index (DLQI),Assessment of Pruritus, Patient Satisfaction questionnaire. and Patient Global Assessment (PtGA)

Eligibility Criteria:
Inclusion Criteria:

* Subjects must be in general good health as judged by investigator
* Female of childbearing potential (FCBP) must have a negative pregnancy test at screening and Baseline.
* FCBP must use an approved method of contraception as outlined in the protocol.
* Male subjects who engage in activity in which conception is possible must use barrier contraception as defined in the protocol.
* 18 years of age or older
* Understand and voluntarily sign the Informed Consent
* Able to adhere to study visit schedule
* Moderate plaque type psoriasis as define by a a PGA of 3
* BSA 0f 5-10% or a DLQI score of 7 or more
* History of uncontrolled plaque psoriasis after either stable dose of high potency topical steroids for 2 weeks or mid-potency steroids for 4 weeks within the last 6 months

Exclusion Criteria:

* Any clinically significant disease as determined by the investigator or major disease that is currently uncontrolled
* Any condition, including the presence of laboratory abnormalities, which would place the subject at unacceptable risk
* Prior history of suicide attempt at any time in the subject's lifetime prior to screening or randomization, or major psychiatric illness requiring hospitalization within the last 3 years
* Pregnant or breastfeeding, FCBP who are not willing to use acceptable birth control methods.
* Active substance abuse or a history of substance abuse within 6 months prior to screening.
* Malignancy or history of malignancy except fo treated (cured) basal cell or or squamous cell in situ skin carcinomas, treated (cured) cervical intraepithelial neoplasia or carcinoma in situ of the cervix with no evidence of recurrence within the previous 5 years
* Has not completed the prescribed washout for restricted treatments
* Known or suspected allergy to investigational product
* Other types of psoriasis
* Prior history of depression
* Prior use of apremilast
Evaluate the Effect of Growth Hormone (GH) Treatment on Fibroblast Growth Factor 23, a Known Phosphaturic Agent

The purpose of this study is to evaluate the effect of growth hormone treatment on phosphorus levels in the body. Phosphorus is an important mineral for bone growth. It is well known that growth hormone treatment improves bone density and bone mineral content. The amount of phosphorus is maintained by the kidneys. Fibroblast Growth Factor 23 has recently been recognized to help kidneys control phosphate levels.

This study will compare Fibroblast Growth Factor 23 levels in children with and without growth hormone deficiency. Children with growth hormone deficiency will have levels taken before starting growth hormone replacement and after it has been initiated.

Eligibility Criteria:
Inclusion Criteria:

* Twenty children with significant short stature \< 3rd percentile, ages 3-14 years, and referred to Children's Hospital of Alabama
* Normal healthy volunteer children 3-18 years with normal stature

Exclusion Criteria:

* Patients on medication including GH
* Patients with concomitant hormonal abnormalities
* Patients with disorders of calcium and phosphate metabolism
* Active neoplasms
* Closed epiphysis
* Known bone disorders
The Cartilage and Muscle Thickness on Knee Pain in Patients With Rheumatoid Arthritis

The knee pain status of the patients who are followed in the rheumatology special branch of the Physical Medicine and Rehabilitation Outpatient Clinic and who meet the inclusion criteria will be questioned. In patients with or without knee pain, the cartilage thickness measurement of the knee joint will be measured from 3 points by ultrasound. At the same time, Quadriceps and Hamstring muscle thickness measurements of the patients will be made from the midpoints where the muscle thickness is the highest. The physician who performed the ultrasonographic measurements of the knee pain status of the patients does not know.


Eligibility Criteria:
Inclusion Criteria:

* Rheumatoid Arthritis \> Diagnosed for 1 year
* -Female gender
* -The patient has been in remission or low disease activity for at least 3 months
* -Be able to ambulatory
* -No significant deformity in the lower extremity joints

Exclusion Criteria:

* Patient with active arthritis or high disease activity

  * - Significant deformity of the lower extremity joints and inability to ambulate
  * -Pregnant patient
  * - Presence of malignancy
  * - Patient with a severe psychiatric disorder and difficulty in cooperation
  * - Presence of cardiovascular and pulmonary comorbidities that will prevent exercise
  * -Male gender
A Comparison of General Versus Peripheral Nerve Block for Lower Extremity Amputation in Diabetic Patients With Bleeding Tendency: a Retrospective Study

Retrospective data collection. The aim of this study is to compare general anesthesia and nerve block anesthesia with respect to the postoperative complications in patients undergoing diabetic leg amputation and having bleeding tendency.


Eligibility Criteria:
Inclusion Criteria:

1.Adults patients ≥20 years who underwent lower extremity amputation for diabetic foot under general anesthesia or PNB and having coagulopathy in which condition that neuraxial block is contraindicated

Exclusion Criteria:

1. patients with prior surgical history within 1 month
2. combined operation (joint operation)
3. patients who required continuous intravenous administration of vasopressors and/or mechanical ventilation prior to surgery
4. combination of general anesthesia and PNB
A Study to Access Safety and Efficacy of Nebulized Tobramycin in Patients With Bronchiectasis

This is a study to evaluate the efficacy,indications,adverse reactions and resistance of combined administration of nebulized tobramycin compared with systemic administration alone in patients with Bronchiectasis in acute exacerbation of Bronchiectasis.

Bronchiectasis is a chronic disorder of the major bronchi and bronchioles characterized by permanent dilation, microbial infection, a persistent inflammatory response with the release of immune mediators and microbial toxins leading to destruction. The origin of bronchiectasis varies, but the presence of microbial infection and a persistent inflammatory response is typical of the disease. The chronic nature of the infection and the associated considerable morbidity provides the rationale for using aerosolized antibiotics for the treatment of bronchiectasis patients.

This is a study of safety and efficacy of combined administration of nebulized tobramycin compared with systemic administration alone in patients with Bronchiectasis in acute exacerbation of Bronchiectasis. Study subjects will be randomized to receive either study drug or placebo by inhalation via a nebulizer. Each subject will complete 14 days of daily dosing.

Clinical laboratory parameters,clinical adverse events and pulmonary function will be evaluated for all study subjects in order to determine the qualitative and quantitative safety and efficacy of nebulized tobramycin.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female study subjects ≥18 years of age and ≤80 years of age
2. Confirmed diagnosis of idiopathic bronchiectasis or postinfectious bronchiectasis
3. Confirmation of infection with P. aeruginosa at screening
4. Are sensitive to Tobramycin
5. Acute exacerbation of bronchiectasis -

Exclusion Criteria:

1. Bronchiectasis due to special causes.
2. Smokers.
3. Are associated with bronchial asthma.
4. Have any serious or active medical or psychiatric illness.
5. Are not tolerant to nebulised tobramycin
6. FEV1.0 reduces ≥ 15% after inhaling tobramycin. -
Phase 1, QT/QTC Interval Study in Healthy Subjects

This study is designed to evaluate the effect of multiple doses of lumacaftor in combination with ivacaftor on cardiac repolarization, as detected by QT/QTc interval corrected for heart rate in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must be willing and able to comply with scheduled visits, treatment plan, lifestyle guidelines, laboratory tests, contraceptive guidelines, and other study procedures.
* Subjects must be healthy, as defined by no clinically relevant abnormalities identified by a detailed medical history, physical examination, including blood pressure and pulse rate measurement, and 12 lead ECG.
* Subjects must weigh \>50kg

Exclusion Criteria:

* Abnormal renal function at Screening
* Plasma donation within 7 days before first study drug dose or blood donation of 1 pint (500mL) within 56 days before first study drug dose
* Positively screen for Hepatitis B, Hepatitis C, HIV
* Known hypersensitivity or prior adverse reaction to moxifloxacin or other quinolones
* Any condition possibly affecting drug absorption (e.g., gastrectomy, or other gastrointestinal tract surgery, except appendectomy or cholecystectomy or polypectomy) or regular use of acid-lowering therapies (H2 blockers, proton pump inhibitors, and antacids).
* Female subjects who are pregnant, nursing, or planning to become pregnant during the study or within 90 days of the last study drug dose and female subjects of childbearing potential who are unwilling or unable to follow the contraceptive guidelines from at least 14 days before the first study drug dose.
* Male subject who has a female partner who is pregnant, nursing, or planning to become pregnant during the study or within 90 days of the last study drug dose; male subjects who are unwilling or unable to follow the contraceptive guidelines
Clitoris Potential Analgesic Function Research by Pregnant Women : Feasibility Study

Assessment of the acceptability by pregnant women on the research of the potential analgesic function of the clitoris.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant woman, whatever the term, primiparous or multiparous
* Age ≥ 18 years old
* Patient having read and understood the information letter and signed the consent form
* Patient affiliated to Social Security

Exclusion Criteria:

* Inability to understand French or information,
* Person deprived of their liberty by an administrative or judicial decision
* Person placed under the protection of justice
* Person under guardianship or curatorship
A Practical Clinical Study Comparing the Fixed-cycle Regimen Containing Orelabrutinib With BTKi Monotherapy

Prospective, interventional, and practical clinical studies


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 70 years, with no gender restrictions;
* Patients with CLL/SLL who meet the iwCLL2018 diagnostic criteria;
* Indications for treatment
* ECOG performance score of 0-2;
* Patients are untreated or have not received standardized treatment
* Before the trial screening, the subject or their legal representative voluntarily signs a written informed consent form, indicating that they understand the purpose of the study and the necessary research steps, and are able to comply with the protocol and follow-up.

Exclusion Criteria:

* Has been diagnosed or treated for malignancies other than CLL (including active central nervous system lymphoma) within the past year;
* there is clinical evidence of Richter transformation;
* Participant cannot receive or plan to receive another treatment during study participation
* Other conditions that the investigator considers inappropriate for participation
Accelerated iTBS for Post Partum Depression

Study 1: The investigators are studying the feasibility and tolerability of 10x/day intermittent theta burst (excitatory) transcranial magnetic stimulation to the left dorsolateral prefrontal cortex over the course of 6 days for women with post-partum depression. The investigators further aim to characterize the anticipated anti-depressant effect of this treatment paradigm.

Study 2: The investigators are studying the feasibility and tolerability of 12 sessions/day of intermittent theta burse (excitatory) transcranial magnetic stimulation to the left dorsolateral prefrontal cortex over 5 days for women with post-partum depression. The investigators aim to compare the two different treatment schedules.

Study 1: This is an open-label study designed to investigate the feasibility and tolerability of a novel TMS treatment protocol to treat depression in women with post-partum depression. It is known that TMS can effectively treat depression. The FDA approved protocol lasts 6 weeks and is not feasible for many women with post-partum depression. The investigators are investigating a 6 day treatment for depression which may be more acceptable for this population. The investigators further aim to characterize the ant-depressant effect of this protocol in order to design a larger trial.

Study 2: In part 2 of this study, the treatment schedule is 12 sessions over 5 days that can be completed with 8. All other procedures, inclusion/exclusion criteria, and number of total pulses delivered is the same as study 1.

Eligibility Criteria:
Inclusion Criteria:

1. Participants must be able to provide informed consent and function at an intellectual level sufficient to allow accurate completion of all assessment instruments.
2. Participants must be over the age of 18.
3. Participants must meet criteria for post-partum depression: a) onset of symptoms in the first year postpartum
4. Participants must have a HRSD17 greater than or equal to 14 at baseline.

Exclusion Criteria:

1. Participants must not be pregnant.
2. Participants must not meet moderate or severe use disorder of any substance with the exception of Tobacco Use Disorder.
3. Participants must not have current psychotic symptoms.
4. Participants must not have a history of dementia or other cognitive impairment.
5. Participants must not have active suicidal ideation requiring hospitalization or a suicide attempt within the past 3 months.
6. Participants must not have any contraindications to receiving rTMS (e.g. metal implanted above the neck, history of seizure, any known brain lesion).
7. Participants must not have any unstable general medical conditions.
8. Participants must not have had eclampsia during pregnancy.