cyrilzakka/clinical-trials huggingface dataset:
Weekly Doxycycline DOT for STI Prevention Among Cisgender Women Taking HIV PrEP in Kisumu, Kenya

The first study of doxycycline postexposure prophylaxis for cisgender women did not reduce incident STIs likely due to low use of doxycycline. Researchers will conduct a pilot study of once-weekly doxyxycline to prevent bacterial STIs among Kenyan cisgender women using PrEP for HIV prevention.

A study evaluating doxycycline prophylaxis to prevent sexually transmitted infections (STIs) in PrEP-taking African women, who are a priority population for STI prevention, given their high risk and engagement in longitudinal prevention services. The primary study objective is to assess the acceptability of once weekly doxycycline prophylaxis and assess persistence in once weekly doxycycline delivered as directly observed therapy (DOT). STI prophylaxis carries substantial potential benefits but also important potential risks, and we have framed our work as capturing key data to inform this question. Researchers hypothesize that weekly doxycycline will substantially reduce the incidence of curable STIs, particularly C. trachomatis, the most common bacterial STI and the one responsible for greatest morbidity.

Researchers' secondary study objectives are to evaluate the impact on incidence rate of STIs in women given once-weekly doxycycline DOT in comparison with data collected among participants assigned to received standard of care in recently completed dPEP Kenya study as well as to assess tolerability of once weekly doxycycline prophylaxis. Researchers will collect samples for future doxycycline hair drug level testing, antibiotic resistance testing, and microbiome evaluation.

Eligibility Criteria:
Inclusion Criteria:

1. Willing and able to give written informed consent
2. Age 18-30 years
3. Female sex assigned at birth
4. HIV-seronegative, according to national HIV testing algorithm
5. Has a current prescription for PrEP, \> 1 month, according to the national guidelines of Kenya

Exclusion Criteria:

1. Pregnant
2. Breastfeeding a child
3. Allergy to tetracycline class
4. Current medications which may impact doxycycline metabolism or that are contraindicated with doxycycline, as per the prescribing information. These include systemic retinoids, barbiturates, carbamazepine, phenytoin, and warfarin.
5. Active, clinically significant medical or psychiatric conditions that would interfere with study participation, at the discretion of the site investigator or designee.
6. Prior enrollment in The dPEP Kenya Study
Intranasal Cocaine and Temperature Regulation During Exercise

Assess the effects of intranasal cocaine on temperature regulation and whole-body sweat rate during exercise in warm environmental conditions.

Previously it was shown that intranasal cocaine attenuates skin blood flow and sweating responses during passive heat stress, when compared to placebo. However, nothing is known about the effects of cocaine on whole-body temperature regulation during mild to moderate exercise in warm environmental condition.

This project will test the hypothesis that intranasal cocaine attenuates whole-body sweat rate, resulting in greater elevations in core temperature during mild to moderate exercise in warm environmental conditions.

Primary data include core temperature, skin temperatures, and whole body sweat rate. Secondary variables include cardiovascular responses, perceptions of exercise exertion and thermal comfort, and metabolic heat production. Intranasal lidocaine will be used as the placebo for cocaine. The selection of the drug administered during the first experimental trial will be randomized, with the other drug administered during the second experimental trial.

Eligibility Criteria:
Inclusion Criteria:

* 18 to 50 years of age
* Healthy
* Body mass index less than 31 kg/m\^2
* Speak English
* Systolic blood pressure \<140 mmHg
* Diastolic blood pressure \<90 mmHg

Exclusion Criteria:

* Subjects not in the defined age range
* Participants who have cardiac, respiratory, neurological, and/or metabolic illnesses
* Any known history of renal or hepatic insufficiency/disease
* Pregnancy or breast feeding
* Body mass less than 60 kilograms
* Current smokers, as well as individuals who regularly smoked within the past 3 years
* Individuals with a history of drug abuse within the past 5 years
* Individuals who have an unexplained positive urine drug screen (e.g., some agents cause false-positive results and when agent abstained the drug screen is negative, one example could be an over the counter supplement)
* Currently taking pain modifying medications
Neurophysiological Study of Sativex in Multiple Sclerosis (MS) Spasticity

Aim of this randomized, double-blind, placebo-controlled, cross-over study is to investigate cannabinoid-induced changes in neurophysiological parameters in a group of 40 patients with secondary or primary progressive Multiple Sclerosis (MS).


Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years or above
* Willing and able to comply with the protocol for the duration of the study
* Diagnosis of Secondary-Progressive or Primary-Progressive MS from at least 12 months
* Relapse free from at least 3 months before screening visit
* Lower limb spasticity
* EDSS from \> 3.0 and \< 6.5
* Moderate to severe spasticity due to MS from at least 6 months and with stable drug treatment not able to relieve symptoms as a whole, deserving a specific add-on treatment
* Immunomodulatory or immunosuppressant therapies not modified during the study and 6 months before starting the study
* Stable doses of anti-spasticity agents from at least 2 months prior to screening visit
* Have given written informed consent

Exclusion Criteria:

* Any concomitant disease that may cause spasticity or that could interfere with subject's spasticity
* Botulinum Toxin injection for spasticity in the 4 months prior to screening visit
* Any known or suspected history of psychotic illness, alcohol or substance abuse, epilepsy, hypersensitivity to cannabinoids
* Significant cardiac, renal or hepatic disease
* Female subjects of child bearing potentials and male subjects whose partner is child bearing potential, unless willing to ensure that they or their partner use contraception during the study
* Female subjects who is pregnant lactating or planning pregnancy during the course of the study and for three months thereafter
* Sativex® SmPC contraindications
Study to Evaluate the Efficacy and Safety of Elafibranor in Patients With Primary Biliary Cholangitis (PBC) and Inadequate Response to Ursodeoxycholic Acid

The primary objective of the study is to compare the effect of daily oral administration of elafibranor 80mg and 120 mg on change in serum alkaline phosphatase (ALP) to that of placebo in patients with PBC and inadequate response to Ursodeoxycholic acid (UDCA).


Eligibility Criteria:
Inclusion Criteria:

1. Must have provided written informed consent
2. Definite or probable PBC diagnosis as demonstrated by the presence of at least 2 of the following 3 diagnostic factors:

   * History of elevated ALP levels for at least 6 months prior to Day 0 (randomization visit)
   * Positive Anti-Mitochondrial Antibodies (AMA) titers (\> 1/40 on immunofluorescence or M2 positive by enzyme-linked immunosorbent assay (ELISA) or positive PBC-specific antinuclear antibodies
   * Liver biopsy consistent with PBC
3. ALP \>= 1.67x upper limit of normal (ULN)
4. Taking UDCA for at least 12 months (stable dose for ≥ 6 months) prior to screening visit
5. Contraception: Females participating in this study must be of non-childbearing potential or must be using highly efficient contraception for the full duration of the study and for 1 month after the end of treatment.

Exclusion Criteria:

1. History or presence of other concomitant liver diseases
2. Screening creatine phosphokinase (CPK) \> upper limits of normal (ULN)
3. Screening alanine transaminase (ALT) or aspartate aminotransferase (AST) \> 5 ULN
4. Screening total bilirubin \> 2 ULN
5. Screening serum creatinine \> 1.5 mg/dl
6. Significant renal disease, including nephritic syndrome, chronic kidney disease (defined as patients with markers of kidney damage or estimated glomerular filtration rate \[eGFR\] of less than 60 mL/min/1.73 m\^2).
7. Patients with moderate or severe hepatic impairment (defined as Child-Pugh B/C)
8. Platelet count \<150 X 10\^3/microliter
9. Albumin \<3.5 g/dL
10. Presence of clinical complications of PBC or clinically significant hepatic decompensation
11. If female: known pregnancy, or has a positive urine pregnancy test (confirmed by a positive serum pregnancy test), or lactating
12. Known history of human immunodeficiency virus (HIV) infection
13. Medical conditions that may cause non-hepatic increases in ALP (e.g., Paget's disease)
Tailored Approach to Sleep Health Education: A Community Engaged Approach

This study aims to develop educational tools and platforms to promote the transfer of sleep health information to blacks to foster adoption of healthful sleep practices.


Eligibility Criteria:
Inclusion Criteria:

* self-reported race/ethnicity as African American, African, Caribbean American or black men and women; ages ≥18 years;
* accessible by telephone; no plans to move away from the region within the year following enrollment;
* consent to participate, which includes permission to release medical record information;
* documented OSA risk based on scores received from the Apnea Risk Evaluation System questionnaire

Exclusion Criteria:

* progressive medical illness in which disability or death is expected within one year;
* impaired cognitive or functional ability which would preclude meaningful participation in the study;
* sleep apnea diagnosis;
* stated intention to move within the same year of enrollment.
Scalpel Versus Diathermy for Transverse Abdominal Incision in First Elective Caesarean Section

The objective of this study will be to compare two methods of skin incisions during the first caesarean section (CS), that is scalpel and diathermy, assessing differences in blood loss during incision, incisional time, total surgery time, post-operative pain, wound healing, complications, and cosmetic outcomes.

The scalpel has been historically used as the primary cutting tool during caesarean section (CS). However, advancements in surgical devices have introduced alternatives, such as the option to make a diathermic cut using electrosurgical units.

General surgeons have extensively demonstrated the advantages of diathermy over the scalpel for abdominal wall incisions, including faster opening time, reduced incisional blood loss, decreased post-operative pain, and a comparable wound complication rate.

In obstetrics, there is a scarcity of evidence in this regard, and no consensus or guidelines have been established regarding the optimal method for making a transverse abdominal incision during the first elective CS. Currently, the choice between using a scalpel or diathermy remains at discretion of the obstetric surgeon. The objective of this study will be to compare both methods of skin incisions during the first CS, assessing differences in blood loss during incision, incisional time, total surgery time, post-operative pain, wound healing, complications, and cosmetic outcomes.

Eligibility Criteria:
Inclusion Criteria:

1. Women without a history of previous cesarean section or other abdominal surgery
2. Age greater then 18 years (only adult patients)
3. Body Mass Index (BMI) between 18.5 and 29.9 kg/m2
4. Gestational age greater then 37 weeks (at term pregnancies)
5. No contraindications to spinal anesthesia
6. Indication to elective CS: extra-obstetrical reasons, failure of medical induction of labor, breech fetal presentation
7. Informed consent

Exclusion Criteria:

1. Women refusing to participate in the study
2. Women undergoing urgency or emergency cesarean deliveries
3. Women with a history of previous cesarean section or abdominal surgery
4. Women with multifetal pregnancies
5. Necessity of general anesthesia
6. Use of anticoagulants
7. Patients needing a median longitudinal abdominal section
8. Patients with pacemakers
9. Allergy to cephalosporins
10. Any medical disorder that can affect wound healing as diabetes, hypertension, hepatic or renal diseases, chronic anemia, chronic skin conditions, congenital or acquired bleeding diathesis.
Dispensing Study for a New Study Lens

This study investigated the performance criteria over one week of daily wear to determine if the comfilcon A asphere lens (test) performed equivalently to the comfilcon A sphere (control) in terms of measurement and subjective ratings of visual performance.

This study was a prospective, single site, daily wear, double masked, randomized bilateral cross over dispensing study of binocular wear of comfilcon A asphere lens (test) and comfilcon A sphere lens (control) over 1 week of daily wear.

Eligibility Criteria:
Inclusion Criteria:

A person is eligible for inclusion in the study if he/she:

* Oculo-visual examination in the last two years
* Between 18 and 35 years of age and has full legal capacity to volunteer
* Has read and understood the informed consent letter
* Is willing and able to follow instructions and maintain the appointment schedule
* Is correctable to a visual acuity of 20/25 or better (in each eye) with their habitual correction or 20/20 best corrected
* Currently wears, or has previously successfully worn, soft contact lenses between -1.00D (Diopoter) and -4.00D
* Spherical Contact Lens Rx between -1.00 and -4.00 and spectacle cylinder \<-0.75
* Has not worn lenses for at least 12 hours before the initial visit
* Has a subjective response at baseline, which indicates suitability for this study
* Currently spends a minimum of 4 hours a day; 5 days a week on digital devices and can replicate this time during the study period
* Is willing and able to wear the study contact lenses a minimum of 10 hours per day; 5 days a week

Exclusion Criteria:

A person will be excluded from the study if he/she:

* Has never worn contact lenses before
* Any systemic disease affecting ocular health
* Is using any systemic or topical medications that will affect ocular health
* Has known sensitivity to the diagnostic pharmaceuticals or study products used in this study.
* Has any ocular pathology or anomaly that would affect the wearing of the lenses
* Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye
* Is aphakic
* Has anisometropia of \>1.00
* Has undergone corneal refractive surgery
* Has strabismus
* Has any ocular amblyopia \>= 1line of HC (High Contrast) Visual Acuity
* Is participating in any other type of eye related clinical or research study
* Has previously participated in study of the Phenacite lenses
Performance of a Photoscreener for Vision Screening in a Haitian Pediatric Population

Screening of haitian children between the ages of 3 and 6 years old for amblyogenic risk factors with the use of the Spot photoscreener. The photoscreener results will be compared to the complete ophthalmologic evaluation. Primarily, this will allow evaluation of the performance of the spot photoscreener in the haitian children population. Secondarily, this study will gather epidemiological information on vision problems in the haitian children population.

Screening of haitian children between the ages of 3 and 6 years old for amblyogenic risk factors with the use of the Spot photoscreener before and after cycloplegia. The photoscreener results will be compared to the complete ophthalmologic evaluation. The ophthalmologic evaluation includes visual acuity, ocular alignment, slit lamp evaluation, cycloplegic refraction and dilated fundus evaluation. First of all, this will allow evaluation of the performance of the spot photoscreener in the haitian children population. Second of all, this study will gather epidemiological information on vision problems in the haitian children population.

Eligibility Criteria:
Inclusion Criteria:

* Haitian children aged 3-6 years of age
* Signed consent form from a legal guardian

Exclusion Criteria:

* Previous vision problem diagnostic
* Unsigned consent form
Nasonex (Mometasone Furoate Nasal Spray) in Adenoids Hypertrophy in Children (P04367)

To document the short term \& long term effect of treatment with Nasonex (mometasone furoate nasal spray) in moderate to severe adenoids hypertrophy (which cause \> 50% obstruction of the posterior choanae).


Eligibility Criteria:
Inclusion Criteria:

* 2-11 years of age, nasal obstruction for 3 months, adenoids hypertrophy \> 50% of posterior choanae.

Exclusion Criteria:

* adenoids hypertrophy \< 50% of posterior choanae

recurrent epistaxis or immunodeficiency, severe septal deviation, kissing tonsils, choanal atresia, large masses, known allergy to nasonex (mometasone furoate nasal spray), chronic otitis media, cystic fibrosis, acute infection.
Effect of Bilateral Distalization of Upper First Molars in a Group of Patients After Extraction of Maxillary Second Molars

There is a scarcity in the current literature regarding such appliance and its effect on distalizing the first maxillary molar in absence of the second molar. Therefore, this study was made to evaluate the effect of bilateral distalization of upper first molars in a group of patients after extraction of maxillary second Molars using infra zygomatic mini implants.

The appliances available for distalization used to be mainly extraoral distalizing appliances which depended entirely on patient cooperation and compliance. Even after the emergence of intra-oral distalizing appliances they had adverse dentoalveolar effect such as anchorage loss and flaring of the upper anterior teeth. Thus, this study was made in order to evaluate the efficiency of our proposed appliance in the treatment of Class II patients while avoiding the adverse effects mentioned above.

Eligibility Criteria:
Inclusion Criteria:

* Female Patients with cervical vertebra maturation index (CVMI) 5 \& 6.
* From quarter unit to 3\\4-unit class II molar relationship.
* An overjet of an average 6mm.
* Full Set of permanent dentition except for the maxillary second molar.
* Favorable path of eruption for the maxillary third molar.

Exclusion Criteria:

* Medically compromised Patients.
* Patients under long term medications.
* Patients having sever periodontal disease.
* CVMI 3 or less
* Full unit class II cases
Does Doxazosin Attenuate Stress-induced Smoking and Improve Clinical Outcomes?

The purpose of this study is to examine whether doxazosin will attenuate the ability of stress to precipitate smoking lapse behavior in treatment seeking daily smokers. Participants will participate in a smoking cessation attempt after the laboratory sessions.


Eligibility Criteria:
Inclusion Criteria:

* Ages 18-60
* Able to read and write English
* Smoker
* Motivated to Quit Smoking

Exclusion Criteria:

* Any significant current medical conditions that would contraindicate smoking
* Current Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) abuse or dependence of other substances, other than nicotine dependence or alcohol abuse
* Positive test results at intake appointment on urine drug screens for illicit drugs
* Past 30 day use of psychoactive drugs including anxiolytics and antidepressants
* Women who are pregnant or nursing
* Suicidal, homicidal or evidence of current severe mental illness such as schizophrenia, bipolar disorder or major depression, or anxiety disorders
* Participants who have donated blood within the past 6 weeks
* Individuals who are currently taking other medications prescribed for smoking cessation
* Specific exclusions for administration of doxazosin or any alpha blocker
Hepatitis B Virus Reactivation After Withdrawal of Prophylactic Antiviral Therapy in Lymphoma Patients

This study is a retrospective analysis to explore the incidence of hepatitis B virus reactivation after withdrawal of prophylactic antiviral therapy, the efficacy and safety of chemotherapy, and overall survival rate in lymphoma patients with hepatitis B virus infection.

All eligible patients received prophylactic antiviral therapy during and within 6 months after chemotherapy in previous sudy. We did not assign specific interventions to the subjects in this study. The primary endpoint of this study is the incidence of hepatitis B virus reactivation after withdrawal of prophylactic antiviral therapy. The secondary endpoints include the incidence of hepatitis flare related to hepatitis B virus reactivation after withdrawal of prophylactic antiviral therapy, the tumor response rate, and overall survival rate.

Eligibility Criteria:
Inclusion Criteria:

* treatment-naive patients with lymphoma
* patients with a history of previous exposure to hepatitis B virus (HBV): HBsAg or hepatitis B core antibody (anti-HBc) positive

Exclusion Criteria:

* HBsAg and HBcAb negative
Food Provision in CenteringPregnancy Prenatal Care

The overarching research question is: "Does the provision of healthy food during pregnancy reduce the proportion of women who experience excessive gestational weight gain compared with standard of care (SoC)?" To answer this question, the investigators will conduct a cluster-randomized controlled trial with 400 pregnant women who are enrolled in CenteringPregnancy classes. CenteringPregnancy classes (clusters) will be randomized to either the Food Provision arm or the SoC arm, with approximately 200 participants per arm. Participants randomized to the SoC arm will receive the standard clinical protocol for nutritional and gestational weight gain counseling recommended for all pregnant women, as well as $500 after delivery to be used specifically for baby items.Those randomized to the Food Provision arm will be provided the same nutritional and gestational weight gain counseling, as well as a total of $1000 during pregnancy to be used specifically for the purchase of healthy foods recommended in the nutritional counseling. Data for the primary outcome will be collected from birth records and from surveys conducted at baseline (pre-intervention), midpoint (between 24-36 weeks gestation), and post-intervention (\~8 weeks post-partum).


Eligibility Criteria:
Inclusion Criteria:

* Aged 16-44 years
* Pregnant
* Enrolled in CenteringPregnancy
* Speaks English, Spanish, or Marshallese
Application of the Best Evidence of Neonatal Individualized Developmental Care Assessment Program (NIDCAP) in Very Low Birth Weight Infant (VLBWI)

In order to help THE GROWTH and development of VLBWI in Neonatal Intensive Care Unit (NICU) and reduce the interference of external environment to them, we summarized the best evidence of NIDCAP care, and applied the evidence to the intervention group, and observed the compliance of nurses in the intervention group to the application of evidence, and the short-term outcomes of VLBWI.


Eligibility Criteria:
Inclusion Criteria:

* Birth weight \<1500g;
* admit within 24 hours of birth;
* The guardian signs the informed consent;
* OI (oxygenation index \>300)

Exclusion Criteria:

* Newborn with severe congenital malformations or various chromosomal diseases, genetic metabolic diseases, severe neurological diseases;
* Newborn who did not achieved discharge or death at the end of the study period