cyrilzakka/clinical-trials huggingface dataset:
Drug Exposure and Depot Medroxyprogesterone Acetate (DMPA) in Adolescent Subjects

The investigators are doing this study to look at how different doses of the Depot medroxyprogesterone acetate (DMPA) shot effect weight gain and bone mineral density in teens. The investigators hope that what the investigators learn from this study will be used to develop ways to keep girls from gaining weight or losing bone density when receiving DMPA.

Depot medroxyprogesterone acetate (DMPA) is a generic form of the DepoProvera® shot. When receiving the birth control shot some girls gain a lot of weight while others do not. Some girls also lose bone mineral density (BMD). Bone mineral density is the amount of weight and thickness of the bones.

In this study 1 of 3 doses of DMPA will be given as an injection into the muscle in the arm. The 150mg dose is approved for use in this age group by the Food and Drug Administration (FDA) when given into the muscle. The 104mg dose is approved for use in this age group by the FDA only when given under the skin therefore it is considered experimental. The 75mg dose is also considered experimental as this dose is not FDA approved regardless of how it is given.

Eligibility Criteria:
Inclusion Criteria:

1. Age 12-21 years
2. Healthy, post-menarcheal female
3. Self-selected to initiate depot medroxyprogesterone acetate (DMPA)
4. Willingness to use a barrier method of contraception in addition to DMPA

Exclusion Criteria:

1. Chronic disease known to affect weight or bone mineral density (BMD) (e.g. diabetes, kidney)
2. Use of medication known to affect weight or BMD (e.g. corticosteroids)
3. DMPA use within the past 12 months
4. Pregnancy within the past 6 months
5. Etonogestrel implant, levonorgestrel-releasing intrauterine system or combined estrogen/progesterone contraceptive use within the past 30 days (OC, patch, vaginal ring)
6. Weight exceeding 450 lbs
7. Need for confidential contraceptive care for individuals \< 18 years of age.
A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Tocilizumab (TCZ) Administered to Participants With Giant Cell Arteritis (GCA).

This study will evaluate the pharmacokinetics, pharmacodynamics, and safety of two dose levels of tocilizumab (TCZ) administered by intravenous (IV) infusion every 4 weeks (Q4W) to participants with giant cell arteritis (GCA).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of GCA as classified according to protocol-specified criteria;
* Participants entering Period 1 must be receiving treatment with TCZ 8 mg/kg IV Q4W.

Exclusion Criteria:

* Treatment with any other investigational agent besides TCZ within 12 weeks (or 5 half-lives of the investigational drug, whichever is longer) prior to screening;
* Evidence of serious uncontrolled disease;
* Known active current or history of recurrent bacterial, viral, fungal, mycobacterial, or other infections;
* Active TB requiring treatment within the previous 3 years.
Assessment of Oral Health Status of Children With Primary Ciliary Dyskinesia

The aim of this study is to compare the oral health findings, salivary parameters and pediatric oral health related quality of life of children with Primary Ciliary Dyskinesia (PCD) with healthy children

Primary Ciliary Dyskinesia (PCD) is a rare genetic disorder that affects the function of cilia, which are tiny hair-like structures responsible for moving mucus and other substances in the respiratory tract and other parts of the body. Dysfunctional cilia lead to impaired mucociliary clearance, resulting in chronic respiratory infections, sinusitis, and bronchiectasis. PCD can also cause situs inversus, where internal organs are mirrored from their normal positions, and other complications like chronic otitis media and fertility issues. Early diagnosis and management are crucial to prevent progressive lung damage and improve the quality of life in affected individuals.

This study aims to compare the oral and dental health of children diagnosed with Primary Ciliary Dyskinesia (PCD) to that of healthy controls. The study includes assessments of dental caries (using DMFT, dmft, and ICDAS II indices), salivary parameters (flow rate, pH, buffering capacity, oxidant-antioxidant levels, tissue factor activity), enamel defects (using the Modified Developmental Defects of Enamel Index), and oral hygiene (gingival and plaque indices). The Pediatric Oral Health-Related Quality of Life (POQL) scale will be used to evaluate the impact of oral health on quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Not having any systemic disease.
* Not being on any regular medication.

Exclusion Criteria:

* Having any systemic disease.
* Being on any regular medication.
Effects of Platelet-Rich Fibrin and Kinesio Taping on Postoperative Recovery in Oral Surgery

This study investigates the effectiveness of Platelet-Rich Fibrin (PRF) and Kinesio Taping in reducing postoperative pain, edema, and improving recovery following impacted third molar surgery. A prospective, randomized clinical trial was conducted with 44 patients aged 18-35 years. Patients were assigned to three groups: (1) PRF applied locally to the extraction socket, (2) Kinesio Taping applied postoperatively and removed on the third day, and (3) a control group receiving standard postoperative care. Postoperative outcomes were assessed on days 3 and 7, including pain levels, edema, and quality of life. This study aims to evaluate PRF and Kinesio Taping as non-pharmacological adjuncts in oral and maxillofacial surgery.

This study investigates the effectiveness of Platelet-Rich Fibrin (PRF) and Kinesio Taping in postoperative management following impacted mandibular third molar surgery. Postoperative complications, such as pain and edema, are commonly observed and may impact patient comfort and recovery. This study aims to evaluate the feasibility of two non-pharmacological approaches-PRF and Kinesio Taping (Elastic Bandaging)-in postoperative care.

A total of 44 patients aged 18-35 years participated in this prospective, randomized clinical trial. Patients were assigned to one of three groups:

PRF Group: Platelet-rich fibrin (PRF) was applied locally into the extraction socket.

Kinesio Taping Group: An elastic bandage was applied postoperatively to the surgical area and removed on the third day.

Control Group: Standard postoperative care was provided with no additional intervention.

Postoperative evaluations were conducted on the 3rd and 7th days. The measured parameters included:

Edema: Measured using anthropometric techniques.

Pain: Assessed with the Numerical Rating Scale (NRS).

Quality of Life: Evaluated using the Oral Health Impact Profile-14 (OHIP-14).

This study aims to assess the feasibility of PRF and Kinesio Taping in postoperative management.

Eligibility Criteria:
Inclusion Criteria:

* Ages 18-35 years
* Systemically healthy individuals
* Non-smokers
* No psychological disorders
* Preoperative pain level between 0-3 on the Numerical Rating Scale (NRS)
* No preoperative edema in the surgical area
* Impacted mandibular third molars classified as Class 1 or 2, Level B, and mesioangular according to the Pell-Gregory classification
* Signed an informed consent form

Exclusion Criteria:

* Under 18 or over 35 years old
* Presence of chronic or systemic diseases
* Pregnant or breastfeeding patients
* Surgical duration exceeding 45 minutes
* Smokers
* Patients requiring prophylactic antibiotics due to systemic health conditions
* Patients who did not meet the study criteria or did not sign the informed consent form
The Effects of Combined Spinal-epidural Anesthetics During Labor

Women who fulfil the inclusion criteria and who intended to regional anesthesia will be randomized into the epidural anesthesia arm or to the spinal-epidural anesthesia arm. Sonographic evaluation of the flow in the uterine artery, umbilical artery, and middle cerebral artery will be documented to each patient prior and following the regional anesthesia.

Patients will receive information regarding the available anesthesia during labor that are available in the delivery room including regional and systemic.

After receiving the patient informed consent for regional anesthesia (epidural or spinal-epidural), patients will be offered to participate in our study.

After receiving the patients' informed consent for participating in the study, patients will be randomized to either the epidural anesthesia group or to the spinal-epidural anesthesia group.

A doppler ultrasound will be performed on each patient prior to and following the regional anesthesia, the flow in the uterine artery, umbilical artery, and the middle cerebral artery of the fetus will be recorded.

Demographic and obstetrical information will be collected from the patients' electronic files.

Eligibility Criteria:
Inclusion criteria:

Gestational age of 37 and above Singleton Vertex presentation Desired regional anesthesia

Exclusion criteria:

Contraindication to regional anesthesia Placental abnormalities (placenta previa, placenta accreta, placental separation) Pregnancy following fetal reduction or intrauterine fetal death (IUFD) Fetal malformations Intrauterine growth retardation (IUGR) Suspected chorioamnionitis (including body temperature above 38.5 degrees Celsius)
BEZ235 Trial in Patients With HER2-(Human Epidermal Growth Factor Receptor 2 Negative) /HR+ (Hormonal Receptor Positive) Metastatic Breast Cancer

This is a prospective, multi-center, open-label, single arm, phase II study with a 2-stage design and Bayesian interim monitoring to investigate the safety and efficacy of BEZ235 in patients with progressive metastatic HR+ HER2- breast cancer who have received at least one prior line of endocrine therapy and two to three prior lines of chemotherapy for metastatic disease. Patients will be stratified into 3 groups according to their PI3K (phosphatidylinositol 3-Kinase) pathway activation status.


Eligibility Criteria:
Inclusion Criteria:

* Female ≥ 18 years
* ECOG performance status ≤ 2
* Histologically and/or cytologically confirmed diagnosis of breast cancer presenting with metastatic disease (hormone receptor positive and HER2 negative)
* Known PI3K activation status (defined by PIK3CA (Phosphoinositide-3-kinase, catalytic, alpha polypeptide) mutation and PTEN PTEN (Phosphatase and Tensin Homolog) mutation/expression)
* Prior treatment with at least one prior line of endocrine therapy and at least two and no more than three prior lines of chemotherapy for metastatic breast cancer
* Objective and radiologically confirmed progression of disease after prior treatment and at least one measurable lesion as per RECIST
* Adequate bone marrow and organ function

Exclusion Criteria:

* Previous treatment with PI3K and/or mTOR inhibitors
* Symptomatic Central Nervous System (CNS) metastases
* Concurrent malignancy or malignancy in the last 5 years prior to start of study treatment
* Wide field radiotherapy ≤ 28 days or limited field radiation for palliation ≤ 14 days prior to starting study drug
* Active cardiac disease (e.g. Left Ventricular Ejection Fraction (LVEF) \< 50%, QTcF \> 480 msec on screening ECGelectrocardiogram (ECG), unstable angina pectoris, ventricular, supraventricular or nodal arrhythmias)
* Inadequately controlled hypertension
* Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of BEZ235
* Treatment at start of study treatment with drugs with a known risk to induce Torsades de Pointes, moderate and strong inhibitors or inducers of isoenzyme CYP3A4, warfarin and coumadin analogues, LHRH agonists
* History of photosensitivity reactions to other drugs
* Pregnant or nursing (lactating) woman

Other protocol-defined inclusion/exclusion criteria may apply
Immediate Changes After Manual Therapy in Patients With Non-specific Back Pain

The purpose of this trial is to investigate the immediate effects of neuro-lymphatic treatment, thoracic vertebral and costal articulatory in terms of back pain levels, cervical and dorsal flexibility, sense of body comfort and satisfaction with the treatment received.

Subjects:

The study was conducted at the Faculty of Physiotherapy of the University of Valencia (Spain). Persistent non-specific back pain subjects between 20 and 30 years old were recruited and voluntarily participated in the study. Excluded subjects with musculoskeletal injuries such as spine or balance disorders, those which were recovering from an injury of the locomotor or neurological system, or those who had sequelae from any trauma suffered in the past six months that could affect the results of the study.

Study design:

The conducted study was an experimental, longitudinal and prospective, controlled, randomized and single-blind design (subjects and therapists didn't know the objectives of the treatment nor how many treatments were offered, evaluators were unaware of the treatments applied). There were 3 groups: a) neuro-lymphatic treatment; b) vertebral articulatory treatment; c) proximal costal articulatory treatment.

Eligibility Criteria:
Inclusion Criteria:

* Non-specific Back Pain subjects between 20 and 30 years old were recruited and voluntarily participated in the study.

Exclusion Criteria:

* Excluded subjects with musculoskeletal injuries such as spine or balance disorders
* Those which were recovering from an injury of the locomotor or neurological system, or
* Those who had sequelae from any trauma suffered in the past six months that could affect the results of the study.
Immune Restoration by Lipoic Acid in AIDS

The purpose of this study is to determine the immunomodulatory and antiviral effects of the glutathione-restoring dithiol, alpha lipoic acid (ALA) in HIV-infected persons unresponsive to highly active antiretroviral treatment (HAART).

AIDS is characterized by infection with HIV which leads to collapse of the immune system. Although highly active antiretroviral therapy (HAART) has contributed significantly to lowering morbidity and mortality from AIDS, antiretroviral drugs do not fully restore the immune system and patients often fail multi-drug treatment. Hence, there is a need for alternative/complementary medicine (CAM) that can restore an immune system ravaged by HIV/AIDS. To address this need, investigators have formed a multidisciplinary collaboration to evaluate and demonstrate utility of natural immune-based modulators in ethnically diverse patients with HIV/AIDS. The long-term goal of this proposal is to develop a CAM therapy to facilitate immune reconstitution and HIV eradication following cessation of antiretroviral treatment or concurrent with continued antiretroviral treatment. It is based on the premise of a widespread deficiency of glutathione (GSH), vital to lymphocyte function, in patients with HIV/AIDS. The proposed project will study the immunomodulatory and antiretroviral effects of a dietary antioxidant, alpha-lipoic acid (ALA), which is known to efficiently boost systemic GSH.

In this study, HIV-infected adults unresponsive to HAART (i.e. those with persistent CD4+ count \> 50 cells/mm3, viral load\> 10,000 copies/cc) will be randomized into a treatment or a control arm. The treatment group will be given 300 mg ALA thrice daily for 6 months and the control group will receive inert placebo. Studies performed at baseline and at 2,4, and 6 months will include estimation of CD4+ count, HIV RNA, T-cell reactivity in vitro and whole blood GSH level. Significance of changes from baseline parameters will be analyzed by t-tests. The proposed research will show whether GSH augmentation by ALA increases CD4+ cell number and T cell function and reduces viral load in subjects unresponsive to antiretroviral therapy.

Eligibility Criteria:
Inclusion Criteria:

* HIV-positive status
* HAART non-responsiveness as defined by 1) previous experience with at least 2 different protease inhibitors plus nucleoside analogs; 2) viral load of \>10,000 copies/cc and CD4+ cell count \>50 x 1000 cells/liter at time of enrollment

Exclusion Criteria:

* Diabetic patients
* Pregnant women
* Asthmatic patients
* Severely thiamine-deficient persons (e.g. alcoholics and those with polyneuritis)
* History of supplementing on excessive amounts of N-acetylcysteine, glutathione or other antioxidant supplements, during the 2 months prior to study entry.
Shockwave™Peripheral Intravascular Lithotripsy Balloon for Advanced Endovascular Aortic Repair

Shockwave TEVAR is a nonrandomized, prospective, international, multi-center, PMCF, obervational study.

The aim of this study is to evaluate the outcomes of the Shockwave™ Peripheral Intravascular Lithotripsy Balloon (Shockwave Medical Inc.) in the routine treatment of hostile iliac accesses during TEVAR and F/BEVAR.

Standardized forms will collect data on the performed procedure, underlying pathology, cardiovascular risks and information on preoperative examinations. Physiological parameters routinely measured prior, during and after any surgical intervention will be recorded as well. A 1 month, 6-months and 12-months follow-up visit will be conducted to assess adverse events and outcome of the index procedure.

In addition, this study aims to analyze the technical and procedure success to gain access via hostile iliac access vessels withShockwave Peripheral Intravascular Lithotripsy Balloon in patients submitted for complex endovascualre thoracic, throaco-abdominal or abdominal aortic repair.

Eligibility Criteria:
Inclusion Criteria:

1. Patient (m/f) age ≥ 18 years at time of enrollment.
2. Diagnosis of thoracic and/or thoraco-abdominal (Extent I-V) and juxta/para-renal/short-neck aneurysm requiring the implantation of a thoracic and/or thoraco-abdominal fenestrated/branched aortic endograft with delivery system introducer sheath diameter equal or larger than 18 Fr (6 mm).
3. Hostile iliac access was defined in the presence of:

   * Heavily circumferential calcified iliac arteries
   * Inner diameter ≤ 6 mm
   * Severe stenosis (\> 50%; \> 2.5 m/s peak velocity; absence of triphasic duplex signal in ipsilateral common femoral artery)
4. We will accept the following presentations of aneurysm:

   * urgent cases,
   * elective,
   * symptomatic
   * and fast growing.
5. The repair was performed using Shockwave™ before the introduction of the main endograft. The iliac procedures can be accompanied by angioplasty and/or stent and stent-graft positioning.

Exclusion Criteria:

1. Patients submitted to surgical conduit bypass.
2. Not-severely calcified disease (absence of calcification).
3. In-stent restenosis/occlusion.
4. Inability to cross with 0.014 guidewire.
5. Any significant medical condition which, in the investigator's opinion, may interfere with the subject's optimal participation in the study.
6. Pre-stented iliac access vessels at the level of Shockwave implementation.
Effect of 8-week Incremental Elastic-Resistance Kick Training in Taekwondo Athlete's

This study aimed to assess the effects of an 8-week incremental elastic-resistance kick training program on the roundhouse kick quality and physical performance, in comparison to conventional training methods of youth Taekwondo athletes. A two-group parallel, randomized, quasi-experimental design was used, dividing Participants into experimental (n=11, age: 15.5 ± 1.5 years, stature: 169.5 ± 15.5 cm, body mass: 63.2 ± 26.2 kg; training experience: 7.0 ± 3.0 y) and control group (n=10, age: 14.8 ± 1.2 years, stature: 162.0 ± 14.0 cm, body mass: 53.15 ± 21.4 kg; training experience: 5.5 ± 1.5 y), undergoing tailored Elastic Resistance training alongside their regular Taekwondo regimen. The study measured various performance metrics including Roundhouse Kick velocity, impact scoring, isometric muscle strength, counter movement jump performance, and simple reaction times.


Eligibility Criteria:
Inclusion Criteria:

* Being part of a unified youth development program;
* Minimum of four weekly training sessions, each session lasting 90 minutes.

Exclusion Criteria:

* Musculoskeletal, neurological, or orthopedic injury that may impair their participation.
Effects of Mango or Low-Fat Cookie Consumption on Gut Health, and Its Relationship With Mental, Sexual and Skin Health

The objective of the proposed research is to determine the effects of fresh mango consumption on gut microbiome, and its relationship with skin health, sexual and mental health in relatively healthy adults.


Eligibility Criteria:
Inclusion Criteria:

* Generally healthy subjects
* BMI 20-40 kg/m2

Exclusion Criteria:

* Smoker
* Pregnant woman
* Required antibiotics use
* Required dietary supplement use
* Required medication of metabolic disorders, mental health and sexual health
* Allergy to mango or wheat
Preterm Lung Function and Exercise Response Measured by OEP

This study will explore lung function and respiratory health in school-aged children who were born prematurely at \<32 weeks gestation. It will involve full lung function assessment, a questionnaire and discussion about respiratory health, and an exercise test using optoelectronic plethysmography (OEP) to measure breathing patterns.

Preterm are born during a critical stage of lung development, and can have abnormalities in lung function that persist with age. Previous studies have shown that children with BPD have reduced lung function and limited exercise capacity. These studies have used conventional lung function testing which requires a tight fitting mask. This is uncomfortable, may alter normal breathing patterns and cannot measure changes in total lung volume.

Optoelectronic plethysmography (OEP) indirectly measures lung volumes and breathing patterns using cameras to track the position of marker stickers on the chest, back and abdomen. It is comfortable, does not require a mask and allows us to track changes in total lung volume.

This study will use standard lung function testing and OEP to measure lung function and breathing patterns at rest and during exercise in school-aged children born prematurely, compared to healthy children born at full term. All participants will complete standard lung function tests, a questionnaire and structured interview to qualitatively assess respiratory health, and an exercise test using OEP to assess how breathing changes with exercise.

Eligibility Criteria:
Inclusion Criteria:

* Age 8-16 years
* Born at \<32 weeks gestation (preterm) or \>37 weeks gestation (controls)
* Parental consent obtained

Exclusion Criteria:

* Unable to comply with test procedure
* Respiratory illness within last 2 weeks
* Cardiac disease (excludes ligated PDA)
* Neuromuscular disease