cyrilzakka/clinical-trials huggingface dataset:
BradycArdia paCemaKer With AV Interval Modulation for Blood prEssure treAtmenT

A prospective, multinational, randomized, double-blind, clinical trial evaluating the safety and effectiveness of a novel atrioventricular interval modulation (AVIM) algorithm downloaded into a dual-chamber Medtronic Astra/Azure pacemaker.

The study will be conducted in three phases: 1) Screening Phase, 2) Double-blind Randomized phase (1 year), and 3) Unblinded phase (2 years). Patients who are scheduled to undergo implantation of a, or already have an implanted, de novo Astra/Azure pacemaker system, who also have uncontrolled hypertension may be screened for inclusion into this study. All eligible subjects will receive the AVIM RAMware and be randomized 1:1 to either have AVIM therapy turned On or turned Off. All subjects will continue to receive antihypertensive drug therapy.

Eligibility Criteria:
Inclusion Criteria:

1. Patient has or is indicated for a de novo dual chamber pacemaker. Patient informed consent must be obtained within 30 days prior to a planned de novo implant of a Medtronic Astra/Azure dual chamber pacemaker system or up to 365 days after
2. On a stable antihypertension treatment regimen with 1, 2, or 3 classes of antihypertensive drugs
3. Office SBP ≥140 mmHg and \<180 mmHg
4. Average 24-Hour aSBP ≥130 mmHg and \<170 mmHg

Exclusion Criteria:

1. LVEF \<50%
2. NYHA Class II-IV
3. History of cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 6 months
4. Myocardial infarction (MI) within 3 months
5. Prior percutaneous or surgical coronary, carotid, or endovascular intervention within 3 months
6. Persistent or permanent atrial fibrillation
7. Mitral valve regurgitation greater than grade 3
8. Aortic stenosis with a valve area less than 1.5 cm2
9. Has an active or prior device-based anti-hypertensive treatment (e.g., renal denervation procedure, baroreflex activation therapy)
10. Has an existing active cardiac device or neurostimulator other than the recent Astra/Azure pacemaker implant
Evaluate the Clinical Effectiveness of RegenKit Platelet-rich Plasma (PRP) in Androgenetic Alopecia Treatment

Platelet rich plasma (PRP) therapy is a novel therapeutic modality that has seen broad applications for a number of medical indications including those in orthopedics, dentistry, and dermatology. In dermatology, its uses have included treatment of chronic wounds and facial rejuvenation. More recently, anecdotal reports have suggested some efficacy in the treatment of hair loss, but to the best of our knowledge, there has been only one published case series documenting its use for this indication.

This study was designed to better assess the efficacy of PRP in hair loss, we therefore propose to study interval intralesional PRP injections for patients with androgenetic alopecia (AGA). Androgenetic alopecia is the most common form of hair loss world-wide. Although there are currently numerous treatment options for this indication including minoxidil, 5-alpha reductase inhibitors and follicular unit transplant, many of the medical treatment options have undesirable side effects, particularly in women of child bearing age. These well-documented adverse reactions include impotency, hypertrichosis, and birth defects.

Eligibility Criteria:
Inclusion Criteria:

* Men and women, age 18-60 with AGA
* Completed informed consent form
* Ludwig stage 1-2 for women
* Norwood Hamilton Stage 3 to 5 for men

Exclusion Criteria:

* Pregnancy or breastfeeding
* Younger than 18 years
* Uses of minoxidil and/or 5-alpha reductase inhibitors (such as finasteride or dutasteride) within 3 months of enrolling in the study
* History of hair transplantation
* Use of any cosmetic product aimed at improving or correcting the signs of hair loss within 2 weeks prior to screening
* Facial cancer (squamous and basal cell carcinoma, melanoma)
* Hereditary or acquired hematologic/coagulation disorders such as: platelet dysfunction syndrome, critical thrombocytopenia, hypofibrinogenemia, impaired coagulation, drepanocytosis (sickle cell anemia).
* Hemodynamic instability
* Acute infection
* Auto-immune disease such as Hashimoto, rheumatoid arthritis, or lupus (exception: vitiligo and alopecia areata)
* Malignancy with or without metastatic disease
* Chemotherapy
* Dermatological diseases affecting the face (e.g. porphyria)
* Anticoagulant therapy
* Patients taking Aspirin or other NSAIDs (Nonsteroidal anti-inflammatory drugs) such as Nurofen, Voltaren, Diclofenac or Naproxen can participate, provided medication is interrupted 7 days before beginning of the treatment
* Patients taking vitamin E supplements can participate, provided medication is interrupted 14 days before beginning of the treatment
Efficacy Study Of Oral Glecaprevir/Pibrentasvir Tablet In Pediatric (12 Years and Older) And Adult Treatment-Naive Participants With Chronic Hepatitis C Genotypes 1 To 6 And Liver Cirrhosis

Hepatitis C Virus (HCV) infection is among the most common of all chronic liver diseases. HCV predominantly affects liver cells and causes the liver to become inflamed and damaged. This can lead to cirrhosis (scarring of the liver) and liver cancer leaving trial participants with need for liver transplant. The purpose of this study is to see how effective Glecaprevir/Pibrentasvir (GLE/PIB) is in a real world setting of participants with chronic HCV genotypes 1 to 6 and liver cirrhosis who have never received any treatment for HCV.

GLE/PIB is a drug developed for the treatment of HCV infection. This is a prospective (future), observational study in treatment-naive (those who have not received treatment) participants with HCV genotypes 1 to 6 and compensated cirrhosis. All study participants will receive GLE/PIB as prescribed by their study doctor in accordance with approved local label. Pediatric (12 years and older) and adult participants with a diagnosis of HCV genotypes 1 to 6 and compensated cirrhosis will be enrolled in the study in Russian Federation.

Participants will receive GLE/PIB tablets to be taken by mouth daily according to their physicians' prescription. The total duration of the study is 20 weeks, with a treatment period of 8 weeks and a follow up period of 12 weeks.

There is expected to be no additional burden for participants in this trial. All study visits will occur during routine clinical practice and participants will be followed for 12 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Treatment-naïve male or female with confirmed CHC, genotypes 1, 2, 3, 4, 5, or 6, with compensated liver cirrhosis, receiving combination therapy with the all oral GLE/PIB regimen for 8 weeks according to standard of care, international guidelines and in line with the current local label.
* Participants may be enrolled up to 4 weeks after treatment initiation.

Exclusion Criteria:

* Participating or intending to participate in a concurrent interventional therapeutic trial.
DPBRN Reasons for Placing the First Restoration on Permanent Tooth Surfaces

The purpose of this study was to document the reasons for placing the first restoration ("filling") on a previously un-restored surface in a permanent ("adult") tooth.

The aims of this study were to (1) quantify DPBRN practitioner-investigators pre-operative and post-operative assessments of the depth of the caries lesion being treated; (2) quantify the prevalence of dental material types used to restore the first restoration in a permanent tooth surface; and (3) test the hypothesis that DPBRN practitioner investigators in the "Assessment of caries diagnosis and caries treatment" study who stated that they wait until the caries lesions reach dentin before they place the first restoration are in fact more likely in this study to do restoration in teeth that have caries reaching into dentin.

The aims were met by enrolling 230 DPBRN practitioner-investigators in the "Reasons for placing the first restoration on permanent tooth surfaces" study, each of whom recorded information about approximately 50 consecutive restorations that they placed on unrestored surfaces. This study about restorative treatment received by patients provided the opportunity to record the variations in the treatment provided, and also provided a basis for subsequent future studies to investigate how defects on fillings develop over time. These results will also be related to the findings from "Assessment of caries diagnosis and caries treatment" study where practitioners outlined how they detected dental decay, the stage at which the decay was treated by placing fillings, and how they rely on preventive measures to stop the decay process without placing fillings.

Eligibility Criteria:
Inclusion Criteria:

* participants directly involved in this study were patients who sought dental treatment in the practitioner-investigators' practices
* any tooth surface that was previously unrestored was eligible for this study, provided that it was on a permanent ("adult") tooth. This means that permanent first molars were eligible, which typically erupt at about age 6 years. This means that persons age 6 and older were enrolled in the study and there was no upper age limit.

Exclusion Criteria:
Anxiety in Non-professional Football Players With Recurrent Hamstring Injuries.

Introduction. Faced with the risk of injury relapse, and as athletes train and compete, they generate anxiety that limits their ability to push themselves to the maximum, influencing their performance.

Objectives. i) To identify the state and trait anxiety of non-professional athletes with previous hamstring injuries; ii) To evaluate the main prognostic factors of anxiety in these athletes; and iii) To analyze the best predictive model of anxiety in soccer players with previous hamstring injuries.

Material and method. Ambispective cross-sectional cohort study. 88 players will be recruited. The primary variable of the study will be anxiety (State-Trait Anxiety Inventory), with the number of recurrences of the study injury being the dependent variable. The secondary variables, estimated as modifying or confounding, will be the main sociodemographic variables (age, type of school/work activity), clinical (number of hamstring injuries, number of relapses of injury in the same location, duration of injury in weeks, date of last injury), sports (weekly training load, seasons competing, regular starting line-up) and anthropometric (weight).


Eligibility Criteria:
Inclusion Criteria:

* Male athletes aged 18 to 19
* Registered in the Division of Honor category of the Region of Murcia
* Who are university students
* With previous hamstring injuries in the last 12 months.

Exclusion Criteria:

* Athletes with an injury, muscular or not, at the time of the study
* Athletes in their first year as registered soccer players.
Effects of Melatonin on Sleep, Ventilatory Control and Cognition at Altitude.

Low oxygen at altitude causes pauses in breathing during sleep, called central sleep apnea. Central sleep apnea causes repeated awakenings and poor sleep. Low oxygen itself and the induced oxidative stress can damage mental function which is likely worsened by poor sleep. Reduced mental function due to low oxygen can pose a serious danger to mountain climbers. However there is also mounting evidence that even in populations of people that live at high altitudes and are considered adapted, low oxygen contributes to reductions in learning and memory. Therefore there is a serious need for treatments which may improve sleep, control of breathing and mental function during low oxygen. Melatonin is a hormone produced in the brain during the night which regulates sleep patterns with strong antioxidant and anti-inflammatory properties. A study previously reported that melatonin taken 90 mins before bed at 4,300 m (14,200 ft) induced sleep earlier, reduced awakenings and improved mental performance the following day. However how melatonin caused these effects was not determined. Therefore this study aims to determine how melatonin effects control of breathing, sleep and mental performance during exposure to low oxygen.


Eligibility Criteria:
Inclusion Criteria:

-

Exclusion Criteria:

* Sleep disorders
* Pregnant females
* Smokers (quit ≥ 1 year ago acceptable)
* Any known cardiac (apart from treated hypertension with acceptable drugs, see below), pulmonary (including asthma), renal, neurologic (including epilepsy), neuromuscular, hepatic disease, or patients with diabetes.
* Prior or current use of melatonin.
* Use of any medications that may affect sleep or breathing, blood-thinning medications (anticoagulants), antioxidants, anti-inflammatories, medications that suppress the immune system (immunosuppressants), diabetes medications and birth control pills.
* A psychiatric disorder, other than mild depression; e.g. schizophrenia, bipolar disorder, major depression, panic or anxiety disorders.
* Substantial alcohol (\>3oz/day) or use of illicit drugs.
* Previous occurrence of high altitude pulmonary or cerebral edema.
* Recent exposure to altitude (\>8000ft) in the last month or having slept at an altitude \>6000ft in the last month.
* Inability to provide written informed consent or able to complete the experiment.
* Non-English speakers (necessary to complete neurocognitive testing).
* More than 10 cups of beverages with caffeine (coffee, tea, soda/pop) per day.
Assessment of Left Ventricular Filling Pressure by Applying Artificial Intelligence Algorithms to Left Atrial Speckle-tracking Echocardiography

The goal of this single-center, prospective, observational study is to validate a software package based on an artificial intelligence algorithm for automated non-invasive estimation of LVFP against invasively measured ones by left and right heart catheterization; In addition, the added value of this new automated software to detect increased LVEDP \> 15 mm Hg compared to the current ASE/EACVI algorithm for assessing diastolic dysfunction and longitudinal left atrial strain during the reservoir phase will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 yo,
* Signed informed consent to be part of this study,
* No pregnancy,
* Good acoustic window and patient cooperation to obtain good 2- and 3-dimensional datasets focused on left atrium (LA),

Exclusion Criteria:

* Unwillingness to be part of the study,
* Patients with poor 2-dimensional imaging quality in ≥ 1 LA segment or lacking of a discernible R-R interval, which might preclude accurate strain measurements,
* Patients with more than mild mitral valve heart disease, aortic regurgitation, left side valvular prosthesis or mitral valve repair, mitral annulus calcification (≥ 5 mm),
* Patients with history or presence of atrial fibrillation (AF), supraventricular arrhythmias, ventricular paced rhythm, left bundle branch block (LBBB),
* Patients taking diuretics or vasodilators (nitrates) on the day of the examination, which could alter loading conditions.
Dydrogesterone in the Treatment of Endometrial Polyps

This study is intended to observe the therapeutic effect of dydrogesterone on endometrial polyps and provide a reference for clinical treatment.

Endometrial polyps are a common female endometrial lesion.The long-term unrestrained exposure of estrogen to local tissue is one of the causes of polyp formation.Studies suggested that the progesterone can accelerate the regression rate of endometrial polyps due to its antiestrogenic effects.Based on this, investigators intended to observe the therapeutic effect of dydrogesterone on endometrial polyps and provide a reference for clinical treatment.

Eligibility Criteria:
Inclusion Criteria:

1. women of childbearing age from 20 to 50 years old
2. with or without menstrual changes:

   1. menostaxis (longer than 7 days)
   2. shortened menstrual cycles(less than 23 days)
   3. menorrhagia(more than twice as much as usual)
   4. abnormal vaginal bleeding(non-menstrual vaginal bleeding)
3. with following signs of vaginal ultrasound in the follicular phase (day 1 to day 10 of a menstrual cycle):

   1. typical signs with a suspect of EP: (median/high) echo with a regular contour within the uterine lumen;
   2. atypical signs with a suspect of EP: punctate cystic areas within the endometrium and the endometrial thickness \>1cm;

Exclusion Criteria:

1. no menses within half a year;
2. surgery or drug treatment of endometrial lesions in the past half year;
3. with current intrauterine device;
4. combined with other acute gynecological inflammation;
5. with clinically suspected malignant tumors;
6. long-term use of oral contraceptives;
7. with abnormal liver and kidney function;
8. with benign or malignant breast tumors;
9. with any systemic malignant tumor or a history of tumors;
10. participants who are pregnant.
A Trial to Compare American Heart Association (AHA) and Simple (SIM)Method to Give Adenosine to Treat Supra-ventricular Tachycardia (SVT)

Study to compare non inferiority of giving adenosine with the simplified method vs the AHA method

tle: A randomised controlled trial of the standard versus a simplified adenosine administration method in the treatment of adult patients with supra- ventricular tachycardia (SVT

Eligibility Criteria:
Inclusion Criteria:

* Svt
* normal blood pressure
* normal mentation
* Give consent

Exclusion Criteria:

* recent coffee
* Allergy to adenosine
* Asthma
* cardiac operations
Efficacy of Retinal Nerve Fiber Layer (RNFL) / Ganglion Cell Layer Thickness Ratio by RT-View Utilizing Spectral -Domain Technology as a Diagnostic Predictor of Glaucoma.

RT-View utilizes spectral domain technology to assess both RNFL and ganglion cell layer thickness. This study aims to correlate visual field defects in patients with glaucoma to both RNFL and ganglion cell layer thickness.


Eligibility Criteria:
Exclusion Criteria:

* Evidence of retinal disease
* Neovascular glaucoma
* Secondary glaucoma due to intraocular inflammation
* Lens induced glaucoma
* Tumor induced glaucoma
Blood Stem Cell Transplantation for the Treatment of Older Patients With Acute Myelogenous Leukemia

The prognosis for older individuals with acute myelogenous leukemia (AML) has been historically poor, with 2 year disease-free survival rates \< 20% reported. Younger patients with AML in first complete remission are routinely treated using a full intensity (myelo-ablative) chemotherapy followed by a blood stem cell transplant. For the older patient with AML, full intensity therapy transplants have been greatly limited by increased rates of toxic effects related to this type of conditioning regimen. Reduced intensity (non-myeloablative) conditioning regimens have been used in a number of clinical settings, including AML therapy, to lessen the regimen related toxicity in the older patient. Recent data from the University of Michigan Blood and Marrow Transplant Program suggests improved survival for individuals \> 55 years in age undergoing reduced intensity, transplants from unrelated donors. This study will investigate the safety and efficacy of this treatment option for older patients with AML, with the primary goal being to improve the survival and lifespan for older patients with AML.


Eligibility Criteria:
Inclusion Criteria:

For Study Registration:

* Age 55 - 70 years.
* Subjects diagnosed with AML (\> 20% myeloblasts).

For Proceeding to Transplant:

* Subjects must be in either complete remission (CR) or partial remission (PR) within 14 days prior to admission.
* Subjects must be \> 21 days since completion of prior systemic chemotherapy or radiation therapy (including craniospinal XRT), prior to admission .
* Organ function requirements for a reduced intensity (FluBu2) regimen (must be met within 21 days of admission):

  * Cardiac: LV Ejection Fraction \> 40% on MUGA or Echocardiogram.
  * Pulmonary: FEV1 and FVC \> 40% predicted, DLCO \> 40% of predicted.
  * Renal: Serum creatinine \< 2.0 mg/dl. Not on hemodialysis or continuous veno-venous filtration (CVVH).
  * Hepatic: serum total bilirubin \< 3.0 mg/dl and AST / ALT \< 4x ULN
  * Karnofsky \> 60%.
* Organ function requirements for a full intensity (FluBu4) regimen (must be met within 21 days of admission):

  * Cardiac: LV Ejection Fraction \> 40% on MUGA or Echocardiogram.
  * Pulmonary: FEV1 and FVC \> 50% predicted, DLCO (corrected for hemoglobin) \> 50% of predicted.
  * Renal: serum creatinine \< 2.0 mg/dl. Not on hemodialysis or continuous veno-venous filtration (CVVH)
  * Hepatic: serum total bilirubin \< 3.0 mg/dl and AST / ALT \< 4x ULN.
  * Karnofsky \> 60%.

Exclusion Criteria:

For Study Registration:

* Subjects with M3 AML (FAB classification)

For Proceeding to Transplant:

* Subjects who exhibit signs of progressive disease (\> 20% blasts) within 14 days prior to admission for transplant
* Patients with an uncontrolled viral or fungal infection within the prior 28 days.
* Patients who are HIV1 or HIV2 positive.
* Uncontrollable medical or psychiatric disorder
Optimisation of Follicular Recruitment in IVM Cycles

The study will focus on important aspects related to follicle recruitment using exogenous gonadotropins in patients with polycystic ovaries:

1. Early follicle recruitment in patients with polycystic ovaries using corifollitropin alfa: does administration of this drug result in earlier and higher FSH (follicle stimulating hormone) concentrations above the threshold for follicle recruitment in an IVM (in vitro maturation) cycle preceded by oral contraceptive suppression, in comparison to normal daily administration of rFSH (recombinant follicle stimulating hormone, Puregon)?;
2. The maturation rate of the obtained oocyte-cumulus complexes in standard IVM media registered for clinical use: does stimulation with corifollitropin alfa versus recombinant FSH have an impact on the maturation rate and developmental capacity of the oocytes ?


Eligibility Criteria:
Inclusion Criteria:

1. Subfertile patients between 18-36 years old eligible for ART treatment
2. BMI 18-30
3. Polycystic ovaries (PCO) according to the Rotterdam criteria (at least 12 antral follicles per ovary as observed on a baseline ultrasound scan), with or without hyperandrogenism, with or without oligoamenorrhoea. In other words, patients are eligible if they have PCO morphology. A diagnosis of PCOS (polycystic ovary syndrome) based on Rotterdam criteria is not compulsory.

Exclusion Criteria:

1. Antral follicle count (AFC) \<24
2. Anti-müllerian hormone (AMH) \<3,25 in non-OCP (oral contraceptive pill) users and \<4,00 in current OCP users (using Elecsys platform (Roche Diagnostics))
3. Couples requesting PGD (preimplantation genetic diagnosis)
4. Non-obstructive azoospermia in the male partner