cyrilzakka/clinical-trials huggingface dataset:
Platelet Rich Plasm Versus Hyaluronic Acid Injection in Chronic Painful Shoulder

Aim of This study is to compare between the effect of ultrasound-guided local injection of Platelet Rich Plasma (PRP)versus Hyaluronic (HA) for the treatment of chronic shoulder pain.

This study was prospective randomized comparative trial on patients with chronic shoulder pain presented at outpatient Clinic of Physical Medicine, Rheumatology and Rehabilitation Department at Assiut University Hospitals from June 2019 to December 2020. Our study started by 70 patient with chronic shoulder pain 20 of them were missed in follow up period, the range of age from 36 - 56 years, history, clinical examination, Laboratory investigation, and imaging (X-ray or MRI) done for all patient to complete the diagnosis, patient divided randomly into two groups, Group (A) included 25 patients were treated by PRP injection and group (B) included 25 patients were treated by HA injection, both injections were performed under ultrasound (US) guidance. Randomization by sealed envelopes technique, the follow up was at the baseline, 4 weeks and 6 months post injection.

Eligibility Criteria:
Inclusion Criteria:

* Adult patient age \>18 years.
* Patients with chronic shoulder pain more than 6 months not responding to medical treatment or physical therapy.
* Frozen shoulder.
* Rotator cuff disorders (partial tear).

Exclusion Criteria:

* Shoulder joint instability or traumatic shoulder pain.
* Patients with local infection at the shoulder, systemic infection, or inflammatory disease (e.g., rheumatoid arthritis and hepatitis)
* Patients with a history of diabetes mellitus and malignancy (either hematological or non-hematological).
* Pregnancy.
* Patients on anticoagulant therapy.
* Injection of shoulder with corticosteroids in the preceding 6 months.
A Trial to Compare the Ovarian Response of REKOVELLE and GONAL-F in Conventional Dosing in Women Undergoing Controlled Ovarian Stimulation

Hormone preparations like REKOVELLE and GONAL-F are used to make the body produce multiple egg sacs, allowing more eggs to be collected from women undergoing infertility treatment.

The main purpose of this trial is to see how many eggs are produced with a starting dose of 15 µg REKOVELLE compared to a starting dose of 225 IU GONAL-F. This research is intended to provide more knowledge about REKOVELLE, including the doses given in the trial.


Eligibility Criteria:
Inclusion Criteria:

* Infertile women aged 18-40 years
* Diagnosed with tubal infertility, unexplained infertility, mild endometriosis (stage I/II) or partners with decreased sperm quality
* Medically eligible for in vitro fertilization (IVF) and/or intracytoplasmic sperm injection (ICSI)
* Infertility for at least one year for participants ≤ 37 years or for at least 6 months for participants ≥ 38 years
* Regular menstrual cycles of 21-35 days.

Exclusion Criteria:

* Known condition of not functioning ovaries
* Known advanced endometriosis (stage III/IV)
* Considered unsuitable for controlled ovarian stimulation with a dosing regimen corresponding to approximately 225 IU/day gonadotropin, as judged by the investigator
* History of previous episode of OHSS or exuberant ovarian response to gonadotropins, and polycystic ovarian syndrome
* Any known hormonal or metabolic abnormalities which can compromise participation in the trial
* Known tumors of the ovary, breast, uterus, adrenal gland, pituitary or hypothalamus
Programmed Death-1 (PD-1) Antibody Combined With Chemoradiotherapy in High-risk Recurrent Nasopharyngeal Carcinoma

This is a a prospective, single-arm phase II clinical trial. The purpose of this study is to evaluate the efficacy and adverse effect of PD-1 antibody with chemotherapy in high-risk recurrent nasopharyngeal carcinoma.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed as local recurrence ± regional recurrence after ≥1 year of radical treatment;
* Not suitable for surgery;
* Newly histologic diagnosis of NPC (WHO II/III);
* Clinical stage rII-IVa (AJCC/UICC 8th);
* ECOG 0-1 point;
* PRANCIS score \> 252 points;
* No treatment to rNPC, such as radiotherapy, chemotherapy, immunotherapy or biotherapy;
* No contraindications to immunotherapy or chemoradiotherapy;
* Adequate marrow function: WBC count ≥ 3×10E9/L, NE count ≥ 1.5×10E9/L, HGB ≥ 90g/L, PLT count ≥ 100×10E9/L;
* Adequate liver function: ALT/AST ≤ 2.5×ULN, TBIL ≤ 2.0×ULN;
* Adequate renal function: BUN/CRE ≤ 1.5×ULN or endogenous creatinine clearance ≥ 60ml/min (Cockcroft-Gault formula);
* Take effective contraceptions during and two months after treatment;
* Patients must be informed of the investigational nature of this study and give written informed consent.

Exclusion Criteria:

* Have recurrence with local necrosis;
* Have ≥G3 late toxicities, except for skin, subcutaneous tissue or mucosa;
* Unexplained fever \> 38.5 ℃, except for tumor fever;
* Treated with ≥ 5 days antibiotics one month before enrollment;
* Have active autoimmune disease (e.g., uveitis, enteritis, hepatitis, hypophysitis, nephritis, vasculitis, hyperthyroidism, and asthma requiring bronchodilator therapy);
* Have a known history of human immunodeficiency virus (HIV), active Hepatitis B (HBV-DNA ≥10E3copiers/ml) or hepatitis C virus (HCV) antibody positive;
* Have previously treated with PD-1 antibody or other immunotherapy for PD-1/PD-L1 pathway;
* Have New York Heart Association (NYHA) class 3 or 4, unstable angina, myocardial -infarction within 1 year, or clinically meaningful arrhythmia that requires treatment;
* Have known allergy to large molecule protein products or any compound of study therapy;
* Pregnant or breastfeeding;
* Prior malignancy except adequately treated non-melanoma skin cancer, in situ cervical cancer, and papillary thyroid carcinoma;
* Have received a live vaccine within 30 days of planned start of study therapy Has psychiatric drug or substance abuse disorders that would interfere with cooperation with the requirements of the trial;
* Any other condition, including mental illness or domestic/social factors, deemed by the investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interferes with the interpretation of the results.
A Study of Combination or Sequential Treatment With PEGASYS (Peginterferon Alfa-2a) and Entecavir in Patients With HBeAg Positive Chronic Hepatitis B

This 2 arm study will assess the efficacy and safety of Pegasys in combination or sequential treatment with entecavir in patients with HBeAg positive chronic hepatitis B. Patients who have been pretreated with, and responded to, entecavir for 9 to 36 months were randomized to one of 2 groups, to receive Pegasys 180micrograms/week sc for 48 weeks + entecavir 0.5mg po daily for 8 weeks, or entecavir 0.5mg po daily for 48 weeks. The anticipated time on study treatment is 3-12 months.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, \>=18 and \</= 65 years of age
* HBeAg positive chronic hepatitis B
* Pre-treatment with entecavir for 9-36 months

Exclusion Criteria:

* Antiviral, antineoplastic or immunomodulatory treatment
* Co-infection with active hepatitis A, C or D, or HIV
* Evidence of decompensated liver disease
* History or other evidence of a medical condition associated with chronic liver disease other than viral hepatitis
Cleanser Versus Only Water

The aim of this study is to determine the effect of the newborn's first bath with a cleaning product and only water on the barrier function of the skin.

Studies in the literature on the effects of newborn bath types on the effects of body temperature on newborn crying times, on the effects of newborn behavior and stress, the views and practices of mothers with newborn babies on baby bathing, and the effects of bath types on the umbilical cord in term babies, and the effects of bath products on newborns. It seems that there are studies done. However, although studies on the effect of the cleaning product used in the first bath of late preterm and term newborns on the skin barrier are limited in number for term newborns, there are almost no studies for late preterm newborns. The hypotheses of this study are as follows; 1. In late preterm and term newborns, the first bath with cleaning product protects the newborns' Transepidermal Fluid Loss better than the first bath with only water. 2. In late preterm and term newborns, the first bath with cleansing product keeps the skin pH levels of newborns at a more optimal level compared to the first bath with only water.

Eligibility Criteria:
Inclusion Criteria:

* Born between 34 weeks + 0 days and 42 weeks + 6 days (late preterm and term),
* With a body weight of 1800g or more,
* Spontaneous breathing,
* Preterms with stable physiological parameters will be included in the study.

Exclusion Criteria:

* Receiving mechanical ventilation support,
* Mother's baby with HIV, Hepatitis B,
* Preterms who had a bath before the intervention,
* Surgical operation and incision in any area,
* Preterms with a central catheter,
* Preterms with systemic infections,
* Preterms using sedatives and / or muscle relaxants,
* Preterms with congenital or chromosomal anomalies
Hard and Soft Tissue Changes Following Vestibular Socket Preservation Versus Ice Cream Cone Technique for Management of Defective Fresh Extraction Sockets

Evaluation of hard and soft tissue changes following vestibular socket preservation versus ice cream cone technique for management of defective fresh extraction sockets in the esthetic zone.

The aim of this randomized clinical trial is to assess the volumetric and radiographic ridge contour changes following alveolar ridge preservation using Vestibular socket preservation in patient with type II fresh extraction sockets, versus ice cream cone technique.

In patients needing extraction in anterior maxilla with type II sockets, there will be no difference between the Vestibular socket preservation and ice cream cone technique regarding the changes in alveolar ridge contour.

Eligibility Criteria:
Inclusion Criteria:

Adults from the age of 18 - 60 years Patients with non-restorable maxillary teeth/tooth indicated for extraction in the area from 2nd premolar to 2nd premolar Type II sockets will be selected as revealed by Cone beam computed tomography (CBCT).

Intact gingival tissue with at least 2mm keratinized tissue Absence of any systemic disease or drugs that contraindicate oral surgery using Modified Cornell Medical Index . Patients accepts to provide informed consent

Exclusion Criteria:

Pregnant and lactating females. Smokers as smoking is a contraindication for any plastic periodontal surgery. Patients with BOP\&gt;15%. Patients with periodontal diseases . Handicapped and mentally retarded patients. Patients undergoing radiotherapy. Presence of systemic disease that would affect wound healing. Presence of active infection with soft tissue communication.
A Safety and Effectiveness Study of the MD-12-001 Stent in the Treatment of Superficial Femoral Artery or Popliteal Artery Blockages in Japanese Patients

The purpose of this study is to assess the safety and effectiveness of the MD-12-001 stent in the treatment of superficial femoral artery and proximal popliteal artery blockages in Japanese patients.


Eligibility Criteria:
Key Inclusion Criteria:

* Rutherford Category 2-4 (mild intermittent claudication (pain while walking)to ischemic pain (pain due to decreased blood flow) at rest).
* The target lesion(s) has evidence of narrowing or blockage and can be stented.
* The total length of the lesion or series of lesions is estimated to be less than or equal to 150 mm.
* The target vessel reference diameter is greater than or equal to 4.0 mm and less than or equal to 6.5 mm

Key Exclusion Criteria:

* The subject has a known reaction (including allergic reaction) or sensitivity to blood thinning medications, or study device materials (nickel, titanium or tantalum)
* The subject has a known sensitivity to medical imaging substances (contract media) that cannot be pretreated with medications (steroids or/and antihistamines)
* The subject has a history of bleeding disorders (diatheses or coagulopathy).
* The subject has kidney failure or is having dialysis treatment.
* The subject has insufficient liver function, swelling of vein(s) caused by blood clot (thrombophlebitis), uremia, systemic lupus, or deep vein blood clots.
* Subject has Acute Limb Ischemia (a sudden loss of blood flow to the limb).
* Subject has a history of bypass surgery on the study vessel.
* Subject has a history of heart attack or stroke within 6 months of study procedure.
* The subject is receiving immunosuppressive therapy (medications that lower the body's normal immune response).
* The subject is diagnosed with a severe infection (septicemia).
* Principal investigator determines the subject's condition would prevent the subject from undergoing the study procedure or cannot support a vascular bypass graft.
* The subject with a stent previously implanted into the target vessel.
* Subject has disease in both legs where both limbs meet the inclusion criteria and it is planned to treat both limbs within 30 days.
* Pregnant, possibly pregnant and/or nursing female subjects are excluded, as are female subjects who are willing to have a baby during the trial.
* The subject is participating in an investigational drug or another investigational device study.
* Subject has a large amount of blood clot next to the study lesion.
Preoperative and Postoperative Incentive Spirometry in Patients Undergoing Major Abdominal Surgery

The goal of this study is to determine the efficacy of incentive spirometry (IS) to improve pulmonary function in the preoperative and postoperative surgical setting. The investigators hypothesize that IS will improve pulmonary function for patients undergoing major abdominal surgery when controlling for protocol compliance. Additionally, the investigators hypothesize that a digital IS device enabled with a text message-based mobile health intervention will improve pulmonary pre-habilitation and rehabilitation, as well as postoperative compliance with the IS device.


Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled to undergo major abdominal surgery with expected postoperative length of stay of 48 hours or more.
* Access to a smartphone.
* At least 18 years of age.
* Ability to understand and willingness to sign an IRB approved written informed consent document.

Exclusion Criteria:

* Younger than 18 years of age
* No access to a smartphone
The Heidelberg Engineering ANTERION Anterior Segment Cornea and IOL Precision and Agreement Study

This is a prospective clinical study that will be conducted at one clinical site located in the United States to assess anterior segment parameters with the ANTERION


Eligibility Criteria:
Inclusion Criteria:

1. Age 22 years or older
2. Able and willing to undergo the test procedures, sign informed consent, and follow instructions
3. Able to fixate
4. With the following eye pathology status for the individual eye population:

   * A. Eye with normal anterior segment and crystalline lens
   * B. Eye with a cataract of grade 1.5 or higher
   * C. Eye with abnormal corneal shape
   * D. Eye with status post-keratorefractive surgery
   * E. Eye without a crystalline lens

Exclusion Criteria:

1. Subjects which were enrolled in the B-2018-1 clinical study
2. Active infection or inflammation in the study eye
3. Insufficient tear film or corneal reflex
4. Physical inability to be properly positioned at the study devices or eye exam equipment
5. Rigid contact lens wear 2 weeks prior to imaging
6. Soft lenses worn within one hour prior to imaging
7. With the following eye pathology status for the individual eye population:

   * A. Eye meets eligibility criteria for eye populations B, C, D or E
   * B. Eye meets eligibility criteria for eye populations C,D or E
   * C. Eye meets eligibility criteria for eye populations D or E
   * E. Eye with abnormal corneal shape (except status post-keratorefractive surgery)
Fetal Alcohol Syndrome: Socio-Cognitive Habilitation

Comprehensive evaluation (geneticist, psychologist, social worker, education specialist, others as indicated) to determine individual needs and treatment plan. Referrals for specific services (e.g., OT, counseling, medications, etc) will be to clinicians within the families' own communities. All families will receive evaluation, parent education/advocacy, and learning readiness program. Only the intervention group will receive the math intervention.

Learning Readiness Program: This program will include: case management to secure needed services, medication consultation (psychiatrist), educational consultation/ liaison, Behavioral Regulation Training (BRT). BRT will include teaching parents about: 1) recognizing their child's arousal level (to avoid negative episodes), 2) recognizing their own arousal and how it contributes to a situation, 3) principles of social reinforcement (e.g., praise, ignore, etc), 4) "accidental teaching" (i.e., teaching when a situation/opportunity arises), 5) resource/support source identification, 6) to communicate choices rather than authoritative commands, and 6) reduction of repetitive prompts (nagging). The child will be taught: 1) the technique of Escape/No Escape for undesirable tasks, 2) arousal awareness, and 3) verbalization of situations and actions (e.g., I don't like it when mom yells at me for running in the house, so I won't run in the house).

Targeted Area of Intervention: MATH - 6 weeks of individualized math tutoring. Content of the tutoring will be tailored to age levels (either 3-6 yr olds or 6-9 yr olds). The High/Scope curriculum will be used (modified so that it can be individualized). In addition, visual materials and visual aids will be developed to address deficits in the visual-spatial skills of children with FAS/ARND. For teachers, a manual will be prepared to assist them in working with children who have FAS/ARND. The educational specialist will review the manual and techniques with each teacher involved with the child.

Parent component: Individual and small group sessions to include: FAS education, information on education system procedures, instruction for communicating with professionals, and support for advocating for their child. A caregiver manual will be prepared.

Evaluation Plan: Treatment and control groups will be compared using pre- and post-tests measures. Post-tests will be at the conclusion of the intervention and at a 6-month follow-up. Process (e.g., parent satisfaction, compliance, etc) and outcome (e.g., math skill, behavior, family functioning, etc) measures will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of FAS or related condition
* age 3 years six month or older

Exclusion Criteria:

* age 6 years 9 months or older
A Study to Evaluate Effectiveness and Safety of Tyrosine Kinase Inhibitors

This is a real-world non-interventional observational study. The study was designed to evaluate the effectiveness and safety of clinical treatments in the patients with advanced non-small cell lung cancer (NSCLC) complicated with brain metastases in clinical practice.

This is a real-world non-interventional observational study that focuses to evaluate the effectiveness and safety of tyrosine kinase inhibitors (TKIs) in the patients of advanced non-small cell lung cancer (NSCLC) with brain metastases diagnosed by medical imaging methods. The patients with core medical health records who were enrolled in the clinics from 2014 to 2017 and were administered with TKIs only or combination therapies of TKIs will be included in the study. All the treatments followed real-world clinical practices and experiences of clinical physicians.

The effectiveness will be measured by the treatment effects on brain metastases (objective remission rate) and overall survival/progress-free survival. The safety will be evaluated by adverse events, serious adverse events, laboratory tests, electrocardiogram, vital sign, and physical examination. The mutation status of epidermal growth factor receptor (EGFR) and the type of anaplastic lymphoma kinase (ALK) will be assessed. All the study procedures will be in compliance with International Clinical Harmonization - Good Clinical Practice (ICH-GCP), standard operation procedures (SOPs), and regulatory policies/regulations.

Eligibility Criteria:
Inclusion Criteria:

* The patients were treated with lung cancer and were enrolled from Jan 2013 to Jun 2017
* The patients with advanced (Clinical stage: Phase IV) non-small cell lung cancer who have complete core health medical records (HMRs);
* The patients who are observed with brain metastases diagnosed by imaging methods;
* The patients who have complete clinical data for diagnosis time of brain metastases, and overall survival/effectiveness;
* The patients who are administered with tyrosine kinase inhibitors only or combination therapies of tyrosine kinase inhibitors;

Exclusion Criteria:

No exclusion criteria are included in the study given that the study is designed as non-interventional and all the treatments followed real-world clinical practice and experiences of clinical physicians.
Concordance Between the Measurement of Whole Blood Fibrinogen by the qLabs®FIB Analyzer and Its Measurement by Conventional Method (Clauss Fibrinogen) in the Context of Severe Postpartum Haemorrhage

In France in 2021, 11.6% of deliveries were complicated by a postpartum haemorrhage (PPH), including 3.0% by severe PPH (the bleeding volume exceeds 1000 ml). Severe PPH is the 5th cause of maternal death (8.4% or 1.2 deaths per 100,000 live births). These deaths were considered preventable in 90% of cases. A plasma fibrinogen concentration below 2 g/L is considered as a critical threshold which constitutes a marker of severity of PPH and is significantly associated with the occurrence of severe PPH. Measuring the concentration of fibrinogen using a rapid test, simple to perform and interpret, available in the delivery room could optimize the management of severe PPH. The qLabs®FIB analyzer distributed by the Stago Biocare laboratory for the rapid determination of the fibrinogen concentration at the patient's bedside could meet this objective.

In France in 2021, 11.6% of deliveries were complicated by postpartum hemorrhage (PPH), including 3.0% by severe PPH (the bleeding volume exceeds 1000 ml). Severe PPH is the 5th cause of maternal death (8.4% or 1.2 deaths per 100,000 live births). These deaths were considered preventable in 90% of cases. A plasma fibrinogen concentration below 2 g/L is considered as a critical threshold which constitutes a marker of severity of PPH and is significantly associated with the occurrence of severe PPH. Measuring the concentration of fibrinogen using a rapid test, simple to perform and interpret, available in the delivery room could optimize the management of severe PPH. The qLabs®FIB analyzer distributed by Stago Biocare laboratory for the rapid determination of the fibrinogen concentration at the patient's bedside could meet this objective.

The hypothesis of the study is a concordance between the measurement of fibrinogen by the qLabs®FIB Monitoring system and by the Clauss fibrinogen assay in laboratory to identify patients with a fibrinogen level \< 2 g/L.

The prospects are to provide an easy-to-use delocalized biology tool for early diagnosis of a fibrinogen concentration \< 2g predictive of an unfavorable evolution in the context of severe PPH.

Eligibility Criteria:
Inclusion Criteria:

Adult patients having been informed of the study and not having objected to their participation and treated for severe postpartum haemorrhage defined as bleeding greater than 1000 ml within 24 hours postpartum, whatever the route delivery (vaginal route and caesarean section).

Exclusion Criteria:

* Opposition to participation in the study
* Presence of a constitutional fibrinogen deficiency
* Patients under guardianship or curatorship