cyrilzakka/clinical-trials huggingface dataset:
The Effect of Rebozo Technique on Perceived Support and Control in Childbirth

This study was designed as a randomized controlled, 2-group, experimental study to measure the levels of perceived birth support and control between women with and without rebozo technique.

Objective: This study was conducted to measure the perceived support during labor and the level of control over their own labor in pregnant women who underwent rebozo technique.

Method: The study was conducted in a randomized controlled experimental design between September and December 2024. The population of the study consisted of 44 primiparous pregnant women admitted to a district state hospital for delivery. The sample size was calculated and the study was conducted with 44 pregnant women (experiment: 22, control: 22). While rebozo technique was applied to the experimental group during the trauma process, routine midwifery care was applied to the control group. Introductory Information Form, Perceived Support and Control Scale in Childbirth were used to collect data in the study.

Eligibility Criteria:
Inclusion Criteria:

* Volunteering to participate in the research,
* Don't speak Turkish,
* Being literate,
* Having a low-risk pregnancy,
* Primiparous pregnancy

Exclusion Criteria:

* Being out of position
* Having a high-risk pregnancy (vaginal bleeding, no hypertension, etc.),
* Dilatation below 4 cm and above 6 cm,
* Initiation of labor induction,
* Having received childbirth preparation training,
* Absence of a birth attendant in trauma,
Prediction of Perineal Tears by Striae Gravidarum Score

Previous studies concluded that striae gravidarum assessment appears to predict the occurrence of perineal tears and recommend training the health personnel to calculate the total striae score which can help them decide if episiotomy is to be given or not. Episiotomy definitely seems to be preventive for perineal tears but giving episiotomy for the same is still debatable as episiotomy in itself is associated with morbidity. the hypothesis is episiotomy done in patients with high score will definitely protects against perineal tears. So, the aim of study is to determine whether assessment of striae gravidarum score could predict occurrence of tears during labor or not, and if episiotomy will prevent perineal tears in women with high score.


Eligibility Criteria:
Inclusion criteria:

1. Multipara
2. Singleton pregnancy
3. Full-term (37- 40 weeks)
4. Average size fetus (2500-4000 gm)
5. Cephalic-vertex presentation
6. Spontaneous onset of labor
7. No scarred uterus
8. No medical diseases as hypertension
9. No obstetric complications as obstructed labor
10. Women accepted to participate in the study

Exclusion criteria:

1. Multiple pregnancy
2. Women with Previous cesarean sections
3. Preterm labor
4. Malpresentation
5. Fetal macrosomia
6. Medical diseases as diabetes and hypertension
7. Women refuse to participate in the study
Observational Study on the Improvement of Dry Eye Syndrome, Treatment Satisfaction, and Intraocular Tolerance With Diquasol Eye Drops

This study is to verify the efficacy and safety in the treatment of dry eye syndrome in patients prescribed with Diquasol eye drops as a monotherapy, or in combination with Hyaluron eye drops, or in combination with Hyaluronmax eye drops.

This study is to observe the prescription patterns in routine clinical practice and assess the changes in dry eye symptoms, treatment satisfaction, and intraocular tolerance over a 12-week period in patients prescribed with Diquasol eye drops as a monotherapy or in combination with Hyaluron eye drops or Hyaluronmax eye drops for the treatment of dry eye syndrome.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged 19 years and older
* Patients with dry eye syndrome with TBUT of 10 or less
* Individuals scheduled to receive either Diquasol eye drops as a monotherapy or a combination therapy of Diquasol eye drops with Hyaluron eye drops or Diquasol eye drops with Hyaluronmax eye drops, based on clinical judgment for the treatment of dry eye syndrome
* Individuals who have voluntarily provided written consent for participation in this study

Exclusion Criteria:

* Pregnant or lactating women
* Individuals contraindicated according to the approval conditions of Diquasol eye drops, Hyaluron eye drops, and Hyaluronmax eye drops
* Cases where the principal investigator or study personnel deem the individual unsuitable for participation in this clinical study
Oral Tramadol Versus Diclofenac For Pain Relief Before Outpatient Hysteroscopy:

The purpose of this study is there difference between the effect of Tramadol orally and Diclofenac orally with respect to : analgesic efficacy during diagnostic hysteroscopy in nulliparous women.

This prospective double-blind, randomized, clinical trial, will be conducted at Ain Shams University Maternity Hospital- Early Cancer Detection Unite \[ECDU\].

Patients fulfilling inclusion and exclusion criteria will be divided into three groups.

Group A (study group) Include 34 patients who will receive Tramadol 100mg orally 1 hour before the procedure.

Group B (study group) Include 34 patients who will receive Diclofenac 100mg orally 1 hour before the procedure.

Group C (control group) Include 34 patients who will receive a placebo.

Pain will evaluate on two separate occasion: immediately after the procedure and 15 minutes after procedure using a 100mm line visual analog scale.

Eligibility Criteria:
Inclusion Criteria:

* BMI raging between (18.5 - 30 ).
* Scheduled for diagnostic hysteroscopy only.
* All of them should have given informed written consent.

Exclusion Criteria:

* Any contraindication to hysteroscopy (e.g. suspected pregnancy, genital tract infection).
* Receiving any other form of analgesia.
* Patients with known cervical stenosis, polyps and ulcers.
* Previous cervical surgery.
* Patients who are planning to have invasive intrauterine therapeutic interventions during the hysteroscopy.
* known sensitivity to non-steroidal anti-inflammatory and opioids drugs.
* Known gastritis or peptic ulcer or cardiac disease or Respiratory dysfunction.
* Unwilling to comply with the protocol, and Participation in another clinical trial in the last three months prior to the start of this study
Inhaled Treprostinil Expanded Access Program in Pulmonary Hypertension Associated With Interstitial Lung Disease

This is an Expanded Access Program (EAP) for eligible participants with Pulmonary Hypertension associated with Interstitial Lung Disease (PH-ILD) designed to provide access to Inhaled Treprostinil. Availability will depend on territory elegibility.


Eligibility Criteria:
Inclusion Criteria:

1. Patient consent
2. Males and females aged 18 years old or older
3. PH-ILD diagnosis:

   * Confirmed diagnosis of Group 3 PH by Right Heart Catheterization (RHC):

     - mPAP \> 20 mmHg with PAWP ≤ 15 mmHg and PVR ≥ 2 WU and
   * Confirmed diagnosis of diffuse parenchymal lung disease based on imaging (any form of ILD or CPFE)

Exclusion Criteria:

1. Diagnosis of PAH or PH for reasons other than Group 3 PH-ILD
2. Use of concomitant PAH drugs contraindicated for PH-ILD (ambrisentan and riociguat)
3. Use of any concomitant investigational drug
PGE1 Improves Coronary Microcirculation Dysfunction in Patients With CAD and Diabetes

This study is undertaken to determine if intravenous Lipo-PGE1 therapy would improve coronary microvascular perfusion in patients with ischemic heart disease by CMRI.


Eligibility Criteria:
Inclusion Criteria:

1. Patients giving written consent after being provided with sufficient explanation about participation in this clinical trial
2. Patients aged between 35-70, no limitation on gender
3. Patients with significant CAD and no need to PCI: 50%-70% luminal stenosis as determined by diagnostic coronary angiography, and left main coronary artery stenosis less than 50%; no history of revascularization procedures before
4. MPRI\<2.0
5. Type 2 DM patients with glycosylated hemoglobin levels\>7%
6. All patients were PGE1-naive, defined as receiving no PGE1 therapy for more than 7 days during the previous 12 months
7. Hypertension remained stable for last 3 months, patients with controlled BP level: SBP\<160mmHg and DBP\<95mmHg

Exclusion Criteria:

1. Patients with a history of allergic to PGE1 or a history of prior PGE1 treatment.
2. History of revascularization procedures before: PCI or CABG
3. Patients with implanted pacemaker or ICD, ventricular assist device and intra-aortic balloon counter pulsation pump
4. Patients who have experienced myocardial infarction
5. Patients with serious systolic left ventricular function failure: echocardiography EF\<25%
6. Claustrophobia
7. Patients who used Insulin pumps
8. SBP\<90mmHg
9. Chronic renal function failure: creatinine level \>2.5mg/dl or 221umol/l
10. Patients with serious or frequent arrhythmia ,atrial fibrillation、frequent ventricular premature contraction、sick sinus syndrome, second- or third degree atrioventricular block
11. Prior non-cardiac illness with estimated life expectancy \<2-yrs
12. Women who are pregnant, lactation,or maybe pregnant in the study period
13. Unable to give informed consent
Growth Hormone Dynamics and Cardiac Steatosis in HIV

Cardiac steatosis is increased among individuals with HIV, and may predispose to cardiac mechanical dysfunction and subsequent heart failure. The pathogenesis and treatment of cardiac steatosis is not well understood. The investigators have previously shown that perturbed growth hormone (GH) secretion in HIV contributes to ectopic fat accumulation in the viscera and the liver. Moreover, the investigators have found that augmentation of endogenous GH secretion with the FDA-approved medication tesamorelin reduces visceral and hepatic fat. In this longitudinal observational study, the investigators will examine patients with HIV and abdominal fat accumulation who either plan or do not plan to initiate tesamorelin prescribed clinically. The investigators hypothesize that blunted GH secretion in HIV is associated with cardiac steatosis. The investigators also hypothesize that use of tesamorelin for 6 months is associated with a reduction in intramyocardial fat and preserved cardiac function.


Eligibility Criteria:
Inclusion Criteria:

* Men and women, ages 40-70 years
* Documented HIV infection on stable antiretroviral therapy for ≥ 3 months
* Abdominal obesity with waist circumference ≥ 102 cm in men, ≥ 88 cm in women
* Indication for tesamorelin per clinical judgment

Exclusion Criteria:

* CD4 \< 100 cells/mm3 or HIV viral load \> 400 copies/mL
* Current active AIDS-defining illness
* History or symptoms consistent with heart failure
* Standard contraindications to MRI including severe allergy to gadolinium
* Glomerular filtration rate (eGFR) \< 45 mL/min/1.73 m2 within one month of MRI study
* Use of growth hormone-releasing hormone (GHRH) or growth hormone (GH) within the past 6 months
* HbA1c \> 7%, chronic insulin use within the past 6 months, and/or change in anti-diabetic agents within the past 3 months
* Change in statin therapy within the past 3 months
* Chronic corticosteroid use except intermittent topic steroid creams or inhalers
* Pregnancy or breastfeeding
Multi-component Intervention to Increase Physical Activity in Preschool Children

The study addresses a critical public health problem, childhood obesity, by testing a physical activity intervention in the types of preschools that millions of children attend. Information gained in this study may lead to adoption of preschool policies and instructional practices that increase physical activity and reduce the risk of obesity in preschool children.

Obesity rates in 3-5 year-old American children have increased dramatically in recent decades. Concurrent with this alarming trend, time spent by young children in preschool settings has increased and their time spent in unstructured play has decreased. Recent studies have shown that children in preschools are engaged primarily in sedentary activities. Nonetheless, few interventions designed to increase PA or decrease sedentary behavior have been evaluated in preschool children. The proposed investigation tested a multicomponent intervention designed to increase physical activity energy expenditure (PAEE) in 3-5 year-old children. Sixteen preschools were randomly assigned to intervention or control groups. 500 children, in two annual waves of \~250 children, participated in the measurement protocol at baseline and after exposure to the intervention for 9 months. Child-level measures included moderate-to-vigorous PA, sedentary behavior, and PAEE measured by accelerometry; height, weight and waist circumference; and demographics. The intervention consisted of four components: Move IN (physical education and other indoor activity programming), Move OUT (recess and structured outdoor activity), Move to Learn (PA in classroom, academic lessons), and enhancing the social environment to promote PA. The study's intervention coordinator worked with the preschool directors, teachers, and assistant teachers to facilitate intervention implementation by providing training, materials, and ongoing support and feedback. An extensive process evaluation documented the extent to which the intervention was implemented. Effects of the intervention on PA, sedentary behavior, PAEE, and weight status were determined. In addition, the study examined factors that associate with change in physical activity, sedentary behavior, physical activity energy expenditure and body mass index during a school year in preschool children.

Eligibility Criteria:
Inclusion Criteria:

* All children from participating K-4 classrooms at the participating schools were invited to participate.

Exclusion Criteria:

* Children were excluded only if they had a condition that would limit data collection using an accelerometer (e.g., non-ambulatory children)
Assessment of Skin Tolerance and Efficacy of a Cosmetic Product After 5 Days of Use on Subjects With Atopic Dermatitis

The aim of this study is to compare the efficacy and tolerability and of a cosmetic product to one that is already available on the market (benchmark product). Efficacy is assessed by instrumental measurements of skin condition, clinical examinations, and questionnaires.

The objective of this exploratory study is to investigate the efficacy and tolerability of a cosmetic product on subjects with atopic dermatitis after 5 days of use in comparison to a benchmark product.

The efficacy will be evaluated via instrumental measurements of skin hydration by Corneometer, transepidermal water loss by Tewameter and erythema by Chromameter as well as by evaluation of itch by using a Numerical Rating Scale (NRS). For efficacy and tolerability evaluation an objective and, in the case of adults, an additional subjective dermatological assessment will be performed.

Eligibility Criteria:
Inclusion Criteria:

* Written Informed Consent of the subject to participate in the study, or, for underaged subjects of the parents/ legal guardians to let their child participate in the study
* Willingness to actively participate in the study and to come to the scheduled visits or, for underaged subjects, willingness of the parents/ legal guardians to actively support their child's participation in the study and to come to the scheduled visits with their child
* Female and/or male
* Children from 6 months to 14 years of age and Adult subjects between 18 and 65 years of age
* Eczema-prone skin and atopic diathesis, diagnosed by the dermatologist

Exclusion Criteria:

* Female subjects: Pregnancy or lactation
* Drug addicts, alcoholics
* AIDS, HIV-positive or infectious hepatitis
* Conditions which exclude a participation or might influence the test reaction/evaluation
* Participation or being in the waiting period after participation in cosmetic and/or pharmaceutical studies pertaining to the test area
* Cancer not being diagnosed as cured and requiring chemotherapy, irradiation and/or hormonal treatment within the last 2 years
* Insulin-dependent diabetes mellitus
* One of the following illnesses with reduced physical capability/fitness: asthma (symptom-free allergic asthma is not an exclusion criterion), hypertension, cardiovascular diseases
* Documented allergies to cosmetic products and/ or ingredients, skin care and/or skin cleansing products
* Wounds, moles, tattoos, scars, excessive hair growth, etc. at the test area that could influence the investigation
* Systemic therapy with immuno-suppressive drugs (e.g. corticosteroids) and/or antihistamines (e.g. antiallergics) within the last 7 days prior to the start of the study
* Systemic therapy with anti-phlogistic agents or analgetics (e.g. diclophenac), except for minor pain relief medicine like acetylsalicylic acid or paracetamol within the last 3 days prior to the start of the study
The Effect of ASTARTE™ on Recurrent Urinary Tract Infection

Investigate the effect of dietary supplements/probiotic ASTARTE™ ( L. crispatus, L. rhamnosus, L. jensenii, L. gasseri) on the microbiome composition in the intestine and vagina and thereby a reduction of risk factors for the development of rUTI during 6 months of intervention in women aged 18-40 years. This is measured by the incidence of symptomatic UTI.

Urinary tract infection (UTI) is one of the most common infections, contributing to increased antibiotic consumption and high costs. Women are often developing UTI due to the anatomically short distance from the rectum opening to the urethra. There is a risk of serious complications associated with pregnancy, where there is an increased risk of developing pelvic inflammatory disease and premature birth. This will in some cases lead to increased risk of maternal and neonatal morbidity and mortality; especially in infection with Streptococcus agalactiae. Recurrent UTI (rUTI) with urease producing microorganisms such as Proteus and Klebsiella will cause an increased risk of developing stones in the urinary tract.

Scientific studies suggest that probiotics can be effective dietary supplements reducing the risk factors for the development of infections in the intestine and vagina. Probiotics are non-pathogenic microorganisms capable of affecting gastrointestinal microbiota with a change in microbiota composition, thus increasing the production of beneficial substances when ingested in appropriate quantities. The consumption of probiotics is not considered to be associated with adverse reactions to humans because they are usually found naturally in e.g. gastrointestinal and vaginal microbiota.

A prospective study over 2-years which is conducted as a randomized placebo-controlled double-blind study. In this study the investigators will investigate the effect of probiotics ASTARTE™ ( Lactobacillus crispatus, Lactobacillus rhamnosus, Lactobacillus jensenii, Lactobacillus gasseri) on the composition of bacteria in urine, faces and vagina, and a possible reduction of risk factors for development of rUTI in women (18 to 40 years). The investigators will map the microbiota in the faeces and vagina and examine if there are a relationship between colonization of the urinary tract with pathogens and the composition of the intestinal and vaginal microbiota.

Eligibility Criteria:
Inclusion Criteria:

* Women 18-40 years of age
* Recurrent UTI (2 times UTI within 6 months or \> 3 times UTI infection within one year).
* The subjects should be informed about the trial protocol.
* The subject must be able to follow the protocol, have provided voluntary consent and have signed the declaration of consent.

Exclusion Criteria:

* Pregnancy or planning pregnancy
* Breastfeeding
* Participation in another trial with probiotic the last 30 days.
* Hypersensitivity to any ingredient in the study product
* Patients primarily admitted for a disorder other than UTI
* Antibiotic treatment for any other condition than UTI at time of recruitment the last 30 days
OriCAR-017 Chimeric Antigen Receptor (CAR) Modified T Cells for the Treatment of R/RMM

An open label, dose exploratory clinical study to evaluate the safety, efficacy, and pharmacokinetics of OriCAR-017 in R/RMM

This is a Phase I and Phase II, open-label, multi-center study to assess the safety, pharmacokinetics, and efficacy of GPRC5D directed chimeric antigen receptor modified T cells injection (OriCAR-017) in n patients with relapsed and/or refractory multiplemyeloma (R/RMM).

Eligibility Criteria:
Main Inclusion Criteria:

* Diagnosis of R/RMM according to the IMWG criteria;
* Expected survival period is \>12 weeks;
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 or 2 at the time of ICF signature;
* The expression of GPRC5D in bone marrow plasma cells membrane is more than 20% by flow cytometry and/or immunohistochemistry, multiple myeloma with measurable lesions, and at least one of the following criteria must be met:

  1. Serum M protein \>5 g/L;
  2. Urine M protein level \>200 mg/24 hour;
  3. Serum free light chain (sFLC) \>100 mg/L and K/λ FLC ratio is abnormal;
  4. Primitive immature or monoclonal plasma cells \>5% by bone marrow cytology or flow cytometry.
* Subjects who had received at least 3 prior lines of therapy including (but not limited to) immunomodulatory drugs (IMiDs), proteasome inhibitors, anti-CD38 monoclonal antibodies, etc., but have failed treatment, including those who have experienced relapse (within 12 months), refractory or intolerant to the last line treatment regimen.

Main Exclusion Criteria:

* Smoldering myeloma (asymptomatic)
* Multiple myeloma with only extramedullary lesions;
* Plasma cell leukemia;
* Concurrent amyloidosis;
* Central nervous system metastasis, leptomeningeal disease or metastatic central compression;
* HBsAg or HbcAb is positive, and the quantitative detection of hepatitis B virus (HBV) DNA in peripheral blood is more than 100 copies/L; hepatitis C virus (HCV) antibody and HCV RNA in peripheral blood is positive; human immunodeficiency virus (HIV) antibody positive; syphilis antibody is positive at Screening; Cytomegalovirus DNA test is positive;
* Had hypersensitivity or intolerance to any drug/excipient (including conditioning chemotherapy) used in this study;
* Previously received treatment targeting GPRC5D, including but not limited to antibodies, ADC, or CAR-T;
* Subjects who received autologous hematopoietic stem cell transplantation (ASCT) within 8 weeks of Screening Visit or who plan to undergo ASCT during the study;
* Any uncontrolled active infection within 4 weeks prior to ICF signing or leukapheresis requires parenteral antibiotic, antiviral, or antifungal treatment
* Major surgery within 28 days prior to Screening Visit with the exception of a biopsy and an insertion of a central venous catheter or during the study;
* Subjects who received allogeneic stem cell therapy;
* Subjects complications or other conditions evaluated by investigators may affect compliance with the protocol or make them unsuitable to participate in this study;
* Pregnant or breastfeeding.