cyrilzakka/clinical-trials huggingface dataset:
A Dose Escalation Study of Intranasal Neuropeptide Y in Post Traumatic Stress Disorder (PTSD)

This study is designed to investigate the safety of intranasal administration of NPY using a dose escalation, randomized, double-blinded, placebo-controlled crossover design in a medication-free, symptomatic PTSD group.


Eligibility Criteria:
Inclusion Criteria:

* Men and women, age 18-60.
* Participants must have a level of understanding sufficient to agree to all tests and examinations required by the protocol and must sign a written informed consent document. We determine whether they have a sufficient understanding of the study procedures and risks by asking them to explain what's involved in the study and to give examples of study risks and benefits.
* Participants must fulfill DSM-IV criteria for current PTSD, based on the Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-I) and on the Clinician-Administered PTSD Scale (CAPS).
* CAPS score must be at least 40 (moderate PTSD severity) at screening.

Exclusion Criteria:

* Current, primary Axis I disorders other than PTSD.
* History or current bipolar disorder or primary psychotic disorders (e.g. schizophrenia, schizoaffective disorder).
* Current diagnosis of anorexia nervosa or bulimia nervosa.
* Women who are pregnant or are breast-feeding.
* Drug or alcohol abuse or dependence within the preceding 3 months.
* poorly controlled hypertension (manifest by SBP \> 140 and/or DBP \> 90); HR \< 60 or \> 100 at rest at the time of screening and confirmed immediately prior to randomization
* Evidence of coronary artery disease as evidenced by history, abnormal ECG, typical symptoms
* History of arrhythmia, cardiac surgery, or family history of sudden death
* Hepatic dysfunction as defined by AST and ALT \> 2x URL, or alkaline phosphatase and bilirubin \> 1.5 x URL within X days prior to randomization
* Chronic renal disease as defined by serum creatinine \> 1.9
* Any other serious or unstable clinically significant abnormal findings of laboratory parameters, physical examination, or ECG as determined by the PI.
* Any other serious or unstable condition that would put the subjects at undue risk as determined by the PI or additional safety monitor.
* Serious and imminent suicidal or homicidal risk.
* Psychotropic medication that will not be tapered off at least 7 days prior to screening; withdrawal symptoms must be absent at the time of screening
* History of nasal disorders or sinonasal surgery, or significant nasal abnormalities based on nasal exam.
* Received investigational intervention within 30 days prior to randomization
Efficacy of Tenofovir-Emtricitabine and Efavirenz in HIV Infected Patients With Tuberculosis (ANRS129)

Successful therapy of both tuberculosis and HIV disease share similar problems: pill burden, drug interaction, adherence challenge and toxicity. This study will test the efficacy and safety of a once daily antiretroviral regimen in HIV-tuberculosis coinfected patients.

The proposed research consists of conducting a pilot trial "BKVIR" designed to answer the question of whether once daily tenofovir-emtricitabine-efavirenz triple-agent therapy is effective and well tolerated when it must be initiated within three months after initiation of a three-agent or four-agent tuberculostatic therapy in antiretroviral-naive HIV-infected patients. As the proposed pilot trial comprises the initiation of antiretroviral therapy during the three months following the initiation of tuberculostatic therapy, we propose to set up systematic, continuous registration of HIV-infected patients with a diagnosis of tuberculosis in participating centers during the study period in order to evaluate their eligibility for inclusion in the pilot trial. The initial declaration phase in the register, in addition to facilitating inclusions in the pilot trial, should also allow: 1) a better understanding of the reasons for non-inclusion in the trial, allowing the eligibility criteria to be adjusted if necessary during the trial; and 2) to describe the antiretroviral therapies used during co-infection and their time of initiation in relation to tuberculostatic therapy.

This research is expected to contribute to an updating of the treatment guidelines in the context of tuberculosis in HIV-infected patients. The data collected will constitute a unique database on this issue not only in France, but also internationally, which will also be useful to optimize management strategies of these two diseases in developing countries.

Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 18 years
* Infected by HIV-1
* Naive to antiretroviral therapy
* Presenting an indication to start antiretroviral therapy (according to the recommendations of the Delfraissy 2004 report)
* Histologically or microbiologically confirmed tuberculosis
* Receiving tuberculostatic therapy for less than three months

Exclusion Criteria:

* Isolated HIV-2 infection
* Neoplasm treated by chemotherapy and/or radiotherapy
* Pregnancy or plans for pregnancy
* Breastfeeding
* Contraindication to one of the antiretroviral drugs
* Atypical mycobacterial infection
* Hemoglobin below 8 g/dL
* Neutrophils below 750/mm3
* Platelets below 50,000/mm3
* Creatinine clearance below 60 ml/min
* Alkaline phosphatase, ASAT, ALAT or bilirubin over 3 times the upper limit of normal
Two Different Minimal Invasive Techniques in Caries Removal of Primary Teeth

Pain control during dental treatments is the most challenging situations that face the pediatric dentist especially in young and fearful or anxious child. Minimal invasive approach for caries removal includes many techniques to remove caries either by dental excavators, rotatory burs, atraumatic restorative treatment (ART), chemo-mechanical caries removal and smart bur.


Eligibility Criteria:
Inclusion Criteria:

* Each child has three teeth with carious cavity enough for insertion of hand instruments
* Positive or definitely positive child behaviour according to the Frankl Behaviour Scale (FBS)
* Caries lesion in dentin of primary teeth

Exclusion Criteria:

* Negative" or "definitely negative" child behaviour according to the FBS.
* Presence of sign and symptoms of pulp lesion
Lateral Sinus Augmentation Utilizing Bovine Bone Mixed with Platelet-rich Fibrin

Background:

In sinus augmentation procedure, graft resorption remains a major dilemma of various graft materials.

Objective:

To estimate the graft volume changes following lateral sinus augmentation utilizing cone beam computed tomography.

Methods: A total of 34 lateral sinus augmentation operations were performed and 50 dental implants were concomitantly inserted. The sinus augmentation cases were distributed randomly into 3 groups according to graft material: Group A comprised utilizing deproteinized bovine bone alone, group B using deproteinized bovine bone mixed with leukocyte and platelet-rich fibrin, and group C employing deproteinized bovine bone mixed with advanced platelet-rich fibrin. Cone-beam computed tomography was obtained 2 weeks (baseline record) and 24 weeks postoperatively for the measurement of the graft volume changes.


Eligibility Criteria:
Inclusion Criteria:

* requiring lateral sinus lift for implant placement

Exclusion Criteria:

* available bone permits implant placement without need for sinus lifting
Clinical Performance of the Histidine Rich Protein 2 (HRP2) Highly Sensitive Rapid Diagnostic Test (HS-RDT) for Malaria Diagnosis in Pregnant Women in Papua New Guinea

Malaria during pregnancy remains an important public health issue in endemic countries. Most cases of malaria in pregnant women are asymptomatic, and can contribute to adverse outcomes, such as maternal and neonatal anaemia as well as low birth weight. Infections that do not cause symptoms (sub-clinical infections) - particularly in low transmission settings -remain difficult to diagnose during pregnancy but can contribute to adverse outcomes e.g. growth restriction, premature birth, miscarriage and stillbirth.

The Bill \& Melinda Gates Foundation (BMGF) has supported the development of an HRP2-based high sensitivity rapid diagnostic tests (HS-RDT) that has analytical sensitivity ten times better than current RDTs and a sensitivity near 80% when compared to the 'gold standard' of quantitative polymerase chain reaction (qPCR). In this regard, the new HS-RDT may be a promising diagnostic and screening test for subclinical malaria during pregnancy.

The overall aim is to compare the performance of novel high sensitivity rapid detection tests with conventional rapid diagnostic tests for Plasmodium falciparum malaria infection in pregnant women in Papua New Guinea


Eligibility Criteria:
Inclusion Criteria:

* All women must meet all the following inclusion criteria in order to be eligible to participate in the study:

  * Pregnant women attending first antenatal care visit at selected health facilities
  * Resident in the study area for at least 1 year prior to enrolment
  * Age ≥ 16
  * Willing to freely participate with signed informed consent (or, if illiterate, provide a thumbprint in the presence of an independent witness)
  * Willing to provide finger-prick blood sample

Exclusion Criteria:

* Women meeting any of the following exclusion criteria at screening will be excluded from study participation:

  * History of malaria or antimalarial drugs used in the last three months, as recalled or documented in health record
  * Presence of severe malaria as defined by WHO guidelines at the moment of recruitment.

Presence of symptoms and signs of other serious chronic disease such as severe anaemia, tuberculosis and/or central nervous system infections, as defined by WHO guidelines
The Role of Isolated Nocturnal Hypertension Pattern in Nondialysis CKD

Isolated nocturnal hypertension (INH) has been studied among the general population and hypertensive patients. However, little insight is available on the prognostic effect of INH in patients with chronic kidney disease (CKD). This study investigated the prognostic effect of INH in a cohort of Chinese patients with nondialysis CKD.

Patients with or without isolated nocturnal hypertension will be enrolled in this study, and the patients with isolated nocturnal hypertension will be randomly divided into two groups and treated with bedtime or awakening doses of potassium losartan. Any patients who had any antihypertension medication at bedtime would withdrawal the drugs for 2 weeks before ABPM. Patients with isolated nocturnal hypertension will be randomly divided into two groups and received a bedtime or awakening dose of potassium losartan.

Eligibility Criteria:
Inclusion Criteria:

* daytime BP \<135/85mmHg，nighttime BP≥120/70mmHg；；
* presence of CKD;
* estimated GFR (eGFR)\<90 mL⁄ min ⁄ 1.73 m2 (using the Modification of Diet in Renal Disease Study equation) but \>30 mL⁄ min ⁄1.73 m2;
* signed informed consent from participating patients.

Exclusion Criteria:

* pregnancy;
* tumor;
* infection;
* renal replacement;
* history of drug or alcohol abuse;
* night- or shift-work employment;
* treatment with steroids or hormonal therapy;
* acute changes in eGFR \>30% in the past 3 months;
* presence of acquired immunodeficiency syndrome;
* CV disorders (unstable angina pectoris, heart failure, life-threatening arrhythmia, atrial fibrillation, kidney failure,and grade III or IV retinopathy);
* intolerance to ambulatory BP monitoring (ABPM);
* inability to communicate and comply with all of the study requirements.
Clinical Evaluation of Polyherbal Coded Formulation Obesecure for Leptin Regulation and Obesity Management

The study was designed to explore an alternative approach to reduce weight in human beings using a polyherbal formulation. A polyherbal formulation named as Obesecure was developed after screening of local medicinal flora. The formulation was further improved after pilot studies and Phase-I Clinical Trials.

Obesity is a common disease of developing countries including Pakistan. Obesity is a risk factor for many diseases which can be life-threatening or making the person unable to perform daily routine work. Obesity is considered a risk factor for different diseases like cardiovascular diseases, hormonal imbalance, infections, malignancies and chest problems. The leptin hormone has appetite suppressing and energy dissipation activity in the body. A screening study on animals was carried out to find out the leptin enhancing medicinal plants from locally available plants in Pakistan. This study was aimed to see the combined effects of the Leptogenic drug Obesecure on weight management.

Patients of age20 to 50 years with BMI more than 25, not taking any anti-obesity drugs one-month prior to start of study were enrolled. The Participants were randomly allocated to receive either Obesecure or placebo twice a day for three months in Shifa-ul-mulk Hospital, PRIEM Health Care Clinic (Pakistan) and Ria Eastern Medicine Clinic (Pakistan).

An acute toxicity study showed no adverse effect of taking Obesecure prior to clinical trials.

Eligibility Criteria:
Inclusion Criteria:

1. Patients of age20 to 50 years with BMI more than 25
2. Only those participants were included who were willing
3. Patients of any marital status were included
4. Only those participants were included who did not take any antiobesity drug one-month prior to start of study

Exclusion Criteria:

1. Taking an anti-obesity drug in the previous month
2. Pregnant
3. Allergic to laxative drugs
4. Recurrent weight gain history after antiobesity treatment
5. Liver disease
6. Taking hormonal therapy, menopausal women
7. Diabetes mellitus
8. Cardiac problem and hypertension
A Study of ANX009 in Adult Participants With Lupus Nephritis

The main purpose of this study is to determine the safety and tolerability of repeat doses of ANX009 in participants with lupus nephritis (LN).

All participants may continue to receive stable background standard of care therapy for LN and systemic lupus erythematosus (SLE) as permitted by the protocol (for example, mycophenolate mofetil \[MMF\], azathioprine, antimalarials, glucocorticoids, cyclosporin, voclosporin, tacrolimus, angiotensin converting enzyme \[ACE\] inhibitors, angiotensin receptor blockers \[ARBs\]).

Eligibility Criteria:
Key Inclusion Criteria:

* Participants who have a diagnosis of SLE according to European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) 2019 Criteria
* Has a history of International Society of Nephrology/Renal Pathology Society (ISN/RPS) Class III or IV with or without Class V glomerulonephritis on renal biopsy within 24 months prior to screening or as performed during screening.
* Has proteinuria level between ≥0.5 to 3.0 grams (g)/g/day assessed via urine protein to creatine ratio (UPCR) during screening.
* Has evidence of classical complement activation at screening
* Has a history of receiving one or more standard therapies for LN

Key Exclusion Criteria:

* Has a history of ISN/RPS Class VI or isolated Class V (without co-existent/predominant Class III or IV glomerulonephritis) glomerulonephritis on renal biopsy.
* Has severe kidney disease defined as eGFR of \<30 milliliters (mL)/minute/1.73 square meter (m\^2) or end-stage renal disease (ESRD) requiring dialysis or kidney transplantation.
* Has a concurrent systemic autoimmune disease that may confound study assessments other than SLE, LN, or cutaneous lupus erythematosus.

NOTE: Other inclusion and/or exclusion criteria may apply.
Delivery Room Skin-to-skin Study

The first hours after birth are a sensitive period for promotion of optimal mother-child-interaction and secure attachment. Maternal sensitivity and responsivness are high in the first hours after birth due to high oxytocin levels. Developing optimal mother-child-interaction is more difficult for preterm mothers because mother and child are separated after birth and the preterm infant is not able to show strong signs to promote maternal sensitivity. We hypothesize that promoting skin-to-skin contact of VLBW infants and their mothers for 60 minutes within the first hours after birth improves mother-child-interaction at 5 to 6 months corrected age. We also hypothesize that reactivity of HPA axis and molecular patterns of stress signaling pathways differ in preterm infant with or without SSC after birth.


Eligibility Criteria:
Inclusion Criteria:

* Birthweight \<1500g, first child, informed consent

Exclusion Criteria:

* Multiples, malformation
School Based Program to Prevent Teen Dating Violence

This study is a school-based cluster randomized trial of the 7th grade version of Fourth R, a promising teen dating violence prevention program, with 24 ethnically diverse middle schools (12 intervention schools, 12 control schools) in one of the nation's largest school districts. Students (N = 3,375) will be the unit of analysis and studied prospectively (baseline, \[post-intervention\], and annually for 3 years) to determine the impact of the program by comparing students in intervention schools with those in control schools.

The prevalence of teen dating violence (TDV), as well as the adverse mental, physical, and relationship health outcomes associated with it, underscores the need for effective TDV prevention programs, of which there are few.

The study will evaluate a new 7th-grade version of Fourth R, which has been rewritten to be developmentally appropriate and correspond to national health standards for this younger age. The 7th-grade version of Fourth R is innovative because it emphasizes socio-emotional learning, includes lessons on mental health, and addresses technology and cyber TDV. These additional components will strengthen the core social-emotional competencies of youth, competencies that are critical for the creation of healthy relationships and avoidance of unhealthy ones. A TDV prevention program aimed at promoting healthy relationships at this developmentally important age holds tremendous promise.

The primary aim is to determine whether Fourth R reduces students' TDV, as indexed by less perpetration and victimization of physical, sexual, and psychological TDV, relative to students in control schools.

The secondary aims are to determine whether Fourth R, relative to control, 1) improves students' \[relationship quality\], emotional well-being, and increases their acquisition and use of healthy relationship skills, as indexed by improved problem-solving, communication, and conflict resolution skills; 2) ameliorates the modifiable cognitive and behavioral correlates associated with the perpetration and victimization of TDV, as indexed by fewer attitudes justifying dating violence, decreased substance use, risky sexual behavior, fighting, and bullying, increased school connectedness, improved academic performance, and decreased psychological symptoms; and \[3) improves school climate as indexed by student, teacher, and staff reports of school environment as it relates to healthy relationships and TDV; and by reductions in school disciplinary actions related to violence, substance use, and academic failure\]. Prespecified differences by gender and ethnicity will be examined, as well as the acquisition and utilization of various program components.

Eligibility Criteria:
Inclusion Criteria:

* Attending 7th grade health class in Houston area middle schools

Exclusion Criteria:

* n/a
Effect of Low-calorie Diet and Orange Juice on Body Weight and Metabolic Parameters of Obese Subjects

This study aimed to verify if combination of a low calorie diet and orange juice consumption results in weight loss and ameliorates metabolic obesity-related biomarkers.

Seventy-eight obese subjects aged 36 ± 1 years and BMI of 33 ± 3 kg were randomly divided into two parallel groups: (1) orange juice (n = 39), composed of individuals subjected to a diet low caloric diet and plus intake of 500 ml orange juice; (2) control (n = 39) composed of individuals subjected to a diet low in calories. The recruitment process began in September 2015, the intervention was carried out from October 2015 to January 2016, and the data analysis started in February 2016. The sample number took into account variances on body weight with a type I error α = 0.05 and a type II error β = 0.2 (80% power). The minimum sample size should have 36 individuals per group (n = 72), considering an approximately 15% dropout rate. Thus, the final sample size of study was constituted by 39 individuals per group (n = 78). Primary and secondary endpoints were the reduction of weight and modification of the levels of obesity-related metabolic biomarkers, respectively. Normality and homogeneity of data were tested. T-test was conducted to identify possible differences between OJ and control groups at baseline. A linear mixed-effects model was apply to determine the time effect within and between groups (post hoc), and P significance was set up ≤ 0.05. The assessment of body composition, metabolic biomarkers and food intake were analyzed over a 12-week intervention.

Eligibility Criteria:
Inclusion Criteria:

* 30 \> BMI \< 40 kg/m2

Exclusion Criteria:

* Dieting last year,
* Use of drugs, vitamins and dietary supplements
* Alcohol consumption (\> 20 g alcohol/d)
* Intense physical activity (\> 5 hours/week).
The Effect of Treadmill Training With Visual Feedback and Rhythmic Auditory Cue on Gait and Balance in Cerebral Palsy

The development of efficient and independent walking is an important therapeutic goal for many children with cerebral palsy (CP). Consequently, there has been growing interest in determining the effects of treadmill training programs for these children.

This study helped to investigates the effect of treadmill training with visual feedback and rhythmic auditory cue (VF+RAC) for walking symmetry and balance ability. Participants were chosen from Sehat medical complex and they were randomly allocated to either the VF+RAC or the Control group. The VF+RAC group received treadmill training with VF and RAC, and the Control group undergo treadmill training without any visual and auditory stimulation. VF+RAC and Control groups was trained five times per week for eight weeks. After eight weeks of training the gait pattern and balance were evaluated by the gait parameters, 6min Walk test, Pediatric Balance Scale and Berg balance scale.

Cerebral palsy is the most common cause of childhood-onset, lifelong physical disability in most countries, affecting about 1 in 500 neonates with an estimated prevalence of 17 million people worldwide. Cerebral palsy is a non-progressive brain injury or lesion acquired during the antenatal, perinatal or early postnatal period. The clinical manifestations of cerebral palsy vary greatly in the type of movement disorder, the degree of functional ability and limitation and the affected parts of the body.

Auditory entrainment can influence gait performance in movement disorders. The entrainment can incite neurophysiological and musculoskeletal changes to enhance motor execution. Biofeedback systems have been extensively used in walking exercises for gait improvement.

Eligibility Criteria:
Inclusion Criteria:

* children having GMF level 1 and 2,
* willing to participate,
* Pediatric subjects Diagnosed with cerebral palsy, receiving Neurodevelopmental
* Rehabilitation program regularly.

Exclusion Criteria

* Child using any sort of auditory aid
* Children with visual limitation,
* Child using orthosis for lower extremity