cyrilzakka/clinical-trials huggingface dataset:
A Study to Evaluate the Safety and Tolerability of Efgartigimod PH20 SC Given by Prefilled Syringe in Kidney Transplant Recipients With Antibody-Mediated Rejection (AMR)

The purpose of this study is to assess the safety, tolerability, and efficacy of efgartigimod PH20 SC given by a prefilled syringe in participants with Antibody-Mediated Rejection (AMR) after kidney transplantation.

After a screening period of up to 6 weeks, eligible participants will be randomized in a 1:1:1 ratio. The study drug will be administered subcutaneously while patients remain on their standard background immunosuppression therapy (tacrolimus, mycophenolate mofetil, steroids) during the treatment period (48 weeks). At the end of the treatment period, the participants will enter an observational/follow-up period (approximately 24 weeks). The participants will be in the study for up to 78 weeks.


Eligibility Criteria:
Inclusion Criteria:

* The participant is within the ages of 18 and 80 years old
* The participant had a kidney transplant (living or deceased donor) at least 6 months before the study
* The participant has received a diagnosis of active or chronic active antibody-mediated rejection (AMR) with detectable donor-specific antibodies at time of the study
* A participant may be allowed into the study if they receive the following medications:

  1. Received mycophenolate mofetil for at least 20 weeks before the study
  2. Has remained on a stable dose of mycophenolate mofetil and tacrolimus for at least 4 weeks before being allowed to participate in the study
  3. Has remained on tacrolimus doses between 5 to 10 ng/mL at least 4 weeks before being allowed to participate in the study
  4. Steroid dose was between 0 to 10 mg per day of prednisone (or dose equivalent) for at least 4 weeks before being allowed to participate in the study

Exclusion Criteria:

* Confirmed T-cell or mixed rejection at time of the study
* Recent change in immunosuppressive therapy agents
* Any other medical condition that, in the investigator's opinion, would interfere with the results of the study or put the participant at undue risk
* Pregnant or lactating state or intention to become pregnant during the study

The complete list of criteria can be found in the protocol
Atacicept Demonstrating Dose RESponSe

Systemic lupus erythematosis (SLE) is an autoimmune disease, meaning that the body's immune system attacks its own organs and tissues. Within the immune system, B-cells and plasma cells make proteins called antibodies, which in autoimmune disease can bind to one's own tissues and are thus referred to as autoantibodies. Atacicept blocks 2 factors in the body, called BLyS and APRIL, which are important for the maintenance of B-cells and plasma cells, and thus the production of antibodies. This study will assess whether treatment with atacicept can reduce SLE disease activity. Atacicept is still an experimental drug, meaning that it is not available outside of a clinical trial, and that its potential benefits and risks have not been fully determined.

A total of 175 subjects are planned to be randomized (35 subjects per treatment arm) in a 1:1:1:1:1 ratio to receive either atacicept 5 mg, atacicept 25 mg, atacicept 75 mg, atacicept 115 mg or matching placebo, given subcutaneously once weekly for 24 weeks.

The primary objective of the trial is to evaluate the efficacy of atacicept compared to placebo in reducing SLE disease activity in subjects treated with standard of care (SoC) therapy and to investigate the dose-response relationship.

The secondary objectives of the trial are:

* To evaluate the effect of atacicept in reducing corticosteroid usage
* To evaluate the safety and tolerability profile of atacicept in subjects with SLE
* To confirm the PK and PD profiles of atacicept in SLE subjects
* To evaluate the changes in the Medical Outcomes Study Short Form General Health Survey \[SF-36\].


Eligibility Criteria:
Inclusion Criteria:

* Male or female of ≥18 years of age
* Written informed consent
* Diagnosis of SLE satisfying at least 4 out of the 11 ACR criteria during the course of their illness
* Disease duration of at least 6 months
* SLEDAI-2K score ≥ 6 at screening
* Positive test results for antinuclear antibody (ANA) (HEp-2 ANA ≥1:80) and/or anti-double-stranded deoxyribonucleic acid (dsDNA) (≥30 IU/mL) at screening
* Negative serum pregnancy test and highly effective method of contraception for woman of childbearing potential.

Exclusion Criteria:

* Increase in dosing of corticosteroids within 2 weeks prior to screening
* Introduction of MMF within 3 months prior to TD1 or increase in dosing within 1 month before screening
* Change in dosing of immunosuppressants or corticosteroids during the screening period
* Serum IgG \< 6g/L
* Estimated Glomerular Filtration Rate (GFR) \<50 mL/min/1.73m²
* Urinary protein:creatinine ratio \>2 mg/mg
* History of demyelinating disease
* Breastfeeding or pregnancy
* Legal or limited legal capacity

Additional exclusion criteria also apply
Studying Patient Experiences in Osteoporosis Clinical Trials

Clinical trials for osteoporosis are designed to assess the safety and effectiveness of novel osteoporosis treatments. These trials play a crucial role in establishing whether these new treatments outperform existing options and provide substantial evidence to support their adoption within the wider population.

The primary aim of this particular study is to investigate the experiences of individuals diagnosed with osteoporosis who participate in a distinct clinical trial involving a medical intervention. The focus will be on closely monitoring the rates of trial completion and withdrawal among these participants.


Eligibility Criteria:
Inclusion Criteria:

* Patient has been diagnosed with osteoporosis
* Patient has self-identified as planning to enroll in an observational clinical trial
* Patient is a minimum of 18 years or older

Exclusion Criteria:

* Pregnant or nursing patients
* Inability to perform regular electronic reporting
* Patient does not understand, sign, and return consent form
An Open-Label Study of Atomoxetine in Children With Attention-Deficit/Hyperactivity Disorder

A single arm, open-label, phase 3 multicenter study to evaluate the effectiveness and tolerability of atomoxetine (given once daily, target dose 1.2 mg/kg/day), as perceived by patients, parents and physicians, and its impact on quality of sleep in children (aged 6 through 11 years) with Attention-Deficit/Hyperactivity Disorder treated as outpatients in Germany. An 8-week treatment phase is followed by a 16-week extension period.


Eligibility Criteria:
Inclusion Criteria:

* Male or female outpatients who are at least 6 years of age and who will not have reached their 12th birthday
* Diagnosis of ADHD
* Normal intelligence

Exclusion Criteria:

* Weigh less than 20 kg or more than 60 kg at study entry
* Other relevant psychiatric diagnoses
* Are at serious suicidal risk as determined by the investigator
* Have a history of severe allergies
* Alcohol or drug abuse within the past 3 months
PHS, Lichtenstein Mesh, and PerFixPlug for Primary Inguinal Hernia Repair - 3 Years Results

Three different techniques for the surgical repair of groin hernias are compared. Focus has been set on operation times, time to full return of functional abilities like walking in stairs etc, and if any technique has more complications than the others. Three years results are presented in the study.

Dissection requirements differ between various methods for inguinal hernia repair, which may effect operation times, pain response and possibly recovery time. The objectives of this study were to establish if any differences concerning these aspects could be detected after three principally different techniques for primary inguinal hernia repair.

472 men between 30 and 75 years with primary inguinal hernias were included in a prospective controlled study and randomised to Lichtenstein mesh (L), PerFix Plug® (P) or the Prolene® Hernia System (PHS) procedure. All patients were seen and data were collected after 2 weeks, 3 months, 1 year, and 3 years.

Eligibility Criteria:
Inclusion Criteria:

* Age 30-75 years
* Men
* Primary inguinal hernia
* ASA I-III

Exclusion Criteria:

* \> 75 years
* Females
* ASA IV
* Previous ipsi-lateral hernia surgery
* Drug or alchol abuse
* Severe illness
China PEACE Million Persons Project

China PEACE Millions Persons Project is a national screening project for cardiovascular disease in China. This Project was approved by National Health and Family Planning Commission (NHFPC), China and founded by Ministry of Finance, China in 2014.

The specific objectives of the project are to:

1. identify subjects at high-risk of CVD and provide counseling for medication and lifestyle improvements
2. evaluate the feasibility of such screening methods for subjects at high risk of CVD, and to assess the effect of health counseling on CVD incidence rates and risk factors control
3. inform future intervention and long-term follow up efforts for primary and secondary CVD prevention in China.


Eligibility Criteria:
Inclusion Criteria:

1. 35 - 75 years old
2. registered in the Hukou of the selected region
3. sign the consent form

Exclusion Criteria:

-
Comparison of Maitland Oscillatory Mobilizations With Kaltenborn Sustained Stretch Mobilizations in Cervicogenic Headache Patients

Cervicogenic headache is a common headache that causes disability and affects everyday activities. Headache related disorders are the second most common reason for years lived with disability all over the world. According to the latest International Headache Society model, cervicogenicheadache (CGH) is a secondary headache having C1-C2 dysfunction. There is marked limitation in cervical ROM specially rotation. Treatment indicated involves use of electrotherapy and thermal modalities. In addition, use of different manual therapy techniques are advocated to eliminate the root cause i.e. C1-C2 dysfunction. Maitland mobilizations for cervical spine have been found to be effective in treating CGH patients. Maitland mobilizations uses oscillatory mobilizations and has four grades. Kaltenborn, on the other hand, applies sustained stretches and has 3 grades.So, the study will be focusing on comparing the effectiveness of these two mobilizations on cervicogenic headache patients.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-45 years
* Both males and females
* Unilateral headache with no shift of side
* C1-C2 dysfunction
* Headache with neck stiffness
* Headache at least once a month in the last 3 months
* Positive flexion rotation test (Rotation restriction is greater than 10 degrees)
* Headache with a score of at least 4 in the Numeric pain rating scale

Exclusion Criteria:

* Cervical spondylosis
* Headache of non-cervical origin
* Dizziness or visual disturbance
* Cervical radiculopathy/ nerve root involvement/ disc herniation
* Cervical instability/ fracture
* Vertebrobasilar insufficiency
* Thoracic outlet syndrome
* Cervical spine surgery
* Cervical spondylolisthesis
* Spinal infection or tumors
* Osteoporosis
* History of trauma
* Metabolic disorders
* Rheumatoid Arthritis
* Inflammatory Arthritis
A First in Human Study of TT5 in Single and Multiple Ascending Doses in Healthy Volunteers and Surgical Patients

This study is a First in Human, three-parts, double-blind, randomized, placebo-controlled, single and multiple ascending dose study. The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of TT5 at different doses in healthy and surgical participants.

The study will be divided into three parts:

Part A: Single Ascending Dose - healthy participants cohorts with up to 5 dose levels.

Part B: Multiple Ascending Doses - healthy participants cohorts with up to 3 dose levels.

Part C: Surgical patients cohorts with up to 3 dose levels.

The primary Objective is to investigate the safety and tolerability of TT5 in single and multiple ascending intravenous doses in healthy participants and in surgical patients.

The Secondary Objectives are To investigate the pharmacokinetics (PK) of TT5 after single and multiple ascending intravenous doses in healthy participants and after intravenous doses in surgical patients.

* To investigate the acute and chronic psychological subjective response of the healthy participants and surgical patients to TT5
* To assess the pharmacodynamics (PD) of TT5 after intravenous doses in surgical patients. Exploratory Objectives areto explore potential fluid biomarkers for TT5

Eligibility Criteria:
Main inclusion criteria for Parts A and B:

* Non-smoker for the confinement period of the study.
* Medically healthy and without clinically significant abnormalities.
* Negative screen for alcohol and drugs of abuse.
* No history of psychiatric disorders.
* Female participants of non-childbearing potential must be post-menopausal or surgically sterile at least 3 months prior to dosing.
* Sexually active females of childbearing potential and non-sterile males must be willing to use an acceptable contraceptive method throughout the study.
* Able to understand the study procedures and provide signed informed consent to participate in the study in English.

Main exclusion criteria for Parts A and B:

* History of clinically significant asthma, anaphylaxis, major medical, psychiatric illness or surgery.
* Acute or chronic clinically relevant systemic disease or disorder.
* Renal insufficiency
* History of drug or alcohol consumption abuse.
* Drinking excessive amounts of tea, coffee, chocolate and/or beverage containing caffeine.
* Have used any investigational drug or participated in any clinical trial within 4 weeks prior to screening.
* Unable to refrain from strenuous exercise.
* Participant who has received blood or plasma derivatives, who had a surgery or who has given blood within 4 weeks prior to the screening visit or has planned to give blood or sperm within the 90 days following the study.
* Pregnant or lactating female participant.
7 NUTS Study. Diet Modification and Male Fertility.

Setting. Outpatient fertility clinic.

Aim. Investigate if a modification in nutritional habits may improve in the short term the qualities of human sperm, testing two hypothesis:

i) that adding to the diet a natural whole food rich in polyunsaturated fatty acids (PUFA)

OR

ii) that reducing the intake of saturated fatty acids and increasing the consumption of PUFA may affect beneficially sperm parameters.

Population. N. 100 hypofertile male subjects attending a fertility clinic.

Type of study. Interventional study. No drugs or pharmacologic supplementation will be required nor allowed.

Two different type of intervention are scheduled:

* Supplementation to western style diet with nuts, naturally rich in PUFA
* Diet modification increasing intake of PUFA-rich foods and cutting the consumption of food rich in saturated fats.

Protocol

* Baseline visit and recruiting.
* Informed consent
* Randomized allocation to treatment group in a 1: 1 manner

Blinding. Investigators deputed to sperm analysis and statistician are blinded as to type of intervention.

Phases:

* i) basal
* ii) after 15 weeks That interval is chosen because encompasses an entire spermatogenesis cycle.

Outcomes. Primary

* sperm count, concentration,morphology and mobility.

Secondary:

* serum folate assay,
* plasma PUFA (ALA, EPA, DHA) assay,
* body weight and BMI variation

Statistics. A comparison for all sperm parameters (count,concentration,morphologic abnormalities, mobility) will be carried out by an analysis within groups and within patient.

The planned trial is nutritional based only, with a modification of diet in order to obtain an increase of PUFA intake with/without a reduction of saturated fatty acid intake.

Two different types of intervention are scheduled:

* Supplementation to western style diet with food naturally rich in PUFA
* Diet modification, increasing intake of PUFA naturally rich foods and cutting the consumption of saturated fats.

The supplementation is obtained adding 7 nuts a day to regular diet. The diet modification is obtained by increasing intake of nuts and seeds (walnuts, hazelnuts, almonds, peanuts, sesame, sunflower, flaxseed) and derived oils, fish and vegetables; cutting the consumption of processed meat and dairy products is required as well.

The type of diet or supplementation is supported by oral and written information. The compliance to diet will be followed by administration of validated questionnaires.

The effect of the diet modifications will be followed by a number of plasma biomarkers we plan to compare at baseline and post intervention. The body weight and BMI will be checked, as both types of intervention are intended to not affect significantly mean body weight.

Eligibility Criteria:
Inclusion Criteria:

* sperm concentration \> 5.000.000 ml
* progressive motile forms \< 35%
* BMI \< 30
* normal FSH (Follicle Stimulating Hormone reference values 1-10 IU)

Exclusion Criteria:

* allergy to nuts or seeds
* clinical varicocele
* recent surgery for varicocele
* vasectomy
Colchicine and Post-COVID-19 Pulmonary Fibrosis

Pulmonary fibrosis is a sequela to adult respiratory distress syndrome (ARDS). 40% of patients with corona virus disease 2019 (COVID-19) develop ARDS, and 20% of them are severe. Clinical, radiographic, and autopsy reports of pulmonary fibrosis were commonplace following SARS and MERS, and current evidence suggests pulmonary fibrosis could complicate infection by SARS-CoV-2 too. Colchicine has a direct anti-inflammatory effect by inhibiting the synthesis of tumor necrosis factor alpha and IL-6, monocyte migration, and the secretion of matrix metalloproteinase-9. It suppress secretion of cytokines and chemokines as well as in vitro platelet aggregation. All these are potentially beneficial effects that might diminish the COVID-19 inflammatory storm associated with severe cases.

Approximately 96 million people have been diagnosed with severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), and around two million people have died from this deadly disease worldwide. The pulmonary symptoms associated with SARS-CoV-2 vary from mild respiratory symptoms to severe respiratory failure. Of those infected with SARS-CoV-2, 40% will progress to ARDS.

Radiologically, most of those infected by SARS COV 2 have bilateral lower lobes ground-glass opacities with or without consolidation. However, long term lung impairment may develop particularly interstitial lung disease (ILD), the fibrotic type. Besides, pulmonary fibrosis (PF) is recognized sequelae of ARDS, and several studies have shown that protective lung ventilation tends to diminish the radiographic abnormalities following ARDS.

Colchicine has anti-fibrotic effects as a microtubule-destabilizing agent. In an in vitro study using human lung fibroblasts, colchicine inhibited myofibroblast differentiation via Rho/serum response factor (SRF) dependent. In COVID19 cases, colchicine was used by where they assessed its impact on the inflammatory biomarkers and clinical outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are confirmed to have COVID-19 clinically, radiologically and PCR
* Age above 18 years old
* Informed written consent

Exclusion Criteria:

* History of hypersensitivity to colchicine
* Pregnancy or breastfeeding women.
* Patients with severe renal impairment (creatinine clearance (CCL) \<30 mL / min)
* Patients with severe hepatic impairment (AST or ALT\> 5 times the normal limits in International Units (ULN)
* Patients with blood dyscrasias, neutrophils \<1.000 / mmc or platelets \<50.000 / mmc
* Patients with history of severe cardiac insufficiency
* Patients with history of pulmonary fibrosis
* Severe diarrhoea or bowel diverticulitis, or perforation
* Patients who cannot take oral therapy
* Patients already in ICU or requiring mechanical ventilation
* Patients already enrolled in other clinical trials
* Patients with taking P-glycoprotein inhibitor (e.g. ciclosporin, verapamil or quinidine) or a CYP3A4 inhibitor (e.g. ritonavir, remdesivir, atazanavir, indinavir, clarithromycin, telithromycin, itraconazole or ketaconazole) or Tocilizumab
Psychological and Psychosocial Intervention With War-Affected Children

The investigators are interested in knowing whether a group-based, trauma-focused intervention (Trauma Focused Cognitive Behavioral Therapy) is superior to a more general, non trauma-focused, psychosocial intervention (Child Friendly Spaces) in reducing post-traumatic stress, depression and anxiety and conduct problems and increasing pro-social behavior among war-affected children in the Democratic Republic of Congo.


Eligibility Criteria:
Inclusion Criteria:

* under 18 years of age,
* witness to a violent event involving a real or perceived direct threat to life,
* ability to attend a 3-week intervention

Exclusion Criteria:

* psychosis,
* mental retardation,
* inability to understand Swahili,
* severe emotional \& behavioral problems that made group participation impossible
Pain and Discomfort With Anterior Versus Posterior Builds-up

Orthodontic build-ups are made by composite/resin material bonded to the palatal or occlusal surfaces of teeth (usually molars or incisors). Their primary purpose is to prevent heavy contact of the upper teeth with lower fixed appliances in patients with overbite reduction to avoid brackets detachment. These appliances disarticulate the posterior teeth, deprogram the masticatory muscles and allow for eruption, extrusion, and uprighting of the posterior teeth. Build-ups are usually placed in the first months of the fixed orthodontic treatment and contribute to increasing the perception of pain. In the orthodontic daily practice, the pain is the most frequent symptom during treatment and is the one that most frightens/worries the patients. Literature shows that fear of pain is one of the primary reasons that patients fail to seek orthodontic care. Pain has a negative effect on patients' compliance, oral hygiene, and missed appointments. Its effects on patients' daily lives is a major reason for discontinuance of orthodontic treatment.

In the literature the prevention of pain and management of orthodontic builds-ups is a poorly analyzed topic, despite being a daily problem in orthodontic clinical practice. So, the aim of the present study is to investigate and analyze the perception of pain and function impairment with different type of build-ups (anterior or posterior) to identify an efficient clinical management protocol and an effective pain and discomfort prevention strategy.


Eligibility Criteria:
Inclusion Criteria:

* Patient with reduced overbite treated with orthodontic fixed appliance
* Angle Class I, Class II or Class III malocclusion

Exclusion Criteria:

* Hypodontia in any quadrant excluding third molars
* Craniofacial syndromes, or cleft lip or palate