cyrilzakka/clinical-trials huggingface dataset:
Growth Arrest in Focal Dermal Hypoplasia

Focal dermal hypoplasia (FDH) is a rare genetic disorder of ectodermal dysplasia caused by mutation in the Porcupine Homolog (Drosophila) (PORCN) gene which results in skin, hair, limb and eye abnormalities. Short stature and underweight have been noted in the majority of these patients. Since the pituitary gland arises from ectodermal tissue, the investigators suspect that pituitary deficiencies may contribute to poor linear growth. This study will examine the nutritional, gastrointestinal and endocrine mechanisms that may account for linear growth stunting and low weight that is observed in FDH. The investigators will utilize standard clinical tools including a bone age xray, glucagon stimulation test to evaluate growth hormone status, baseline laboratory analysis of hormone and nutritional/gastrointestinal markers, food diaries, symptom diaries, and growth charts.

Focal dermal hypoplasia (FDH) is a rare genetic disorder of ectodermal dysplasia caused by mutation in the Porcupine Homolog (Drosophila) (PORCN) gene which results in skin, hair, limb and eye abnormalities. Short stature and underweight have been noted in the majority of these patients. Since the pituitary gland arises from ectodermal tissue, the investigators suspect that pituitary deficiencies may contribute to poor linear growth. This study will examine the nutritional, gastrointestinal and endocrine mechanisms that may account for linear growth stunting and low weight that is observed in FDH. The investigators will utilize standard clinical tools including a bone age xray, glucagon stimulation test to evaluate growth hormone status, baseline laboratory analysis of hormone and nutritional/gastrointestinal markers, food diaries, symptom diaries, and growth charts.

Eligibility Criteria:
Inclusion Criteria:

* patients with focal dermal hypoplasia
* between the ages of 3 and 18 years
* ability to fast overnight, and
* weight at least 9 kg

Exclusion Criteria:

* pregnant individuals,
* weight less than 9 kg
Safety and Efficacy Study of Fostamatinib to Treat Immunoglobin A (IgA) Nephropathy

The purpose of this study is to determine whether fostamatinib is safe and effective in the treatment of IgA Nephropathy


Eligibility Criteria:
Inclusion Criteria:

* Renal biopsy findings consistent with IgA nephropathy
* Treatment with an Angiotensin Converting Enzyme inhibitor (ACEi) and/or an Angiotensin II Receptor Blocker (ARB) for at least 90 days at the maximum approved (or tolerated) dose
* Proteinuria \> 1 gm/day at diagnosis of IgA nephropathy and Proteinuria \> 0.50 gm/day at the second Screening Visit
* Blood pressure controlled to ≤ 130/80 with angiotensin blockade with or without other anti-hypertensive agents

Exclusion Criteria:

* Recent use of cyclophosphamide, mycophenolate mofetil, azathioprine, or Rituximab.
* Use of \> 15 mg/day prednisone (or other corticosteroid equivalent).
Convalescent Plasma as Treatment for Acute Coronavirus Disease (COVID-19)

There is currently no effective treatment for COVID-19 except best supportive care. The aim is assess the safety, tolerability and efficacy of convalescent plasma for treatment of patients with varying degrees of COVID-19 illness.

Convalescent plasma has been shown to be safe and effective for treatment of several diseases. Preliminary data indicates that it is safe and effective for treatment of COVID-19. However, data is limited to small studies and case series on severely ill patients. The proposed study assesses the safety and efficacy earlier in the course of illness, in slightly less severe patients with the possibility of detecting less severe adverse events and the potential for early treatment to hinder the development of severe disease. Plasma is collected from consenting donors who have recovered from SARS-CoV-2.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 and \<81 years
* Active COVID-19 defined as symptoms + SARS CoV-2 identified from upper or lower airway samples
* Fever ≥38.5C, admitted to a study hospital, hypoxemia defined as having a peripheral oxygen saturation below 93% (measured by pulse oximetry) and a breathing rate of \>20 breaths per minute without supplemental oxygen treatment
* A negative pregnancy test taken before inclusion and use of an acceptable effective method of contraception until treatment discontinuation if the participant is a woman of childbearing potential
* Written informed consent after meeting with a study physician and ability and willingness to complete follow up.

Exclusion Criteria:

* No matching plasma donor (exact matching in both the ABO system and the Rh system is required)
* Unavailability of plasma
* Significant growth of alternative lower airway pathogen such as Streptococcus pneumoniae or Haemophilus influenzae in sputum
* Disease duration \>8 Days
* Estimated glomerular filtration rate \<60 (kidney failure stage III or more)
* Pregnancy (urinary-hcg), breast feeding,
* History of severe allergic reactions
* Inability to give informed consent
* Significantly compromised immunity.\*

  * Compromised immunity includes but is not limited to treatment with major immunosuppressive agents including high dose corticosteroids, anti-tumor necrosis factor (TNF) agents, calcineurin inhibitors, mTOR inhibitors, lymphocyte depleting biological agents, chemotherapeutic anti neoplastic agents. Also patients with advanced HIV/AIDS, severe immunodeficiency such as hypoglobulinemia, decompensated liver cirrhosis and bone marrow transplant the last year will be excluded.
Effect of Preoperative Exercise Habits on Knee Function and Recurrence Rate After Anterior Cruciate Ligament Reconstruction

The aim of this study is to compare the knee function between patients with and without preoperative exercise habits at 1, 2 and 5 years after ACL surgery, and further analyze the effect of maintaining exercise habits on knee function and recurrence rate

Objective:

1. To compare the knee function between active and inactive patients at 1, 2, and 5 years after ACL surgery.
2. To investigate the difference of knee function and recurrence rate between patients with and without postoperative exercise habit.

Methods: This is a single-center, controlled follow-up cohort study. Inclusion criteria included patients aged 18-45 years with confirmed ACL injury who were scheduled to undergo ACL reconstruction surgery. Exercise habits were recorded before operation, and knee joint function and exercise level were evaluated by questionnaires. All patients received standardized ACL reconstruction surgery and rehabilitation program after surgery. In prospective cohort study, 121 patients were divided into running group and non-running group according to their preoperative exercise habits. At 3 months after surgery, running was included in the rehabilitation program, and the patients were further divided into postoperative running and non-running groups and followed up for one year.In Postoperative cohort study， follow-up was collected and evaluated at 1 year, 2 years and 5 years, including knee function, exercise level and recurrence. The study was divided into four groups: preoperative running group , preoperative non-running group , preoperative and postoperative running group and preoperative non-running and postoperative running group to analyze the effects of preoperative and postoperative exercise habits on knee joint function and recurrence rate. The results of this study will help to deepen the understanding of the impact of preoperative exercise habits and postoperative exercise maintenance on knee function and recurrence rate after ACL reconstruction, and then provide guidance for clinical practice, optimize postoperative rehabilitation programs, and ultimately improve the quality of life of patients.

Subjects: Patients with anterior cruciate ligament rupture in Department of Sports Medicine, Peking University Third Hospital 1.1.1 Inclusion criteria

1. Age of 18-45 years old, male or female.
2. Patients were diagnosed with anterior cruciate ligament injury and planned to undergo anterior cruciate ligament reconstruction surgery 1.1.2 Exclusion criteria Presence of other severe knee disorders (e.g., arthritis).

   * Prior history of other knee surgeries
   * Inability to complete a postoperative rehabilitation program or long-term follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Patients with anterior cruciate ligament rupture in Department of Sports Medicine, Peking University Third Hospital

Exclusion Criteria:

* Severe other knee disorders (e.g., arthritis) are present.
* Prior history of other knee surgeries
* Inability to complete a postoperative rehabilitation program or long-term follow-up
Awareness of Climate Change Impacts Among University Students

This study evaluates college students' awareness of climate change and its effects on the environment through a questionnaire.


Eligibility Criteria:
Inclusion Criteria:

* All the university students are eligible to participate in the study

Exclusion Criteria:

-
Biofeedback With Cycling Exercise in OA Knee Patients

Osteoarthritis (OA) is one of the most common joint diseases causing pain, muscle weakness and disability in older population. Quadriceps muscle weakness is one of the recognized risk factors for the development and the progression of the disease. Increasing the muscle strength could actually bring many benefits to the knee OA patients. The purposes of this study are 1) to investigate the effects of combining the EMG biofeedback technique into a stationary cycling exercise on the activities of vastus medialis (VM) in people with medial compartment knee OA; 2) To investigate the efficiency of a 6-week cycling exercise program on improving of quadriceps muscle strength and endurance, physical functions and pain in these patients and compare between the conditions of with or without EMG biofeedback; 3) To determine the relationships between the muscle activities and the kinematics of the knee joint during this cycling exercise program; and therefore to find the mechanism of the improvement on muscle activities in the intervention of cycling combining EMG biofeedback. In this study, we will enroll the knee OA patients from our hospital, and they will be randomly assigned either to the control group, who will cycle without biofeedback, or the biofeedback group, who will cycle with a real-time visual EMG biofeedback, during the six-week training program. The exercise program consisted of a 5-minute warm-up with low-resistance cycling, 30-minute moderate-resistance cycling exercise, and 5-minute cool down session. . The knee adduction angle, quadriceps strength and endurance, KOOS Chinese version, VAS scale will also be measured at baseline and after six weeks of intervention. Mixed-model repeated measure analysis of variance (ANOVA) will be used to determine if there are any differences in the kinematic, myoelectric, muscle strength and endurance. It is hoped that the results of this study could provide information regarding the proper and efficient training strategy for the OA knee patients, and deliver the concepts of proper exercise technique to enhance health in the community.


Eligibility Criteria:
Inclusion Criteria:

* the OA knee patients are those who had medial compartment tibiofemoral osteoarthritis in either one or both of their knees, had at least a grade 2 on the Kellgren-Lawrence score, which was verified with radiographs and a diagnosis by a physician

Exclusion Criteria:

* if the participant had been diagnosed with OA in the hip or ankle joints, had a lower extremity joint replacement, had knee joint arthroscopic surgery or intra-articular injections within 3 months prior to testing, had systemic inflammatory arthritis such as rheumatoid or psoriatic arthritis, had lower back pain that referred to the lower limbs, or those who had cardiovascular disease or other risk factor which precluded participation in aerobic exercise
Brief Mindfulness Intervention for Pain Before an In-clinic Orthopedic Procedure

This project is a single-site, randomized controlled trial designed to investigate the impact of a 7-minute mindfulness intervention on pain among patients undergoing kyphoplasty or radiofrequency ablation.


Eligibility Criteria:
Inclusion Criteria:

* Undergoing Kyphoplasty or Radiofrequency Ablation at Tallahassee Orthopedic Center
* Fluency with English
* Being 18 and above

Exclusion Criteria:

* Unable to consent because of physical or mental incapacity.
Precision Medicine for Every Child With Cancer

To improve outcomes for childhood cancer patients through the implementation of precision medicine.

Through the pilot TARGET and national PRISM trials the feasibility and benefits of using comprehensive molecular profiling and preclinical drug testing in real time for high-risk (HR) patients has been demonstrated. However, the role of precision medicine, especially in facilitating diagnosis and risk stratification in non-HR childhood cancers has not been studied. Integrative tumor-germline whole genome sequencing (WGS) analysis has the potential to advance our understanding of cancer predisposition. In this study, the ZERO platform will be extended to all children with cancer in Australia and New Zealand, evaluating the benefits of precision medicine in different childhood cancer types and risk groups.

Eligibility Criteria:
Inclusion Criteria:

1. Age \< 18 years Note: Individual patients aged 19 - 25 years old with a pediatric cancer, e.g., neuroblastoma, may be enrolled after discussion with, and at the discretion of, the Study Chair or their delegate.
2. Life expectancy \>6 weeks at time of enrolment
3. Consent i. Signed and dated informed consent for study enrolment from participant aged ≥ 18 years or from parent/guardian of participant aged \<18 years. ii. Separate signed and dated informed consent for understanding the role of germline testing and choice for the return of germline results.
Airway Collapse in Patients With Mounier-Kuhn Syndrome: Titration With Positive Pressure to Reduce Collapse

Mounier-Kuhn syndrome (MKS), or congenital tracheobronchiomegaly, is an entity characterized by dilation of the trachea and bronchi, associated with respiratory infections.The main signs and symptoms are cough, bulging and purulent expectoration, digital clubbing, dyspnoea, and wheezing.Some of these symptoms are believed to be due to excessive collapse of the intra-thoracic trachea and bronchi, resulting in airways obstruction of more than 50% . The purpose of this study is to identify and reduce tracheal collapse.

Mounier-Kuhn syndrome (MKS), or congenital tracheobronchiomegaly, is an entity characterized by dilation of the trachea and bronchi, associated with respiratory infections. The prevalence among patients with respiratory symptoms is 0.4 to 1.6%. Its histological features include the atrophy or absence of longitudinal elastic fibers and smooth muscle cells of the airways, responsible for the structural alterations found, such as tracheobronchiomegaly, the presence of inter cartilaginous diverticula, bulging and dilation of the walls of the trachea and bronchi. The main signs and symptoms are cough, bulging and purulent expectoration, digital clubbing, dyspnoea, and wheezing and wheezing accompanied by recurrent respiratory infection. There may be association with other comorbidities such as gastroesophageal reflux disease, chronic obstructive pulmonary disease, bronchiectasis and obstructive sleep apnea / hypopnea syndrome (OSAS). Some of these symptoms are believed to be due to the tracheobronchial disease present in some patients, defined by excessive collapse of the intrathoracic trachea and bronchi resulting in airways obstruction of more than 50%. The main clinical impact is obstruction to expiratory airflow, with consequent air entrapment, reduction of cough and bronchial hygiene effectiveness, facilitating recurrent respiratory infections. Because it is a rare morbidity and little studied, the specific therapy is not consensual, and the main interventions are extrapolated from other pathologies. The use of non invasive mechanical ventilation (NIMV) with continuous positive airway pressure (CPAP) is reported as an option for treatment, however, there are no randomized studies proving its efficacy. The purpose of this study is to identify and reduce tracheal collapse and bronchi of SMK carriers with the use of positive pressure (CPAP-NIV) and to analyse their repercussion in the small airways.

Eligibility Criteria:
Inclusion Criteria:

* Has Mounier-Khun Syndrome
* Accept and signed informed consent form

Exclusion Criteria:

* Other morbidity avoiding study procedures
Study on the Application of Convenient Foot-control Exhaust Method in Endoscopic Thyroidectomy

Endoscopic thyroidectomy developed rapidly in recent years, and the most popular surgical approach was endoscopic thyroidectomy by bilateral areola approach, but some operative steps was required optimization. One of the most annoying problem was the smog blurring endoscopic lens during surgery. The researcher summarized a set of convenient foot-control exhaust method and carried out this prospective study.

The patients with papillary thyroid microcarcinoma were included according to the inclusive criteria and randomly divided them into two groups (foot-control exhaust group and direct exhaust group). The foot-control exhaust group used the foot-control exhaust method by the way of adjustable Pressure to intermittent exhaust, while direct exhaust group exhaust through the Trocar hole. Comparison of operation time, times of wiping the endoscopic lens, volume of postoperative drainage, and number of identified parathyroid gland between two groups.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with maximum tumor diameter ≤1 cm;
2. patients without lateral neck lymph node metastases;
3. patients without distant metastases;
4. patients who only needed unilateral surgery following the guidelines;
5. patients with strong cosmetic requirement.

Exclusion criteria:

1. Patients with maximum tumor diameter \>1 cm;
2. patients who needed complement total thyroidectomy according to the guidelines, including tumor extrathyroidal extension as well as large amount of neck lymph node metastases and distant metastases;
3. patients without cosmetic requirements.
Efficacy and Safety Study of SBG vs Placebo in Head and Neck Cancer Patients Undergoing Radiation Therapy

The purpose of this study is to evaluate the efficacy and safety of SBG vs placebo on oral mucositis in head and neck cancer patients undergoing radiation therapy.

The objective of the study is to evaluate the efficacy and safety of soluble beta-1,3/1,6-glucan (SBG) on oral mucositis compared to placebo in head and neck cancer patients undergoing radiation therapy with or without chemotherapy.

Eligibility Criteria:
* Patients with a normal oral mucosa who is scheduled to receive radiation therapy for their head and neck cancer will be enrolled into the study.
* Patients with previous head and neck cancer and/or radiation therapy in the head and neck area and history/clinical evidence of active significant acute or chronic conditions that may compromise the ability to evaluate or interpret the effects of the study treatment on mucositis will be excluded.
Exercise to Restore 24h Rhythms in Metabolism

This study will investigate the effect of exercise training on 24h rhythms in substrate metabolism in overweight subjects with impaired glucose tolerance. Subjects will perform exercise training for 12 weeks. Before and after the exercise period, they will be admitted to research facilities for 45 hours to assess 24h rhythms in substrate metabolism. In a single-arm longitudinal design, subjects will serve as their own control.

Recent evidence shows that pre-diabetes is characterized by marked alterations in 24h substrate metabolism, indicating metabolic inflexibility with an inability to fully switch to fat oxidation during the night. Whereas exercise has been shown to promote mitochondrial function and insulin sensitivity, it is unknown to if exercise training is able to restore 24h rhythmicity in overall substrate metabolism and muscle metabolism in human subjects with pre-diabetes.

In this single-arm longitudinal design, subjects will serve as their own control. Subjects will perform high-intensity interval training for 12 weeks (3x times per week) on a cycle ergometer at the research facility. Pre and post exercise, subjects will stay in a metabolic chamber and adhere to a relatively normal life-style in order to standardize the main 24h measurement period. As the primary outcome, substrate metabolism will be measured with a ventilated hood system and by indirect calorimetry in the chambers. Muscle biopsies from the vastus lateralis and frequent blood samples will also be taken over the course of the 24h. Thereby, ex-vivo skeletal muscle mitochondrial function and muscle clock gene expression will serve as the main secondary outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Caucasian
* Healthy (as determined by dependent physician)
* Overweight: BMI 25 - 35 kg/m2
* Prediabetic based on one or a combination of the following criteria:

  * Impaired Glucose Tolerance (IGT): plasma glucose values ≥ 7.8 mmol/l and ≤ 11.1 mmol/l 120 minutes after glucose drink consumption during OGTT in screening.
  * Impaired Fasting Glucose (IFG): Fasting plasma glucose ≥ 6.1 mmol/l and ≤ 6.9 mmol/l.
  * Insulin Resistance: glucose clearance rate ≤ 360ml/kg/min, as determined using the OGIS120 model.
  * HbA1c of 5.7-6.4%.
* Regular sleeping time (normally 7 - 9h daily)
* Stable dietary habits: no weight gain or loss \> 3kg in the last three months.

Exclusion Criteria:

* Use of anticoagulants
* Previously diagnosed with type 2 diabetes
* Current alcohol consumption \> 20 grams alcohol/day
* Extreme early bird or extreme night person (score ≤ 30 or ≥ 70 on MEQ-SA questionnaire)
* Heavily varying sleep-wake rhythm
* Nightshift work during last 3 months
* Travel across \> 1 time zone in the last 3 months
* Significant food allergies/intolerance (seriously hampering study meals)
* Using \> 400mg caffeine daily (more than 4 coffee or energy drink)
* Smoking
Grazoprevir (MK-5172) With Peg-Interferon and Ribavirin in Participants With Chronic Genotype 2 or 3 Hepatitis C (MK-5172-012)

This study will evaluate the safety, tolerability, and antiviral activity of grazoprevir (MK-5172) when administered concomitantly with peg-interferon alfa-2b (Peg-IFN) and ribavirin (RBV) to treatment-naïve participants with chronic genotype 2 (GT2) or genotype 3 (GT3) hepatitis C virus (HCV) infections.


Eligibility Criteria:
Inclusion Criteria:

* Body weight ≥ 88 lbs and ≤ 275 lbs
* Documented chronic Hepatitis C (CHC) GT2 or GT3 infection
* No known cirrhosis
* Agrees to use two acceptable methods of birth control during study and through 6 months after last dose of study drug
* Chest X-ray within the last 6 months
* Eye exam within the last 6 months

Exclusion Criteria:

* Known to be human immunodeficiency virus (HIV) positive or co-infected with active hepatitis B virus (positive for Hepatitis B surface antigen)
* Prior approved or investigational treatment for hepatitis C
* Evidence of hepatocellular carcinoma
* Diabetic and/or high blood pressure with clinically significant eye exam findings
* Pre-existing psychiatric condition
* Clinical diagnosis of abuse of certain substances within specified timeframes
* Known medical condition that could interfere with participation
* Active or suspected cancer within the last 5 years
* Female who is pregnant, breastfeeding, or expecting to conceive or donate eggs
* Male who is planning to impregnate partner or donate sperm
* Male with a pregnant female partner
* Chronic hepatitis not caused by HCV