cyrilzakka/clinical-trials huggingface dataset:
Illizarov Fixation in Open Type III (A&B) Pediatric and Adolescent Tibial Shaft Fractures

The Ilizarov method is our usual treatment of choice for open, complex, physeal or unstable fractures and for patients in whom non-operative or other treatments have failed .

Tibial fractures are the third most common injury involving a long bone in children. Most occur in the distal third, and approximately 10% are open.High-energy injuries with soft tissue compromise or segmental bone loss, present specific challenges. There is a significant risk of nonunion (7.5%),malunion (17%),infection (10%),and loss of reduction (32%).Many forms of treatment are available including a cast, elastic nailing, and external fixation using either a monolateral fixator, or a circular frame . In complex adult tibial fractures, evidence for the effectiveness of definitive external fixation using a circular frame continues to emerge.Fixators may be used for the correction of tibial deformities in children.Currently, only relatively small case series have been published describing their use for trauma in children and adolescents, albeit with good results.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 8-16 years old.
* Diagnosed to have open grade IIIA and IIIB tibial fracture according to Gustilo-Anderson fracture classification system.
* Fractures of the shaft of the tibia or distal tibial fractures involving the ankle joint and were complicated by bone and/or soft-tissue loss of more than 3 cm.
* An external fixator could be placed in the proximal lower extremity, distal lower extremity, or foot, and normal bone segments available for osteotomy.
* Admitted in the duration between 1st of January 2022 until end of December 2023.

Exclusion Criteria:

* Patients requiring free flap or local flap transfer to close the wound.
* Open grade IIIC tibial fractures (with vascular injury).
* Loss to follow-up.
Study of FORTEO Use in Subjects in the Community Setting

The purpose of this study is to evaluate the long-term effectiveness, safety, and tolerability of FORTEO in a larger, more diverse "real world" population than studied in clinical trials

Subjects will be followed through a course of FORTEO therapy for up to 24 months and for an additional 24 months after FORTEO treatment is stopped. Subjects may participate in this study for up to 48 months. All aspects of patient care, including diagnostic and therapeutic interventions, will be chosen and conducted at the discretion of the participating study physician according to their clinical judgment and the local standard of medical care.

Eligibility Criteria:
Inclusion Criteria:

* Men and women who are judged by the study physician to be suitable for FORTEO therapy. The FORTEO product labeling specifies those individuals diagnosed with osteoporosis who are considered to be at high risk for fracture

Exclusion Criteria:

* Subjects who have an increased baseline risk for osteosarcoma. These include Paget's disease of bone, pediatric populations and young adult patients with open epiphyses, prior external beam or implant radiation therapy involving the skeleton
* Subjects who have administered FORTEO or PTH therapy for more than two weeks directly before study entry
* Subjects who have completed a course of FORTEO or PTH therapy of at least 18 months duration before study entry
A Study of TH-SC01 in the Treatment of Radiation-induced Rectal Injury

The purpose of this study is to evaluate the efficacy and safety of allogeneic umbilical cord mesenchymal stem cells in the treatment of radiation-induced rectal injury.

radiation-induced rectal injury (RRI) is a common clinical disease. The symptoms of RRI often include: Abdominal pain, diarrhea, hematochezia, etc., especially chronic radiation-induced late rectal injury (RLRI), are easy to cause the disease to prolong and not heal. Some patients will have severe complications such as massive rectal bleeding, rectal stenosis, intestinal obstruction, deep ulcer, intestinal perforation, and fistula formation after the disease progresses to the advanced stage, most of which occur 2-5 years after the end of radiotherapy. The incidence of radiation rectal injury is high, which has a serious impact on the health and quality of life of patients. Currently, the commonly used treatment methods include non-steroidal anti-inflammatory drugs, mucosal protective agents, hemostatic agents, compound enema preparations, hyperbaric oxygen, surgical treatment, etc., but there is still no standard treatment strategy and effective plan, and clinical treatment is extremely difficult.

Mesenchymal stem cells have the properties of proliferation, differentiation, immune regulation and angiogenesis. There are few clinical studies on the use of mesenchymal stem cells in the treatment of radiation-induced rectal injury. Good therapeutic effect was achieved in vivo and in vitro in the preliminary experiment. The aim of this study was to verify the safety and efficacy of allogeneic mesenchymal stem cells from healthy donors in RRI patients.

Primary objective: To assess the safety (incidence of treatment emergent adverse-events) of TH-SC01.

Eligibility Criteria:
Inclusion Criteria:

1. Fully understand and sign the informed consent form;
2. Age ≥18 years and \<80 years;
3. Patients diagnosed with chronic radiation rectal injury after radiation therapy;
4. Patients with LENT-SOMA scale score ≥1;
5. Good physical condition (WHO functional status score 0-1).

Exclusion Criteria:

1. The patient had severe liver and kidney disease;
2. Severe congestive heart failure or coronary heart disease;
3. Patients have allergic constitutions or severe systemic immune diseases;
4. The patient had active gastrointestinal hemorrhage or acute intestinal obstruction;
5. Patients were pregnant or had other conditions that the investigators deemed unsuitable for inclusion in the study.
Randomized Trial Comparing Robotic and Open Radical Cystectomy

The purpose of this study is to determine if using robotic surgical technology during bladder cancer surgery helps to reduce complications during and after the surgery. The removal of the bladder and lymph nodes will be done by a robotic or by an open technique. It may be a Robotic-assisted Radical Cystectomy (RARC) and Pelvic Lymph Node Dissection. Or it may be an Open Radical Cystectomy (ORC) and Pelvic Lymph Node Dissection.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years.
* Scheduled for radical cystectomy at MSKCC

Exclusion Criteria:

* Prior pelvic or abdominal radiation therapy;
* Prior extensive open abdominal surgery, defined by the discretion of the attending surgeon
* Any clinical contraindication for Trendelenburg positioning
Endobronchial Ultrasound Guided Transbronchial Lung Biopsy With or Without Guide Sheath in Lung Tumors and the Analysis of Echoic Patterns of Lung Tumors and Mediastinal Lymph Nodes, and the Association Between Diagnostic Yield of Transbronchial Lung Biopsy and EBUS Echoic Features.

1. Endobronchial ultrasonography (EBUS) is useful in localizing peripheral lung lesions. The EBUS, further combined with the guide sheath (GS) technique, has been reported to increase the yield of transbronchial biopsy. However, there are no reports comparing the GS technique and the traditional EBUS technique in diagnosing the peripheral lung tumor.
2. Previous reports have revealed that several characteristic echoic patterns correlate well with the histopathological findings of benign and malignant lesions. Therefore, EBUS may also be useful in the differential diagnosis of malignant lesions of the lung.


Eligibility Criteria:
Inclusion Criteria:

* Patient with radiologically confirmed peripheral lung mass

Exclusion Criteria:

* Patient clinically not indicated for bronchoscopy exam within the abovementioned cohort
Structural and Functional Grey and White Matter Changes in Patients With Pain Disorders

The goal of this observational study is to examine the association between exact lesion location and presence of thalamic CPSP (Central post-stroke pain) in a larger number of patients after thalamic stroke.

The researchers will explore how the brain areas and mechanisms of brain plasticity are involved in the generation of thalamic CPSP, compared to other pain disorders, using structural and functional magnetic resonance imaging (MRI) at 3 Tesla. The functional magnetic resonance imaging (fMRI) will be also used to assess the cerebral processing of heat/cold stimuli in patients with thalamic pain compared to thalamic stroke patients without pain, to patients with migraine (other central pain disorder) and to normal controls. In addition the researchers want to assess the somatosensory profile of thalamic pain patients and compare it with thalamic stroke patients without pain, patients with migraine (pain control) and normal controls.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with thalamic central post-stroke pain (CPSP) :

   Patients fulfilling all of the following inclusion criteria are eligible for the study:
   * Informed Consent as documented by signature (Appendix Informed Consent Form)
   * History of thalamic stroke (infarction or bleed)
   * Diagnosis of definite central-post stroke pain (according to the criteria proposed by Klit et al, 2009)
   * No other chronic pain condition
   * Age: ≥18 years old
2. Patients with thalamic stroke without CPSP:

   Patients fulfilling all of the following inclusion criteria are eligible for the study:
   * Informed Consent as documented by signature (Appendix Informed Consent Form)
   * History of thalamic stroke (infarction or bleed), at least 2 years ago
   * No chronic pain condition (neither CPSP or other pain condition)
   * Age ≥18 years old
3. Patients with migraine (other pain condition):

   Patients fulfilling all of the following inclusion criteria are eligible for the study:
   * Informed Consent as documented by signature (Appendix Informed Consent Form)
   * History of highly frequent (≥8 monthly migraine days) or chronic migraine (≥15 monthly migraine days).
   * No history of stroke
   * Age ≥18 years old
4. Healthy controls:

Participants fulfilling all of the following inclusion criteria are eligible for the study:

* Informed Consent as documented by signature (Appendix Informed Consent Form)
* No history of stroke
* No chronic pain condition
* Age: ≥18 years old

Exclusion Criteria:

* History of severe neurological, internistic or psychiatric disease
* MRI related exclusion criteria:

  * paramagnetic and/or superparamagnetic foreign objects in the body (especially when located close to the brain)
  * Pacemaker
  * Claustrophobia
  * Pregnancy
Exercise Interventions on Problematic Mobile Phone Use: a Multi-arm Randomized Controlled Trial

Problematic mobile phone use (PMPU) has been described as a growing public health issue. This randomized controlled trial aimed to determine if aerobic exercise or Tai Chi Chuan as compared to the wait-list control group decreased PMPU-related symptoms; and to analyze the composition of the intestinal flora in the three study groups to explore the correlation between PMPU scores and flora species. A consecutive sample of 90 college students with PMPU was randomized to the aerobic exercise group (AE group, n = 30), the Tai Chi Chuan group (TCC group, n = 30), or the wait-list control group (WLC group, n = 30). The primary outcome was addiction symptoms, i.e., the PMPU score as assessed by the Smartphone Addiction Scale-Short Version (SAS-SV). Secondary outcomes were the emotion-related symptoms (depression, anxiety, self-esteem and self-efficacy), and physical-related symptoms (sleep quality, physical-fatigue and mental-fatigue). Intervention effects were analyzed via generalized estimated equation analysis (GEE).


Eligibility Criteria:
Inclusion Criteria:

* (1) be 18 years or older; (2) college students; (3) fulfill the Smartphone Addiction Scale-Short Version (SAS-SV) criteria for PMPU; (4) have a low level of daily physical activity.

Exclusion Criteria:

* (1) regular practice of moderate and higher intensity exercise (Physical activity was measured using the Physical Activity Rating Scale-3 (PARS-3), which is a 3-item self-reported scale comprising intensity, duration and frequency \[14\]. Exercise was considered to be of more than moderate intensity when the PARS-3 scores was \>42); (2) any major disease (cardiovascular disease, respiratory illness, and musculoskeletal disorder) that can affect them to participate in exercise training; (3) any gastrointestinal diseases and other diseases affecting intestinal bacteria; and (4) any severe mental illness (e.g., depression, anxiety, bipolar disorder, obsessive-compulsive disorder, eating disorder, and post-traumatic stress disorder).
MRI Based Biomarkers in Pediatric Autoimmune Liver Disease

Autoimmune liver diseases (AILD), which include Primary Sclerosing Cholangitis (PSC) and Autoimmune Hepatitis (AIH) are a common etiological factors for chronic liver disease among adolescents. In all these conditions, autoimmune lymphocyte responses are thought to orchestrate inflammatory injury against hepatocytes (primarily in AIH) or cholangiocytes (in PSC). In this proposal we aim to evaluate the Magnetic Resonance Imaging (MRI) modalities; MR cholangiopancreatography (MRCP) and MR elastography (MREL), as non-invasive biomarkers to assess two primary pathophysiological processes of AILD: bile duct damage and liver fibrosis. In this cross-sectional study MRI based findings of bile duct injury and liver fibrosis will be correlated with both liver histology and circulating biomarkers of these disease processes.


Eligibility Criteria:
Inclusion Criteria:

1. Age 6-23 years old.
2. Established or suspected clinical diagnosis of AIH or PSC.

Exclusion Criteria:

1. History of liver transplantation.
2. Chronic Hepatitis B or untreated hepatitis C virus infection.
3. Pregnancy.
4. Absolute contraindication for MRI (e.g. pacemaker, metallic implants, claustrophobia).
5. Diagnosis of cystic fibrosis or biliary atresia
6. Diagnosis of cardiac hepatopathy.
7. Diagnosis of Wilson's disease, Alpha-1 Antitrypsin deficiency, or Glycogen storage disease.
8. Skin conditions which could be aggravated by MREL (i.e. Epidermolysis bullosa).
The Pharmacologic Profile of Sodium Thiosulfate in Renal Failure and Healthy Volunteers

The pharmacokinetics of sodium thiosulfate in humans with different degrees of renal failure and in healthy volunteers will be after two single shot applications.

Two single shot applications of i.v. sodium thiosulfate will be given to dialysis patients. One application will be given immediately before a dialysis session and the second dose will be given after the consecutive dialysis session.

In healthy volunteers sodium thiosulfate will be given only once. In both groups, dialysis patients and healthy volunteers, blood and urinary/dialysate samples will be collected at defined time points.

Eligibility Criteria:
Inclusion Criteria:

* healthy volunteer or patient with renal failure

Exclusion Criteria:

* pregnancy
* withdrawal of consent
Topical Timolol 0.5% in Atrophic Acne Scar

The aim of the study is to evaluate the efficacy and safety of microneedling combined with topical timolol 0.5% in the treatment of atrophic acne scars.

Acne vulgaris (AV) is a common chronic inflammatory disease of skin that develops from sebaceous glands associated with hair follicles. Typically AV begins at puberty and may continue through adulthood affecting the comedogenic areas of face, back and chest (Mazzetti et al., 2019).

One of the undesirable outcomes of acne is acne scars that are divided into two main types based on a loss (atrophic) or gain (hypertrophic) of collagen. Atrophic type is the most common type, further subdivided into three subtypes: icepick, boxcar and rolling scar (Bahl et al., 2020).

Post acne scars occur in nearly 75% of patients with acne affecting both male and female equally (Khunger and Kumar, 2012). Acne scars impair quality of life and may be a risk factor for depression, suicide, low academic performance and unemployment (Sood et al., 2020).

There are different therapeutic modalities for atrophic acne scars including microneedling, chemical peeling, laser, filler, surgical procedures (punch excision, punch grafts) and fat transfer (Pavlidis and Katsambus, 2017).

Microneedling is considered safe for all skin types. It is performed by dermapen or dermaroller to induce new collagen formation that remains for a few months after the procedure (Cohen and Elbuluk, 2016).

Microneedling enhances the effect of topical preparations when used combined with them due to increasing their absorption by creating small channels through the epidermis to the dermis (Jaffe, 1981).

Ghassemi et al. (2021) observed that application of 0.5% timolol after TCA-CROSS caused a slight increase in scar improvement with more physician and patients' satisfaction.

Timolol, a beta-adrenergic receptor blocker, improves healing of skin wounds by increasing the phosphorylation of extracellular signal regulated kinases (ERK) leading to keratinocyte migration (Zeigler et al., 1999). Also, ERK initiate signaling cascades leading to fibroblast mitosis and proliferation with regulation of fibroblast functions in replacement of disorganized collagen and the reposition of the extracellular matrix (de Araújo et al., 2019).

Eligibility Criteria:
Inclusion Criteria:

1. All types of facial atrophic acne scars
2. Patients aged \>18 years
3. Both sexes

Exclusion Criteria:

1. Pregnancy and lactation
2. Active acne or any active facial lesion
3. History of keloid scar
4. History of systemic diseases as DM or hypotension
5. Bleeding and coagulation disorders
6. Infection and immunosuppression
Trial to Compare Effectiveness of 2 Insecticides in Preventing Malaria

Twenty-four (24) clusters, each containing between 250-300 houses were selected throughout Bioko Island to be sprayed with either a long lasting pyrethroid insecticide, K-Othrine SC 62.5, or a bendiocarb insecticide, FICAM. Parasite prevalence in children aged 2-14 was measured before and after the application of insecticide.

In 2013, a new long lasting pyrethroid insecticide, K-Othrine SC 62.5, that has been developed by Bayer AG, was used for the IRS program in Bioko Island, Equatorial Guinea, for the first time. This change coincided with a marked increase in parasite prevalence in 2-14 year olds as measured in the Annual Malaria Indicator Survey (14% to 28%, respectively). In order to determine whether the change in insecticide caused the increase in prevalence, a cluster randomized control trial was designed.

Twenty-four (24) clusters, each containing between 250-300 houses were selected throughout Bioko Island. Clusters were chosen with an attempt to maximize the geographical space between clusters (to minimize possible residual effects from insecticides), while ensuring that areas with historically higher acceptance rates for Indoor Residual Spraying (IRS) were selected. Each cluster had a buffer zone of 300m (or halfway between clusters less than 600m apart).

A team of 10 local surveyors conducted a baseline survey in each cluster area, measuring prevalence through malaria Rapid Diagnostic Test (RDT) positivity, net ownership, spray coverage, and hemoglobin levels. Approximately 100 children in each cluster were tested. These data were then used for a restricted randomization. Each cluster was then sprayed with either deltamethrin or bendiocarb, depending on randomization. The IRS team put equal amount of effort into each cluster, as determined by number of sprayers/house/day in an attempt to minimize bias.

An end-line survey was conducted using an ODK Collect application in the same cluster areas. Prevalence was measured by RDT, and hemoglobin data was gathered. In addition, the head of household was asked about the acceptability to IRS and their willingness to receive the insecticide in a future round.

Eligibility Criteria:
Inclusion Criteria:

* Children between 2-14 years old who reside in a household within the intervention area
* Household clusters chosen among those with historically high IRS acceptance rate
* Household clusters chosen to maximize distance between clusters.

Exclusion Criteria:

* Areas with historically high rates of refusing IRS
Sodium Picosulfate Plus Magnesium Citrate Versus Macrogol 4000 in the Bowel Cleansing Procedure: a Comparison of Efficiency and Compatibility

For effective cleansing of the bowel prior to colonoscopy polyethylene glycol (e.g. macrogol) has widely been used in Germany. Usually patients have to drink between 4 an 6 liter of macrogol in a split dose (3 liter on the day before and 1 to 3 liter on the of the examination). One handicap of using polyethylene glycol is the occurence of nausea and vomiting which is due to the high amount of the laxativ and its bad taste. Therefore in a pilot study the investigators have detected a high fraction of patients who consider the cleansing procedure wich macrogol as "very distressing". Thus patient acceptance of the colonoscopy procedure altogether is low.

Since a few month sodium picosulfate/magnesium citrate is available for bowel cleansing in Germany. This preparation tastes better and needs less fluid intake. Usually 150 ml of sodium picosulfate/magnesium citrate are given twice within a 12 hour interval. Patients are instructed to drink plenty of water in addition to the laxative. In the mentioned pilot study the investigators found the cleansing procedure with picosulfate/magnesium citrate to be much more compatible compared to the macrogol regime. The effectiveness expressed by the cleanness of the bowel was equal in both groups.

The investigators believe that a new protocol which contains sodium picosulfate/magnesium citrate instead of macrogol will benefit the patients by fewer abdominal side effects while cleanness of the bowel at the same time will be warranted. This presumption is the reason for the present study.


Eligibility Criteria:
Inclusion Criteria:

* Age \>= 18
* Scheduled for colonoscopy

Exclusion Criteria:

* No informed consent
* ASA IV or V
* Pregnancy
Evaluation of PICOLIGHT Plus COOLPREP, PICOLIGHT Plus CLICOLON for Bowel Preparation

The purpose of this study to bowel cleansing evaluation of mixed two other type bowel preparation drug(PICOLIGHT plus COOLPREP, PICOLIGHT plus CLICOLON).

To evaluate mixed-drug bowel preparation methods for decreasing side effect and increasing compliance

Picolight + Coolprep \[Day-Prior\] Picolight + Clicolon \[Day-Prior\] Picolight + Coolprep \[Split-Dose\] Picolight + Clicolon \[Split-Dose\]

Eligibility Criteria:
Inclusion Criteria:

* 20-65 years of age
* Elective colonoscopy of outpatients(consent to the study)

Exclusion Criteria:

* Active enteritis, enteric bleeding, obstruction
* Pregnant or lactating women
* Severe liver or renal insufficiency
* Allergic to any preparation components
* History of heart disease (ischemic heart disease, congestive heart failure, arrythmia)
* History of colorectal surgery
* History abdominal surgery within 6 month
* Toxic colitis or megacolon
* Nausea or vomiting
* Status emergent abdominal surgery (ex. acute appendicitis)
* Uncontrolled clinically significant pre-existing electrolyte disturbance
* Dehydration
* Phenylketonuria
* Glucose-6-phosphate dehydrogenase deficiency
* Ileus
* Suspicious hyperphosphatemia
* Acute phosphate nephropathy