cyrilzakka/clinical-trials huggingface dataset:
Exercise in Critically Ill Patients With Sepsis

This study will investigate whether early exercise in critically ill patients will decrease inflammatory markers, increase pro-inflammatory markers and prevent loss of muscle mass.

This study will investigate the effects of an early targeted rehabilitation program on inflammatory markers and muscle mass in patients with sepsis syndromes in intensive care.

The Primary Hypothesis is that an early targeted rehabilitation ICU patients with sepsis syndromes over 7 days will Prevent loss of lean muscle mass by within 7 days of recruitment to the study. Decrease pro-inflammatory and increase anti-inflammatory cytokines within 7 days of recruitment to the study.

Eligibility Criteria:
Inclusion Criteria:

* Systemic inflammatory response syndrome with a proven or suspected infectious etiology.
* 18 years and over
* Relatives willing to give consent
* Admitted to intensive care and likely to remain ventilated for \> 48 hours

Exclusion Criteria:

* Patients with septic shock unresponsive to maximal treatment or who are moribund or have an expected mortality within 48 hours
* Head injuries
* Burn injury
* Multiple lower limb fractures
Comparing the Effects of Holmich Protocol Exercise Therapy and Joint Mobilization Training on Pain, Balance, Function of the Lower Limb, and Muscle Activity in Soccer Players with Athletic Groin Pain.

The goal of this clinical trial is comparison the Holmich protocol exercise therapy and joint mobilization training, investigating their respective effects on muscle activity in soccer players with athletic groin pain.

The main questions it aims to answer are:

Is there a difference between Holmich protocol exercise therapy and joint mobilization training on pain, balance, function of the lower limb, and Muscle activity in Soccer Players with athletic Groin Pain ?

Researchers will compare Holmich protocol exercise therapy (HT)with joint mobilization training (JMT) to see if the exercises are effective on pain, balance, lower limb function, and muscle activity.

Participants will:

Practice Holmich protocol exercise therapy (HT) three times a week, 90 minutes per session, for 12 weeks.

Practice joint mobilization training (JMT) for 12 weeks.


Eligibility Criteria:
Inclusion Criteria:

1. Male
2. between 18-35 years old
3. Have a normal body mass index (BMI)
4. Desire to return to the former level of sports activity
5. groin pain for at least 2 months
6. Pain at palpation of the adductor tendons or the insertion of the pubic bone or both; Groin pain during active adduction against resistance (squeeze test); Pain during adduction against resistance had to be less than six\*, based on the visual analogue scale (VAS).
7. In addition, at least two of the following criteria had to be present: a clear history of groin pain and stiffness in the morning, cough induced or sneeze-induced groin pain, nocturnal groin pain or radiological evidence demonstrating osteitis pubis or pain at the symphysis pubis due to palpation.

Exclusion Criteria:

1. Receiving physical therapy or other conventional therapy in the past 6 months.
2. Absence in one of the pre- or post-test sessions.
3. Absence of more than two sessions in practice sessions.
A Study of Laparoscopic Right Hemicolectomy Using the Caudal-to-cranial Approach

To investigate the clinical application value of laparoscopic radical right hemicolectomy using the caudal-to-cranial approach versus the medial-to-lateral approach by prospective randomized controlled clinical study.

To compare the caudal-to-cranial approach with the medial-to-lateral approach in laparoscopic right hemicolectomy for the advance right colon cancer.

A prospective randomized controlled trial will be performed in the GI department,the Guangdong provincial hospital of Chinese Medicine from October 2016 to October 2024.The sample size，150 cases with advanced right colon cancer, will be needed after calculated by the statistics .The 150 cases will be randomly divided into two groups: laparoscopic radical right hemicolectomy using the caudal-to-cranial(CtC) approach(GroupCtC) and laparoscopic radical right hemicolectomy using the medial-to-lateral(MtL) approach (GroupMtL). Primary outcomes are the operative time，The secondary outcomes are the total blood loss,the number of lymph nodes dissected,the average time of ground activities,the time to first flatus,the hospital stay,the intra-operative complication and the post-operative complication，and others' outcomes are the Disease-free survival rate(DFS) at 3 years and 5 years,the Overall survival rate（OS）at 3 years and 5 years.The data in two groups will be compared.

Eligibility Criteria:
Inclusion Criteria:

1. The age limits is 18-80 years old;
2. The clinical staging was II,III carcinoma of right colon，located in right-sided colon;
3. The preoperative imaging confirmed that the tumor did not involve adjacent organs;
4. American Society of anesthesiologists (ASA) score less than or equal to Level III;
5. Criteria of performance status karnofsky is greater than or equal to 60.

Exclusion Criteria:

1. The patients' age limits is Less than 18 years old, or more than 80 years old
2. The preoperative imaging confirmed that the tumor involve adjacent organs;
3. The tumor have been finding distant metastases;
4. American Society of anesthesiologists (ASA) score more than 3;
5. Criteria of performance status karnofsky is lower than 60;
6. It is the carcinoma of right colon with multiple colonic polyps Disease;
7. there is a laparoscopic surgery contraindications.
Cold Knife Conization With and Without Lateral Hemostatic Sutures

The treatment of high grade Cervical Intraepithelial Neoplasia (CIN) 2, 3 is defined according to the colposcopic evaluation of the patient. In case colposcopy findings are satisfactory (visible squamocolumnar junction), both ablative and excisional methods are adequate. In the middle of the 20th century, lateral hemostatic sutures were added to the cold knife conization surgical technique to reduce blood loss. Some authors recommend that these branches should be ligated, but it remains unclear whether these sutures are actually effective in reducing bleeding.This study compared blood loss during cold knife conization of the cervix with and without lateral hemostatic sutures.

This is a study that will evaluate two groups of patients undergoing cold-knife conization for cervical intraepithelial neoplasia high grade where 50% will undergo hemostatic sutures in the lateral cervical and 50% of patients will not be subjected to these sutures. The main objective of the study is to evaluate the amount of intraoperative bleeding.

Eligibility Criteria:
Inclusion Criteria:

* indication of cold knife conization

Exclusion Criteria:

* conization using techniques other than the cold knife;
* previous cervical conization using any other technique;
* previous pelvic radiotherapy;
* pregnancy; and
* refusal to participate in the study
Life Skills Intervention for Adolescents Perinatally Infected With HIV

The life skills intervention model is designed to help adolescents promote their physical and mental health through cognitive and behavioral techniques (e.g., problem solving, coping, and communication skills) designed to help them achieve social and personal competencies used to manage various life challenges.

One of the salient advantages of this intervention model is that it has been developed and implemented in several studies with adolescents. However, data concerning the effects of this model are much less extensive with adolescents perinatally infected with HIV. The proposed study is designed to address this gap in knowledge by conducting a pilot intervention tailoring the life skills intervention to the needs of young adolescents, perinatally infected with HIV, and to their primary caregivers. Given the emphasis on peer group interaction, the proposed intervention model also has the potential to reduce some of the social isolation imposed by the experiences related to HIV infection by creating opportunities for adolescents to interact with others who are managing comparable stressors and treatment regimens.

Eligibility Criteria:
Inclusion Criteria:

* Clinically-identified HIV-1 infected participants 11-14 years of age and their primary caregivers.
* HIV status has been disclosed to the adolescent.
* Caregiver is the legal guardian of the adolescent as indicated by the medical team.
* Adolescent lives with the caregiver
* Adolescent and caregiver speak and understand English.

Exclusion Criteria:

* Caregiver consent or permission denied or adolescent does not assent.
* Adolescent diagnosed as mentally retarded as previously reported or confirmed through chart review.
* Adolescent and/or caregiver too medically fragile. Medically fragile is functionally defined as being physically unable to attend the group.
A Study to Assess the Safety, Tolerability, and Efficacy of Long-term SOBI003 Treatment in Pediatric MPS IIIA Patients

MPS IIIA, also known as Sanfilippo A, is an inherited lysosomal storage disease (LSD). MPS IIIA is caused by a deficiency in sulfamidase, one of the enzymes involved in the lysosomal degradation of the glycosaminoglycan (GAG) heparan sulfate (HS). The natural course of MPS IIIA is characterized by devastating neurodegeneration with initially mild somatic involvement. The aim of the present study is to assess the safety, tolerability and efficacy of long-term SOBI003 treatment. SOBI003 is a chemically modified recombinant human (rh) Sulfamidase developed as an enzyme replacement therapy (ERT).

This is an open, single-arm, multicenter extension study to assess the safety, tolerability and efficacy of long-term SOBI003 treatment in pediatric MPS IIIA patients. The study is an extension of the First in Human (FIH) SOBI003-001 study, allowing continuous treatment of SOBI003 for up to 2 years. Study patients who complete Week 24 of the FIH study (SOBI003-001) will be invited to continue to Week 25 in the extension study.

When entering the extension study, these patients will receive the highest dose that has been declared safe in the ongoing FIH study (SOBI003-001). Upon completion of the FIH study, an analysis aimed at selecting the dose for forthcoming studies will take place. Once the dose has been selected, this dose will be applied to all patients enrolled in the extension study. The total duration of the extension study for an individual patient is 80 weeks, resulting in a total of 104 weeks (2 years) of SOBI003 treatment.

Eligibility Criteria:
Inclusion Criteria:

* Completion of study SOBI003-001
* Informed consent obtained from the patient´s legally authorized representative

Exclusion Criteria:

* If, in the opinion of the investigator, there are patient specific safety concerns that contraindicates further treatment with SOBI003
A Comparison of McGrath MAC Videolaryngoscopy and Macintosh Laryngoscopy for Orotracheal Intubation in Children With Torticollis

The primary purpose of this study is to investigate the effects of McGrath MAC videolaryngoscopy on the intubation time for orotracheal intubation in children with torticollis.

The secondary purpose of this study is to investigate the effects of McGrath MAC videolaryngoscopy on Cormack and Lehane Grade for orotracheal intubation in children with torticollis.


Eligibility Criteria:
Inclusion Criteria:

* orotracheal intubation under general anesthesia
* torticollis

Exclusion Criteria:

* •oral lesions, congenital anomaly, cervical spine instability, rapid sequence intubation
Pilot RCT Local Gentamicin for Open Tibial Fractures in Tanzania

Local application of antibiotics directly to the traumatic wound is a promising strategy for the prevention of infection after open tibia fractures, which are a significant source of disease burden globally, particularly in low-income countries. This pilot study aims to assess feasibility of a randomized controlled trial to measure the effect of locally applied gentamicin on risk of infection for open tibial fractures in Tanzania. If proven effective, local gentamicin would be a highly cost-effective strategy to reduce complications and disability from open tibial fractures that could impact care in both high- and low-income countries.

This pilot study is being conducted in Dar es Salaam, Tanzania to assess the feasibility of a masked, placebo-controlled, randomized trial to compare local gentamicin injection to saline injection in open tibial shaft fractures. The study will enroll patients within 1 week of injury. The active or placebo agent will be administered during the initial surgical debridement based on a web-based randomization tool. Patients will be followed for 1 year after surgery to assess for the occurrence of fracture-related infection (FRI), a consensus definition of infection after open fracture or insertion of internal fixation to treat fracture. Additional clinical and economic endpoints will also be measured.

Depending on the outcome of the feasibility study, we may undertake a definitive trial to test the effectiveness of local gentamicin to prevent FRI. If proven effective, local gentamicin would impact the clinical care of open fracture patients both in Tanzania and likely in high-income settings as well. These data will also deepen the understanding of the clinical and economic impact of FRI in open fracture populations.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female patients age 18 or older
2. Diagnosis of an acute open tibial shaft fracture meeting the following criteria:

   1. AO/OTA Type 42
   2. Primarily closable wound
   3. Type I, II, or IIIA Gustilo- Anderson (GA) Classification

Exclusion Criteria:

1. Time from injury to presentation \> 48 hours
2. Time from injury to surgery \>7 days
3. History of Aminoglycoside allergy
4. GA IIIB or IIIC open fractures
5. Bilateral open tibial fractures
6. Severe brain (GCS\<12) or spinal cord injury
7. Severe vascular injury
8. Sustained severe burns (\>10% total body surface area (TBSA) or \>5% TBSA with full thickness or circumferential injury)
9. Pathologic fracture
10. History of active limb infection, ipsilaterally
Perspective Analysis of Coronal Imbalance in Degenerative Scoliosis

Currently there is paucity of information on the prevalence of pre-operative coronal imbalance in patients with degenerative lumbar scoliosis (DLS) and its influence on surgical outcomes. This study aims to investigate in DLS, the prevalence of coronal imbalance, to propose a novel classification system and to investigate whether pre-operative coronal imbalance affects clinical outcomes following osteotomy. A total of 284 DLS patients were recruited.

A total of 284 DLS patients were recruited into this two-stage study, among which 69 patients were treated by posterior-only correction and the remaining 215 patients received conservative treatment. Using pre-operative long-cassette X-ray films, all patients were classified based on coronal balance distance (CBD) defined as the horizontal distance between C7 plumb line and central sacral vertical line: Type A, CBD \< 3cm; Type B, CBD \> 3cm and C7PL shifts to the concave side of curve; Type C, CBD \> 3cm and C7PL shifts to the convex side of curve. The prevalence of pre-operative coronal imbalance was calculated for stage I study. Post-operative CBD in patients who received surgery was measured to evaluate clinical outcomes for stage II study.

Eligibility Criteria:
Inclusion Criteria:

age \> 50 years, diagnosis of DLS based on radiographies and previous medical history and Cobb angle \>25°.

Exclusion Criteria:

-
Efficacy and Safety of NovoMix® 30 in Subjects With Type 2 Diabetes

This trial is conducted in Europe. The aim of this trial is to investigate the efficacy and safety of biphasic insulin aspart (NovoMix®30) to that of biphasic human insulin (Mixtard® 30) in subjects with type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes for at least 24 months
* Insulin treatment for the pase 3 months
* HbA1c (glycosylated haemoglobin) below 13%
* BMI (Body Mass Index) below 40 kg/m\^2
* Ability and willingness to perform self-blood glucose monitoring

Exclusion Criteria:

* Receipt of any investigational drug within 4 weeks prior to this trial
* Treatment of OHAs (Oral Hypoglycaemic Agents) within 4 weeks prior to this trial
* Total daily insulin dosage less than or equal to 1.8 IU/kg
T2* MRI Analysis for Sarcoma

T2\* imaging is a method to identify labile iron pools in tumor cells. These iron pools may be linked to better treatment outcomes for specific types of therapy. This is a small pilot study to see if radiation therapy changes the amount of iron in a sarcoma tumor.


Eligibility Criteria:
Inclusion Criteria:

* pathologically confirmed Sarcoma, by biopsy or excision
* prescribed radiation therapy as per standard of care
* treatment to begin within 5 weeks after surgery or biopsy
* ECOG 0, 1, or 2
* ability and willingness to provide informed consent

Exclusion Criteria:

* \< 18 years of age
RhGM-CSF as Adjuvant Immunotherapy in Treating Stage III Colon Cancer

This study is to investigate the efficacy and safety of rhGM-CSF as adjuvant immunotherapy for patients with resectable stage III colon cancers.

This study is to investigate the efficacy and safety of rhGM-CSF as adjuvant immunotherapy for patients with resectable stage III colon cancers. Patients were randomly assigned to rhGM-CSF group or placebo group and treated with rhGM-CSF or placebo perioperation and during the adjuvant chemotherapy. The purpose of the study is to evaluate the antitumor immune effect of rhGM-CSF before surgery and adjuvant chemotherapy through DFS of 5 years and to observe the safety during the treatment in order to provide evidence for improvement in treating resectable colon cancer patients.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed as resectable stage III colon cancer
2. 18-70 years old
3. ECOG performance status ≤2
4. Unexposed to rhGM-CSF in 6 months
5. Signed an informed consent document

Exclusion Criteria:

1. Secondary primary cancer, or concurrent primary malignancies (except for basal cell or squamous cell skin cancer, cervical cancer in situ, and other cancer with disease free for more than 5 years)
2. Complete intestinal obstruction
3. Events within 6 months before randomization: myocardial infarction, sever or unstable angina, coronary artery or peripheral arterial bypass surgery, congestive heart failure ( NYHA functional class of III or IV ), stroke and any myocardial dysfunction in a transient ischaemic attack
4. Abnormal liver and kidney function (Serum creatinine \> 1.5 x ULN, total bilirubin \> 1.5 x ULN, transaminase \> 3 x ULN ), abnormal pulmonary function (FEV1\<60% or diffusing capacity of the lung for carbon monoxide \< 55% )
5. Bone marrow dysfunction ( Hb\<9.0 g/dL、ANC\<1.5 x 109/L、PLT\<100 x 109/L )
6. ITP or immunodeficiency
7. Uncontrolled infection, including HBV, HCV, HIV infection
8. Female patients who has been pregnant or planning to, and those during lactation
9. Known allergic to E.coli agents or rhGM-CSF or any severe allergic history to other drugs
10. Other cases that the researcher found ineligible
Follow-up of the Natural Course of the Small EUS-suspected Gastric Gastointestinal Stromal Tumors

Gastric gastrointestinal stromal tumors (GISTs) less than 2 cm are usually followed up conservatively. However, little is known about the natural course of small GISTs. The goal of this study was to evaluate the clinical course of the small EUS-suspected gastric GISTs and to determine the size predicting subsequent progression with increased malignant potential.


Eligibility Criteria:
Inclusion Criteria:

* (1) a small tumor size, less than 3 cm;
* (2) patients declined surgical intervention at initial identification of the lesion;
* (3) at least two EUS follow-up procedures were recorded;
* (4) the EUS follow-up period was more than 24 months.

Exclusion Criteria:

* (1) a tumor size, larger than 3 cm;
* (2) less two EUS follow-up procedures were recorded;
* (3) the EUS follow-up period was less 24 months.
A Comparison of ISIS 2922 Used Immediately or Later in Patients With Cytomegalovirus (CMV) of the Eyes

To determine a clinically safe and effective dose of intravitreally injected ISIS 2922 and to compare the safety and efficacy of immediate versus delayed treatment in AIDS patients with previously untreated, peripheral cytomegalovirus ( CMV ) retinitis.

In Stage 1 (dose escalation), patients receive either 75 or 150 mcg intravitreal ISIS 2922. In Stage 2 (randomization), patients are enrolled in either the immediate treatment group or delayed treatment group. Immediate treatment consists of intravitreal ISIS 2922 every 7 days for 3 injections (Induction) then every 14 days for 18 weeks (Maintenance). Patients in the delayed treatment group receive no immediate anti-CMV treatment but are monitored weekly for disease progression. If disease progresses, patient receives ISIS 2922 on an identical dosage regimen as those on immediate treatment. Patients may continue ISIS 2922 on a biweekly extended maintenance schedule if dose is considered safe and the CMV retinitis is clinically controlled. Per 2/8/96 amendment, patients are now in Stage 2 at 150 mcg.

Eligibility Criteria:
Inclusion Criteria

Patients must have:

* AIDS.
* Clinical diagnosis of previously untreated peripheral CMV retinitis in one eye.
* Leading edge of a CMV retinitis lesion is at least 750 microns from zone one. NOTE:
* Patients with CMV retinitis in zone three only may be eligible if the lesions can be reliably photographed to follow progression.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions in the eye to be treated are excluded:

* External ocular infections.
* Other herpetic infections of the retina, toxoplasma retinochoroiditis, or other disease of the fundus.
* Ocular conditions that will obstruct visualization of the posterior ocular structures.
* Retinal detachment.
* Silicone oil in eye.

Patients with the following other symptoms or conditions are excluded:

* Known or suspected allergy to phosphorothioate oligonucleotides.
* Syphilis.
* Pseudoretinitis pigmentosa.

Concurrent Medication:

Excluded:

* Current treatment for extra-ocular CMV infection.
* Ganciclovir.
* Foscarnet.
* Mellaril.
* Stelazine.
* Thorazine.
* Clofazimine.
* Ethambutol/fluconazole combination.
* Investigational medications for CMV retinitis.

Concurrent Treatment:

Excluded:

* Investigational procedures for CMV retinitis.

Patients with the following prior conditions are excluded:

* History of surgery to correct retinal detachment in the eye to be treated.
* History of syphilis.

Prior Medication:

Excluded:

* Prior anti-CMV retinitis treatment in either eye.
* Anti-CMV therapy for extra-ocular infection within the past 2 days.