cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety Study of NV1FGF in Patients With Severe Peripheral Artery Occlusive Disease.

Peripheral Arterial Occlusive Disease (PAOD) is a condition caused by ischemia in the legs due to atherosclerotic disease affecting the larger arteries of the legs. Chronic PAOD can be regarded as a marker of generalized atherosclerosis. PAOD threatens the survival of an extremity and often causes lifelong disablement from a painful leg. The clinical consequences of PAOD include pain on walking (claudication), pain at rest and loss of tissue integrity in the distal limbs.A variety of medical therapies have been investigated for patients with PAOD. There is currently no evidence to suggest that any medical therapy is effective for patients with rest pain and/or ischemic ulcers.

Also, the use of intramuscular angiogenic VEGF-A gene transfer has recently demonstrated a improvement in clinical and hemodynamic status in patients with severe PAOD


Eligibility Criteria:
Inclusion Criteria:

1. Informed consent was to be signed before proceeding with any study procedure.
2. Patients with severe PAD.
3. Trophic lesions with no signs of healing (no reduction in ulcer size or depth) for at least 2 weeks prior to first study treatment administration (Day 1).
4. Patients with objective evidence of peripheral vascular disease in the diseased limb on 2 consecutive examinations performed at least 1 week apart.
5. Demonstration or documentation of total occlusion of the affected limb of one or more of the iliac, superficial femoral, popliteal and/or one or more infrapopliteal arteries as assessed by angiography or magnetic resonance angiography (MRA)
6. Transcutaneous oxygen pressure (TcPO2): mean resting supine TcPO2 of the foot of ≤40 mmHg based on 2 separate measures performed at least 1 week apart
7. Poor/not candidates for revascularization

Exclusion criteria

1. Previous or current history of malignant disease.
2. Positive cancer screening (liver, prostate, colon, cervix, breast, lung)
3. Successful lower extremity surgery (bypass/angioplasty of the leg to be treated) within 3 months prior to the first administration of study treatment \[Day 1\]).
4. Patients planned to undergo amputation of target limb within 1 month following the first administration of study treatment.
5. Patients with a history of severe renal failure.
6. Creatinine \>2.0 mg/dL (176 µmol/L) or estimated creatinine clearance \<30 mL.
7. Serious concomitant medical conditions not adequately controlled (other than severe PAD),
8. Buerger's disease.
9. Patients in dialysis.
10. Active proliferative retinopathy
11. Patients who had a stroke or neurologic deficit presumed to be due to stroke within 3 months prior to the first administration of study treatment.
12. Previous treatment with any angiogenic growth factor.
13. Positive serology for HIV 1 or 2.
14. Participation in clinical trials of non-approved experimental agents within 4 weeks before study entry.
Endostomal Three-dimensional Ultrasonography for Parastomal Hernia

The intention is to examine the role of ultrasonographic examination inside intestinal stomas in diagnosing parastomal hernia. Patients with a stoma since at least one year back who are being scheduled for abdominal surgery will be examined for eligibility according to the selection criteria. Included patients will undergo routine clinical examination, endostomal ultrasonography and computerized tomography scan of the abdomen. Findings will be correlated to findings during surgery (gold standard). Values for sensitivity, specificity, predictive values and likelihood ratio will be calculated.

Parastomal hernia (PSH) is one of the most common stoma complications, with an incidence of 30-50 % within just a couple of years of stoma creation. Surgical parastomal hernia repair is a morbid and complicated procedure, with a 30-day reoperation rate of 13 % and 30-day mortality rate of 6 % in population-based surveys. There is no established gold standard diagnostic modality. Routinely, patients are examined clinically in various positions with and without increased intra-abdominal pressure. It has been shown in previous studies that clinical examination has a very low inter-observer reliability. Computerized tomography is often performed in addition to clinical examination, but is not ideal in diagnosing PSH either, not only beacause of insufficient test characteristics but also since the examinations should ideally be performed with specific protocols, prone position and be reviewed by a dedicated radiologist. The risk of incorrectly diagnosing a PSH (false positive) is that patients might subsequently be exposed to complex and dangerous surgical interventions without any health benefit, while incorrectly ruling out a PSH (false negative) can cause the patient to have to live with potentially treatable symptoms, life-threatening bowel incarceration being the most severe potential complication.

Thus, improved diagnostic accuracy is required. A method that has been developed within our research group is endostomal tree-dimensional ultrasonography, which has preliminarily proven to be approximately as sensitive as CT, with a markedly higher specificity. A larger and less selected study needs to be conducted in order to reliably calculate test characteristics, predictive values and likelihood ratio.

Eligibility Criteria:
Inclusion Criteria:

* End colostomy or end ileostomy since ≥ 1 year
* Planned for laparotomy or laparoscopy
* Age ≥ 18
* Speaks and reads Swedish language
* Informed consent

Exclusion Criteria:

* Known parastomal hernia only indication for laparotomy or laparoscopy
Effect of HABIT-ILE on the Body Function and Structures of Children With Cerebral Palsy

There is strong evidence that recent intensive interventions based on motor skill learning principles are efficient on functional and neuroplastic changes of children with cerebral palsy (CP).

Besides, impaired selective voluntary motor control (SVMC) is one of four interrelated neuromuscular deficits in children with CP and is listed in the ICF-CY (International Classification of Functioning, Disability and Health for Children and Youth) under body functions. Additionally, impaired SVMC has been shown to negatively affect the motor and functional abilities of children with CP. However, there have been little scientific investigations on the trainability of SVMC according to therapeutic interventions.

Therefore, the study aims to evaluate the effect of Hand and Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) on the body function and structures of children with bilateral and unilateral cerebral palsy, including SVMC and brain structure.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed bilateral and unilateral cerebral palsy,
* MACS levels from I to IV,
* GMFCS levels from I to IV,
* Ability to follow instructions and complete testing.

Exclusion Criteria:

* Orthopedic surgery, botulinum toxin injections or another unusual intervention less than 6 months before or within the study period.
* Unstable seizure
* Severe visual or cognitive impairments likely to interfere with intervention or testing session completion
Camrelizumab Combined With Famitinib Malate for Treatment of Recurrent/Metastatic Cervical Cancer

This study is a randomized, open-label, controlled, multi-center Phase III clinical study, aimed to evaluate the efficacy and safety of camrelizumab combined with famitinib malate versus platinum-based chemotherapy in the treatment of recurrent/metastatic cervical cancer. All enrolled patients will be randomly divided into 2 groups and continuously treated until any event that meets the criteria for end of the clinical trial.


Eligibility Criteria:
Inclusion Criteria:

1. Female aged 18-75 years (including 18 and 75 years, calculated based on the signing date of the informed consent)
2. Histopathologically confirmed recurrent/metastatic cervical squamous cell carcinoma that cannot be radically treated by surgery, radiotherapy or chemoradiotherapy
3. No prior systemic anti-cancer therapy for recurrent/metastatic disease
4. According to RECIST v1.1 criteria, the patient must have at least one measurable lesion
5. Able to normally swallow drug tablets
6. The organ function level is good
7. Willing to participate and able to comply with research programme requirements

Exclusion Criteria:

1. Has any malignancy \<5 years prior to study entry.
2. Known to have brain or meningeal metastasis
3. Known to have autoimmune disease
4. Received live vaccinations 4 weeks before randomization or during the study period
Text Messaging-Based Smoking Cessation Program for Homeless Youth

Unaccompanied homeless youth smoke at much higher rates than non-homeless adolescents and young adults. Many homeless youth smokers are motivated to quit; yet, strategies specifically developed for this vulnerable population are lacking. This study will develop and pilot test a text messaging intervention (also known as a TMI) to help homeless youth quit smoking. Text messaging can provide ongoing support for homeless youth during a quit attempt, which is important given that these youth tend to be highly mobile and lack regular access to health services. Participants in this study will be homeless youth who currently smoke and are motivated to quit smoking. All participants will receive a 30-minute group-based smoking cessation counseling session and a nicotine replacement product. Half of these smokers will also receive the TMI, for 6 weeks following the group counseling session, which will provide ongoing support for quitting. The main goal of this study is to investigate whether receiving the TMI results in greater reductions in cigarette smoking over a 3-month period compared to receiving the group counseling session alone.


Eligibility Criteria:
Inclusion Criteria:

* between ages of 18-25
* seeking services at one of the participating drop-in centers for homeless youth
* smoked at least 5 cigarettes per day on at least 20 days in the past month
* motivated to quit in next 30 days
* has a cell phone to receive text messages and willing to receive text messages

Exclusion Criteria:

* currently pregnant or breastfeeding, or planning to become pregnant or breastfeed in the next 6 months
* has a medical condition (based on self-report) which would prevent using the nicotine replacement product
* used pharmacotherapy to reduce or stop smoking in the past 30 days
* currently receiving other smoking cessation services
Testicular Function and Semen Quality in Male Childhood and Adolescent Cancer Survivors

Cancer treatment can affect the testicular function, including sperm and hormonal functions. The aim of this study is to assess the testicular function and semen quality in young men who recover from childhood and adolescent cancer in Hong Kong. This can provide more information for pre-treatment counselling as well as improve post treatment survivorship care. The testicular function will be compared to aged-matched controls from men attending the Family Planning Association for premarital check-up.

This is a cohort observational study. The target population for the trial will be men who have received chemotherapy and/ or radiotherapy for cancer diagnosed when they were \< 18 years old, currently \> 18 years old to 50 years old and cancer in remission for at least 2 years. The testicular function, including sperm and hormonal functions, will be compared with aged-matched controls from men attending the Family Planning Association for premarital check-up.

Eligibility Criteria:
Inclusion Criteria:

* Men who have received chemotherapy and/ or radiotherapy for cancer diagnosed when they were \< 18 years old.
* \> 18 years old to 50 years old
* Cancer in remission for at least 2 years

Exclusion Criteria:

* Unable to ejaculate by masturbation to provide semen samples
* Cryptorchidism, testicular cancer, history of vasectomy
* On testosterone replacement therapy
* Refusal to join the study
Effectiveness of Laserpuncture and Standard Antiemetic on RINVR Scores in Adolescent Patients Undergoing Chemotherapy

Chemotherapy is a common treatment for treating cancer. Chemotherapy induced nausea and vomiting (CINV) is nausea and vomiting that occurs after chemotherapy. Complete protection of standard antiemetic drugs against CINV symptoms in children and adolescents receiving moderately and strongly emetogenic chemotherapy drugs was less than 50%.

The side effects of chemotherapy in the form of CINV are so unpleasant that chemotherapy causes extreme anxiety and stress. The psychological characteristics of adolescents who have a greater perception of the changes that occur cause more frequent anxiety which can increase the risk of CINV.

Acupuncture with laserpuncture modality is a non-pharmacological therapy that has a good effect on CINV symptoms in adolescents. This research was conducted for the first time in Brazil in 2019, while in Indonesia there has never been any research on this matter. So it is hoped that this research will be the first research in Indonesia to prove that the effect of laserpuncture plays a role in CINV symptoms in adolescents and can be an additional treatment in standard therapy for CINV problems in adolescents.

This is a clinical trial study to evaluate and compare the effects of laserpuncture and sham laserpuncture as a therapy for Chemotherapy induced nausea and vomiting (CINV) . The subjects are 58 males/female and will be randomly assigned to 2 groups: (1) laserpunctur and (2) Sham laserpuncture. The outcome will be assessed before treatment (baseline), in chemotherapy procedure and 3 days after chemotherapy. Patients and the outcome assessors will be blinded to the group allocation.

Eligibility Criteria:
Inclusion Criteria:

1. Adolescent cancer patients aged 10 - 18 years
2. Patients undergoing chemotherapy with moderate and/or strong emetogenic chemotherapy drugs
3. Patients with CINV and/or at risk of CINV
4. Willing to take part in research until completion
5. The patient has not received acupuncture therapy in the last 1 week

Exclusion Criteria:

1. Patients with cancerous lesions or ulcers at the location of the acupuncture points to be selected
2. Patients with digestive tract organ malignancies with complaints of nausea and vomiting before chemotherapy
3. Patients with unstable hemodynamic conditions
Two Approaches to Providing HIV/AIDS Services in the Community to People Living With HIV/AIDS

This study will examine the effects of having a case manager help PHAs access and use health, social services and practical resources that are helpful to their needs as compared to the usual more PHA self-managed approach of deciding and using services as they see necessary. New and existing users of HIV/AIDS services in Wellington-Dufferin, Waterloo and Grey-Bruce Regions who consent to this study will be randomized to receive their usual self-directed supportive, educational, medical and medical care services when they seek assistance according to their needs or these usual services augmented by case management services. They will be measured before randomization and at 3, 6 and 12 months following service use for their satisfaction with HIV/AIDS services, compliance with HIV/AIDS medication, improvement in quality of life, psychological distress, risk behaviours and expenditures for the use of a range of publicly funded services.


Eligibility Criteria:
Inclusion Criteria:

* HIV-positive individuals
* living in the community setting

Exclusion Criteria:

* cognitive impairment
GlideScope Groove Versus Macintosh Blade for Double-Lumen Endotracheal Tube Intubation

A new GlideScope videolaryngoscope has been developed, which utilizes a track on the superior surface of the blade to guide the endotracheal tube, which is advanced in the track as opposed to "free-hand" along the inferior surface, where the camera is located. This new GlideScope can be used for double-lumen endotracheal tubes (DLT). The investigators hypothesize that this GlideScope will be easier to use than the Macintosh blade.


Eligibility Criteria:
Inclusion Criteria:

* Any adult patient booked for elective surgery requiring orotracheal intubation with a double lumen endotracheal tube.

Exclusion Criteria:

1. Any patient with cervical spine abnormalities.
2. Any patients with known or probable difficult airways.
3. Any patient requiring rapid sequence induction.
A Pilot Test of t:Slim X2 With Control-IQ Technology

A 36-48 hour admission testing the t:slim X2 with Control-IQ Technology

The objective of the study is for clinical staff to gain experience using the proposed artificial pancreas system named t:slim X2 with Control-IQ Technology and assess usability in a supervised setting prior to initiating home use in a Training protocol.

Eligibility Criteria:
Inclusion Criteria:

To be eligible for the study, a subject must meet the following criteria:

1. Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least one year and using insulin for at least 1 year
2. Use of an insulin pump for at least 6 months with established parameters for basal rate(s), carbohydrate ratio(s) and insulin sensitivity factor(s) for at least 3 months.
3. Age 18.0 to \<75.0 years
4. Hemoglobin A1c \<10.5%
5. For females, not currently known to be pregnant If female and sexually active, must agree to use a form of contraception to prevent pregnancy while a subject in the study. A negative serum or urine pregnancy test will be required for all premenopausal women who are not surgically sterile. Subjects who become pregnant will be discontinued from the study. Also, subjects who during the study develop and express the intention to become pregnant within the timespan of the study will be discontinued.
6. Willingness to suspend use of any personal CGM for the duration of the clinical trial once the study CGM is in use
7. Investigator has confidence that the subject can successfully operate all study devices and is capable of adhering to the protocol
8. Currently using no insulins other than one of the following rapid-acting insulins at the time of enrollment: insulin lispro (Humalog), insulin aspart (Novolog), or insulin glulisine (Apidra). Willingness to switch to lispro (Humalog) or aspart (Novolog) if using glulisine (Apidra).
9. Total daily insulin dose (TDD) at least 10 U/day and ≤100 U/day
10. Weight at least 25 kg and not greater than 140 kg

Exclusion Criteria:

1. More than one episode of diabetic ketoacidosis (DKA) in the 6 months prior to enrollment
2. More than one episode of severe hypoglycemia involving seizure or loss of consciousness in the 6 months prior to enrollment
3. Concurrent use of any non-insulin glucose-lowering agent (including GLP-1 agonists, Symlin, DPP-4 inhibitors, SGLT-2 inhibitors, biguanides, sulfonylureas and naturaceuticals).
4. Hemophilia or any other bleeding disorder
5. A condition, which in the opinion of the investigator or designee, would put the subject or study at risk
6. Participation in another pharmaceutical or device trial at the time of enrollment or during the study
7. Employed by, or having immediate family members employed by Tandem Diabetes Care, Inc. or TypeZero Technologies, LLC, or having a direct supervisor at place of employment who is also directly involved in conducting the clinical trial (as a study investigator, coordinator, etc.); or having a first-degree relative who is directly involved in conducting the clinical trial
Efficacy of Albumin Therapy With Standard Medical Treatment (SMT) as Compared to Standard Medical Treatment (SMT) in Improving Patient Survival and Immune Modulation in Patients With Acute on Chronic Liver Failure (ASIA Trial).

The AIM of the study is to study the efficacy of intravenous albumin and standard medical treatment as compared to standard medical treatment alone in ameliorating/preventing SIRS and improving survival at 28 days .The project will be conducted in ILBS from august 2018 to December 2019Concept is to understand the immunology, pathophysiology and effects of albumin in the management of ACLF for betterment of the patient's condition and early recovery.

All ACLF patients will be included as per the inclusion and exclusion criteria , after taking informed consent from the patient or their relatives. Will be evaluated for the possible risk factors for the development of SIRS/sepsis in ACLF patients and possible beneficial factors for resolution of SIRS /sepsis in ACLF patients. The effects of albumin administration as per this protocol versus standard medical treatment alone will be reviewed If patient develops allergic reactions to albumin, fluid overload, albumin will be stopped and patient will be treated accordingly to medical condition.


Eligibility Criteria:
Inclusion Criteria:

1. Age \>18 years to 65 years
2. ACLF patients

Exclusion Criteria:

1. Patients who have already received albumin in last 1 week
2. Patients who require albumin like PICD (Paracentesis-Induced Circulatory Dysfunction)

   ,SBP (Spontaneous bacterial peritonitis),LVP(large volume paracentesis),HRS(hepatorenal syndrome)
3. Not given consent
4. Significant cardiopulmonary or structural heart disease/ CKD(chronic kidney diseses) /volume overload /upper GI bleed.
5. Pregnant/ HIV / HCC \>2cm size
6. Alcoholic hepatitis eligible for steroids
7. Previous known allergic/adverse reaction to albumin
8. Any clinical condition which the investigator considers would make the patient unsuitable for the trial
9. Patients who will receive palliative treatment only during their hospital admission
Tibial Nerve Versus Sciatic Nerve Block

The purpose of this study is to analyse the ability to selectively block the posterior tibial nerve sparing the function of the common peritoneal nerve. To assess the efficacy of blocking the posterior tibial nerve will give the same post-operative pain relief after total knee surgery compared to a sciatic nerve block.


Eligibility Criteria:
Inclusion Criteria:

* total knee replacement

Exclusion Criteria:

* History of neuralgia, diabetes, pregnancy, allergy to local anesthetic solutions