cyrilzakka/clinical-trials huggingface dataset:
NGS as the First-line Treatment in Advanced Biliary Tract Cancer

To evaluate disease objective response rate (ORR) of nivolumab in combination with gemcitabine and TS1 in patients with advanced biliary tract cancer

The primary endpoint will be evaluating overall response rate (ORR) of nivolumab in combination with gemcitabine and TS-1 in patients with advanced BTC. Simon's two-stage design will be used. If there are 3 or fewer subjects with controlled disease in these 19 patients, the study will be stopped. Otherwise, 25 additional patients will be accrued for a total of 44. The null hypothesis will be rejected if 11 or more subjects with controlled disease are observed in 44 patients.

Eligibility Criteria:
Inclusion Criteria:

1. histologically confirmed locally advanced or metastatic biliary tract carcinoma (including intrahepatic bile duct, extrahepatic bile duct, gallbladder and ampulla of vater);
2. no history of chemotherapy or radiotherapy for biliary tract cancer, except those delivered as adjuvant setting that completed at least 6 months before documentation of recurrence by imaging study.
3. presence of at least one measurable tumor lesion which is defined as lesions that can be accurately measured in at least 1 dimension with longest diameter (LD) ≥20 mm using conventional techniques or ≥10 mm with spiral CT and MRI; measurable lymph nodes must be ≥15 mm in the short axis;
4. adequate hematopoietic function which is defined as below:

   1. hemoglobin level ≥ 9 g/dL;
   2. absolute neutrophil count (ANC) ≥ 1,500/mm3;
   3. platelet count ≥ 100,000/mm3;
5. adequate hepatic function which is defined as below:

   1. total bilirubin \< 2 mg/dL;
   2. Alanine aminotransferase (ALT) ≤ 3 x ULN; ≤ 5 x ULN if liver metastasis
6. adequate renal function: creatinine clearance rate (CCr) ≥ 50 mL/min ((based upon Cockroft-Gault formula or 24-hour urine collection); \< Cockroft-Gault formula \> Male: ((140 - age) × weight \[kg\])/(72 × serum creatinine\[mg/dL\]) Female: 0.85 x estimate for male
7. age of 20 years or above;
8. ECOG performance status 0-1;
9. life expectancy of at least 12 weeks;
10. patients with childbearing potential shall have effective contraception for both the patient and his or her partner during the study.
11. ability to understand and willingness to sign a written informed consent document.

Exclusion Criteria:

1. other malignancy within the past 5 years except for adequately treated basal or squamous cell skin cancer or cervical cancer in situ;
2. history or known presence of brain metastasis;
3. presence of grade 2 or above ascites or pleural effusion;
4. presence of grade 2 or above diarrhea;
5. presence of mental disease or psychotic manifestation;
6. active or uncontrolled infection;
7. significant medical conditions that is contraindicated to study medication or render patient at high risk from treatment complications based on investigator's discretion;
8. pregnant women or nursing mothers, or positive pregnancy test for women of childbearing potential.
9. History of active autoimmune disease within 3 years or long-term use of steroid more than prednisolone 10mg/day.
Postoperative Complications of Orthopedic Surgery in Patients From High-altitude Regions

This study will focus on orthopedic surgery patients from high-altitude regions, utilizing smart wearables and monitoring tools to gather perioperative data, including heart rate, oxygen saturation, sleep quality, stress levels, and other relevant metrics. Regular follow-ups will assess recovery and complications, in addition to collecting medical records, lab results, imaging data, and other pertinent records. The ultimate goal is to establish a comprehensive follow-up cohort of orthopedic surgery patients from high-altitude areas.

Prolonged exposure to hypoxic and low-pressure environments leads to structural remodeling and functional abnormalities in the cardiovascular, respiratory, and hematological systems of high-altitude populations. This elevates the risk of postoperative complications, particularly in patients undergoing orthopedic surgery, significantly impacting their recovery and quality of life. This study will focus on orthopedic surgery patients from high-altitude regions. Using smart wearable devices and other monitoring tools, comprehensive perioperative dynamic data of participants, including heart rate, heart rate variability, oxygen saturation, respiratory rate, sleep quality, activity levels, stress index, and other relevant indicators will be collected. Regular follow-ups will be conducted to evaluate postoperative recovery and monitor the incidence of perioperative complications. Additionally, perioperative data such as electronic medical records, laboratory test results, ECG waveforms, echocardiography, chest CT images, and other pertinent records will be also collected. Through that, this study aims to establish a follow-up cohort of orthopedic surgery patients from high-altitude regions.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years;
2. ASA classification I-III;
3. Patients who have lived at an altitude above 2500 meters for more than 6 months ;
4. Patients scheduled for elective orthopedic surgery.

Exclusion Criteria:

1. Urgent or emergent surgery;
2. Expected hospital stay \< 48 hours;
3. Inability to provide informed consent；
4. Patients who have been out of high-altitude regions for over three months.
Clinical Trial to Evaluate the Use of Platelet Rich Plasma in Front Hyaluronic Acid in Coxarthrosis

To evaluate the efficacy and safety of platelet rich plasma (PRP) in patients with coxarthrosis who don´t respond to treatment with NSAIDs, compared to treatment with hyaluronic acid (Hylan G-F 20).


Eligibility Criteria:
Inclusion Criteria:

* Patients\> 30 years.
* Patients who voluntarily express their intention to participate by informed consent.
* Diagnosis of coxarthrosis who have failed conservative treatments for 6 months
* Women of childbearing potential must have a negative pregnancy test during screening and must agree to use adequate contraception (or two contraceptive methods, of which one is barrier) while participating in the trial.

Exclusion Criteria:

* Treatment with infiltrations 3 months prior to the study
* Prior treatment with NSAIDs 24h prior to extraction
* Pre-Surgical Treatment of Hip affects
* Diabetics
* Severe liver or kidney disease at the time of extraction
* Thrombocytopenia (\<100,000 platelets / ml) at baseline
* Anemia (Hb 9 \<mg / dl) at baseline
* Hyaluronic acid Allergy
* History crystal arthropathy, inflammatory arthritis or neuropathic arthropathy.
* Acetabular protrusions
* History of infectious arthritis
* Excessive deformity (acetabular dysplasia, Perthes)
Transfusion Requirements After Head Trauma

TRAHT is a pilot randomized clinical trial designed to evaluate safety and feasibility of two red blood cells transfusion thresholds in moderate or severe traumatic brain injured patients


Eligibility Criteria:
Inclusion Criteria:

* Age equal to or greater than 18 years
* Moderate or severe traumatic brain injury, defined as Glasgow coma scale less than or equal to 12 at hospital admission
* Hemoglobin lower than 9.0 g/dL within 7 days from hospital admission

Exclusion Criteria:

* Glasgow coma scale equal to 3 with dilated pupils bilaterally
* Previous neurological sequelae
* Pregnant women
* Jehovah's Witnesses
* Hemorrhagic shock at randomization
* Moribund patients
* Unable to provide consent
Neurostimulation Applied to Fibromyalgia

NeuroFibro is a double-blind, randomized, placebo-controlled clinical trial, using neurostimulation in women with fibromyalgia.


Eligibility Criteria:
Inclusion Criteria:

* (1) diagnosis of fibromyalgia, according to the American College of Rheumatology criteria;
* (2) been diagnosed for at least three months;
* (3) be female;
* (4) be in the age group between 25 and 60 years of age; and
* (5) sign the consent form.

Exclusion Criteria:

* (1) cognitive deficit, evaluated through the Mini Mental State Examination (MMSE);
* (2) illiterate;
* (3) people with metallic implants located on the head, cochlear implants and cardiac pacemaker;
* (4) history of convulsion;
* (5) severe depression, measured by score greater than 36 on Beck Depression Inventory; and
* (6) be pregnant.
Burden of Cancer in Children: A Pilot Study to Investigate the Impact and Content of Video Illness Narratives

In order to gain a greater understanding of the full experience of children with life-threatening illness, this study will provide video cameras to ten to fifteen 10-18 years olds in active treatment for cancer, and instruct them to make video illness narratives over the course of 1-3 months. The narratives will be studied as an intervention; each of the participants will be administered a measure of physical symptoms (the Memorial Symptom Assessment scale 10-18) and a measure of self-esteem (the Rosenberg Self-Esteem Scale). The video narratives will also be analyzed for content by theme in order to understand the participants' experiences in their own words. Our hypothesis is that these narratives will provide insight into the lives of children with cancer, increase their self-esteem, and decrease symptom distress, and improve communication between patients and their doctors.

In addition to the above outcome measures:

The video narratives will also be analyzed for content by theme in order to understand the participants' experiences in their own words.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with cancer
* Age 10-18
* In active treatment for cancer
* Followed at the Strong Memorial Hospital/Golisano Children's Hospital

Exclusion Criteria:

* Non-English Speaker
* Cognitively impaired so as to make data collection difficult
CyberKnife Radiosurgery for Organ-Confined Prostate Cancer: Homogenous Dose Distribution

The purpose of this study is to determine the effects of CyberKnife radiosurgery in patients with early stage organ-confined prostate cancer.

The CyberKnife Robotic Radiosurgery System is a unique radiosurgical system capable of treating tumors anywhere in the body noninvasively and with sub-millimeter accuracy. The CyberKnife System delivers radiation using a precise targeting methodology allowing a focal treatment margin around the target, thus limiting the volume of adjacent tissue receiving high doses radiation. This in turn allows the delivery of high doses of radiation to the prostate over a short series of treatments.

Eligibility Criteria:
Inclusion Criteria:

* Patient must be at least 18 years of age
* Histologically proven prostate adenocarcinoma
* Patients belonging in one of the following risk groups:

Low: Clinical Stage (CS) T1b-T2a and Gleason 2-6 and Prostate Specific Antigen (PSA) ≤ 10, or Intermediate: CS T2b and Gleason 2-6 and PSA ≤ 10 or CS T1b-T2b, and Gleason 2-6 and PSA ≤ 20 ng/ml or Gleason 7 and PSA ≤ 10 ng/ml

* Prostate volume: ≤ 100 cc
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1

Exclusion Criteria:

* Prior prostatectomy or cryotherapy of the prostate
* Prior radiotherapy to the prostate or lower pelvis
* Implanted hardware or other material that would prohibit appropriate treatment planning or treatment delivery, in the investigator's opinion
* Chemotherapy for a malignancy in the last 5 years
* History of an invasive malignancy (other than this prostate cancer, or basal or squamous skin cancers) in the last 5 years.
* Hormone ablation for two months prior to enrollment, or during treatment.
Neurobiology of Opioid Dependence: 3 - 3

The purpose of this study is to study the effects of cycloserine on naloxone-precipitated opiate withdrawal.


Eligibility Criteria:
Please contact site for information.
The Effects of Rotator Interval Hydro-dissection in Primary Adhesive Capsulitis.

Adhesive capsulitis (AC) is a significant cause of chronic shoulder pain and disability. Non-surgical option consisting of intraarticular corticosteroid (IA CS) injection with structured physiotherapy (PT) is the current standard of care. More recent randomized controlled trials have found that rotator interval (RI) hydro-dissection approach leads to better improvement in pain as compared to IA approach. Despite being non-inferior to surgical management, long-term outcome studies of patients treated with IA CS injection and PT have shown that patients only achieve satisfactory outcomes in 72.3% of patients after a mean symptom duration of 41.8 months. Furthermore, CS injections are associated with significant systemic and local adverse effects such as Cushing syndrome, osteopenia/ osteoporosis, infection, and hyperglycemia. In recent years, dextrose injection has emerged as an effective alternative to CS-based injections to treat chronic painful musculoskeletal conditions such as chronic low back pain, peripheral nerve entrapment and lateral epicondylitis.

The investigators aim to study the effects of RI hydro-dissection with dextrose 5% (D5%) on pain relief, shoulder ROM and shoulder function in patients with primary AC.


Eligibility Criteria:
Inclusion Criteria:

* patients with primary adhesive capsulitis
* aged 35 to 65 years of age
* duration of symptoms in between 3 to 18 months
* limitation in flexion, abduction, and external rotation greater than 30 degrees compared to normal
* limitation in internal rotation with hand to back shoulder test below L4

Exclusion Criteria:

* diagnosis of connective tissue disease or inflammatory arthritis
* history of surgery to the affected shoulder
* history of shoulder dislocation/ fracture
* neurological weakness of the affected upper limb
* ultrasound findings of rotator cuff or LHBT tendinopathy
* plain radiographs showing significant glenohumeral joint osteoarthritis (Kallgren-Lawrence grade 3 or 4)
* other sources of chronic pain
* bilateral adhesive capsulitis
* history of pain intervention to the shoulder joint in the past 3 months
* allergic reaction to local anesthetic agent
A 6-Month Consumer Behavior Study of a Self-Management System (0803-084)(COMPLETED)

The purpose of this study is to evaluate the ability of patients with intermediate risk of heart disease to appropriately use a Self-Management System.

The duration of treatment is 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Must be able to read and understand English without assistance.
* For Males: Minimum age 45 years and Maximum age N/A (No limit).
* For Females: Minimum age 55 years and Maximum age N/A (No limit).

Exclusion Criteria:

* Pregnant or nursing
* Drug allergy
Habitual and Neurocognitive Processes in Adolescent Obesity Prevention

The study tested an intervention that used a cue-removal and implementation intentions based strategy to change habitual dietary behaviors. The intervention was evaluated using a randomized experimental design that consisted of two conditions including (1) a control condition or (2) a cue and implementation intention-based intervention. High schools (N=22) were randomly assigned to one of the two conditions. Families (N=187), with a family defined as an adolescent and one participating parent, were recruited from within the 22 schools. All of the families from each school were assigned to the same condition.

Families that were eligible for the study and that were interested in participating scheduled an appointment to complete informed consent. After written parental consent and youth assent was obtained, the participants had their height and weight measured and completed a series of questionnaires programmed on laptops. In addition, the adolescent took part in a 24 Hour Dietary Recall Assessment. The family was also informed that a second 24 Hour Dietary Recall Assessment would be administered to the adolescent over the phone in approximately 3-14 days.

Families that were from a school assigned to the control condition received an intervention on sun safety that consisted of a 10-minute meeting with a trained Health Coach, two generic newsletters, an email, and a text message. Families from a school assigned to the cue- and implementation intentions condition received an intervention on healthy snacking and the reduction of sugar sweetened beverage consumption that consisted of a 90-minute meeting with a trained Health Coach, two 20-minute phone calls, four tailored newsletters, and a series of emails and text messages. Both of these interventions were delivered over a period of 3-10 weeks depending on the self-directed pace of the participants. All participants were then asked to complete a follow-up assessment appointment three months after their original consenting appointment. Our hypotheses focused on dietary behaviors and stated that adolescents assigned to the cue-removal and implementation intentions intervention would consume significantly fewer daily servings of high fat snacks, high sugar snacks, and sugar sweetened beverages than adolescents in the control condition.

See above.

Eligibility Criteria:
Inclusion Criteria:

* Eligibility criteria for adolescents included being English-speaking,
* between the ages of 14 and 17,
* free of major illness,
* not receiving clinical treatment for obesity,
* possessing a cell phone with text messaging capability.

Exclusion Criteria:

* failure to meet inclusion criteria
oVRcome - Self Guided Virtual Reality for Social Anxiety Disorder

Social anxiety is characterised by excessive fear of being negatively judged, embarrassed or humiliated during social interactions and is common with a lifetime prevalence of 12.1%. Cognitive behavioural therapy is the first line of treatment, but people may not seek treatment due to a number of factors including the discomfort experienced in seeking help, inconvenience, and the experience of psychotherapy itself. With Virtual Reality (VR), users can have increased control in how gradually they expose themselves to social situations. In studies of VR in people with specific phobias, 76% of people prefer VR exposure to in vivo exposure. There is emerging evidence for the use of VR in social phobia.

oVRcome, is a self-help VRET for social anxiety symptoms and specific phobias, that is delivered through a smartphone application (app) in combination with a low cost headset that holds the smartphone and uses 360º video.

This study will evaluate the effectiveness of the oVRcome social anxiety program for social anxiety symptoms. We hypothesize that oVRcome will reduce social anxiety symptom severity over a 6-week treatment period compared to waiting-list control


Eligibility Criteria:
Inclusion Criteria:

* are between 18-64 years old
* have moderate (or higher) social anxiety disorder symptoms on Liebowitz social anxiety scale (\>60)
* have access to a smart phone and internet
* willing to participate in the research study and providing informed consent

Exclusion Criteria:

* present with symptoms of severe depression or suicidality respectively as measured with the PHQ-9; total score \> 19, =3 on suicidality item
* have insufficient knowledge of the English language
* are under current treatment for social phobia or psychotropic medication (unless on stable dosage for the previous 3 months and no changes planned during the study period).
Impact of Different Contraceptives on the Immune System of HIV Infected Women in Zambia

In this study, 66 HIV-infected women who desire contraception will be randomly assigned to use either an IUD or Depo Provera, and will be followed for six months. The study is intended to help investigators understand potential mechanisms by which hormonal contraception may hasten HIV disease progression.

In this randomized controlled trial, 66 HIV-infected women who desire contraception will be assigned to one of two treatment groups: IUD or Depo Provera. The study builds on findings from a previous study which examined the safety and acceptability of hormonal contraception and IUD among HIV-infected women. Secondary analyses from the previous study indicated that women who were assigned to the hormonal arm appeared to have faster disease progression based on death and decline in CD4+ count as compared to women assigned to the IUD arm. With the current study, investigators seek to understand potential mechanisms for the effect of hormonal contraception on hastening HIV disease progression. Enrolled women will be asked to use the assigned contraception method for a period of six months, and various indicators of disease progression will be collected at four follow-up visits after randomization.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed HIV status by local rapid test algorithm
* Willingness to be randomized to a contraceptive method and continue that method for at least 6 months.
* Intention to stay in the study area for at least 6 months

Exclusion Criteria:

* Currently pregnant or pregnant within the prior 6 months
* Currently breastfeeding
* Documented liver disease
* History of coagulation disorder
* Active tuberculosis
* Anemia, defined as Hgb \<8gm/dL
* Age \< 16 years (the age of consent in Zambia);
* Eligible for antiretroviral therapy based on Zambian National Guidelines (CD4+ \< 200, or WHO stage IV, or CD4+\< 350 and WHO stage III)
* Currently using an IUD or hormonal method of contraception, or have used a hormonal contraceptive in the past 6 months
Magnesium Supplementation for Hypomagnesemia in Chronic Kidney Disease

Randomized placebo-controlled interventional trial to investigate the effect of oral magnesium supplementation on intracellular magnesium in subjects with chronic kidney disease. We hypothesize that oral magnesium supplementation will increase intracellular magnesium in subjects with chronic kidney disease as well as increase serum magnesium.

Chronic kidney disease (CKD) is associated with increase cardiovascular morbidity and mortality independent of traditional cardiovascular risk factors due to increased vascular calcification. Epidemiological and experimental data suggest that hypermagnesemia and magnesium supplementation reduce vascular calcification in chronic kidney disease by increasing calcium/phosphate solubility in serum, by inhibiting calcium influx into vascular smooth muscle cells (VSMC), by inhibiting intracellular pro-calcification enzymes in VSMC and by increasing activity of intracellular anti-calcification enzymes in VSMC. A trial to investigate the effect of oral magnesium supplementation on vascular calcification in subjects with CKD is currently being planned, but prior to initiating such a trial it is necessary to determine the dose of oral magnesium needed to increase intracellular magnesium and serum magnesium.

Eligibility Criteria:
Inclusion Criteria:

* Estimated Glomerular filtration rate (eGFR) \< 60 mL/min.
* Serum magnesium \< 0.82 mmol/L.
* Written informed consent.

Exclusion Criteria:

* Hemodialysis.
* Peritoneal dialysis.
* Kidney transplant recipient.
* Parathyroid hormone \> 600 pg/L.
* Pregnancy.
* Comorbidity that makes study participation and completion impossible.