cyrilzakka/clinical-trials huggingface dataset:
Acupuncture for Body Weight Control

In this study, a 18-week, single-blinded, randomized controlled clinical trial will be conducted to evaluate the effectiveness, efficacy and safety of acupuncture on weight control in Hong Kong.

This is a pilot single-blind, randomized, sham-controlled trial. 72 participants will be randomly assigned to acupuncture group or control group. The duration of the treatment will be 8 weeks with 2 sessions per week and the follow-up period will be 8 weeks.

Eligibility Criteria:
Inclusion Criteria:

* aged between 18 and 65 years old;
* body mass index (BMI)≥25 kg/m2;
* having not received any other weight control measures or any medical and/or drug history within the last 3 months.

Exclusion Criteria:

* endocrine diseases;
* heart diseases;
* patients with pacemaker;
* allergy and immunology diseases;
* having bleeding tendency;
* pregnant or lactating women;
* having impaired hepatic or renal function;
* stroke or otherwise unable to exercise.
Pain Control After Trauma

Using Virtual Reality as a form of pain control for trauma patients.

The purpose of the study is to investigate the effectiveness of virtual reality (a form of distraction) in order to reduce patients' pain from trauma.

Eligibility Criteria:
Inclusion Criteria:

* Age greater than or equal to 12 years
* Compliant and able to complete questionnaires
* Hospitalization for internal injuries requiring a laparotomy or for orthopedic injuries (closed long bone or calcaneus fractures).
* A minimum of 3 days hospitalization
* No history of psychiatric (DSM-IV-R Axis I) disorder
* Not demonstrating delirium, psychosis or any form of Organic Brain Disorder
* Able to communicate verbally
* Able to take oral medications
* Baseline pain level of \>=5/10
* English-speaking

Exclusion Criteria:

* Age less than 12 years
* Not capable of indicating pain intensity
* Not capable of filling out study measures
* Hospitalization of less than 3 days
* Evidence of traumatic brain injury
* History of psychiatric (DSM-IV-R Axis I) disorder as evidenced in the admitting RN and MD admission notes.
* Demonstrating delirium, psychosis or any form of Organic Brain Disorder and associated memory problems.
* Unable to communicate orally.
* Unable to take oral medications
* History of sig. cardiac, endocrine, neurologic, metabolic, respiratory, gastrointestinal or genitourinary impairment
* Receiving prophylaxis for alcohol or drug withdrawal
* Developmental disability
* Mini-mental status score of greater than 20 in patients older than 80 years or suspected of cognitive deficits
* Non-English Speaking
* Extreme susceptibility to motion sickness
* Seizure history
Treatment of Chronic Lymphocytic Leukemia in Patients Previously Exposed to Rituximab

The purpose of this research is to evaluate the safety and effectiveness of the drugs lenalidomide and ofatumumab in the treatment of chronic lymphocytic leukemia (CLL).


Eligibility Criteria:
Inclusion Criteria:

1. Subjects must have confirmed diagnosis of chronic lymphocytic leukemia (CLL).
2. Prior therapy with at least one regimen containing rituximab
3. Age \> 18 years.
4. Life expectancy greater than 12 months.
5. ECOG performance status \<2
6. Patients must have normal organ function as defined in the protocol.
7. Patients must have adequate bone marrow function as defined in the protocol.
8. Ability to understand and the willingness to sign a written informed consent document.
9. All study participants must be registered into the mandatory RevAssist® program, and be willing and able to comply with the requirements of RevAssist®.
10. Females of childbearing potential (FCBP)† must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10 - 14 days prior to and again within 24 hours prior to prescribing lenalidomide (prescriptions must be filled within 7 days) and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking lenalidomide. FCBP must also agree to ongoing pregnancy testing. Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy.
11. Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients intolerant to ASA may use warfarin or low molecular weight heparin.

Exclusion Criteria:

1. Patients who have had chemotherapy or radiotherapy within 4 weeks or received any monoclonal antibody within 6 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
2. Patients may not be receiving any other investigational agents or other anti-cancer agents or treatments.
3. History of allergic reactions attributed to compounds of similar chemical or biologic composition to ofatumumab or lenalidomide.
4. Uncontrolled concomitant illness.
5. Pregnant women are excluded from this study because lenalidomide is believed to be teratogenic.
6. HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with ofatumumab or lenalidomide.
7. Prior treatment with lenalidomide
8. Evidence of laboratory TLS by Cairo-Bishop Definition of Tumor Lysis Syndrome. Subjects may be enrolled upon correction of electrolyte abnormalities.
9. All patients will undergo screening for hepatitis B and may or may not be eligible based on the results as outlined in the protocol.
Feasibility of Virtual, Tailored, Music-Based Relaxation for Anxiety in Adolescent and Young Adult Cancer Survivors

Demonstrate the feasibility of conducting an eight-week, (45 min/week), theory driven, virtually-delivered, tailored music-based relaxation (TiMBRe) intervention to decrease anxiety in adolescent and young adult (AYA) cancer survivors with clinically-relevant anxiety.

Initially Sessions 7 and 8 were both body percussion; however, the 04FEB2025 changed this to Session 7 will be body percussion and session 8 will be selected by the participant. This will allow for more tailoring of the intervention.

Eligibility Criteria:
Inclusion Criteria:

* 15 - 39 years old
* at least one month post cancer treatment
* report clinically relevant anxiety in the past seven days (PROMIS Anxiety 4a scores ≥ 55)35
* speak/read English.

Exclusion Criteria:

* prognosis less than 3 months
* documentation of significant hearing impairment
* plan to receive surgery, radiation, or chemotherapy for cancer treatment during the study period
* plans in place to begin new psychosocial (i.e., cognitive behavioral therapy14 or mindfulness-based stress reduction15) or pharmacological treatments for anxiety during the study. Although, participants may continue psychosocial or pharmacological treatments for anxiety if the treatments were initiated at least eight weeks prior to study enrollment, the dose has not changed, and they report clinically relevant anxiety in the last week.
The Effect of Diabetes on the Newborn

The aim of this study is to test and compare biochemical, hematological, and inflammatory factors in diabetic and healthy pregnant mothers and in their newborns.


Eligibility Criteria:
Inclusion Criteria:

* pregnant women

Exclusion Criteria:

-
The ECOG-ACRIN SUPPORT Trial: Multilevel Intervention to Improve Diverse Enrollment in Cancer Clinical Trials

The purpose of this study is to conduct a Hybrid Type 1 cluster-randomized, roll-out effectiveness-implementation trial in NCORP community oncology practice sites (N= 500 Black and Latino cancer patients) to evaluate the effectiveness of the EA SUPPORT intervention combining CT navigators and CT research literacy tools in improving Black and Latino patient referral and accrual to NCI-supported CTs (primary outcomes) and participant and provider awareness and knowledge of CTs (secondary outcomes) while assessing implementation factors. Also, with the CUSP2CT data, Evaluation, and Coordinating Center, conduct final site evaluation and disseminate the SUPPORT intervention to NCORP community oncology sites, research bases, and affiliated trial networks.

The purpose of this study is to conduct a Hybrid Type 1 cluster-randomized, roll-out effectiveness-implementation trial in NCORP community oncology practice sites (N= 500 Black and Latino cancer patients) to evaluate the effectiveness of the EA SUPPORT intervention combining CT navigators and CT research literacy tools in improving Black and Latino patient referral and accrual to NCI-supported CTs (primary outcomes) and participant and provider awareness and knowledge of CTs (secondary outcomes) while assessing implementation factors. Also, with the CUSP2CT data, Evaluation, and Coordinating Center, conduct final site evaluation and disseminate the SUPPORT intervention to NCORP community oncology sites, research bases, and affiliated trial networks.

Eligibility Criteria:
Inclusion Criteria:

Participant must be ≥ 18 years of age. Participant must self-identify as Black and/or Latino. Participant must be an oncology patient at a participating NCORP. Participant must be eligible to participate in an ECOG-ACRIN clinical trial. Participant must have the ability to understand and the willingness to sign a e-consent document.

Participant must be receiving care at a participating NCORP affiliated community oncology site.

Participant must be English or Spanish speaking to be eligible. Participant must have access to a landline, smartphone, computer, or tablet.

Exclusion Criteria:

-
Efficacy and Safety of Convalescent Plasma in Treating COVID-19 Hospitalized Patients

This is a Phase II study. This research study is being conducted to use convalescent donor plasma in seriously ill patients who have COVID-19.

This is an open label phase 2 trial assessing the efficacy and safety of anti-SARS-CoV-2 convalescent plasma in hospitalized patients with acute severe respiratory symptoms from COVID-19. Symptomatic patients with clinical or radiological interstitial COVID-19 pneumonia and within 21 days of onset of symptoms will be enrolled in 2 cohorts - an ICU cohort and a hospitalized non-ICU cohort.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years or older
2. Hospitalized as an in-patient with positive COVID-19 test by PCR
3. Presence of respiratory symptoms with any of severe features as below:

   * Respiratory Rate ≥ 24/min
   * Oxygen Support \>3L/min by nasal cannula
   * New onset or worsening of respiratory symptoms with radiologic confirmation of bilateral ground glass opacities that cannot be attributed to another cause
4. Patient / HCPOA must agree to storage of blood specimens for future testing.
5. Patient / HCPOA is willing and able to provide electronic informed consent and comply with all protocol requirements. If patient is unable to consent due to incapacity, health care POA should be defined and able to consent for the patient.
6. Patients are allowed to receive all standard of care. Co enrollment in other clinical trials is permitted.

Exclusion Criteria:

1. FCBP with positive pregnancy test (mandatory)
2. Breastfeeding females
3. Receipt of pooled immunoglobulin (e.g. IVIG or other hyperimmune globulin products) in past 14 days. This does not apply to monoclonal antibodies .
4. Mechanical ventilation for \> 14 days
5. Days from symptom onset \>21 days
6. Expected survival \< 72 hours
7. Contraindication to transfusion or history of prior reactions to transfusion blood products including any proven history of TRALI
8. Patients who were previously admitted to ICU cannot be enrolled in the non-ICU cohort. These patients could need ICU level care subsequently and at that time point could be considered for ICU cohort .
Bortezomib and Flavopiridol in Treating Patients With Recurrent or Refractory Indolent B-Cell Neoplasms

Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary for their growth. Drugs used in chemotherapy, such as flavopiridol, work in different ways to stop cancer cells from dividing so they stop growing or die. Bortezomib may increase the effectiveness of flavopiridol by making cancer cells more sensitive to the drug. Giving bortezomib together with flavopiridol may kill more cancer cells. This phase I trial is studying the side effects and best dose of bortezomib and flavopiridol in treating patients with recurrent or refractory indolent B-cell neoplasms.

PRIMARY OBJECTIVES:

I. To determine the recommended phase II dose of bortezomib and flavopiridol in patients with recurrent or refractory indolent B-cell neoplasms.

SECONDARY OBJECTIVES:

I. To determine the toxic effects and maximum tolerated dose of this regimen in these patients.

II. To determine disease-related effects of this regimen in these patients. III. To determine the pharmacodynamics of this regimen in patients with myeloma.

IV. To determine the pharmacokinetics of this regimen in these patients.

OUTLINE: This is a dose-escalation, multicenter study.

Patients receive bortezomib IV over 3-5 seconds followed by flavopiridol IV over 1 hour on days 1, 4, 8, and 11.

Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Eligibility Criteria:
Inclusion Criteria:

* WBC \< 50,000/mm\^3 for patients with circulating tumor cells
* No prior allergic reaction to compounds of similar chemical or biological composition to and presumably able to tolerated bortezomib, flavopiridol, allopurinol, sodium polystyrene sulfonate, or dexamethasone
* No neuropathy \>= grade 2
* No other condition that would preclude study participation
* Not pregnant or nursing
* Fertile patients must use effective contraception during and for 3 months after study participation
* Prior autologous stem cell transplantation is allowed
* No prior allogeneic stem cell transplantation
* No other concurrent anticancer agents
* No other concurrent investigational agents
* Hemoglobin \>= 8 g/dL
* Platelet count \>= 100,000/mm\^3
* Absolute neutrophil count \>= 1,500/mm\^3
* Bilirubin =\< 2 times upper limit of normal (ULN)
* AST/ALT =\< 3 times ULN
* Creatinine =\< 2 times ULN or Creatinine clearance \>= 50 mL/min
Study on the Efficacy and Tolerance of a New Anti-regurgitation Infant Formula (STELLAR)

The aim of the study is to assess the effectiveness of this new formula on regurgitations and secondarily its effect on digestive tolerance through a randomized, controlled, double-blind trial against a comparator.

The study duration is 1 month and 2 days. It is possible to add 2 additional months (optional).

The 2 first days (from D-3 to D0) correspond to the pre-selection period. These 2 days are followed by the follow-up month (from D0 to D30). It is possible to add an optional follow up of 2 months (form D30 to D90).

Eligibility Criteria:
Inclusion Criteria:

* ≥ 2 regurgitation episodes per day during the last 2 weeks and ≥ 4 regurgitation episodes per day in average during the last 2 days,
* exclusive or predominant formula feeding
* whose parents signed informed consent

Exclusion Criteria:

* preterm infants or birthweight \<2500g
* Post enteritis lactose intolerance
* Suspected or diagnosed cow's milk protein allergy requiring an eviction diet
* Use of medications that may interfere with regurgitation or gastrointestinal transit (such as alginates, laxatives, antibiotics...). All these medications have to be stopped at least 7 days before inclusion visit (V1)
* Infants presenting with any situation which, according to the investigator, may interfere with the study participation, or lead to a particular risk for the subject
The Effect of Liposomal Bupivacaine on Post Operative Pain and Narcotic Use After Bariatric Surgery

This study is prospective, randomized trial in which the efficacy of liposomal bupivacaine (Exparel®) is compared to standard bupivacaine local surgical site injection in reducing total IV and oral morphine equivalents required after laparoscopic bariatric surgery. Liposomal bupivacaine is a 72-hour bupivacaine that is slowly released from tissue over the course of three days. Having a long acting local anesthetic should provide better pain control than conventional bupivacaine which has a 3.5-hour half-life. In some studies, the use of liposomal bupivacaine has been shown to decrease pain and narcotic use after surgery. This has not yet been studied in bariatric patients and the use of liposomal bupivacaine can potentially improve patient post-operative pain control, decrease narcotic use, decrease hospital length of stay and readmission rates and improve patient satisfaction after bariatric surgery.


Eligibility Criteria:
Inclusion Criteria:

* All patients undergoing elective laparoscopic sleeve gastrectomy or Roux-en-Y gastric bypass surgeries.
* Fulfills NIH criteria for bariatric surgery

Exclusion Criteria:

* Patients deemed not a candidate for laparoscopic bariatric surgery
* Patients with previous bariatric or gastric surgeries.
* BMI \<35 and \> 60 kg/m2
* Preoperative inability to ambulate and confined to wheelchair.
* American Society of Anesthesiologist (ASA) score \>3
* Concurrent ventral hernia repair or intraoperative extensive lysis of adhesions
* Not able to understand informed consent, or unwilling to sign consent.
* Not able to understand and read English
* Currently pregnant or lactating.
* Age \<18 or \>65
* Patients intolerant of opiates, NSAIDS, acetaminophen or local anesthetics.
* Patients requiring opiate use within 30 days prior to time of surgery.
* Patients with reported use of narcotics greater than 2 weeks in preceding year before surgery.
* Patients with history of substance abuse, alcohol addiction
* Patients with diagnosis of chronic pain, history of fibromyalgia, chronic regional pain syndrome (dystrophic pain syndrome).
* Bupivacaine use within 96 hours before operation
* Prisoners
* Bariatric surgery operation \>3 hours.
* More than 5 laparoscopic incision sites used during surgery, conversion to open operation, placement of a feeding tube or drain.
* Patients with renal failure or hepatic failure.
Surgical Technique, Open Versus Minimally-invasive Gastrectomy After CHemotherapy

Laparoscopic surgery has been shown to provide important advantages in comparison with open procedures in the treatment of several malignant diseases, such as less peri-operative blood loss, faster patient recovery and shorter hospital stay. All while maintaining similar results with regard to tumour resection margin and oncological survival. In gastric cancer the role of laparoscopic surgery remains unclear.

Current recommended treatment for gastric cancer consists of radical resection of the stomach, combined with lymfadenectomy. The extent of lymfadenectomy is considered a marker for radicality of surgery and quality of care. Therefore, It is imperative that a new surgical technique should be non-inferior with regard to radicality and lymph node yield.

Preliminary studies show promising results for laparoscopic gastrectomy, but the number of studies is small and due to lower incidence of gastric cancer in the West they are often underpowered. A prospective randomised clinical trial is indicated in order to establish the optimal surgical technique in gastric cancer: open versus minimally invasive gastrectomy.

Results of the STOMACH trial will further aid in determining the optimal surgical technique in patients with gastric cancer.


Eligibility Criteria:
Inclusion Criteria:

* Age equal to or above 18 years
* Primary adenocarcinoma of stomach, indication for total gastrectomy with curative intent.
* Neoadjuvant therapy (epirubicin, cisplatin, capecitabine)
* Surgical resectable (T1-3, N0-1, M0)
* Informed consent

Exclusion Criteria:

* Previous or coexisting cancer
* Previous surgery of the stomach
* ASA classification (American Society of Anaesthesiologists) score 4 or higher
Motor Development and Orthoses in Spinal Muscular Atrophy (SMA)

Spinal Muscular Atrophy (SMA) is neurodegenerative disease of anterior horn cells of spinal cord and represents the second more frequent pathology in childhood.

According to the age of onset and the maximum motor function the disorder is classified in 4 types. Patients with SMA II and SMA III often use orthoses to achieve postural and dynamic functions.

In this retrospective observational study the investigators describe the characteristics of sitting position, standing and walking correlated to type and time of orthoses used.

We collect data from patients with SMA II and SMA III referred to UDGEE from jan. 1995 to dec. 2008.

We estimate to achieve informations about 50-70 patients.

Eligibility Criteria:
Inclusion Criteria:

* Clinical and genetics diagnosis of SMA II and SMA III

Exclusion Criteria:

* N/A
Broccoli Sprout Extract in Preventing Lung Cancer in Smokers

RATIONALE: Chemoprevention is the use of certain drugs or substances to keep cancer from forming, growing, or coming back. The use of broccoli sprout extract may prevent lung cancer.

PURPOSE: This clinical trial is studying how well broccoli sprout extract works in preventing lung cancer in smokers.

OBJECTIVES:

Primary

* Evaluate the effect of broccoli sprout extract on levels of DNA adducts in participants who smoke.
* Determine the effectiveness of broccoli sprout extract in reducing tobacco-carcinogen induced DNA adducts in these participants.

Secondary

* Determine the effects of broccoli sprout extract on markers of the Nrf2 pathway in these participants.
* Determine the effectiveness of broccoli sprout extract, in increasing the activity of the Nrf2 pathway, in these participants.
* Evaluate the feasibility of using lymphocytes and buccal cells to monitor DNA adducts and changes in the Nrf2 pathway in these participants.

OUTLINE: Participants are stratified according to GST genotypic polymorphism (M1 vs T1).

Participants receive oral broccoli sprout extract daily for 3 weeks. Participants keep a daily diary of their eating and smoking habits for 3 weeks before, during, and for 3 weeks after study treatment. They must continue to smoke during the study, but are encouraged to quit after completing the study treatment.

PROJECTED ACCRUAL: A total of 70 participants will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Current smoker with ≥ 30 pack-year history of smoking

PATIENT CHARACTERISTICS:

Performance status

* ECOG 0-2

Life expectancy

* Not specified

Hematopoietic

* WBC \> 4,000/mm\^3
* Platelet count \> 100,000/mm\^3

Hepatic

* Bilirubin ≤ 1.5 mg/dL

Renal

* Creatinine ≤ 1.5 mg/dL

Other

* Not pregnant or nursing
* Negative pregnancy test
* Fertile participants must use effective contraception
* No other medical condition that would preclude study treatment or compliance
* No gastrointestinal condition that would affect absorption, preclude taking oral medication, or necessitate IV alimentation

PRIOR CONCURRENT THERAPY:

Surgery

* No prior surgery affecting absorption

Other

* More than 6 weeks since prior vitamins, herbal supplements, non-steroidal anti-inflammatory drugs, or antibiotics
* No concurrent dietary intake of cruciferous vegetables