cyrilzakka/clinical-trials huggingface dataset:
BIOpsychosocial Approach of the CAncer-RElated FAtigue (BIOCARE FActory)

One of the most common and stressful side effects of the disease and associated treatments is cancer-related fatigue. It deeply disrupts quality of life and can have a negative impact on patient survival. However, cancer-related fatigue is largely underestimated by patients and poorly taken into account by clinicians. One of the reasons for its poor management is a lack of knowledge of the underlying mechanisms and risk factors.

Although a multiplicity of factors are associated with the appearance of cancer-related fatigue, we do not know their respective share, nor the nature of their interactions. The phenomenon studied reveals complex and systemic interactions between the biological, psychological and social dimensions. Recent systematic reviews clearly identify 2 locks currently preventing a better understanding of the mechanisms of cancer-related fatigue: i) lack of longitudinal studies, ii) lack of interdisciplinary studies. It is precisely these two challenges that the BIOCARE FActory project wishes to respond to.


Eligibility Criteria:
Inclusion Criteria:

* Patient followed at the Victor Hugo Clinic, Le Mans.
* Patients aged \>or= 18 and \< 80 years old at the time of inclusion
* Patients with a histologically proven primary breast cancer from stage I to IIIc
* Naive patient of anti-cancer treatment for this cancer
* Agreement to participate in the study by written, informed and signed consent of the patient
* Affiliated patients or beneficiaries of a social security scheme
* ECOG Performance Status score ≤ 2

Exclusion Criteria:

* Comorbidity which can explain the symptoms of fatigue (Long-term illness other than cancer, chronic fatigue syndrome)
* Breathing difficulties requiring the use of respiratory assistance
* Signs of polyneuropathy, amyotrophy or myasthenic syndrome
* Contraindications to physical exercise linked to heart failure.
* Treatment based on psychostimulants, psychotropics, antidepressants, antiepileptics or benzodiazepines for more than 3 months at the time of the study
* Presence or history of psychosis, bipolarity or severe depression
* History of stroke
* History of chronic fatigue
* History of musculoskeletal disorders of the lower limbs
* Pregnancy, breastfeeding
* Patient unable to undergo protocol monitoring for psychological, social, family or geographic reasons
Will Radiation/Chemotherapy Treatment of Cervical Cancer Work Better With Medication That May Improve Anemia?

This is a clinical trial (a type of research study) designed to describe the efficacy (effectiveness) and toxicity (safety) of a new medical treatment, NESP (Novel Erythropoiesis Stimulating Protein). This study will be offered to patients with cervical cancer undergoing a combination of chemotherapy and radiation. This treatment may lower your red blood cells. The use of NESP may stimulate the body to produce more red blood cells. Our hypothesis is that higher red blood cells will be beneficial to the patient during treatment for cervical cancer.


Eligibility Criteria:
* Consent form completed and signed
* Hemoglobin between 9-13 g/dL
* Life expectancy of at least 4 months
* Karnofsky Performance Status =/\> 70
* No evidence of hemolysis, GI bleeding, or bleeding due to recent surgery
* Adequate renal and liver function
Effect of Increasing Doses of Tiopronin on Cystine Capacity in Patients With Cystinuria

The purpose of this study is to determine the minimum effective dose of the cysteine binding thiol drug (CBTD) Tiopronin on urine cystine capacity, which is a measure of cystine solubility in the urine, in patients with cystinuria to evaluate the effect of escalating doses of cystine binding thiol drugs on the cystine capacity of the urine. The overall goal will be to help guide therapy and ultimately minimize unnecessary side effects caused by larger dosages.

Cystinuria is a rare genetic disease that can lead to significant morbidity in affected patients due to the recurrent nature of the disease. This study will follow the levels of urine cystine capacity in order to help guide treatment and to use lower than usually prescribed Tiopronin doses to decrease the potential side effects while maintaining therapeutic benefit. This will increase adherence with the medications by decreasing the burden of the large number of pills that need to be taken daily.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a confirmed laboratory diagnosis of cystinuria who meet the following criteria: (1) stone analysis demonstrating cystine as a component, or (2) increased urinary cystine excretion (\>250mg/24hrs in adults).
* A medical regimen that includes Tiopronin.
* Willing to use a medically accepted form of birth control, if female and of child bearing- potential
* Ability to reliably urinate in a collection vessel and measure urine volume.
* Ability to give informed consent.
* Documentation of a stable complete blood count (CBC) and urinalysis (UA) in the six month period prior to the date of enrollment.
* Enrollment in Rare Kidney Stone Consortium (RKSC) Protocol 6401 (Cystinuria Registry)

Exclusion Criteria:

* Women who are pregnant, breastfeeding, or trying to become pregnant
* Patients with renal colic
* Patients who are scheduled to undergo a surgical procedure
* Inability to give informed consent
Effects of Brain Training Games on Cognitive Function and Quality of Life in MCI

The study aims to determine the effects of brain training games on cognitive function and Quality of life among older adults with MCI.

The study aims to determine the effects of brain training games on cognitive function and Quality of life among older adults with MCI.This study will assess the efficacy of Brain training games. Lumosity on the cognitive function and Quality of life among older adults with MCI .Beyond cognitive rehabilitation, this intervention holds promise as a cost-effective approach to delay, maintain, or even improve cognitive decline associated with the aging process.

Eligibility Criteria:
Inclusion Criteria:

* Older adults of age \>50 years and above
* Both male and female
* Education level matriculation at least
* Mild cognitive impairment ( MOCA score of 18-25)
* Active independent individuals with normal hearing and normal or corrected-to-normal vision.

Exclusion Criteria:

* Moderate to severe cognitive impairment
* Diagnosed case of dementia, depression or other mental issues.
* Current plans to move to another city.
The Utility of the Validated Intraoperative Bleeding Scale in Spine Surgery

This is a single-center, prospective, observational study that will compare the blood transfusion rate between intraoperative bleeding severity characterized using the Validated Intraoperative Bleeding Scale (VIBe).

Primary Aim: Assess the association between the VIBe scale and intraoperative and postoperative blood transfusion rates for posterior thoracolumbar spine surgery.

Primary Hypothesis: Patients with higher recorded VIBe grades during the five stages of spine surgery (exposure, decompression, instrumentation, fusion, and closing) will have a higher rate of receiving blood transfusions.

Secondary Aims: Determine the association between the VIBe scale and other postoperative outcomes and complications.

Eligibility Criteria:
Inclusion Criteria:

* Ages 18 to 88 years
* Patients receiving elective open, posterior thoracolumbar surgery

Exclusion Criteria:

* Patients receiving non-elective or trauma surgery
* Patients with pathologic spine fracture or metastatic disease to the spine
* Patients receiving thoracolumbar surgery through anterior or lateral approach
* Patients receiving spine surgery for debridement of suspected or confirmed infection
Study to Determine Effects of Vesicare on Return to Continence Post - Radical Prostatectomy (Part II)

Prostate cancer is the most common non-cutaneous malignancy in men and is the 2nd leading cause of death from cancer in men. Radical prostatectomy is one of the treatment options available for organ-confined disease. Over 100,000 radical prostatectomies cases (total removal of the cancerous prostate by surgery) are performed in the United States yearly. Unfortunately nearly all of the men undergoing surgery report diminished Quality of Life (QOL) scores due in part due to a postoperative incontinence which may require the use of multiple urinary pads per day. Many of these men also report debilitating irritative voiding symptoms of urinary urgency and frequency, and have overall decreased urinary satisfaction scores. Abatement of these symptoms can take up to one year in men, and in 5-20% of patients symptoms may persist for longer periods.

Our recent published findings suggest that instability in the bladder muscle is likely an underlying etiology in postoperative urinary incontinence. This 'Detrusor Muscle' instability results in excess contractions of the urinary bladder ('urgency to urinate'), and can result in the feeling of needing to urinate more frequently. Consistent with this hypothesis of detrusor muscle instability, men with postoperative dribbling had more complaints with urgency, frequency and bother scores when queried with validated questionnaires. We suspect that a transient bladder muscle contraction may overcome the urinary sphincter valve resistance and result in the patient's dribbling of urine.

By treating the bladder muscle instability, we expect improved postoperative continence and improved quality of life in patients after undergoing surgery for total removal of a cancerous prostate. This pilot study will assess the statistical requirements for the number of subjects needed for a fully 'powered' randomized prospective study to fully evaluate whether medications such as solifenacin significantly improve patients' quality of urinary life and improve postoperative urinary incontinence after surgery.

\*This study has been modified from the original protocol with the clinicaltrials.gov ID: NCT00581061.


Eligibility Criteria:
Inclusion Criteria:

* Patients that have been diagnosed with prostate cancer and will undergo treatment for the disease as part of standard clinical care
* Patients that have multiple pad use a few days after standard of care catheter removal

Exclusion Criteria:

* Contra-indication to Solifenacin
* Narrow angle glaucoma
* Hepatic impairment
* Renal impairment
* CYP3A4 inhibitors (e.g. Ketoconazole)
* Gastric Retention (delayed or slow emptying of the stomach)
* Lives in a different country
Comparing Reports Recorded by the Patients at the Time at Which They Feels Pain to What Patients Report at Monthly Visits to Assess Symptoms of Musculoskeletal Diseases.

Patients will be introduced to the use of a mobile application for their smartphone to record the Ecological Momentary Assessment (EMA). This app will ask the patients to assess their pain and function two times daily for 2 months.

After 1 month and at the end of the 2 months, follow-up visits will be performed and patients will be asked to retrospectively evaluate the pain that they suffered and the level of function they had during the last month.


Eligibility Criteria:
Inclusion Criteria:

* Symptomatic patients
* Patients able to give informed consent and to follow the protocol of the study (i.e. able to use a smartphone)
* Patients \>18 years
* BMI \<35 and \>18.5
* Patients with a smartphone with Android or iOS as operative systems

Exclusion Criteria:

* Patients unable to follow the protocol of the study (i.e. unable to use a smartphone, not owning a smartphone or unwilling to download or use the application)
* Patients with a diagnosis of a musculoskeletal injury but without symptoms
* Patients without a radiological examination confirming the diagnosis of musculoskeletal disease
* Patients with planned surgery in the following 60 days
* Pregnant or lactating woman
* Patients with other diseases causing pain in the involved joint (e.g. rheumatoid arthritis or other rheumatologic diseases).
* Surgical treatment in the last year and intra-articular injection in the last 6 months
One Piece Closed Pouch in Subjects With a Colostomy

A study to assess the safety and performance of an enhanced one piece closed pouch in a 12 subjects with a colostomy.

Twelve subjects are to be recruited into this 10 day single centre study to assess primarily safety in terms of adverse events and condition of the skin surrounding the stoma and condition of the stoma. Performance will also be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Of legal consenting age and able to provide written informed consent
* Is able to read, write, and understand the primary language of the investigative site.
* Have a colostomy for more than 3 months
* Currently a one or two piece closed or drainable pouch user (all attempts will be made to include ConvaTec Active Life or Esteem Plus one piece closed pouch users)
* Have unbroken peri-stomal skin (healthy normal skin to L1 on the SACs Instrument Scale # 1)
* Have a stoma considered 'normal' in appearance in accordance with the stoma, color, moisture and structure rating scales
* Be willing to wear a one piece closed pouch with moldable wafer according to the usual wear pattern of this type of pouch
* Be willing to participate in the trial for 10 days plus 1 visit prior to the in-residence study period.
* Be willing to remain in residence for 3 days at a central location
* Be willing to meet with the investigator for a total of nine scheduled visits.
* Be willing to discontinue the use of pastes, adhesive strips and rings/seals used to seal the area between the skin barrier wafer and stoma during the use of the study device
* Other than their colostomy considered to have a healthy/stable health status
* Have good manual dexterity and be able to take care of their stoma independently
* Be willing and able to complete a diary card for the duration of the study.
* Be willing to take photographs of the stoma and pouch on pouch removal

Exclusion Criteria:

* Subjects with a history of sensitivity to any one of the ostomy products or the components being studied
* Subjects with stoma duration of less than 3 months
* Subjects who currently use a belt with their usual appliance
* Subjects who have been entered into the study before, or who have previously taken part in a study in the last month.
* Subjects who require convexity or other skin fillers (pastes, seals, or rings) to even undulations of the peristomal skin
* Subjects undergoing chemotherapy or radiotherapy
* Subjects who have any other medical condition which, according to the investigator justifies exclusion from the study
Dose Exploration Intramuscular/Intravenous Prophylaxis Pharmacokinetic Exposure Response Study

This is a dose exploration study to evaluate the safety and pharmacokinetics (PK) of AZD3152 in healthy adult male and female participants, across different dose levels and routes of administration (ie, Intramuscular \[IM\] injection and Intravenous \[IV\] infusion).

The study will be conducted in the United States of America.

Eligible healthy participants will be randomized to receive either AZD3152 or placebo administered IM or IV, across 5 fixed-dose cohorts. Participants will receive a single dose of AZD3152/placebo.

Cohort 1: Dose X of AZD3152 or placebo, as an IM injection Cohort 2: Dose X of AZD3152 or placebo, administered IV Cohort 3: Dose Y of AZD3152 or placebo, as an IM injection Cohort 4: Dose Y of AZD3152 or placebo, administered IV Cohort 5: Dose Z of AZD3152 or placebo, administered IV

The study will comprise of:

* A Screening Period of maximum 28 days.
* A Treatment Period of one Day.
* A Follow-up Period of 12 months after study intervention (Day 365).

Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female participants.
* Participants have suitable veins for cannulation or repeated venipuncture.
* Negative SARS-CoV-2 RT-PCR or SARS-CoV-2 rapid antigen test result at Visit 1.
* Body weight ≥ 45 kg and ≤ 110 kg and body mass index ≥ 18 and \<32 kg/m2 at Screening.
* Able to complete the Follow-up Period up to Day 365 as required by the protocol.

Exclusion Criteria:

* History of any clinically important disease or disorder.
* Receipt of any immunoglobulin (either COVID-19 or non-COVID related) or blood products within 6 months prior to Day 1.
* Receipt of an EVUSHELD monoclonal antibody (mAb) against SARS-CoV-2 within last 15 months before Day 1.
* Receipt of a COVID-19 vaccine within 14 days prior to Visit 1.
* SARS-CoV-2 infection within one month prior to Visit 1 (confirmed either by laboratory testing or a rapid test \[including at-home testing\]).
* Women who are pregnant, lactating, or of childbearing potential and not using a highly effective method of contraception or abstinence from at least 4 weeks prior to study intervention administration and until at least 6 months after study intervention administration.
* Known or suspected congenital or acquired immunodeficiency, or receipt of immunosuppressive therapy,
* Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of study intervention. This includes any acute (time-limited) or febrile (temperature ≥ 38.0°C \[100.4ºF\]) illness/infection on day prior to or day of planned dosing; participants excluded for transient acute illness may be dosed if illness resolves within the Screening Period or may be rescreened once.
* Any abnormal laboratory values as described in protocol.
* Any known HIV or hepatitis B or C infection at Screening.
* History of alcohol or substance abuse that in the opinion of the Investigator might interfere with the trial conduct or completion.
* Known hypersensitivity to AZD3152.
* Previous hypersensitivity or severe adverse reaction following administration of a mAb.
Evaluation Of Semaglutide in Adults With Cocaine Use Disorder With and Without HIV

The purpose of this research study is to find out if semaglutide is safe and well tolerated in adults with cocaine use disorder who do and do not have human immunodeficiency virus (HIV). Participants will complete a screening process and if you are able to participate, you will be assigned to one of two treatment groups: semaglutide or placebo.

Participants will:

* Visit the clinic once a week for semaglutide or placebo injections
* Visit the clinic once every two weeks for labwork, assessments and/or surveys

STAC is a 16-week, double-blind, placebo-controlled, pilot, dose-escalation study that aims to determine the dose of semaglutide that is safe and tolerable in individuals with cocaine use disorder, including those with and without HIV; whether semaglutide improves drug use outcomes for cocaine use; and whether semaglutide improves cardiac and inflammatory biomarkers. Interested participants will be consented and screened, and after screening process is completed, all eligible participants who desire to continue with the study will be randomized either to semaglutide injections or placebo injections. Participants will receive semaglutide or placebo injections once a week from Day 0 through Week 16, and a final assessment will be completed at Week 16. Study visits will also intermittently complete labwork, medical examinations, clinical assessments and surveys.

Eligibility Criteria:
Inclusion Criteria:

1. At least 18 years old
2. Meet criteria for CUD according to the Diagnostic and Statistical Manual Version 5
3. Used cocaine at least 7 out of the past 14 days
4. Body Mass Index between 20 - 50 kg/m2
5. English proficiency
6. In people of childbearing potential, agree to use an acceptable method of birth control

Exclusion Criteria:

1. Triglycerides \> 500 mg/dL
2. History of gall bladder disease
3. Personal or family history of medullary thyroid carcinoma, or patients with a history of Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
4. History of diabetic retinopathy
5. Being prescribed glucose-lowering medications
6. An estimated glomerular filtration rate of less than 45 ml/min
7. Lifetime history of taking semaglutide or other GLP-1 RAs
8. Current suicidal ideation or suicide attempts within the past 24 months
9. Present diagnosis of diabetes mellitus OR screening hemoglobin A1C \>/= 6.5
10. Use of weight-lowering medications
11. History of gastric bypass surgery
12. History of myocardial infarction or stroke within the past 12 months
13. Pregnant, breastfeeding, or the patient intends to become pregnant during the next four months
14. Any contraindicated medical issues identified by the study investigators
15. Risk of conditions that are under Warning and Precautions section of OZEMPIC and WEGOVY including but not limited to known history or current report of clinically relevant hypoglycemia, gastroparesis, or pancreatic disease.
16. Calcitonin value equal to or above 50 ng/L
Combined Pericapsular Nerve Group Block and Lateral Femoral Cutaneous Nerve Block for Pediatric Hip Surgeries

combined pericapsular nerve group PENG block and lateral femoral cutaneous nerve block may be effective in reducing post-operative pain after open hip surgery in children.

All children will be assessed clinically, and investigations will be done to exclude the exclusion criteria mentioned above. Laboratory works needed: complete blood count (CBC), prothrombin time, concentration, partial thromboplastin time. Midazolam (0.5mg/kg) will be given orally to each child in both groups as a premedication half an hour before the procedure.

General anesthesia will be induced in a supine position under standard basic monitoring of vital signs with inhalational anesthetic using (100%) O2 + Sevoflurane.

Group C will receive caudal analgesia Bupivacaine 0.25% at a dose of 1 ml/kg. Group B will receive PENG block Bupivacaine 0.25% at a dose of 1 ml/kg and lateral femoral cutaneous nerve block Bubivacaine 0.25% at 0.1 ml/kg.

After receiving the block, a surgical incision will be done after 15 minutes. Continuous recording of heart rate and blood pressure will be carried out from the moment of injection at timely intervals intra-operative. Intra-operatively, an increase in hemodynamics in response to the skin incision by more than 30% from baseline values 5 min after intubation or thereafter is managed by intravenous administration of fentanyl 1 µg/kg to a maximum dose of 2 µg/kg. Postoperative pain assessment using the FLACC score will then follow for 24 hours.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) physical status I, II.
* Unilateral hip surgery.

Exclusion Criteria:

* Parents' refusal to participate in the study.
* Coagulopathy (i.e. Platelets ≤ 50,000 and/or INR\> 1.5).
* Localized infection at the site of needle insertion.
* Known hypersensitivity or allergies to any of the used drugs.
* Bilateral hip surgery in the same session.