cyrilzakka/clinical-trials huggingface dataset:
Benefits of a Cannabidiolic Acid Topical Cream for the Treatment of Restless Leg Syndrome

The goal of this open label clinical trial is to reduce the effects of restless leg syndrome. The main it questions it aims to answer are:

1. Reduce or eliminate the symptoms of restless leg syndrome.
2. Improve the quality of life of participants with restless leg syndrome.

Participants will be asked to apply the topical cream to the affected area 30 to 45 minutes before bedtime for 14 consecutive days.

Restless Leg Syndrome (RLS) is multifactorial disease state with many different potential pathophysiological mechanisms, which includes dysfunctions from the cerebral cortex and spinal cord to mechanosensitive channels at the musculoskeletal periphery.1 Most therapeutic agents' effectiveness focuses on the CNS (e.g., dopaminergic drugs) or Renshaw cells. To our knowledge, therapeutic agents that are focused on the periphery were not very effective.

This technology focuses on the peripheral musculoskeletal component of the disease and is directed at treatment modalities that correct the dysfunction of mechanosensitive channels. By combining what is known about cannabinoids activity at the transient receptor potential channel of ankyrin 1 (TRPA1)2 and the role TRPA1 plays in regulating the shape and rigidity of the surrounding membrane structure at the Piezo channels3, an effective therapy at the site of discomfort should emerge. Moreover, the lessening of membrane tension is imparted by molecules that readily penetrate the membrane4, which Chylobinoid, the topical active ingredient, is uniquely designed to do.

Eligibility Criteria:
Inclusion Criteria:

* Patients with at least 3 month-course of symptomatic restless leg syndrome
* Must meet International Restless Legs Syndrome Study Group (IRLSSG) criteria of at least mild symptoms.
* Age \> 18 years, including both males and females
* Patient provides informed consent

Exclusion Criteria:

* Previous operative procedure for treatment of RLS;
* Current use of TENS (transcutaneous electrical nerve stimulation or plasma exchange;
* Allergy to Cannabidiol (CBD) Cannabidiolic acid (CBDa), or any other ingredient contained in the topical cream;
* Pregnant participants (participants who have the potential for being pregnant will sign a waiver), or breast feeding;
* History of recreational substance abuse, fibromyalgia, Chronic Regional Pain Syndrome (CRPS), psychiatric history including but not limited to schizoaffective disorder, bipolar disorder, chronic depression, and suicidal ideation;
* Conditions affecting capacity and adherence to study regimen including but not limited to dementia/delirium, Alzheimer's, Down's syndrome;
* A need for elective surgery involving preoperative or postoperative analgesics or anesthetics during the study period;
* No recent cannabinoid use in the last 2 months, and no use during the study.
A Phase 1, Dose Finding Study of CC-90002 in Subjects With Advanced Solid and Hematologic Cancers

CC-90002-ST -001 is an open-label, Phase 1, dose escalation clinical study in subjects with advanced, refractory solid and hematologic cancers.

CC-90002-ST-001 is an open-label, Phase 1, dose escalation, first in human (FIH) clinical study of CC-90002, administered by intravenous (IV) infusion, in subjects with advanced, refractory solid and hematologic cancers.

The study will be conducted in two parts. Part A dose escalation phase will explore escalating dose cohorts of the study drug CC-90002.

Part B dose escalation will explore escalating doses of CC-90002 in combination with rituximab in subjects with CD20-positive NHL.

Eligibility Criteria:
Inclusion Criteria:

1. Men and women, 18 years or older, with advanced, relapsed or refractory solid tumors, Multiple Myeloma (MM) or non-Hodgkin's lymphoma (NHL) in Part A. In Part B, relapsed and/or refractory CD20-positive NHL subjects only.
2. At least one site of measurable disease in subjects with solid tumors and NHL.
3. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.
4. Subjects must have adequate hematopoietic, liver, renal and coagulation function as assessed by specific laboratory criteria.
5. Females and males must agree to contraceptive methods and avoid conceiving throughout the study, and for up to 8 weeks following the last dose of CC-90002. If participating in Part B, females of child bearing potential should continue to use effective contraceptive methods for 12 months following treatment with rituximab

Exclusion Criteria:

1. High grade lymphomas (Burkitts or lymphoblastic), plasma cell leukemia.
2. High grade, rapidly proliferative solid tumors (eg, small cell lung cancer, germ cell tumors, neuroblastoma) with extensive tumor burden.
3. Symptomatic central nervous system involvement.
4. Impaired cardiac function or clinically significant cardiac disease.
5. Prior Red blood cell (RBC) transfusion \< 3 months prior to starting CC-90002 (Part A only).
6. Prior autologous stem cell transplant ≤ 3 months prior to starting CC-90002.
7. Prior allogeneic stem cell transplant with either standard or reduced intensity conditioning ≤ 6 months prior to starting CC-90002.
8. Prior systemic cancer-directed treatments or investigational modalities ≤ 5 half lives or 4 weeks prior to starting CC-90002, whichever is shorter.
9. Major surgery ≤ 2 weeks prior to starting CC-90002.
10. Pregnant or nursing females.
11. Known HIV infection.
12. Known chronic, active hepatitis B or C (HBV/HCV) infection.
13. Ongoing treatment with chronic, therapeutic dosing of anti-coagulants.
14. History of autoimmune hemolytic anemia or autoimmune thrombocytopenia.
15. History of concurrent second cancers requiring active, ongoing systemic treatment.

concurrent second cancers requiring active, ongoing systemic treatment.
Topiramate and Severe Obesity

The purpose of this study is to evaluate the efficacy of Topiramate on the decrease of Body Mass Index compared to placebo at 9 months.

Childhood obesity remains through adulthood in main cases, and is associated with an early increase of cardiovascular risk and an excess mortality in young adults due to stroke and cancer.

Bariatric surgery is very rare in France for children and can cause severe complications. Long term effects are still unknown.

Topiramate is already use in thousands of children in neurology, its effects are already well known, and no lethal complication is reported.

The hypothesis is that Topiramate associated with standard treatment of obesity is more effective than standard treatment alone.

This will be a 4.5-years, randomized, double-blind, placebo-controlled, clinical trial of topiramate (9 months) vs placebo (9months) for Body Mass Index reduction in 160 adolescents (ages 9-17 years old) with severe obesity.

The main objective is to evaluate the efficacy of Topiramate on the decrease of Body Mass Index compared to placebo at 9 months.

The secondary objectives are to evaluate:

* the decrease of Body Mass Index Z-score
* the tolerance of Topiramate
* the effectiveness of Topiramate on weight decrease and decrease of Body Mass Index and Body Mass Index Z-score at 1, 3 ,4 and 6 months
* the effectiveness of Topiramate on eating behaviour, physical activity, calculated with validated questionnaires and scales at 6 and 9 months
* the pharmacokinetic of Topiramate in obese children and adolescents

Eligibility Criteria:
Inclusion Criteria:

* 9-17 years old
* Body Mass Index Z-score ≥ 4 SD of French reference
* Weight at enrolment ≥ 50 kg
* Therapeutic failure \> 6 months
* For girls of childbearing age, willing to have an acceptable method of contraception (no estrogens plus progestin)
* Negative pregnancy test for girls of childbearing age
* Agreeing to participate upon written informed consent
* Appropriate understanding of the study

Exclusion Criteria:

* Syndromic or secondary obesity
* Major neurological or psychiatric disorder
* Current or history of suicidal thought/attempts
* Current or history of breakdown
* Previous bariatric surgery
* Severe hypercapnia
* Renal dysfunction
* Deformity in the urinary tract or solitary kidney
* History of renal lithiasis or glaucoma
* Poorly controlled diabetic children or adolescents (HbA1c \>10%) and diabetic patients treated with Metformine and/or glibenclamide
* Hepatic dysfunction
* Bicarbonate ≤16 mmol/L
* Known hypersensitivity to the active substance or to one of the excipients
* Intolerance to saccharose
* Enrolment in another therapeutic study
* High probability to fail to comply with treatment
* Females: Pregnant, planning to become pregnant
* No signature on consent form
* Uncovered by the French National health Insurance system (Sécurité sociale)
Trial of Adjuvant Chemotherapy in Breast Cancer Patients With Pathological Partial Response and Complete Response to Neoadjuvant Chemotherapy

This trial will compare the administration of 2 cycles of paclitaxel and cisplatin (DP) versus 4 cycles of CEF as adjuvant chemotherapy for the patients with locally advanced breast cancer and who were pathological partial response to DP as neoadjuvant chemotherapy. Those who had pathological complete response to DP will be randomized to have 2 cycles of DP or have no further chemotherapy.

All the patients who had neoadjuvant chemotherapy and had pathological complete response (pCR) or partial response to DP will enrolled in this trial. Those who had pCR will randmized to have two cycles of DP as adjuvant chemotherapy or have no further chemotherapy. Those patients who had PR will be randomized to have two cycles of DP or four cycles of CEF. All the patients with hormonal receptor positive or Her2 overexpress tumors are allowed to accept endocrine therapy or anti-Her2 target therapy.

Eligibility Criteria:
Inclusion Criteria:

1. Women aged ≥18years and ≤70 years;
2. Patients with locally advanced breast caner and had weekly paclitaxel and cisplatin as neoadjuvant chemotherapy.
3. Patients with pathological partial response or pathological complete response to neoadjuvant chemotherapy according to the Response Evaluation Criteria in Solid Tumors (RECIST).
4. Endocrine therapy and trastuzumab were allowed to use.
5. ECOG 0-2;
6. Adequate bone marrow function:WBC≥4.0×109/L, Absolute neutrophil count（ANC）≥1.5×109/L, Platelets（PLT）≥100×109/L, Hemoglobin（Hb）≥90g/L;aspartate aminotransferase(AST),Alanine aminotransferase (ALT)≤1.5 upper normal limit (UNL), creatinine≤1.5 UNL, bilirubin≤1.5UNL;
7. No obvious main organs dysfunction.

Exclusion Criteria:

1. Unwilling or unable to use an acceptable method of contraception in 8 weeks (including 8 weeks) after final dose of test drug;
2. Patient is pregnant or breast feeding;
3. Metastatic breast cancer;
4. Any evidence of sense or motor nerve disorders;
5. Patients with medical conditions taht indicate intolerant to neoadjuvant therapy, including uncontrolled cardiovascular disease, severe infection;
6. Any concurrent malignancy other than breast cancer;
7. Know severe hypersensitivity to any drugs in this study.
Educational Intervention - Improving Knowledge and Screening Rates for Colorectal Cancer

This clinical trial studies how well educational intervention works in improving knowledge and screening rates of colorectal cancer. An educational intervention, such as viewing an inflatable colon, PowerPoint presentation, or flip books/flipcharts, may help improve knowledge about colorectal cancer and how often people get checked for colorectal cancers.

PRIMARY OBJECTIVES:

I. To increase colorectal cancer (CRC) knowledge, attitudes, positive behavior change, intent for screening, and screening among at-risk groups.

OUTLINE:

Participants attend educational sessions comprising of an inflatable colon interactive exhibit that allows visitors to walk through a colon while seeing images, or a PowerPoint presentation that contains messages that are tailored to meet the cultural and linguistic needs of Black/African Americans, Appalachians, and Hispanics/Latinos, and flip books/flip charts. Participants also receive a copy of the study information sheet which contains the basic elements of informed consent and a pre-education session knowledge survey.

Eligibility Criteria:
Inclusion Criteria:

* Participants from Franklin County or from Appalachia Ohio (depending on program location)
Clinical Study of Self-gripping Mesh in TAPP Versus Lichtenstein Hernia Repair

The goal of this prospective study is to compare the clinical efficacy of self-gripping mesh in laparoscopic transabdominal preperitoneal versus Lichtenstein hernia repair, in order to improve the outcome of inguinal hernia treatment. The main question it aims to answer is, in which procedure is the self-gripping mesh more effective.

Participants will be divided into the TAPP group and the Lichtenstein group by random number table method, the TAPP group underwent laparoscopic transperitoneal preperitoneal hernia repair, and the Lichtenstein group underwent Lichtenstein hernia repair, both groups used self-gripping meshes.

Researchers will compare the operation time, postoperative time out of bed, postoperative hospital stay, hospital costs and postoperative complications between the two groups to see the clinical efficacy of self-gripping mesh in laparoscopic transabdominal preperitoneal versus Lichtenstein hernia repair.


Eligibility Criteria:
Inclusion Criteria:

* Male patients aged 18 years and older.
* Patients with a definite diagnosis of unilateral primary inguinal hernia.
* Patients and their families were informed about the study protocol and agreed to participate in the study.

Exclusion Criteria:

* Patients with femoral, recurrent, bilateral, incarcerated and strangulated hernias.
* Patients with previous history of lower abdominal surgery.
* Patients with contraindications to anaesthesia.
* Patients with contraindications to laparoscopic surgery.
* Failure to follow up patients as scheduled.
* Patients with abdominal infections.
* Those who cannot tolerate general anaesthesia surgery due to serious coagulation disorders, cardiopulmonary disorders, etc.
Health Related Quality of Life (HrQoL) in Classical Homocystinuria (CBS Deficiency)

Patients, parents of young / handicapped patients, and experts will be interviewed to collect contents relevant for HrQoL in CBS deficiency. Based on these data, a questionnaire will be developed and tested for comprehensibility in patients and parents of young / handicapped patients. A final questionnaire version will be tested for psychometric criteria including validity and reliability.


Eligibility Criteria:
Inclusion criteria

* Patients with CBS deficiency from age 8 years
* Parents of patient(s) \< 18 years with cognitive impairment
* Parents of patients between age 4 and 7
* Experts on CBS deficiency
* Able to give informed consent as documented by signature

Exclusion criteria

- Sufficient command of the German or the English language
ROPI Study : Ropivacaine Interest in Postsurgical Pain After Mastectomy

After surgery for breast cancer, the prevalence of chronic pain is estimated between 20 and 68%. They begin after surgery and may persist until more than 6 months. They respond poorly to opioid analgesics impair the quality of life.

Among the different postoperative analgesic techniques used, the use of a local anesthetic infiltration continues catheter has advantages including improving the quality of analgesia, with a significant decrease in average of VAS (scale visual Analogue), a decrease in morphine consumption, improving the quality of life of patients.

Our study aims to evaluate the effectiveness of a continuous local anesthetic infiltration in the control of postoperative pain after mastectomy.


Eligibility Criteria:
Inclusion Criteria:

Age\> 18 years

* ASA I-II, WHO 0-1
* mastectomy alone, mastectomy + GGS + mastectomy CA
* No previous history of chronic pain requiring regular intake of analgesics or long-term
* Failure to take opioids within 30 days before surgery

Exclusion Criteria:

* Long-term treatment analgesic or taking opioids within 30 days before surgery
* Concurrent treatment with a drug test, participation in another therapeutic clinical trial within \<30 days
* proven allergy to local anesthetics of the amide
* Skin Inflammation
* Sepsis local
* Kidney failure, liver failure, severe or poorly controlled diabetes
* Inability to respond to the assessment of pain using a visual analogue scale (VAS) or a numerical scale (FR).
* mastectomy with immediate breast reconstruction
Health Effects of Milk Proteins in Elderly Subjects

The aim of the present study is to investigate effects of milk on body composition and muscle strength, inflammation, appetite, DNA damage/repair and PBMC whole genome transcriptomics in elderly subjects.


Eligibility Criteria:
Inclusion Criteria:

* ≥ 70 years of age
* reduced gait speed or
* reduced "five times sit to stand test" or
* reduced "timed step stair test " or
* reduced grip strength
* Stable body weight (last 3 months)
* Mini Nutritional Assessment (MNA®) score ≥ 17
* Mini-mental status (MMSE-NR) score: ≥ 24
* Willing to participate according to the protocol

Exclusion Criteria:

* Allergy/intolerance to milk/dairy products
* High intake of milk and yoghurt
* Physical active subjects
* Known diabetes type I or II, or HbA1c ≥ 6,5%
* Recent events of acute cardiovascular disease including stroke
* Rapidly evolving diseases (active malignancy) or history of cancer (malignant tumors) last 3 years.
* Severe inflammation-related diseases such as e.g. Crohn disease and arthritis
* Chronic obstructive pulmonary disease
* Increased blood pressure
* High intake of alcohol
* Reduced kidney function (GFR \< 45 ml/min)
* Increased hsCRP, ASAT, ALAT
* Increased or suppressed TSH
* Hormone therapy
* Systemic use of glucocorticosteroids (anti-inflammatory steroid hormones). Use of spray and inhalator use is not exclusion.
* Disability preventing physical tests
* Using medications known to affect protein metabolism
Couples Intervention to Improve Mental Health

Over the last decade, suicide rates have risen within the military and have remained high. Converging evidence suggests that suicide prevention efforts may be enhanced by explicitly including family members in treatment. The study's objectives are to test the effect of the CCRP, a targeted single session couples intervention on suicide ideation among military service members and Veterans, and to understand how the use of the CCRP impacts suicide risk during the 6 months immediately postdischarge from a psychiatric inpatient unit.

Over the last decade, suicide rates have risen within the military and have remained high. Converging evidence suggests that suicide prevention efforts may be enhanced by explicitly including family members in treatment, however no couple-bases suicide-specific interventions exist.

The study's objectives are to test the effect of the Couples Crisis Response Plan (CCRP), a targeted single-session couples intervention, on suicide ideation among military service members and Veterans, and to understand how the use of the CCRP impacts suicide risk during the period of time immediately post-discharge from a psychiatric inpatient unit. The CCRP will be compared to an active control condition (mental health education).

The primary aim is to compare the effect of the CCRP to an active control condition on suicide ideation in the 6 months following treatment among military service members and Veterans who have been psychiatrically hospitalized for acute suicide risk and their partners. The CCRP is specifically adapted for use with partnered service members at elevated risk for suicide. A secondary aim is to determine how use of the CCRP skills impacts suicidal ideation over time and identify the role partners play in encouraging use of the plan and managing suicide risk.

Eligibility Criteria:
Inclusion Criteria:

1. military service member (active duty or veteran) of any branch or component that has served since 9/11/2001 or the partner of such a service member;
2. that the service member reports active suicide ideation and/or a suicide attempt within the previous 30 days;
3. that the service member is in a committed, exclusive, cohabiting relationship of at least 6 months;
4. the willingness of the service member's partner to participate in research.

Exclusion Criteria:

1. a psychiatric condition, medical condition, or cognitive disability/deficit that precludes the ability of either partner to provide informed consent
2. physical aggression within the past year reported by either partner on a behaviorally-anchored screener for moderate to severe partner violence or extreme relationship distress (a score of of less than 9 on the Couples Satisfaction Index-4)
3. inability of either partner to read or speak English
Maternal Oxygen Administration for Fetal Distress

Supplementary oxygen is routinely administered to patients, even those with adequate oxygen saturations, in the belief that it increases oxygen delivery. However, oxygen delivery depends not just on arterial oxygen content but also on perfusion.

Maternal oxygen administration has been used in an attempt to lessen fetal distress by increasing the available oxygen from the mother. However, the effect of supplemental maternal oxygen therapy on fetal acid base status has been debated for more than seven decades.

Hypothesis: Prophylactic maternal low flow nasal oxygen administration during the second stage of labor can relieve fetal distress.

A report from the cochran library (Cochrane Database Syst Rev. 2012 Dec 12;12:CD000136.):

Too little evidence to show whether oxygen administration to the woman during labour is beneficial to the baby.

Some babies show signs of distress, such as unusual heart rates or the passing of a bowel motion (meconium) during their mother's labour. This may be caused by a lack of oxygen passing from the woman to the baby through the placenta. Sometimes, women may be encouraged to breathe extra oxygen through a facemask (oxygen administration) to increase the oxygen available to the unborn baby. A review of two trials found too little evidence to show whether oxygen administration to the woman during the second stage of labour is beneficial to the baby. No trials of oxygen administration when the baby is showing signs of distress were found. Further research is needed.

Eligibility Criteria:
Inclusion Criteria:

* at term
* singleton
* primigraida
* cephalic presentation
* spontaneous or induced labor
* normal labor
* normal FHR tracings in the first stage
* at the onset of second stage

Exclusion Criteria:

* respiratory disease
* cardiovascular disease
* diabetes mellitus or insulin-treated gestational diabetes mellitus
* hypertension or preeclampsia
* oligohydramnios
* fetal growth restriction
* placental abruption
* anemia
* disorders in oxygen saturations
* received oxygen therapy in the first stage