cyrilzakka/clinical-trials huggingface dataset:
Cetuximab + Taxotere With Low Dose Fractionated Radiation for Head and Neck Carcinoma

Whether low-dose radiation in addition to Taxotere and Erbitux improves the response rate of patients with recurrent unresectable head and neck squamous cell carcinoma.

The investigator's approach is based on the following reasons:

* Low dose hyper-radiation sensitivity response will be significantly enhanced in Taxotere- induced G2/M cell cycle arrest.
* LDFRT will render enhanced bax activation mediated mode of cell death.
* Erbitux will arrest the cells in G1/G0 phase leading to p21-mediated mode of cell death.
* The toxicity profile is expected to be minimal.

Based on the above mentioned reasons, we propose this novel schema of treatment in recurrent SCCHN.

Eligibility Criteria:
Inclusion Criteria:

1. Patients must have pathologically confirmed recurrence (reappearance of previously cleared) squamous cell cancer primary in the upper aerodigestive tract .Patients may have experienced more than one recurrence as long as the first recurrence occurred ≥ 6 months following the end of the prior RT.
2. The recurrence must have defined bi- or uni-dimensional measurements.
3. Recurrence must be confined to the head and neck above the clavicles (loco-regional recurrence).
4. The patient must not be a candidate for surgical resection.
5. Patients must be at least 6 months from completion of prior chemotherapy and radiation therapy.
6. Patients may have received prior chemotherapy as a component of their primary treatment, but not for recurrent disease.
7. Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
8. Granulocytes ≥ 1500/mm3, platelets ≥ 100,000/mm3, serum bilirubin ≤ 1.5 mg/dl, creatinine \< 1.5 mg/dl within 3 weeks prior to registration.
9. Liver Function Tests (LFTs) ≤ 2 x normal (serum glutamic oxaloacetic transaminase (SGOT)/serum glutamic-pyruvic transaminase (SGPT)/Alkaline Phosphatase). If \> 2 x normal, liver ultrasound or CT is required to exclude metastases. If negative for metastases, patients are eligible.
10. Patients must sign a study-specific informed consent form prior to study entry.

Exclusion Criteria:

1. Distant metastases outside of the head and neck.
2. Primary disease in the nasopharynx or the salivary gland.
3. Other concurrent invasive malignancies.
4. Prior invasive malignancy unless disease free for at least two years (except prior in situ malignancies, e.g. cervix, breast, non-melanomatous skin cancer, etc. are permissible).
5. Intercurrent medical illnesses which would impair patient tolerance to therapy or limit survival.
6. Pre-existing grade ≥ 2 peripheral sensory neuropathy
7. Pregnant and nursing women are excluded because of the potential teratogenic effects and potential unknown effects on nursing newborns.
8. Prior history of sever hypersensitivity reaction to Docetaxol, Cetuximab or a drug with formulated with Polysorbate 80.
Involvement of SK3 Calcium Channel in Taxane Neuropathy

Taxane neuropathy is a common and long-term side effect of long-term morbidity in patients surviving cancer. No preventive or symptomatic treatment has been shown to be effective. Its pathophysiology is poorly known and probably multifactorial. A possible mechanism would be mediated by the activation of the SK3 calcium channel: a retrospective study carried out at the University Hospital of Tours (Carina RUA) found a significant association between the number of CAG triplets in the KCNN3 gene coding for the SK3 channel and the appearance of a taxane neuropathy.

Patients hospitalized in medical oncology day hospital at the University Hospital of Tours or CHC oncology day hospital, for their chemotherapy with taxanes (paclitaxel or docetaxel) for breast or prostate cancer, will be offered the study.

The mode of administration of chemotherapy and the usual follow-up will not be modified by the protocol The determination of the SK3 status will be made from an additional tube collected during a collection as part of the treatment at the first arrival in a day hospital (no more blood tests). Blood sample of 7mL. Shipments and analyzes of samples in Tours in the pharmacogenetics laboratory under the responsibility of Dr. BARIN-LE GUELLEC.

This study is non-invasive, without impact on the therapeutic management. The result of the polymorphism of SK3 will not be indicated in the record, so as not to influence the follow-up of the treatment and to allow an evaluation of the occurrence of peripheral neuropathy in blindness of the number of repetitions of the CAG triplet of the KCNN3 gene.

Eligibility Criteria:
Inclusion Criteria:

Breast Group

* Age ≥ 18 years
* Breast cancer
* Chemotherapy with paclitaxel or docetaxel
* Adjuvant or neoadjuvant chemotherapy in localized cancer or first-line treatment in metastatic cancer
* Signed informed consent

Prostate Group

* Age ≥ 18 years
* Metastatic prostate cancer
* Chemotherapy with docetaxel in 1st line
* Signed informed consent

Exclusion Criteria:

* Anteriority or concomitance of another chemotherapy provider of neuropathy (platinum salts)
* Another possible cause of neuropathy: diabetes, alcoholism, vitamin B9 / B12 deficiency, neurodegenerative disease, Raynaud's syndrome
Extension Study of Asenapine [P06107 (NCT01244815)] for Pediatric Bipolar Disorder (P05898)

This study will investigate the safety and tolerability of a flexible dosing regimen of asenapine for the long-term treatment of manic or mixed episodes associated with bipolar disorder I in children and adolescents who completed study P06107.


Eligibility Criteria:
Inclusion Criteria:

* Completed study P06107 and demonstrated acceptable degree of compliance with medication, visits and other study requirements
* Must be male or a female who is not of childbearing potential and is not sexually active or is using a medically accepted method of contraception; or female who is not pregnant, or not lactating.
* Must have a caregiver or responsible person living with the participant who agrees to provide support to ensure compliance with treatment, visits, and protocol procedures

Exclusion Criteria:

* Positive pregnancy test or intention to become pregnant during the study
* At imminent risk of self-harm or harm to others
* Under involuntary inpatient commitment
* Known serological evidence of human immunodeficiency virus (HIV) antibody
Phase 1b Malaria Clinical Trial Using Argemone Mexicana in Healthy Adults in Mali

The main objective is to study the pharmacokinetics, pharmacodynamics and tolerability of the decoction of the aerial parts of Argemone mexicana (AM), administered in healthy volunteers.

This is an open non comparative safety and pharmacokinetic (PK) study clinical trial. Healthy volunteers aged from 18 to 50 years old will be recruited and followed 42 days after treatment initiation as in the current World Health Organization malaria drug protocol efficacy assessment protocol.

Each volunteer will be take oral Argemone mexicana in decoction formulation. For the PK assessment purposes, 3 groups have been constituted: (i) a group will receive a unique dose of with blood withdrawal scheduled at 0 hour, 30 minutes, 1 hour, 2 hours, 4 hours, 6 hour , 8 hours and 12 hours. (ii) a group will receive two doses (morning and evening) of Argemone mexicana for 14 days with blood withdrawal scheduled at 0 hours, 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours, 3 days, 7 days and 14 days. (iii) a group will receive two doses (morning and evening) of Argemone mexicana for 14 days with blood withdrawal scheduled at 0 hour, 12 hours, 14 hours, 16 hours, 18 hours, 20 hours, 22 hours, 24 hours, 3 days, 7 days, 14 days and 21 days Safety will be assessed clinically (Clinical exam and Electrocardiography) and biologically (hematology and biochemistry parameters will be measured) throughout the 42 days of thefollow-up.

Eligibility Criteria:
Inclusion Criteria:

* age of 18-50 years old;
* be in good general health;
* be available for the duration of the study;
* agreement to participate in the study
* be a resident of the village known study;
* acceptance of the conservation laboratory specimens for future research.

Exclusion Criteria:

* Plasmodium falciparum infection with clinical manifestations;
* Presence of severe or complicated malaria;
* Acute medical condition;
* Any other medical condition that requires medical attention inconsistent with the study or interfere with the study;
* Severe medical conditions;
* Allergy to the product of the study,
* Pregnant women or nursing
* Taking a derivative product of the study or other known antimalarial within 14 days before enrollment.
* Refusal to participate
In Vivo Evaluation of the Nipro Elisio™ Dialyzer

The purpose of this study is to compare the efficacy and biocompatibility of the Nipro Elisio 210H dialyzer between two dialysis modalities, conventional hemodialysis and on line hemodiafiltration.

Hemodiafiltration, a convective-based therapy combining both diffusive and convective transports appears as the treatment modality of choice for hemodialysis patients. Indeed, this innovative technique offers an effective dialysis modality removing spectrum of uremic solutes with an optimized biocompatibility of the extracorporeal circuit obtained with use of ultrapure dialysis and sterile substitution fluids. However, such therapy can not be proposed in all dialysis centers due to major drawbacks of this technique over conventional hemodialysis, the complexity of the system and its increased costs. Alternatively, enhancement of convective transport may now be achieved by use of innovative dialyzers allowing more internal filtration. This is the case of ELISIO™-H dialyzers which possess fibers of a greater internal length which potentially allow more internal filtration. Aim of the present study was therefore to evaluate efficacy and biocompatibility of internal filtration-enhanced hemodialysis using this dialyzer compared to hemodiafiltration, over a four-month period.

Eligibility Criteria:
Inclusion Criteria:

* CKD dialysis patients on treatment with three times a week HD for more than three months
* with a stable anticoagulation scheme
* with haemoglobin level \>10.5 g/dL
* with vascular access allowing a stable blood flow of 300 mL/min during treatment

Exclusion Criteria:

* patient already enrolled in another study
* pregnancy
* symptoms or signs of acute/chronic inflammatory or infectious diseases
Study of Vorasidenib (AG-881) in Participants With Residual or Recurrent Grade 2 Glioma With an IDH1 or IDH2 Mutation (INDIGO)

Study AG881-C-004 is a phase 3, multicenter, randomized, double-blind, placebo-controlled study comparing the efficacy of vorasidenib to placebo in participants with residual or recurrent Grade 2 glioma with an IDH1 or IDH2 mutation who have undergone surgery as their only treatment. Participants will be required to have central confirmation of IDH mutation status prior to randomization. Approximately 340 participants are planned to be randomized 1:1 to receive orally administered vorasidenib 40 mg QD or placebo.


Eligibility Criteria:
Key Inclusion Criteria:

* Be at least 12 years of age and weigh at least 40 kg.
* Have Grade 2 oligodendroglioma or astrocytoma per WHO 2016 criteria.
* Have had at least 1 prior surgery for glioma (biopsy, sub-total resection, gross-total resection), with the most recent surgery having occurred at least 1 year (-1 month) and not more than 5 years (+3 months) before the date of randomization, and no other prior anticancer therapy, including chemotherapy and radiotherapy and not be in need of immediate chemotherapy or radiotherapy in the opinion of the Investigator.
* Have confirmed IDH1 (IDH1 R132H/C/G/S/L mutation variants tested) or IDH2 (IDH2 R172K/M/W/S/G mutation variants tested) gene mutation status disease by central laboratory testing during the Prescreening period and available 1p19q status by local testing (eg, fluorescence in situ hybridization \[FISH\], comparative genomic hybridization \[CGH\] array, sequencing) using an accredited laboratory.
* Have MRI-evaluable, measurable, non-enhancing disease, as confirmed by the BIRC.
* Have a Karnofsky Performance Scale (KPS) score (for participants ≥16 years of age) or Lansky Play Performance Scale (LPPS) score (for participants \<16 years of age) of ≥80%.

Key Exclusion Criteria:

* Have had any prior anticancer therapy other than surgery (biopsy, sub-total resection, gross-total resection) for treatment of glioma including systemic chemotherapy, radiotherapy, vaccines, small-molecules, IDH inhibitors, investigational agents, laser ablation, etc.
* Have features assessed as high-risk by the Investigator, including brainstem involvement either as primary location or by tumor extension, clinically relevant functional or neurocognitive deficits due to the tumor in the opinion of the Investigator (deficits resulting from surgery are allowed), or uncontrolled seizures (defined as persistent seizures interfering with activities of daily life AND failed 3 lines of antiepileptic drug regimens including at least 1 combination regimen).
Epigenetic Regulation of Altered T-cell Immunity in Sarcoidosis

Sarcoidosis is a multi-system granulomatous disorder that is triggered and influenced by gene-environment interactions. Although sarcoidosis predominantly affects the lungs in most cases, the clinical disease course is highly variable and any organ can be affected leading to end organ damage despite currently available therapeutics that unfortunately also have numerous and potentially devastating side effects. The environmental triggers of sarcoidosis are unknown but several occupational, environmental and infectious agents have been associated with sarcoidosis in susceptible hosts. Exposure to these triggers result in inflammation, characterized by activation of CD4+ T-cells, cytokine production, subsequent recruitment of other immune cells, and granuloma formation. Although several genetic markers have been associated with sarcoidosis, none fully explain individual susceptibility or clinical course variability, strongly implicating the environment and epigenetics. We have the ability to generate a map of the epigenetic histone modifications in immune cells via Chromatin Immuno-Precipitation coupled with next generation sequencing (ChIP-seq) and a map of transcriptome profiles via RNA-seq. The availability of histone and transcriptional signatures defining T cell activity in sarcoidosis will help identify the specific molecular programs affected by disease processes and can become the basis for future discovery of novel biomarker diagnostics in a clinical setting.


Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 18 and 85
* Diagnosis of sarcoidosis confirmed by either biopsy or by manifestations consistent with acute sarcoidosis in absence of other known diagnosis.
* Have a suspected diagnosis of sarcoidosis and is scheduled to undergo a biopsy procedure to confirm a diagnosis of sarcoidosis.
* Able to tolerate and willing to undergo study procedures

Exclusion Criteria:

* Current cigarette smoking or smoking within six months prior to the study
* Currently or recently (\<6months) on immunosuppressive therapy
* Pregnancy
* Patient inability to participate in the study, such as undergo venipuncture and or BAL
Supreme LMA and Endotracheal Intubation Use in Caesarean Section

The LMA Supreme (SLMA) is a single-use supraglottic device that provides a good seal for positive pressure ventilation and good first attempt insertion rate of 98% in low-risk patients undergoing Caesarean section. It has a double aperture design that facilitates the introduction of an orogastric tube to aspirate gastric contents. The current practice is to use endotracheal intubation with rapid sequence induction in general anaesthesia for Caesarean section.

The primary study hypothesis is the first attempt insertion success rate of SLMA and endotracheal intubation are equivalent with a difference of less than 3%.

We propose a randomised controlled trial to study the first attempt insertion success rate of supreme LMA versus endotracheal intubation in general anaesthesia for elective Caesarean section.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 50 years old
* ASA 1 or 2
* Fasted at least 6 hours
* Weight 40 to 75kg
* Normal airway assessment
* Singleton term pregnancy (\>36weeks)
* Elective Caesarean section

Exclusion Criteria:

* In labour
* Body mass index \>35
* Difficult airway (Mallampati 4 or abnormal airway assessment)
* Gastrooesophageal reflux disease
Clinical Trial to Assess the Safety and Efficacy of Sodium Stibogluconate (SSG) and AmBisome® Combination, Miltefosine and AmBisome® and Miltefosine Alone for the Treatment Visceral Leishmaniasis in Eastern Africa

This study is to assess if shorter combinations of SSG plus single dose AmBisome®, Miltefosine plus single dose AmBisome® and Miltefosine alone are effective in treating visceral leishmaniasis in Eastern Africa.

The current study intends to look at potential feasible short course combination therapies as well as evaluate (and possibly register) miltefosine in its conventional dose against VL in Sudan and Kenya.

Eligibility Criteria:
Inclusion Criteria:

* Patients with clinical signs and symptoms of VL and diagnosis confirmed by visualization of parasites in tissue samples (lymph node, bone marrow or spleen where relevant) on microscopy.
* Patients aged between 7 (to allow for blood sampling) and 60 years (inclusive) who are able to comply with the protocol.
* Patients for whom written informed consent has been signed by the patients themselves (if aged 18 years and over) or by parents(s) or legal guardian for patients under 18 years of age.
* HIV negative status

Exclusion Criteria:

* Patients who have received any anti-leishmanial drugs in the last 6 months/ relapse cases.
* Patients with a negative lymph node/bone marrow (or spleen) smears.
* Patients with severe protein and or caloric malnutrition (Kwashiorkor or marasmus ; Adults: BMI \</= 15, Children W/H\<70, presence of oedema)
* Patients with previous history of hypersensitivity reaction to SSG or Amphotericin B.
* Patients suffering from a concomitant severe infection such as TB or any other serious underlying disease (cardiac, renal, hepatic) which would preclude evaluation of the patient's response to study medication.
* Patients suffering from other conditions associated with splenomegaly such as schistosomiasis.
* Patients with previous history of cardiac arrhythmia or an abnormal ECG
* Patients who are female of child bearing age (all females who have achieved menarche) / pregnant or lactating.
* Patients with haemoglobin \< 5gm/dl.
* Patients with WBC \< 1 x 10³/mm³.
* Patients with platelets \< 40,000/mm³.
* Patients with abnormal liver function (ALT and AST) tests of more than three times the normal range.
* Patients with serum creatinine outside the normal range for age and gender.
* Major surgical intervention within 2 weeks prior to enrolment.
A Comparative Study Between Intrathecal Dexmedetomidine VS Ketamine With Intrathecal Bupivacaine in Orthopedic Lower Limb Surgeries.

Orthopedic anaesthesia and acute postoperative pain management, two anesthesiology subspecialties,are getting more credit for reducing hospital stays, promoting functional recovery and improving patient satisfaction.


Eligibility Criteria:
Inclusion Criteria:

-The study will include 100 adult patients (18 to 50 years old) with ASA physical status class I and class II undergoing orthopedic lower limb surgeries under itrathecal anathesia .

Exclusion Criteria:

* Patient refusal.
* Drug abuse.
* Patient with neurological, psychiatric or neuromuscular disease.
* Chronic pain on medicine.
* Known allergy to the study medications.
* Patients e contraindications to intrathecal anesthesia .
Implementing 3-Step Workout for Life in Home Health

The purpose of this project is to study how to adapt and implement the 3-Step Workout for Life program in a local home health agency. A series of learning cycles will be conducted to adjust the treatment dose and delivery mode. The specific aim is to evaluate the implementation-related clinical and patient outcomes.

Medicare beneficiaries admitted to home health agencies are often in frail status with decreased muscle strength and difficulty in performing activities of daily living. The purpose of the proposed research is to study how to adapt and implement the 3-Step Workout for Life program by the physical therapy and occupational therapy practitioners in a local home health agency. A series of learning cycles will be conducted to adjust the treatment dose and delivery mode, so that the program can be implemented at low cost but remains effective in improving self-care ability for Medicare beneficiaries. The specific aim is to evaluate the implementation-related clinical and patient outcomes.

Eligibility Criteria:
Inclusion Criteria:

* is a Medicare beneficiary
* admitted to the partnered home health agency
* show or experience muscle weakness
* demonstrate functional limitation on at least one of the OASIS self-care items

Exclusion Criteria:

* has an acute fracture with surgical or weight-bearing restrictions
* has elective joint replacement surgery
* has a lower extremity amputation
* is receiving active treatment for cancer diagnosis
* has on-going dialysis treatment
* had acute cardiac surgery
* with acute stroke or neurologic disorder that limits motor movements
* in terminal stages of congestive heart failure
* has been referred to hospice care
* has severe cognitive deficits limiting verbal communication
* has significant medical complications that preclude safe participation in resistance exercise
Electrical Stimulation for the Treatment of Back Pain Using Peripheral Nerve Stimulation (PNS)

The purpose of this study is to evaluate the effectiveness of electrical stimulation (low levels of electricity) on low back pain. This study involves the SPRINT Peripheral Nerve Stimulation (PNS) system. The System delivers mild electrical stimulation to the nerves in the low back. The System includes up to four small wires (called "Leads") that are placed through the skin into the muscles in the low back. The wires attach to device(s) worn on the body that deliver stimulation (called Stimulators).


Eligibility Criteria:
Key Inclusion Criteria:

* At least 21 years of age
* Chronic low back pain

Key Exclusion Criteria:

* Infection on or around the low back
* Conditions with increased risk of infection (e.g., valvular heart disease, compromised immune system, history of recurrent skin infections)
* Implanted electronic device
* Body Mass Index (BMI) \> 40
* Pregnant