cyrilzakka/clinical-trials huggingface dataset:
Nivolumab-ipilimumab and Chemoradiation for Cervical Cancer

A total of 112 patients with locally advanced cervical cancer will be randomized 1:1 to standard therapy with cisplatin-based chemoradiation or nivolumab-ipilimumab induction followed by cisplatin-based chemoradiation. The primary outcome will be 3-year disease-free survival.

Patients with adenocarcinoma or squamous cell carcinoma of the cervix, FIGO Stage IB2-IB3 node positive or Stage IIB-IVA will be randomized to conventional cisplatin-based chemo-radiation or to 4 cycles of induction immunotherapy with nivolumab 1mg/kg and ipilimumab 3mg/kg every 3 weeks, followed by cisplatin chemo-radiation with concurrent nivolumab 240mg every 2 weeks. Primary outcome will be 3-year progression-free survival.

Eligibility Criteria:
Inclusion Criteria:

* Female participants older than 18 years
* Documented evidence of cervical adenocarcinoma or squamous carcinoma FIGO Stage IB2-IB3 node positive or Stage IIB-IVA
* No prior chemotherapy, immune checkpoint inhibitors or radiotherapy for cervical cancer
* WHO/ECOG performance status of 0-1
* At least 1 lesion, not previously irradiated, that qualifies as a RECIST 1.1 Target Lesion at baseline.

Exclusion Criteria:

* Diagnosis of small cell (neuroendocrine) histology cervical cancer
* Intent to administer a fertility-sparing treatment regimen
* Undergone a previous hysterectomy
* Evidence of metastatic disease per RECIST 1.1 including lymph nodes ≥15 mm (short axis) above the L1 cephalad body or outside the planned radiation field.
* History of allogeneic organ transplantation
* Active or prior documented autoimmune or inflammatory disorders
* Uncontrolled intercurrent illness
* History of another primary malignancy and active primary immunodeficiency
* Patients with active infection

Laboratory values that fall into:

1. WBC count (WBC) \< 2000/μL ;
2. Neutrophil count \< 1500/μL;
3. Platelet count \< 100 x 103/μL;
4. Hemoglobin level \< 9.0 g/dL;
5. Serum creatinine \> 1.5 x upper limit of normal (ULN) unless creatinine clearance is

   ≥ 40 mL/min (measured or calculated using the Cockcroft-Gault formula);
6. Aspartate aminotransferase (AST)/Alanine aminotransferase (ALT): \> 3.0 x ULN;
7. Total bilirubin \> 1.5 x ULN (except participants with Gilbert Syndrome who must have a total bilirubin level of \< 3.0 x ULN);
8. Any positive test result for hepatitis B virus or hepatitis C virus that indicates the presence of the virus, for example, positive Hepatitis B surface antigen (HBsAg, Australia antigen) or Hepatitis C antibodies (anti- HCV) positive (unless the HCV-RNA is negative).

   * Participants with a condition requiring systemic treatment or with corticosteroids (\>10 mg daily of a prednisone equivalent) or other immunosuppressive drugs within 14 days of initiating study treatment.
   * Pregnant or breastfeeding woman
Dosage of Serum Tryptase Levels in a Population of Premature Newborns to Evaluate Mast Cell Activity

Compare serum tryptase levels of premature babies (\<37 weeks of amenorrhea) to children born at full term.

Study the evolution of serum tryptase levels in premature babies(\<37 weeks of amenorrhea). Study the relationship between the onset of infectious complications, mainly the type of necrotizing enterocolitis seen in premature babies (\<37 weeks of amenorrhea) and the evolution profile of serum tryptase levels.

It seems appropriate to believe that prematurity associated or not with a genetic-related sensitivity, involving several signaling pathways, makes children more vulnerable to different environmental, infectious factors that could trigger the different pathologies of premature babies. Mast cell, via its mediators, seems to play a key role.

Dosage of serum tryptase levels which is easily accessible and the work by Vitte let us imagine that the younger the child, the greater the mast cell expression, thus opening a capital pathway in the comprehension of immune system phenomena in premature babies and investigators can hope that by performing regular workups of serum tryptase levels, investigators could validate that some premature babies will express this activity in a more important manner. The relationship to eventual pathological phenomena such as necrotizing enterocolitis, but also bronchopulmonary dysplasia could then be highlighted.

Eligibility Criteria:
Inclusion Criteria "Patients" :

* all premature babies (\<37 weeks of amenorrhea)
* managed in the first 24 hours of life at the Reims university hospital
* parents accepted to participate in the research - social security card

Inclusion Criteria "Controls" :

* children born full term, just after each "patient" child included
* managed in the first 24 hours of life at the Reims university hospital
* parents accepted to participate in the research.

Exclusion Criteria "Patients" and "Controls"

* Not managed in the first 24 hours of life at the Reims University Hospital,
* Person, who has parental authority, protected by law,
* Newborns with a life and death emergency in the first 24 h of life,
* Person, who has parental authority, under age 18
Meal Glycaemic Index and Exercise After Gastric Bypass

The study will evaluate postprandial glucose excursions and gut hormone secretion after ingestion of meals with different glycaemic index (GI) values (high vs low) followed by an acute bout of exercise or rest in gastric bypass operated subjects and matched control subjects.


Eligibility Criteria:
RYGB patients:

Inclusion Criteria:

* Undergone Roux-en-Y gastric bypass (RYGB) without complications at least 12 months prior to inclusion.
* Achieved \> 50% Excess BMI Loss
* Weight stability (no fluctuations over ± 5 kg the last 3 months)
* HBA1c \< 48 mmol/mol before and after surgery without the use of anti-diabetic medication
* The participant must be able to ingest the meals

Exclusion Criteria:

* Low hemoglobin levels (\< 6.5 mM)
* Pregnancy (determined by human chorionic gonadotropin (hCG) test) or breastfeeding
* Dysregulated thyroid gland affection
* The use of medication which affects heart frequency (i.e. Beta-blockers)
* Complications following RYGB consisting of dysphagia or other problems associated with ingestion of normal foods (i.e. vomit, diarrhea or strong abdominal pain).

Control group:

Inclusion Criteria:

* Matched with the RYGB patients on gender, age (± 5 years), menopausal state (pre- versus post-menopausal) and BMI (± 3 points).
* Weight stable ( ± 5 kg during 3 months)
* HBA1c \< 48 mmol/mol

Exclusion Criteria:

* Prior bariatric surgery or prior surgery in the upper gastrointestinal tract.
Chromium and Insulin Resistance

Chromium is an essential nutrient for the maintenance of normal glucose tolerance and its deficiency causes insulin resistance. Chromium administration has also been shown in several studies to lower glucose and insulin levels in patients with type 2 diabetes. Accordingly, we propose to perform a placebo-controlled study of chromium picolinate administration in a cohort of non-obese, non-diabetic, insulin resistant subjects. These subjects will be randomized to 16 weeks of therapy with either 500 mcg twice a day of Chromium or placebo.

Chromium is an essential nutrient for the maintenance of normal glucose tolerance and its deficiency causes insulin resistance. Chromium administration has also been shown in several studies to lower glucose and insulin levels in patients with type 2 diabetes. Moreover, studies in humans, animals and cell culture indicate that chromium enhances insulin signaling. While these studies suggest that chromium administration increases insulin sensitivity, it has not been directly demonstrated that chromium has an effect in well defined insulin resistant subjects independent of hyperglycemia. Accordingly, we propose to perform a placebo-controlled study of chromium picolinate administration in a cohort of non-obese, non-diabetic, insulin resistant subjects. The insulin sensitivity of 80 subjects will be measured by a euglycemic insulin clamp. Approximately 40 insulin resistant subjects will be randomized to 16 weeks of therapy with either 500 ug twice a day of chromium picolinate or placebo. To quantitate the chromium-induced improvements, euglycemic hyperinsulinemic clamps to evaluate insulin sensitivity, OGTT using deuterated glucose to evaluate glycolytic glucose disposal, and muscle biopsies to evaluate insulin signaling pathways, will be performed before and after treatment. We believe these studies will (1) confirm the beneficial effect of chromium on insulin sensitivity; (2) further our understanding of the molecular mechanisms of chromium action; and (3) because these insulin resistant subjects are at risk for the development of type 2 diabetes, the Metabolic Syndrome, and coronary artery disease (CAD), a demonstration of the beneficial effects of chromium on insulin action could ultimately have important public health consequences.

Eligibility Criteria:
Inclusion Criteria:

* Not exercising regularly, healthy, non-diabetic.

Exclusion Criteria:

* Diabetes, heart disease, hepatitis, HIV, impaired glucose tolerance, abnormal liver enzymes, abnormal TSH levels, other abnormal lab values.
A Study to Assess the Safety, Tolerability and Clinical Activity of TD-1211 in Patients With Opioid-Induced Constipation

A dose-escalation study to assess the safety, tolerability and clinical activity of TD-1211 in patients with opioid-induced constipation.


Eligibility Criteria:
Inclusion Criteria:

* Males and females between 18 and 65 years of age, inclusive
* Subjects with documented OIC on stable opioid regimen
* Willingness to stop all laxatives throughout run-in and treatment period

Exclusion Criteria:

* Any clinically significant findings in subjects with OIC
* Have participated in another clinical trial of an investigational drug 30 days prior to screening
* History of chronic constipation prior to opioid therapy in OIC subjects
* Active medical disorders associated with diarrhea or intermittent loose stools in OIC subjects
Safety and Efficacy Study of Fentanyl Buccal Tablet Use in the Emergency Department for Isolated Extremity Injury

The primary purpose of this study is to evaluate fentanyl buccal tablet (FBT) for analgesia in comparison to standard analgesia, to determine if the FBT allows for faster achievement of "significant analgesia"

The subjects/patients will be asked if they would desire a low dose or high dose pain medication regimen. The low dose (low-FBT) group will receive FBT at a dose of 100 mcg, as well as an oral (pill) placebo preparation. The low dose (low-control) group will receive an "inactive comparator" (lansoprazole rapidly-dissolving buccal 15mg, " FBT placebo") and a dose of 5/325 Percocet tablet (oxycodone/acetaminophen 5/325). The high dose (high-FBT) group will receive 200 mcg FBT plus 2 placebo tablets. The high dose (high-control) group will receive the "FBT placebo" and a dose of 2, 5/325 Percocet tablets.

Eligibility Criteria:
Inclusion Criteria:

* pain sufficient to warrant medication stronger than acetaminophen (Tylenol) or aspirin
* only if Emergency Department provider approves
* a negative pregnancy test is required for participation for women of childbearing age

Exclusion Criteria:

* If treating provider determines intravenous analgesia is required
* allergy to acetaminophen or any opiate/opioid, or lansoprazole patients currently taking phenothiazines, CNS depressants (including alcohol), or if they have taken an monoamine oxidase inhibitor (MAOI) or selective serotonin reuptake inhibitor (SSRI) in the past two weeks
* if patient has already been administered an opioid analgesic for their current injury
* patients on chronic opioids therapy or a history of opioid abuse
* breastfeeding mothers
* patients who plan to drive home after their emergency department visit
* history of phenylketonuria (due to phenylalanine in the formulation of the lansoprazole solutab)
Management of Dyslipidemia in Adult Type 2 Diabetes Patients in India

The purpose of study to assess the control of dyslipidemia in the Indian diabetic population treated with any hypolipidemic agent.


Eligibility Criteria:
Inclusion Criteria:

* Adult who is a known Type 2 diabetic as per the ADA 2010 criteria OR controlled diabetic (taking any antidiabetic medication)
* Patients in the study will have been on lipid lowering drugs at a stable dose for the last three months before the designated study visit.

Exclusion Criteria:

* Type 1 diabetic patients
* Patients with a history of hepatic or renal diseases
* Hypertension due to organic diseases
Prevalence of Genital HPV Infection in Males Following Introduction of Universal Male HPV Vaccination

This study will examine how common HPV infection is in teenage males in Australia before and after the introduction of universal school based vaccination of males in Australia.

Males aged 17 to 19 in Australia will be recruited from 2014. Men will undergo sampling from the penis for HPV. The prevalence of HPV infection will be determined in 2014-2015 and compared to the prevalence in 2016-2017.

Eligibility Criteria:
Inclusion Criteria:

* Male
* Aged 17 to 19
* Able to complete study requirements
* Residing in Australia from 12 years of age

Exclusion Criteria:

-Males reporting sex with males in the past 12 months
Electronic Pillbox-enabled SAT Versus DOT for TB Medication Adherence and Treatment Outcomes

To address the multifaceted challenges associated with tuberculosis (TB) in-person directly observed therapy (DOT), the World Health Organization recently recommended countries maximize the use of digital adherence technologies. Sub-Saharan Africa needs to investigate the effectiveness of such technologies in local contexts and proactively contribute to global decisions around patient-centered TB care. This study aims to evaluate the effectiveness of pillbox-enabled self-administered therapy (SAT) compared to standard DOT on adherence to TB medication and treatment outcomes in Ethiopia. It also aims to assess the usability, acceptability, and cost-effectiveness (health-related quality of life and catastrophic costs) of the intervention from the patient and provider perspectives. It is designed as a multicenter, randomized, controlled, open-label, non-inferiority, effectiveness-implementation hybrid, mixed-methods, two-arm trial.


Eligibility Criteria:
Inclusion Criteria:

* Patients with new or previously treated bacteriologically confirmed drug-sensitive pulmonary TB
* Eligible to start the standard 6-month first-line anti-TB medication
* Outpatient
* Men or women age 18 years and above
* Able and willing to provide informed consent

Exclusion Criteria:

* Patients with known drug-resistant TB
* Any condition that causes cognitive impairment such as severe acute illness or injury, developmental retardation, or severe psychiatric illness and thus precludes informed consent or safely participating in the study procedures
* Inpatients
* Concurrent extrapulmonary TB
* Contraindicated medications
* Active liver disease that requires a TB regimen other than HREZ
Relative Bioavailability of BI 10773 and Linagliptin in Healthy Male Volunteers

Study to investigate the relative bioavailability of BI 10773 and of linagliptin after concomitant multiple oral administration of 50 mg BI 10773 tablets and 5 mg linagliptin in comparison to 50 mg BI 10773 and 5 mg linagliptin given alone.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male volunteers according to the following criteria:

  * Based upon a complete medical history and physical examination including vital signs (BP (blood pressure), PR (pulse rate)), 12-lead ECG (electrocardiogram) and clinical laboratory tests
* Age 18 to 50 years (inclusive)
* BMI 18.5 to 29.9 kg/m2 (inclusive)
* Signed and dated written informed consent prior to admission to the study in accordance with GCP (Good Clinical Practice) and the local legislation.

Exclusion Criteria:

* Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance
* Any evidence of a clinically relevant concomitant disease
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Surgery of the gastrointestinal tract (except appendectomy)
* Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
* History of relevant orthostatic hypotension, fainting spells or blackouts
* Chronic or relevant acute infections
* History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
* Intake of drugs with a long half-life (\> 24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial
* Participation in another trial with an investigational drug within two months prior to administration or during the trial
* Smoker (\> 10 cigarettes or \> 3 cigars or \> 3 pipes/day)
* Inability to refrain from smoking on trial days
* Alcohol abuse (more than 30 g/day)
* Drug abuse
* Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
* Excessive physical activities (within one week prior to administration or during the trial)
* Any laboratory value outside the reference range that is of clinical relevance
* Inability to comply with dietary regimen of trial site
Study Evaluating Venlafaxine ER in Recurrent Depression

The purpose of this study is to review the long-term comparative efficacy of venlafaxine ER in achieving and sustaining remission (wellness) in patients with recurrent major depression


Eligibility Criteria:
Inclusion Criteria

* Clinical diagnosis for recurrent major depression

Exclusion Criteria

* The patient has failed on an adequate trial of fluoxetine, venlafaxine or venlafaxine ER during the current episode of major depression or the patient is treatment-resistant
* Known hypersensitivity to venlafaxine or fluoxetine
* History or presence of clinically significant hepatic, cardiovascular or renal disease, or other serious medical disease, including history of seizure disorder
Pre-Approval Access Program for Talquetamab in Relapsed or Refractory Multiple Myeloma

The purpose of this pre-approval access program is to give talquetamab monotherapy (treatment with single drug) to participants with relapsed or refractory multiple myeloma (a type of cancer that begins in plasma cells \[white blood cells that produce antibodies\] which has returned or difficult to treat) who have relapsed on or are refractory to all locally available and clinically appropriate treatment and who are not eligible for a clinical trial.

Talquetamab (JNJ-64407564) is a humanized immunoglobulin G4 proline, alanine, alanine (IgG4PAA) bispecific antibody designed to target G-Protein Coupled Receptor (5DGPRC5D) and cluster of differentiation 3 (CD3). Redirecting T-cells to a tumor surface antigen using bispecific antibody approaches may be an effective means to harness the immune system to destroy cancer cells expressing GPRC5D and create meaningful and long-lasting clinical responses. Talquetamab is supplied as single-dose Investigational Product (IP) vials for subcutaneous administration. Safety assessments will include adverse events, serious adverse events, adverse drug reactions, and special situations which will be reported during the duration of the pre-approval access program.

Eligibility Criteria:
Inclusion Criteria:

* Participant diagnosed with relapsed or refractory multiple, myeloma
* Participant exhausted all commercially approved and clinically appropriate treatment options, and is ineligible for a clinical trial
Polycystic Ovary Syndrome (PCOS) - Effect Of Physical Exercise And Electroacupuncture

Hypothesis:

The overall hypothesis is that women with PCOS, both obese and non-obese, have larger adipocytes, altered metabolism and signs of inflammation in adipose tissue and that these changes are associated with high sympathetic nerve activity, hyperandrogenism hyperinsulinaemia, insulin resistance with progression to type II diabetes and cardiovascular disease (CVD) as well as psychological distress and reduced quality of life. Physical exercise and electro-acupuncture decrease high concentrations of androgens, induce regulare menstrual pattern, inhibits high sympathetic activity and restore the PCOS induced disturbances.

Primary outcome: Changes in androgen concentrations and menstrual pattern

Secondary outcome: changes in sympathetic nerve activity, uterus peristalsis, ovarian morphology, adipose tissue related variables, insulin sensitivity, coagulation factors and health related quality of life and symptoms of anxiety and depression.

Eligibility Criteria:
Inclusion Criteria:

* To get the diagnosis polycystic ovary syndrome (PCOS), ultrasonography should reveal at least 1 ovary with PCO according to the Rotterdam diagnostic criteria as well as one of the following two symptoms:

  1. Anovulation/oligoovulation defined as ≥ 35 days during the last year
  2. Clinical signs of hyperandrogenism (hirsutism, acne)

Exclusion Criteria:

* Cardiovascular disease
* Diabetes mellitus
* Other endocrine disease (congenital adrenal hyperplasia, androgen producing tumour, Cushing's syndrome)
* Estrogen/gestagen treatment during the last 3 months
* Breast-feeding the last 6 months
* Antiandrogen treatment the last 3 months
A Comparison of Electrical Ilioinguinal Nerve Stimulation With Intravesical Irrigation for Bladder Pain Syndrome

The purpose of this study is to determine whether electrical ilioinguinal nerve stimulation (EINS) is more effective than intravesical irrigation (II) in treating bladder pain syndrome.

The purpose of this study is to determine whether electrical ilioinguinal nerve stimulation (EINS) is more effective than intravesical irrigation (II) in treating bladder pain syndrome.

Eligibility Criteria:
Diagnostic Criteria:

1. Complaint of suprapubic pain related to bladder filling, accompanied by other symptoms such as increased daytime and night-time frequency, in the absence of proven urinary infection or other obvious pathology.
2. Negative in urine routine test or urine cultivation.
3. Urinating at least 7 times per day or having some urgency or pain (measured on linear analog scales)

Inclusion Criteria:

1. Providing informed consent to participate in the study;
2. Willing to undergo a cystoscopy under general or regional anesthesia when indicated during the course of the study;
3. Female patients meeting the diagnostic criteria;
4. Age ≥18 years and ≤80 years.
5. Disease course ≥ 6 months

Exclusion Criteria:

1. Bladder capacity of greater than 350 mL on awake cystometry;
2. Absence of an intense urge to void with the bladder is filled to 150 mL of liquid filling medium;
3. The demonstration of phasic involuntary bladder contractions on cystometry using the fill rate just described;
4. Duration of symptoms less than 9 months;
5. Absence of nocturia;
6. Symptoms relieved by antimicrobial agents, urinary antiseptic agents, anticholinergic agents, or antispasmodic agents;
7. A frequency of urination while awake of less than 8 times per day;
8. A diagnosis of bacterial cystitis or prostatitis within a 3-month period;
9. Bladder or ureteral calculi;
10. Active genital herpes;
11. Uterine, cervical, vaginal, or urethral cancer;
12. Urethral diverticulum;
13. Cyclophosphamide or any type of chemical cystitis;
14. Tuberculous cystitis;
15. Radiation cystitis;
16. Benign or malignant bladder tumors;
17. Vaginitis;
18. Age younger than 18 years.